Observacion y Practica de Aferesis

III Encuentro de Inmunohematología y
Medicina Transfusional
Observacion y Practica
de Aferesis
. . . . . . . . .
Proceso de selección de donantes, cuestionario y análisis de
laboratorio a los cuales se somete a los donantes
voluntarios antes de realizar el proceso de aféresis.
Incluye la preparación del equipo de aféresis, parámetros
operativos y control del donante.
Giovanna Figueredo, MD
Fellow – Transfusion Medicine
UT M.D. Anderson Cancer Center
Giovannaf@juno.com
Indice de Contenido
Introducción 5
Procedimientos 6
1.00 DONOR SELECTION
Donor Registration 7
1.11 Donor Confidentiality

1.12 Donor Registration
1.13 Deferral List Checking
Consent Forms 14
1.20 Consent Forms

1.21(S) Directed / Designated Donor Consent Form; Spanish
1.22(S) Consent for Plateletpheresis on Automated Blood Cell Separator; Spanish
1.24(S) Consent for Leukopheresis on Automated Blood Cell Separator; Spanish
Medical History 26
1.31 Obtaining Donor Medical History and Final Donor Selection

1.32 Donor History Questionnaire
1.33 Use of Davis's Drug Guide
Physical Examination 44
1.41 Blood Pressure & Pulse

1.43 Fingerstick
1.44 Copper Sulfate Method for Hemoglobin Determination
1.45 HemoCue® Photometer for Hemoglobin Determination
Donor and Product Safety 56
1.51 Donor Arm Preparation

1.52 Donor Reactions & Preventive Measures
1.52.1 Post Donation Donor Call-Back Care & Report
1.54 Disposal of BioHazard Waste
2
Collection 71
1.61 Routine Venipuncture
Post Donation 75
1.71 Preparation of Donor Registration Log

1.71.1 Donor Deferral Review
1.72 Post Collection Preparation and Transporting
1.73 Monitoring Blood Product Temperature After Collection
3.00 SINGLE DONOR PLATELET COLLECTION
Platelet Donor Selection & Documentation 86
3.11 Donor Selection and Registration

3.13.1 Weighing Product Concentrates & Collecting Product Samples
3.13.2 Aborted Procedures
3.15 Apheresis Worksheet Preparation & Calculations
3.15.1 Apheresis Worksheet
3.16.2 Room Temperature Monitoring
COBE BCT Spectra 110
3.21 COBE Spectra Blood Cell Separator - Dual Needle Operation

3.22 COBE Spectra Blood Cell Separator - Single Needle Operation
3.26 COBE Spectra Emergency Rinseback
3.27 COBE Spectra - Corrective Action to Prevent Citrate Reaction
Fenwal CS3000® PLUS Blood Cell Separator 137
3.31 CS3000® PLUS - Dual Needle Operation

3.32 CS3000® PLUS - with PLT-30 Collection Chamber
3.35 CS3000® PLUS - Gravity Reinfusion of Donor RBCS
3.36 CS3000® PLUS - Blood Cell Separator Quality Control Procedure
Other Equipment 156
3.61 Use & Care of SEBRA Hand-held sealer
4.00 GRANULOCYTE CELL COLLECTION
Donor Selection and Preparation 161
4.11 Leukapheresis Pre, Post, and Donation Procedures

4.12 Preparation of Hetastarch for Use
3
COBE Spectra 170
4.21 Leukapheresis Using the COBE Spectra
Fenwal CS3000 Plus® 182
4.31 Leukapheresis Using the Fenwal Model CS3000 Plus®
10.00 OPERATION POLICIES & PROCEDURES
Operational Policies & Procedures 186
10.21 Management of Hearsay Information about Blood Donors

10.22 Donor Record Maintenance
10.23 Standard Operating Procedures
10.24 Deferral List Maintenance
10.25 Blood Bank Product Receiving
10.25.1 Management of Blood Product Unit Numbers
10.25.2 Blood Product Supply Storage
10.26 Employee Competency Assessment
Apendices 204
A(S) UTMDACC Blood Bank Donor Card (Spanish)

B(S) UTMDACC Blood Bank Donor Information Card (Spanish)
C Blood Assurance Plans
D List of Aspirin, Acetaminophen, and Ibuprofen Containing Medications
E List of Immunizations
F List of Malaria, Chagas, and other High Risk Travel Areas
G Guide to Commonly Used Medications
H Health Conditions -- Quick Deferral Reference
I Prospective Platelet Donor Information
4
Introducción
Este taller práctico y de observación se concentrara en el proceso de recolección de

plaquetas y granulocitos por aféresis. Mostraremos al participante todos los aspectos
relacionados con la selección y cuidados del donante durante el procedimiento, el
establecimiento de los parámetros operativos de los equipos y la utilización del proceso
con la obtención del producto.
Todos los procedimientos contenidos en el material educativo que será entregado a cada
participante forman parte del Manual de Procedimientos del Banco de Sangre del hospital
oncológico M. D. Anderson Cancer Center.
5
PROCEDIMIENTOS
6
DONOR SELECTION
1.11 DONOR CONFIDENTIALITY
PRINCIPLE:
It is the policy of the U.T. M.D. Anderson Cancer Center Blood Bank to
guarantee complete donor confidentiality at all times.
PROCEDURE:
1. All donor interviews are to be conducted in an area that

guarantees adequate visual and verbal privacy.
2. All donor interviews must be conducted in a soft voice to assure

that the conversation is not overheard.
3. All donor records will be maintained in file cabinets and secure

areas with authorized personnel access.
4. File cabinets of donor records will be locked each evening by the

front desk secretary and the keys left in a designated area.
5. Donor information will not be given out over the telephone.
6. All phone conversations with donors will be conducted in

professional confidential manner.
7. All deferral lists must be maintained in areas that are only

available to authorized personnel.
8. No donor records are to be left on the Apheresis room cabinets,

or in any area that might be accessible to public viewing.
9. All confidential donor information in the laboratory information

system will be protected by password so that only authorized
persons have access to the information.
7
DONOR SELECTION
1.12 DONOR REGISTRATION
PRINCIPLE:
The Code of Federal Regulations, Title 21, Part 606.160, requires that legible and indelible (ink) records be kept by the
Blood Bank so that a complete history of the work performed is recorded. Each donor must be clearly and uniquely
identified so that a specific donor can be traced through the entire process. To be able to trace each step, the technician
performing that step must make documentation at the time for each activity that indicates the results and who performed
them.
SUPPLIES NEEDED:
1. Donor Information and Instructions Sheet

2. Donor card
3. Registration Sheet
4. Blood Assurance Plans sheet
5. Consent Form for release to Military Medical Authority
6. Donor Incident Form
PROCEDURE:
1. In order to be as efficient as possible, Mobile Operations

personnel may fill in date, group name (organization's name), and
type of Plan on donor card prior to arriving at drive location.
2. Greet donor. Give donor the information about AIDS (Acquired

Immune Deficiency Syndrome) titled "Donor Information and
Instructions". Instruct the donor to read the entire sheet and
keep to refer to later.
3. Refer any questions about AIDS information to the History

technician or supervisor.
4. Instruct the donor to legibly print, using black ink only, the
following information on the donor card: name, address, phone
numbers, social security number, sex, age, birthdate and driver's
license number, or passport number, or student picture I.D. The
donor must have social security number or passport number and
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picture I.D. to donate. Technician must initial indicating having
seen a picture identification, after ensuring all information on
donor card matches identification.
5. Instruct donor to read, sign, and date the "Donor Release

Statement and Consent" statement on donor card.
1.12b - Donor Registration
6. If applicable, instruct donor to read "Blood Assurance Plans", if

he/she has questions. See Appendix C in Procedure Manual.
7. Circle type of plan selected and instruct donor to complete

beneficiary section.
a. Blood Assurance: List the names of the individuals being

covered, and circle 25% or F&I.
b. Donor Club: Write group name and circle DC.
c. Replacement (Repl) or Directed (DD): List patient's name,

hospital and hospital number (if known), and circle REPL or
DD. These donors are not eligible for F&I Blood Assurance.
d. Gift Donation: Circle Gift and list hospital name.
8. If the donor requests a blood type card, have him/her self-

address an envelope and write his/her own name and social
security number on the blood type card.
9. Check age of donor; it must be from 17 to 75 years. At a high

school drive, if the donor does not a have a student picture ID,
check the roster (birthdate) and yearbook (picture).
NOTE: 75 year olds: If a donor is 75 years of age and has been a

frequent blood donor, contact the TMP for donation approval. If
they have never donated, or not for a long period of time, the
donor should be deferred.
10. At military base, all active or reserve military donors must read
and sign a "Consent Form for Release to Military Medical
Authority". Circle "military" consent on donor card after
obtaining signed form.
11. The donor may answer history questions up to the designated

"Please Stop Here". Read the questions to the donor if the donor
requests or is having trouble reading the questions.
9
12. Check donor card for completion and legibility. Upon completion,
the technician must initial below Question #23.
13. The technician in registration may also perform the following

questions or observations, general appearance, arm inspection,
expected hazardous or strenuous activity post donation, has
donor eaten within four hours of donation, and take temperature,
pulse and blood pressure according to policies, "Obtaining Donor
Medical History" and "Final Donor Selection." At this time, the
technician must initial as an "Examiner" on the Donor Card.
1.12c Donor Registration
14. Each technician performing any donor activity must indicate

which step they performed by initialing that activity. It is
therefore possible that several technicians will have initialed for
various steps.
15. Give donor card, Donor Information and Instructions Sheet and
donor type card to the donor and send him/her to History station.
REFERENCES:
1. Code of Federal Regulations, Title 21, 1997.
2. AABB Standards, 18th Edition, 1997.
3. AABB Technical Manual, 12th Edition, 1996.
10
DONOR SELECTION
1.13 DEFERRAL LIST CHECKING
PRINCIPLE:
To help assure the safety of the blood supply and the donor, the donor
deferral checking process must be completed every time the donor
registers to donate. Every potential donor must have their social
security number and /or an acronym composed of their initials+birth
date checked against all deferral lists to ensure that the donor has not
been previously permanently or temporarily deferred as a blood product
donor. This procedure may be done at any convenient step in the donor
screening process, however, it must be completed prior to the actual
phlebotomy.
For various reasons, even those donors that are deferred for another
reason must have their deferral status checked. If they are actually on
the list, they would need to know not to return to attempt to donate.
Many potential donors state that they did not know they were on a
deferral list. The donor may be able to change their status after
checking with the Blood Bank that deferred them.
SUPPLIES NEEDED:
1. U.T.M.D.A.C.C. Permanent Deferral Lists (Monthly computer print

out and Daily Updates)
2. U.T.M.D.A.C.C. Temporary Deferral List (Daily Update)
3. Gulf Coast Regional Blood Center Permanent Deferral List
(Computer print out)
4. Prospective donor deferral information letter.
5. Donor Card
PROCEDURE:
1. Obtain daily all updated copies of the UTMDACC temporary and

permanent deferral list updates. (See Procedure 113.1 for
directions on obtaining these lists).
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2. Place the daily additions in the notebooks containing the current
UTMDACC and Gulf Coast computer printout lists. All lists are to be
kept in a secure and confidential area.
3. In a confidential method, discard the previous daily update report.
4. Donor must have social security number or passport number in

order to donate. It is not required that they have it with them.
5. Donor must have some valid form of picture I. D. (Driver's license,

passport, employee card, student card, etc.). For younger donors,
you must have some method to assure that the donor is at least 17
years of age. (At some high schools you may have to work with the
chairperson to obtain this information)
1.13b Deferral List Checking
Note: Some donors will NOT be happy to provide their social

security number and identification. However, you should try
to inform them that currently there is no other method to
screen donors to help assure a safe blood supply. They would
not want to receive blood from a donor that was previously
positive for an infectious disease and now their testing is
very weak and appears negative. Assuring their identification
with a picture, prevents someone else from donating and
using their name.
If the donor refuses to provide this information, thank them

very much for their time and interest in donating, but
regulations prohibit you from accepting them.
6. Those donors that are from a foreign country, other than Mexico &
Canada, must have a passport number. That number should be
placed in the driver’s license number box and the country that
issued the passport must be identified. Persons from Mexico and
Canada are able to cross the border without a passport. They
should have a driver’s license number from their country. Be sure
to indicate what type of number it is.
7. Donors without a social security number will be indicated on the

deferral lists with their initials acronym + date of birth.
8. After the donor has completed registration, technician must verify

that the donor card information corresponds with that of the
picture I. D. Do not allow donor to proceed without clarification of
any discrepancies.
12
NOTE: Donors from out of state and foreign countries must
give their permanent address, NOT a locale temporary
address.
9. Donor is given their donor card and donor information sheet and is
directed to the History station or other designated private area.
10. The technician that conducts the interview should greet the donor,
ask them their name and again verify that the name corresponds
to that on the donor card.
11. Conduct donor interview in an area that allows for both visual and
audible privacy.
12. Check donor card for completeness of information.
13. Ask donor if they have read the "Donor Information and
Instructions" sheet.
14. Very carefully scan ALL permanent and temporary deferral lists for
the donor's social security number and/or initial+birth date
acronym.
Note: Donor deferral checking may be done at any stage in the

donor registration or history, prior to fingerstick. If a donor is
found to be on a temporary deferral list, it is desired that they
complete the donor history questionnaire so that any additional
information since they last attempted donation can be acquired.
This will keep the donor from returning sooner than they will
actually be eligible to donate.
1.13c Deferral List Checking
a. Social Security Numbers are listed numerically
b. Passport numbers are no longer listed on the MDA list. All

previously deferred donors without a social security number
can not be located using their initials acronym + Date of
birth..
c. To locate a donor without a social security number:
Use the donor's first and last letter of their last name and the
first letter of their first name to obtain the "coded initials".
Use donor's birth date after the letters.
For example: John S. Doe born on June 14, 1970
13
Becomes: DEJ061470
d. If you find a donor on the MDACC temporary deferral list, you

must also check the Gulf Coast permanent list.
12. If donor is not identified on a lists, circle "NO" in the proper section
of the donor card and sign your name on the "Checked by" space.
There is a separate space for each Blood Bank’s deferral list check.
Both must be marked and signed separately.
SS# on MDA D.L. YES NO Checked By:

____________________
GC D.L. YES NO Checked By:
____________________
13. If donor is located on any deferral list, circle "YES" on the donor
card and sign your name in the "Checked by" space. Notify a
supervisor to explain the permanent or temporary deferral to the
donor.
13. The supervisor will indicate on the deferral notification letter from
the Transfusion Medicine Physician which blood bank deferral list
the donor identification was located and give the letter to the
deferred donor.
 If the donor is located only on the Gulf Coast list then that
box is marked.
 If the donor is located on only the MDA or BOTH Blood bank
lists then the MDA box is marked.
NOTE: The reason to mark MDA when the donor is listed on

BOTH lists is because MDA sends their permanent
deferral list to Gulf Coast. The number is then placed on
their list. Thus, unless the donor was deferred recently,
all MDA permanently deferred donors should be on
BOTH lists.
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CONSENT FORMS
1.20 CONSENT FORMS
PURPOSE:
The required consent of a potential donor of any blood product must be obtained and
documented prior to the donation. Details of the donation procedure must be
provided to the prospective donor, in terms that the donor can understand. It should
include information about potential risks of transmission of infectious diseases to the
recipient and possible reactions to the donation procedure. All donor questions must
be answered before they sign the consent form for that particular procedure.
SUPPLIES:
1. Donor Card, English & Spanish

2. Directed/ Designated Donor Consent Form, English & Spanish
3. Consent for Plateletpheresis on Automated Blood Cell Separator, English &
Spanish
4. Consent Form for Release to Military Medical Authority
5. Consent for Leukapheresis on Automated Blood Cell Separator
PROCEDURE:
1. At the time of donor registration, have the donor read and sign the required
consent form(s) for the potential donation. If the donor has questions at this
time, please provide the information before the donor continues.
2. Consent forms must be provided in a language that the donor can read and
understand. If the donor is not able to read the language that the consent form
is written, attempt to locate another person that is not a Blood Bank employee
and not related to the donor to translate the consent for them. If no one can be
reached to perform the translation, the person can not donate at this time.
2. Military consent forms are to be attached to the donor card and sent with the
unit to Transfusion Medicine. This consent form will be filed with the donor
card.
3. Plateletpheresis consent forms are to be completed once each calendar year for
each donor. The consent forms for plateletpheresis are maintained in the
donor's folder.
4. Directed donor consent forms are maintained in the Blood Bank. They will be
attached to the donor card after it is returned to the Blood Bank. It will be
filed with the donor card. 15
1.20b Consent Forms
5. Leukapheresis consent forms are to be completed for each

series of donations. The consent form is to be maintained in
the donor's folder.
REFERENCES:

16
M. D. ANDERSON CANCER CENTER BLOOD BANK
Consentimiento para el Donante Directo / Designado
Yo, Numero Hospitalario

______________, Nombre del Paciente (Use letra de imprenta)
AUTORIZO a la persona indicada en este documento a ser mí donante

Directo / Designado.
Nombre Donante Directo/Designado

Fecha
Firma del Paciente o Guardián Legal
INFORMACION PARA EL DONANTE DIRECTO / DESIGNADO
Para participar en el programa de donación de sangre directa/designada

usted debe estar informado de las siguientes condiciones concernientes a su
donación:
1. Cualquier tipo de pago por donación de sangre o plaquetas, de

cualquier forma, automáticamente lo descalificara como dador en
nuestro programa.
2. El dador directo designado tiene que cumplir con todos nuestros

requisitos, para la donación de sangre.
3. Cada vez que Ud. done como dador directo/designado, al paciente se le

cobrara $15.00 por gastos administrativos. Por esta razón, Ud. deberá
tener el permiso del paciente o guardián para donar como dador
directo/designado.
4. Si su donación de sangre directa/designada es compatible con la sangre

del paciente, la sangre será conservada para el paciente hasta la fecha
de expiración de la unidad, generalmente 42 días.
5. Si la donación de sangre directa/designada es aceptada para

transfusión, la sangre estará disponible (en la mayoría de los casos) a
la mañana siguiente de la donación.
17
6. La sangre será guardada para el paciente hasta la fecha de expiración
(42 días). Si no se usa antes de este periodo de tiempo, la sangre será
descartada y se le cobrara al paciente por el procesamiento de la
unidad de sangre.
7. No se garantiza que la donación directa/designada este disponible,
dada la posibilidad de errores o accidentes durante el procesamiento
de la unidad de sangre. U.T.M.D. Anderson Cancer Center no se
responsabiliza por problemas que se encuentren durante las pruebas
de compatibilidad de la unidad de sangre directa/designada con la
sangre del paciente.
8. Toda sangre donada será analizada como lo requiere la FDA y American

Association of Blood Banks. U.T.M.D. Anderson Cancer Center no
garantiza ni asegura de ninguna manera que la transfusión de sangre
de dador directo/designado no pudiera causar enfermedades
transmisibles a través de la sangre.
9. El Servicio de Transfusiones Sanguíneas no dará ningún tipo de

información concerniente a ningún dador en particular o información
sobre la unidad sanguínea, que implique violar la confidencialidad del
dador. La información a cerca del dador y su donación es
absolutamente confidencial.
10. Solamente el medico del paciente puede ordenar la transfusión de

sangre o componentes sanguíneos.
Por medio de mi firma, yo aseguro que he leído la información mencionada en

este circular de información con respecto al donante directo/designado, y
acepto tales condiciones como están descritas en este documento.
Firma del Donante Directo/Designado Fecha
Firma del Testigo Relación con el

Paciente
18
Consentimiento para Plaquetoféresis en el Separador Automático de

Células Sanguíneas
Plaquetoféresis (también conocido como aféresis) es un procedimiento que consiste en la separación de

algunas de las plaquetas de la sangre para obtener un componente llamado "concentrado de plaquetas".
Las plaquetas son necesarias en el cuerpo porque forman parte en el proceso de coagulación. Si el nivel
de plaquetas de un paciente es críticamente bajo, hay un alto riesgo de sangrado o hemorragias, y la
muerte puede ocurrir como resultado de esta hemorragia. La única fuente de plaquetas para
transfusión son donadores sanos. Si yo consiento a este procedimiento, yo entiendo
que la cantidad de plaquetas removidas por el procedimiento automático de
plaquetoféresis, me dejara con un nivel suficiente y seguro de plaquetas en
mi propio cuerpo.
Yo entiendo que el que yo done o no depende solamente de mi decisión.

También entiendo que yo puedo parar o discontinuar el procedimiento en
cualquier momento. Sin embargo, para colectar suficientes plaquetas para
transfundir al paciente, entiendo que el procedimiento no debe ser
discontinuado tempranamente.
Como solo hay un método disponible para plaquetoféresis en este Banco de

Sangre, la única alternativa a este procedimiento es el rechazar el
consentimiento.
El procedimiento para obtener plaquetas usa un separador de células

sanguíneas, que es una máquina diseñada para colectar diferentes
componentes de la sangre. Mi sangre es drenada asépticamente a través de
una aguja en mi brazo, hacia un recipiente estéril en la centrifuga de la
máquina. Una solución anticoagulante estéril (Acido-Citrico-Dextrosa, formula
A) es mezclada con mi sangre para prevenir coagulación. En el caso que
plasma sea colectado junto con las plaquetas, un poco de solución salina
fisiológica estéril puede ser mezclada con mi sangre durante el
procedimiento, para mantener la línea intravenosa abierta y para reemplazar
la perdida de volumen sanguíneo en forma de plasma. Como solo plaquetas,
con o sin plasma, serán colectadas, el resto de los glóbulos rojos y plasma
serán regresados a mí. Este proceso dura aproximadamente 1-1/2 a 2-1/2
horas, y la(s) aguja(s) permanecen en mi(s) brazo(s) durante este tiempo.
Puede que yo note una sensación transitoria de adormecimiento u hormiguéo

alrededor de mi boca o en otras áreas cuando la sangre o plasma procesados
son regresados a mi cuerpo. Este efecto colateral no es peligroso y es
causado por el anticoagulante, el cual fue usado para prevenir la coagulación
de la sangre colectada. Yo entiendo que otros efectos colaterales posibles de
este procedimiento son desmayos, nausea, o sensación de frío debido al
retorno de la sangre mas fría que la temperatura del cuerpo, y otras
ocurrencias menos comunes como sobredilución de mi sangre, extracción de
demasiada sangre y posible hemólisis o coagulación de mi sangre debido a un
19
fallo mecánico. También, un pequeño número de glóbulos blancos llamados
linfocitos es removido durante este procedimiento, lo cual puede producir una
disminución transitoria de estas células en mi sangre. Todavía no se sabe
cual es el efecto a largo plazo de la pequeña reducción de estas células en
donantes normales y sanos.
Sí mi sangre ya procesada esta muy hemolizada para regresármela, o

insegura para regresarla por cualquier otra razón, un medico responsable de
la Sala de Donantes deberá ser consultado para determinar si es seguro para
mí él marcharme sin que me hayan regresado esa parte de mi sangre.
Si yo me siento enfermo durante el procedimiento, un medico será notificado

inmediatamente para ayudar a prevenir cualquier complicación futura
causada por el procedimiento.
Si la máquina sufre una falla, yo entiendo que se hará el mayor esfuerzo

posible para regresarme todos mis glóbulos rojos, siempre en una forma
segura. Como no hay mas del 15% del volumen total de mi sangre fuera de mi
cuerpo en un momento dado del procedimiento, en caso de que sea imposible
regresar la sangre colectada, yo entiendo que esto todavía me dejara con una
cantidad suficiente y segura de glóbulos rojos, glóbulos blancos y plaquetas
en mi cuerpo. Si los glóbulos rojos no pueden ser regresados, yo entiendo
que no me será permitido donar otra vez hasta que mi cuerpo haya
reemplazado suficientemente las células perdidas.
Yo entiendo que este consentimiento es requerido de todas las personas

participando en este procedimiento por primera vez.
Se me ha permitido hacer preguntas concernientes al método con el que se

realiza este procedimiento, los posibles riesgos o efectos colaterales, o
cualquier tópico pertinente a este procedimiento.
Si yo no entiendo esta información, el procedimiento con sus riesgos y efectos

colaterales se me explicara verbalmente de una manera en que yo pueda
entenderlo.
El beneficio esperado para el paciente ha sido descrito con anterioridad, pero

se me ha permitido hacer preguntas concernientes a esto, y se me ha
explicado satisfactoriamente en caso que yo no lo haya entendido por escrito.
Yo entiendo que puedo hablar con un médico con respecto a este

procedimiento, si yo lo deseo.
Yo entiendo que puedo decidir no participar en este procedimiento en

cualquier momento antes de empezar, o durante el procedimiento.
Yo entiendo que este es el único procedimiento para plaquetoféresis que se

realiza en este Banco de Sangre, y que la única alternativa a la participación en
el procedimiento de plaquetoféresis es no dar mi consentimiento.
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Yo voluntariamente estoy de acuerdo en participar como donador en el
procedimiento automático de plaquetoféresis tal como se ha descrito
anteriormente en este circular informativo.
Firma del donante Fecha Firma de Persona

Autorizada
y relación con el donador
Técnico de Apheresis Fecha
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CONSENTIMIENTO INFORMADO DEL DONANTE
Administración de Factor Estimulante de Colonias de

Granulocitos (G-Csf) y Leucoféresis en un Separador
Automático de Células Sanguíneas
Nombre del Donante (Letra de Imprenta)
Usted tiene el derecho de saber acerca del procedimiento que está a punto
de comenzar, para darle la oportunidad de tomar la decisión de hacerlo o no,
después de conocer los riesgos o peligros involucrados en el mismo. Esta
información no tiene el propósito de asustarlo o alarmarlo; es solo un
esfuerzo para informarle mejor, de manera tal que usted dé su
consentimiento con toda la información necesaria para participar en este
procedimiento. Este consentimiento informado no reemplaza otros
consentimientos que Ud. haya firmado anteriormente.
PROPOSITO DEL PROCEDIMIENTO
Este es un procedimiento que recoge glóbulos blancos de donantes

voluntarios normales estimulados por G-CSF para transfundirlos a pacientes
con infecciones debidas a bajos niveles de glóbulos blancos.
DESCRIPCION DEL PROCEDIMIENTO
Familiares u otros individuos son considerados candidatos apropiados para

donar componentes sanguíneos, y quienes llenen los requisitos estipulados
por la FDA para donar componentes sanguíneos son elegibles para tomar
parte en este procedimiento.
Los glóbulos blancos viven probablemente menos de un día en la sangre.

Para asegurar la mejor supervivencia posible de los glóbulos blancos
transfundidos al receptor (paciente), es importante hacer una prueba
cruzada (de compatibilidad) entre el donante y el receptor. Es también
importante recolectar un gran numero de glóbulos blancos del donante para
proporcionarle al receptor una transfusión efectiva. La única fuente para
obtener concentrado de glóbulos blancos es un donante saludable.
22
Para estimular un mayor número de glóbulos blancos, los donantes recibirán
G-CSF, un “factor de crecimiento” que está normalmente en el cuerpo
humano normal en bajas concentraciones, y que ahora es producido por la
industria farmacéutica. G-CSF es aplicado a través de una inyección
subcutánea en la piel del brazo el día anterior a cada donación programada
de glóbulos blancos. El número de glóbulos blancos en la sangre del
donante será determinado antes de cada recolección, y después de la ultima
donación. La dosis de G-CSF dada puede ser ajustada dependiendo del peso
del donante. Los donantes pueden recibir G-CSF para un total de 4-5 dosis.
De 12 a 14 horas después de recibir G-CSF, los glóbulos blancos serán
recolectados de la sangre del donante.
La colección de glóbulos blancos se realiza a través de un proceso de aféresis

llamado leucoféresis, el cual es realizado por una máquina llamada separador
celular. Esta es una máquina especial diseñada para la colección de
diferentes componentes sanguíneos. La sangre es extraída asépticamente a
través de una aguja colocada en uno de los brazos hacia un contenedor
estéril dentro de la centrífuga, ésta remueve glóbulos blancos y algo de
plasma, plaquetas y glóbulos rojos. Durante la extracción de la sangre una
solución estéril de almidón y anticoagulante es mezclada con la sangre para
prevenir que la sangre se coagule. El componente de almidón (6%
Hetastarch) de esta solución permite que los glóbulos rojos sean separados
del concentrado de glóbulos blancos y permite que los glóbulos rojos sean
retornados al donante.
Una solución salina fisiológica estéril pasará a través de las tubuladuras que
utiliza el procesador celular hacia uno de los brazos, mientras la sangre está
siendo procesada. Esta solución salina mantiene abierta la línea venosa.
Después que los glóbulos blancos han sido removidos de esta porción de la
sangre, los glóbulos rojos remanentes son retornados a través de otra aguja en
el otro brazo. Este proceso continua aproximadamente por 2 1\2 - 3 horas,
durante las cuales las agujas permanecen inoculadas en ambos brazos.
POSIBLES RIESGOS, EFECTOS COLATERALES, E INCONVENIENTES PARA LOS

DONANTES
Usted puede notar una sensación temporal de hormigueo y entumecimiento

alrededor de la boca o en otras áreas a medida que el plasma o la sangre
procesada regresa al cuerpo; este efecto colateral no es peligroso y es
causado por el anticoagulante, el cual se une al calcio para prevenir la
coagulación de la sangre colectada. Otros síntomas asociados con un bajo
nivel de calcio pueden ser náuseas, calambres musculares, y sensación de
opresión en el pecho. Si es necesario, la reposición con calcio oral será
administrada durante el procedimiento.
El día después del procedimiento usted podrá notar un aumento de peso

temporal debido a la retención de líquidos y sal. Esto es causado por la
solución de almidón, y desaparecerá a medida que el almidón sea removido y
excretado del cuerpo.
23
El almidón no es antigénico; sin embargo, reacciones alérgicas o de
sensibilidad se han comunicado. Si tales reacciones ocurren, son
rápidamente controladas por supresión de la droga, y si fuera necesario se
administrará un agente antihistamínico.
Otras posibles reacciones adversas al almidón han sido comunicadas, tales

como: vómitos, leve elevación de la temperatura, escalofríos, comezón,
agrandamiento de las glándulas submaxilares (debajo de la mandíbula) y
parótida (cerca del oído), síntomas parecidos a una leve influenza, dolor de
cabeza, dolor muscular, edema periférico (retención superficial de líquidos)
en las extremidades inferiores, y reacciones anafilácticas que consisten en
edema periorbitario (retención de agua alrededor de la órbita del ojo),
urticaria (un tipo de rash), y jadeo.
Se ha observado Disminución significativa en el recuento plaquetario y en los

niveles de hemoglobina en donantes en los que se realizaron repetidos
procedimientos de leucoféresis, debido al efecto expansor del almidón sobre
el volumen sanguíneo. Los niveles de hemoglobina usualmente regresan a lo
normal 24 horas después del procedimiento.
También pueden presentarse síntomas tales como fatiga y reacciones

alérgicas (estornudos, jadeos parecidos los producidos por el asma, comezón,
etc. ) pueden ocurrir, pero son muy raros. Este procedimiento puede
involucrar riesgos indeseables para el participante.
Todos los separadores de células sanguíneas tienen el riesgo potencial de

destrucción de glóbulos rojos por falla mecánica o anticoagulación
inadecuada, y esto podría resultar en la pérdida de hasta una unidad de
sangre entera. Si la sangre procesada está demasiado hemolizada, o por
cualquier otra razón es insegura para devolverla al donante, el médico
responsable de la Sala de Donantes será consultado para determinar si para
el donante es seguro abandonar la sala sin haberle reinfundido esta parte de
su sangre.
Otros posibles efectos colaterales del procedimiento son debilidad, náuseas,

sensación de frío debido al retorno al cuerpo de sangre más fría que la
temperatura normal del mismo. Otros efectos menos comunes son: exceso
de dilución de la sangre, extracción de demasiada sangre, hemólisis, o
problemas de coagulación de la sangre debido a mal funcionamiento de la
máquina.
La administración de G-CSF puede representar riesgos indeseables para el

feto; por lo tanto si los participantes son sexualmente activos deben
practicar métodos adecuados de anticoncepción durante el período que
comprenda la realización de los procedimientos. Para prevenir daño
potencial hacia los lactantes, las mujeres participantes deben abstenerse de
dar leche materna (amamantar) durante la participación en este
procedimiento.
Los efectos colaterales asociados con G-CSF pueden incluir dolor en los
huesos, dolor en el sitio de la inyección, agrandamiento del bazo, dolor de
cabeza, dolor de articulaciones, o fiebre.
24
PROCEDIMIENTOS O TRATAMIENTOS ALTERNATIVOS
Debido a que hay sólo un método disponible para leucoféresis en este Banco de
Sangre, la única alternativa a este procedimiento es negarse a firmar el
consentimiento y no participar en este proceso.
ENTENDIMIENTO DEL DONANTE
Yo entiendo que si yo noto cualquier síntoma después de abandonar la sala de

donantes, debo notificar al médico encargado de la Sala de Donación para su
evaluación.
Si yo llegara a enfermarme durante el procedimiento, un médico será consultado

inmediatamente para ayudar a prevenir cualquier complicación posterior causada por
el mismo. Si la máquina presentara cualquier falla, yo entiendo que se realizaran todos
los esfuerzos para retornarme todos los glóbulos rojos, si se considera seguro el
hacerlo. Si resultara imposible el regresar la sangre recolectada, yo entiendo que esto
me dejará con cantidades seguras de glóbulos rojos, glóbulos blancos y plaquetas en
mi cuerpo. Si mis glóbulos rojos no pueden ser regresados, yo entiendo que no podré
donar otra vez hasta que mi cuerpo haya reemplazado las células perdidas
suficientemente.
Entiendo que si yo consiento este procedimiento, la cantidad de glóbulos blancos

extraída, me dejará con un nivel seguro de glóbulos blancos en el cuerpo.
Entiendo que es enteramente mi decisión el que yo done o no. Suspender el

procedimiento tempranamente puede significar que la cantidad de glóbulos blancos no
sea suficiente para producir una respuesta benéfica en el receptor, sin embargo, yo
entiendo que puedo detener el procedimiento en cualquier momento.
Yo entiendo que el consentimiento informado es requerido por todas las personas

participantes en este procedimiento. Yo he podido hacer todas las preguntas que he
deseado acerca del método usado para la realización de este procedimiento, los
posibles riesgos o efectos colaterales del mismo, o cualquier otro aspecto concerniente
a este procedimiento. También entiendo que el médico estará dispuesto a responder
a cualquiera de mis inquietudes o preguntas.
Si yo no entendiera el lenguaje escrito anteriormente, se me explicará verbalmente y

de una manera en que yo pueda entender, todos los riesgos y efectos colaterales de
este procedimiento.
El beneficio esperado hacia el paciente ha sido escrito y explicado anteriormente, pero

se me ha permitido hacer mas preguntas acerca de este beneficio, y el que se me
explique a mi entera satisfacción, si acaso no entiendo la manera en el que esta
escrito.
Yo entiendo que el esquema de colección de glóbulos blancos de cada

donante será determinado por el médico de Medicina Transfusional y el
médico del paciente.
25
Yo autorizo al Doctor _______________________________________ y a sus
colaboradores designados a llevar acabo el procedimiento.
Yo entiendo que puedo consultar con un doctor acerca de este procedimiento,

si ese es mi deseo. Se me ha explicado y he entendido que mi participación
en este procedimiento es voluntaria. Yo puedo decidir no
participar o cancelar mi consentimiento y discontinuar mi participación en
cualquier momento.
Además, yo entiendo que el doctor puede discontinuar el procedimiento si,

en su opinión, el procedimiento o tratamiento no ofrece al paciente
suficiente o ningún futuro beneficio, o si la disponibilidad del medicamento
cesa o se agota, o por otras razones medicas relacionadas con el donante que
prevean la continuación de este procedimiento.
Se me ha asegurado que se mantendrá confidencialidad, excepto cuando

inspectores de la Administración de Drogas y Alimentos (FDA) requieran
revisar mis archivos cuando lo consideren apropiado y necesario. Mi nombre
no será revelado en ningún reporte o publicación que resulte de este
procedimiento, a menos que yo exprese consentimiento para ello.
Se me ha informado de que si yo llego a sufrir alguna lesión como resultado

de mi participación en esta actividad, cuidados médicos razonables estarán
disponibles para mi tratamiento en esta institución. De cualquier manera, yo
entiendo que no debo esperar de esta institución, el recibir ningún tipo de
crédito o compensación por gastos, o cualquier compensación financiera por
dicha lesión.
Yo podré discutir preguntas o problemas durante o después de este

procedimiento con el Doctor Benjamin Lichtiger al teléfono 713) 792-2644.
CONSENTIMIENTO:
Yo voluntariamente consiento el participar como donador en el proceso de leucoféresis

descrito anteriormente, y he recibido una copia de la forma de consentimiento.
___________________________________________________________ ___________________
Firma del Donante
Fecha
Firma del Testigo
26
I have discussed this procedure with the participant and/or his or her
authorized representative, using a language which is understandable and
appropriate. I believe that I have fully informed this participant of the
nature of this procedure and its possible benefits and risks, and I believe
that the participant understood this explanation.
__________________________________________________________ __________________
Transfusion Medicine Physician Date
27
DONOR SELECTION
1.31 OBTAINING DONOR MEDICAL HISTORY AND FINAL DONOR

SELECTION
PRINCIPLE:
Donor selection is based on a limited physical and medical history that

contributes to the safety of the donor and recipient. This is done under
the direction of the Transfusion Medicine Physician (TMP). The
phlebotomist must ensure that all medical criteria are met and that
there is no reason to defer a prospective donor.
SUPPLIES NEEDED:
1. Donor card
2. Donor information and instruction sheet
3. Davis' Drug Guide
4. Procedure Manual
5. U.T.M.D.A.C.C. (MDA) Permanent Deferral List (Computer Printout)
6. U.T.M.D.A.C.C. (MDA) Permanent Deferral List (Daily Additions)
7. U.T.M.D.A.C.C. (MDA) Temporary Deferral List (Daily Additions)
8. Gulf Coast Regional Blood Center (Gulf Coast) Deferral Lists
9. Deferred Information Letter
10. Consent Form for release to Military Medical Authority
11. TMP on call list
12. Watch or clock with second hand
PROCEDURE:
1. Perform the interview and donor examination in a manner that

assures privacy, relieves apprehensions, and allows time for
necessary explanation. The donor must donate voluntarily.
2. Greet donor, ask his/her name and verify with name on donor card.
Review questions and answers of first section on donor card for
completeness and any necessary clarification.
3. Carefully check both Gulf Coast's and MDA's Permanent Deferral

Lists and MDA's daily permanent and temporary additions for the
donor's social security number.
a. If not on the list, circle "NO" on donor card by each list

checked and sign your name on the "checked by" line.
28
b. If on the list, defer the donor, circle "YES" by each list that
the donor is indicated, and sign your name. Notify supervisor
and give the donor a deferred information letter.
4. Ask donor the questions indicated on donor card to be asked

by staff member and mark responses. See Procedure, "Donor
History Questionnaire".
5. Review questions with the donor and consult with the supervisor
or TMP on all deferrals.
a. If donor indicates on one question an answer that would

cause him/her to be deferred temporarily or permanently,
continue to complete all questions with the donor.
b. On any question that would place the donor on temporary

deferral, acquire the dates of pertinent information.
c. Record explanations and deferrals with the question number

referenced in the "comments" section. Record the time and
sign your name. If the TMP defers the donor, write reason,
TMP's name, time and your name as the "screener".
d. Do not perform vital signs or hemoglobin testing on a donor

that does not pass the questionnaire screening process.
e. If donor has ALT letter removing them from deferral list,

please note on donor card as "ALT Letter."
f. Deferred donor cards are logged on a donor registration form

as deferrals and returned to Blood Bank for review.
6. Refer to the appendices in procedure manual for additional

information:
Appendix A: Donor Card

Appendix B: Donor Information
Appendix C: Blood Assurance Plans
Appendix D: Aspirin-Containing Medications
Appendix E: Immunizations
Appendix F: Malaria Areas
Appendix G: Guide to Commonly Used Medications
Appendix H: Health Conditions -- Quick Reference Guide
7. Page the TMP to discuss any question not clearly resolved by

procedure. Record any change to the selection guidelines or any
29
special directives on the comment area with the TMP's name, the
time, and your initials.
STEPS 8-15 MAY ALSO BE PERFORMED DURING DONOR REGISTRATION.
Note: Different staff members may by performing various parts of

the following steps. Thus, each person performing a step, must
initial that step in the designated space to the right of the result. If
one person performs all steps, a line may be drawn through all the
spaces and one initial applied.
8. Donated Before? YES NO
MDA Other When?

_________________
a. Circle YES or NO. Either is acceptable.
Note: First time donors need a little more information and

attention.
b. If they answer “Yes”, then ask if it was with M. D. Anderson

(circle “MDA”) or at another blood bank (circle “Other). Ask if
they know approximately when it was. You may write “last
year, last month, a couple of years ago”.
Note: If it was whole blood it must be at least 56 days

ago before they can donate whole blood again.
9. General Appearance (Looking healthy, not intoxicated)
a. Circle OK or NOT OK depending on your observation of the

donor.
b. Observe donor's general appearance; donor should appear to

be in good health, alert, and free from respiratory distress.
c. Donor should appear mentally stable, free from the influence

of drugs or alcohol, not excessively nervous.
d. Temporary defer any donor that does not meet these criteria.
Thoroughly document your observation.
10. Arm Inspection (Both) No lesion @ site. No needle tracks.
30
a. Examine both arms for signs of narcotic habituation such as
needle puncture marks and/or sclerotic veins. Venipuncture
site must be free of lesion.
b. If you observe any suspicious signs, contact a supervisor or

TMP. Make careful documentation on the donor card and
defer as instructed.
11. Hazardous/Strenuous Activity Expected hazardous activity post

donation is not a cause for deferral in most cases. Refer any
questionable cases to the TMP. If the donor will be working in
areas that any slight post-donation light-headedness would be
hazardous, such as working on tall building construction or piloting
an airplane, they should not donate at this time.
12. Eaten within 4 hours?
a. It is recommended, but not required, that all donors have

eaten a meal within the four hours prior to donation.
b. If the donor has not eaten, ask them to have some juice and
cookies prior to their donation. Donors, especially platelet
donors, should not have Grape juice BEFORE donating.
13. Weight ( 110 lbs.):
a.  110 lbs Acceptable
b. < 110 lbs Not Acceptable. Note: On some occasions the TMP
may approve the collection of a donor that weighs
< 110 lbs. When approval is received,
documentation must be made and TMP signature
acquired.
Platelet donors: 100 lbs or greater is acceptable.
14. Temperature (< 99.6F):
The oral temperature of the donor must not exceed 99.5F

(37.5C), or the donor must be deferred. However, using the
Tempa-DOT, 99.6F is acceptable. See Procedure "3MTempa-DOT
for Temperature Determination". Tempa-DOT must remain under
tongue a minimum of 1 minute. After removing Tempa-DOT, wait
approximately 10 seconds for dots to lock in.
15. Pulse (50-100/min):
31
The pulse should be from 50 up to 100 beats per minute and
should have even spaces between beats. Count for at least 30
seconds and for one minute if irregular or if 50 or less
beats/minute. If the prospective donor is an athlete with high
exercise tolerance, a lower pulse rate may be accepted only if
approved by the TMP. Consult TMP for donors with irregular pulse.
(See procedure #1.41)
16. Blood Pressure (90-180/50-100 mm Hg):
The systolic blood pressure (first heart sound) shall be between 90

and 180 mm of mercury, and the diastolic blood pressure (last
fading heart sound) shall be between 50-100 mm of mercury.
Prospective donors with diastolic blood pressure readings below
50 or above 100 mm mercury, may be accepted only if approved by
the TMP. Use the correct size of blood pressure cuff to get the
correct reading. (See Procedure #1.41)
17. Hemoglobin HGB ( 12.5 g%):
a. The hemoglobin value must not be less than 12.5 g%.
b. Perform the copper sulfate screening test as described in

procedure, "Copper Sulfate Method for Hemoglobin
Determination".
c. If the donor is not acceptable by Copper Sulfate Method,

perform hemoglobin as described in procedure "Hemocue
Photometer for Hemoglobin Determination."
18. Review all sections of the donor card. All questions must be
completed. Mark card "YES or NO" in appropriate section to
ACCEPT DONOR and sign your name as examiner.
19. If donor is accepted, select a blood bag, record bag lot number and
bag lot expiration date on donor card.
20. Assign unique unit number. Place one bar-coded number over the
star on blood type card and place card in envelope.
21. Write date drawn on blood bag and satellite bag(s) labels. Write
"M" for male or "F" for female on the plasma bag. Record "ASA" on
primary blood bag if donor has taken aspirin.
22. Give donor the blood bag and donor card and send him/her to
phlebotomy. Do not assign unit number until donor is ready to
proceed directly to phlebotomy.
32
REFERENCES:

33
DONOR SELECTION
1.32 DONOR HISTORY QUESTIONNAIRE
PRINCIPLE:
Donor selection is based on a limited physical and medical history that

contributes to the safety of both the donor and recipient of the
product. This is done under the direction of the Transfusion Medicine
Physician (TMP). The questions and acceptable responses are
developed from guidelines established by the American Association of
Blood Banks standards and the regulations and recommendations of
the Food and Drug Administration (FDA).
SUPPLIES NEEDED:
1. Donor Card ( English & Spanish versions)

2. Donor Information and Instruction Sheet ( English & Spanish
versions)
3. Davis' Drug Guide
4. Procedure Manual
Appendix D: Aspirin Containing Medications
Appendix E: Immunizations
Appendix F: Malarial Areas
Appendix G: Guide to Commonly Used Medications
Appendix H: Health Conditions -- Quick Reference
5. TMP On-Call List
PROCEDURE:
A. After the potential donor has completed registration, had their identification verified, and had all deferral lists
checked for deferral status, they are instructed to carefully read and answer "YES" or "NO" to questions #1
through #23 and then stop.
B. Donors must be provided a confidential area to answer all of the

questionnaire. All donor interviews must be conducted in an area
that allows both visual and audible privacy that assures
confidentiality.
C. When a potential donor responds to a question that is cause for

deferral, continue until all questions have been completed. (You
may temporarily defer a donor for one question, when a further
34
question would cause them to be deferred for a longer period of
time, or even permanently.)
D. All unacceptable responses are to be documented and

clarification made in the "COMMENTS" area after question #47.
The technician that asks the donor questions signs as the
"screener".
E. Any donor that give a response to an AIDS High Risk question

that results in the donor not being eligible to donor, should be
offered printed material pertaining to AIDS high risk activity.
QUESTIONS:
1. Have you ever donated, or attempted to donate blood using a

different (or another) name here or anywhere else?
"NO" = Acceptable
"YES" = Indicate all previous names for which they
have donated blood. Indicate if they were at MD
Anderson.
2. In the past 8 weeks, have you given blood, plasma, or platelets

here or anywhere
else?
"NO" = Acceptable
"YES" = Potential Whole Blood Donor:
If they Donated Whole Blood in past 8 weeks -

Defer for 8 weeks (56 days) from last donation
date.
If they Donated Platelets - Defer for 48 hours

from last donation date.
For qualifying circumstances that are evaluated
on an individual donation basis, documentation
must be made by the TMP.
= Potential Apheresis Platelet Donor:
If they donated Whole Blood in past 8 weeks or

donated platelets and it was not possible to
return donor's red blood cells:
= Donor must wait at least 72 hours and meet

all criteria for donation.
35
3. Have you for any reason been deferred or refused as a blood
donor or told not to donate blood?
"NO" = Acceptable
"YES" = Document all reasons. If reason(s) can be
evaluated based on the approved donor criteria,
accept or defer as indicated. Refer all other
questions to the TMP for determination of
suitability.
4. Are you feeling well and healthy today?
"YES" = Acceptable
"NO" = Record reason, defer as appropriate for the
condition (Refer to other donor history questions,
Appendix H, etc.
5. In the past 12 months have you been under a doctor's care or had
a major illness or surgery?
"NO" = Acceptable
"YES" = Under Doctor's Care - Record all information.
If reason is detailed in criteria already indicated
in this policy, accept or defer accordingly. For
reasons not already detailed, contact TMP to
determine suitability for donation.
Major Illness – Refer to Appendix H, other donor

history card questions, or contact TMP for
evaluation.
NOTE: MAJOR SURGERY usually refers to open and deep

surgical procedures. They involve incision with a
scalpel and direct contact of the surgeon with the
patients’ body cavities, including the skull, chest,
abdomen and pelvis. This includes all spinal
surgery and cosmetic procedures involving
liposuction or breast augmentation/ reduction.
Temporary Deferral for 12 months from date of

surgery.
If necessary, contact TMP for necessary

clarification of any donor deferred for this reason.
36
Minor Surgery - Defer until the healing is
complete, no longer using antibiotics, pain killers,
etc., donor is feeling well
NOTE: Appendix I (Surgical Procedures – Quick

Reference Guide) may provide assistance for
some common surgical procedures.
6. Have you ever had chest pain, heart disease, recent or severe
respiratory disease?
"NO" = Acceptable
"YES" = Lung disease, emphysema = Donor must be
free of acute respiratory distress.
Stroke, active heart disease, past rheumatic

heart disease or rheumatic fever (that caused
known residual damage) = Permanent donor
deferral.
= Contact TMP to disqualify any donor as a

permanent deferral. Make documentation of all
calls to the TMP.
7. Have you ever had cancer, a blood disease, or bleeding problem?
"NO" = Acceptable
"YES" = Cancer - History of Basal Cell Carcinoma of
the skin - Acceptable. Squamous Cell Carcinoma
of the uterine cervix in situ - Acceptable.
Skin Cancers such as Melanoma, Kaposi's

Sarcoma, or Squamous Cell Carcinoma -
Permanent Donor Deferral
All other forms of Cancer, including leukemia and

lymphoma = Permanent Donor Deferral.
Blood Diseases - Consult TMP; record and defer as

indicated.
Abnormal Bleeding - Donors who bleed for a long
time when injured or have a tooth pulled, or who
have a coagulation factor deficiency must be
evaluated by the TMP. Record and defer as
indicated.
37
Hemophilia or related clotting disorder =
Permanent Donor Deferral.
8. Have you ever had yellow jaundice, liver disease, viral hepatitis,
or a positive test for hepatitis?
"NO" = Acceptable
"YES" = Hepatitis - Permanent Donor Deferral if had
viral hepatitis or donated the only unit of blood or
blood component transfused to a patient who had
transfusion-associated hepatitis within six
months.
Yellow Jaundice - At birth/newborn is acceptable.

If after infancy, Permanently Defer. If you need
clarification, contact TMP.
Liver Disease - Acute or chronic liver disease,

cirrhosis, and active liver disease - Permanent
Donor Deferral.
Positive Test for Hepatitis - Permanent Donor

Deferral.
9. Have you ever had malaria, Chagas’ disease, or Babesiosis?
"NO" = Acceptable
"YES" = Malaria - Temporary donor deferral for 3
years after becoming asymptomatic.
Chagas' disease - Permanent Donor Deferral.
Babesiosis - Permanent Donor Deferral.
10. Have you ever taken etretinate (Tegison®) for psoriasis?
"NO" = Acceptable
"YES" = Psoriasis treated with Tegison® = Permanent
donor deferral.
11. In the past 3 days have you taken piroxicam (Feldane®), aspirin
or anything that has aspirin in it?
"NO" = Acceptable
"YES" = Whole Blood: Acceptable. Mark bag label
with "ASA"
= Platelets: Not Acceptable. Defer for 72 hours
from last medication.
38
12. In the past month have you taken isotretinoin ( Accutane®), or
finasteride (Proscar® or Propecia®)?
"NO" = Acceptable
"YES" = Accutane® = Defer for 4 weeks past
last dose. Generic name is
isotretinoin. Record last date.
Proscar® = Defer for 4 weeks past last dose.

Generic name is finasteride.
Record last date.
Procepia®= Defer for 4 weeks past last dose.

Generic name is finasteride, same
as Proscar®. This is a treatment
for hair-loss in men.
13. In the past 4 weeks, have you taken any pills or medications?
"NO" = Acceptable
"YES" = Refer to Davis’ Drug Guide (See “Use of
Davis’ Drug Guide” Procedure # 1.33) and
Appendix G – Guide to Commonly Used
Medications. Record all medications being taken.
If you do not find a clear answer, contact the TMP.
Accept or defer donor for indicated length of
time.
14. In the past 4 weeks, have you had any shots or vaccinations
"NO" = Acceptable
"YES" = Medications by shots: See response to
“YES” on question #13.
NOTE: There is no deferral for allergy shots
= Vaccinations: Refer to Appendix E

(Immunizations). Accept of defer as indicated.
Record all responses and deferral time.
15. In the past 12 months, have you been given rabies shots?
"NO" = Acceptable
"YES" = Temporary deferral for 12 months after
vaccine treatment for rabies.
16. Had convulsions (seizures), or epilepsy?

39
"NO" = Acceptable
"YES" = If donor has been free of seizures for at
least 12months they are eligible to donate.
This is not dependent on being medication free.
Donors that have had a seizure in the past 12

months are to be deferred for 12 months from
date of last seizure. Document last seizure date.
17. FEMALE DONORS: In the past 6 weeks, have you been pregnant
or are you pregnant now?
"NO" or N/A (Males)=Acceptable

"YES" = Temporary donor deferral during
pregnancy and for 6 weeks after natural
delivery or termination of pregnancy. C-
Section = 12 month temporary deferral.
18. In the past 3 years, have you been outside the United States or
Canada?
"NO" = Acceptable
"YES" = Travelers who have been in an area
considered endemic for malaria (See Appendix "F"
for these areas) may be accepted as regular
blood donors 1 year after they return irrespective
of the receipt of antimalarial prophylaxis.
Immigrants, refugees or citizens coming from a

country considered endemic for malaria may be
accepted as blood donors 3 years after departure
from the area.
If born or lived in certain African countries since

1977 (Cameroon, Central Africa Republic, Chad,
Congo, Equatorial Guinea, Gabon, Niger, or
Nigeria), = Permanent Deferral.
If traveled to the above countries since 1977,

indicate this information on the card.
If travel has been within the past 12 months;

Temporary Deferral for 12 months from time of
departure.
40
19. Have you ever received human pituitary-derived growth
hormone?
"NO" = Acceptable
"YES" = Permanent Donor Deferral
20. Have you received a dura mater (or brain covering) graft?
"NO" = Acceptable
“YES” = Dura Mater = Permanent Donor Deferral
21. Have you or any of your blood relatives ever had Creutzfeldt-Jakob
disease or have you ever been told that your family is at an
increased risk for Creutzfeldt-Jakob disease?
"NO" = Acceptable
"YES" = Prospective donors who have a family
history of Creutzfeldt-Jakob disease or who have
received tissue or tissue derivatives known to be
a possible source of the Creutzfeldt-Jakob agent
(e.g. dura mater, pituitary growth hormone of
human origin) shall be Deferred Permanently.
22. In the past 12 months, have you been in jail or prison?
"NO" = Acceptable
"YES" = Individuals who have been incarcerated for
more than 72 consecutive hours during the
previous 12 months are Temporarily Deferral for
12 months from last date of incarceration.
23. Unexplained weight loss or diarrhea in the past 10 days?
"NO" = Acceptable
"YES " = Temporary Donor Deferral for 6 months for any
UNEXPLAINED history of weight loss or diarrhea
within the past 10 days that cannot be attributed
to eating irregularities.
24. In the past 12 months, have you had close contact with a person
with yellow jaundice or viral hepatitis, or have you been given
Hepatitis B Immune Globulin (HBIG)?
"NO" = Acceptable
"YES" = GG (Gamma Globulin/Hepatitis B Immune
Globulin) - Temporary Deferral for 12 months from
last injection. Record dates as indicated.
41
Close Contact - Temporary Donor Deferral for 12
months from last contact. Close contact generally
refers to cohabitation. Contact TMP for any
necessary clarification. Record all responses and
dates.
25. In the past 12 months have you taken (snorted) cocaine through
your nose?
"NO" = Acceptable
"YES" = Temporary Deferral for 12 months from that date
of use.
Note: Marijuana use is also a 12 month

temporary deferral from the last date of use.
26. In the past 12 months, have you received blood or had an organ or
tissue transplant or graft?
"NO" = Acceptable
"YES" = Temporary Deferral for 12 months from last
date received,
unless the product was received outside the
United States or Canada (See Questions #44 &
#46) or meets the Creutzfeldt-Jakob risk criteria.
(See Question # 21 and information below).
Prospective donors who have a family history of

Creutzfeldt-Jakob disease or who have received
tissue or tissue derivatives known to be a
possible source of the Creutzfeldt-Jakob agent
(e.g. dura mater, pituitary growth hormone of
human origin) shall be Deferred Permanently.
27. In the past 12 months, have you had a tattoo applied, ear or skin
piercing, acupuncture, accidental needle stick, or come in contact
with someone else's blood?
"NO" = Acceptable
"YES" = 12 month Temporary Deferral from last date of
exposure.
a.) Tattoo.
b.) Mucous membrane exposure to blood.
c.) Nonsterile skin penetration with instruments
or equipment contaminated with blood or
body fluids.)
42
d.) Sexual or household contact with an
individual with viral hepatitis.
e.) Sexual contact with an individual with HIV or
at high riskof HIV infection.
f.) Blood and body fluid contact with an open
wound, non-intact skin or mucous
membrane.
NOTE: At MDA all body piercings are Temporary Deferral

for 12 months. No exceptions made for
procedures supposedly done in a doctor’s office.
NOTE: If received Hepatitis B Immune Globulin as a
result of exposure, deferral will be from time of
last injection.
28. In the past 12 months, have you had a positive test for syphilis?
"NO" = Acceptable
"YES" = Temporary Donor Deferral for 12 months
after completion of therapy.
NOTE: Genital Herpes = Temporary Donor Deferral until

genital warts disappear or until at the inactive
stage.
29. In the past 12 months, have you had or been treated for syphilis or
gonorrhea?
"NO" = Acceptable
"YES" = Gonorrhea/syphilis - Temporary Donor
Deferral for 12 months after completion of
therapy.
30. In the past 12 months, have you given money or drugs to anyone
to have sex with you?
"NO" = Acceptable
after the last event.
31. At any time since 1977, have you taken money or drugs for sex.
"NO" = Acceptable
"YES" = Persons who have engaged in sex for money
and/or drugs since 1977 should not donate blood.
= Permanent Deferral
43
32. In the past 12 months, have you had sex, even once, with anyone
who has taken money or drugs for sex?
"NO" = Acceptable
"YES" = Persons who have engaged in sex with a
person who received money and/or drugs for sex
in the past 12 months should not donate.
= Temporary Deferral for 12 months
33. Have you ever used a needle, even once, to take drugs that were
not prescribed for you by a doctor?
"NO" = Acceptable
"YES" = Use of a needle, even once, to take any
illegal drug,
= Permanent Donor Deferral. Verify any
questionable drugs in drug book or with TMP.
who has used a needle to take drugs not prescribed by a doctor.
"NO" = Acceptable
"YES" = Persons who have had sex with any person
who is a past or present I.V. drug user should not
donate blood or blood components
= Temporary Deferral for 12 months from date of
last exposure.
35. FEMALE DONORS: In the past 12 months, have you had sex with a
male who has had sex, even once since 1977, with another male?
"NO" = Acceptable
from date of last exposure.
MALES = Circle “NA”
36. MALES ONLY: Have you had sex with another male, even once,
since 1977?
"NO" = Acceptable
FEMALES = Circle “NA”
37. Have you ever taken clotting factor concentrates for a bleeding
problem, such as hemophilia?
44
"NO" = Acceptable
"YES" = Persons with hemophilia or related clotting
disorders who have received clotting factor
concentrates should not donate blood or blood
components.
= Permanent Donor Deferral.
Refer any donor hemophiliac questions to the TMP.
38. In the past 12 months have you had sex, even once, with anyone
who has taken clotting factor concentrates for a bleeding
problem such as hemophilia?
"NO" = Acceptable
"YES" = Had sex with a hemophiliac or person taking
clotting factor,
= Temporary Donor Deferral for 12 months from
date of last exposure.
39. Do you have AIDS or have you had a positive test for the AIDS
virus?
"NO" = Acceptable
"YES" = Has AIDS or Positive test for AIDS =
Permanent Donor
Deferral
who has AIDS or has had a positive test for the AIDS virus?
"NO" = Acceptable
"YES" = Had sex in past 12 months with someone
who has AIDS or has a positive test for the AIDS
virus?
= Temporary Donor Deferral for 12 months from
date of last exposure.
41. Are you giving blood because you want to be tested for HIV or the
AIDS virus?
"NO" = Acceptable
42. Do you understand that if you have the AIDS virus, you can give it
to someone else even though you may feel well and have a
negative AIDS test?
"YES" = Acceptable
45
"NO" = Temporary Donor Deferral
= Donors should be informed that there is an
interval during early infection when the HIV
antibody test may be negative although the
infection may still be transmitted.
If donors needs more information and has

additional questions, provide the donor with the
contact number the TMP and suggest that they
contact them or their own personal physician for
more information. Tell donor that the Transfusion
Medicine Physician may be contacted at the
telephone number indicated on the Donor
Information sheet.
43. Were you born in, have you lived in, or have you traveled to any
African country since 1977?
"NO" = Acceptable
"YES" = If born or lived in certain African countries
since 1977 (Cameroon, Central Africa Republic,
Chad, Congo, Equatorial Guinea, Gabon, Niger, or
Nigeria),
= Permanent Deferral.
If traveled to the above countries since 1977,

indicate this information on the card, and defer
according to other questions related to travel.
44. When you traveled to <country(ies)> did you receive a blood

transfusion or any other medical treatment with a product made
from blood?
"NO" = Acceptable
"YES" = Received Blood Transfusion or any medical
treatment with a product made from blood, in any
of the African countries indicated in question
#43?
= Permanent Donor Deferral
45. Have you had sexual contact with anyone who was born in or lived
in any African country since 1977?
“NO" = Acceptable
"YES" = Had sexual contact with anyone who was
born in or lived in any of the African countries
listed in question #43?
= Permanent Donor Deferral
46
46. Have you ever received a blood product transfusion outside the
United States and Canada?
"NO" = Acceptable
"YES" = Contact TMP for each “YES” to this
question. Before calling TMP, determine exactly
where they were, etc: City & country, type of
facility, when, and how many units did they
received.
47. Have you read and understood all the donor information
presented to you, and have all your questions been answered?
"YES" = Acceptable
"NO" = Donor must read and understand all the
information provided. Give donor time to go back
and read all of the information and answer all
questions that they have. Re-ask this question.
If the answer is "YES" - Acceptable, if "NO", do
not accept the donor. Ask if they would like to
talk to the TMP about concerns that they have
with the donor information. Record all responses
and questions that the donor has.
REFERENCES:
2. Code of Federal Regulations, Title 21.
3. AABB Standards for Blood Banks and Transfusion Services, 18th
Edition, 1997
1.33 USE OF DAVIS'S DRUG GUIDE
PRINCIPLE:
The eligibility of a donor taking medication must be confirmed. Appendix

G is a quick reference to many generic medications, however the
content of many others must be determined. Davis’s Drug Guide for
Nurses provides such a reference.
SUPPLIES NEEDED:
1. Davis's Drug Guide for Nurses, Deglin, Vallerand. F.A. Davis
2. Transfusion Medicine Physician (TMP) On-Call List
3. M. D. Anderson Cancer Center Blood Bank Procedure Manual -

Appendix G ( Guide to Commonly used Medications)
47
PROCEDURE:
1. Obtain the name of the drug that the donor is taking. Document
name of drug in comments section.
2. Use the Comprehensive Index in current Davis's Drug Guide for

Nurses (back section) to find the drug name and refer to the page
indicated.
3. Ask donor the reason drug is being taken, then determine the
classification from the listing in the shaded box on page indicated.
4. Refer to this classification in the Table of Contents (front section)

and obtain page number for the specific verification.
5. Instructions on the page will indicate:
A. Accept donor
B. Defer donor (inform supervisor)
C. Call TMP (inform supervisor)
6. If TMP is called, must have donor card completed, except for

hemoglobin.
7. If medication is not listed in drug guide, inform supervisor or TMP.
8. Document instructions and all follow-up (call TMP, supervisor

notified, accept donor, defer donor) in the comments section with
initials and signature as "screener".
48
DONOR SELECTION
1.41 BLOOD PRESSURE & PULSE
PRINCIPLE:
Pulse and blood pressure are required measurements on each blood

donor to ensure established criteria are met for accepting donor.
SUPPLIES NEEDED:
1. Watch with second hand

2. Regular adult blood pressure cuff
3. Large adult blood pressure cuff
4. Stethoscope
5. Donor card
PROCEDURE:
A. Blood Pressure
1. Daily, prior to use, check that each sphygmomanometer

(blood pressure cuff) reads 0 mm Hg when no pressure is
applied. If reading is acceptable (0 mm), record on
appropriate quality control form (See attached example).
Do not use cuffs which show unacceptable readings.
Note: On large adults, a large blood pressure cuff must be

used to prevent erroneous readings.
2. Place the blood pressure cuff on the donor's arm.
3. Place stethoscope ear pieces in your ears.
4. Use your fingertips to locate donor's brachial pulse

(Optional).
5. Place the diaphragm of the stethoscope directly over the

brachial pulse site. Do not touch the cuff with the
diaphragm of the stethoscope.
6. With the bulb valve (thumb valve) closed, inflate the cuff.
You will soon be able to hear pulse sounds. Continue to
inflate the cuff until the gauge reads 30 mmHg higher than
the point where the pulse sound disappeared.
49
7. Slowly release air from the cuff by opening the bulb valve,
allowing the pressure to fall smoothly.
8. Listen for the start of pulse sounds (clicking or tapping

sounds.) When you hear the beginning of those sounds,
note the reading on the gauge. This is the systolic pressure.
9. Continue to deflate the cuff, listening for the point at which

these distinctive sounds fade (not when they disappear).
When the sounds turn to dull, muffled thuds, the reading on
the gauge is the diastolic pressure.
10. After obtaining the diastolic pressure, let the cuff deflate
rapidly. If you are not certain of a reading, repeat the
procedure. You should use the other arm or wait one
minute before reinflating the cuff.
11. The systolic blood pressure (top number) should be no

higher than 180mm, nor lower than 90 mm of mercury. The
diastolic pressure (bottom number) should be no higher
than 100 mm, nor lower than 50mm of mercury.
12. If the donor has a blood pressure lower than either of the
lower values indicated above, they may be eligible to
donate, based on TMP approval. Thus, whenever a donor
has values lower than limits indicated, contact the TMP.
13. Record the measurements on the donor card as systolic

pressure/diastolic pressure. Blood pressure is reported in
even numbers.
14. The technician performing the blood pressure must

place their initials in the space to the right of the result.
15. If you obtain an abnormal reading, you must have another

technician take a second reading on the other arm. Both
results should be recorded and initialed.
16. Prospective donors that initially have an elevated reading may be asked if they would like to rest a
while, have something to drink, and try again in about 10-15 minutes.
B. Pulse
1. With the hand straight, not bent, place your third and fourth
fingers on the lateral side (thumb side) of the donor's wrist,
just at or above the crease.
50
2. Count the pulsations for 30 seconds and multiply by 2 to
determine the beats per minute. Record pulse on donor
card.
3. The technician performing the pulse count must place their

initials in the space to the right of the result.
4. If any type of irregularities in the pulsations are felt, count the pulsations for 1 minute. Record the
number felt on the donor card. Also, determine the irregularity of the pulsations and record on the
donor card. Then inform the Mobile Team Leader so that an evaluation may be done on the donor.
5. The pulse shall reveal no pathologic cardiac irregularity and

should be between 50 and 100 beats per minute. If a
prospective donor is an athlete with high exercise tolerance,
a pulse rate lower than 50 beats per minute may be accepted
upon TMP approval.
6. If you obtain an abnormal reading, you must have another

technician take a second reading on the other arm. Both
results should be recorded and initialed.
7. Prospective donors that initially have an elevated reading may be asked in they would like to rest a
while, have something to drink, and try again in about 10-15 minutes.
REFERENCES:
1. Brady Emergency Care, Grant, Harvey D.; Murray, Robert H. Jr.;

Bergeron, J. David;, 5th Edition, Prentice Hall, Inc., 1990, p86, 88-
89.
4. Code of Federal Regulations, Title 21, 1997, 640.4.
51
DONOR SELECTION
1.43 FINGERSTICK
PURPOSE:
To help assure that the most accurate possible hemoglobin

determination can be made, a good clean fingerstick puncture must be
done. Donors frequently state that their fingerstick hurt more than the
venipuncture. Fingers are used for feeling and for that reason they
have many nerves. When a good fingerstick is performed, and does not
require squeezing of the finger to obtain a sample, there will be
minimal donor discomfort afterwards. A poorly performed fingerstick
that requires squeezing will not only result in a very poor hemoglobin
value, but will cause the donor more long lasting discomfort.
SUPPLIES NEEDED:
1. Disposable Lancet - Microtainer® Brand Safety Flow Lancet
(Becton Dickinson #36-6356)
2. Alcohol Preps
3. Dry Gauze or Cotton Balls
4. Gloves
PROCEDURE:
1. Always wear gloves when performing fingersticks. Change gloves

between every donor.
2. Select finger for puncture. Preferably, use the donor’s ring finger.
If you are right handed if will be easier for you to stick the
donor’s right hand (left side facing you). Usually he skin on the
thumb and first 2 fingers on either hand is thicker because these
are the fingers that are used most often.
3. Cleanse puncture site with alcohol, and allow site to dry.
4. Open carefully a new sterile lancet, Do not touch the end that will
touch the finger.
5. Following these steps, puncture finger slightly to the side to

avoid the most sensitive part of the finger.
a. Hold lancet on site with moderate pressure.
b. Depress plunger with index finger to make puncture.

52
c. Immediately release plunger while holding lancet on site.
d. Remove lancet and dispose into sharps container.
6. Wipe the first drop with a dry gauze or cotton ball to

eliminate tissue fluid or alcohol which will dilute test sample.
7. Collect appropriate specimen as designated in copper sulfate

method or Hemocue photometer method for hemoglobin
determination.
8. Upon completion of collection, cleanse site with alcohol and

apply bandaid.
9. Ask donor to hold finger firm for a short while.
REFERENCES:

2. Becton Dickinson Microtainer® Brand Safety Flow Lancet Package
53
DONOR SELECTION
1.44 COPPER SULFATE METHOD FOR HEMOGLOBIN DETERMINATION
PRINCIPLE:
The copper sulfate method is based on the fact that whole blood
dropped into a solution of copper sulfate becomes encased in a sac of
copper proteinate. The specific gravity of this drop is not changed for
about 15 seconds. If the drop of blood has a satisfactory specific
gravity, it will sink within 15 seconds. If not, the sinking drop will
hesitate, remain suspended, or rise to the top of the solution.
Copper sulfate with a specific gravity of 1.053 is equivalent to 12.5 gm%

hemoglobin.
This is not a quantitative test and will show only that the hemoglobin
concentration is below or above acceptable limits. If the donor is not
acceptable by this method, test as described in procedure, "HemoCue
Photometer for Hemoglobin Determination".
SUPPLIES NEEDED:
1. Heparinized micro-hematocrit capillary tubes

2. Cooper sulfate solution: Specific gravity 1.053
3. A 50 ml disposable container with secure cap
4. Calibrated hydrometer (range to 1.060)
5. A 50 ml graduated cylinder
6. Disposable Lancet (Microtainer Brand Safety Flow Lancet #36-
6356)
7. Biohazard Sharps Container
8. Alcohol Preps
9. Dry Gauze or Cotton Balls
10. Gloves
11. Quality Control Form
12. Small biohazard labels
13. Content Labels for container
QUALITY CONTROL:
1. When a new lot is received it is tested at the same time that a

current lot is tested to help assure that a donor will have the same
reading with both lot numbers. The new and old lots must have the
same required reading. After this done, an entry will be made on
the Blood Product Receiving Log for that product. The entry will
indicate, “lot to lot check” and be dated and initialed by the
person performing the check.
54
2. Each day prior to use, quality control of solution that is to be used
must be done.
3. Check expiration date of solution.
4. Prior to the verification of the specific gravity of the Copper

Sulfate, the hydrometer should be checked to verify that it is
properly functioning. To do this follow the steps below:
a. Pour 50 ml of water into the graduated cylinder
b. Place the hydrometer into the water and allow it to float

freely for about 10 seconds.
c. Verify that the reading is “1.000”
d. Record this reading on the daily QC sheet.
e. If this hydrometer does not read “1.000” do not use. Start

again with another hydrometer and report this problem to a
supervisor.
5. Pour 50 ml of the copper sulfate solution into the cylinder.
6. Place hydrometer into solution and allow it to float freely for about
10 seconds. Read hydrometer and record reading, lot number of
the copper sulfate, date and initials on quality control form. (See
attached)
7. Do not use the copper sulfate solution if it does not have a specific
gravity of 1.053.
8. When a new lot number of copper sulfate is received, a lot-to-lot

performance check must be done on the new lot to assure that it is
reading the same as the previous lot. This is then documented in
the product log book.
9. Date and initial each bottle of solution when initially opened.
PROCEDURE:
1. Pour 30 ml of copper sulfate solution that has had specific gravity

quality control performed on that day, into the disposable
container. Label each container with lot number, specific gravity,
date, and technician initials. Also apply a small biohazard label to
the disposable container.
55
Note: If you are anticipating more than 20 donors, you may
pour over and label the number of containers that you anticipate
that you will need.
2. ** Keep all containers covered when not in use.***
3. Wear gloves when performing fingerstick and handling filled

capillary tubes.
4. Perform finger stick according to Fingerstick Procedure.
5. Fill capillary tube ¾ full without air bubbles.
6. Add a drop of blood from a height of about 1 cm to the copper

sulfate solution.
a. A drop expelled too high may break into small droplets when
it strikes the solution.
b. A drop expelled too low may not break through the surface
film at all.
7. Observe the drop carefully from the instant it enters the solution.
The drop must sink to the bottom within 15 seconds for acceptable
results.
8. On donor card, record results as "OKAY" or "NOT OKAY".
9. After every 20 tests, or after last donor, tightly secure lid on used
copper sulfate in the disposable container and place in appropriate
biohazard container for final disposal.
** Hint - If you have difficulty keeping track of number of tests

done on that vial, keep a tally of marks on the label.
Note: If used for too many tests, the specific gravity of the solution
is affected.
10. Repeat step #1 with a new container.
11. Always store copper sulfate at room temperature in a tightly

capped container. Evaporation will result in an increased specific
gravity.
REFERENCES:
1. AABB Technical Manual, 12th Edition, 1996

56
57
DONOR SELECTION
1.45 HEMOCUE® PHOTOMETER FOR HEMOGLOBIN DETERMINATION
PRINCIPLE:
The HemoCue® Hemoglobin Photometer measures hemoglobin, without dilution, at two wave lengths (570 and 880mm)
as azide methemoglobin. The HemoCue® blood Hemoglobin system consists of disposable microcuvettes with reagent
(sodiumdesoxycholate) in dry form and a single purpose designed photometer. The photometer is calibrated at the
factory against the hemiglobincyanide (HiCN) method, which is the international reference method for the determination
of the total hemoglobin concentration in blood.
SUPPLIES NEEDED:
1. HemoCue® Hemoglobin Photometer

2. HemoCue® Control cuvette
3. HemoCue® microcuvettes
4. Disposable lancet (Microtainer® Brand Safety Flow Lancet #36-
6356)
5. HemoCue® Photometer case
6. Cotton ball or gauze
7. Biohazard Sharps Container
8. Quality Control Form appropriate for location.
QUALITY CONTROL:
Perform each day of use.
1. Match serial number of photometer and control cuvette.
2. Turn power on.
3. Pull out the cuvette holder to insertion position. The display

shows the letters "Hb".
4. After six seconds "READY" appears on the display.
5. Put the red control cuvette (standard) into the cuvette slide and
push it into the measuring position. The display now shows
"MEASURING".
6. After 10-15 seconds, the measurement is completed and the

photo-meter displays a value in g/dL. Record the value result and
the serial number of the control cuvette on the quality control
form for hemoglobin (See attached). The value should not deviate
from the standard value by more than ± 0.3 g/dL.
58
7. On the appropriate quality control form, record the following
information in the designated areas:
a. HemoCue Control Cuvette Serial number

b. Standard value of the Control Cuvette
c. Control Cuvette reading
d. Microcuvette lot number(s) being used at location.
8. If the standard is outside the acceptable range, clean the cuvette

holder, dry completely and rerun the standard. If it continues to
be outside acceptable range, inform a supervisor and also refer
to the Troubleshooting guide following this procedure.
9. If the machine cannot be calibrated, use the copper sulfate

method to determine donor eligibility. The Apheresis section may
use the Coulter Hematology Analyzer or send a sample to
Hematology for testing as a backup method.
HANDLING OF THE HEMOCUE MICROCUVETTES:
1. Date and initial the microcuvette vial when it is initially opened.
** Once opened, the microcuvettes are stable for 90 days.**
2. Remove only the microcuvettes required for immediate testing.
3. The reagents within the microcuvette are moisture sensitive.

Keep dessicant in vial
4. REPLACE CAP IMMEDIATELY AFTER EACH MICROCUVETTE IS

REMOVED FROM THE CONTAINER.
5. Unused microcuvettes must remain in the original package.
6. As this test method relies on photometric measurement, care

should be taken not to hold the microcuvette by the filling tip.
7. Keep all microcuvettes stored at 15 - 30 C ( 59-86 F). Do not

refrigerate. Do not leave vials on mobile coaches when not in use.
PROCEDURE:
1. Turn the photometer "ON". Make sure that the cuvette-holder is

in its outer position. When flashing dashes and “READY” are seen
in the display, the photometer is ready for use. The photometer
59
will show the letters “Hb” for 2 seconds in its display when
switched on.
2. Always wear gloves when performing fingersticks and handling

filled cuvettes. Change gloves between every donor.
3. The shape of the cuvette and parts are seen in figure 1.
4. Take the microcuvette out of the vial. Hold the cuvette by the
winged rear end.
5. Perform fingerstick according to Fingerstick Procedure #1.43.
6. Make sure the blood drop is sufficient to completely fill the whole
cuvette.
7. The cuvette is held by two fingers in its rear end and the filling
end is brought in contact with the blood sample. See figure 2.
Avoid contaminating the optical eye.
8. Allow the cavity of the microcuvette to fill completely by capillary

action. Do not refill the cavity of the cuvette. If air bubbles are
seen in the optical eye of the cuvette due to inadequate filling of
blood, the cuvette should be discarded and another sample
taken.
9. When completely filled, wipe off the outside of the cuvette with a
clean and lint-free tissue; see figure 3. Do not touch the slit of
the microcuvette.
10. Place the cuvette in the holder of the photometer (figure 4.).
11. Push the cuvette-holder to its inner position. When the cuvette-
holder reaches its inner postion, fixed dashes and “MEASURING”
will appear in the display.
12. After 30-50 seconds the photometer will find the steady-state of
the chemical reaction and the result will appear in the display.
The display will show the result for 5 minutes provided the
cuvette-holder is left in its inner position. After 5 minutes the
display will show the letters “Hb”.
13. A remeasurement may be initiated by moving the cuvette-holder

to its outer position, wait for the flashing dashes and “READY” to
appear in the display, and push the cuvette-holder back to its
inner position. On this second measurement, it will take only 10-
20 seconds for the result to show up in the display.
60
14. Record hemoglobin result on donor card in appropriate space.
15. Record second reading on donor card next to previous reading

and record the Hemocue serial number.
16. Dispose of microcuvette in sharps container once the test is

completed.
17. If the second reading is more than ± 0.3 g/dL different from the
first, the reading is not valid; begin with step 5 and repeat
procedure. If results are still invalid, notify a supervisor or TMP
for further instructions.
18. If you receive an error code refer to the troubleshooting guide

following this procedure.
19. Turn power "OFF". If photometer has rechargeable batteries,

leave it plugged into a power source when not being used.
20. Clean the cuvette holder daily with alcohol or mild soap solution
after completely removing it from the photometer. It is important
that the holder is completely dry before being replaced in the
photometer.
21. Store and transport the photometer in its case.
REFERENCE:
1. HemoCue® Hemoglobin Photometer Operating Manual,
Aktieblolaget Leo Diagnostics, Helsingborg, Sweden.
2. HemoCue® B Hemoglobin Microcuvettes package insert.
61
DONOR SELECTION
1.51 DONOR ARM PREPARATION
PRINCIPLE:
Blood once it is outside the body is an excellent medium for bacterial

growth. Since there is currently no means of sterilizing blood with
destroying the blood components, skin preparation prior to phlebotomy
is an essential step in ensuring the overall quality of the product. The
primary objective of the skin preparation is to prevent contamination at
the time of needle withdrawal. Adequate preparation reduces the
bacteria on the skin surrounding the venipuncture site, thus decreasing
the number of bacteria that can be transferred into the deeper tissues
from the skin when the needle is inserted. This provides protection for
the donor as well as the potential recipient.
Since some people are allergic to iodine and may develop a dermatitis
following exposure, it is important that before the skin preparation,
each donor should be questioned about any allergy to iodine. If the
donor is allergic, an alternative procedure such as the use of tincture of
green soap and 70% isopropyl alcohol may be used.
Although the skin cannot be sterilized, skin preparation will render the
phlebotomy site “aseptically clean.” The basic principles of asepsis
should be followed. If the scrubbed area is touched prior to
venipuncture, it must be considered contaminated. This may occur if the
donor bends the arm, if the area is touched with any object such as the
tourniquet, blood pressure cuff or tubing, or if the phlebotomist
repalpates the vein. In preparing the skin, always work from the clean
area (point of intended entry) to the dirty area (surrounding area).
SUPPLIES NEEDED:
1. BBL Culturette EZ II Becton Dickinson Microbiology Systems

#4360217.
3. Blood pressure cuff or tourniquet
4. Prepackaged 7.5% scrub solution of iodophor compound
(Povidone-Iodine "Duo-Swab #1, Scrub", Professional Disposables,
Inc., Cat. No. 523125)
5. Prepackaged iodophor complex prep solution (10% Povidone-
Iodine "Duo-Swab #2, Prep", Professional Disposables, Inc., Cat.
No. 523125)
6. Dry, sterile gauze
7. Tincture of green soap Cliniswabs (The Clinipad Corporation, Cat.
No. 1235)
62
8. 70% isopropyl alcohol Cliniswabs (Professional Disposables, Inc.,
Cat. No. 584925)
9. Special test requisition form (= green slip)
PROCEDURE:
1. Inspect both arms and select the best vein for venipuncture in the
fold of the elbow (antecubital fossa).
2. Apply a blood pressure cuff or tourniquet to the donor's upper arm,

inflate the cuff to 50-100 mm of mercury and instruct donor to
open and close fist.
3. When the vein has been selected, release the blood pressure cuff
or tourniquet.
METHOD #1:
1. Perform arm prep by the following steps:
a. If donor is allergic to iodine or betadine, use method #2

found at the end of this procedure.
b. Using sterile "Duo-Swab #1, Scrub", vigorously scrub for a

minimum of 30 seconds up to one minute at least 1½ inches
in all directions from the intended site of venipuncture (i.e. 3
inches in diameter).
c. Vary the direction of scrubbing from up and down the arm to

across and around in small circles so that all areas are well
covered several times over. Discard swab.
d. The arm need not be dry before proceeding to the next step.
e. Using a sterile "Duo-Swab #2, Prep", apply iodophor complex

solution by starting at the intended site and moving outward
(not touching any area twice) in a spiral to cover the entire
area of at least a 1½ inch radius around the site. Discard
swab.
f. Let solution dry.
g. NOTES:
63
(1) Iodophor complex solution must dry a minimum of 30
seconds to sterilize the site. It is the drying with iodine
that kills the bacteria.
(2) This solution contains 1% free iodine and need not be

removed before completing venipuncture.
h. After the prep has dried for 30 seconds, cover the site with a
dry sterile gauze to prevent contamination prior to
phlebotomy.
i. NOTES:
(1) Do not touch gauze that will go next to site with your
fingers.
(2) Do not touch site with fingers.
(3) Do not repalpate vein.
(4) Do not repalpate vein through gauze
(5) Do not place gauze outside of sterile area.
(6) Prep must be done over if any contamination occurs at

any stage.
METHOD #2:
1. Using tincture of green soap Cliniswab or surgical green soap,

vigorously scrub for a minimum of 30 seconds up to one minute at
least 1½ inches in all directions from the intended site of
venipuncture. Vary the direction of scrubbing from up and down
the arm to across and around in small circles so that all areas are
well covered several times over.
2. Remove soap with Cliniswabs saturated with 70% isopropyl

alcohol. Start at the intended site and move outward in a spiral
(Not touching any area twice). Allow the area to dry so that the
solution has time to penetrate to its fullest depth. The acetone-
alcohol wash removes any residual oils and fats that remain
superficially.
QUALITY CONTROL:
64
1. Monthly all phlebotomists must randomly have an arm prep
checked for sterility.
2. After preparation of site and prior to venipuncture, remove the

sterile swab from plastic chamber.
3. Using swab, immediately wipe the dry preparation site.
4. Carefully replace the swab securely back into the storage chamber
and place tape around the interface to secure the closure.
5. Write employee's name, unit number and date on chamber's ID

label.
7. Complete a Special Test requisition (green slip): Employee’s name,

donor unit number, date, time, Duo-Swab Lot # & Expiration Date,
and Dr. Lichtiger's name as requesting physician. Also record "Arm
Prep Sterility Check (Infection Control)" and "Send Results to
Transfusion Service, Box 7".
8. Send the arm prep culture and requisition to Microbiology.
REFERENCES:

3. Code of Federal Regulations, Title 21, 1996, 640.
4. Blood Donor Collection Practices, AABB, 1993.
65
DONOR AND PRODUCT SAFETY
1.52 DONOR REACTIONS AND PREVENTIVE MEASURES
PRINCIPLE:
The majority of donations occur without any complications, however,

occasionally a donor will have an adverse reaction to the donation.
Most reactions are vasovagal reactions (fainting). The reactions can
be roughly categorized into the groups based on degree of severity --
mild, moderate and severe.
GENERAL PREVENTIVE MEASURES:
1. If donor has not eaten within the last 4 hours, give Sprite or
Coke and cookies 20 minutes prior to phlebotomy. Give
explanation for importance of eating.
2. If donor appears nervous or has a pulse rate higher than 100

beats per minute, invite the donor to relax until calm, or ask
donor to return later. Explain that it is in his/her best
interest to postpone the donation.
3. Reassure the donor, explain the procedure, and discourage

him/her from looking at the needle. Inform donor of
precautionary measures that will be done. Place cold pack
behind neck and elevate feet. Keep close observation and
DO NOT LEAVE DONOR UNATTENDED.
4. Avoid HYPERVENTILATION by diverting the donor's attention.

If donor starts to hyperventilate, explain what he/she is
doing and encourage donor to slow down breathing. If
symptoms persist, have donor breathe into a brown paper
bag.
5. After the donation, instruct the donor to:
a. Avoid strenuous activity.

b. Sit down immediately and place head between knees if
he/she feels faint.
c. Drink nonalcoholic fluids.
d. Eat regular meal.
GENERAL INSTRUCTIONS:
66
1. Take action immediately according to the type of reaction.
Notify supervisor or TMP of any reaction or complaint. Types
of reactions are:
a. Painful phlebotomy and/or hematoma

b. Fainting or feeling faint
c. Nausea and vomiting, headache
d. Twitching muscle spasms or paresthesia
e. Convulsions
f. Cardiac or respiratory difficulties
g. Chills
h. Air embolus
2. Check blood pressure and pulse rate periodically until donor

recovers, recording all vital sign readings.
3. If donor does not respond rapidly or has more serious

symptoms, call TMP.
4. During a serious reaction, if unable to contact the TMP, call

Station 19 if in donor room, or call 911, if on a mobile.
5. If the donor falls or is injured, notify TMP and get help

immediately. Take steps to get the donor to the appropriate
place for treatment. The institutional Variance Report form
must be completed within 24 hours; notify a supervisor so
this can be done.
6. Record slight reactions on donor card and moderate to

severe on "Record of Donor Complication".
7. The nature and treatment of ALL reactions or donor

complaints should be recorded in detail by the phlebotomist,
to be reviewed by a supervisor and TMP. Record date and
time of the reaction, the time donor was released, and the
instructions given to the donor.
8. Bruise or hematoma reports are recorded on the donor card

by the phlebotomist.
9. The TMP (or a qualified physician) should be available to

attend the donor within 15 minutes when an Apheresis
procedure is being performed, and should be available for
consultation and management of donor adverse reactions. A
registered nurse may administer drugs/medication per TMP.
TREATMENT OF REACTIONS:
67
1. Painful Phlebotomy and/or Hematoma:
a. Remove tourniquet or blood pressure cuff immediately.
b. Discontinue bleeding and carefully remove needle.
c. Place sterile gauze over the hematoma and apply firm

digital pressure with the arm elevated and straight
above heart level until the site of the venipuncture
stops bleeding (at least 5 minutes).
d. Apply cold compresses to the hematoma for 5-10

minutes.
e. Instruct donor to avoid aspirin-containing medication

for 48 hours and to use the arm at a minimum.
f. Advise donor that the area will turn dark blue, purple,
green and finally yellow, and it will fade away in about
8-10 days.
g. Instruct the donor that if further discomfort or pain

develops, or if he/she has any questions, to call (713)
792-2644 for the TMP.
h. If the donor is still in pain or still has unresolved

complaints, contact the TMP immediately for
instructions.
2. Fainting or Feeling Faint:
a. Place donor on his/her back; raise feet above the level

of the head. Adjust donor chair accordingly.
b. Continue talking to donor to reassure them while

monitoring their alertness.
c. Loosen tight clothing. Vasovagal symptoms (fainting)

tend to occur more frequently when the room is too
warm or poorly ventilated. Adjust room temperature or
improve ventilation, if necessary.
d. Make sure donor has adequate airway. Ask the donor

to take 2-3 deep breaths, and instruct him/her to keep
eyes open.
e. Apply cold compresses to forehead or back of the neck.

68
f. If donor continues to feel faint, administer aromatic
spirits of ammonia by inhalation. The vial should not
be too close to nose; strong ammonia may injure the
nasal membranes.
g. Check blood pressure and pulse every five minutes until

the donor recovers. If the symptoms are progressive
toward shock (cold, clammy skin, pallor, etc.),
discontinue bleeding. If blood pressure remains low,
notify the TMP immediately and follow instructions.
h. If cyanosis is present, call a TMP immediately; on

mobile call 911. If oxygen is available, administer by
inhalation.
i. If the donor responds to treatment, keep him/her

reclined until recovery, then allow to gradually sit up
and carefully ambulate. Do not release donor until
after at least 5 minutes after sitting up without feeling
ill and clearly stating that he/she is well and wants to
leave.
3. Nausea and Vomiting:
a. Make the donor comfortable. Have emesis basin or

bedside bag and tissue or wash cloth available.
b. If Apheresis, immediately slow down the reinfusion.
NOTE: Two Tams tablets (calcium carbonate) may be offered

to the donor and repeated every thirty minutes if necessary.
c. To help the nausea, have the donor breathe deeply and

slowly through the mouth.
d. Apply cold compresses to the donor's forehead and

back of neck.
e. If the donor vomits, hold an emesis basin or container

and have ready cleaning tissues or a damp towel.
Clean the donor's face and clothing as necessary, and
give the donor a paper cup of water to rinse out mouth.
f. Be sure that the needle remains in the proper position

in the vein.
69
g. Allow the donor to recover and provide fluid as
tolerated.
h. For continuous intense nausea or vomiting more than

twice, contact the TMP for further instructions.
4. Twitching, Muscle Spasms, or Paresthesia:
a. Nervous donors may hyperventilate causing faint

muscular twitching or tetanic spasm of the hands or
face.
b. Divert donor's attention and engage donor in

conversation to interrupt the hyperventilation pattern.
If donor still continues to hyperventilate, have donor
rebreathe into paper bag to bring prompt relief.
c. Automated Apheresis donors may exhibit similar

symptoms, but they are probably caused by reinfusing
donor cells too quickly (the anticoagulant can cause the
tetany). If this occurs, slow down the infusion and
collection rate and give "Tams" antacid tablets (2 or 3)
to the donor. If donor's condition does not improve,
call a TMP immediately and follow instructions.
5. Convulsions:
a. Call someone to help you immediately.
b. Discontinue bleeding. Remove the needles and

tourniquet promptly, if possible.
c. Prevent the patient from injuring himself.
d. If possible, HOLD THE DONOR IN THE DONOR CHAIR, if

not, PLACE THE DONOR ON THE FLOOR. Do not restrain
the movements of the donor's extremities completely,
but try to prevent donor from self-injury and from
injuring you.
e. Be sure that the donor has an ADEQUATE AIRWAY.

Loosen any tight clothing.
f. Call the TMP immediately if necessary.
6. Cardiac or Respiratory Difficulties:
a. Call TMP immediately.

70
b. Discontinue bleeding. Apheresis: Keep line open with
saline, if possible.
c. Be sure donor has adequate airway. If oxygen is

available, administer by inhalation.
d. If you are in donor room, call hospital "HEART ATTACK"

number 2-7099, if unable to reach TMP immediately. If
on a mobile, call 911.
e. If donor is in cardiac arrest, begin CPR immediately and

continue until medical aid arrives.
f. Move Emergency Cart nearby and have ready for TMP.

If on mobile, in Houston, call Houston ambulance at 911
immediately and notify TMP later. If 911 does not work,
ask operator to call a local ambulance.
7. Chills:
a. Treat symptomatically with blankets. If Apheresis, slow

reinfusion.
b. If chills persist or worsen, notify TMP immediately.
8. Air Embolus:
a. Air embolism is rare, but possible during Apheresis

procedures.
b. Symptoms of air embolus are chest pain, shortness of

breath, shock, pallor, sweating, mental confusion, and
syncope (fainting).
c. Air embolus occurs when air is inadvertently pumped

into the donor's vein. To prevent this, the flow of blood
should be observed constantly during Apheresis.
d. If an air embolus should occur, place the donor

horizontally, lying on his left side with head down and
feet up.
e. Administer oxygen by inhalation (if available) and

notify TMP immediately.
9. Medical Care After Phlebotomy:
71
For any complications that develop after the donor has been
released, call or page TMP at once for instructions.
DRUGS AVAILABLE IN THE APHERESIS DONOR ROOM EMERGENCY CART:
Drawer #1: 3 Syr. ATROPINE 1 mg

5 Syr. CALCIUM CHLORIDE 1 gm
6 Syr. DOPAMINE 200 mg (Intropin)
4 Syr. EPINEPHRINE 1:10,000
5 Syr. LIDOCAINE 2% 100 mg (Xylocaine)
2 Syr. LIDOCAINE 2 gm (Xylocaine)
10 Syr. SODIUM BICARB 50 meg
Drawer #2: 2 Amps. AMINOPHYLLINE 500 mg

2 Amps. AMYL. NITRATE
1 Vial BACTERIOSTATIC NaC1 30 ml
1 Vial BACTERIOSTATIC WATER 30 ml
4 Amps. BRETYLIUM TOSYLATE 500 mg (Bretylol)
2 Syr. DEXTROSE 50% (50 Ml)
4 Syr. DIAZEPAM 10 mg (Valium)
1 Amp. DIAZOXIDE 300 mg (Hyperstat)
2 Amps. DIGOXIN 0.5 mg
2 Syr. DIPHENHYDRAMINE 50 mg (Benadryl)
4 Vials DOBUTAMINE 20 mg (Dobutrex)
1 Vial EPINEPHRINE 1:1,000 ml
4 Amps. FUROSEMIDE 100 mg (Lasix)
2 Vials HEPARIN 10,000 uts/ml 4 ml
3 Syr. ISOPROTERENOL 1:5,000 (5 ml)
2 Amps. LEVARTERENOL 4 mg (Levophed)
2 Syr. METARAMINOL 100 mg (Aramine)
3 Vials METHYLPREDNISILONE 1 gm (Solu Medrol)
2 Amps. NALAXONE 0.4 mg (Narcan)
3 Syr. PHENYTOIN 100 mg (Dilantin)
5 Amps. PROPRANOLOL 1 mg (Inderal)
Drawer #3: 3 Bags D-5-W, 500 ml

1 Bag D-5-½ NS, 1,000 ml
1 Bag LACTATED RINGERS, 1,000 ml
1 Bag NORMAL SALINE 1,000 ml
2 Btls. PLASMA PROTEIN 250 ml
REFERENCE:

72
3. Modern Blood Banking and Transfusion Practices, Harmening,
Denise H., 3rd Edition, 1994, p217-218.
4. Donor Reactions and Incidents, Blood Systems, Inc., 1993 (Video
and Printed Supplement)
73
DONOR SELECTION
1.52.1 POST DONATION DONOR CALL-BACK CARE & REPORT
PURPOSE:
Every donor is susceptible to possible post blood donation reactions.

These reactions may include very minor bruising, major hematomas,
weakness, fainting, nausea and other related symptoms. If a donor
calls to the Blood Bank, or back to an ongoing drive to report ANY type
of reaction or concern they have about their donation, a complete
record of the call must be made.
SUPPLIES:
1. Donor Call-Back Report form

2. Donor card, or a copy.
PROCEDURE:
1. If a call is received from a donor who has donated any blood

product and reports that they are experiencing some post
donation discomfort of minor or major severity, as much
information as possible must be obtained from the donor. To
assist in this documentation a “Donor Call-Back Report” form has
been developed. Either complete this form while speaking with
the donor, or complete it immediately afterwards. If you complete
the form afterwards, you must make sure to document the
information accurately on another piece of paper as you are
speaking with the donor. Do NOT rely on your memory.
2. Obtain the donor’s name and all appropriate phone numbers.
3. Obtain the Date and Location of the donation.
4. Obtain donor’s social security number and if possible, the unit

number.
5. Obtain and document as much information as possible from the

donor.
6. If the donor has a hematoma, and the donation was within the
past 3 days, recommend ice packs and Tylenol (not aspirin
containing products) for the discomfort.
If the donation was MORE than 3 days ago, recommend heat

packs and Tylenol (not aspirin containing products) for the
discomfort.
74
7. Assure the donor that what has occurred is bleeding into the
tissues and that it will subside within 2 to 4 weeks. If the
discomfort should continue, ask the donor to call back for further
evaluation.
8. If the donor is experiencing symptoms with which you are not

familiar, inform the donor that you will contact a Transfusion
Medicine Physician for further information. Let them know you
will call them back as soon as possible.
9. Assure the donor that you are VERY interested in their well being,
and that if at any time they feel that might need additional
medical attention, that one of the Tranfusion Medicine Physicians
will be happy to talk with them, or if necessary have the donor
come in for an evaluation.
10. Write all information communicated to the donor, and from the
donor, on the Donor Event Report and give to Blood Bank
supervisor for any required follow-up.
11. As soon as you have an opportunity, find the original donor card,
make a copy of both sides, and attach it to the report form.
REFERENCES:

2. AABB Standards, 18th Edition, 1997
75
DONOR AND PRODUCT SAFETY
1.54 DISPOSAL OF BIOHAZARD WASTE
PRINCIPLE:
Proper and safe discarding of donor collection material, sharps

containers, or any other material contaminated with blood or body fluids
must be followed to help prevent the transmission of blood-borne
pathogens. To minimize the volume of material that is sent for
biohazardous disposal, all employees must assure that only those items
requiring biohazardous disposal are placed in those designated
containers. Items such as paper, supply packaging, canteen containers,
etc. must be placed in non-biohazardous containers.
SUPPLIES NEEDED:
1. Biohazard boxes and liners

2. Biohazard labels
3. Clear plastic tape and dispenser
4. Beta chips
5. Bedside bag
6. One-Cup or Two-Cup Measuring Cup
7. Sharps Containers, Large & Small
PROCEDURE:
NOTE: Follow all blood and body fluid precautions whenever

handling biohazard marked containers. Please refer to the M.
D. Anderson and Laboratory Medicine Safety Manuals for
additional information on handling biohazardous material.
1. Sharps must be disposed in properly designed sharps container

which will not allow penetration. When not in use, these containers
should be covered to help prevent possible spillage.
2. Contaminated waste, tubing, gauze, and alcohol must be placed in

properly designed, labeled biohazard bags.
At a Mobile Drive Location:
1. All small, non-sharp donor collection material should be placed in a

bedside bag.
2. Sharp items and larger blood collection items should be placed in

appropriate sharps containers.
76
3. At the end of the drive all bedside bags and securely closed sharps
containers are to be placed in a biohazard bag.
4. At the Blood Bank, a biohazard box is prepared with a liner bag

and beta chips, as indicated below. The bags from the drive are
placed in these boxes and prepared for further disposal.
At a fixed Collection Site:
1. Prepare boxes as indicated below.
2. Use the boxes directly for large items
3. Place appropriate sharps containers in necessary areas.
4. Once sharps containers are ¾ full, secure the lid, and place in a
biohazard box.
Preparation of Biohazard Boxes:
1. To prepare the biohazard box for use, open and secure bottom
firmly in place. If box needs additional security, seam the bottom
with clear tape.
2. If box is not already labeled with a biohazard label, place a label on

each side of the box.
3. Place one biohazard liner inside box.
3. Add 2 cups of beta chips inside the first bag. Do not put them in
the bottom of an unlined box.
4. Place second biohazard liner inside the first,
5. Fill about ¾ full with contaminated waste and/or sharps

containers. No clean paper trash. If you fill the bag too full, you
will not be able to properly close the bag for disposal.
6. Close the double liner by twisting and securing with tape.
7. Close the box securely. If top needs additional security, reinforce

with packing tape.
8. Place the box in a designated area (dirty utility room or apheresis

lab area).
77
REFERENCES:
1. AABB Standards, 18th Edition, 1997,

2. AABB Technical Manual, 12th Edition, 1996,
3. U.T.M.D.A.C.C. Division of Laboratory Medicine Safety Manual, June
1997.
DONOR SELECTION
1.61 ROUTINE VENIPUNCTURE

PRINCIPLE:
The phlebotomist is a VITAL staff member of the blood collection facility! They are frequently the only representatives
of the organization that the donor ever meets. As a customer service representative for the blood bank, they have several
very important roles to play. The phlebotomist helps to ensure the safety, purity and potency of the product that is
collected while ensuring that the donor has a safe and relatively pleasant experience.
As a customer service representative and recruiter, the phlebotomist meets the psychological needs of the donors. It is
important that the donation process does not provoke anxiety and that a personal interest is taken in the donor. In a study
cited in Blood Donor Collection Practices, 68% of the customers who are lost believe that staff just do not care and are
indifferent toward the customer.
Phlebotomists must be vitally aware of both their verbal and nonverbal communications. Since the donor is the most
important person in the blood collection process, and the reason for the phlebotomist being there, phlebotomists must
take every opportunity to interact with and thank each donor. Donors have a need to have a feeling that they are a giving
person.
The comfort of the donation process and the ability to collect a quality unit of blood in the designated time frame is
frequently dependent on the quality of the venipuncture. The best vein is not always the one that can be seen and the
location of veins may differ from person to person. Venipuncture is considered a minor procedure causing no great
danger to the donor.
This first step in performing a venipuncture is to explain the procedure to the donor. An excellent method to gain the
donor’s confidence is to anticipate and answer any questions that the donor may have. The explanation for a first-time
donor should include approximately how long the donation will take, what is being done, and how much discomfort may
be expected. The donor should be given some notification before the needle is inserted.
SUPPLIES NEEDED:
1. Donor Card; Donor Information and Instructions Sheet

2. All supplies for Donor Arm Preparation as indicated in procedure # 1.51
3. All supplies for Collection of Whole Blood from Donor as indicated in procedure
# 2.21.
4. Smile !
PROCEDURE
1. Donor identification is the single most important process of the phlebotomy procedure and it is the
responsibility of the phlebotomist to make certain that all blood unit numbers match and are applied
properly.
78
2. The phlebotomist must identify the donor verbally by asking the donor his/her name and verify that the
name matches that on the donor card and ensure donor numbers on paperwork, collection bags, and test
tubes match
3. Prepare the collection bag according to “Collection of Whole Blood” Procedure.
4. The most widely accepted areas for venipuncture for donor collection are in
the antecubital area of the arm. Only in special circumstances would the
forearm or hand be used. The antecubital area of the arm is where the medial
cubital, cephalic, and basilic veins are located. (See diagram)
79
80
5. Apply tourniquet or blood pressure cuff about two (2) inches above the antecubital area. If a blood
pressure cuff is used apply 60mm pressure.
6. To estimate 60 mm pressure put BP cuff on staff member arm with

60 mm pressure and apply tourniquet to other arm. Have staff
member say whether you need more or less pressure. Practice will
allow approximately 60 mm pressure with tourniquet.
NEVER exceed the diastolic pressure of the donor as this occludes arterial pressure.
7. Ask the donor to squeeze the handgripper and then continue to grasp it firmly
8. Palpate using tip of finger. Do not use thumb. Visible veins are not always the best
9. During palpation the phlebotomist is checking for:
Size or diameter of the vessel

Bounce or elasticity
Depth
Firmness
Good Surrounding Tissue
Widest part of vein
Scar tissue from previous venipunctures
Direction
Varicosity
If still having difficulty locating a vein attempt to bend the arm

approximately 30 degrees which will relax muscles that may have caused
distortion of vein or vein to appear thinner.
10. Once vein has been located the phlebotomist can mark the vein,
particularly deep vessels, using the end of a pen or the end of the DUO
Swab stick making a small indentation in the skin.
11. Release the tourniquet/BP cuff.
12. Perform “Donor Arm Preparation” according to Procedure #1.51
1.61c Routine Venipuncture
13. After the prep has dried for 30 seconds and been covered with a dry sterile
gauze, using universal precautions, prepare needle for venipuncture by
removing cap, inspecting needle for any defects, and tapping butt of needle
to remove excess anticoagulant from needle.
14. Anchor vein
15. At this time it is wise to tell the donor to take a deep breath and you are
going to feel a stick to alert them to be still.
81
16. Holding needle with bevel up in one quick easy motion at a 30 - 45 degree
angle insert needle and once under skin and into vessel, flatten needle to a
10 degree angle. The needle should be inserted in the direction of vein.
17. Release hemostats and ensure a good blood flow. Once there is good flow,
cover the needle with a dry, sterile gauze and secure to arm using tape.
18. Now, ask the donor to open and close their hand on the handgripper every
3 to five seconds.
19. The tourniquet/BP cuff can be released slightly at this point to a more
comfortable level for the donor, but still support a good steady flow.
20. Once the designated amount of blood has been collected and the pouch is
full, place hemostat between needle and pouch and release tourniquet.
21. Remove tape, and quickly withdraw needle, immediately applying pressure
to venipuncture site. Ask donor to raise arm straight into the air while
holding gauze firmly to sight. DO NOT ALLOW DONOR TO BEND ARM
BECAUSE A HEMATOMA MAY RESULT DUE TO IMPROPER PRESSURE.
22. Apply needle protector over needle, fill test tubes and review paperwork as
discussed in “Collection of Whole Blood” Procedure. 2.21.
23. Have donor lower arm and check to ensure bleeding has stopped. Once
bleeding has stopped apply pressure bandage and give donor post donation
instructions.
If bleeding has not stopped, apply direct pressure up to five minutes with
ice pack to ensure bleeding has stopped. If further problems exist notify
Transfusion Medicine Physician for further instructions.
REFERENCES
1. Garza, Diana and Becan-McBride, Kathleen, Phlebotomy Handbook, fourth

edition, 1996.
2. Blood Donor Collection Practices, American Association of Blood Banks,
1993.
82
DONOR SELECTION
1.71 PREPARATION OF DONOR REGISTRATION LOG
PURPOSE:
All persons that come to any blood product collection site to donate
must have a record made of their donation or deferral. The various
collection sites may have varying types of forms to meet their
particular needs, however all registration forms will identify the same
essential information. Each form will include, but not be limited to; the
date, location, indication of product type, name of donor, unit number
of any product collected, initials of person collecting the product,
PROCEDURE:
MOBILES:
A. Whole Blood Deferrals:
1. Upon completion of screening the potential donor and

determining they will not be able to donate for reasons
documented on donor card, keep card for registration,
review, and permanent records of the Blood Bank.
2. The donor cards for potential donors that have been

deferred must be reviewed and signed by the respective
Mobile Team Leader, to assure all information is complete
and accurately documented.
3. A donor registration log must be completed for deferrals

separate from donors not deferred.
4. The deferral registration must include the mobile drive

location, date, mobile team leader, recruiter, and donor
name.
5. Upon return to the Blood Bank, all deferred donor cards are
placed in designated location for supervisor review for
possible placement on the Donor Temporary or Permanent
Deferral Log.
6. The deferred donor registration log is attached with the

collected donor registration log, Mobile Report, and Mobile
Information Sheet and placed in a designated location at the
Donor Center.
83
B. Whole Blood Donations:
1. A separate sheet is made for those donors that actually

donate. It will include the same basic information as the
deferral log, however the unit number assigned to the
product will be included.
2. The same Mobile Team Leader review will be made of the

donor card to assure that all information is complete and
accurately documented.
3. The donor registration log is placed in a designated location

at the Donor Center for further use by recruiters and
supervisors.
DONOR CENTER:
A. Whole Blood & Directed Donors:
1. A new registration form is started for each day of collection.
2. All required information indicated above for both actual

donors and those deferred will be provided on the same
form.
3. The next day these forms are picked up by an administrative

person for donor card verification and filing.
4. Directed Donor donations, as well as all other whole blood

donations, are maintained on the same log page. Directed
donations are indicated as described in Procedure #2.31.
B. Aphersis Procedures:
1. A new registration form page is started new for each day

and each draw location.
2. Registration forms from satellite draw locations are

returned to the Donor Center. All forms are maintained by
date.
3. Forms are completed as described in Procedure #3.11

(Apheresis Donor Selection and Registration).
AUTOLOGOUS & THERAPEUTIC:
A. Collections & Deferrals:

84
1. The autologous & therapeutic registration form is a
continuous one for each month. It requires the patient
Medical Record Number as well as an indication of the
number of autologus donations the patient has made.
2. Patients that are not acceptable for donation are also

indicated on the same form.
3. These forms are returned the Donor Center at the end of

each month for documentation and filing.
85
DONOR SELECTION
1.71.1 DONOR DEFERRAL REVIEW
PURPOSE:
Every donor encounter that results in the eventual deferral of that

donor, whether it is only for one day or if the donor should be placed
on permanent deferral, will have that donor card reviewed by a
supervisor. This review is used for several reasons. One is that the
supervisor will determine if the donor needs to be placed on the donor
deferral registry. The deferral will also be recorded by reason and by
technician. This allows deferrals to be monitored and trended for
possible quality improvement.
PROCEDURE:
1. All donor cards for donors that are eventually deferred are
completed according to the standard operating procedure for
each aspect of the donor encounter. All appropriate
documentation is to be noted on the donor card according to
procedure.
2. After the donor card is completed it is placed in the appropriate

designated location for supervisor review.
3. Daily, except on weekends and some holidays, a supervisor will

thoroughly review each card for completeness in all aspects of
documentation. Since 15-18% of whole blood donors and 20-25%
of apheresis donors are routinely deferred, this allows
supervisory review of a representative number of donor cards.
4. Donor cards that lack documentation will be returned to the

responsible technician for further completion. Those technicians
that fail to follow standard operating procedures will have
documentation made of these issues. Thus, when required,
employees will have documented action taken of retraining up to
disciplinary action.
5. The supervisor will determine if the donor is deferred only for a

day, e.g. low hemoglobin, or need to be placed on the donor
deferral registry.
6. Donor cards of donors that do not require placement on the

deferral registry, are sent for filing.
86
7. Those donors cards that clearly indicate that a donor should be
placed on temporary deferral for a standard length of time are
marked with a stamp, with red ink, that states “Temporary
Deferral”. It has a blank that states “Until” ( a future date) and a
signature line for the reviewing person to sign.
8. Temporary deferrals are usually for a standard length of time, as
indicated in the standard operating procedures. If a donor
indicates an exact date of the event that resulted in their deferral
they will be deferred according to the date. However, if they do
not indicate such a date, the deferral length will be for the
longest date that is appropriate.
For example if a donor says they had a tattoo on May 15, 1997,
they will be eligible to donate on May 16, 1998. However, if they
do not indicate an exact date, but say they had a tattoo last May
(1997), they will be temporarily deferred until June 1, 1998.
9. These donor cards are then sent to a Transfusion Medicine

laboratory supervisor for actual placement on the computerized
donor deferral registry.
10. All donor cards responses, or screening results, that according to

standard operating procedures indicate that the donor should be
placed on permanent deferral are sent to a Transfusion Medicine
Physician (TMP) for review and approval. Once the TMP has
approved this deferral, they will indicate “P.D. or Permanent
Deferral” on the back of the donor card and sign the card. This
card is then given to a Transfusion Medicine laboratory
supervisor for actual placement on the deferral registry as
indicated.
11. Any donor response, or screening result, that led to the donor
deferral, but do not have a standard deferral indicated in the
procedures will be sent by the Blood Bank supervisor to the TMP
for deferral status determination and if appropriate, length of
deferral. As with other deferrals these donors will be recorded in
the deferral registry as appropriate.
12. This process, as well as results from testing, brings changes to

the deferral registry daily. Thus, an updated donor deferral list
must be obtained and utilized daily.
13. Upon completion of processing by the Transfusion Medicine

laboratory, these cards are returned to the Blood Bank for filing.
14. When returned, these permanently deferred donor cards are

matched with the printed donor deferral registry to verify that
these donors are recorded appropriately.
87
15. All returned donor cards are sent for filing. Donor cards marked
as permanent deferral are maintained separately.
REFERENCES:

88
DONOR SELECTION
1.72 POST COLLECTION PREPARATION AND TRANSPORTING
PURPOSE:
The blood products that are collected on mobile drives are packaged
and prepared at the drive site before transporting to the Transfusion
Medicine laboratory. Proper packaging, handling, and temperature are
critical to ensure the quality and the viability of the various
components of the blood product.
SUPPLIES:
1. Component Delivery Temperature Record Form

2. Transport container
3. Tubing strippers
4. Tubing sealer
5. Packing tape
6. Temp-Chex Thermometer. Readable Range 20 to 50C. Streck
Laboratories, Inc. Omaha, NE, for each transportation container.
PROCEDURE:
1. See Procedure 1.73, Monitoring Blood Product Temperature After

Collection, for procedure of monitoring environmental
temperature during the drive and after transport.
2. After the whole blood product is collected, strip the tubing three
consecutive times. Start each stripping from the end of the
tubing to the base of the collection bag.
3. Make the tubing into segments using the tubing sealer. Make
each seal approximately on the designated "X" on the tubing.
This helps assure that segments are of adequate length for
laboratory use.
4. The tubing is folded in accordion style at each seal. Secure the

folded tubing with a rubber band.
5. Place a rubber band around the whole bag and component bags.
6. Place the blood bags in numerical order in a transport container.

All transport containers must have a biohazard label.
7. Place red top tubes in numerical order in a rack. Wrap each rack
89
in an empty blood bag storage bag, and then seal securely with
tape. Place tubes in the transport container with corresponding
blood components.
8. Completed donor cards are also placed in transport container

with corresponding blood components.
9. A Component Delivery Temperature Record Form and

thermometer are included in each transport container on top of
the component bags.
10. Blood units should be delivered to Transfusion Medicine within

four to five hours from initial draw time. Keep blood units at room
temperature, unless delivery will be delayed past seven hours
after collection. If any units are going to be delivered to the
laboratory close to this seven hour period, you should call the lab
at 792-8630 before delivery, so that they will have technicians
available to handle the products upon delivery.
11. If the time elapse between collection and delivery is to exceed

seven hours, at time of transport sealed bags of ice must be
packed with the blood units. As above, a temperature form is
included and documentation made that ice accompanied the
units.
REFERENCES:

90
DONOR SELECTION
1.73 Monitoring Blood Product Temperature After Collection
PRINCIPLE:
Immediately after collection, whole blood units shall be placed in

storage at a temperature between 1 and 6 Centigrade, except if they
are to be used for preparation of components (i.e. platelets), in which
case up to 8 hours may elapse before refrigerated storage at 1-6
Centigrade. M. D. Anderson Blood Bank strives to prepare platelets
from every unit of whole blood. Thus, blood intended for preparation
of platelets shall be stored in a manner intended to reach a
temperature of 20-24 C. This same temperature should be maintained
until the products are delivered to the Transfusion Medicine
Laboratory.
Apheresis single donor platelets are collected in an environment that

is maintained at 20 -24 C. Thus, this same temperature range should
be maintained during transport to the Transfusion Medicine laboratory.
SUPPLIES:
1. Igloo® or any other type of transport container that is

manufactured to provide protection from the temperature
elements.
2. Temp-Chex Thermometer. Readable Range 20 to 50C. Streck

Laboratories, Inc. Omaha, NE for each transportation container.
3. Blood Product Delivery Temperature Record Form
PROCEDURE:
1. A thermometer must be available for each container. Therefore,

the team must prepare in advance for the number of anticipated
donors. Mobile Team Leaders should always carry back-up
thermometers.
2. At the start of each drive the temperature of the blood delivery

container is measured and recorded. Place a Temp-Chex
Thermometer with a reading range of 20 to 50 C in each delivery
container. Allow thermometer to come to room temperature
range before reading. This may take about 10 minutes.
91
3. Record the temperature of the open container on the Blood
Product Delivery Temperature Record form. The desired
temperature range should be in the 20-24 Centigrade range.
Note: If the temperature is < 20 indicate this on the form

and when the blood is delivered to the Transfusion Medicine
Laboratory, you must bring this to the attention of a
supervisor. They will take the temperature of the blood units
to determine if platelets should be prepared.
4. If the temperature of the coach or the donation room is not in

this desired range, wait about 5 minutes to see if the
temperature reading on the thermometer is coming into
acceptable range. If the reading still remains out of desired
range, attempts should be made to have temperature adjusted
accordingly.
This will usually only be possible if you are on a coach or on a

drive in a small room that has an individual thermostat. If
adjustments have been made, wait about 30 minutes and take
another reading. Record the second reading.
If it is not possible to make temperature adjustments, just make

a note on the form. (i.e. In High School auditorium - not possible
to adjust temperature).
5. Until units are ready to be transported, keep the thermometer in

the transport container.
6. When units are ready to be transported, place them in the

transport container. Fill in the indicated information on the Blood
Product Delivery Temperature Record. (Time of first and last
draw, delivery person, number of units). Place the record form in
the top of the container. Place thermometer near the top of the
container, so that it can easily be read upon delivery.
7. During transportation, blood product containers should not be

placed in a location, such as direct sun light or closed
unairconditioned vehicle, that would cause heating (or cooling in
the winter) of the units to an unacceptable level.
8. When the products are delivered to the Transfusion Medicine

Laboratory, the person delivering the products will read the
temperature on the container again and record it on the record
form. The temperature should read between 20 - 37 C. If the
temperature is not within this range. Notify a Transfusion
Medicine supervisor immediately. Do not remove the units from
92
the transport container.
9. If temperature is in the desired range, the delivery person will

place all blood products and donor cards in designated areas. The
container with the thermometer is returned to the blood bank.
The temperature form is given to a supervisor for review and
filing.
10. Note: These thermometers have a protective container to reduce

breakage and spillage. If at any time you notice that the
indicator fluid has breaks in it, it should be returned to a
supervisor. The thermometers should not be removed from the
outside casing. In case of thermometer breakage, this case will
protect the technician as well as the blood products. Dispose of
thermometer in a container suitable for glass.
11. If a delivery service is utilized for the delivery of products, the

temperature before delivery will be monitored as indicated
above, however, the technicians in the Transfusion Medicine
laboratory will take the temperature of the container upon
delivery. The container and completed form will be returned to
the blood bank.
REFERENCE:

93
M. D. ANDERSON CANCER CENTER - HOUSTON, TX
BLOOD BANK
BLOOD PRODUCT DELIVERY TEMPERATURE RECORD
 Whole Blood # units ___________  Platelets # units ____________
Date: Location:
Beginning Container Temperature Time Arrived in Laboratory:

(Desired Range 20 - 24 C)
Time: Tech Initials:
Second Reading ( if necessary) Temperature of Container:

Time: Tech Initials: Desired Range: 20 - 37 C
Third Reading (if necessary) CERNER (Donorlink) File name:

Time: Tech Initials:
Time of First Draw: Comments:
Time of Last Draw:
Delivery Person:
Reviewed by / Date: _________________________________
94
SINGLE DONOR PLATELET COLLECTION
3.11 DONOR SELECTION AND REGISTRATION
PURPOSE:
The suitability of each apheresis donor is to be determined by the

results of the donor physical and the donor history (questionnaire) on
each day of donation. Each donor selection and procedure is performed
under the direction of the Transfusion Medicine Physician (TMP) and
following all approved standard operating procedures in the Donor
Selection and Single Donor Platelet sections of the procedure manual. A
Transfusion Medicine Physician is assigned to provide medical
assistance to all the Apheresis collection sites every day of operation. As
indicated in this procedure, and other applicable procedures, the TMP
must be appraised immediately of any condition or event that needs
their approval, intervention, or medical intervention. The TMP page / call
list is updated monthly and as needed. See Procedure #1.34 for
instructions.
The donor interview must be conducted in suitable location that assures

visual and verbal confidentiality. Only those donors that meet the
required standards to be a platelet donor can be accepted.
SUPPLIES:
1. Platelet Apheresis Donor Card

2. Platelet Apheresis Consent Forms (English & Spanish)
3. Davis’s Drug Guide
4. All supplies necessary for routine donor screening
5. 2.5 ml Lavender top vacutainer tube
6. Routine blood collection supplies
7. Dr. Lichtiger letter on platelets (English & Spanish versions)
8. Terumo AVF Set 17G x 1” (Code AV *17CO2) Ultra Thinwall
Siliconized Needle
9. Terumo 19G x ¾” SurfloWinged Infusion Set
10. Vacutainer Brand 23G ¾” x 12” Safety-Lok Blood Collection
Set
DONOR INTERVIEW:
It is very important to establish donor confidence immediately. The time

of the interview is very short and any barriers to communication and
understanding must be overcome as soon as possible. Trust and
confidence enables the donor to provide accurate information. This
should not be just a question and answer period, but a time for
95
exchange of information between donor and interviewer. Donating
platelets may be a routine procedure for the apheresis staff, but to most
donors it is perceived as a medical encounter. There frequently are
strong emotions associated with the procedure and the possibility of
physical discomfort. The examiner's patience and understanding will
contribute greatly to a successful "selection" interview and ultimately a
better donating experience for the donor.
DONOR SELECTION:
1. All potential platelet donors must meet the same standard criteria
as potential whole blood donors, except with a few additional
criteria.
2. Complete the donor card documentation, donor questioning, pulse,

temperature, blood pressure, etc. as described in Section 1 on the
procedure manual.
3. Since aspirin interferes with the function of platelets, potential

platelet pheresis donors must not take aspirin or aspirin containing
derivatives three days (72 hours) prior to donation. Check Davis's
Drug Guide, list of medications containing aspirin listed in
Appendix D, or call the TMP to verify any drugs of question that
the donor has taken.
4. Acceptable Plateletpheresis Donation Intervals:
a. Minimum interval of 48 hours
b. Gift Donor - 24 times a year = once every two weeks
c. HLA Crossmatched Donors, Pediatric Directed Donors and

donor for other patient special needs = Frequency of
donation based on TMP approval.
d. More than 4 donations in 30 days require TMP approval.

Check the donor’s folder to verify donation frequency.
Document this contact and response on the donor card.
5. Platelet apheresis donor must weigh at least 100 pounds. (Still 110
pounds for whole blood donors.)
6. Persons may donate platelets after 72 hours of donating whole

blood, as long as they meet all screening standard donation
criteria.
96
7. Donors must meet all donor criteria indicated in section 1.00 Donor
Selection to determine donor suitability. The hemoglobin should be
made when the CBC is done, and not by a separate fingerstick. At
off site locations this may vary depending on availability of
Hematology analyzer. Previous counts qualify non-first time
donors.
8. Donors should be given a donor information sheet each time they

come to donate. Ask the donor if they have read the information on
the this form, and make sure the donor takes it with them when
they leave
9. The donor must read and sign the platelet apheresis consent on
automated blood cell separator. It is VERY important that you ask
the donor if they have any questions about the procedure or any of
the information given to them. Remind them to freely ask any
questions that they might have during the procedure.
NOTE: Signed consent forms are to be updated every calendar year

and kept in donor file folder. In addition to having the donor
read the special consent form, the procedure should be
explained to the donor and the donor's questions must be
answered. The donor may want to discuss the procedure
with the TMP.
If the donor is still uncertain about the procedure, you may

suggest that they watch a donation for a while, and perhaps
ask a previous donor some questions. If at any time you feel
that they really are not comfortable with the procedure,
advise them to come back at another time.
10. Explain to the donor that since platelets should be ABO blood type
compatible with the patient. Thus, the person that they are
donating for may or may not receive the exact unit that they
donate. To provide our patients with the best product possible, all
units donated are transfused by 6:00 P.M. the next day.
11. If the donor is donating for a pediatric patient, indicate on the top
of the donor card that the platelets are for a pediatric patient,
provide patient identification number, and indicate “DD” on the
unit card.
12. If the donor is donating for an HLA crossmatched donor indicate

the same on the donor card.
13. After completing the above, collect a blood sample for hematology
analysis from the donor.
97
14. Before sticking the donor for the hematology sample, verify the
donor’s identification by asking them to repeat their name and
social security number. Write the social security number, as they
are repeating it on the back of the donor card in the lower left
corner.
Verify that the social security number is what is indicated on the

front of the card. If there is a discrepancy, ask the donor about it.
You must make note of this event on the bottom of the donor card.
If the number on the front of the donor card is in error, have the
donor draw a line through the number in error, write the correct
one, and initial the change.
You must then check this second SS# for any listing in the deferral
registry and make documentation of this.
15. Care must be taken to preserve the integrity of the vein that may
be needed for the collection procedure,
a. Using a vacutainer needle, collect a 2.5 ml lavender top

vacutainer tube.
b. After venipuncture, apply sterile gauze to the site
c. Ask donor to apply pressure to site
d. Analyze the sample on the hematology analyzer
according to procedure for that analyzer.
e. Any value that falls outside the acceptable range
should be run in duplicate.
f. Accept or reject donor according to established

guidelines. The TMP may be called for approval for
donors that are minimally below the guidelines, if there
is a special need for the product. Accept or reject the
donor based on the TMP decision. Document all
conversations with the TMP.
Those donors with special approval MUST

have the donor card signed by the TMP. You must make
note of this and assure that the TMP receives the card
for signature approval.
g. Apply bandaid to venipuncture site.
NOTE: On donors that have poor venous access another

method of acquiring the sample may be used to
minimize the number or venipunctures that the donor
must have.
98
1. Prepare the phlebotomy site following the standard
DuoSwab procedure.
2. Acquire venous access with either a 19G x ¾” winged
infusion set needle or a 17G x 1”AVF set needle.
3. Maintaining sterility, remove a Vacutainer luer adapter
from a 23G ¾” x 12” butterfly needle set and attach it
to either the 19G or 17G needle.
4. Attach a Vacutainer holder to the adapter and obtain
the necessary samples.
5. Clamp off the access line.
6. Maintaining sterility, remove the vacutainer holder from
the adapter.
7. Leave access line in place while hematology sample is
being analyzed. (You must not waste time, because this
access line is not anticoagulated).
8. If donor hematology results are acceptable, maintaining
sterility, remove the luer adapter, and attach the primed
kit return line to the access line.
NOTE:
(a.) In the absence of a platelet analyzer:
According to AABB standards, if plateletpheresis is

performed more frequently than every 4 weeks, a
platelet count shall be obtained and must be more than
150,000 /L prior to performing subsequent
plateletpheresis.
A platelet count is not required prior to the first

procedure if the interval between plateletpheresis
procedures is at least 4 weeks.
The result of a platelet count done before or after a

procedure may be used to qualify a donor for the next
procedure.
(b.) At Exxon apheresis satellite unit draw an EDTA tube and

perform hemoglobin using the Hemocue. The pre
donation samples are brought to the Blood Bank for
testing. The results of the pre sample are to be
reviewed to determine donor suitability for those
donors that want to donate more frequently than four
weeks.
Those donors that have a value outside the acceptable

range must come in the day before their next donation,
99
to have a CBC sample taken and found acceptable,
before they can donate again.
16. Acceptable Hematology values, unless otherwise approved by the

TMP.
Platelet count > 150 x 109/L.
WBC < 10,000/ul ** For non-smoker.

If donor is a smoker and has a WBC value >10,000, contact
TMP for approval.
Hemoglobin > 12.5 g/dl
17. If the donor does not qualify to donate platelets:

a. Document in the comment section of the donor card the
reason(s) for deferral. If donor should be placed on
deferral list, be sure to indicate all necessary
information that is required.
b. Log all required donor information on the daily

apheresis registration form. Highlight the entry with
the blue marker pen.
c. Place donor card in “deferral” folder for supervisor

review.
18. If donor is accepted and a successful unit is collected, register the

donor in the Cerner LIS following Procedure #9.12 = Clinical Order
Entry (COE).
19. Remember, if the TMP makes special approval for any donor to
donate, the signature of that TMP must be obtained on the donor
card.
20. First time donors must have each step of the process explained to
them BEFORE it occurs. Allow the donor adequate time to ask
questions.
21. Register the donation on the daily apheresis registration form for
the collection location. You must provide all of the following
required information: Donor name, donor social security #, name
of patient receiving coverage or “gift”, unit number, instrument
the procedure was done on, Cerner LIS accession # for bag count,
pre platelet count, and technician initials.
22. The technician that performed the procedure will fill in product
yield (units) field. This person should review the registration log
daily for procedures performed on the previous day. They should
100
go to the results for that procedure in the computer and place
them on the worksheet and the yield on the registration form.
REFERENCES:
101
3.13.1 DOCUMENTING APHERESIS PROCEDURES
WEIGHING PRODUCT CONCENTRATES &
COLLECTING PRODUCT SAMPLES
PRINCIPLE
All pertinent donor and procedure information must be legibly, timely,

and appropriately documented on the Apheresis Worksheet, specimen
tubes, product bags, and all other pertinent forms.
SUPPLIES
1. A set of 20 unit numbers which consist of both eye readable and

bar codes.
2. Two 7ml red top tubes and one 7ml lavender top tube (For donor
processing)
3. One 5 ml red top tube
4. Transfusion Medicine Unit Card.
5. Apheresis Comment sheet.
6. Apheresis Worksheet
7. Platelet Consent form (English /Spanish).
8. Platelet product Labels.
9. Donor Folder
10. Donor Card
PROCEDURE:
1. Ascertain whether the donor is new or repeat donor. If she/he is a

repeat donor obtain donors old folder. If the donor is new, a
folder will be prepared that will contain:
a.) Signed consent form
b.) Donor Comment page
c.) Documentation of any aborted procedures.
2. A worksheet is completed for each procedure according to

Procedure 3.15.
3. Donor processing samples may be obtained either from a

separate venipuncture on the donor or from the product
collection kit pouch during the procedure.
5. Two - 7 ml red top and one 7ml lavender top vacutainer tubes are
obtained from donor. Tubes should have appropriate labels
applied either immediately before the sample is collected, or the
donor’s full name may be written on EACH tube with the
102
technician initials and date. These tubes may have the unit
number labels applied when a unit number is assigned.
PLACEMENT OF UNIT NUMBERS
1. Each set of unit numbers contains 20 number labels.

10 Bar Coded numbers
10 "Eyereadable" numbers
(Do not have a Bar Code label, thus can not be read by
a scanner)
2. Each donation of platelets/blood uses a new set of numbers not

used for any other unit.
3 Attach each label as indicated. Any used labels are attached to

the back of the bag and sent with the product.
a.) Front of donor card: 1-eye readable label
b.) Back of donor card: 1 Bar-coded label
c.) Donor instructions: 1 eye-readable label
d.) Worksheet 1 eye-readable label
e.) On each of two red top tubes, place one non removable bar
code. Align the bar code so that it is close to red stopper
and runs from top to bottom.
103
f.) On the third 7cc purple top tube place one non removable
bar-coded unit number and one removable bar-coded unit
number. Initial each tube.
g.) Product Bag Count Tube 1 eye-readable label
h.) Registration log 1 eye-readable label
i.) Comment sheet 1 eye-readable label
j.) Transfusion Unit Card (1-2) 1 bar-coded label
k.) The remainder of the unit numbers are to be placed on the

back of the product bag.
4. To obtain blood into three 7cc red top tubes. Collect blood
samples from the pouch attached to the needle site on the
apheresis kit. Label tubes with Donor I.D. Number and technician
initials.
NOTE: When a collection kit does not have a sample collection

pouch, samples may be collected with the CBC sample
or at the end of the procedure. To collect at the end,
disconnect the access tubing from access needle and
drip into tubes. If applicable, after the reinfusion is
complete, from the port attached to the return tubing.
Since the sample is mixed with ACD, collect one 7 cc
red top for discard, then collect the other 3 tubes.
NOTE:
a. While obtaining blood samples, the integrity of the kit

should not be compromised. That is, since each set is a
closed system, if any activity performed enters this closed
system, the "integrity" of the kit is compromised.
If the integrity of kit is compromised then the expiration

date on the product must be adjusted to expire in only 24
hours.
b. Make sure the samples do not contain anticoagulant.
6. If platelets are donated for a specific cross match patient, or as

instructed by TMP prepare a white label with the patient's name,
number, date and technician initials. Add "or anyone" after the
104
patients' name. Place the label on the platelet concentrate. For
all other platelet concentrates no labels are needed.
When the platelets collected are designated as cross matched:
a. Stamp "X-Match Platelets" across the top of the donor card.

b. Use the "X-Match Donor" stamp on a plain white label,
complete the information and place the label on the front of
the platelet concentrate.
7. If donor is donating platelets for a pediatric patient. Keep one

copy of the green miscellaneous slip in the donor file and affix
one to the donor card.
8. Procedures done on any of the cell separators must have one unit
number on the product bag before heatsealing and detaching
them. Make sure at least 20 to 25 inches of tubing is left attached
to the bag. Place platelet label, if not already provided by the
manufacturer, on the bag. Do not record the expiration date until
the procedure is complete.
9. Obtain the weight of the product. This method will vary by

instruments. The COBE instruments display the weight of the
product with the weight of the bag already taken into
consideration. The CS3000 instruments do not provide this
feature. On the CS3000, an estimated weight (volume of plasma
collected + 31ml of platelets in PLT30 chamber) is to be verified
by using the scale on the Haemonetics V50 instrument or some
other controlled scale.
Remember if you use an external scale, deduct the wt. of empty

bag to obtain the net weight of the product.
105
NOTE: WEIGHT OF ONE EMPTY PLATELET
BAG
- CS3000 Plus - 26 grams
- COBE Spectra - 38 grams
COLLECTING PRODUCT SAMPLE:
Before collecting a product sample for counting. Do the following.
1. Seal off and discard the unused platelet bag
2. Strip the tubing attached to the platelet bag containing the

product.
3. Use A Stripper or a clamp to strip the concentrate into the

platelet bag and clamp using a hemostat.
4. Mix gently for a few minutes and release the clamp.
5. Make sure the tubing fills up with homogenous platelet

concentrate.
6. Heat seal the tubing. six inches below the 'Y' manifold.
7. Cut both ends of the sample tubing and transfer the product into
one 5ml red top tube.
8. If a low volume platelet product is requested:
a.) Collect all product in one bag
b.) After the procedure is complete seal and remove the unused
platelet bag
c.) Leave a long tubing tail of about ten (10) inches attached to
the platelet bag.
9. Label the tubes in the following manner.
Label on 5ml red top tube, must have
a. Donor Name.
106
b. “BG BB CONC” Accession Number (Computer number for
bag count)
c. Weight of Product Concentrate
d. Date.
e. Tech Initials
12. Complete Transfusion Medicine Unit Card As follows:
a. Fix a Bar Code in the Donor section

b. Date Product was Prepared
c. Date Product Expires
d. Cell Separator Used
e. Tech initials printed plainly
f. Weight Concentrate
g. “BG BB CONC” Accession #
If a unit of plasma is collected, a second unit card is prepared:
a. Fix a Bar Code label in the Donor section

b. Date Product was prepared
c. Volume of plasma
d. Time procedure ended
107
Note:
* Plasma must be transported to the Transfusion Medicine
laboratory within 7 hours of when the procedure was ended.
* Inform a supervisor that you are delivery a plasma product.
DO NOT PLACE PLASMA ON A SHAKER AT THE BLOOD BANK
OR LAB.
13. Place the following on the Comment Sheet in the Donor's folder
a. Date
b. Component Unit Number
c. Instrument type and instrument number
d. Technician's Initials
e. Brief comment on procedure outcome
f. Complications or any problems encountered.
14. Copies of all incident and aborted reports must be filed in donor
charts.
15. Document donor social security # on the inside of donor file.
16. After the procedure is completed the donor chart containing

consent form and comment sheet should be filed alphabetically.
17. The product should be transported to transfusion medicine as

soon as possible.
18. The following will accompany the product.
a). Donor Card.

b). Three donor processing tubes.
c). One Wt Concentrate Tube.
d). One Transfusion Medicine Unit Card.
108
109
DOCUMENTING APHERESIS PROCEDURES
3.13.2 ABORTED PROCEDURES
PURPOSE:
An aborted procedure is one that is stopped, for a any of a variety of

reasons, after the donor has been stuck with a needle and a kit has
been used. This may result in no blood component being harvested
and thus no samples sent to the Transfusion Medicine laboratory for
processing, or it could be one that has to be cut short for some reason
and only a partial product was collected.
The majority of apheresis donors will experience no ill effects from the
platelet donation procedure. Approximately 1-2% may experience a
physiological response, possibly resulting from the emotional effects
of stress or anxiety, and they may not want to complete the procedure.
Some procedures may be aborted due to poor venous access, or they
may be discontinued because of a defective kit or an instrument
problem. There are numerous other events that out of no fault of the
donor or technician, the procedure cannot continue to the anticipated
finish.
Proper documentation of these events must be made so that if there

are any issues resulting from the stopping of the procedure, complete
information will be available to assist those that will need it.
SUPPLIES:
1. Donor Card
2. All unit numbers that were originally assigned to the product
3. Aborted Platelet Apheresis Procedures Form
4. Donor Incident Report Form
PROCEDURES:
NOTE: Whenever an apheresis procedure is aborted, it is

required to inform the Transfusion Medicine Physician.
Documentation must be made on their recommendations and
comments. Donor card must be sent to TMP for signature.
1. If the donation procedure is requested to be stopped by the

donor, if possible return the blood back to the donor and remove
the needle as soon as possible.
110
2. If the extracorporeal blood can not be returned to the donor (e.g.
due to infiltration), inform the donor. Due to this loss of blood,
their hemoglobin value may be low and prevent them from
returning to donate until their value returns to an acceptable
level of 12.5 g/dl.
3. Instruct the donor to take liberal amounts of fluids to restore any

alterations that may have occurred.
4. If the procedure was stopped due to a reaction of any form,

calmly reassure the donor and provide any possible protection
from embarrassment. The technician should attempt to convert a
bad experience into a more positive event that will want the
donor to return to donate at a future date.
5. After cleaning and wrapping the phlebotomy sites, escort the

donor to the refreshment area. Show appreciation to the donor
for their support. Be sure the donor knows that we want them to
return soon.
6. It is very important that all documentation of the event be

thoroughly completed shortly after the aborted procedure.
Technicians MUST NOT wait till the next day to do so. If the donor
were to have some problems after leaving and medical assistance
becomes necessary, the Transfusion Medicine Physician will
REQUIRE documentation of all related events.
7. Complete the Apheresis Worksheet
8. Make a brief, but complete, note on the donor’s apheresis

Comment Page maintained in their folder.
9. On the Incident Report form place all of the unit numbers that
were being used for the procedure. Explain in detail why the
procedure was aborted. (See example)
10. This form should be given to a supervisor for review and

signature.
11. Attach to the form the donor card and the worksheet.
12. Supervisor will review and sign the original of the donor card and
worksheet. Copies of both will be attached to the aborted procedure
report. A copy of the report will be placed in the donor’s folder.
13. Complete ALL information required on the Aborted Platelet

Apheresis Procedures form. Do not leave any questions
111
unanswered. Indicate “N/A” when necessary if this is not
applicable to this event. (See example)
14. Have a supervisor review this form. After the supervisor has
signed this form, it must be placed in the donor’s permanent
folder.
15. Register as usual all donor information on the daily donor

registration log sheet. Highlight this entry with a green (or yellow
+ blue) highlight marker.
Note:. According to current AABB standards; when it becomes

impossible to return the donor’s red blood cells during
plateletpheresis or leukapheresis, at least 4 weeks should elapse
before a subsequent cytapheresis procedure unless: 1) the
hemoglobin requirement is met and more than 72 hours have
elapsed; or 2) the collected cells are expected to be of special
value to a recipient and the physician supervising the procedure
documents that the donor’s health permits apheresis.
REFERENCES:
112
U. T. M. D. ANDERSON CANCER CENTER – HOUSTON, TX
BLOOD BANK
ABORTED PLATELET APHERESIS PROCEDURES
** This form is to be completed immediately after the procedure is aborted. The technician that was primarily involved with the
donor should complete it. Any other technicians that assisted should also sign the report.
Donor Name: ___________________________________________ Unit Number: ____________________
Date: _______________ Procedure Start Time: ______________ Stop Time:______________
Instrument: COBE CS3000 No: __________ Kit Lot Number:________________________
Due to defective kit? YES NO If yes, was manufacturer notified? NA YES NO

(If yes, notify a supervisor. All other kits of this lot number must be located.)
Due to malfunction of instrument? YES NO

If so, please describe:
_________________________________________________________________________________________________________________
_________________________________________________________________________
Other reason for aborting the procedure:__________________________________________________________

_____________________________________________________________________________________________
Was all blood returned to the donor? NA YES NO

If “NO”, how much was not returned? ______________ ml
Name of TMP called: ______________________________________________ Time:________________
TMP recommendations to the donor______________________________________________________________

_________________________________________________________________________________________________________________
_________________________________________________________________________
Describe in detail events leading up to the aborted procedure and all actions taken:
_________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________
__________________________________________________________________________________________________________
Time /Condition of donor upon release: __________________________________________________________
How can this be prevented in the future?

_________________________________________________________________________________________________________________
_________________________________________________________________________
Technician(s) signature / Date: _________________________________________________________________
Supervisor Review / Date: ______________________________________________________________________
1
3.15 - APHERESIS WORKSHEET PREPARATION & CALCULATIONS
PRINCIPLE:
Each apheresis must have all pertinent steps, product information, and appropriate
donor information recorded on the apheresis “Worksheet” for each apheresis
procedure performed on the donor. This record combined with the donor card, and
comment sheet, becomes the official documentation of the procedure performed. It
is extremely important that all information be provided correctly and timely.
Each pheresis procedure must also have calculations performed on the product
yields in order to determine the effectiveness of the procedure. In the Cerner
Laboratory Information System, when the bag counts are resulted, the yield
calculations are automatically performed. The formulas for the yields are provided to
show you how they are made and what information is necessary to perform them.
PROCEDURE:
A. WORKSHEET DOCUMENTATION:
1. Carefully complete all worksheet required information legibly and as soon

as possible during the procedure. Do not wait till the end.
2. In the top right corner of the worksheet fill in the following:

a) Donor’s Complete Name
b) Date
c) Unit Number (when assigned)
d) Circle type of Product (Platelets or Granulocytes)
3. Indicate donor information from donor card in the top center box:
a) Blood Pressure
b) Pulse
c) Height
d) Weight
4. Enter donor’s Pre-CBC results in the top left box
5. When you have started the procedure, enter the lot numbers and
expiration date of ALL reagents, kits, and bags that are used. If for any
reason you use a second bag of reagent or kit this must be documented in
addition to the first one used.
On leukapheresis procedures the Hespan and citrate lot numbers are to

be documented. Since it is not uncommon to use part of a second bag of
hespan+citrate, this must be documented as well as the lot number of the
transfer pack if one is used.
2
6. All data regarding the procedure are to be recorded as indicated for each
of the various instruments that might be used. (e.g. Instrument #, etc.)
7. Record the following:

a.) Venous Access arm used (Right or Left)
b.) Return arm used (Right or Left)
c.) Time procedure started
d.) Time procedure ended
e.) If plasma collected, the volume
8. If the Transfusion Medicine Physician was consulted for any aspect of the
procedure, indicate this in the comment section of the worksheet. If the
TMP has made exception to the policy for the donor to be drawn, this
worksheet is to be flagged for TMP signature.
9. After the procedure, all worksheets are put in the notebook. The
notebook is maintained by date of collection. Worksheets are NOT to be
left in the donor’s folder, awaiting calculations.
10. Specimen Count (product yields) fileds will be filled in by the technician
that performed the procedure. This person should review the registration
log and worksheet notebook daily for procedures performed on the
previous day. They should obtain the results for that procedure from the
computer and place them on the worksheet.
11. A supervisory technician is assigned to review ALL worksheets and sign as

verification of the review of this information for completeness. If
information is not being completed in a timely manner, technicians will
first be reminded of this issue by the person performing the review.
NOTE: All worksheet and donor charts that the TMP was called for
consultation or approval must be reviewed by the TMP on a weekly
basis.
A Random - 10%-20% of regular donor charts are also reviewed by

the TMP on a weekly basis.
B. CALCULATIONS USED IN APHERESIS PROCEDURES:
1. CALCULATING ESTIMATED DONOR BLOOD VOLUME:
NOTE: Calculate before starting plateletpheresis.
a. You must know:
1) Donor's height in inches

2) Donor's weight in pounds
3) Donor’s Hematocrit
3
b. Using the nomogram for the total blood volume, find the estimated
blood volume based on donor's height and weight. Write this
number on Line A of the Apheresis record worksheet.
c. To estimate blood volume:
Males
a) Weight in pounds  2.2 = weight in kilos
b) Weight in kilos x 77 = Estimated blood volume in ml
Females
a) Weight in pounds  2.2 = weight in kilos
b) Weight in kilos x 67 = Estimated blood volume in ml
2. PLATELET YIELD:
NOTE: This must be calculated for all apheresis procedures after results are
available on the concentrate. Currently in the Cerner Laboratory Information
System, when the bag counts are results, the yiedl calculations are
automatically performed. If for some reason this function is not available,
calculations must be done following the guidelines below.
a. You must know:
1) Net weight of concentrate bag in grams.
2) Platelet count ( x 103/mm3) on concentrate sample.
*To obtain net weight:

(Total weight of concentrate) - (Weight of empty bag) = Net weight of
conc.
b. To determine the total platelet yield of the concentrate (expressed in

x 1011) multiply the weight of the concentrate times the platelet
count, then move the decimal 5 places to the left.
Example: Platelet count = 1,640 x 106 /l

Wt. concentrate = 280 gm.
280 x 1640 (x 106) = 459,200 (x 106)
(moving decimal 5 places to left) = 4.592 (x 1011)
(rounding to 1 decimal) = 4.6 x 1011 total platelet yield
NOTE: A minimum total platelet yield of 3.0 x 1011 or (5.45 units) in 75% of
automated plateletapheresis procedures is desired.
4
c. One unit of platelets is a minimum of 0.55 x 1011 platelets. To
determine the number of units in the concentrate, divide the total
platelet count (x1011) by 0.55 x 1011.
Example: 4.6 x 1011 / 0.55 x 1011. = 8.4 units of platelets
3. WHITE CELL YIELD ON LEUKAPHERESIS PRODUCTS:
NOTE: This must be calculated for all leukapheresis procedures after the
results are available on the concentrate. As with the platelet yields these
values are not in the Cerner LIS.
a. You must know:
1) Net wt. of the concentrate in grams
2) WBC count (x 103/mm3) on concentrate sample sent to

hematology lab
b. To determine WBC yield, multiply the weight of the concentrate

times WBC count of the concentrate then move the decimal 4 places
to the left.
Example: WBC count = 185.0 x 103/mm3
Volume. of conc. = 386 ml = 386 x. 103l
(185.0 x 103/mm3) x (386 x 103) = 71,410. x 106
moving decimal 4 places to the left = 7.1 x 1010 total WBC yield
NOTE: For leukapheresis procedures a WBC yield greater than or equal to

1.0 x 1010 is desired.
REFERENCES:
1. Blood Transfusion Therapy. A Physicians Handbook, AABB, 1983.

5
THE UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER
BLOOD BANK -- HOUSTON, TEXAS
APHERESIS WORKSHEET
DONOR OPERATIONS
CBC PRE-COUNT DONOR

NAME: ______________________________________________
WBC _________ x 103/mm3 BP: ________________
DATE: ______________________________________________
RBC _________ x 106/mm3 Pulse: ________________
UNIT ___________________________________________
Hgb _________ g/dl Height: ________________ NUMBER:
Hct _________ % Weight: ________________ Circle One: Platelets

Granulocytes
Plt _________ x103/mm3
COBE SPECTRA CS3000 PLUS # VENOUS ACCESS RT LT

# _____________________ ________________
RETURN RT LT
CCM ___________________ INTERFACE _________________
DBL STICK YES NO
PLASMA COLLECTED ____________
ml
ESTIMATED BLOOD VOLUME FINAL VOLUME PROCESSED PROCEDURE START TIME: _________________
( WT2.2 ) x 67 FEMALES
77 MALES _______________________ ml PROCEDURE STOP TIME: _________________
________________ ml
Cerner Bag Count Plasma Unit Collected: YES NO

Accession #
Volume of Plasma: ________________________ ml
___________________________
SPECIMEN COUNT COMMENTS:
WBC ___________ x 103m ____________________________________

____________________________________
Plt ___________ x ______________________
103/mm3
____________________________________
Wt ___________ g ____________________________________
______________________
YIELDS
Plt ___________ x 1011 ____________________________________
____________________________________
WBC ___________ x 1010 ______________________
Units ___________ ____________________________________

____________________________________
TRANSFUSION MEDICINE PHYSICIAN /DATE APHERESIS SUPERVISOR / DATE

Rev 2/98
6
3.16.2 APHERESIS QUALITY CONTROL
ROOM TEMPERATURE MONITORING
PRINCIPLE:
Platelets are to be stored at 20 - 24 C with continuous gentle agitation. The

temperature in the immediate vicinity of the platelet storage area must be
monitored and recorded to ensure that the storage temperature is within the
proper range. This ambient temperature shall be recorded at least every 4 hours.
The Temp-Chex (Streck Laboratories, Inc.) is manufactured to meet NIST (NBT)

standards of accuracy is a certified traceable to an NIST (NBT) standard
thermometer to be accurate to ±1. Temp-Chex is not an NIST thermometer.
The Temp-Chex consists of a short stem bulb immersion thermometer inserted

through a rubber stopper into a 10 ml vial containing a 49% solution of ethylene
glycol. The thermometer and vial are enclosed in a plastic tube. The tube will
contain the mercury should breakage occur. This assembly is attached
magnetically to the wall surface near the storage area for the platelet products.
SUPPLIES:
1. Temp-Chex Incubator Thermometer (Range 20 to 50 C) Streck

Laboratories, Inc.
2. Monthly ambient room temperature quality control form
PROCEDURE:
1. Verify that the thermometer appears functional.

a. The mercury should be clear and have regular diameter.
b. There should not be any breaks in the mercury column.
2. At least every 4 hours of operation the room temperature of the area where
platelets are to be stored ( Donor room and any apheresis drive) is to be
recorded on the monthly ambient room temperature quality control form.
3. The reading for the temperature range should be between 20 - 24 C at all
times.
4. Record the temperature, time, and technician initials in the appropriate

space.
5. If the readings are not within this range:
a. Notify a supervisor immediately.
b. Take platelets to the Transfusion Medicine Laboratory
c. Contact the Doctors Center building engineering department to adjust
the temperature.
NOTE:
7
The mercury and ethylene glycol contained in the Temp-Chex unit may be
hazardous if the container is broken, avoid contact and dispose off damaged units.
In the event breakage occurs. Thermometer and mercury are disposed off by
covering with water to prevent vapors from escaping. Call BIOMED at 792-2233.
REFERENCES:
1. American Association of Blood Banks (AABB) Standards, 17th Ed. 1996

2. AABB Technical Manual, 12th Ed. 1996.
3. Temp-Chex, Streck Laboratories, Inc. Dec. 1992.
8
3.21 COBE SPECTRA BLOOD CELL SEPARATOR - DUAL NEEDLE OPERATION
PRINCIPLE:
This procedure is intended for collecting leukocyte reduced extended life platelets
for transfusion to thrombocytopenic patients. The COBE Spectra Apheresis system
is an automated centrifuge based blood cell separator that provides the functions
necessary to control and monitor the extracorporeal circuit during an Apheresis
procedure. The Spectra blood tubing set consists of a separation channel that
spins in the centrifuge to separate blood into its components.
First it separates the platelets and plasma from the red blood cells; then it
concentrates the platelets by reducing the plasma volume. The system's
automated procedures set and maintain the red cell/plasma interface by defining
the pump flow rates, runtime and centrifuge speed. This automation is enhanced
by a communications display and associated keyboard.
SUPPLIES NEEDED:
1. COBE Spectra Apheresis System #950000-000

2. Dual Stage Platelet Channel Filler
3. Collect Flow Path Over Lay #777066-556
4. ACD - A 500 ml or 1000 ml
5. 0.9% Sodium Chloride For Injection 1000 ml
6. Disposable Dual Needle ELP Blood Tubing Set (Catalog 777-003-000)
7. Blood Pressure Cuff
8. Duo Swab #1 and #2
9. 2 x 2 Sterile Gauze
10. Alcohol Preps
11. Hemostats
12. 16 or 17 Gauge Sterile Single Use Needles
13. Adhesive Bandage
PROCEDURE:
Check System
1. Plug in Spectra
2. Turn power switch On.
3. Verify the following:
Yellow warning LED is illuminated.
COBE Spectra (Version 4.7/or 5.1 LRS Software)" is displayed.
PAUSE LED is flashing.
9
Cartridge clamps are in load position.
Document all supply/reagent numbers on Apheresis worksheet.
4. Install Dual Stage Channel Filler.
a). Press the unlock cover key located on the control panel.
b). Slide the Centrifuge cover back.
c). Lower the centrifuge door.
d). Rotate the centrifuge so that the centrifuge loading port (with the
alignment dot) is facing the front.
e). Place the filler over the centrifuge assembly and press down until the
filler locking pin is securely in place. See Diagram A.
f). Lower the filler latch.
g). Lift up on the filler to ensure that it is securely in place.
h). Close the centrifuge door and cover.
5. Install the correct flow path overlay (dual and SN ELD).
SETTING UP DUAL NEEDLE DISPOSABLE SET:
1. Place tubing on front panel and swing control panel arm to the side.
2. Peel back cover on disposable package.
3. Place disposable set package on centrifuge cover.
4. Package should be held secure by placing it underneath loading panel edge.
5. Remove inlet coil and remove white paper tapes (three tubing lines; green
stripe, red stripe and plain).
6. Hang donor/patient connection on hook on left side of IV pole.
7. Place access saline line (green striped) over the top of the system.
8. Remove return line coil and remove white paper tapes (two tubing lines: blue
stripe, plain).
9. Hang donor/patient connection on hook on left side of IV pole.
10. Place return saline line (plain tubing) over the top of the system.
11. Hang bags on hooks on the IV pole as follows (see order below). Two platelet
collection bags have two ports.
* * * * * *
ELP ELP
AC Saline Waste Plasma Collect Collect
10
12. Remove return pump cartridge and snap it into cartridge clamp between
plasma and collect/replace pump (COBE label on cartridge should be facing
up).
13. Remove access pump cartridge and snap it into cartridge clamp between the
AC and inlet pumps (COBE label on cartridge should be facing up).
14. Place AC line over top of the system.
15. Ensure all tubing is clear of pumps and untangled.
16. Press Continue Key to load tubing into pump housing. Cartridge clamps
retract and tubing headers are threaded onto pump rotors.
17. Verify all four pumps are loaded.
18. Put lines in collect/replace and plasma valves.
19. Place sensor on return pressure sensor housing, press down and turn
clockwise to lock in place.
20. Install Collect Concentration Monitor cuvette as follows:
a. Pull housing out and turn counter-clockwise to lock into Load (Open)
position.
b. While holding tubing on both sides of cuvette, slide cuvette into position
in collect concentration monitor, being sure that a flat side of the
cuvette is parallel to the front panel. NOTE: Take care not to touch
cuvette because finger prints may cause inaccurate platelet readings.
21. Release housing by turning clockwise and gently lower over cuvette to lock
into position.
22. Place RBC line in RBC valve. Ensure line is completely inserted in RBC
detector.
23. Position return and inlet air chambers in air detectors with air chamber filters
located below air detector housing. Ensure waste divert lines are toward you.
24. Put waste lines in waste divert valve assembly.
25. Place line in centrifuge pressure sensor housing. Use a "flossing" action to
ensure line is completely inserted in pressure sensor.
26. Place sensor in access pressure sensor housing. Push down an turn clockwise
to lock in place.
27. Position return line (blue stripe) in return valve so line runs horizontally
through center of valve.
28. Release four-lumen tubing from package retainers.
11
Installing Channel in Centrifuge:
1. Remove channel from package.
2. Discard package.
3. Press UNLOCK COVER key.
4. Slide centrifuge cover back.
5. Lower centrifuge door.
6. Rotate centrifuge so loading port is open to the front.
7. Ensure that centrifuge collar holder is resting on the outer rim of the filler. If
centrifuge collar holder is not resting on the outer rim of the filler, push filler
latching pin toward center of centrifuge, raise filler latch and place it on the
outer rim.
8. Extend centrifuge loop to full length to ensure four-lumen tubing is not

twisted.
9. Fold channel in half as follows:
a. Hold channel so control chamber is toward you.

b. Place hands on either side of control chamber and press sides of channel
together.
c. Channel should be collapsed with control chamber at one end, forming a
banana shape.
CAUTION: Be careful not to stretch the tubes when folding the dual-stage
channel.
10. Thread channel through lower loading port and pull it out from the top.
11. Position channel in correct orientation above filler slots before placing
centrifuge collar into centrifuge collar holder.
12. Load centrifuge collar into centrifuge collar holder, closing cover over collar.
13. Lower filler latch into locked position.
14. Press channel into position, ensuring it is completely loaded in filler. Start at
control chamber and work around in both directions toward the collection
chamber.
15. Press tubes into appropriate slots in filler, ensuring all tubes are completely
inserted.
16. Place lower bearing in lower bearing holder.
12
17. Place upper bearing in upper bearing holder.
18. Place upper collar in upper collar holder. ensure that collar is held securely
by visually checking that both black sides of holder are equally closed around
collar and that an edge between two of the upper collar's six sides is facing
out. Be sure that one of the upper collar's six sides is not facing out.
19. Use a "flossing" action to place four-lumen tubing in exit slot on right side of
system. Ensure that the line to the Collect Concentration Monitor is not
kinked or twisted.
20. Rotate centrifuge several times to ensure tubing does not twist and upper
bearing remains in place.
WARNING: Inspect all lines, especially those in the centrifuge and on the front
panel, to ensure they are not kinked. Lines that are occluded, or partially
occluded, may lead to the procedure not operating correctly.
21. Close centrifuge door and cover.
PRIME DUAL NEEDLE TUBING SET:
1. After checking al luer connections to ensure that they are secure press 1 key
to select ELP tubing set.
SELECT SET
1 = ELP, 2 = TPE, 3= WBC, 4
= RBCX
2. If you make a mistake and enter the wrong set number:
a. Press the change mode key.

b. Press the 1 key to select "loadset". The tubing set selection message
above is redisplayed.
c. Press the appropriately to select the tubing set for the procedure you
want to conduct.
3. Then the message center will display.
SELECT
1 = SINGLE NEEDLE, 2 = DUAL
NEEDLE.*
4. The asterisk indicates that 2 = Dual Needle is the default selection
5. Press enter.
13
6. Close the white pinch clamps on the access and return lines near the luer
connections.
7. Close the roller clamps on the access and return saline lines.
8. Press Continue Key.
Caution: Use Aseptic technique throughout this procedure.
9. Connect anticoagulant (AC) line to ACD-A container. Place AC line in AC level

detector (upper left side), ensuring filter is placed below detector.
10. Connect inlet and return saline lines to same saline container. Using aseptic
technique, clean injection port with alcohol prep before inserting metal spike
into
it. Then place plastic spike in spike port (after removing cover). Fill drip
chambers 1/2 full.
CAUTION: Ensure lines are attached to correct fluid containers.
a. AC line to anticoagulant container.

b. Access and return saline lines to normal saline container.
11. Visually verify that fluid is flowing into the access, return, and AC drip
chambers.
12. Press Continue Key.
13. Open access and return saline roller clamps.
14. Press Continue Key to prime tubing set.
15. NOTE: Cuvette should not be disturbed once priming begins because the
Collect Concentration Monitor is calibrated during Prime mode.
16. Close slide clamp between ELP collect bags. (Platelet concentrate should be
collected into one bag for optimal 5-day storage. If collect volume is over 400
m at end of procedure, transfer about one-half of platelet concentrate to the
second ELP collect bag.)
3.21g COBE Spectra - Dual Needle Operation
WARNING
Once fluid has entered the tubing set, do

not disturb sensors in pressure sensor
housings because this will prevent
transducers form monitoring pressures
accurately.
14
NOTE: The Priming sequence goes through a number of checks testing
sensors values and pumps, several values change positions the priming
sequence then stops and the following measure is seen.
PRIME ACCESS AND RETURN

CONNECTIONS
(AND SPECTRA THERM LINE) CONTINUE
1. Open the white pinch clamp. Near the access needle or luer connection.
Allow saline to fill the luer lock connection by gravity.
2. Close white pinch clamp.
3. Open the white pinch clamp near the return needle. Allow saline to run
through till all air is expelled.
4. Press continue.
5. After the above steps the following message appears.
WARNING
DO NOT CONNECT DONOR PATIENT.

BEFORE RUNNING ALARM TESTS -
CONTINUE
6. Press Continue - The following message will be seen.
PERFORM ALARM TESTS (YES/NO)
7. Press the "Yes" key to run alarm tests.
8. Before connecting the donor enter donor data by following the steps listed in
section 3:22 of SOP.
CONNECT DONOR:
15
WARNING: Before connecting donor, check access and return lines for air. If
air is present in these lines, do not connect donor. Remove air before starting
procedure.
Connect access and return lines.

Close access saline. Press CONTINUE
to Run.
1. Perform venipuncture at access and return needle sites.
WARNING: The extended storage of platelets at 22°C requires strict

awareness of any possible sources of contamination. Rigorous attention
should be paid to proper venipuncture site selection and decontamination.
2. Open white pinch clamp on access and return lines.
3. Leave a saline drip on the return line to keep return needle from clotting.
4. Close roller clamp on access saline line.
START RUN MODE
1. Press CONTINUE key to start system in Run mode.
2. a. If you want to divert the prime saline to the waste bag, continue with
Step 3.
b. OR, if you do not want to divert the prime saline to the waste bag and,
instead, want to return it to the donor, follow these steps:
(1) Press the CHANGE MODE key.

(2) Press 3 key to select Run.
(3) Close the roller clamp on the return saline line. )The system will
not prompt you to do this.)
(4) Press CONTINUE key.
(5) Continue with Step 4, but do not press CLEAR.
3. Use roller clamp to close the return saline line because blood flow is being
returned to donor.
4. Press CLEAR key.
5. If you have already entered the Run mode before you decide to concurrently
collect plasma, you can do so at this point by following these steps:
a. Press TARGET key to display current end-of-run target values.

b. Press PLASMA VOLUME key.
c. Enter volume of plasma you want to collect.
16
d. Press TARGET key a second time to redisplay the screen immediately
above with its current actual volume values.
6. Press 2 key to continue Run mode. (To start Rinseback mode, press 1 key and
skip to Start Rinseback Mode section.)
7. Select flashing target value on bottom row of display.
8. To increase inlet volume or time, press appropriate key.
9. Enter new target value on numeric keypad. Then press ENTER.
Run mode continues until target values are reached. Values that have
exceeded their limits will be flashing. There are audio and visual warnings
when Run mode is complete.
End of Run: 1 = Rinseback, 2 =

Continue Run
PLTC
1. Rinseback: Follow instructions

Listed in Section 3.22 of SOP.
2. Disconnect Donor: Follow instructions

3. Removing Disposables: Follow instructions

REFERENCES:
1. COBE Spectra Apheresis System Operators Manual (1996/07) for use with
Version 4.7 /or 5.1 LRS Software.
17
3.22 COBE SPECTRA BLOOD CELL SEPARATOR

SINGLE NEEDLE PROCEDURE
PRINCIPLE:
The procedure is intended for use when a single needle extended life platelet
blood tubing set is used to collect single donor platelets for storage. Using the
same donor a 5% to 10% longer procedure time may be required to produce a yield
of single needle platelet product equivalent to the yield of a dual needle platelet
procedure.
SUPPLIES:
1. COBE Spectra Apheresis System #950000-000

2. Dual Stage Platelet Channel Filler
3. Collect Flow Path Over Lay #777066-556
4. ACD - A 500 ml or 1000 ml
5. 0.9% Sodium Chloride For Injection 1000 ml
6. Disposable Single Needle ELP Blood Tubing Set (Catalog #777003-200)
7. Return Flow Controller (Catalog #951000-000)
8. Blood Pressure Cuff
9. Duo Swab #1 and #2
10. 2 x 2 Sterile Gauze
11. Alcohol Preps
12. Hemostats
13. 16 or 17 Gauge Sterile Single Use Needles
14. Adhesive Bandage
PROCEDURE:
1. Check System
a. Plug in Spectra Apheresis System.

b. Turn power switch ON.
c. Verify the following:
 COBE Spectra (Version 4.7 /or 5/1 LRS Software)" is displayed.
 PAUSE LED is flashing.
 Cartridge clamps are in load position.
 Document all supply/reagent numbers on apheresis worksheet.
2. Install Dual Stage Channel Filler.
18
a. Press the unlock cover key located on the control panel.
b. Slide the Centrifuge cover back.
c. Lower the centrifuge door.
d. Rotate the centrifuge so that the centrifuge loading port (with the
alignment dot) is facing the front.
e. Place the filler over the centrifuge assembly and press down until the
filler locking pin is securely in place. See Diagram A
f. Lower the filler latch.
g. Lift up on the filler to ensure that it is securely in place.
h. Close the centrifuge door and cover
3. Install the correct flow path overlay (dual and SN ELP).
4. INSTALL RETURN FLOW CONTROLLER:
The return flow controller may be clamped to either the top horizontal
segment or side vertical segment of the Spectra IV Pole.
a. RIGHT VERTICAL SEGMENT OF IV POLE
To clamp the Return Flow Controller to the right vertical segment of the
IV pole, use both of the Return Flow Controller's two back-mounted
clamps as follows:
(1) Unscrew the two thumb nuts on both clamp bars (Figure B) until
the slotted back clamp bars on the back of the Return Flow
Controller will pivot one-quarter turn, clearing space for the IV
pole.
(2) Lift the Return Flow Controller to the desired position against the
right vertical segment of the IV pole.
(3) Place the front clamp bars' V-seats against the IV pole.
(4) Continue to unscrew the thumb nuts until you can pivot the slotted
back clamp bars back against the threaded post.
(5) Use enough force to tighten the thumb nuts down onto the back
clamp bars on the IV pole to ensure that the Return Flow Controller
is secure.
b. HORIZONTAL SEGMENT OF IV POLE
The clamp the Return Flow Controller to the horizontal segment of the IV
pole, use only the top-mounted clamp as follows:
(1) Unscrew the two thumb nuts until the slotted top clamp bar will
pivot one-quarter turn, clearing space for the IV pole.
(2) Lift the Return Flow Controller to the desired position under the IV
pole.
19
(3) Place the bottom clamp bar's V-seat against the bottom of the IV
pole.
(4) Continue to unscrew the thumb nuts until you can pivot the slot
top clamp bar over the top of the IV pole and back against the
threaded post.
(5) Use enough force to tighten the thumb nuts down onto the top
clamp bar on the IV pole to ensure that the Return Flow Controller
is secure.
(6) In this position, the bag hooks on the horizontal segment of the IV
pole will prevent the Return Flow Controller from rotating around
the IV pole.
CAUTION:
Be sure that the return flow controller is mounted high enough to clear the spectra
system's control panel. this will prevent inadvertent damage to either assembly
when the control panel is swiveled.
When the return flow controller is mounted on the right vertical segment of the iv
pole, carefully check door clearances when moving the spectra system, as the
return flow controller must be rotated inward to clear some doorways.
SETTING UP SINGLE NEEDLE DISPOSABLE:
1. Swing control panel to the side.
4. Package should be held securely by placing it underneath packaging hook on

front panel.
5. Remove access coil and remove white paper tape.

a. Hang access connections on hook on left side of IV pole.
b. Place access saline line (green-striped) over the top of the system.
6. Hang bags on one hook on the IV pole.
7. Remove return pump cartridge and snap it into the cartridge clamp between
plasma and collect/replace pump. (COBE label on cartridge should be facing
up.)
the AC and inlet pumps. (COBE label on cartridge should be facing up.)
11. Press CONTINUE key to load tubing into pump housings.
20
12. Verify all four pumps are loaded.
14. Place sensor in return pressure sensor housing. Turn clockwise to lock in
place.
15. Install Collect Concentration Monitor cuvette as follows:
a. Pull housing out and turn counterclockwise to lock into the Load (Open)
position.
b. While holding tubing on both sides of cuvette, slide cuvette into position
in collect concentration monitor, being sure that a flat side of the
cuvette is parallel to the front panel.
NOTE:
Take care not to touch cuvette because finger prints may cause inaccurate
platelet readings.
Release housing by turning clockwise and gently lower over cuvette to lock
into position.
16. Place RBC line in RBC valve. Ensure line is completely inserted in RBC
detector.
17. Position return and inlet air chambers in air detectors with air chamber filers
located below air detector housings. Ensure waste divert lines are toward
you.
18. Put waste lines in waste valve assembly.
20. Place sensor in access pressure sensor housing. Push down and turn
21. Position return line in return valve so line runs horizontally through center of
valve.
23. Install Single-Needle Bag
a. Place Return Flow Controller into Load position by turning its flow
control handcrank all the way counterclockwise to the Load position.
21
b. Load the single-needle bag into the space that Step 1 created at the top
of the Return Flow Controller:
NOTE: The single-needle bag is symmetrical and may be loaded with

either side up.
c. Hold bag in your right hand so that the end with the locator hole is
pointing toward your left.
d. Loosely fold the bag in half lengthwise to facilitate its insertion into the
Return Flow Controller.
e. Insert the locator hole end of the bag into the right side of the space
made at the top of the Return Flow Controller.
f. Grasp the bag's load tab through the Return Flow Controller's left side
access port and place the bag's locator hole over the bag locator pin on
the bag mounting plate.
g. Ensure that the bag is lying flat on the plate.
h. Place the bag's tubes on either side of the bag alignment block.
24. Install Channel in Centrifuge
a. Remove channel from package.
b. Discard package.
c. Press UNLOCK COVER key.
d. Slide centrifuge cover back.
e. Lower centrifuge door.
f. Rotate centrifuge so loading port is open to the front.
outer rim.
26. Extend centrifuge loop to all length to ensure four-lumen tubing is not
twisted.
27. Fold channel in half as follows
a. Hold channel so control chamber is toward you.
22
b. Place hands on either side of control chamber and press sides of channel
together.
c. Channel should be collapsed with control chamber at one end, forming a

banana shape.
CAUTION
Be careful not to stretch the tubes when folding the dual-stage channel.
centrifuge collar into centrifuge collar holder.
control chamber and work around in both directions toward the collection
chamber.
inserted.
34. Place lower bearing in lower bearing holder
35. place upper bearing upper bearing holder.
36. Place upper collar in upper collar holder. Ensure that collar is held securely
by visually checking that both black sides of holder are equally closed around
collar and that an edge between two for the upper collar's six sides is facing
37. Use a "flossing" action to place four-lumen tubing in exit slot on right side of
system. Ensure that the line to the Collect Concentration monitor is not
kinked or twisted.
WARNING
Inspect all lines, especially those in the centrifuge

and on the front panel, to ensure they are not kinked.
Lines that are occluded, or partially occluded, may
lead to the procedure not operating correctly
Close centrifuge door and cover.
23
39. Press continue key to load the tubing into the pump housings cartridge
clamps are retracted, and tubing headers are threaded on to the pump rotors after
pumps are loaded valves automatically open to the load position.
40. Verify all pumps are loaded.
41. Put the lines in the collect/replace and plasma values.
42. Place the sensor in the return pressure sensor housing push downward and
turn clockwise to lock in place.
43. PRIME TUBING SET
a. After checking all luer connections to ensure that they are secure press
1 key to select ELP tubing set.
SELECT SET
1 = ELP, 2 = TPE, 3 = WBC, 4= RBCX
b. If you make a mistake and enter the wrong set number:
(1) Press the change mode key.

(2) Press the 1 key to select "Loadset". The tubing set selection
message above is redisplayed.
(3) Press the appropriate key to select the tubing set for the
procedure you want to conduct.
c. Then the message center will display.
SELECT
1 = SINGLE NEEDLE, 2, DUAL
NEEDLE.*
(1) Press 1 key.

(2) The asterisk will move to 1 selection. Press enter when you select
single needle option the following message is displayed.
SET RETURN FLOW SCALE TO PRIME

CONTINUE SINGLE NEEDLE PRIME
(YES/NO)?
d. Place the return flow controller in prime position by cranking its flow
control hand crank clockwise unit it can no longer turn do not use
excessive force when cranking the handcrank.
e. Verify that the single-needle bag is pressed flat between the plates of
the Return Flow Controller and that the lines leaving the right side of
the bag are not kinked or twisted.
24
f. Press the YES key to verify that you want to continue with single-needle
prime. The following message will be seen.
Clamp sample system and needle

lines.
Close saline line. Press

CONTINUE
g. Close the white pinch clamp on the needle line. Close the white pinch
clamp to the blood sampling bag. Close the white roller clamp located
between the two "Y manifolds. Close the roller clamp on the access
saline line.
h. Press CONTINUE KEY.
i. Connect Platelet tubing set to fluid containers.
j. Connect the AC line to the Anticoagulant Container and place the AC line
in the AC Level Detector. Make sure the filter is placed below the AC
Level Detector.
k. Connect Access saline line to plastic spike port on saline container.
CAUTION
Ensure lines are attached to correct fluids:
(1) AC line to anticoagulant container.
(2) Access saline line to normal saline container.
(3) Visually verify that fluid is flowing into the access and AC drip
chambers.
l. Press continue key.
WARNING
Once fluid has entered the tubing set, do not disturb

sensors in pressure sensor housings because this will
prevent transducers form monitoring pressures
accurately.
m. The following screen appears.
OPEN SALINE LINE
25
PRESS CONTINUE TO PRIME
n. Open access saline roller clamp.
o. Press continue key to prime the tubing set.
NOTE: The single needle kit includes a cuvette. The cuvette should not be
disturbed once priming begins because the collect concentration
monitor is calibrated during prime mode.
p. Move bags to correct position on IV pole as follows:
* * * * * *
Inlet ElP ELP
Single
AC Saline Collect
Waste Needl Plasm Collect
e a
* Because of the space occupied by the Return Flow Controller, some bags, for
example, the AC and inlet saline bags, will need to share the front and back
of the same hook.
q. Close slide clamp between ELP collect bags. (Platelet concentrate

should be collected into one bag for optimal 5-day storage. If collect
volume is over 400 ml at end of procedure, transfer and one half of
platelet concentrate to the second ELP collect bag.)
NOTE: The priming sequence goes through a number of checks testing sensors
valves and pumps. Several valves change positions. The single needle
bag is primed. The priming sequence then stops and the following
message is seen.
PRIME BETWEEN Y MANIFOLDS
(AND SPECTRA THERM LINE) CONTINUE
r. Open white pinch clamp on the needle line.
s. If saline goes past the "Y" manifold, raise the needle line above the
saline bag and allow the saline to go to the correct position by gravity.
t. PRESS Continue key.
26
u. Use the roller clamp to close the green-striped access saline line, close
the white access pinch clamp above the roller clamp, and press
CONTINUE to test the inlet/AC ratio or the Access Pressure Sensor.
v. After the above step is completed the following message is seen:

CLOSE SALINE LINE
CLAMP ACCESS LINE AT
ACCESS MANIFOLD. CONTINUE
WARNING
DO NOT CONNECT DONOR PATIENT
BEFORE RUNNING ALARM TESTS.

CONTINUE
w. Press Continue - the following message will be seen.
PERFORM ALARM TESTS (YES/NO)
x. Press the "yes" key to run semiautomatic alarm tests. To verify that key
alarm systems are fully operational. Follow various messages on the
display panel.
CLOSE SALINE LINE

CONNECT DONOR
TAKE SAMPLE
PRESS CONTINUE TO RUN
y. Before connecting the donor enter donor data:
Enter donor data:
The Spectra system will customize platelet collections by using donor

data to calculate pump flow rates, centrifuge speed, collect volume,
inlet/anticoagulant ratio, and procedure time.
Select sex: 1=Male, 2=Female

(ENTER = Male)
(1) Enter donor sex:

- Press 1 if male.
- Press 2 if female.
- Press ENTER for default (data in parentheses).
27
(English units 0 enter feet):
Enter height,
in feet: {0}, and/or inches: 0
(Range: 1 to 7 feet)
(2) Enter donor height:
Feet and Inches Inches Centimeters

___feet plus ENTER ENTER - ___centimeters
plus ENTER
then then
___inches plus ENTER ___inches plus ENTER

Range: 1-7 ft Range: 12-84 in. Range: 30-220 cm
(3) Enter donor weight in pounds then press enter key. The message
center will display.
Total blood volume = { } ml.

( in, lbs, Female). OK
YES/NO)?
To confirm input, the Spectra system displays estimated total blood

volume and donor data. Total blood volume is calculated from the donor
data entered into the system. The second line of the display reviews
data input: height, weight, and sex.
(4) Press enter.
Message Center will display.
Enter HCT % [41]
(5) Enter hematocrit as a whole number. (Decimal point is not

required.) Then press ENTER.
NOTE: It is important to enter the correct hematocrit to avoid red blood

cell spillover and ensure that the maximum plasma volume is
available for platelet and plasma collection. If the default value is
used, the best collection performance will not be obtained.
(6) Message Center will display.
ENTER PLATELET PRE-COUNT

28
IN CELLS/MICROLITER {250} X 100
Enter donor platelet pre-count then press Enter.
(7) The Display Center will show.
1-No Plasma, R= Collect Plasma
ENTER = No Plasma
(8) The Spectra System will Display.
Yield = . E11, collect = , conc = ,

,
plasma = , time = min. OK (YES/NO)?
The Spectra system uses donor data (entered by the operator ) and
microprocessor algorithms to calculate and show the following
information on the platelet yield display:
• Platelet yield displayed to the eleventh power (for example,

4E11=4x1011).
• Program to collect 200-300 ml
• Collect volume displayed in milliliters.
• Platelet concentration in collect bag displayed in thousands per
microliter (x1000). (Default value is 1,400,000 per microliter.)
• Plasma volume in milliliters, if being collected.
• Run time displayed in minutes. (Default value is 100 minutes or the
value you configured for the default.)
NOTE
Platelet concentrations above 2,100,000/microliter have not been

validated for extended storage.
(9) Press ENTER after documenting values in the Apheresis Worksheet.
(10) Press Continue to connect donor.
CONNECT DONOR
NOTE: Before connecting donor check access and return lines for air:
29
1. Close the roller clamp on the access saline line.
2. Perform Venipuncture at the needle site as per SOP.
3. Open the white pinch clamp on the needle. Open the white pinch clamp on
the tubing leading to the blood sampling bag.
Allow the blood sampling bag to fill to the desired volume. To improve
antecubital access flow, maintain a cuff pressure of between 10 and 20 mmHg
on the access/return arm.
When the bag is filled to the desired volume, close the white pinch clamp on
the tubing leading to the blood sampling bag.
To prevent clotting of the access line and the line attached to the needle,
flush the line with saline. Open the access line pinch clamp. Open the white
roller clamp between manifold "Ys". Open the saline line roller clamp until
the lines are cleared of blood. Leave a saline drip on the needle line to keep
the needle from clotting.
Failure to flush tubing with saline may result in

blood clotting which may result in clot(s) being
returned to the donor.
Permanently and hermetically seal the inlet tube to the blood sampling bag
as close to the "Y" manifold as possible.
Remove samples as soon as possible from the blood bag using evacuated
blood collection tubes. After all samples are taken, disconnect the sampling
bag and needle and dispose of both in an appropriate biohazard disposal
container.
START RUN MODE:
1. Press continue key to start the system in run mode.
2. Make sure the saline line roller clamp is fully closed at the time.
Several valves change position and several pumps change flow rates as the
system performs a final valve position check once the patient has been
connected. The return valve remains closed during this test.
3. Set return flow scale to 3 or 2 . Press Continue. Follow messages on display

panel.
4. Note the number on the screen above. Turn flow control handcrank on the
Return Flow Controller counterclockwise until the return flow indicator points
to that number on the return flow scale.
Press the CONTINUE key.
30
NOTE: When the single-needle return phase is reached, the Return Flow
Controller will apply the appropriate pressure to the single-needle
bag so that the blood components withdrawn during the single-
needle draw phase are returned back to the donor at the correct
flow rate.
The Spectra system displays pump flow rates, inlet/AC ratio, centrifuge rpm,
accumulated volumes processed by each pump, run time (in minutes), and
procedure
type. For single-needle procedures, average flow rates are displayed. Step 5
below explains how to display instantaneous single-needle flow rates.
AC Inlet Plasma Collect Inlet/AC Spin

Replace Ratio RPM
. . . . . .
SNPLTC
AC Inlet Plasma Collect Time Procedur
Replace Min e
5. Press CONTINUE.
6. After establishing the interface the DISPLAY will show.
SET RETURN FLOW TO 7
PRESS CONTINUE:
7. Press the CONTINUE key.
Turn the handcrank on the Return Flow Controller clockwise until the
indicator points to "7" on the return low scale.
8. To monitor instantaneous draw phase flow rates:
a. Press the MENU ON/OFF key.
1=Data Entry, 2=Pressure Display,

3=CCM,
4=Air Remove, 5=Strobe, 6=Config.,
7=SN.
b. Press the 7 key to select "SN" and display the single-needle statistics
message.
31
c. Press the MENU ON/OFF key to leave the single-needle statistics
message and redisplay the Spectra SNPLTC procedure screen above.
9. If you have already entered the Run mode before you decide to concurrently
collect plasma, you can do so at this point by following these steps:
a. Press the TARGET key to display current end-of-run target values.
b. Press the PLASMA VOLUME key.
c. Press the TARGET key a second time to redisplay the screen in Step 4
with its current actual volume values.
10. Run mode continues until target values are reached. Values that have
exceeded their limits will be flashing. There are audio and visual warnings
when Run mode is complete.
AC Inle Plas Collect Time Proced

t ma Replac Min ure
e
11. Press 1 key and enter.
To start Rinseback Mode.
RINSE BACK:
1. Clamp access and open access saline.
2. Close the white pinch clamp on the access line between the "Y" manifold and
the access manifold. Open the roller clamp on the green striped access saline
line to allow saline to enter the system.
3. Press continue to rinse back.
NOTE: The message in the display center will show
CLAMP AND DISCONNECT COLLECTION

BAGS
PRESS CLEAR
4. Heat seal the collect line above and below the leur connection and remove
the platelet product bags.
Note: 150 - 400 ml of product can be stored in one bag.
32
5. Seal off and discard unused plateltet bag
6. Label bags as per procedure.
7. Press CLEAR to continue RINSEBACK.
8. When RINSEBACK is completed the following message appears.
RINSEBACK COMPLETED DISCONNECT

RETURN LINE CLOSE FLUIDS PRESS
CONTINUE
DISCONNECT DONOR:
1. When the Rinseback mode is completed, close the white pinch clamp on the
return line or access/return line. disconnect the needle. Close the roller
clamp on the green-striped access saline line. If applicable, close slide
clamps on other lines.
2. To ensure that fluids do not leak when disposables are removed, close the
appropriate slide clamps and, when possible, connect the Return line or
access/return line to the collect line (where the collect bags were
disconnected).
3. Press the CONTINUE key.
4. Record on subject or procedure records the final volumes processed during

the procedure.
5. Clean donor's venipuncture site.
6. Apply pressure bandage.
REMOVING DISPOSABLES:
1. The following messages will seen before the disposables are ejected from the
pumps.
a. Final valves
b. Unloading pumps
c. Disconnect donor / patient!
d. Clamp access and saline lines
e. Unloading pumps
f. Donor / Patient disconnected ???
g. Pumps will unload ! ! (Yes / No)
Press “YES” and pumps will unload
2. Place the ends of the subject access and return lines or access/return line in
an appropriate biohazard disposal container.
33
3. Press the UNLOCK COVER key.
4. Slide the centrifuge cover back.
5. Lower the centrifuge door.
6. Remove the lumen tubing from the exit slot on the right side of the system.
7. Remove the collar from the upper collar holder.
8. Remove the upper bearing from the upper bearing holder.
9. Remove he lower bearing from the lower bearing holder.
10. Push the filler latching pin toward the center of the centrifuge and raise the
filler latch.
11. Pull the tubes from the slots in the filler.
12. Pull the channel from the filler.
13. Open the hinged cover on the centrifuge collar holder and remove the collar.
14. Raise the channel above the filler.
15. Fold the channel in half and pull it through the loading port/
16. Discard the channel in the biohazard disposal container. (Channel will still be
connected to tubing.)
17. Close the centrifuge door and cover.
REFERENCES:
1. COBE Spectra Apheresis System Operators Manual for use with Version
4.7 /or 5.1 LRS Software Program. 1996/07.
34
3.26 COBE SPECTRA EMERGENCY RINSEBACK
PRINCIPLE:
This procedure is to be utilized when there is a prolonged power failure or system

failure that does not allow the COBE Spectra to be turned back on.
PROCEDURE:
1. Advise donor of situation.
*If the power fails after few minutes into the procedure explain to the donor
that the venous access and return lines can be kept open by running saline
for up to 30 minutes.
*If the donor wants to come back for a repeat donation within eight weeks
the transfusion medicine physician must be consulted because of the small
amount of blood loss.
*If power fails towards the end of the procedure follow the steps outlined
below.
2. Turn the Spectra System's power switch-off.
3. a. Close white pinch clamp on access needle line and disconnect access
needle.
b. For single needle clamp access line.
WARNING
To avoid inadvertent removal of additional

blood from donor or return of fluids to donor,
ensure access is disconnected before
starting manual rinseback for single needle
procedure ensure access line is clamped
4. Use screw driver to open waste valve. This will relieve pressure from
centrifuge.
5. Set valves to the following positions.
Waste Closed
Return Open
RBC Open
35
Plasma Return
Collect Collect
6. Remove tubing from return line valve.
7. Open access saline roller clamp all the way.
8. Turn inlet pump counter clockwise until RBC line is visually depleted of red
cells. This can be done by turning the knob on top of the inlet pump. Use
approximately 200ml from saline container.
9. Close RBC valve.
10. Turn plasma pump counterclockwise approximately 100 revolutions.
11. Close white pinch clamp on return line, and disconnect return needle.
12. Close access saline roller clamp.
13. Remove disposables from system as follows:
a. Clamp or seal and remove collection bag(s).
b. Unlock centrifuge cover.
c. Open centrifuge cover and door to remove channel from filler.
d. Move valves to open/load positions.
e. Free pump cartridges from actuators.
f. Free tubing loops from pumps by rotating pumps counterclockwise and

pulling tubing up.
g. Remove lines from front panel.
h. Remove fluid containers and waste bag, and place in appropriate

biohazard disposal container along with tubing.
WARNING
Alarm system is inactivated with

puller off watch for Air in the
Return Line while Returning Blood
to Donor if you see air Discontinue
Rinse Back Immediately
36
REFERENCE:
1. COBE Spectra Apheresis System Operators Manual for use with Version 4.7
Software Program. 1996/07.
37
3.27 COBE SPECTRA - CORRECTIVE ACTION TO PREVENT CITRATE REACTION
PURPOSE:
In order to prevent platelet clumping and citrate reactions, technicians must be

prepared to take appropriate measures when they problems occur.
SUPPLIES:
1. COBE Spectra - Version 4.7 / 5.1 software
PROCEDURE:
1. Corrective action to be taken when platelet clumping occurs primarily below

pump.
a. Decrease ratio by 1-2 ml.
b. Wait 5 minutes; if clumping persists, decrease ratio by 1.
c. Continue with step #2 until platelet clumping is resolved.
2. Corrective action to be taken when platelet clumping occurs above the pump.
a. Increase COLLECT TARGET VOLUME by 50 ml once.
b. Wait 5 minutes. If clumping continues, decrease INLET: AC RATIO by 0.5.
c. Wait another 5 minutes, check for clumps. If clumping is still present,

decrease INLET: AC RATIO by 0.5ml.
CORRECTIVE ACTION TO BE TAKEN

WHEN CITRATE REACTION OCCURS
AC PUMP INLET PUMP
 
38
Decrease Speed Decrease Speed
CORRECTIVE ACTION TO BE TAKEN

WHEN CLUMPING OCCURS PRIMARILY BELOW PUMP
INLET PUMP INLET : AC RATIO
 
Decrease Speed Decrease Speed
1. Decrease ratio by 1-2
2. Wait 5 minutes; if clumping persists, decrease ratio by 1.
3. Continue with #2 until clumping is resolved.
CORRECTION ACTION TO BE TAKEN WHEN CLUMPING OCCURS ABOVE THE PUMP
1. Increase COLLECT TARGET VOLUME by 50 ml once.
2. Wait 5 minutes -- if clumping continues, decrease INLET: AC RATIO by 0.5ml.
3. Wait another 5 minutes, check for clumps, if persists, decrease INLET AC

RATIO by 0.5ml.
NOTE: COBE Service # - 1-800-525-2623
REFERENCES:
1. COBE Spectra Operators Manual 1996/07.
39
3.31 FENWAL CS-3000® PLUS BLOOD CELL SEPARATOR
DUAL NEEDLE OPERATION
PRINCIPLE:
The CS-3000® PLUS blood cell separator is a self contained, continuous flow
centrifugal device which separates anticoagulated whole blood into some of its
components. Collection of specific blood components like platelets can be
automatically implemented and monitored. A program for platelet collection
procedure is stored in the solid state memory of the separator. Two modes of
operation are provided: Automatic and manual. A message center on the operator
panel provides operator help messages and status messages.
Blood components are collected in a sterile, disposable Apheresis kit. The

components are centrifugally separated within the Apheresis kit by density
differences. A two stage centrifugation process is used in platelet collection.
The cell separator components include a centrifuge, two peristaltic fluid pumps
and a microcomputer based system of controls and monitors.
Saline solution is used to prime the Apheresis kit after it is installed in the
separator. whole blood from donor is mixed with ACD-A (Anticoagulant) and
pumped into separation container in the centrifuge. In the separation container
Anticoagulated whole blood is separated into component rich plasma (CRP) and
packed red blood cells (PRBC). The CRP is pumped from the separation container
into the collection container by the plasma pump. The components in the CRP are
concentrated in the collection container and the remaining component poor plasma
(CPP) exits the container. The CPP may be collected in a transfer pack or returned
to the donor.
SUPPLIES:
1. Fenwal closed system Apheresis kit for extended platelet collection storage #
(4R2230).
2. Separation container holder TNX-6 (77-04-00-243) (4R4529)
3. Collection container holder A35 (71-04-00-003)
4. Blood pressure cuff.
5. DUO swab #1 and #2
6. 2 x 2 sterile gauze
7. Alcohol preps.
8. Hemostats.
9. 16 or 17 gauge sterile single use needles.
10. Adhesive Bandage.
PROCEDURE:
Setup of Closed System Apheresis Kit:
1. Press the Power push button to power on the instrument.
40
2. Set the Prime switch to the Auto position. Set the Run switch to the desired
position.
3. Close the clear plastic top door of the separator and place the carton
containing the Apheresis Kit on the door.
4. Hang the 1000 ml container of 0.9% Sodium Chloride Injection, USP

Processing Solution on the rack, third hook from the right.
5. Hang the 1000 ml container of the Anticoagulant Citrate Dextrose Solution,

USP Formula A (ACD) on the rack, second hook from the right.
6. Open the monitor assembly door and raise the handles on the Plasma and
WB/ACD pumps to expose the rollers. Insert the monitor assembly on the
monitor panel and close the monitor assembly door. Install the Plasma pump
tubing, the Whole Blood pump tubing, and the ACD pump tubing over the
appropriate rollers and lower the pump handles.
7. Turn the master reset control counterclockwise until all clamps are open.
Position each tubing in the appropriate clamp.
8. Turn the master reset control completely clockwise until all the clamps close.
9. Remove the remainder of the kit from the carton. Hang the two PL 732®
Plastic 1000 ml Transfer Pack Containers (platelet storage) and the Pl 146®
Plastic 600 ml Transfer Pack Container (plasma collect) on the left most hook.
Ensure that the roller clamps (A and B, Fig.2) on the platelet storage
containers are closed and that the roller clamp (C, Fig. 2) on the plasma
collect container is open.
10. Open the top and front doors of the separator.
11. Rotate the rotor shield by hand until the restraining arm is centered in front,
thus aligning the guide hole for container insertion.
*** Caution: Do not place fingers between container holders and rotor shield.
12. Remove the restraining collar from the center of the rotor.
13. Place the separation and collection containers together and roll into a
cylindrical shape. Untwist the multiple lumen tubing until the stripe is
straight.
14. Insert the rolled-up containers into the guide hole and pull them up through
the center of the rotor. Unroll the containers.
15. Place the restraining collar around the lower hex strain relief. Close the
restraining collar and insert this assembly into the rotor and rotate until a
distinct click is heard or detent is felt.
41
16. Open the collection container holder. Make certain the tubings from the
restraining collar are not twisted or pinched. Place the collection container
over the 3 locating pins. The container must lie flat against the holder with no
folds. Close and latch the holder. Make certain the tubing is not twisted or
pinched.
NOTE: PRBC line must be placed into the slot on the top of the red metal plate.
17. Open the separation container holder. Make certain the tubings from the
restraining collar are not twisted or pinched. Place the separation container
over the 3 locating pins. The container must lie flat against the holder with
no folds. Close and latch the holder. Make certain the tubings are not
twisted or pinched.
18. Place the multiple lumen tubing to the right of the restraining arm on the
rotor shield. Untwist the multiple lumen tubing until the stripe is straight. It
may be necessary to repeat steps 12-17 to ensure the multiple lumen tubing
is straight.
19. Rotate the rotor shield counterclockwise until restraining arm and multiple
lumen tubing are directed to the right of the centrifuge compartment.
** Caution: Do not place fingers between container holders and rotor shield.
20. Align the upper hex strain relief on the support bar located above the
centrifuge. Close the support bar latch. Insert the multiple lumen tubing
inside the restraining arm along its entire length.
21. Insert the plastic multiple lumen tubing retainer to assure the multiple lumen
tubing is in he proper position.
a) Hold the multiple lumen tubing retainer with the logo at the top and
facing the operator.
b) Slide the multiple lumen tubing retainer down the edge of the
restraining arm until it reaches the end of the groove (Fig 1).
22. Ensure that the following conditions exist:

• Multiple lumen tubing stripe is straight and not twisted.
• Containers, associated tubing and holder handles are in proper position.
• Hex strain reliefs are properly positioned in the support bar and white
restraining collar.
• White restraining collar is latched in place.
• Multiple lumen tubing is inside the restraining arm along its entire
length.
• Multiple lumen tubing retainer is properly positioned.
23. Close the front door of the separator.
24. Place the multiple lumen tubing in the slot provided on the left side of the top
door track and close the top door.
25. Pull the multiple lumen tubing so that its excess length is outside the
centrifuge compartment.
42
26. Close the roller clamps on the Return line and inlet line. Ensure that the
fistula needles are securely attached to the Return and Inlet needle adapters.
Close Roberts clamp on blood sampling pack (Fig. 2).
27. Break the in-line cannulae above the drip chamber of the 0.9% Sodium
Chloride Injection, USP Processing Solution and ACD containers and fill the
drip chambers 3/4 full.
PRIMING THE KIT:
1. Press "Mode", then press "Start-Resume. Message center reads "inlet-line

sensor check ". then ACD/Inlet Line Preprime. The above steps when seen
require operator action. To allow ACD to flow through the tubing, lift the
WB/ACD pump handle to prime the inlet line.
2. Close the roller clamp when the ACD is observed exiting the WB/ACD pre-
pump tubing. Tubing may be closed using a hemostat or the roller-clamp.
3. Place ACD tubing at the WB/ACD selector wheel. (Be sure ACD tubing is at
the back of the WB pump roller).
4. Close WB/ACD pump handle. Make sure to open the ACD roller clamp.
5. Press "Resume".
6. Invert air trap below the monitor panel immediately until it is full and release.
7. Priming will continue until steps 1-18. At end of prime "Normal Status" will
appear on the message center. A two note chime will notify the operator that
the separator is in the pre-run state.
DONOR ARM PREPARATION AND STARTING APHERESIS:
1. Prepare the donor's arms for venipuncture following the standard procedure.
2. Uncoil access and return tubing.
3. After completion of auto-prime, open return line roller clamp and allow saline
to flow into the Y-junction adjacent to the blood sampling pack tubing (Fig 2).
Tubing beyond the Y-junction to the return line needle should remain dry.
Close return line roller clamp.
*** Warning: Inadvertent opening of the return line roller clamp after
venipuncture and before sampling pack is filled may result in air
embolism.
4. Inflate pressure cuff to approximately 80 mmHg and perform Return line

venipuncture.
5. Release pressure cuff to approximately 40 mmHg.
43
6. Open Roberts clamp on tubing leading to sampling pack.
7. Allow blood sampling pack to fill to desired sample volume.
8. When pack is filled to desired volume, close Roberts clamp and release
pressure cuff.
9. Place a hermetic seal on the blood sampling pack tubing as close to the Y-
junction as possible (Fig.2).
10. To prevent clotting of the Return line, the line should now be rapidly cleared
with saline by opening the Return line roller clamp.
*** Warning: Failure to rapidly flush tubing with saline may result in blood
clotting in the Return line tubing, which may result in clot(s) being returned
to the donor.
11. Collect Blood samples using the vaccutainer method, and remove the BPCUFF
12. Open inlet roller clamp and prime inlet line through the needle for 10-15
seconds or till all the air is expelled.
13. Perform inlet venipuncture and initiate Apheresis procedure.
14. Press "Mode" and then press "start resume"
15. Open access and return power clamps completely.
16. Make sure ACD is dripping.
17. Count the drops and adjust the ratio according to ACD drop count guide
provided in the procedure.
PROGRAMMING THE INSTRUMENT FOR COLLECTING PLATELETS:
1. Calculate the donors total blood volume as per SOP and program to process
at least one blood volume.
NOTE:
The Preset run parameters are:
RUN PARAMETERS PRE-SET:
Procedure select key 1

Blood Flow Rate 50ml/min
WB ACD-A 9-11:1
Centrifuge Speed 1600 RPM
Interface detector offset 6
End Point Volume 5000 ml Blood
44
2. END POINT VOLUME:
a) Press Display/Edit Key (1).

b) Use Up/Down Arrows (2) to display Endpoint Volume in message center.
Display Edit
Endpoint Volume
5000
c) Press Enter Key (3) to display current and new values.
d). Use up/down arrows to change values.

• Double arrows change by 100s
• Single arrows change by 10s
Display Edit Current

New
Endpoint Volume 5000
6000
e. Press Enter Key (3) to store.
f. Press Display/Edit(1) to exit.
NOTE: End point volume is based on the total blood volume of the donor.
Calculate the blood volume of the donor (See Procedure # 3.15)
and process as close to that volume as possible. To harvest a good
platelet yield, process as minimum of 5000 ml.
3. ENTER WHOLE BLOOD FLOW RATE
Press Display/Edit Key (1).
Use up/down arrows (2) to display Whole Blood Flow Rate in message center.
Display Edit
Whole Blood Flow Rate
50.0
Press Enter Key (3) to display current and new values.
Use up/down arrows to change values:


New
45
Whole Blood Flow Rate 50.0
40.0
Press Enter Key (3) to store.
4. ENTER INTERFACE DETECTOR OFFSET

CHANGE FROM PRE-SET VALUE OF 6 TO 10 OR AS DIRECTED BY TMP
Press Display/Edit Key (1).
Use up/down arrows 2 to display interface Detector Offset in message center.
Display Edit
6
Interface Detector Off
Use up/down arrows to change values

Display Edit
Current New
Interface Detector Offset 6
10
Press Display/Edit Key (1) to exit.
5. ENTER PLASMA COLLECT DURING CELL COLLECTION:
Set the Collect Plasma Key (1) to plasma. Press Display/Edit Key (2).
Use up/down arrows (3) to display Plasma Volume (Coll/Exch) in message

center.
Display Edit
Plasma Volume (Coll/Exch)
0
Use up/down arrows to change values.

46
New
Plasma Volume (Coll/Exch) 0
50-200*
* Plasma volume may vary according to directions of TMP.
Press Display/Edit Key (2) to exit.
6. Do not change any of the other pre-set values.
COMPLETION OF PLATELET COLLECTION:
1. When the endpoint is reached (BLOOD VOLUME display equals or exceeds

ENDPOINT display),
a. Message 60 (Endpoint Reached) will be displayed

b. A one-note chime will sound,
c. The MODE and START/RESUME LEDs will flash.
2. To discontinue the run procedure and initiate the reinfuse operation:
a. Press the MODE key to select reinfuse.

b. Then press the START/RESUME key to initiate the reinfuse operation.
3. To continue the procedure:
a. Select a new endpoint using the Display/Edit function

b. Then press the START/RESUME key.
4. If it is desired to terminate the procedure before the endpoint is reached,

press the HALT/IRRIGATE key. At this time, the MODE and START/RESUME key
to initiate the reinfuse operation.
a. Close the inlet line, using the roller clamp.
b. Release the pressure from blood pressure clamp and remove it.
c. Remove the needle, apply pressure, and cut the needle.
d. Cleanse the site and apply a pressure dressing.
e. When the auto-reinfusion is complete, a two-note chime will notify the

operator that the procedure is complete. Message reads status 25. The
47
centrifuge will stop. All clamps will close. The two note chime can be
silenced by pressing the mute key.
f. Close the return line, using the roller clamp.
g. Remove needle, apply pressure.

h. Cleanse the site and apply a pressure dressing.
RESUSPENSION AND TRANSFER OF PLATELETS:
NOTE: For extended platelet storage, approximately equal volume of

suspended platelets must be transferred to the two PL 732® Plastic
storage containers as outlined below.
At the completion of the collection procedure, transfer the platelets from the
collection container to one of the two platelet storage containers as follows:
1. Close the roller clamp on the tubing leading to the plasma collect transfer
pack container.
2. Remove the multiple lumen tubing from both the upper support bar and the
lower restraining collar.
3. Open the separation and collection container holders and remove the
separation and collection containers.
4. Resuspend the platelets in the collection container by vigorous agitation for

3-5 minutes, or until aggregates are no longer visible.
5. Temporarily invert one of platelet storage containers. Open roller clamp, and
transfer the air contained in the platelet storage container into the collection
container, by squeezing the pack to expel air. Then transfer the plasma from
plasma bag into the platelet container. Disconnect and discard empty plasma
bag.
6. Before releasing the platelet storage container, close the roller clamps. Place
the platelet storage container in the bottom of the centrifuge compartment.
7. Hang the collection container on the WB/ACD pump handle.
8. Open the roller clamp on the platelet storage container and allow all of the
platelet concentrate to drain into this platelet storage container.
9. Close the roller clamp on the filled platelet storage container and gently mix
the platelet concentrate.
10. Roll this storage container to push the air toward the ports of the container.
Open the roller clamp on this storage container and purge the air into the
48
component poor plasma line. For samples continue to purge some of the
platelet concentrate into this line as well.
11. Close the roller clamp on the filled platelet storage container.
12. Make three hermetic seals directly above the manifold on the tubing leading
to the plasma collect transfer pack container. Cut between the seals, leaving
two seals on the platelet storage transfer pack container assembly.
13. To detach the platelet storage transfer pack container assembly from the
Apheresis kit, make three hermetic seals, leaving two seals on the platelet
storage transfer pack container assembly.
14. To equilibrate fluid volume in the platelet storage containers, open roller
clamps on the platelet storage containers. ensure that the tubing connecting
from an IV rack until the fluid levels are approximately equal. Close both
roller clamps on the platelet storage containers.
15. Temporarily invert the platelet storage containers, open both roller clamps
and remove the platelet concentrate remaining in the tubing connecting the
storage containers by displacing them with the residual air from the
containers. Tube stripping is not recommended. Close the roller clamps on
the platelet storage containers.
16. Platelet concentrate is stored for an extended period at 20-24C with

continuous gentle agitation.
17. Weigh the platelets and subtract 52 gms the weight of the two transfer bags
to obtain the weight concentrate. Record the weight concentrate on the
hematology request slip.
MANUAL PRIME BYPASS:
The manual prime operation is used only as a procedure for retesting the auto-
prime or bypassing the auto-prime after the run operation has been interrupted by
a power failure, a nonrestartable with start/resume alarm condition, or by
disengaging the master reset control.
1. Auto/Manual Prime key in manual (1).

2. Record data.
3. Open and close master reset control or power off. After 5 seconds power on.
4. Mode will be flashing.
5. Press Mode to select prime (2).
6. Press Start/Resume (3).
7. Clear prime step failures by pressing Start/Resume (3).
8. 86 manual prime bypass complete will be displayed.
TO RESTART AUTO PRIME:
1. Put auto/manual prime key in auto position.

49
2. At step 2 of prime lift WB/ACD pump handle until the light goes off; close
pump handle.
3. Press Start/Resume to start prime.
TO RESTART RUN WITH DONOR CONNECTED:
1. Press Mode to get into run.

2. Press Start/Resume.
3. Set Auto/Manual Prime key to auto position.
4. Press Start/Resume to start run.
TO RESTART RUN WITH DONOR NOT CONNECTED:
1. Press Mode to get into run.

2. Press Start/Resume.
3. Press Halt/Irrigate.
4. Set Auto/Manual Prime key to auto position.
5. Press Start/Resume to start run.
REFERENCES:
1. CS-3000® Plus Blood Cell Separator Operator's Manual Baxter Health Care
Corporation Fenwal Division. June 1991.
50
3.32 CS3000® PLUS WITH PLT-30 COLLECTION CHAMBER
PRINCIPLE:
The procedure is intended to collect a therapeutic dose of platelets using the PLT-
30 collection chamber that increases platelet yield and simplyfies product
handling. The unique geometry of the PLT-30 collection chamber also permits
resuspension within 15 seconds.
SUPPLIES:
1. CS3000® PLUS Blood Cell Separator with TNX-6 Separation Chamber

2. PLT-30 Collection Chamber (4R4543)
3. Closed System Apheresis Kit for use with CS-3000 (4R2230)
4. Duoswab
5. Sterile Gauze
6. Hemostats
PROCEDURE:
** Refer to directions for use in section [3.32] of the MDA Blood Bank SOP for
Full Instructions to operate the CS3000® PLUS Blood Cell Separator and to
prime the closed apheresis kit for extended platelet storage.
1. Select Procedure 1 - PLATELET COLLECTION using the PROCEDURE SELECT

KEY.
2. Place the standard TNX-6 Separation and the PLT-30 Collection Chamber
into their respective clamp assemblies.
3. Install the Apheresis kit and pinch off the PRBC line in the groove on the TNX-
6 Separation Plate.
4. Press the MODE key and START/RESUME key to initiate prime.
5. At the completion of prime, set the COLLECT PLASMA key to Plasma.
6. Press the Display/Edit key, and use the up Arrow keys to select the desired
end point volume (NOTE: The yield predictor feature may be used in place of a
fixed end point volume to determine the total blood volume to be processed.)
Parameter Preset
Program Value
End Point Volume 5000 As
required
51
7. While in the Display/Edit mode, program the CS-3000® PLUS Separator to
collect the plasma volume for storage and/or additional byproduct. Refer to
table for guidelines on plasma collection volumes.
a. Use the Up/Down Arrows to display Plasma Volume (Coll/Exch) in he

message center.
b. Press Enter to display current and new values.
c. Use Up/Down Arrows to change values.
Display/Edit Current
New
Plasma Vol. (Coll/Exch) 0
300
Due to the fact that approximately 30 ml of saline is pumped into the

plasma transfer pack during prime, the CS-3000® Plus Separator should be
programmed to collect 300 ml of plasma for an end volume of approximately
330 ml.
Display/Edit Current
New
Yield Predictor Calibration 0
1.13
*The Default Valve is 1.00
The yield predictor calibration is changed from 1.00 to 1.13 for more
efficient collection.
d. Press Enter to store the new variable value.
e. Press Display/Edit key to exit.
f. Assure that the COLLECT PLASMA key is set to Plasma.
7. For those procedures in which a plasma by-product is collected, the operator

may choose to collect plasma in either of the following ways:
a. Plasma volume for platelet storage into one of the Platelet Storage
Containers, and the by-product plasma into the Plasma Collect Transfer
Pack Container
52
NOTE: The kit should be installed with the roller clamp on the Plasma
Collect Transfer Pack closed and the roller clamp on one of the Platelet
Storage Containers open prior to initiating prime.
After the plasma volume for platelet storage has been collected into one
of the Platelet Storage Containers and immediately following the
completion of the next spillover, close the roller clamp on the Platelet
Storage Container and open the roller clamp on the Plasma Collect
Transfer Pack Container.
Enter the DISPLAY/EDIT MENU and program the desired amount of

additional plasma to be collected into the plasma collect transfer pack
container.
Exit the DISPLAY/EDIT MENU. The plasma by product will now be

collected into this container.
b. Total Plasma for by product and platelet storage into a single container
No alteration to the set up of the kit prior to prime is required.

Following prime, using the Display/Edit menu, program he desired total
plasma volume. (the total volume will be collected into the Plasma
Collect Transfer Pack.)
8. Press the MODE key to enter Run mode, followed by the START/RESUME key
to initiate platelet/plasma collection.
9. Approximately 20 minutes into the run, check to ensure that plasma is being
collected in the Plasma Collect Transfer Pack (or Platelet Storage Container, if
applicable.)
10. When Code 60 appears in the message center, press the MODE key to enter
the Reinfuse mode. Press the START/RESUME key to initiate the return of red
cells to the donor. Close the inlet line roller clamp and disconnect the inlet
line needle from the donor's arm.
11. After reinfusion is completed, disconnect return line needle from the donor's
arm.
12. Resuspension and Transfer of Platelets
a. At the completion of the collection procedure (Code 25), remove

collection container from the PLT-30TM COLLECTION CHAMBER.
b. Agitate the collection container for approximately 15 seconds.
c. While continuing to agitate the platelets, allow the plasma volume

collected for storage to enter the collection container by pressing
START/RESUME to open the plasma collect clamp and opening the roller
clamp on the appropriate container.
53
d. When the plasma has been transferred, close the roller clamp. Ensure
that the platelets are completely resuspended.
e. Transfer the platelet product into the platelet storage containers by

using the residual air in both the Plasma Collect Transfer Pack and
Platelet Storage Containers. (Refer to Apheresis Kit product insert.)
f. Purge air from platelet storage containers. To obtain product yield

sample, purge some platelet product into the CPP line directly below the
manifold to the platelet storage containers.
g. Make 3 hermetic seals directly above and below the manifold on the
platelet storage assembly. Cut between seals, leaving two seals on
each side of the platelet storage assembly.
h. Detach product yield sample by making three hermetic seals at the "y"
site of the CPP line. The resultant section of the component poor
plasma line contains the product yield sample.
i. Transfer the product sample into an EDTA tube as soon as possible.
j. Prepare platelet product for storage.
k. If a plasma by-product has been collected into the Plasma Collect

Transfer Pack, make 3 hermetic seals 3-4 inches below the port. Cut
between the seals leaving 2 seals on the side of the plasma Transfer
Pack. Prepare plasma product for storage.
Platelet Additional Plasma Plasma

Yield Volume Program
Required for Storage Volume
Up to 6.2 x 330 ml 200-250 ml
cells
REFERENCES:
1. Update. PLT-30 Collection Chamber for use with the CS3000® Plus Blood Cell
Separator. Baxter Healthcare Corporation. 1/94
54
3.35 CS3000® PLUS - GRAVITY REINFUSION OF DONOR RBCS
PRINCIPLE:
In the event of a power failure or instrument failure, blood can be reinfused to the
donor. The packed red blood cells from the separation container can be returned
to the donor by gravity reinfusion.
SUPPLIES:
1. 3 - 4 Hemostats
2. Sterile Gauze
PROCEDURE:
1. Unplug the power cord to the CS-3000.
2. Explain the procedure and reassure the donor.
3. Remove the draw needle. Leave return needle in the donor's arm.
4. Open the roller clamp on the left side of the saline tube and close the roller
clamp on the right side. Close roller clamps on ACD tubing, plasma and
transfer bag.
5. Manually remove the tubing from the vent and return clamps. Start a slow
saline drip to keep the vein open (KVO).
6. Open the centrifuge compartment and remove the MLT from the upper hex, J
arm and collar. Remove the collection and separation bags from their
respective chambers.
7. Open the plasma pump handle and hemostat the RBC line which lies next to
the return line below the assembly kit. Squeeze the contents of the
separation bag into the collection bag. When the separation bag is empty,
close the plasma pump handle and remove hemostats from the RBC line.
Hemostat the tubings above the separation and platelet bags.
8. Remove the plasma pump handle and hemostat the RBC line which lies next
to the return line below the assembly kit. Squeeze the contents of the
separation bag into the collection bag. When the separation bag is empty,
close the plasma pump handle and remove hemostats from the RBC line.
Hemostat the tubings above the separation and platelet bags.
9. Elevate the filled transfer bag on the IV hook, close the saline drip, and open
transfer bag.
55
10. Return the contents to the donor at a moderate drip and close the roller
clamp when empty.
11. Remove needle and ask donor to apply pressure until bleeding has stopped.
12. Apply pressure dressing.
NOTE: In the event red blood cells cannot be returned to the donor, notify the
TMP and advise him of the approximate amount of red blood cells which
were not reinfused and follow his instructions.
If the single donor plasma is to be returned also, open roller clamp and
allow the plasma to return to donor at a moderate drip. Proceed with
#11.
REFERENCE:
1. CS-3000® PLUS Blood Cell Separator Operator's Manual. June 1991.
56
3.36 CS-3000® PLUS BLOOD CELL SEPARATOR QUALITY CONTROL
PRINCIPLE:
The Quality Control program is to be performed on each instrument every month to

help insure trouble free operation, safety of the donor, and to collect high quality
blood products. The quality checks are necessary to check and verify the internal
electronics of the instrument.
SUPPLIES:
1. Gloves
2. Dispatch
3. Quality Control form for each instrument
4. Lubricant (e.g. Dow Corning High Vacuum Grease)
PROCEDURE:
1. Press DIAG key to enter diagnostic mode.
2. Press ENTER key to start a test.
3. Press DIAG key to exit a test.
CALIBRATION/AUTOVOLTS TEST:
1. Place PRIME and RUN keys in manual position. Voltage Limits
2. Return line pressure (press transducer,

note change). 5.88 ± 0.30
3. Blocked line pressures (press transducer,

4. Inlet line pressure. 5.88 ± 0.30
5. Interface detector (obstruct light path,

6. Plasma pump speed (turn on pump to read

87.5±2.5 mL/min). 5.00 ± 0.15
7. WB/ACD pump speed (turn on pump to read

87.5±2.5 mL/min). 5.00 ± 0.15
8. Centrifuge speed (turn centrifuge on**). 5.00 ± 0.20
57
9. Blood flow rate control (pump off). Adjust WBFR control until
voltage reads 10.00 ± .20
10. Plasma flow rate control (pump off). Adjust PFR control until voltage reads
10.00 ± .20
11. Rotor speed control (centrifuge off). Adjust centrifuge speed control until
voltage reads 10.00 ± .20
12. Reference.5.00 ± 0.08
13. Are all clamps closed except the RETURN clamp? YES or NO
NOTE: **Remove container holder assemblies before turning centrifuge on.
AUTO LIGHT/KEY TEST:
Set PRIME and RUN in manual mode. Answer questions YES or NO.
1. During first 5 seconds of the test, are all pixels of the message center on?
2. Are all digits of the seven segment LEDs showing 8s?
3. Are the blood, plasma, mode, start/resume, halt/irrigate, purge, display/edit,

enter, help, mute, edit and store key LEDs flashing?
4. Are the inlet line, return line, blocked line, plasma, saline, prime auto, prime
manual, run auto, run manual and interface LEDs on steadily?
5. Press the double up arrow, single up arrow, single down arrow, double down
arrow, mode, start/resume, halt/irrigate, purge, display/edit, enter, help, mute,
proc select, collect plasma, prime, run, location up arrow, location down arrow,
edit, store, contents up arrow, and contents down arrow keys.
Does the beep sound and the correct description of the key appear on the
bottom line of the message center for each key pressed?
6. To end light/switch test, exit using DIAG key.
MANUAL CONTROL PANEL TEST:
Answer questions YES or NO.
1. Do all clamps open and close except RETURN clamp, which is always open?
2. Do the pumps rotate 48 ± 1 revolutions at a speed of 87.5 mL/min?
58
3. Do the pumps and centrifuge respond to speed and direction controls?**
NOTE: **Remove container holder clamp assemblies before turning centrifuge

on.
PRESSURE SENSOR O-RING MAINTENANCE:
Lubricate rings monthly.
1. Lubricant applied. YES or NO
** NOTE: The following procedures are done by Fenwal Technical

Representative as part of the biannual preventative maintenance program.
Have them document the results of their testing on the Quality Control form.
1. CENTRIFUGE SPEED CONFIRMATION**:
a. Centrifuge speed - does RPM display and external strobe reading

agree within 30 rpm at 1200 rpm?
At 1600 rpm? YES or NO
2. TEMPERATURE OF CENTRIFUGE COMPARTMENT**:
a. Is the temperature of the centrifuge compartment no higher than

36C after running for 15 min? YES or
NO
3. HUMIDITY SENSOR CHECK

Not performed in diagnostic mode.**
a. Did status code 42 (fluid spilled in centrifuge) appear in message

center when water was sprayed on rotor shield of centrifuge?
YES or NO
NOTE: Remove container holder assemblies before turning centrifuge on.

If instrument does not perform as described, contact Fenwal
Technical Affairs.
REFERENCE:
1. CS-3000® Plus Blood Cell Separator Owner's Manual.
59
SINGLE DONOR PLATELETS
3.61 USE & CARE FOR SEBRA HAND HELD TUBE SEALER
PURPOSE:
The SEBRA Model 2380 Mini Hand-Held Sealer is a compact portable battery
powered device which employs smart electronics to generate radio frequency (RF)
to make uniform, quality seals on a variety of tubing sizes without power
adjustment by the user. The sealer comes with hand held manually activated
sealing head which creates a seal that is formed by the sealing head jaws in such a
way as to make segment separation easy and uniform. The sealing head is
equipped with a splash guard for operator protection from inadvertent contact
with the blood product, if tubing should rupture.
The sealer will automatically detect a battery low condition and notify the operator
of impending seal deterioration. This detection circuit is activated when the
battery voltage has dropped to a point in which a limited number of good seals
remain.
SUPPLIES:
1. SEBRA Model 2380 Mini Hand-Held Sealer

2. Rubbing alcohol
3. Gloves - used at all times when cleaning equipment
STARTING PROCEDURES:
WARNING: When seals are being made it is recommended that ANY person wearing
pacemakers remain at least 8 feet away from the sealing device.
1. Check to see that the power switch is in the "O" (Off) position.
2. Open the battery compartment door on the power source case by sliding the
latch to the right.
3. Position the battery connector as shown in the diagram above.
4. Slide the battery into the battery compartment and position the connectors
as show in the diagram below.
5. Once the battery is fully seated, engage the RF power source connector to
battery connector.
Caution: The battery pack and RF power source connectors are keyed to engage
properly. Be sure that the red battery pack connector is engaged into
the red power source connector and the black into the black. If they do
not engage easily, do not attempt to force the connectors together.
60
Improper battery connection will result in damage to the RF power
source.
6. Close the latch on the battery compartment door
7. Install the RF power source into its carrying pouch.
8. Attach one end of the RF power cable to the power source and the other end
to the sealing head.
9. Connect the cable by pushing the connectors together and rotating clockwise
until locked. (See diagram below).
10. Turn on the unit by pushing the rocker type power switch on the power panel
to the "X" (On) position.
11. After a short time the RF "Ready" light on the power panel will illuminate,
which indicates that the sealer is ready for use.
SEALING PROCEDURE:
1. For sealing and segmenting tubing, hold the sealing head in the palm of
either hand with the fingers on the moveable lever so that the splash guard
and sealing indicator light face the operator. In this position the tubing can
be easily placed into the space, "Sealing Region", between the RF and ground
jaws, sealed and pushed through the region to the next sealing position by
the operators free hand.
NOTES:
a. The sealing region must open facing upward so the operator may ensure
that the tubing is fully seated between the RF jaw and ground jaw and
be able to clearly observe the sealing indicator lamp on the sealing
head.
b. Do Not pull the tubing through the sealing region. If the tubing is pulled
at the instant of sealing, a rupture may occur, which will not only
possibly subject the blood product to non-sterile conditions, but the
operator to potentially biohazardous fluids.
In addition the sealing head may become damaged by arcing caused by

the contamination of the sealing region.
2. To make a seal, squeeze the lever until it touches the sealing head body, and
hold it there until the sealing indicator light goes out. This compresses the
tubing and activates the sealing energy, which is visually indicated by the
illumination of the sealing indicator light. Holding the lever closed will not
cause overheating or burn through the tubing.
61
3. The seal is typically completed in one second, as indicated when the light on
the sealing goes out. After that time, the lever may be released.
BATTERY CHARGING:
1. The battery charger should never be us as an AC adapter by plugging the RF

power source connector into the battery charger connector. The sealer will
not function properly and the charger may be damaged.
2. Once the battery pack is removed from the RF power source, plug its red and
black connector to the matching connector on the battery charger.
3. Plug the battery charger into an AC power source and verify that the red
charger light is illuminated.
4. Charge the battery pack for 12 - 16 hours to ensure total recharge.
5. Charging for a period exceeding 16 hours may result in reduced battery life.
6. Disconnect the battery pack from the charger and reinstall into the RF power
source or set aside as a back-up.
MAINTENANCE:
WARNING:
Because the Model 2380 is capable of detecting RF arcing which may
be due to moisture or other contaminants in the sealing region, the
Sealer performance will be reduced if the sealing region becomes
contaminated or wet with fluids. (note that arcing at the sealing head
may cause a battery low condition to be indicated, even when the
battery is not low.) to obtain satisfactory seals at all times, be sure
the sealing region and all adjacent areas are always kept clean and
dry.
NOTE: It is recommend that topical cleaning of the sealing head be performed

when blood or moisture contaminate the immediate vicinity of only the
sealing region, i.e., the area where seals are produced between the
ceramic RF jaw and the ground jaw.
General cleaning of the sealing head should be performed after every

5,000 seals, or when blood or moisture contaminate the area outside the
immediate vicinity of the sealing region.
CAUTION:
Do NOT, under any circumstances, submerge the sealing head in any

kind of liquid.
***** This will seriously damage the RF jaw/tube assembly.
62
1. Verify the movement of the ground jaw while squeezing the lever. The RF jaw
and ground jaw should just touch with approximately 1/8 inch gap between
the lever magnet and the sealer body.
2. Check to see that the RF ready light illuminates when the power switch is
turned to the "X" (On) position. Failure of the switch to illuminate may
indicate internal damage.
3. Disconnect the sealing head from the power source by removing the RF
power cable at the sealing head.
4. Hold the sealing head with the sealing region upward thereby exposing
the space between the ground and RF jaws.
5. Clean the open sealing region with alcohol (denatured or isopropyl)

applied to one end of a cotton swab, in Figure. Be sure the RF power
cable is disconnected from the sealing head!
Be Sure RF Power Cable Is Disconnected!
WARNING:
Failure to separate the sealing head from the power source
prior to cleaning may result in an RF burn to operator during
the cleaning process.
6. After cleaning the contaminated areas of the sealing region,

immediately dry with the dry end of the cotton swab.
7. Clean all areas adjacent to the sealing region using an alcohol-

moistened cotton swab, giving special attention to grooves and other
recesses where fluids or other contaminates may become trapped. Be sure to
dry immediately with the dry end of the cotton swab. Cleaning can be
facilitated by squeezing the lever to expose contaminated areas along the
sides of the ground jaw and RF jaw. Be sure the RF power cable is
disconnected from the sealing head!
If the splash guard was removed for topical cleaning, be sure to follow the
lever cleaning procedure in Section 4.5 before reinstalling a new splash
guard. Verify the movement of the ground jaw while squeezing the lever
before returning the sealing head to service. The sealing region should close
evenly before the lever comes in contact with the tube body.
Properly dispose of all used cleaning materials.
DISASSEMBLY OF THE SEALING HEAD
1. The sealing head is designed for quick disassembly for cleaning ease. See the
beginning of this chapter for the recommended cleaning schedule.
63
2. Disconnect the sealing head from the power source by removing the RF power
cable at the sealing head.
WARNING: Failure to separate the sealing head from the power source
prior to cleaning may result in an RF burn during the
disassembly process.
3. Remove the splash guard from the lever, if necessary. Properly dispose of the
used splash guard.
4. Holding the sealing head in a vertical position, use thumb to completely close
the ground jaw, thereby releasing the ground jaw spring tension and the
resulting force on the lever. If required, additional leverage may be obtained
by placing the connector end of sealing head tube on a padded surface. Be
sure the RF power cable is disconnected from the sealing head!
5. Slightly release the ground jaw. Remove the lever by rotating it away, and
pulling it down, from the RF jaw.
6. Remove ground jaw by pulling jaw up and away as shown in Figure. Be sure
the RF power cable is disconnected from the sealing head!
REASSEMBLE OF THE SEALING HEAD
1. To reassemble the sealing head, slide the round jaw onto the RF jaw/tube
assembly, being especially careful that the ground jaw return spring is
properly seated and retained.
Note: Mating tabs on each of the internal sides of the ground jaw
and mating grooves on both sides of the RF jaw. See below.
2. With thumb, slide ground jaw down the grooves in the RF jaw. While
maintaining constant pressure, depress the ground jaw return spring.
3. Replace lever so that its internal pivot pins slide in beneath the bottom edge
of the ground jaw and are positioned to enter into the pivot pin slots. A small
adjustment of the position of the ground jaw may be required to engage the
lever. Be sure the RF power cable is disconnected from the sealing head!.
4. Once the sealing head is disassembled, use denatured or isopropyl alcohol (or
other selected disinfectant) applied to a cotton swab to clean the ground jaw,
RF jaw/tube assembly and the lever, paying particular attention to the small
grooves and slots on the plastic portion of the head. Be sure to clean all
areas which may have been subjected to contamination.
5. Dry the separate sealing head components thoroughly with a soft, dry tissue
before reassembling. Do not reinstall a splash guard on the lever until the
sealing head has been reassembled.
64
GROUND JAW RETURN SPRING REPLACEMENT
NOTE: If the lever assembly is very loose, allowing it to move freely under
its own weight, then the ground jaw return spring may be worn to the
point that it cannot expand to its full extent. If the jaws won't stay open
at all, it is possible the spring has broken or fallen out of the sealing
head entirely. In either case, the following instructions should be used
to replace the defective or missing spring.
1. Turn the power source off and disconnect the sealing head from it before
attempting the spring replacement.
WARNING: Failure to separate the sealing head from the power source
prior
to spring replacement may result in an RF burn.
2. Pull the spring from its mounting hole, being sure to remove all of the old
spring. The factory-installed spring is mounted in the hole with a small
amount of silicone adhesive to hold it in place. Occasionally, the spring will
break when being pulled, leaving one or two coils remaining in the mounting
hole.
WARNING: It is very important that any remaining coils and/or old

silicone be completely dislodged from the mounting hole.
Adding a new spring on top of any coils or old silicone may
result in poor seals and possible ruptured tubing.
3. Install a new spring (SEBRA P/N 11051005) into the mounting hole.
Reassemble the sealing head and observe the operation of the jaws when the
lever is closed.
4. If arcing is a problem, check the following:
a. The outside of the tubing: The sealing region and adjacent areas are
free of moisture and any other contaminants.
WARNING: To avoid problems with the Sealer, keep the tubing exterior and
sealing head clean and dry at all times.
b. The sealing head assembly is being held properly, with the sealing
region opening upright.
c. The sealing indicator light is completely out before releasing the sealing
head lever.
d. The sealing region closes evenly before the lever comes in contact with
the tube body.
NOTE: Arcing at the sealing head may cause a battery low condition to be
indicated, even when the battery is not low.
65
5. If bad seals are occurring, check the following:
a. Although the sealing heads are generally interchangeable it is possible

that a particular sealing head/power source combination may not give
optimum performance. Check to see if another sealing head connected
to the power source gives better results.
b. That the tubing for blood and blood products (usually PVC) is being
used. Some other tubing materials may give poor seals, or none at all.
c. That the sealing region closes evenly before the lever comes in contact
with the tube body.
d. That the ground jaw return spring is functioning, or, if applicable, that it
has been repaired properly.
6. If the red indicator light on the battery charger fails to illuminate, check the
following:
a. That the battery pack is properly connected to the charger.
b. Be sure the battery charge is connected to the proper AC power source.
REFERENCES:
1. SEBRA Model 2380 Mini Hand Held Tube Sealer Instruction Manual, 1995.
66
GRANULOCYTE DONOR SELECTION AND PREPARATION
4.11 LEUKAPHERESIS PRE, POST, AND DONATION PROCEDURE
PURPOSE:
Persons that have been approved to participate in a Granulocyte Donation protocol will have been interviewed by
persons involved in the protocol. This department will be notified when they have been approved to be further
screened by the Blood Bank. At this time the decision will have been made as to which protocol this prospective
donor will be assigned. Depending on this information, the procedure for the indicated protocol number will be
followed.
SUPPLIES NEEDED:
1. Informed Donor Consent for the Administration of G-CSF and Leukapheresis on Automated Blood Cell
Separator.
2. Granulocyte Donor Information & Instructions (“Blue Sheet”)
3. Granulocyte Donor History Card - Peach colored
4. 21 Gauge Vacutainer Needle
5. 25G 5/8 needle
6. 2cc or 3cc syringe
7. Granulocyte Product Labels with Bar Codes
8. Set of Blood Product Unit numbers
8. 2.5 cc Lavender Top Tube (1)
9. 7 cc Red Top Tubes (3)
10. 7cc Lavender Top Tube (1)
11. G-CSF (Neupogen)
12. Red folder
13. Urine container for pregnancy testing
14. Brown foil-lined bags for product transportation
PROCEDURE:
1. When a Leukapheresis procedure is to be performed to harvest granulocytes, the Transfusion Medicine

Physician (TMP) requesting the collections will FAX or telephone the patient data information to the Blood
Bank.
2. Donors should not donate more than 4 times in a 10 day period, unless approved by the TMP.
3. Two days before the anticipated procedure, the following is to be done:
a. Pre-screen Donor:
1.) Have the donor complete the donor card according to procedure. Take all required vital signs
according to procedure. Contact TMP if there are any unacceptable values. Write "WBC-
Prescreen" across the top of the donor card.
3.) Have donor read and sign the leukapheresis informed consent forms. Answer any questions that
the donor might have, or contact the TMP. Apheresis technician should sign as the witness on
the form. The chart must be sent to the TMP for signature on the consent form.
67
If they request one, make a copy of the consent form for the donor.
4.) Check both arms of the donor for good venous access. If the donor has poor veins, explain to
the donor that they may not be a suitable person for this WBC procedure. ** Always make sure
a second technician evaluates the venous access, before informing the person that they will not
be able to donate.
5.) Draw one 2.5 cc lavender top tube (CBC), one 7cc red top tube (chemistry profile), and 2-7cc-
red top tubes + 1 - 7cc top lavender top tube (for pheresis donor battery) of blood from the
donor.
6.) Label all tubes initially with the name of the donor.
7.) Run CBC on Hematology analyzer. Contact TMP if there are any values not in compliance with
current operating procedures.
8.) If all values are acceptable, assign the donor a unit number.
9.) Order a “Donor Screen” with client code “00000” using the Patient number. Follow Procedure
# 9.12 (Clinical Order Entry = COE) for ordering tests in the Cerner Laboratory Information
System. Print a copy.
Register Prescreen Donor in COE (Client Code “00020”) and order a “*BB CHEM”
(Chemistry Profile) and “U HCG” on appropriate females. Print a copy.
NOTE: Due to a small potential for GCSF to cause problems to expectant women, all female donors of
childbearing age must have a pregnancy test run before they can be accepted to start the series of donations.
a.) Samples for Donor Blood Bank Screening:
* Label the three donor screening tubes according to standard policy for labeling.
* Write accession number on each of the tubes.
* Staple the print-out copies of the donor testing to the donor card. Do not write
the accession #s on the card.
* Deliver these samples with the donor card to Transfusion Medicine Laboratory
b.) Chemistry and Urinalysis Samples:
* Place an eye-readable unit number on both the chemistry and urine samples.
* Write the appropriate Accession Number on each sample.
* Write donor name on all samples
* Write Date, Time, and Technician Initials on all samples.
* Deliver Chemistry and Urinalysis samples to the Laboratory Central Processing
room within 1 hour of collection.
10.) Inform donor to contact the charge person at 792-7777 the following day to find out if results of
the screens are acceptable and to set up medication and donation schedule.
11.) Make a donor folder for consent form, comment sheet and prescreen CBC results.
68
12.) Chemistry profile results are usually available a few hours from receipt. If there are any
abnormal results (indicated by "H" by the result) contact the TMP. Document their instructions
on the comment sheet.
13.) A supervisor, or registered designee, will register each donor that passes the initial donor
screening and has samples sent for laboratory testing, into the PDMS (Protocol Data
Management System) using the appropriate protocol number.
14.) Register donor in Granulocyte Donor Log Book. Provide the following information.
 Donor's Name
 Donor's 800,000 number
 Donor's Date of Birth
 Donor's relationship to patient
 Patient's Name & Hospital Record Number
 Donor's Phone Number & Mailing Address
15.) Send folder to Transfusion Medicine Physician for signature on consent form.
4. Pre-Medication the day before the scheduled procedure:
a.) TMP will write a prescription for the appropriate dose of medication necessary for the donor.
(A single dose of 5 micrograms/kg body weight subcutaneously the day before the day of the
procedure)
b.) The medication is to be picked up by the donor or other designated person from the outpatient
pharmacy and then brought to the Blood Bank at 7000 Fannin.
The outpatient Pharmacy is located on the second floor in the Rose Zone in the Clark Clinic Building.
Phone # is 792-6125 and the FAX # is 794-1616.
NOTE: Some donors may directly pick up the medication from the pharmacy and make other
arrangements for the injection of the medication. This is coordinated through the Transfusion Medicine
Physician.
c.) Immediately upon delivery to the Blood Bank, the medication must be placed in the laboratory
refrigerator until use. This refrigerator must have it's temperature monitored and documented daily.
d.) Injectable medication will be administered under the direction of the TMP and by only those personnel
that have had documented training and observation by the TMP.
e.) Appropriate medication will be injected subcutaneously utilizing a tuberculin needle with a 2 syringe
or a 3 cc syringe with a 25G 5/8 needle.
f.) Document in donor folder all medication information. (Your name, date, time, amount given, site)
g.) Inform the Transfusion Medicine Supervisor at 792-8630 of the Granulocyte schedule and donor
information.
5. Day of Donation:
a. Ask the donor to fill out a donor history card and obtain vital signs.
69
b. Draw one 2.5 lavender top for the CBC and two 7 cc red top tubes and one 7cc lavender top tube for
processing.
c. Do a CBC on the Lavender top. Label all processing tubes according to standard procedure.
d. Inform the TMP on call about the cell counts.
e. The TMP may determine which Cell Separator instrument will be used to harvest the granulocytes,
based on the donor’s cell count.
f. On the last donation of the series for that particular donor (this may be after only 3 donations, but
usually after the 4th donation), draw a 7ml red top tube and order a Chemistry Profile on the donor,
using the unit number. Follow COE procedure #9.12 for ordering. Follow procedure above for labeling
and delivering procedure.
g. When results are available, print these results and attach to the donor comment sheet in their folder.
h. Inform the TMP of any abnormal results and document this call in the donor's folder.
i. Harvest granulocytes according to selected instrument procedure.
j. It is very important that as much of the procedure paperwork is completed during the procedure so that
the product is ready to be sent to the Transfusion Medicine laboratory immediately.
(1.) Register donor on the registration log

(2.) Place one (1) bar-coded unit number on the front of the product bag. ( see example for correct
positioning).
(3.) Place a Granulocyte Product Label on the Bag (see example)
(4.) Write the date the product was collect and the date that it expires on the Granulocyte Product
Label.
k. At the end of the procedure obtain the product bag weight.
l. After procedure is completed, obtain a well-mixed sample of the finished product in lavender top tube.
Order a bag count (BG BB BAT) using client code “00020” for this according to COE procedure
#9.12. Deliver this specimen to the Hematology Laboratory.
* Write the accession number on the tube

* Write the WEIGHT of the concentrate on the tube!
* Date and initial the tube
NOTE:If Pre-Screen is expiring (close to 10 days), order a “DON RESCRN” = Donor Rescreen in
COE with Client Code “00020”according to procedure. Also reorder the “*BB CHEM”
and “U HCG” on appropriate donors.
**** TRANSPORT PRODUCT TO TRANSFUSION MEDICINE WITHIN 30 MINUTES OF PROCEDURE

COMPLETION.
6. After last donation in a series:
70
a. Collect a 2.5 cc lavender top tube and a 7cc red top tube from the donor by a separate venipuncture.
b. Run the lavender top sample on hematology analyzer to obtain CBC values.
c. Attach a copy of the report to the comment page in the donor's folder and indicate these results in the
"comment" section of the worksheet.
d. Call the TMP with these results before dismissing the donor and document any TMP comments in the
folder.
e. Order a *BB CHEM (Chemistry profile) as indicated before on the other tube.
f. Label as indicated before and deliver to Central Processing.
7. Occasionally it may be necessary for a potential donor to have their initial donor screening drawn at another
area and mailed to M. D. Anderson.
a. When these samples are received in the Transfusion Medicine Laboratory they will notify an apheresis
technician and the apheresis technician will then follow these guidelines.
b. When the samples are mailed in:
* Assign a unit number to the samples

* Order a “DONOR PRE” on the donor using the patient number
* If no date of birth is indicted, use “01-01-50”.
* Make a folder with donor’s name
* Make a note in the folder that a sample was mailed in on “_____” date.
* Indicate what unit number was assigned to the sample. Indicate the accession number also.
* Log as much of the donor information as is available on the daily donation log sheet.
* Note: Do NOT order a chemistry profile, even if there is a sample mailed in that is indicated for
this purpose.
c. When the potential donor first comes to the Blood Bank:
* Successfully complete donor card screening

* Successfully pass all Hematology screening (Hgb, Plt. Ct, and WBC)
* Complete the consent form
* Order “*BB CHEM” and “U HCG” on appropriate females.
* Order “DON RESCRN” under “00020” Client Code.
* Donor can not receive medication injection until all steps are completed and resulted.
* On day of first donation, you must confirm the results of the rescreen before starting the
collection process.
71
GRANULOCYTE DONOR SELECTION AND PREPARATION
4.12 PREPARATION OF HETASTARCH FOR USE
PURPOSE:
Granulocyte harvest can be improved by more complete separation between

granulocytes in the lower, denser portion of the buffy coat and the underlying red
cells. Rouleaux-promoting agents cause red cells to aggregate and thereby
sediment more completely than single cells during centrifugation. This enhances
granulocyte harvest and minimizes red-cell contamination of the component.
Hydroxyethyl starch (Hetastarch) is a synthetic polymer of amylopectin that, when
present in the donor’s circulation, greatly increases separation between red cells
and granuloctyes.
Hetastarch is an artificial colloid derived from a waxy starch composed almost

entirely of amylopectin. Hydroxyethyl ether groups are introduced into the glucose
units of the starch and the resultant material is hydrolyzed to yield a product with
a molecular weight suitable for use as a plasma volume expander and erythrocyte
sedimenting agent.
Although cleared by macrophages from the circulation with an intravascular half-

life of 24-29 hours, residual hetastarch can be detected for as long as a year after
injection. Since hetastarch is a colloid, it acts as a volume expander, and donors
who have received hetastarch may experience headaches or peripheral edema
because of expanded circulatory volume. Citrate anticoagulant is added to assure
effective anticogulation of the blood as it flows through the leukapheresis
machine.
SUPPLIES:
1. 6% Hetastarch in 0.9% Sodium Chloride Injection - 500 ml bag. Abbott

Laboratories (NDC 0074-7248-03). Contains 6 G Hetastarch and 0.9 G Sodium
Chloride in water for injection. May contain sodium hydroxide for pH
adjustment.
2. TriCitrasol-Anticoagulant Sodium Citrate Concentrate (46.7% Trisodium
Citrate)- 30 ml vial
Note: Each 10 ml of concentrate contains 4.67 grams of Trisodium
Citrate (dihydrate) in water for injection, approx pH (6.4-7.5), adjusted
with citric acid.
3. 30 cc Luer-lock sterile syringe
4. 18 G 1½ Injection Needles
5. Alcohol Preps
6. Fenwal 300ml Transfer Pack with Coupler ( 4R2014)
7. Hemostat
8. Sebra Hand-Held Sealer
PROCEDURE:
72
1. Remove the clear plastic overwrap on the hetastarach container by tearing
down at the notch . Check for minute leaks by squeezing solution container
firmly. If leaks are found, discard solution as sterility may be impaired.
2. Remove the red plastic top from the 30 ml TriCitrasol vial
3. Wipe the top of the TriCitrasol vial with an alcohol prep.
4. Wipe the injection port of the hetastarch with alcohol prep.
5. Attach an 18 G needle to a 30 cc syringe.
6. Invert the TriCitrasol vial and insert the needle into the middle of the
cleaned cap.
7. Aspirate the entire 30 ml contents of the vial into the syringe.
8. Inject the entire 30 ml of the TriCitrasol into the hetastarch bag.
9. Dispose of syringe and needle into appropriate biohazard container.
10. Hold the bag with both hands and mix well for at least 1 minute and about
every 15 minutes during the procedure..
11. Hang bag on selected apheresis instrument and follow instrument procedure.
*** NOTE:
Frequently it is necessary to use an additional amount of the hetastarch

+TriCitrasol mixture to complete a procedure. In that case, a second bag must be
prepared. Usually the procedure will not require more than 150 ml of the mixture
for completion.
If there is only one granulocyte collection procedure, this second bag is prepared
and used as usual. However, if there are 2 or more granulocyte procedures being
done at the same time, the amount of this mixture that is discarded can be
minimized by dividing it, using aseptic technique, into 2 or 3 bags.
One bag of hetastarch, if necessary, can usually be divided into 3 approximately

equal bags. Thus, if you have 2 donors, divide into 2 bags; 3 donors, divide into 3
bags; 4 donors, do two separate divisions into 2 bags each. It is important to plan
ahead and work with the other technician(s) doing the procedures.
Follow the procedure indicated below for dividing the hetastarch + TriCitrasol
mixture.
1. Prepare 500ml of hetastarch and 30 ml of TriCitrasol as indicated above.
2. Obtain a Fenwal 300 ml Transfer Pack with Coupler, and place a hemostat on
the tubing. As with any other product, do not use if coupler cover is removed,
or anything appears damaged.
73
3. Expose outlet port of the hetastarch bag.
4. Immediately remove the transfer pack coupler cover.
5. Immediately insert the coupler into the outlet port with a firm, slightly
twisting motion until firmly connected.
6. Remove the hemostat from the transfer pack line.
7. Hold hetastarch bag above transfer pack to transfer desired amount of

solution into the pack.
8. When you have transferred the appropriate amount into the transfer bag,
clamp the line off with a hemostat to stop.
9. Using the hand-held heat sealer, make several seals (no less than 3) fairly
close together on the transfer pack tubing.
10. Carefully sever the transfer pack from the original hetastarch pack. Make
sure that there is at least one intact seal on each side of the division to
maintain sterility.
11. Leave the coupler in the hetastarch port until it is time to hang the bag. At
that time you will you will remove the coupler and hang as usual.
12. If you are going to divide the original bag into 3 equal portions using a
second transfer bag, obtain the second bag and place a hemostat on the
tubing as before.
13. Remove the coupler of the first bag from the hetastarch and immediately, and
aseptically insert the coupler from the second bag.
14. Transfer the desired amount of the solution and seal as before.
15. Write on EACH transfer pack, the date, time, your initials, and the Lot
numbers of both the hetastarch and the TriCitrasol. This is very important!
REFERENCES:
1. TriCitrasol package insert. Cytosol Laboratories, Inc. Braintree

Massachusetts. 8/93.
2. 6% Hetastarch in 0.9% Sodium Chloride Injection package insert. Abbott
Laboratories, North Chicago, IL, 60064, USA 58-0392-R5. May 1998.
4. COBE Spectra Apheresis System Operators Manual, Version 4.7 / 5.1.
1996/07.
5. Baxter Fenwal CS3000 Plus Blood Cell Separator Operator’s Manual, June
1991.
74
75
GRANULOCYTE CELL COLLECTION
4.21 LEUKAPHERESIS USING THE COBE SPECTRA
PRINCIPLE:
This is the procedure for collection of granulocytes from donors. The indications for
granulocyte transfusions are to treat or prevent sepsis in neutropenic patients and
patients with leukocyte dysfunction. A sedimenting agent of 6% hetastarch with
trisodium citrate added as anticoagulant is necessary for the collection of
granulocytes. Pre-stimulation of the donor with steroids or GCSF will augment
granulocyte yield.
SUPPLIES:
1. COBE Spectra Apheresis System (Version 4.7 / 5.1 /7.0 LRS turbo Software)
2. Single Stage Channel Filler
3. Collect Flow Path Overlay
4. Disposable WBC Blood Tubing Set (Catalog #777006-000)
5. 1000 ml 0.9% Sodium Chloride for Injection
6. 1-2 bags of Hetastarch + TriCitrasol (See Procedure #4.12 for preparation)
8. Apheresis arm preparation supplies
9. 17G x 1” Terumo AVF Set Needles
10. COBE Spectra WBC Colorgram
11. 19G x ¾” winged infusion sets
The Spectra system requires operator attention during this procedure.
NOTE: For Granulocyte procedures, the Transfusion Medicine Physician (TMP)

may prescribe that donors receive steroids, GCSF, prior to the procedure
to stimulate the release of granulocytes into the peripheral circulation.
1. Plug in Spectra Apheresis System.
2. Turn power switch on.
3. Verify the following:
a. Yellow warning LED is illuminated.

b. "COBE Spectra (Version 4.7/ 5.1 /or 7.0 LRS Software)" is displayed.
c. PAUSE LED is flashing
d. Cartridge clamps are in load position.
INSTALL FILLER
76
4. Rotate centrifuge so centrifuge loading port (with alignment dot) is facing the
front.
5. If a dual stage channel filler is in place, remove it as follows:
a. Push filler latching pin toward center of centrifuge and raise filler latch.
b. Push filler locking pin toward center of centrifuge and raise filler.
6. Position single-stage channel filler so dots on centrifuge and filler are aligned.
7. Place filler over centrifuge assembly, and press down until filler locking pin is
securely in place.
8. Lower filler latch.
9. Lift up on filler to ensure it is securely in place.
11. Install collect flow path overlay on front panel.
SETTING UP WBC DISPOSABLE
1. Place tubing on front panel.
2. Swing control panel to the side.
5. Package should be held securely by placing it underneath packaging hook on

front panel.
6. Remove inlet line coil and remove white paper tapes.
a. Hang donor connection on hook left side of IV pole. (For identification

purposes, the three lines attached to this connection are taped together
with red tape until they reach the front panel.)
b. Place access saline line (green striped) over top of the system.
7. Remove return line coil and remove white paper tapes.
a. Hang human subject connection on hook on left side of IV pole. (For

identification purposes, the two lines attached to this connection are
taped together with blue tape until they reach the front panel.)
77
b. Place return saline line over top of the system.
8. Hang bags on one hook on the IV pole.
the plasma and collect/replace pumps. (COBE label on cartridge should be
facing up.)
10. Remove access pump cartridge and snap it into the cartridge clamp between
the AC and inlet pumps. (COBE label on cartridge should be facing up.)
13. Press CONTINUE key to load tubing into pump housings. Cartridge clamps are
retracted and tubing headers are threaded onto pump rotors.
14. Verify all four pumps are loaded. After pumps are loaded, valves automatically
open to load position.
16. Place sensor in return pressure sensor housing. Turn clockwise to lock in place.
17. Place RBC line in RBC valve. Ensure line is completely inserted in RBC detector.
18. Position return and inlet air chambers in air detectors with air chamber filters
located below air detector housings. Ensure waste divert lines are toward you.
19. Put waste lines in waste valve assembly.
21. Place sensor in access pressure sensor housing. Push downward and turn
22. Position return line in return valve so line runs horizontally through center
valve.
INSTALL CHANNEL IN CENTRIFUGE
1. Remove channel from package.
2. Discard package.
78
6. Rotate centrifuge so loading port is open to the front.
outer rim.
8. Extend centrifuge loop to full length to ensure four-lumen tubing is not twisted.
9. Fold channel in half.
centrifuge collar into collar holder.
the collection chamber and inlet chamber and work around to the opposite side
of the channel.
inserted.
16. Place lower bearing in lower bearing holder.
17. Place upper bearing in upper bearing holder.
18. Place upper collar in upper collar holder. Ensure that collar is held securely by
visually checking that both black sides of holder are equally closed around
collar and that an edge between two of the upper collar's six sides is facing
19. Use a "flossing action" to place four-lumen tubing in exit slot on right side of
the system
WARNING: Inspect all lines, especially those in the centrifuge and on the front
panel, to ensure they are not kinked. Lines that are occluded, or partially
occluded, may lead to the procedure not operating correctly.
79
PRIME TUBING SET
1. Press 3 key to select WBC tubing set. If you make a mistake and enter the
wrong set number:
a. Press CHANGE MODE key.
b. Press 1 key to select Load Set. The tubing set selection message above is
redisplayed.
c. Press the 3 key to select the WBC blood tubing set and continue with Step
2.
2. Close white pinch clamps on access and return lines near luer connections.
Close roller clamps on access and return saline lines. Clamp access and return
lines. Close both saline lines. Press CONTINUE.
3. Press CONTINUE key. Connect WBC tubing set to fluid containers. Press
CONTINUE.
CAUTION: Use aseptic technique throughout this procedure.
4. Connect AC line to hetastarch/sodium citrate container (each 500 ml of 6%

hetastarch diluted with 30-40 ml of sodium citrate concentrate).
5. Connect inlet and return saline lines to same saline container. Using aseptic
technique, clean injection port before inserting metal spike into it. Then place
plastic spike in spike port (after removing cover). Fill drip chambers 1/2 full.
CAUTION: Ensure lines are attached to correct fluids:

a. AC line to anticoagulant container.
b. Access and return saline lines to normal saline container.
Visually verify that fluid is flowing through the access, return, and AC spike and
drip chambers.
6. Press CONTINUE. Open access and return salines lines. Press CONTINUE to
prime.
WARNING: Once fluid has entered the tubing set, do not disturb sensors in
pressure sensor housings because this will prevent transducers from
monitoring pressures accurately.
7. Open access and return saline roller clamps.
8. Press CONTINUE key to prime tubing set.
80
9. Move bags to correct positions on IV pole as follows:
• • • • • •
AC Saline Waste Plasm WBC
a Bag
10. Donor data can be entered before tubing set is primed, during Prime mode, or
after priming is complete.
a. To enter data before Prime mode, select set type (3=WBC) and press
MENU ON/OFF key. Continue with Step 10d.
b. To enter data during Prime mode, press MENU ON/OFF key. Continue with
Step 10d.
c. To enter subject data after priming in complete, continue with Step 11.
d. Press 1 key to select "Data Entry."
11. Open white pinch clamp near access luer connection. Allow saline to fill luer
lock connection by gravity. Close white pinch clamp.
12. Open white pinch clamp near return luer connection. Allow saline to fill luer
lock connection by gravity. Close white pinch clamp.
13. Press CONTINUE key.
14. Use roller clamp to close green-striped access saline line, close white access
pinch clamp, and press CONTINUE to test the AC ratio.
15. Press CONTINUE key to clear this warning from screen.
16. Press YES key to run semiautomatic alarm tests. Refer to SECTION 9 -
DIAGNOSTICS for ALARM TESTS procedure.
NOTE: To clear saline from return saline drip chamber (so saline drip can be
observed), do the following:
a. Clamp line below chamber.
b. Invert container and squeeze saline from drip chamber into saline
container.
c. Rehang saline container.
d. Remove clamp.
ENTER DATA
81
WBC procedures will start with following values:
Run Parameter Value

Time 120 min
MNC Inlet:AC 12:1
Ratio
PMN Inlet:AC 13:1
Ratio
Collect Rate 3 ml/min
The Spectra control program then uses donor sex, height, weight, and hematocrit to
calculate values for the following Run parameters:
Subject Data Run Parameters

Sex, height, and AC and inlet pump
weight flow rates
Centrifuge rpm
Hematocrit Plasma pump flow
rate
1. Enter subject sex:
a. Press 1 if male.
b. Press 2 if female.
c. Press ENTER for default (data in parentheses).
2. Enter donors height.
3. Enter donors weight in pounds then press enter key.
4. Confirm donor data input.
5. Enter hematocrit as a whole number then press enter.
6. The Spectra system allows mononuclear or polymorphonuclear cell removal:
a. Press 1 key or ENTER to select MNC removal.
b. Press 2 key to select PMN (Granulocyte) removal.
7. Approve white cell removal values:
a. Press YES = exit subject data entry displays and continue to Connect
Donor section.
82
b. Press NO = next display: white cell removal settings menu.
Important:When one value is changed, this will affect other values. For
instance, see table on the next page.
The spectra system uses subject data (entered by the operator) and
microprocessor algorithms to calculate and show the following information on
the white cell removal results display:
• Inlet volume displayed in milliliters.

• Inlet pump flow rate displayed in milliliters per minute.
• Procedure time displayed in minutes
• Collect volume displayed in milliliters.
Changed Value Affected Value

Run Time Inlet Volume
Collect Volume
AC Volume
Inlet Flow Inlet Volume

AC Volume
AC Flow Rate
Plasma Flow Rate
Collect Volume
Collect Volume *Collect Pump Flow Rate

AC Pump Flow Rate
Inlet Pump Flow Rate
Plasma Pump Flow Rate
Inlet Volume
AC Volume
Inlet Volume Run Time

Collect Volume
AC Volume
8. Select white cell removal value to be changed:
9. Using arrow keys, change selected value. the up arrow key increased the
value, and the down arrow key decreases it. Affected value(s) will also be
changed. When satisfied
that changed and affected values are appropriate, press ENTER to return to
white blood cell removal results message (precedes Step 7 above).
When changing white blood cell removal values, the following value ranges are
allowed for changed values:
Changed Value Allowed Range

Run Time 10-999 min
Inlet Flow 15-150 ml/min
83
Collect Volume 10-9999 ml
Inlet Volume 100-32,000 ml
CONNECT SUBJECT
WARNING: Before connecting subject, check access and return lines for air. If air is
present in these lines, do not connect subject. Remove air before starting
procedure.
1. Perform venipuncture at access and return needle sites.
2. Open white pinch clamps on access and return lines.
3. Leave a saline drip on return line to keep return needle from clotting.
4. Close roller clamp on access saline line.
START RUN MODE
1. Press CONTINUE key to start system in Run.
NOTE: When setting the desired inlet:anticoagulant ratio, consider the

following:
12:1 = starting MNC ratio value

13:1 = starting PMN ratio value
The following may be helpful when determining appropriate ratio:
9:1 = (low ratio) normal hematocrit and normal platelet count.

15:1 = (high ratio) low hematocrit and low platelet count.
Since red blood cells have a buffering capacity, subjects with normal to high
hematocrits and normal platelet counts require more anticoagulant to avoid
platelet clumping than subjects with low hematocrits and low platelet counts.
If clumping is seen in collect line, lower the inlet:AC ratio or increase the collect
pump flow rate.
2a. If you want to divert the prime saline to the waste bag, continue with Step 3.
OR
2b. If you do not want to divert the prime saline to the waste bag and, instead,
want to return it to the subject, follow these steps:
• Press the CHANGE MODE key.
• Press 3 key to select Run.

84
• Close the roller clamp on the return saline line. (The system will not
prompt you to do this.)
• Press CONTINUE key.
• Continue with Step 4, but do not press CLEAR.
3. Use roller clamp to close return saline because blood flow is being returned to
subject.
4. Press CLEAR key.
NOTE: When setting the desired collect pump flow rate, consider the following:
3 ml/min = remove large amount of cells

<3 ml/min = (low flow) may be desirable for certain procedure (e.g., stem
cells). However, there is a higher risk of fluid imbalance and
clumping.
>3 ml/min = (high flow) deplete buffy coat.
5. Through the centrifuge door view port, observe WBC collect tube (WBC out) to
ensure correct removal. To establish RBC/plasma interface at beginning of run,
changes in plasma pump flow rate will be frequent and in large increments. As
interface becomes established, these changes will be less frequent and in
smaller increments.
Operator Action
If collecting too deep into red cell layer, WBC collect tube will be filled with red
cells. To correct this, decrease plasma pump flow rate (in 3 ml/min increments)
until quantity of red cells being collected is at desired level.
If not collecting deep enough into white cell layer, WBC collect tube will be
clear in color with no red cells present. To correct this, increase plasma pump
flow rate until quantity of white cells being collected is at desired level.
Once interface is established, smaller and less frequent changes in plasma pump
flow rate may be required to maintain interface. Because separation channels
require a minute to two to respond to a change in flow rate, changes in plasma pump
flow rate should be made gradually (0.5 ml/min changes every 5 to 10 minutes for
MNC procedures and 0.2 to 0.3 ml/min changes every 5 to 10 minutes for PMN
procedures).
NOTE: White blood cell removals should ideally have a minimum of red cells
and a maximum of white cells. Typically, there is a significant
number of white cells and platelets mixed in with innermost layer
(top) of red cells. Therefore, it is necessary to collect some red cells
to get a maximum white cell yield. WBC collect tube will contain
streaks of red cells.
85
NOTE: The COBE Spectra WBC Colorgram is an approximation of ideal
hematocrits for the collection of granulocytes and mononuclear cells
using the COBE Spectra Apheresis System. Insert the Colorgram
beneath the clear, small diameter collect line where it exits the
centrifuge, prior to the four lumen connector. The most accurate
color comparison is made by observing under cool, white fluorescent
light. The Colorgram should be used as a general guideline to
determine the correct position of the blood/plasma interface and
should not be used as a final means of determining specific
hematocrit of a product.
For complete instructions on carrying out WBC procedures using the Spectra
system, see the WBC Operation section of the COBE Spectra Operator's Manual
If a granulocyte procedure is being performed, the abbreviation in the bottom

right-hand corner of the display screen would be "PMN" rather than "MNC"
Run mode continues until target values are reached.
There are audio and visual warnings when Run mode is complete. The values
that have exceeded their limits will be flashing.
6. Press 2 key to continue Run mode. (To start Rinseback mode, press 1 key and
skip to Start Rinseback Mode section.)
7. Select flashing target value on bottom row of display.
8. To increase inlet volume or time, press appropriate key.
9. Enter new target value on numeric keypad. then press ENTER.
START RINSEBACK MODE
1. Press 1 key to start Rinseback mode.
2. Close white pinch clamp on access line. Open roller clamp on green-striped
access saline line to allow saline to enter system.
3. Press CONTINUE key to start Rinseback.
4. Disconnect access needle and place in appropriate needle disposal container.
5. IMPORTANT: Clamp or seal collect line and remove WBC bag.
6. Press CLEAR to continue Rinseback.
DISCONNECT DONOR
NOTE: Before disconnecting donor, verify that WBC bag is clamped or sealed and
removed.
86
1. When Rinseback mode is completed, close white pinch clamp on return line.
Disconnect return needle. Close roller clamp on green-striped access saline
line.
2. To ensure that fluids do not leak when disposables are removed, when possible,
connect return line to collect line (where collect bags were disconnected).
3. Press CONTINUE key.
4. Record on subject records final volumes processed during procedure.
REMOVING WBC DISPOSABLE - OPERATOR ACTION
1. Place ends of donor access and return lines in appropriate biohazard disposal
container.
5. Remove four-lumen tubing from exit slot on right side of system.
6. Remove collar from upper collar holder.
7. Remove upper bearing from upper bearing holder.
8. Remove lower bearing from lower bearing holder.
9. Push filler latching pin toward center of centrifuge and raise filler latch.
10. Pull tubes from slots in filler.
11. Pull channel from filler.
12. Open hinged cover on centrifuge collar holder and remove collar.
13. Raise channel above filler.
14. Fold channel in half and pull through loading port.
15. Discard channel in appropriate biohazard disposal container. (Channel will still
be connected to tubing.)
17. Remove lines from the following;
• Collect and plasma valves
87
• Return pressure sensor
• Waste divert valve
• RBC line valve
• Return and inlet air detectors
• Centrifuge pressure sensor
• Access pressure sensor
• Return line valve
• Anticoagulant level detector
18. Press CONTINUE key to unload pumps.
19. Remove lines from cartridge clamps (press clamps up to release pump
cartridges).
20. Remove return needle and needle in saline container from tubing set and place
them in appropriate needle disposal container.
21. Remove fluid containers and waste bag from Spectra system, and place in
appropriate biohazard disposal container along with tubing.
NOTE: In the event of a power failure, start a slow saline drip. when the power is
back on, the display on the Spectra keyboard panel will show the
message, "Continue with Previous Procedure YES/NO". Press Yes and
continue with procedure.
REFERENCES:
1. COBE Spectra Apheresis System (Version 4.6 / or 5.1 LRS) Operators Manual,
1996/07.
88
GRANULOCYTE CELL COLLECTION
4.31 - LEUKAPHERESIS USING THE FENWAL MODEL CS3000 PLUS®
PRINCIPLE:
This is the procedure for collection of granulocytes from donors. The indications for
granulocyte transfusions are to treat or prevent sepsis in neutropenic patients and
patients with leukocyte dysfunction. A sedimenting agent of 6%) hetastarch with
trisodium citrate added as anticoagulant is necessary for the collection of
granulocytes. Pre-stimulation of the donor with GCSF will augment granulocyte
yield.
SUPPLIES:
1. Baxter Fenwal CS3000 PLUS® Open System Apheresis Kit for Blood Component
Collection with the CS-3000 or CS3000 PLUS® Blood Cell Separator Code:
4R2210
2. 1-2 bags of Hetastarch+ TriCitrasol solution (See Procedure #4.12 for
preparation)
3. Apheresis arm preparation supplies
4. 16 g and 17g, and disposable syringe needles
5. Alcohol swabs
6. 1000 ml Sterile Saline (0.9%)Bags (2)
7. 600 ml Transfer Packs
8. CS3000 GRANULO (Revision E) Granulocyte Collection Chamber
PROCEDURE:
1. Set the following Run Parameters:
Preset
PROCedure SELECT Key. . . . #2
Separation Container Holder . . GRANULO* (Revision E)
Collection Container Holder . . . A35
Blood Flow Rate . . . . . . . . . . . 50 mL/min
WB: HES/Citrate. . . . . . . 13:1
Centrifuge Speed. . . . . . 1000 rpm
Interface Detector Offset . . . . . 15
End Point Volume. . . . . 9000 mL Blood ( 9 liters)
May be less for small donors.
2. Set up the Open System Apheresis Kit for Blood Component Collection with the
CS3000 PLUS® according to Figure 1 and all steps for the CS3000 PLUS®
Preparation (Steps 1 - 25), Priming (Steps 1 -7), and Donor Preparation (Steps
1-10) described in Procedure 3.311 for CS3000 PLUS® Plateletpheresis.
3. For Granulocyte Collections: The PRBC line between the WB line and the CRP
line must be placed into the slot on the white plastic portion of the blue metal
plate.
89
4. The Open Apheresis Kit does not have fluid containers attached as in the single
donor platelet closed system. Connect the following fluids..
a. Connect the ACD line to 500 ml Hespan + Citrate mixture (See Procedure
#4.12 for directions)
b. Connect saline line to a 1000 ml bag of sterile saline
c. Insert the vent line needle into the injection port of the saline bag.
d. Connect the Plasma Collect Line to an empty 600 ml Transfer Pack
NOTE: Although the machine has preset run parameters, the operator may alter
these values to meet individual donor/patient needs and to ensure an
effective, efficient procedure.
3. Auto Run - Instructions to the Operator
a. Prior to priming the system, prepare the 6% HES/trisodium citrate by

adding the contents of a 30 mL vial of 46.7% trisodium citrate to 500 mL
6% HES using aseptic technique (See Procedure #4.12). Initially mix the
HES/citrate solution vigorously for at least 3-5 minute, and then every 15
minutes throughout the run procedure.
CAUTION: Failure to periodically re-mix anticoagulant/HES solution may

lead to variability in anticoagulant administration as well as
product yields.
b. To conserve the HES/citrate solution for the run procedure, regulate the
drip rate of the HES/Citrate solution to 56-60 drops/min.
c. Ensure that the AUTO/MANUAL RUN key is set to AUTO (AUTO LED on) and
press the PROCedure SELECT key to select procedure 2 (Granulocyte
Collection) as displayed in the message center.
d. Ensure that the inlet and return line roller clamps are completely open.
e. Press the MODE key to select Run. With RUN displayed in the message
center, press the START/RESUME key to initiate the Auto Run. RUN stays
in the message center, the ELAPSED TIME and VOLUME PROCESSED
displays reset to zero, message 84 (Enter Single Access Cycle Volume) is
displayed and the START/RESUME LED flashes.
 If a single access procedure is to be performed, the draw cycle volume

must be entered at this time using the Display/Edit function.
 If a dual access procedure is being performed, press the

START/RESUME key to continue.
90
f. The centrifuge will start immediately. If within the first 60 seconds of run
time the pumps and centrifuge stop, pressing the START/RESUME key will
restart the centrifuge and pumps simultaneously (except with Non-
resumable alarms). After the first 60 seconds of run time, pressing the
START/RESUME key will start the centrifuge first and then the pumps 17
seconds later.
g. Check the anticoagulant flow rate by monitoring the drip rate in the
Anticoagulant line drip chamber of the Apheresis Kit.
h. Ensure that the roller clamps on the saline and vent lines are completely
open. This will allow free flow of saline solution whenever the
HALT/IRRIGATE key is pressed.
i. Within 5 to 10 minutes the first spillover should occur, message 80

(Spillover Steps in Progress) appears. At this time the whole blood flow
rate will decrease and the plasma pump will reverse and draw fluid from
the Transfer Pack Container to clear the CRP line of some of the red cells.
As the CRP line clears, the plasma pump will return to the forward
direction, pumping some fluid into the Transfer Pack Container, then both
pumps will return to the previous rates, message 80 changes to 89 (run in
Progress).
After the plasma flow rate stabilizes, spillovers will occur approximately
every 0.5 to 2.5 minutes throughout the procedure. During subsequent
spillovers, the plasma pump slows but does not reverse and the CRP line
may not be cleared of red cells, allowing the collection of some red cells
with the granulocytes. If a spillover does not occur within approximately
15 minutes of the start of the run procedure, or more than approximately
15 minutes after the previous one, message 62 (Spillover Late) appears.
If message 62 appears, refer to Chapter 12 in the CS3000 Plus Operator's
Manual for troubleshooting instructions.
j. After the second spillover, change the interface offset detector from 15 to
33. To make this change; Press DISPLAY/EDIT; then ENTER; enter new
value of "33"; press ENTER; press DISPLAY/EDIT to return screen.
k. At this time program the instrument to:
1.) Collect 100 - 150 ml of plasma. This will be added to the granulocyte
product at the end of the procedure
2.) Program volume to be processed = 9000 ml.
l. Vigorously mix the HES/citrate solution every 15 minutes to ensure

consistent anticoagulant delivery.
m. After approximately 5600 mL of blood has been processed, message 61

(Check Anticoagulant Container) will alert the operator to ensure that
sufficient anticoagulant remains to complete the procedure. When the
HES/citrate solution container is empty, replace with another HES/citrate
91
solution container or discontinue the procedure. This message is
applicable to WB:HES ratios greater than 11:1.
Caution: Do not change the anticoagulant solution to ACD to complete

the procedure. Changing the anticoagulant solution to ACD will alter the
sedimenting properties of the blood to the extent that red blood cells and
lymphocytes will be collected with few additional granulocytes being
added to the product.
n. The Auto Run will continue until the end point is reached unless an alarm
condition interrupts the procedure.
o. If it is desired to terminate the procedure before the end point is reached,

press the HALT/IRRIGATE key. At this time the MODE and START/RESUME
LEDs will flash.
* Press the MODE key to select Reinfuse. Press the START/RESUME key to
initiate the reinfuse operation and continue to complete the procedure
according to the Completion of Platelet Collection (Steps 1 -10) of
Procedure 2.11.
p. When the end point is reached (BLOOD VOLUME display equals or exceeds
END POINT display), message 60 (End Point Reached) will be displayed, a
one-note chime will sound and the MODE and START/RESUME LEDs will
flash.
 To discontinue the run procedure and initiate the reinfuse operation,

press the MODE key to select Reinfuse. Then press the START/RESUME
key to begin the reinfuse operation according to the Completion of
Platelet Collection indicate above.
 To continue the procedure, select a new end point using the Display/Edit
function and then press the START/RESUME key.
q. Open the granulo collection container and remove the product. Double
heat seal the CRP and CPP lines.
r. Follow post after procedure instructions indicate in Procedure 2.24 (Steps

3 g-h).
4. If there is a power failure or instrument is powered off during a trouble

shooting mode, follow standard CS3000 Manual Run or Manual Prime Bypass
procedure
5. When the component collection is complete, the red cells in the separation
container may be returned to the donor/patient by performing the Reinfuse
Procedure as described in Procedure # 3.31.
6. Perform the Termination of Procedure as described in Procedure # 3.31
92
7. At the completion of the procedure (after disconnecting the donor/patient) the
granulocyte product must be resuspended and transferred to a 600 ml Transfer
Pack.
8. Mix the product by gently agitating the bag. Disconnect an approximate 10

inch section of tubing.
9. Transfer contents of this tubing into a 5ml RED top vacutainer tube.
10. Should the separator be exposed to blood or plasma, it may be cleaned with a
ten percent (10%) solution of sodium hypochlorite or similar product
(Dispatch)
Caution: If cleaning of the interior of the centrifuge compartment is required,

the compartment must be thoroughly dried prior to the next use to permit
proper humidity sensor alarm function.
Caution: Do not allow fluid to come into direct contact with the humidity
sensor or permanent sensor damage may result which would render the sensor
inoperative.
11. Product is maintained at room temperature, without agitation, and transported

immediately.
REFERENCES:
1. Baxter Fenwal CS-3000 PLUS® Blood Cell Separator Operator's Manual,

June 1991.
93
U. T. M. D. ANDERSON CANCER CENTER BLOOD BANK
HOUSTON, TX
POLICIES
10.21 MANAGEMENT OF HEARSAY INFORMATION ABOUT BLOOD DONORS
Occasionally information may be received post donor screening, or even post

donation, from a third party alleging that a blood donor does not meet the
established health history criteria established for M. D. Anderson Cancer Center
Blood Bank. This communication might be received via the telephone, from other
donors, or other means of communication following the donation.
Hearsay information may pertain to the qualifications and/or behavior of a specific

blood donor. In order the maintain the duty of providing a safe blood supply, each
employee should attempt to document all information as indicated as accurately
and efficiently as possible.
1. Please take the following actions if someone other than the donor (a third
party) provides you with disqualifying information.
2. When possible identify the relationship the third party member has to the
donor that supposedly allows them to be able to provide this information.
3. Please try to obtain contact information from the third party for further
confidential follow-up by the TMP.
4. The third party should be informed that all information will be forwarded to
the Transfusion Medicine Physician. The blood bank employee should not
make any comment on the information received or actions that will be taken.
5. Carefully document, in detail, all information on a blood bank incident report

form. Do not indicate any of this alleged information on the donor card. If
the information is provided before the unit is delivered, place a unit number
on the form and attach the incident form to the donor card.
6. If the information is accompanying the unit of blood when it is delivered, a

Transfusion Medicine supervisor must be notified. If the information is
received after the unit has been received in Transfusion Medicine, contact the
TMP or Transfusion Medicine supervisor as soon as possible.
7. All associated components will be immediately quarantined, awaiting disposal

instructions by the TMP. Units not already tested will be tested according to
standard procedures.
8. The Transfusion Medicine Physician will determine what actions, if any, must
be taken regarding the final disposition of the donated blood and the future
eligibility of the blood donor. The TMP will also determine if the information
warrants any type of lookback and/or retrieval of previous donation
components.
94
95
POLICIES
10.22 DONOR RECORD MAINTENANCE
PURPOSE:
All blood bank records must be complete in documentation, preserved and protected
from accidental or unauthorized destruction or modification, and retrievable in a
reasonable period of time. These procedures must be followed at all times, to
ensure confidentiality of donor and patient records.
PROCEDURE:
1. DONOR CARD COMPLETION
a. The donor card is completed according to all standard operating

procedures and policies.
2. DONOR REGISTRATION SHEET
a. Whole Blood and Apheresis
1.) The donor's information (name and unit number) is recorded from
the donor card onto a registration sheet.
2.) The current month's registration sheets are maintained by the

Information Systems Technician (IST). At the end of the month these
are filed in a file cabinet in the Mobile Operations area.
3.) Registration sheets are maintained for a minimum of two years.
4.) Before 1995, whole blood Directed Donor consent forms were filed
by month in the Apheresis files. Beginning in 1995, these consent
forms are to be filed with the donor card when it returns to the
blood bank for filing. After the donation, the consent form is
maintained by the IST, till the donor card is returned.
b. Autologous Whole Blood
1.) The registration sheets are returned from the Autologous Donor
Room via inter-office mail to the Apheresis Supervisor who maintains
them for a minimum of two years.
3. DONOR CARD MAINTENANCE
a. Apheresis, Whole blood, Autologous
1.) The donor card accompanies the blood product to the Transfusion
Service lab for processing.
96
2.) After donor processing is completed, Apheresis and homologous
whole blood donor cards are returned to the Blood Bank through the
inter-office mail. The mail is to be picked up from Transfusion
Service daily by employees delivering blood products.
3.) Autologous
a.) The (autologous) donor cards are kept in Transfusion Service

for a minimum of 5 years.
b.) The consent forms are maintained in the Autologous Donor

Room by the technician.
4. REGISTRATION VERIFICATION
a. Whole Blood and Apheresis
1.) The receipt of each donor card is verified via the registration sheet.
2.) Each donor card is checked off on the registration sheet in red ink by
the IST.
3.) Donor credit information is obtained at that time.
4.) The status of any outstanding donor card is requested from the lab
at the end of every month by the IST.
b. Autologous
1.) The donor card is checked off on the registration sheet in red ink by
the technician.
5. FILING OF DONOR RECORDS
a. Whole Blood
1.) The donor cards are separated in an accordion file in letter order and
later alphabetized and filed in lateral file cabinets located in the
Administration area.
2.) The file cabinets are locked at the end of each day and the keys are
maintained by the Administrative Assistant.
3.) Donor cards marked as permanent deferrals are filed in a separate

lateral file cabinet which is locked at all times.
Access to Administration Area is limited to the employees who work

in that area.
4.) A minimum of two years of original donor cards are maintained.

97
5.) Microfilm reels of donor cards (whole blood) from 1976 to present
are also maintained in a file cabinet in the Administration area.
b. Apheresis
1.) Donor charts, that contain the procedure consent form and any
necessary procedure information, are maintained in the apheresis
area in lateral file cabinets located in the Reception area.
2.) Since these files do not contain any confidential donor information
they are not locked on a routine basis. The location of the files is in
an area not readily accessible to anyone outisde the department.
2.) At the first on each calendar year, a new consent form is obtained
for additional apheresis procedures. Past year consent forms are
deleted as time and space allow.
6. MICROFILMING OF RECORDS
a. Annually:
1.) In December, the donor cards from two years prior to the current
year are prepared for microfilming by U.T. Health Science Center.
2.) A Request for Microfilm Utilization form is completed and forwarded

to the Records Management Analyst in the Facilities Resources
Department @ Box 175.
3.) The form is authorized by Records Management. A copy of the form

is returned to the department and a copy is sent to U. T. Health
Science Center.
4.) After microfilming, the original donor cards are stored offsite at
Rockall Services. Rockall Services is located at 1875 W. Sam
Houston Parkway North, Houston, TX. 77043
5.) The microfilm reels (Reel A) are kept at the Blood Bank and a
duplicate set of reels (Reel B) are kept in Transfusion Service.
7. LONG TERM STORAGE
a. Request
1.) A Records to Storage Transmittal form is filled out listing the

complete contents of each box to be stored.
98
2.) The transmittal is forwarded to the Records Management Analyst
who prepares identification forms for each box.
3.) The forms are returned to the Blood Bank and placed on each box
and the boxes are transported by Labor Services from the Blood
Bank to the records shipping area at Records Management.
4.) Records Management will verify the contents of the boxes and then
notify Rockall Services for pick-up and storage.
8. RETRIEVAL
a. Requests
1.) A Records Transfer Request form with the records "request from
storage" portion filled out, is submitted to Records Management
who contacts the storage facility.
2.) The requested box is delivered to the Records Staging Area at the
Physical Plant building and then Labor Services picks up the box and
delivers it to the Blood Bank.
3.) The entire retrieval process takes approximately 2 to 3 days. When

there are more than 6 boxes the delivery is only on Tuesday and
Thursdays. Rush delivery, after hours, and holiday deliveries are
available upon special request and additional cost.
4.) When records are ready for return to storage, a Records Transfer
Request form with the "Returned to Records Storage" portion is
filled out. This form is then again sent to Records Management.
5.) Records Management will forward the form to Labor Services to

make arrangements for pickup.
REFERENCES:
1. AABB Standards for Blood Banks and Transfusion Services, 16th Edition,
1994.
2. Code of Federal Regulations, Title 21, 1994, Part 606.
99
POLICIES
10.23 STANDARD OPERATING PROCEDURES
PURPOSE:
The University of Texas M. D. Anderson Cancer Center Blood Bank shall establish
Standard Operating Procedures for all procedures that the employees of this
department are responsible for performing. These procedures will be established
in accordance to all requirements and guidelines of the American Association of
Blood Banks (AABB), the Food and Drug Administration (FDA), and/or any other
regulatory agency with authority to assure that the operations of this department
comply with mandates that promote patient, donor, and employee safety and
product potency and purity.
SUPPLIES:
1. American Association of Blood Banks Standards for blood banks and

Transfusion Services - current edition.
2. Food and Drug Administration - Code of Federal Regulations (CFR) - related
parts.
3. AABB Accreditation Requirements Manual - current edition
4. M. D. Anderson Cancer Center Laboratory Medicine Safety Manual - current
edition
5. Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
Accreditation Manual - current edition
6. College of American Pathologists - Commission on Laboratory Accreditation
Inspection Checklists - current edition
7. Procedure manuals and package directions for all supplies and equipment
used for each procedure - current editions.
8. National Committee for Clinical Laboratory Standards (NCCLS) Procedure
manual approved guidelines.
PROCEDURE:
1. All procedures are performed under the direction of the Section Chief for the
department of Transfusion Medicine.
2. All current guidelines, standards and current literature are reviewed for
recommended changes in policies and procedures.
3. All policies are to be written following the NCCLS guidelines.
4. Policies and procedures are to be written by a supervisor or another person

that has good knowledge of the subject.
5. A supervisor will review, sign and date all policies and procedures.
6. The Section Chief for the Department of Transfusion Medicine will make final
review and signature approval for all policies and procedures.
100
7. Each procedure will be signed and dated by the person writing the procedure,
the person reviewing it, and the Section Chief.
8. At least once annually all procedures, and accompanying forms, will be

reviewed by a person knowledgeable of the procedure. This person will
assure that the procedure follows current requirements and current
operations. Documentation will be made by all persons making this review.
9. At least once annually all employees will review the current operating
procedures and make documentation that they have done so.
10. When a small step in a procedure needs to be changed, the entire procedure
does not require complete reprinting. The step that needs to be changed
should have a line drawn through the incorrect information and the correct
information written above it. The change should be initialed and dated by
both the supervisor and Section Chief. Distribution of this change will be
made appropriately.
11. Copies of all retired procedures will be maintained indefinitely. The

department will keep at least the past 2 years readily available.
12. Whenever a new procedure is adopted or a current one revised, each

employee responsible for performing the procedure shall be presented the
new procedure and inserviced on all changes. The employee shall be allowed
to ask any questions and receive additional training until the employee has
demonstrated competency and knowledge.
13. When a procedure is first introduced, revised, or retired a record will be

prepared that indicates when the change was made and the reason for the
change. This form will indicate all locations where the change was distributed
or removed, the date, and the person making this change. This form will be
attached to the retired procedure that is maintained indefinitely.
REFERENCES:

101
POLICIES
10.24 DEFERRAL LIST MAINTENANCE
PRINCIPLE:
To help assure that no potential donor is collected that has been previously
determined to be included on a permanent or temporary deferral list, all deferral
lists must be managed timely and carefully. Blood donor deferral lists are always
maintained in a confidential area. These various lists provide information on the
donation eligibility of many people.
SUPPLIES NEEDED:
1. Gulf Coast Regional Blood Center Permanent Deferral List

2. U.T.M.D. Anderson Cancer Center Permanent Deferral List
3. Daily MDACC Temporary & Permanent Deferral List
4. MDA Blood Bank Deferral List Log
PROCEDURE:
A. Gulf Coast and U.T.M.D. Anderson Cancer Center Permanent Deferral Lists
1. When Gulf Coast and M.D.A.C.C. Permanent Deferral Lists are received
at the Doctors Center, the date of receipt, and the date of printing are
posted on the deferral list log and lists are distributed to all appropriate
areas indicated in the log book.
2. One list printed by Gulf Coast Blood Bank will list all deferred donors by
name, all others include only the donor's social security number or
deferral acronym. The list with names is taken to the Transfusion
Medicine Laboratory and all other lists are used by Donor Operations.
3. The old lists are returned and the date of return is also posted on the
log.
4. One copy of each list is retained in the Blood Bank.
5. Out dated lists are destroyed in a confidential manner.
B. MDACC Daily Deferral Lists
1. Every day the Transfusion Medicine Laboratory updates the list of social
security numbers of those donors that are to be placed on our
102
permanent and temporary deferral lists. These numbers will be
incorporated in the in-house deferral list, when a new composite list is
printed.
2. These daily updates are printed as directed in procedure 1.13.1

(Printing M. D. Anderson Blood Donor Deferral Lists)
3. If there are times that it is not possible to update the computer record,
Transfusion Medicine will send a hand written list of add-on numbers.
When this occurs, follow the steps indicated below. Use the updated list
in addition to the previous daily and monthly lists.
a. Transfusion Medicine will FAX these updated lists to the Blood Bank
each evening.
b. An Apheresis technician must sign the bottom of the FAX form, to

indicate that it was received, and then FAX this signed form back
to Transfusion Medicine.
c. Make 8 copies of the updated list and distribute as follows:
1.) FAX a copy to Exxon apheresis site.
2.) Place one copy in each of the two Apheresis notebooks

containing the MDACC Deferral lists. Discard the lists that are
replaced.
3.) Place one copy in the Mobile Apheresis drive box. The most
recent copy must be taken on each mobile Apheresis drive.
4.) Place the other 5 copies in the new daily deferral folder in
Mobile Operations. Mobile Team Leaders will pick up new lists
as they depart for their drives.
5.) Place the original FAX in the mail holder on the Laboratory
Manager's door.
6.) Original copies of the deferral list FAX will be maintained

indefinitely.
103
POLICIES
10.25 BLOOD BANK PRODUCT RECEIVING
PURPOSE:
To be able to keep pertinent documentation of receipt and usage, all blood product
containers and disposable products that are used directly in the collection of any
blood product must have appropriate documentation made when received by the
department
SUPPLIES:
1. Blood Bank Product Receipt Log and Product Forms
PROCEDURE:
1. When products are delivered to the Blood Bank, either by MDA materials
management or by other carrier, a designated person will make appropriate
documentation of the product receipt.
2. A separate page for each separate product number will be maintained in the
Blood Bank Product Receipt Log.
3. Each product page should include the product name & manufacturer, the
manufacturer's product order number, and the materials center order number,
if appropriate.
4. When the product is received, the following information is documented on the

receipt form at the time of delivery. Do NOT use a pencil.
a. Date of receipt
b. Number of boxes/cases of the product received
c. All lot numbers
d. Expiration date, if applicable, of all lot numbers
e. Initials of person receiving the product
Note: If there is more than 1 lot number received per delivery, indicate
information on a separate line for each lot number.
5. If there is an error in documentation, draw one line through the incorrect

entry and enter the correct information, then initial the correction. Do not
use "white-out" or other similar materials.
6. The person receiving the products should make note of the expiration dates.
If any product is received that has a unreasonably short expiration date, the
receiving person should bring this information to the attention of a
supervisor.
104
7. The Blood Bank Product Log will be kept indefinitely, or until it is determined
appropriate for its disposal.
8. When new lot numbers of Copper Sulfate and Temp-A-Dots are received, the
receiving person will notify the mobiles supervisor.
REFERENCES:

2. AABB Accreditation Requirements Manual, 6th Edition, 1995.
105
U. T. M . D. ANDERSON CANCER CENTER
HOUSTON, TEXAS
BLOOD BANK PRODUCT RECEIPT LOG
PRODUCT NAME: _______________________________________________________________
MANUFACTURER: _______________________ MFG PRODUCT #: ____________________
MATERIALS CENTER ORDER NUMBER (If applicable): ______________________________
Date # Pkg Lot Number Expiration Received By

Received Date
106
OPERATION POLICIES & PROCEDURES
10.25.1 MANGEMENT OF BLOOD PRODUCT UNIT NUMBERS
PURPOSE:
To help track the use of blood product unit numbers, and the donation for which
each number was used, numbers should be used as sequentially as possible. To
assist in this process, numbers must be used only for collected products and
testing.
SUPPLIES:
1. Blood component bar-coded / eyereadable sets of sequential unit numbers

2. Blood Bank unit number log form
PROCEDURE:
1. Orders for blood component bar-coded / eyereadable unit numbers are placed
by personnel in the Transfusion Medicine laboratory. They will place the order
so that the manufacturer will supply additional numbers that will be
sequential to the previous order. Thus to avoid the duplication of numbers.
2. These numbers can be used by both personnel in the Transfusion Medicine

Laboratory as well as those in the Blood Bank Donor Collection department.
For this reason, this department may not utilize all the blood bank unit
numbers.
3. When the numbers are received in the Blood Bank, a supervisor will review
the order to verify that the correct type, specified quantity, and appropriate
number sequence are received.
4. The receipt of these numbers is documented on the unit number log form.
5. Each roll will be numbered with large dark numbers in sequential order. Then
they are stacked in order on the designated shelf so that the lowest number
roll is placed in the front for first utilization.
6. When obtaining rolls of unit numbers, technicians must assure that they are
using one with the lowest number.
7. When a roll, or partial roll of numbers is removed from the shelf, this
information and date should be noted on the Blood Bank unit number log.
8. When taking an entire roll to a fixed collection site, indicate this information
on the unit number log.
107
9. Unused sets of unit numbers must be returned to the designated area for
future use. Persons taking out additional unit numbers must attempt to
utilize partial rolls of numbers before taking a new unopened roll.
10. Technicians should make every effort to utilize numbers in numerical

sequence.
11. Unit numbers are not to be assigned until it is determined that a blood
product is being collected. That is, numbers are not assigned to donors that
are deferred or do not have venous access.
12. Unit numbers used, but end up being destroyed, because of a double stick or
aborted procedure must have the appropriate documentation made on a
double-stick report, aborted procedure report, etc. as well as having this
information placed on the donor registration log.
13. When all donor cards are returned to the Blood Bank, they will be matched
with the donor registration form to verify completeness of this form as well
as the return of the donor card for final filing. The person maintaining this
process will work with supervisors to assure that all donor registration and
information is complete.
REFERENCES:

108
OPERATIONAL POLICIES & PROCEDURES
10.25.2 BLOOD PRODUCT SUPPLY STORAGE
PURPOSE:
In order to help assure that current good manufacturing practices are being
followed in all steps in the collection and preparation of a blood product for its
intended patient transfusion, all supplies, containers, reagents, etc. that are
involved in the product preparation must be maintained in a manner to prevent
contamination as well as to permit inspection and cleaning.
PROCEDURE:
1. Any building (collection site) used in the manufacture of a blood product shall
be maintained in a clean and sanitary condition. It must also be maintained in
a good state of repair. Individuals must report any unsatisfactory conditions
to a supervisor and/or building manager as soon as possible.
2. Items must be maintained in a well ventilated area that has appropriate

heating, cooling, and humidity that are appropriate for the product. Improper
heating or cooling may cause deterioration that would contribute to the
contamination or unsuitability of the product.
a. Blood bags, any blood product collection kit, or any other collection
supplies are not to be left in a vehicle or area that does not have
temperature control system at all times.
b. Items that are later found to have been left on a vehicle that has not
been maintained at room temperature must be discarded and a
supervisor should be notified of the event.
2. Each individual that is assigned to work at a particular site is responsible for

assuring that the area is clean, sanitary, unobstructed, and free of clutter at
all times. When areas of work are found to be unsatisfactory, those
individuals that are currently working in the area should immediately clean
the area and then report their findings to a supervisor.
3. Containers of supplies shall be stored off the floor and suitably spaced to
permit cleaning and inspection.
4. Upon receipt all supplies received will have their receipt date, lot number,
expiration date, and any other pertinent information documented ( See
Procedure 10.25).
5. Once supplies are received they are to be stacked appropriately for the item
(e. g. whole blood bags should not be stacked more than 4 containers high).
109
6. Palettes or shelving are available for stacking all products. No supplies are to
be left directly on the floor. If space is not immediately available, the supplies
should be left on a dolly or placed on a table, etc.
7. Most all supplies have a designated storage space that has been determined
to be appropriate for that item.
8. Items should not be stacked so that they come within 18” of the ceiling, even
though shelving will accommodate the item. This is a fire safety requirement.
9. Items should be stored so that if there is a lot number or an expiration date it

can be observed, and thus allow items to be used in order of their expiration
date.
10. When a package of any supply is initially opened, it should be visually

examined to see if there appears to be any damage. Do not use items with
damaged packaging. Report unacceptable items to a supervisor as soon as
possible.
11. Canteen supplies (cokes, juice, cookies, etc.) must be maintained similarly to
other supplies.
a. They are to be stacked according to product on palettes in the canteen

room.
b. Canteen supplies should not be kept on vans, coaches, under cabinets,

etc.
c. Care should be taken with these items to maintain integrity of the

packaging. Cookies that are broken and cans that are dented should be
discarded.
d. When unused beverage cans are returned from a drive, all except the
grape juice may be placed in the apheresis refrigerator, if space is
available. Otherwise, they must be dried completely with a towel before
returning to the canteen shelves.
REFERENCES:

3. Code of Federal Regulations, Part 211.
110
OPERATION POLICIES & PROCEDURES
10.26 EMPLOYEE COMPETENCY ASSESSMENT
PURPOSE:
To assure that all employees upon initial employment, and then on a continuing
basis, have the competency and knowledge to perform all procedures of this
department, competency assessment will be made as indicated. If at any time an
employee fails to demonstrate competency in a particular procedure they will no
longer perform this procedure until documented reinservice and competency is
made. Continued failure to be able to document competency becomes an inability
to perform the essential functions of the position and may result in separation.
SUPPLIES:
1. M. D. Anderson Blood Bank Procedure Manual

2. Appropriate competency assessment forms, tests, etc.
POLICY:
1. Upon initial hire, each new employee will attend the M. D. Anderson Cancer
Center new employee orientations. This will usually consist of 2 to 3 days of
inservices.
2. All employees will participate in annual review of all safety and institutional
programs.
3. Upon initial hire each new employee will be presented with the necessary
information, resources, opportunity to learn and ask questions, etc. that will
allow them to gain competency to perform the essential function of the
position.
4. Throughout their employment, each employee will be provided the same

opportunities to maintain competency in all current and new essential
functions of the position.
5. After initial competency assessment, each employee will be assessed

annually, and documentation made, to show that the employee has
maintained the skill and knowledge to perform the essential functions of the
position.
6. The persons responsible for the training and assessment of competency will
depend on the skill or knowledge being assessed. They may include any of
the below mentioned positions.
a. Apheresis * Senior Apheresis Technician

a * Apheresis technician with seniority and demonstrated
knowledge and proficiency in the skill being learned and
assessed.
111
b. Mobiles * Mobile Team Leader
* Senior mobiles staff member with demonstrated knowledge
and proficiency in the skill being learned and assessed.
c. Administrative Support & Recruitment

* Senior person with demonstrated knowledge and proficiency
in the skill being learned and assessed.
7. Final approval of competency will be made by the Laboratory Coordinator

and/or Laboratory Manager, and the Transfusion Medicine Section Head.
8. Documentation of the all assessments will be maintained for an appropriate

length of time for the position.
9. To maintain competency and knowledge of all essential functions of the

position, each employee must assure that they timely read all
communications, procedure updates, procedure annual reviews, etc.,
document when requested that they have read the information, and
immediately ask questions to clarify anything that they do not completely
understand.
10. Competency assessment will include but not be limited to:
a. Direct observation
b. Verbal questioning
c. Written assessment
11. Each employee after having had documented competency assessment, is

responsible for performing that function exactly as indicated in the M. D.
Anderson Cancer Center manual of operating procedures. Any deviation from
the standard must be documented and approved by the appropriate person.
11. In order to achieve the goals of this department and the institution, each
employee should strive for perfection. They should constantly be seeking
ways to improve the process to assure patient, donor, and employee safety
and satisfaction.
REFERENCES:

112
APENDICES
113
Blood Unit I.D. Number No. del Permiso
de
Conducir\No.
Apellido Nombre Inicial del 2do de Pasaporte
Circule Fecha de Nacimiento Edad
Nombre Femenino Mes/ Dia/Ano
Masculino
Direccion ( Calle, No. Postal, No. Ciudad Estado Codigo Postal
de Apartamento)
Teléfono Particular Teléfono del Trabajo y Ext. Fecha
Group Name (Mobile/Hospital) Nombre y

Número del
Paciente/ Fondo
CONSENTIMIENTO INFORMADO DEL DONANTE:. Yo dono voluntariamente mi sangre/plaquetas/plasma al U. T. M. D. Anderson Cáncer Center.
Concedo la autorización para que el técnico obtenga la cantidad necesaria y adecuada de sangre para que sea examinada y utilizada tal y como el UT M. D.
Anderson Cancer Center considere apropiado. He tenido la oportunidad de preguntar acerca de este procedimiento, y entiendo, de qué se trata y cuáles son sus
riesgos, y también he tenido la oportunidad de rechazar el procedimiento. He revisado y he entendido la información que me dieron en lo referente a la
propagación del virus del SIDA a través de donaciones de sangre, plaquetas o plasma, por lo tanto, si yo me considerara una persona con riesgo de propagar el
virus del SIDA estaría de acuerdo en no donar mi sangre o sus productos para transfusión a otra persona o para su manufacturación en un futuro. Entiendo que mi
sangre será examinada para los anticuerpos del SIDA y otras enfermedades infecciosas. Si estos exámenes indicaran que yo no podré donar sangre o plasma, mi
nombre será puesto en una lista de donantes rechazados indefinidamente y yo seré notificado por correo. En lo que hace a mi conocimiento yo certifico que he
contestado con toda veracidad todas las preguntas. En consideración al servicio que el U.T.M.D. Anderson Cancer Center presta a la comunidad, yo, por medio de
la presente, eximo de toda responsabilidad a esta Institución, a sus miembros, agentes, empleados y a sus sucesores de cualquier reclamo o demanda que yo, mis
herederos, ejecutores o administradores tengan o puedan tener en contra de cualquiera de ellos, en lo que se refiera a esta donación y a cualquier consecuencia
producida como resultado directo o indirecto de ella. Entiendo que durante o después de la donación de sangre, ocasionalmente, puedo sufrir una reacción
inesperada como por ejemplo un hematoma alrededor del sitio de entrada de la aguja, perforación de una arteria y/o desmayos y/o pérdida temporaria
del conocimiento
____________________________________________________
SS# on MDA D.L. YES NO Checked By________________
GC D. L. YES NO Checked By _______________

FIRMA DEL DONANTE Y FECHA:
114
**********************************************************************************************************
1
POR FAVOR MARQUE CON UN CIRCULO: 25. En los últimos 12 meses, ha tomado, o aspirado SI NO
1. Ha donado sangre,o tratado donar sangre SI NO cocaína por su nariz?
usando un nombre diferente aquí o en otro
lugar? 26. En los últimos 12 meses, ha recibido sangre SI NO
o transplante de órganos o tejidos?
2. En las últimas 8 semanas, ha donado sangre, SI NO
plasma, o plaquetas aquí o otro lugar? 27. En los últimos 12 meses, se ha hecho tatuajes, SI NO
perforación de la piel o de la oreja, acupuntura,
3. Por cualquier razón, ha sido rechazado o SI NO punción accidential por aguja o contacto accidental
descualificado como donante de sangre con sangre?
o le han dicho que no puede donar?
28 En los últimos 12 meses, ha tenido un análisis SI NO
4. Hoy se siente bien y goza de buena salud? SI NO positivo de sifilis?
5. En los últimos 12 meses ha estado bajo cuidados SI NO 29. En los últimos 12 meses, ha tenido o fue tratado SI NO
médicos, ha tenido una enfermedad severa o cirugía? por sífilis o gonorrea?
6. Ha tenido dolor en el pecho (tórax), enfermedad del SI NO 30. En los últimos 12 meses, ha dado dinero o drogas a SI NO
corazón, reciente, o enfermedad grave de los pulmones? alguien para que tenga relaciones sexuales con usted?
7. Ha tenido cáncer, o una enfermedad de la sangre, SI 31. Alguna vez, desde 1977, ha recibido dinero o SI NO
NO drogas para tener relaciones sexuales?
o problema de sangrado anormal?
32. En los últimos 12 meses, ha tenido relaciones SI NO
8. Ha tenido ictericia, (piel amarilla), hepatitis, SI NO sexuales, aunque sea una sola vez, con alguien que
enfermedades del higado, o un análisis positivo haya recibido dinero o drogas para tener relaciones
por hepatitis? sexuales?
9. Ha tendio malaria, enfermedad de Chagas, o SI NO 33. Se ha inyectado drogas, aunque sea una sola vez,que SI NO
babesiosis? no hayan sido indicadas por un medico?
10. Ha tomado etretinate (Tegison®) para la psoriasis? SI NO 34. En los últimos 12 meses, ha tenido relaciones SI NO
sexuales alguna vez, con alguien que haya usado
11. En los últimos 3 días ha tomado piroxicam SI NO drogas inyectables que no fuesen indicadas por un médico?
(Felden ®), aspirina o cualquier medicamento
que contenga aspirina? 35. SOLO MUJERES: En los últimos 12 meses, N/A SI NO
ha tenido relaciones sexuales con un hombre que
12. En las últimas 4 semanas, ha tomado isotretinoin SI NO haya tenido contacto sexual, aunque sea una sola vez
(Accutane®) or finasteride (Proscar®) (Propecia)? desde 1977, con otro hombre?
13. En las últimas 4 semanas, ha tomado medicamentos SI NO
o remedios?
14. En las últimas 4 semanas, ha recibido vacunas o SI NO
immunizaciones?
15. En los últimos 12 meses, le han aplicado la vacuna SI NO
de la rabia?
16. Ha tenido convulsiones (desmayos) o epilepsia? SI NO
17. SOLO MUJERES: En las últimas 6 semanas, N/A SI NO
ha estado embarazada o está embarazada actualmente?
18. En los últimos 3 anos, ha estado fuera de los SI NO
Estados Unidos o Canadá?
19. Ha recibido hormona de crecimiento humana? SI NO
20. Ha recibido transplante de duramadre (coberturas SI NO
de cerebro)?
21. Ha tenido Ud.o un familiar consanguíneo la SI NO
enfermedad Creutzfeldt-Jakob,o han sido informados
que están en riesgo de estar afectadoS por la
enfermedad de Creutzfeld-Jakob?
22. En los últimos 12 meses, ha estado preso o en la SI NO
cárcel por un período mayor de 72 horas?
23. Ha sufrido pérdida de peso inexplicable o SI NO
diarrea en los últimos 10 días?
**** PARE AQUI ****
********** POR FAVOR PARE AQUI **********
LAS SIGUIENTES PREGUNTAS SERAN
PREGUNTADAS POR UN EMPLEADO
24. En los últimos 12 meses, ha tenido contacto íntimo SI NO
con alguien que haya padecido de hepatitis o haya
tenido ictericia (piel amarilla) o que haya recibido
gamma Globulina Anti-Hepatitis B (HBIG)?
2
36. SOLO HOMBRES: Ha tenido relaciones N/A SI NO
sexuales con otro hombre desde 1977, aunque 43. Ha nacido, ha vivido, o ha viajado a cualquier SI NO
sea una sola vez? estado de Africa, desde 1977?
37. Ha recibido concentrados de factores de la SI NO 44. Cuando viajó a <páis(es)> recibio N/A SI NO
coagulación para un problema de sangrado, tal transfusión de sangre o cualquier tratamiento médico
como hemofilia? con un producto hecho a partir de sangre humuna?
38. En los últimos 12 meses, ha tenido relaciones SI NO 45. Ha tendio relaciones sexuales con alguien que nació SI NO
sexuales aunque solo sea una vez, con alguien que o vivio en cualquier estado de Africa, desde 1977?
recibiera concentrados de factores de la coagulación,
tal como hemofila? 46. Ha sido transfundido con sangre o hemoderivados SI NO
fuera de los Estados Unidos o Canada?
39. Tiene SIDA o análisis positivo de SIDA? SI NO
47. Ha leído y entendido toda la información que se la ha SI NO
40. En los últimos 12 meses, ha tenido relaciones SI NO presentado, y han respondido satisfactoriamente
sexuales, aunque sea una sola vez, con alguien que todas las preguntas por usted formuladas?
tiene SIDA o análisis positivo de SIDA?
COMMENTS:
41. Dona sangre para que se le haga el análisis para SI NO
detectar el VIH o SIDA?
42. Sabe usted que si tuviese el virus del SIDA lo SI NO
puede contagiar aun estando aparentemente sano y SCREENER:
ser negativo en los análisis de SIDA?
3
***************************************************************************************************************
*
PLEASE CIRCLE THE CORRECT ANSWER: VITAL SIGNS:
DonatedBAG
Before? YES NO
LOT # _____________________ LOT EXP DATE ________________ EXAMINER
Weight ( ≥ 110 ________________________
lbs.) UNIT ID
#______________________ lbs.
MDA Other When? _________________________
*************************************************************************************************************
Temperature (< 99.6°F) °F
General ******
appearance OK NOT OK
_______ Pulse (50-100/min)
PHLEBOTOMY RECORD: Time Minutes CHECKED BY:
Arm Inspection (Both) OK NOT OK _______ Blood Pressure (90-180/50-100 mm Hg)
Arm (circle): L R Double Stick Short Difficult Reactions (circle) N Y (list below) Phlebotomist
Hazardous/Strenuous Activity YES NO Copper Sulfate (Sinks < 15 Sec.) OK
_______ NOT OK
*************************************************************************************************************
HGB (12.5 g/dl) g/dl
Eaten within
******4 hours? YES NO _______
ACCEPT _ _ _-
DONOR: -
Refreshments First
YES ASPIRIN
NO
HEMOCUE SERIAL
YES ___________________________________________
NO
NO.
Phlebotomist's Signature _____________________________
4
The University of Texas
M. D. ANDERSON CANCER CENTER
INFORMACION E INSTRUCCIONES PARA EL DONADOR
POR FAVOR LEA LA SIGUIENTE INFORMACION CUIDADOSAMENTE. Si usted tiene

cualquier duda o pregunta hable con nosotros.
POR FAVOR NO DONE SANGRE SOLO POR OBTENER UN EXAMEN PARA EL SIDA.
USTED PUEDE TRANSMITIR EL SIDA A UN PACIENTE Y COMETER UN DELITO.
NO DEBERIA DONAR SANGRE SI USTED:

• No tiene una identificación con su fotografía
• Es menor de 17 anos de edad, o pesa menos de 110 libras/50 kgs.
• Se ha hecho perforaciones en su piel: aretes, tatuajes, acupuntura, etc. (hace menos de 1
ano)
• Ha tenido cáncer, excepto carcinoma de células basales de la piel o carcinoma in situ del
cuello uterino.
• Ha usado drogas ilegales por vía intravenosa, aunque haya sido una sola vez.
• Ha Ud. inhalado o ha hecho uso de cocaína en los últimos 12 meses.
• Es un hombre, que ha tenido sexo con otro hombre después del ano 1977,
aunque haya sido una sola vez.
• Es un hemofílico.
• Ha tenido un resultado positivo en un examen para el virus del SIDA.
• Ha tenido sexo con alguien incluido las categorías de arriba, o con una persona
diagnosticada con SIDA, en los últimos 12 meses.
• Ha estado detenido (en la cárcel, en la prisión, o en una institución correccional) por mas
de 72 horas consecutivas, durante los últimos 12 meses.
• En los últimos 12 meses ha tenido sexo, aunque haya sido una sola vez, con un hombre o
mujer que practican la prostitucion.
• Tiene cualquiera de estos síntomas, los cuales están asociados con el SIDA:
 Reciente perdida inexplicable de peso de mas de 10 libras en menos de 2 meses.
 Sudoracion inexplicable, especialmente en la noche.
 Fiebre de mas de 99F, por mas de una semana.
 Glándulas inflamadas, engrandecimiento de nódulos linfáticos en el cuello, axila o
región inguinal, con o sin
dolor.
 Manchas rosas, azules o moradas, planas o elevadas, tumoraciones en o por debajo
de la piel o membranas
mucosas. Pueden verse como moretones pero no desaparecen.
 Manchas blancas en la boca (llagas).
 Tos persistente o respiración dificultosa.
 Diarrea persistente.
USTED TAMBIEN DEBE SER INFORMADO QUE:
• Hay un intervalo, llamado el periodo de ventana, durante el cual los exámenes para HIV
(SIDA) pueden ser negativos, sin embargo la infección puede ser transmitida.
• Una muestra de su sangre será examinada por anticuerpos de HIV y usted será notificado
si el resultado es positivo; individuos con un resultado positivo serán diferidos
indefinidamente de futuras donaciones de sangre o plasma.
• Los nombres de personas con exámenes reactivos para anti-HIV-1 o anti-HIV-2 serán
incluidos en un registro de donantes diferidos en forma permanente.
MUCHAS GRACIAS POR SU DONACION !!!
Es EXTREMADAMENTE IMPORTANTE que usted
 Nos haga saber si por CUALQUIER MOTIVO usted piensa que su sangre no es
completamente SEGURA O USABLE para ser transfundida a un paciente con cáncer.
 Cualquier información que usted nos suministre será estrictamente confidencial!
 POR FAVOR llame al (713)792-8630 hoy mismo. Diga "NO USE MI SANGRE" y denos
su numero de donación que es:
SU NUMERO DE DONACION
1. No se vaya hasta que sea dado de alta por un miembro de nuestro personal técnico.
2. Resuma sus actividades normales después de ½ hora, si se siente bien. Es recomendable no
subir a elevadores rápidos, hacer trabajos pesados, ejercicio o visitar un paciente en el
hospital hasta después de haber comido. Estas actividades le pueden causar mareos o
nauseas.
3. Deje el vendaje puesto por cuatro (4) horas.
4. ES MUY IMPORTANTE QUE USTED EVITE REALIZAR EJERCICIOS, LEVANTAR OBJETOS PESADOS
O EL USO EXCESIVO DEL BRAZO DEL QUE LE EXTRAJERON SANGRE DURANTE VARIAS HORAS
DESPUES DE DONAR.
5. A veces usted puede presentar un hematoma (moretón) en la zona de la punción. En caso
de que esto ocurra, aplíquese compresas de hielo para reducir la inflamación. Puede tomar
de 7 a 10 días para que el hematoma desaparezca.
6. Si ocurre sangrado o inflamación en el sitio donde se introdujo la aguja, eleve su
brazo y rápidamente aplique presión por 5 a 10 minutos. Para inflamación
aplique compresas de hielo. Para el dolor tome productos sin aspirina.
7. Usualmente no ocurren efectos colaterales, pero de cualquier manera, si usted
siente ligero dolor de cabeza, siéntese y coloque su cabeza entre sus rodillas o
acuéstese y eleve sus pies.
8. Si cualquier efecto colateral continua, llame al 713-792-7777 y pida hablar con
un supervisor para que le dé instrucciones sobre como mejorarse.
9. No fume por 1/2 hora después de su donación.
10. Coma bien enseguida de su donación.
11. Tome líquidos en abundancia.
12 Es preferible el no consumir alcohol hasta después de que haya comido algo.
13 Un examen positivo para sífilis será reportado al Departamento de Salud de la ciudad de
Houston, como es requerido por la ley de Texas.
14 Usted será notificado por correo, si algunos de los exámenes son positivos para: anticuerpos
de sífilis, hepatitis B, hepatitis C, HIV-1 (examen del SIDA), HIV-2, HTLV-1/II y/o elevación
marcada de ALT (SGPT).
15 Notifique al Director Medico del U.T.M.D. Anderson Blood Bank (Banco de Sangre) al
(713)792-8630 si Usted contrae cualquier enfermedad durante los 3 días después de su
donación.
16 Notifique al Director Medico del U.T.M.D. Anderson Blood Bank (Banco de Sangre al
(713)792-8630 si Usted contrae hepatitis durante los 6 meses después de su donación; o si
contrae SIDA en cualquier momento después de su donación.
Blood Assurance Plans
M. D. Anderson Blood Bank

7000 Fannin - Suite 170
Houston, TX 77030
713-792-7777
What is a Blood Assurance Plan ?.. . .
A valuable resource for M. D. Anderson Cancer Center blood donors. It is a
means of providing much needed blood and blood components from
volunteer donors to cancer patients. Secondly, a Blood Assurance Plan is
designed to meet the blood needs of the donor, or those persons covered
by the plan, if and when those needs arise.
What different Blood Plans are available?

M. D. Anderson Cancer Center provides four types of Blood Assurance
Plans. They are designed to meet the needs of various types of donors and
groups.
Plan 1 - Family & Individual (F & I) Plan
Plan 2 - 25% Group Coverage Plan
Plan 3 - Donor Club Plan
Plan 4 - Blood Replacement Plan
Who is Eligible to Donate Blood?

In general, any adult in good health, weighing 110 lbs or more with no
recent serious illness or history of certain diseases may give blood. Blood
Donors should be at least 17 years of age. Please check with a Blood Bank
representative if you have any questions.
Who should use which plan?
Plan 1 - (F & I) Plan
This plan is intended for those individuals that are not part of
another donor plan, but want to have full blood coverage for their
immediate family or two other persons designated at time of
donation. At the time of donation a donor may cover another family
unit, other than their own. In this case, the donor does not receive
coverage. However, donors that donate multiple times each year can
provide F & I coverage for various people.
Plan 2 - 25% Group
This plan is intended for groups that anticipate at least 25%

participation, with a minimum of 25 donations. The plan then
provides full coverage for the actual donors and their family unit
(defined by the exemptions on their Federal Income Tax Return)
Non-donor members of the group and their immediate family receive

partial coverage for their blood needs. Non group persons designated
by a donor receive F & I Plan coverage.
Plan 3 - Donor Club
A group may choose to form a Donor Club in order to provide

coverage to any person that they want to cover when the need
arises. The persons that are covered do not need to be a member of
the group. The donors can not claim individual coverage. The Donor
Club administrator (selected by the group) determines who receives
credits. The number of credits that can be issued equals the number
of units donated to that donor club account.
Plan 4 - Replacement
Designed to allow an individual donor or group to replace blood
previously used by a person and assist in reducing the person’s blood
service fees and to help assure blood availability for other persons.
What is “Coverage”?
M. D. Anderson Blood Bank will issue credits for the service fees of the
blood and blood components used, according to the applicable plan type.
Because blood has been voluntarily donated through M. D. Anderson, there
is no charge to the patient for the actual blood product. The service fee
covers the cost of collection, testing, and storage. Coverage is good not
only at M. D. Anderson Cancer Center, but also at any hospital that belongs
to, and accepts credits, from the National Blood Exchange of the American
Association of Blood Banks. A service fee credit is worth ten dollars.
Coverage does not cover patient testing or the actual transfusion fees that
are provided by the hospital.
Partial Coverage: There is one credit issued for each blood product
used.
Full Coverage: Credits may be issued for the full amount of the service
fee. Some facilities have limits on the amount that may be applied to the
patient bill. The Blood Bank representative will make an inquiry to the
hospital for blood usage and their coverage policies.
What is the length of coverage?

Plan 1 (F&I):
Coverage begins 30 days after donation and continues for one year.
Coverage for accidents and childbirth begin immediately upon
donation.
Plan 2 (25% Group):

Coverage for group members and their immediate families begins
upon achievement of the required number of donations and
continues for one year. Coverage for non group persons designated
by donors (F & I Coverage), begins 30 days after the donation and
continues for one year.
Plan 3 (Donor Club):

The Donor Club coverage is effective immediately upon completion of
the blood drive or the depositing of blood credits into the Donor Club
Account. Credits expire one year from the date of donation.
Available benefits are limited to the number of unexpired credits in
the account.
Are there any Exclusions from Coverage under any of the
Plans?
Plan 1 (F & I):
All coverage begins 30 days after the donation and continues for one full
year. Coverage for accident and childbirth usage begins immediately upon
donation. Blood and blood products used to treat preexisting diseases or
disorders are not covered. This includes, but not limited to: leukemia,
hemophilia, aplastic anemia, hereditary blood disorders, cancer, congenital
or acquired cardiovascular disease requiring surgery; transplants, and
immune disorders.
Plan 2 (25 % Group)
Donors and their immediate family receive Full coverage beginning

immediately upon achievement of the required number of donations and
continues for one year. Newly organized donor groups have 90 days to
achieve their 25% participation. Until achievement of this goal, all donors
and their family unit are covered under an F & I Donor Plan. Upon
achievement of 25% status, members of the group receive full coverage
without a waiting period and without exclusions. Established donor groups
must maintain 25% participation annually. Non-donors and their family
receive partial coverage, if group’s 25% participation is achieved.
How do you file for coverage?
For all credit inquiries call the Blood Bank at (713) 792-7788.
Plan 1 and 2 - F& I and 25% Group Plans When a person covered by either of
these plans uses blood products, notify the M. D. Anderson Blood Bank. If
the person is a patient at M.D. Anderson Cancer Center it is best if you
know their identification number. If they used blood at another hospital,
you should know the hospital name, city, and their hospital identification
number so that proper credit can be issued to their hospital account. If
there is further usage, please call the blood bank again.
Plan 3 - Donor Club: If credits need to be released, contact the group

administrator to authorize the release of available credits. Donor club
credits are released on a “first-in, first-out” basis, so the group’s oldest
credits are always released first. The chairperson or their designee will
notify the Blood Bank. The Blood Bank will not release credits without this
authorization
Plan 4 -Replacements: When possible, these credits will automatically be

processed by the blood bank within a few days of the donation.
A Final Word . . .
Blood donors can give whole blood as often as every

eight weeks. The cancer patients at The University of
Texas M. D. Anderson Cancer Center want you to
know that your generous donation is a key to their
recovery. Because without blood, their treatments
would not be possible. Thank you for lending a
hand for life!
APPENDIX D
ASPIRIN, ACETAMINOPHEN, AND IBUPROFEN CONTAINING
MEDICATIONS
The following is a listing of over-the-counter (OTC) medications that

contain aspirin or aspirin-like compounds (salicylates),
acetaminophen, or ibuprofen. If the medication is not found here
check Davis's Drug Guide for Nurses.
There are many generic products on the market now that have the
same compounds as those listed below. Try to find out from the
donor if they know the name-brand equivalent.
ASPIRIN or ASPIRIN-Like Products:
Mark Whole Blood units as "ASA". Must wait for 72 hours after
taking before donating apheresis platelets.
ACETAMINOPHEN:
NO WAITING for apheresis platelet donation and DO NOT mark whole

blood units.
IBUPROFEN:
Apheresis platelet donors must wait 24 hours after taking

medication before donating. DO NOT mark whole blood units.
OTC medications containing ASPIRIN or ASPIRIN-LIKE Compounds
Absorbine Arthritic Pain

Act-On Rub
Adult Analgesic Pain Reliever
Alka-Seltzer (all products except Effervescent Antacid)
Anabalm
Analgesic Balm
Analval
Anodynos (all products)
Argesic
Arthritis Hot
Arthritis Pain Formula (all products)
Arthropan Liquid
A.S.A. (all products)
Ascriptin (all products)
OTC medications containing ASPIRIN or ASPIRIN-LIKE Compounds -
Continued
Aspercin
Aspercreme
Aspergum
Aspermin
Aspirin (all products)
Aspirtab
Avalgesic
Backaid Pills
Banalg (all products)
Bangesic
Baumodyne
Bayer (all products except Cough Syrup for Children)
BC (all variation)
Ben-Gay (all products except Warming Ice or Children's Vaporizing
Rub)
Betuline
Blis Foot Bath (or To-Sol)
Bromo-Seltzer
Buffaprin
Buffasal
Bufferin (all products)
Buffets II
Buffex
Buffinol
Cama (all products)
Co-Advil
Compound W Wart Remover
Cope
Corrective Mixture with Paregoric
Counterpain Rub
Dasin
Deep-Down
Dencorub
Dermal-Rub
Dermolin
Diurex (all products)
Doan's (all products)
Dolcin
Dr. Scholl's (any Corn Remover product or Wart Remover Kit)
Duradyne
Ecotrin (all products)
Emagrin (all products)
Empirin
Emul-O-Balm
Continued
Epi-derm
Exocaine (all products)
Excedrin (all products)
Exocaine (all products)
Fendol
Fiogesic
Flex-All 454
Freezone Corn and Callus Remover
Gemnisyn
Gensan
Gets-It Liquid
Ger-O-Foam
Goody's (all products)
Go-Pain Analgesic Cream
Gordogesic
Heet
Hista-Compound No.5
Icy Hot
Infantol Pink
Infra-Rub
Magnaprin (all products)
Measurin (all products)
Mentholatum (Deep Heating and Deep Heating Arthritis Formula)
Methagual
Minit-Rub
Mobigesic
Mobisyl
Momentum
Mosco
Musterole Deep Strength
Myoflex
Neogesic
Norwich Aspirin and Extra Strength
Off Ezy Wart Removal Kit
Omega Oil
Pabalate
P-A-C
Pain Reliever Tablets
Panalgesic (all products)
Panodynes Analgesic
Pep-Back
Pepto-Bismol
Phenetron Compound
Continued
Presalin
Pronto
Quiet World Tablets
Rid-A-Pain
Rid-Itch
S-A-C
Salabuff
Salatin Capsules
Saleto
Salocol
Sine-Off (all products)
Sloan's
Sodium Salicylate
Sportscreme
Stanback Powder and Max Powder
St. Joseph Aspirin (all products)
Stimurub
Supac
Surin
ThermoRub
Trigesic
Tri-Pain Caplets
Uracel 5
Ursinus Inlay-Tabs
Valesin
Vanquish Caplet
Verin
Wart-Off
Wesprin Buffered
OTC medications containing ACETAMINOPHEN

Acephen
Aceta
Aceta-Gesic Relief of Pain
Acetaminophen
Actamin (all products)
Actifed Plus
Adult Strength Headache Relief Formula
All-Nite Cold Formula
Allerest (all products except 12 Hour and Children's)
Aminofen
OTC medications containing ACETAMINOPHEN - Continued
Anacin (all products)

Analval
Apacet Chewable Tablets
Aspirin Free Pain Relief
Banacid
Banesin
Benadryl (Plus and Plus Nighttime)
BQ Cole
Buffets II
Chexit
Chlor-Trimeton Sinus
Co-Apap
Codimal
Coldonyl
Comtrex (all products)
Conacetol
Conar-A
Conex Plus
Congespirin for Children, Aspirin Free
Contac (Jr., Nighttime Cole Medicine, and Severe Cold Formula)
Coricidin (all products)
Covangesic
Dapa (all products)
Datril Extra Strength
Daycare
DeWitt's Pills
Dilone
Dolanex
Dorcol Children's Non-Aspirin Fever & Pain Reducer
Drinophen
Dristan (all products except Room Vaporizer)
Drixoral Plus
Duadacin
Duradyne
Dyspel
Excedrin (all products)
Extreme Cole Formula
Femcaps
Fendol
Feverall (all products)
Formula 44M
4-Way Cole
Gemnisyn
Genapap (all products)

Genebs (all products)
Genex
Genite
Goody's (all products)
Halenol (all products)
Hista-Compound No.5
Kolephrin (all products)
Liquiprin (all products)
Lurline PMS
Meda Cap
Meda Tab
Menoplex
Menstra-Eze
Midol (all products)
Multi Symptom Menstrual Discomfort Relief Formula
Myapap Drops
Naldegesic
Neogesic
Neopap Suppositories
Nycold Medicine
Nyquil Nighttime Cold Medicine
Oranyl Plus
Oraphen-PD Elixir
Ornex Plus
Pain-Eze +
Pain Reliever Tablets
Pamprin (all products)
Panadol, Childrens and Infants
Panex (all products)
Panodynes Analgesic
Percogesic
Pertussin PM
PhenAPAP (all products)
Phenaphen
Phenylgesic
Premsyn PMS
Presalin
Pyrroxate
Quiet World Tablets
Rid-A-Pain
Robitussin Night Relief Colds Formula
S-A-C
Salatin Capsules
Saleto
Salocol
Satogesic (all products)
Sinapils
Sinarest (all products)
Sine-Aid (all products)
Sine-Off (all products)
Singlet
Sinulin
Sinutab (all products)
Snaplets-FR Granules
Sominex Pain Relief Formula Tablets
St. Joseph Cold Tablets for Children
Sudafed Sinus
Summit
Sunril
Supac
Suppap Suppositories (120,325,650)
Super Anahist
Synabrom
Tapanol Extra Strength
Tega S-A Tablets
Tempra (all products)
Tenol (all products)
TheraFlu (all products)
Triaminicin
Trigesic
Tri-Pain Caplets
Tussagesic
Ty-Cole
Tylenol (all products)
Unisom Dual Relief
Valadol
Valesin
Valihist
Valorin (all products)
Vanquish Caplet
Viro-Med
OTC medications containing IBUPROFEN
Addaprin
Advil
Genpril
Haltran
Mediprin (all products)
Motrin-IB
Nuprin
Trendar
Ultraprin
Valprin
List Prepared by U. T. M. D. Anderson Cancer Center Department of

Pharmacy.
APPENDIX E - IMMUNIZATIONS
Usually, symptom-free donors immunized with toxoids or killed viral,

bacterial or rickettsial vaccines are acceptable without a waiting
period, and donors immunized with live viral, bacterial or rickettsial
vaccines have a two week to two months waiting period. However, if a
donor has received any vaccine not indicated below, contact the TMP
for approval or deferral.
Vaccine/ Other Acceptability Notes

Biological
Acel-Imune Accept immediately, if Vaccine: diphtheria and
symptom-free. Tetanus Toxoids and
Acellular Pertussis
Adsorbed
ActHIB Accept immediately, if Vaccine: Haemophilus b
symptom-free. Conjugate (Tetanus Toxoid
Conjugate)
Animal Serum Products Defer 2 weeks after last
injection
Anthrax Vaccine Accept immediately, if
symptom-free.
Attenuvax Defer 2 weeks Vaccine: Measles Virus
Live (rubeola)
BCG ( see Tice BCG, USP) See Tice BCG, USP
Biavax II Defer 4 weeks (for Vaccine: Rubella and
rubella). Mumps Virus Live
Botox Defer 1 month after last Vaccine: Botulinum Toxin
injection. type A
Botulinum toxin ( see See Botox
Botox)
Chickenpox Vaccine Defer 4 weeks
(Varicella zoster vaccine)
Cholera Vaccine Accept immediately, if Vaccine: Sterile
symptom-free. suspension of killed Vibrio
cholerae
Comvax Sterile Suspension Defer 1 day (may cause Vaccine: Haemophilus b
positive HbsAg due to Conjugate (Meningococcal
antigen present in the Protein Conjugate) and
vaccine). Defer 12 Hepatitis B (Recombinant)
months if post-
exposure.
Diphtheria and Tetanus Accept immediately, if Vaccine: Combination of
Toxoids and Pertussis symptom-free. purified tetanus and
Vaccine Adsorbed (DTP) diphtheria toxoids
combined with a
suspension of Bordetella
pertussis organisms
Diphtheria Vaccine Accept immediately, if
symptom-free.
DTP (see Diphtheria and
Tetanus Toxoids and
Pertussis Vaccine
Adsorbed)
Eastern Equine Encephalitis Accept immediately, if
(EEE) symptom-free.
Engerix-B Unit-Dose Vials Defer 1 day (may cause Vaccine: Hepatitis B
positive HbsAg due to (Recombinant)
antigen present in the
vaccine). Defer 12
months if post-
exposure.
Flu Vaccine (Influenza) Accept immediately, if
symptom-free.
Fluvirin Accept immediately, if Vaccine: Influenza Virus
symptom-free.

Biological
Gamma globulin Accept for travel if no
known exposure to
hepatitis. Acceptable if
primary illness meets
requirements. (Hepatitis
exposure: 12-month
deferral)
Gamma (see gamma See Gamma globulin
globulin)
German measles (rubella) Defer 4 weeks
vaccine
Havrix Defer 12 months if post- Vaccine: Hepatitis A,
exposure. Accept Inactivated
immediately, if given
prophylactically, not for
exposure.
HBIG Defer 12 months Vaccine: Hepatitis B
Immune Globulin (Human)
Hepatitis A Vaccine Defer 12 months if post-
exposure. Accept
exposure.
Hepatitis B Vaccine Defer 1 day (may cause
positive HbsAg due to
vaccine). Defer 12
months if post-
exposure.
Hep-B-Gammagee Defer 12 months Vaccine: Hepatitis B
Immune Globulin (Human)
Heptavax Defer 1 day (may cause Vaccine: Hepatitis B
positive HbsAg due to
vaccine). Defer 12
months if post-
exposure.
HibTITER Accept immediately, if Vaccine: Sterile conjugate
symptom-free. of Haemophilus b and
diphtheria protein
Immune globulin See gamma globulin
(see gamma globulin)
Imovax Rabies Vaccine Defer 1 year if given for Vaccine: Sterilized rabies
rabies exposure (animal virus
bite); otherwise accept
immediately, if
symptom-free.
Infanrix for Intramuscular Accept immediately, if Vaccine: Diphtheria and
Injection symptom-free. Tetanus Toxoids and
Acellular Pertussis
Adsorbed
Influenza Virus Vaccine Accept immediately, if Vaccine: Influenza Virus
symptom-free.
Ipol Accept immediately, if Vaccine: Poliovirus
symptom-free. Inactivated (injectible)
Japanese Encephalitis Virus See JE-Vax
Vaccine
(see JE-Vax)
JE-Vax Accept immediately, if Vaccine: Japanese
symptom-free and given Encepalitis Virus
prophylactically (prior to Inactivated
travel). Note: evaluate
area of travel for
malarial risk.

Biological
Junin Defer 2 weeks after last
injection
Liquid PedvaxHIB Accept immediately, if Vaccine: Haemophilus b
symptom-free. Meningococcal Protein
Conjugate
Lyophilized PedvaxHIB Accept immediately, if Vaccine: Haemophilus b
symptom-free. Meningococcal Protein
Conjugate
Measles Vaccine See Rubella and Rubeola
(see Rubella and Rubeola Vaccines
vaccines)
Meningococcal Accept immediately, if
polysaccharide vaccine symptom-free.
Menomune-A/C/Y/W-135 Accept immediately, if Vaccine: Meningococcal
symptom-free. Polysaccharide
Meruvax II Defer 4 weeks (for Vaccine: Rubella Virus
rubella) Live
M-M-R II Defer 4 weeks (for Vaccine: Measles, Mumps,
rubella) and Rubella Virus Live.
M-R-VAX II Defer 4 weeks (for Vaccine: Measles and
rubella) Rubella Virus Live
Mumps Vaccine Defer 2 weeks
Mumpsvax Defer 2 weeks after last Vaccine: Mumps Virus Live
injection.
OmniHIB Accept immediately, if Vaccine: Sterile conjugate
symptom-free. of Haemophilus b and
diphtheria protein
Orimune Defer 2 weeks Vaccine: Attenuated
polioviruses
Paratyphoid Vaccine Accept immediately, if
symptom-free.
Pertussis Vaccine Accept immediately, if
symptom-free.
Plague Vaccine Accept immediately, if
symptom-free.
Pneumococcal Vaccine Accept immediately, if
symptom-free.
Pneumovax 23 Accept immediately, if Vaccine: Pneumococcal
symptom-free. Vaccine Polyvalent
Pnu-Imune 23 Accept immediately, if Vaccine: Pneumococcal
symptom-free. Polyvalent
Polio (injectible) Vaccine Accept immediately, if
symptom-free.
Polio (oral)Vaccine Defer 2 weeks
Q Fever Accept immediately, if
symptom-free.
Rabies Vaccine Adsorbed Defer 1 year if given for Vaccine: Sterilized rabies
rabies exposure (animal virus
immediately, if
symptom-free.
Rabies Vaccine, Defer 1 year if given for Vaccine: Sterilized rabies
Imovax Rabies I. D. rabies exposure (animal virus
immediately, if
symptom-free.

Biological
Recombivax HB Defer 1 day (may cause Vaccine: Hepatitis B
positive HbsAg due to (Recombinant)
vaccine). Defer 12
months if post-
exposure.
RhoGAM Accept after pregnancy, Vaccine: Rh Immune
miscarriage, or abortion Globulin
and meets required wait
of 6 weeks.
Rift Valley Fever Accept immediately, if
symptom-free.
Rocky Mountain Spotted Accept immediately, if
Fever Vaccine symptom-free.
Rubella Vaccine Defer 4 weeks
Rubeola Vaccine Defer 2 weeks
Smallpx Vaccine Acceptable after scab
has fallen off or 2 weeks
after an immune
reaction.
Tetanus Vaccine Accept immediately, if
symptom-free.
Tetramune Accept immediately, if Vaccine: Diphtheria,
symptom-free. Tetanus Toxoids,
Pertusssis, and
Haemophilus b Conjugate
Tice BCG, USP If given to treat cancer, Vaccine: Live culture
permanent deferral. If preparation of the Bacillus
given for tuberculosis and Calmette and Guerin
exposure or prevention, (BCG) strain of
defer 2 weeks if Mycobacterium bovis
asymptomatic and
donor meets medical
criteria for tuberculosis.
Tri-Immunol Adsorbed Accept immediately, if Vaccine: Diphtheria and
Pertussis Vaccine
Adsorbed
Tripedia Accept immediately, if Vaccine: Diphtheria and
Pertussis Vaccine
Adsorbed
Tularemai Defer 2 weeks after last
injection.
Typhim Vi Accept immediately, if Vaccine: Typhoid Vi
symptom-free. Polysaccharid
Typhoid (injectible) Vaccine Accept immediately, if
symptom-free.
Typhoid (oral) Vaccine Defer 2 weeks.
Typhus Vaccine Accept immediately, if
symptom-free.
Vaqta Defer 12 months if post- Vaccine: Hepatitis A
exposure. Accept Vaccine, Inactivated
exposure.
Varicella zoster Vaccine Defer 4 weeks
Varivax Defer 4 weeks after last Vaccine: Varicella Virus
injection. Vaccine Live

Biological
Venezuelan Equine Defer 2 weeks after
Encephalitis (VEE) initial injection. Accept
immediately, if booster
and given
prophylactically (prior to
travel). Note: evaluate
area of travel for
malaria risk.
Vivotif Berna Defer 2 weeks. Vaccine: typhoid Vaccine
Live Oral
Yellow Fever Vaccine Defer 2 weeks.
REFERENCES:

APPENDIX F
MALARIA, CHAGAS, and other HIGH RISK TRAVEL AREAS
PURPOSE:
To help assure that all donors that have traveled or lived in other
countries are correctly evaluated and deferred / accepted according
to all standards, each country they have traveled or lived in the
time period defined in procedure 1.32 must be thoroughly reviewed.
Below is a quick reference to all countries. Included are areas of risk
for malaria, Chagas, and other high risk diseases identified by the
FDA.
Malaria Risk: If this chart states “YES”, then review the

accompanying note. If it says “ALL” then ANY travel (or residence) to
this country should be deferred according to Procedure 1.32. Many
countries have only some areas of risk. Talk to the donor to
determine if their travel was to the risk areas indicated. You may
refer to a map if necessary. If still not clear, contact the TMP.
Chagas Disease Risk:The column for Chagas Risk indicates those

countries that are included in the question asking the donor if they
have EVER received a blood product transfusion in Mexico, Central,
or South America. “YES” indicates a country that is in these areas.
Accept / defer donor according to Procedure 1.32.
Other High-Risk Areas: A “YES” indicates a country that is of

High Risk for other reasons identified by the FDA. Donors that have
lived or travel to these countries since 1977 or have had sexual
contact with anyone who was born or lived there should be accepted
/ deferred according to Procedure 1.32.
COUNTRY Chag Other Malari Malarial Notes

as High al Risk
Risk Risk
Afghanistan YES ALL
No No
Albania No No No
Algeria No No YES Very limited risk in Sahara
Region
Andorra No No No
Angola No No YES ALL
Antigua and Barbuda No No No
Argentina YES No YES Rural areas near “Bolivian
border, i.e. Salta and Jujuy
Provinces and along border
with Paraguay, i. e., Misiones
and Corrientes Provinces.

as High al Risk
Risk Risk
Armenia No No No
Australia No No No
Austria No No No
Azerbaijan No No YES Risk in some very small
southern border areas.
Azores (Portugal) No No No
Bahamas No No No
Bahrain No No No
Bangladesh No No YES ALL areas, except no risk in
city of Dhaka.
Barbados No No No
Belarus No No No
Belgium No No No
Belize (Br. Honduras) YES No YES Rural areas (including forest
preserves and offshore
islands, including the resort
areas) No risk in central
coastal District of Belize.
Benin (Dahomey) No No YES ALL
Bermuda (U.K.) No No No
Bhutan No No YES Rural areas in districts
bordering India.
Bolivia YES No YES Rural areas only. No risk in

highland areas, i.e. Oruro
Dept., Prov. Of Ingavi, Los
Andes, Omasuyos and
Pacajes, (La Paz Dept.) and
southern and central Potosi
Dept.
Bosnia/Herzogovina No No No
Botswana No No YES Northern part of country
(north of 21° S).
Br. Honduras (now YES No YES

Belize)

as High al Risk
Risk Risk
Brazil YES No YES Acre and Rondonia States;
Terr of Amapá andf Roraima.
Part of rural areas of the
following states: Amazonas,
Maranhao, Mato Grosso,
Pará and Tocantins. Also in
the outskirts of Manaus and
Porto Velho. No risk in
coastal states from the horn
to the Uruguay border and
Iguassu Falls are not at risk.
– See Map if necessary.
Brunei Darussalam No No No
Bulgaria No No No
Burkina Faso (Upper No No YES ALL
Volta)
Burma (now No No YES See Myanmar
Myanmar)
Burundi No No YES ALL
Cambodia No No YES All areas, except no risk in

Phom Penh.
Cameroon No YES YES ALL
Canada No No No
Canary Islands No No No
(Spain)
Cape Verde No No YES Risk limited to island of São
Tiago.
Cayman Islands (U. No No No
K.)
Central African No YES YES ALL
Republic
Chad No YES YES ALL
Chile YES No No
China No No YES Rural only. No risk in
northern provinces
bordering Mongolia and in
the western provinces of
Heiungkiang, Kirin, Ningsia
Hui Tibet and Tsinghai.
North of latitude 33 N to 25
N, transmission occurs May
to Dec.; south of latitude 25
N, transmission occurs year-
round.
Note: Travelers visiting cities
and popular rural sites on
usual tourist routes are
generally not at risk.

as High al Risk
Risk Risk
Christmas Island No No No
(Australia)
Colombia YES No YES No risk in Bogota and
vicinity. Risk in rural areas
only of Alto Vaupes, (Vaupes
Comisria), Amazonas, Ariari,
(Meta Dept.). Bajo, Cauca-
Nechi (Cauca and Antioquia
Dept.), Caqueta (Caqueta
Intendencia), Catatumbo
(Norte de Santander Dept.),
Guainia (Comisarias),
Magdalena Medio, Pacifico
Central and Sur, Putumayo
(Putumayo Intendencia)
Sarare (Aruca Intendencia),
Uraba (Antioquia Dept.)
Comoros No No YES ALL
Congo No YES YES ALL

Cook Island (New No No No
Zealand)
Costa Rica YES No YES All areas, including tourist
areas. Exception; no risk in
central highlands, i.e.,
Cartago and San Jose
Provinces
Côte d’Ivoire (Ivory No No YES ALL

Coast)
Croatia No No No
Cuba No No No
Cyprus No No No
Czech Republic No No No
Dahomey (now No No No
Benin)
Denmark No No No
Djibouti No No YES ALL
Dominica No No No
Dominican Republic No No YES ALL areas, except no risk in
tourist resorts. Highest risk
in provinces bordering Haiti

as High al Risk
Risk Risk
Ecuador YES No YES All provinces along eastern
border and Pacific coast (See
book/map).No risk to travel
in only Quito and vicinity,
the central highland areas,
or the Galapagos Islands.
Egypt No No YES Rural areas of Nile Delta, El

Faiyum area, the oases and
part of southern (upper)
Egypt. No risk in main
tourist areas, including the
cruises.
El Salvador YES No YES Rural areas only.

Equatorial Guinea No YES YES ALL
Eritrea No No YES ALL areas at risk, except no

risk at altitudes> 2,000
meters. No risk in Asmara.
Estonia No No No
Ethiopia No No YES ALL areas at risk, except no
risk in Addis Ababa and @
2,000 meters.
Falkland Islands (U. YES No No

K.)
Faroe Islands No No No
(Denmark)
Fiji No No No
Finland No No No
France No No No
French Guiana YES No YES ALL
French Polynesia No No No
(Tahiti)
Gabon No YES YES ALL
Gambia No No YES ALL
Georgia No No No
Germany No No No
Ghana No No YES ALL
Gibraltar (U. K.) No No No

Gilbert Islands (now No No No
Kiribati)
Greece No No No

as High al Risk
Risk Risk
Greenland (Denmark) No No No
Grenada No No No
Guadeloupe (France No No No
Guam (U.S.) No No No
Guatemala YES No YES Rural areas only. No risk in
central highlands.
Guinea No No YES ALL
Guinea-Bissau No No YES ALL
Guyana YES No YES Rural, in all interior regions

including Rupununi and
North-West Regions and
areas along Pomeroon river.
Haiti No No YES ALL
Honduras YES No YES Rural areas only.
Hong Kong (U.K.) No No No

Hungary No No No
Iceland No No No
India No No YES Risk in ALL areas, including
the cities of Delhi and
Bombay. No risk in parts of
the States of Himechel,
Pradesh, Jammu and
Kashmir, and Sikkim.
Indonesia No No YES Rural only, except high risk

in all areas of Irian Jaya
(western half of island of
New Guinea) No risk in cities
of Java and Sumatra and no
risk for the main resort
areas of Java and Bali. Note:
Transmission (except for
Irain Jaya) is largely confined
to rural areas not visited by
most travelers; most travel
to rural areas of Indonesia is
during daytime hours when
the risk of exposure is
minimal.

as High al Risk
Risk Risk
Iran, Islamic Republic No No YES Risk in rural areas only in
of the provinces of Sistan-
Baluchestan, the tropical
part of Kerman, Hormozgan,
and parts of Bushehr, Fars,
Ilam, Kohgiluyeh-Boyar,
Lorestan, and Chahar Mahal-
Bakhtiari, and the north of
Khuzestan.
Iraq No No YES ALL of northern region;

provinces of Duhok, Erbil,
Ninawa, Sulaimaniya, Támim,
Basrah.
Ireland No No No
Israel No No No
Italy No No No
Jamaica No No No
Japan No No No
Jordan No No No
Kampuchea, No No No
Democratic
(see Cambodia)
Kazakhstan No No No
Kenya No No YES ALL areas (including game
parks). No risk in Nairobi
and @altitudes > 2500
meters.
Kiribati (was Gilbert No No No

Islands)
Korea, Democratic No No No
People’s Republic of
(North)
Korea, Republic of No No No
(South)
Kuwait No No No
Kyrgyzstan No No No
Lao People’s No No YES ALL areas, except no risk in
Democratic Republic city of Vientiane.
Latvia No No No
Lebanon No No No
Lesotho No No No

as High al Risk
Risk Risk
Liberia No No YES ALL
Libyan Arab No No YES Very limited risk in 2 small

Jamahiriya foci in southwest of country.
Liechtenstein No No No
Lithuania No No No
Luxembourg No No No
Macao (Portugal) No No No
Madagascar No No YES ALL. Highest risk in coastal
areas.
Madeira (Portugal) No No No
Malawi No No YES ALL
Malaysia No No YES No risk in urban and coastal

areas. Peninsular Malaysia
and Sarawak (NW Borneo);
malaria limited to remote
areas. Sabah (NE Borneo) =
malaria throughout.
Maldives No No No
Mali No No YES ALL
Malta No No No
Marshall Islands No No No
Martinique (France) No No No
Mauritania No No YES ALL areas, except no risk in
northern region; Adrar,
Dakhlet-Nauadhibou, Inchiri,
Tiris-Zemour.
Mauritius No No YES Rural only. No risk on

Rodrigues Island.
Mayotte (French No No YES ALL

territorial
collectivity)

as High al Risk
Risk Risk
Mexico
YES No YES Risk: Rural areas of the
following States; Campeche,
Chiapas, Guerrero,
Michoacan, Nayarit, Oaxaca,
Quintana Roo, Sinalos, and
Tabasco.
Major resort areas on the
Pacific and Gulf coasts are
not at risk. The small town
of Huatulco and Ixtapa ARE
at risk.
None of the towns directly across from
the US border are at risk.
The following cities are NOT

at risk for malaria. Acapulco,
Aguascalientes, Cabo San
Lucas, Cancun, Chihuaha,
Ciudad Acuña, Ciudad
Juarez, Ciudad Obregón,
Cozumel, Curernavaca,
Ensenada, Gomez Palacio,
Guadalajara, Guaymas,
Hermosillo, La Paz (on Baja
peninsular), Matamoros (the
border town), Mazatlán,
Merida, Mexicali, Mexico
City, Monterrey, Morelia,
Nogales (the border town),
Nuevo Laredo, Oaxaco,
Piedras Negra (the border
town), Puebla, Puerto
Vallarta, Queretaro, Saltillo,
San Felipe (on Baja
peninsula), San Luis Potosi,
Reynosa, Santa Ana,
Sonoita, Tampico, Tijuana,
Torreón, Toluca, and
Veracruz.
Micronesia No No No
(Federated States of)
Monaco No No No
Mongolia No No No
Montserrat (U.K.) No No No
Morocco No No YES Very limited risk in rural
areas of some provinces
Mozambique No No YES ALL

Myanmar (was No No YES Rural only. No risk in the
Burma) cities of Yangon (formerly
Rangoon) and Mandaly.

as High al Risk
Risk Risk
Namibia No No YES All of Ovamboland and
Caprivi Strip.
Nauru No No No
Netherlands No No No
Netherlands Antilles No No No
New Caledonia and No No No
Dependencies
(France)
New Zealand No No No
Nicaragua YES No YES Rural areas only. Risk exists
in outskirts of Bluefields,
Bonanza, Chinandega, Leon,
Puerto Cabeza, Rosita,
Siuna.
Niger No YES YES ALL
Nigeria No YES YES ALL
Niue (New Zealand) No No No

Northern Mariana No No No
Islands (U.S.)
Norway No No No
Oman No No YES ALL
Pacific Islands, Trust No No No

Territory of the U. S.
A.
Pakistan No No YES In ALL areas below 2,000
meters, including the cities.
Panama YES No YES No risk in the Canal Zone or

in Panama City and vicinity.
Risk; Rural areas in the
eastern provinces (Darien
and San Blas), the
northwestern provinces,
(Boa del Toro and Veraguas),
Lake Boyana area and Lake
Gatún.
Papua New Guinea No No YES ALL
Paraguay YES No YES Rural areas bordering Brazil

as High al Risk
Risk Risk
Peru YES No YES No risk in Lima and vicinity,
coastal areas south of Lima,
or the highland tourist areas
(Cuzco, Machu Picchu, Lake
Titicaca). Risk exists in rural
areas of depts of Amazonas,
Cajamarca (except
Hualgayoc Province) , La
Libertad (except Otuzco,
Santiago de Chuco
Provinces), Lambayeque,
Loreto, Piura (except Talara
Province), San Martin and
Tumbes, Provinces of Santa
(Ancash Dept.), parts of La
Convension (Cuzco Dept.)
Tayacaja (Huancavelica
dept). Satipo (Junin Dept.)
Philippines No No YES Rural Only. No risk in

provinces of Bohol,
Catanduances, Cebu and
metropolitan Manila. Risk
low to daytime travel.
Pitcairn (U. K.) No No No

Poland No No No
Portugal No No No
Puerto Rico (U. S.) No No No
Qatar No No No
Republic of Moldavia No No No
Reunion (France) No No No
Romania No No No
Russian Federation No No No
Rwanda No No YES ALL
Saint Christopher No No No
(Saint Kitts) and
Nevis (U. K. )
Saint Helena (U.K.) No No No
Saint Lucia No No No
Saint Pierre & No No No
Miquelon (France)
Saint Vincent and the No No No
Grenadines

as High al Risk
Risk Risk
Samoa (was Western No No No
Samoa)
Samoa, American (U. No No No
S.)
San Marino No No No
Sao Tome & Principe No No YES ALL
Saudi Arabia No No YES Risk in all of western

provinces. No risk in the
high altitude areas of Asir
Province (Yemen border) and
the urban areas of Jeddah,
Mecca, Medina, and Taif.
Senegal No No YES ALL
Serbia / Montenegro No No No
Seychelles No No No
Sierra Leone No No YES ALL
Singapore No No No
Slovak Republic No No No
Slovenia No No No
Solomon Islands No No YES ALL
Somalia No No YES ALL
South Africa No No YES Rural (including game parks)

in the northern, eastern, and
western low altitude areas
of Transvall and in the Natal
coastal areas north of 28° S.
Spain No No No
Sri Lanka (Ceylon) No No YES Risk in all rural areas. No
risk in the districts of
Colombo, Kalutara, and
Nuwara Eliya.
Sudan No No YES ALL
Suriname YES No YES Rural only. No risk in

Paramaribo District and
coastal area north of 5° N.
Swaziland No No YES All lowland areas.
Sweden No No No

as High al Risk
Risk Risk
Switzerland No No No
Syrian Arab Republic No No YES Rural only, except no risk in
southern and western
districts of Deir-es-zor and
Sweida.
Taiwan No No No
Tajikistan No No YES Southern border.
Tanzania, United Rep. No No YES ALL
Thailand No No YES Limited risk. Risk confined to

forested rural areas,
principally along the borders
with Cambodia and
Myanmar, not visited by
most travelers. No risk in
cities and major tourists
resorts (e.g. Bangkok,
Chiangmai, Pettaya, Phuket)
Togo No No YES ALL

Tokelau (New No No No
Zealand)
Tonga No No No
Trinidad and Tobago No No No
Tunisia No No No
Turkey No No YES Southeast Anatolia.
Cukorova/Amikova areas.
Turkmenistan No No No
Tuvalu No No No
Uganda No No YES ALL
Ukraine No No No
Union of Soviet No No No See individual countries
Socialist Republics
(USSR)
United Arab Emirates No No YES Northern emirates except no
risk in Emirate of Abu Dhabi
or in cities of Ajman, Dubai,
Sharjah, Umm al Qaiwan.
United Kingdom No No No
( with Channel
Islands and the Isle
of Man)

as High al Risk
Risk Risk
United States of No No No
America
Upper Volta (now No No No ALL
Burkina Faso)
Uruguay YES No No
Uzbekistan No No No
Vanuatu (New No No YES All areas, except no risk on
Hebrides) Fortuna Island.
Venezuela YES No YES Rural, in all border states

and territories and the
states of Barinas, Merida,
Portugesa.
Viet Nam No No YES Rural only, except no risk in

the Red River Delta and
coastal plain north of Nha
Trang.
Virgin Islands, British No No No

Virgin Island, U. S. No No No
Wake Island (U. S.) No No No
Yemen No No YES ALL, except no risk in Aden
and airport perimeter.
Yemen Yugoslavia No No No
Zaire No No YES ALL
Zambia No No YES ALL
Zimbabwe Rhodesia No No YES All, except no risk in cities of

Harare and Bulawayo.
REFERENCES:

3. Health Information for International Travel 1996-97, Center for
Disease Control and Prevention, Us Department of Health and
Human Services.
4. FDA Memo 12/11/96
APPENDIX G
GUIDE TO COMMONLY USED MEDICATIONS
PURPOSE:
The purpose of this appendix is to assist M. D. Anderson Cancer

Center Blood Bank technicians in the acceptance / deferral of donors
due to the medications that they might be taking.
SUPPLIES:
1. Davis Drug Guide
PROCEDURE:
1. If the donor knows the name of the medication they are taking,
look for the name in the Davis Drug Guide, and determine the
classification. Some medications will have more than one
classification. When this occurs, you must ask the donor for
the reason they are taking the medication. Look up the
Medication and determine the deferral criteria. In the
procedure manual, some medications that a donor may be
taking (i. e. Tegison) are listed with specific donor instructions.
For donor deferral, follow the instructions provided.
2. If the donor does not know the name of the medication they
have taken, but does know the reason for taking the drug, look
for the reason in this appendix or the Donor History
Questionnaire, Procedure 1.32.
3. Any time that you have a questions about the deferral criteria,
page the TMP on call or call Transfusion Medicine at 713-792-
8630 and ask for a TMP..
CLASSIFICATION COMMON USAGE DEFERRAL CRITERIA
Moderate to severe Determine the reason

Analgesic
pain the donor is taking the
medication and defer if
appropriate. No deferral
if donor feels well.
Heart burn, irritable No deferral if donor is
Antacid
bowel syndrome, gas, asymptomatic.
hyperacidity,
peptic ulcer,
esophageal reflux,
spastic colon.
Alcohol addiction Defer if donors displays
Anti-Alcohol
signs of intoxication.
CLASSIFICATION COMMON USAGE DEFERRAL CRITERIA
Angina. Chest pain. Permanent deferral for

Anti-Angina
medical condition.
Anti-Anorexic Anorexia No deferral if donor
meets weight
requirements.
Stress No deferral.
Anti-Anxiety
Heart arrhythmias, No deferral if donor’s
Anti-Arrhythmics arrhythmia is controlled by
blood pressure,
medication and donor has
palpitation, migraines, regular pulse on day of
tremors. donation. TMP may approve
some conditions: palpitations,
elevated pulse associated
with stress. Document all TMP
approval.
Asthma No deferral if donor has
Anti-Asthmatic
not suffered an attack in
past 7 days or wheezing
is managed by an
inhaler. (Must have
inhaler with them)
Infections. Defer for 72 hours after
Antibiotic
Sometimes given as last dose.
prophylactic - acne, No deferral for acne or
bladder infection. bladder prophylaxis or
for topical antibiotic.
Blood clots, phlebitis Determine reasons for
Anticoagulant
taking drug, and then
(Coumadin /Warfarin, call TMP.
Heparin, Persantine)
Seizures, epilepsy, Refer to procedure 1.32.
Anti-Convulsant
head injury, migraine
headaches
Alzheimer’s disease Permanent deferral for
Anti Dementia
medical condition.
Depression No deferral.
Anti-Depressant
Diarrhea Defer donor for 10 days
Anti-Diarrheal
after last episode of
diarrhea.
Nausea, vomiting No deferral if donor is
Anti-Emetics (Anti-
feeling well.
nausea)
Refer to procedure Refer to procedure 1.32.
Anti-Epileptics
1.32.
Ameobic infection, Defer donor for one
Anti-Flagellant
Giardia infection month after last dose.

Anti-Flatulent
hyperacidity, peptic
ulcer, esophageal
reflux, spastic colon.
Nail, skin, or vaginal No deferral for topical
Anti-Fungal
yeast infection antifungal medication for
nail or skin infection; no
deferral for vaginal or
yeast infection.
Gout, high uric acid No deferral.
Anti-Gout
Granulocyte donors:
Defer if taking
Colchicine.
Allergies, allergic No deferral is donor has
Anti-histamine
reactions, insomnia, no fever or signs of
motion sickness infection; defer donor for
24 hours if donor has
severe congestion.
Inhibitive therapy No deferral.
Anti-hormone
Blood pressure control No deferral if donor’s
Anti-Hypertensive
blood pressure is within
acceptable range and is
in control.
Inflammation of Whole Blood, no deferral
Anti-Inflammatory
muscles, tendons, for medication. Check
arthritis, bursitis, the reason the donor is
migraines taking the drug and
defer if appropriate.
Mark bag and donor card
per Appendix D.
Platelets, check active
ingredient and defer
according to Appendix D.
1. Influenza Defer donor for 72 hours
Anti-Influenza
treatment after completion of
medication and donor is
2. Prophylaxis - see also asymptomatic.
Flu Shot
Treatment of high No deferral.
Anti-Lipid
cholesterol
Prophylaxis for No deferral for
Anti-Malarial
malaria medication. Defer donor
according to rules for
travel in malaria-
endemic areas.
Migraine headaches No deferral if no
Anti-Migraine
headache; 24 hr deferral
if headache at time of
donation. Check for
active ingredient and
defer SDP donors as
indicated in Appendix D.
Cancer, severe forms Permanent deferral.
Anti-Neoplastic
of rheumatoid Refer to procedure 1.32.
arthritis
Parkinson’s disease, Parkinson’s disease

Anti-Parkinson
viral influenza, --permanent deferral. No
tremors, infertility deferral for tremors or
infertility. Early stages of
Parkinson’s disease may
be acceptable -- Call TMP
for approval &
document.
Psoriasis, severe Permanent deferral for
Anti-Psoriatic
dermatitis Tegison (see 1.32). No
deferral for other
medications if
antecubital area is clear.
Psychoses (loss of If for active psychoses --
Anti-Psychotic
contact with reality), defer permanently or
bi-polar conditions, until approved by
manic depression, psychiatrist and TMP.
schizophrenia. Accept if taken for other
reasons, or if donor does
not exhibit signs of
bizarre behavior.
Irritable Bowel No deferral if donor is
Anti-Spasmodic
syndrome asymptomatic.
Tuberculosis Defer for 6 months after
Anti-Tubercular
completion of medication
and symptom free.
Cough No deferral if donor has
Anti-Tussive
no fever or signs of
infection.
Anti-Ulcer
hyperacidity, peptic
ulcer, esophageal
reflux, spastic colon
Viral infections Determine type of viral
Anti-Viral
infection. Refer to
procedure 1.32 for
deferral or call TMP.
Asthma, COPD, No deferral if donor does
Bronchodilator
bronchitis, not have active asthma.
emphysema No deferral if controlled
by inhalers or
prophylaxis.
Permanently defer for
advanced emphysema or
chronic bronchitis. Early
stage emphysema may
be accepted with TMP
approval.
Narcolepsy, attention No deferral if vital signs
Central Nervous
deficit disorder (ADD), are not erratic and other
system stimulant
obesity criteria acceptable.
(Amphetamines)
Cancer treatment Permanent deferral as
Chemotherapy
per procedure 1.32.
Birth control No deferral.
Contraceptives
Allergies, common Whole blood, no deferral
Decongestant
cold, congestion if donor has no fever or
sign of infection. If
symptomatic defer for 24
hours.
Platelets, check for any
inflammatory ingredient
and defer per Appendix
D.
Obesity No deferral if vital signs
Diet Pills
are not erratic and other
See “CNS stimulant” criteria acceptable.
above
Edema, congestive Permanent deferral for

Diuretic
heart failure, swelling, congestive heart failure
elevated blood and severe edema.
pressure Elevated blood pressure,
donor must be controlled
and acceptable BP
range. No deferral if for
simple periodic female
bloating.
Cold, Flu Determine condition and
Expectorant
any inflammatory
ingredients and defer
appropriately.
Influenza prophylaxis No deferral if donor is
Flu Shot
asymptomatic following
vaccine. Indicate date of
vaccine on back of donor
card.
Eye condition No deferral.
Glaucoma
Rheumatoid arthritis, Permanent deferral.
Gold Salts
psoriatic arthritis
Heart block, heart Permanent deferral, per
Heart glycosides
attack, congestive procedure 1.32.
failure, atrial flutter
Herpes Active lesions -- Defer
Herpetic
until lesions have dried.
Prophylaxis -- no
deferral.
Replacement therapy, No deferral.
Hormone (Anti-
Inhibition therapy
Hormone)
Insomnia, psychoses No deferral if taken to
Hypnotic
promote sleep.
Permanent deferral if
taken for psychoses.
Diabetes No deferral for oral
Hypoglycemic, oral
medications
Female infertility No deferral if donor is
Infertility
not pregnant now or in
the past 6 weeks.
Asthma No deferral if donor’s
Inhaler
asthma is not active.
Diabetes No deferral if there are
Insulin
no complications and
diabetes is well
controlled.
Iron supplement No deferral if donor
Iron supplement
meets Hgb
requirements.
Constipation No deferral.
Laxative
Lithium Bipolar disorder No deferral.
(Manic- Depressive)
Back strain, various Whole blood, no deferral.

Muscle relaxant
sports injuries, muscle Platelets, check for any
strain anti-inflammatory
ingredients and defer
per Appendix D.
Potassium supplement Determine reason for
Potassium supplement
taking and follow
procedure 1.32 or
Appendix H for that
condition.
Experimental program Determine medication,
Research Medication
and reason in program.
Call TMP .
For attention deficit No deferral.
Ritalin
disorder
Insomnia, No deferral.
Sedatives
nervousness
Arthritis, Determine reason for
Steroids
inflammation, taking medication and
Immunosuppression, defer if appropriate. No
allergies, asthma deferral for inhalers or
topical steroids, or if
taken for allergies.
Stool softener No deferral.
Stool softener
1. Thyroid supplement 1. Hypothyroidism 1. No deferral.
2. Graves’ disease, 2. Call TMP.
2. Anti-thyroid hyperthyroidism
Anti-anxiety No deferral.
Tranquilizer
Bladder control, No deferral if donor has
Urinary antispasmodic
bladder reflux no active infection.
Hypertension, mild Permanent deferral for
Vasodilator
arteriosclerosis, leg cerebrovascular disorder
cramps, mild & diabetic vascular
circulatory disease. No deferral if
disturbance of inner taken for hypertension,
ear, cerebrovascular mild arteriosclerosis, leg
disorder, diabetic cramps, mild circulatory
vascular disease. problems of inner ear.
Supplementary No deferral.
Vitamins
therapy
REFERENCES:

APPENDIX H
HEALTH CONDITIONS --QUICK REFERENCE
PURPOSE:
This checklist is prepared to be used in tandem with the Donor

History Questionnaire Procedure 1.32. It is intended to provide
the technician a quick reference for commonly encountered
donor health conditions. If at any time there is doubt or
confusion about the donor’s eligibility, contact the Transfusion
Medicine Physician (TMP) for clarification and final decision for
donor acceptance or deferral.
HEALTH CONDITION DONOR ELIGIBILITY
Abortion Defer until fully recovered and off medications.

Abscess Defer for 72 hrs after completion of antibiotics
AND abscess has resolved and donor has no
symptoms.
Acne On medications - Defer appropriately.
No medications - No deferral.
Acromegaly Accept.
Acupuncture Defer as per procedure 1.32. Temporary Deferral
12 months.
Addison’s Disease Defer permanently.
Adenoma Accept.
AIDS Defer permanently.
Alcoholism Accept IF donor is not under the influence.
Allergies On medications: Check and defer appropriately.
No Medications: Accept if not showing severe
symptoms at the time.
Alzheimer’s Disease Defer permanently.
Amyotrophic Lateral Defer permanently.
Sclerosis (ALS – Lou
Gehrig’s Disease)
Appendix H: Health Conditions -- Quick Deferral Reference - pg 2
Aneurysm Defer permanently unless donor has written

approval from their own physician AND has TMP
approval.
Animal Bites Rabies Vaccine - defer for 1 year.
No vaccine - defer for 72 hrs after bite AND any
antibiotics.
Angina Defer permanently.
Angioplasty Defer for 12 months after procedure and donor
has no history of myocardial infarction or
recurrent chest pain.
Appendectomy Temporary Deferral for 12 months after surgery.
Arrhythmias Accept if donor is not on medication, has a
regular pulse, arrhythmias are controlled by
medication, and has no history of heart attack.
Arthritis Rheumatoid arthritis - Accept donor only if
he/she has had no joint involvement and has not
taken medication for RA in the past 3 years.
Minor arthritis - no medication or only aspirin–
accept for whole blood..
Asbestosis Defer permanently.
Asthma Accept if donor has not suffered a recent attack.
Accept if asthma is controlled by an inhaler AND
donor has inhaler with them.
Atrail Septal Defect Accept if repaired at an early age, off
(ASD) medication, and donor has no restrictions.
Babesiosis Defer permanently.
Bell’s Palsy Accept if donor has normal activity.
Benign Prostatic Proscar medication: Defer for 30 days after last
Hypertrophy dose.
Not taking Proscar: Accept donor.
Berger’s Disease Accept if donor is asymptomatic and has normal
activity.
Bites, Animal See Animal bites.
Boil Accept if donor is lesion-free, asymptomatic and
has been off antibiotics for 72 hours.
Bone fracture No surgery: Defer for 48 hours and is symptom
free
Surgery for complicated fracture: 12 month
deferral..
Bowen’s Disease Accept if donor is cured.
Breast Feeding Accept donor if 6 weeks after delivery.
Bright’s Disease Accept if symptom-free and donor does not have

chronic renal disease.
Cancer Defer permanently. Two exceptions listed in
procedure 1.32.
Carpal Tunnel Accept.
Syndrome
Cat Scratch Fever Defer for 1 month after donor becomes
asymptomatic and treatment is complete..
Cerebral Palsy Call TMP for approval.
Cerebral Vascular See “Stroke”.
Accident (CVA)
Cesarean Section Defer for 12 months.
Delivery
Chagas Disease Defer permanently.
Chicken Pox Accept if all sores are gone and donor is feeling
well.
Chlamydia Defer for 1 year after treatment is complete and
donor is symptom-free.
Cholecystitis Accept if symptom free.
Cholera Defer for 1 month after complete recovery.
Cirrhosis Defer permanently.
Cold 1. Defer until donor is feeling well if did not
take antibiotics.
2. Defer for 72 hours after taking antibiotics.
Colitis Accept if donor is symptom free.
Condyloma Accept if symptom free.
Acuminata
Congestive Heart Defer permanently.
Failure
Conjunctivitis Accept if problem is resolved and donor is
asymptomatic.
Convulsions Seizures in the last 1 year = consult TMP, record,
and defer as indicated. More than 1 year since
last seizure, and medication controlled, accept
donor.
Chronic Obstructive 1. If symptomatic or has severe disorder, defer
Pulmonary Disease permanently.
(COPD) 2. If asymptomatic or has mild disorder, call TMP
for approval.
Creutzfeldt Jakob Defer permanently.
Disease
Crohn’s Disease Defer if the disease is active.
If condition is controlled by medication or donor
asymptomatic; accept.
Cushing Syndrome Defer permanently.
Cystic Fibrosis Accept if the donor is off antibiotics for at least

72 hours and has no respiratory symptoms.
Cystitis Defer for 72 hours after completion of antibiotics
and donor is asymptomatic.
Cytomegalovirus Defer for 1 month after complete recovery.
(CMV)
D&C Defer until fully recovered and off medications.
(Dilation and Curettage)
Dengue Fever Defer for 30 days after donor becomes

asymptomatic and treatment is complete.
Dental Work Defer for 24 hours and off antibiotics for 72
(Including Root canal, hours.
tooth extraction,
crowns, etc.)
Depression Accept if mentally competent at the interview.

Dermatomyositis Defer permanently if disease is active.
Diabetes Accept.
(Controlled by diet
or oral
hypoglycemic
medication)
Diabetes 1. Accept if disease is well controlled without
vascular complications, kidney disease, eye
(Insulin Dependent)
disease, or cardiovascular disease; and donor
has no recent (30 days) episode of diabetic
acidosis or hypoglycemia.
2. Defer permanently otherwise.
Dialysis 1. Defer permanently.
2. If donor has had close contact with patient
receiving dialysis defer for 12 months.
3. Organ transplant following dialysis temporary
deferral for 12 months from receipt.
Down’s Syndrome Accept if donor is mentally competent and
understands the procedure.
Dubbin-Johnson Defer permanently.
Syndrome
Dura Mater Defer permanently.
Transplant
Dysplasia Accept.
Dystonia Defer permanently.
Eczema Accept if lesions are not infected.
Embolism Defer for 6 months after episode if donor is

under no restrictions, on no heart medications or
blood thinners, and has no vascular disease.
Otherwise, call TMP for approval.
Emphysema Accept if donor is asymptomatic. See procedure
1.32.
Encephalitis Defer for 6 months after recovery.
Endocarditis Defer for 6 months after recovery.
Endometriosis Accept if asymptomatic.
Epicarditis See Pericarditis.
Epilepsy See Convulsions and procedure 1.32.
Erythema Nodosum Accept if donor is fully recovered and is
asymptomatic.
Esophagitis Accept if asymptomatic; defer for 72 hours after
taking any antibiotics.
Fainting Evaluate cause and severity. If more than one
isolated event contact TMP for approval.
Familial Accept if symptom free.
Mediterranean
Fever (FMF)
Familial Defer permanently.
Adenomatosis
Fibroids Accept.
Fibromyositis Defer permanently.
Fibroneuralgia Accept.
Fifth Disease Accept if asymptomatic.
Floppy Valve Accept if donor is asymptomatic, not on
medication, and is not under doctor’s
restrictions.
Flu or Influenza Defer for 72 hours from time that donor becomes
asymptomatic.
Food poisoning Defer for 48 hours after recovery.
Fungal Infection Accept if infection is associated with skin, nail,
vaginal (yeast) infection, or other localized site.
Gastritis Accept if presently asymptomatic; defer for 72
hours after last dose of antibiotics.
Gilbert’s Disease Defer permanently.
Glaucoma Accept.
Glomerulonephritis Call TMP for approval.
Glucose-6- Defer permanently.

Phosphate
Dehydrogenase
(G6PD) deficiency
Gonorrhea Defer for 12 months after completion of
treatment AND being asymptomatic.
Gout Accept.
Grave’s Disease 1. Accept if disease is well controlled with
thyroid supplement.
2. Defer for 1 month after treatment if donor is
receiving radioactive iodine treatment.
Guillain Barre Defer for 6 months after donor recovers.
Syndrome
Hasimoto’s Accept if condition if fully corrected or
(Thyroiditis) controlled.
Head Injury Accept if donor has not had any associated
problems or seizures in the past 12 months.
Headache 1. Mild, accept donor.
2. If severe or migraine, defer donor for 24
hours.
Hemochromatosis Defer permanently.
Hemorrhoids Accept.
Hereditary Defer permanently.
spherocytosis
Herpes Simples I 1. Accept if donor does not have active lesions
(Fever blister, cold and/or if donor is taking prophylactic medication.
sore) or Herpes
Simplex II (Genital)
Herpes Zoster Accept if off medication for 72 hours and skin has
(Shingles) cleared
Herpes Zosteroticus Accept if off medication and asymptomatic.
(Ramsay Hunt
Syndrome, Viral
neuronitis and
Ganglionitis)
Hiatal Hernia Accept if asymptomatic.
Histoplasmosis Contact TMP for approval.
Hodgkin’s Disease Defer permanently.
Hyperlipedmia Accept.
Hypertension Accept if blood pressure is within standard
acceptable range.
Hyperthyroidism Accept if disease has been treated and donor is
now on thyroid supplement.
(Graves Disease)
Hypoparathyroidism Accept donor.

Idiopathic 1. Defer permanently if disease is chronic.
Thrombocytopenia 2. Defer for one year if donor only had a single
Purpura (ITP) episode, is completely recovered, off treatment,
and has normal platelet count.
IGA Nephropathy See Berger’s Disease.
IGA Deficiency Call TMP for approval.
Influenza Defer for 72 hours from time that donor becomes
asymptomatic.
Jungle Rot Defer for 72 hours from the time the donor
becomes asymptomatic and completes
medication.
Kawasaki’s Disease 1. Accept if donor is off medication,
asymptomatic, under no restrictions and did not
sustain permanent hear damage.
2. Defer permanently if disease is chronic and
donor has permanent heart damage.
Kidney Removal 1. Defer for 12 months if due to injury or organ
donation.
2. Defer permanently if operation was due to
kidney disease.
Kidney Stones Accept if donor is asymptomatic and has no
infections.
Laparoscopy Defer for 6 weeks after surgery.
Laparotomy Determine reason for surgery and defer
appropriately for the reason. Otherwise, defer
for 12 months after surgery.
Legionnaires Defer for 30 days after completion of therapy
Disease and release from physician if donor is
asymptomatic.
Leishmaniasis Defer permanently.
Leukemia Defer permanently.
Lipoma Accept.
Lupus Accept if donor is not taking steroids or
Erythematosus antimalarial drugs.
(Discoid)
Lupus Defer permanently.
Erythematosus
(Systemic)
Lyme Disease Defer for 1 month after donor has completed
treatment and is asymptomatic.
Lymphoma Defer permanently.
Malaria Defer for 3 years from time donor is completely
recovered. See procedure 1.32.
Manic Depressive Accept if donor is mentally competent and

Disorder understands procedure.
Marfan’s Syndrome Accept.
Mastitis Defer for 72 hours after recovery and completion
of antibiotics.
Melanoma Defer permanently.
(Malignant)
Menier’s Disease Defer for 1 week after donor has recovered, no
longer on medication, and is asymptomatic.
Meningitis Defer for 1 month after complete recovery
Mononucleosis Defer for 1 month after becoming asymptomatic.
Multiple Sclerosis Defer permanently.
Mumps Accept if donor is asymptomatic and feeling well.
Muscular Dystrophy Defer permanently.
Myasthenia Gravis Defer permanently.
Myelodysplasia Defer permanently.
Myocarditis Accept if donor is asymptomactic and has no
residual heart damage.
Myocardial Contact TMP and document all responses.
Infarction
(Heart attack)
Narcolepsy Accept if asymptomatic.
Needlestick Injury Defer for 12 months from time of injury.
Nephritis (chronic) Defer permanently.
Nephrosis Defer permanently.
Neuralgia Accept if donor has completely recovered.
(trigeminal)
Neurofibromatosis Accept if venipuncture site is clear.
Niemann Pick Defer permanently.
Disease
Nose Bleed Accept if donor does not have a bleeding
(epistaxis) disorder.
Osteoarthritis Accept.
Osteomyelitis 1. Accept if donor is symptom free, off
antibiotics, and released from physician.
2. Defer permanently if condition is chronic.
Paget’s Disease of Defer permanently.
the breast
Paget’s Disease of Accept, unless taking a medication that would

the bone defer the donor.
Pancreatitis Accept if donor is asymptomatic and released by
physician.
Parasitic Infections Excluding Malaria and Babesiosis. Defer for 1
– worms month after symptom free and off medication.
Parkinson’s Disease Defer permanently.
Pemphigoid Disease Defer permanently.
Pericarditis Accept if donor is asymptomatic and has no
residual damage.
Phenylketonuria Accept if controlled by diet or medication,
(PKU) otherwise, defer permanently.
Phlebitis Defer for 30 days after donor becomes
asymptomatic, and is no longer taking
anticoagulants or antibiotics.
Pinworm Infection Defer for 6 weeks after donor has completed
medication.
Pityriasis Rosea Accept if antecubital area is free of lesions.
Pneumonia Defer for 6 weeks after taking medication and is
asymptomatic.
Pneumothorax Defer for 6 weeks after recovery.
Poison Ivy Accept if antecubital area is free of lesions.
Polio (Poliomyelitis) Accept if disease is inactive.
Polycystic Kidney Accept if has normal renal function.
Disease
Polycythemia Defer permanently.
Polymyositis Defer permanently.
Porphyria Defer permanently.
Pregancy Defer for 6 weeks following uncomplicated
vaginal delivery.
Defer for 12 months following C-section.
Psoriasis Accept donor unless they are taking Tegison,
Defer permanently (See procedure 1.32).
Rape History Defer for 12 months from incident.
Raynaud Defer for 24 hours if donor has any symptoms or
Phenomenon and pain.
Disease
Reiter’s Syndrome 1. Defer for 6 months from the time donor
becomes asymptomatic and has completed
medication.
2. Defer permanently if disease is chronic.
Renal Failure Defer permanently.
(Chronic)
Rendu Syndrome Defer permanently.

(Olser-Weber)
Research Study Determine condition of study, medication,
duration and other pertinent information and
contact TMP for approval.
Retinoblastoma Defer permanently.
Reye’s syndrome History of disease. Call TMP for approval.
Rheumatic Fever 1. Accept if donor had only a single episode, is
symptom-free, and has no residual kidney or
heart damage.
2. Defer permanently if donor is symptomatic,
has limitations, or has residual kidney or heart
damage, or if donor had repeated episodes.
Contact TMP for clarification if necessary.
Rickettsia Defer for 30 days after the time the donor
recovered and completed medication.
Ring worm Accept if antecubital area is free of lesions.
Rocky Mountain Defer for 1 month after becoming asymptomatic
Spotted Fever and completion of medication.
Rotor Syndrome 1. Accept if donor is asymptomatic and not on
treatment.
2. Defer permanently if donor is symptomatic.
Roussy Levy Call TMP for approval.
Rubella (German Defer for 1 week after recovery.
Measles)
Sarcoidosis Accept if donor is off treatment and
asymptomatic.
Scarlet Fever Defer for 1 month after becoming asymptomatic.
Scleroderma Defer permanently.
Shingles (Herpes See Herpes zoster.
zoster)
Sickle Cell Anemia Defer permanently. “SC” hemoglobin also Defer
Permanently.
Sickle Cell Trait Accept.
Spherocystosis Defer permanently.
Splenectomy 1. If removed due to injury, defer for 12 months.
2. If removed due to disease, call TMP for
approval.
Stitches If due to simple laceration, defer for 72 hours
after taking any antibiotics. If for surgery defer
according to particular reason.
Strep-throat Defer for 72 hours after completion of
antibiotics.
Stroke 1. Defer for 1 year after stroke, if it was related
to a head trauma and donor is stable.
2. Defer permanently if donor take blood
thinners and/or stroke was related to heart
disease or embolism.
Stye/Boil Defer for 72 hours from completion of medication
and asymptomatic.
Swelling feet or Determine reason and contact TMP for any
ankles necessary clarification and approval.
Syphilis Defer for 12 months after completing treatment
and being asymptomatic.
Tachycardia Accept if pulse is in standard acceptable range.
TB Skin Test Accept donor = no deferral
Positive
Tetralogy of Fallot Defer permanently.
Thalassemia Minor Accept .
Thalassemia Major Defer permanently.
Thrombophlebitis Defer for at lease 30 days after taking last dose
of blood thinner. Check medicaiton guide for
acceptability.
Toxic Shock Defer for 6 months after becoming
Syndrome asymptomatic.
Toxoplasmosis Defer for 1 month after becoming asymptomatic
and completion of medication.
Transverse Myelitis Defer permanently.
Trigeminal Accept if asymptomatic. Otherwise, defer
Neuralgia permanently.
(Tic Douloureux)
Tuberculosis 1. Defer for 6 months after completion of
medication.
NOTE: DO NOT defer if donor has a positive skin
test and donor is asymptomatic and not
receiving treatment.
2. AFTER 6 months, accept donor only if chest X-
ray is negative, donor is asymptomatic, and has
been released by their physician. Contact TMP
for clarification of any issues.
Tularemia Defer for 30 days after donor becomes
asymptomatic and completes medication.
Typhoid Fever Defer for 6 months after complete recovery.
Ulcer Accept.
Ulcerative Colitis Defer permanently if disease is active.

Accept if condition is controlled on medication or
donor is asymptomactic.
Unconsciousness, 1. Accept if incident was isolated and donor is
history feeling well
2. If taking medication, or there are any other
issues, contact the TMP for approval.
Urticaria Accept if venipuncture site is clear.
Uterine Bleeding Accept if non-malignant and meets donor
Disorders criteria.
Vasectomy Defer for 1 weeks from procedure.
Vitiligo Accept.
Von Willebrand’s Defer permanently.
Disease
Von Accept if venipuncture site is clear.
Recklinghausen’s
Disease
(neurofibromatosis)
Warts Accept if venipuncture site is clear.
Wilson’s Disease Defer permanently.
Wolf-Parkinson Call TMP.
White Syndrome
Yellow Fever Defer for 6 months from the time donor becomes
asymptomatic.
REFERENCES:

U. T. M. D. ANDERSON CANCER CENTER - HOUSTON, TX
BLOOD BANK
** (713)-792-7777**
INFORMATION FOR POTENTIAL BLOOD/PLATELET DONORS
If you wish to become a blood/platelet donor, we have compiled some important information regarding
the locations of M. D. Anderson's collection facilities, the hours of operations, some pre-donation facts,
and the donor selection criteria. We hope that this will be of benefit to you. If after you have read this
information and still have some questions, please give us a call.
GENERAL BLOOD/PLATELET DONOR REQUIREMENTS:
 Social Security Number or Passport Number and Picture Identification

 Feeling good, and have not had any recent serious illness
 Age 17 -75
 Weigh at least 110 pounds (Platelet donors at least 100 pounds)
 Hemoglobin at least 12.5 grams
 Should eat a good low-fat meal within 4 hours, and avoid high fat meals within 24 hours
 Have acceptable pulse and blood pressure
 Platelet Donors = No aspirin or aspirin containing products 72 hours prior to donation (acceptable
if you want to be a whole blood donor)
 No Ibuprofen or Advil products within 24 hours of donation
 No Whole blood or Platelet donation in past 72 hours
 Acceptable Platelet and White Blood Count
YOU SHOULD NOT DONATE PLATELETS OR BLOOD IF YOU:
 Are not feeling well

 Pregnant now, or in the past 6 weeks.
 Have taken Accutane or Proscar in the past 4 weeks
 Are on certain medications or have had a recent vaccination.
(Many are fine, so please call the Blood Bank to answer any of your medication questions)
 Had dental work in the past 24 hours
 Had rabies shots in past 12 months
 Had convulsions (seizures), or epilepsy
 Had mononucleosis in the past 6 months, or a cold sore now
 Had chest pain, heart disease, or lung disease
 Had psoriasis treated with Tegison
 Have ever had cancer, a blood disease, an abnormal bleeding problem, or hemophilia
 Had surgery in the past 6 months
 Have been under a doctor's care for a recent major illness
 Had hepatitis, yellow jaundice, liver disease, or positive test for hepatitis
 Have received GG (Hepatitis B Immune Globulin), clotting factor concentrates, blood or plasma,
had a needle stick injury, or mucous membrane exposure to blood in the past 12 months
 Had intimate contact with someone with hepatitis or yellow jaundice in the past 12 months
 Have ever received Human Growth Hormone
 Have had a tattoo, skin piercing, or acupuncture in the past 12 months
 Traveled to countries considered endemic for malaria in the past 12 months
 Have had malaria in the past 3 years
 Born, lived in, or recent travel to certain African countries
 Had Chagas Disease, Babesiosis, Lyme Disease, or family history of or been told to be of risk of
having Creutzfeldt-Jakob Disease
 Have a persistent cough or shortness of breath
 Have had unexplained weight loss or diarrhea in the past 10 days
 Have had recurring fever or night sweats for more than 10 days
 Have persistent swelling of nodes (glands) in your neck, groin, or under your arms for more than
one month
 Have persistent white spots or unusual blemishes in the mouth
 Have been treated for or had gonorrhea or syphilis in the last 12 months, or have herpes
(coldsores) now.
 Have had a positive test for the AIDS virus
 Have given money or drugs to anyone to have sex with you in the past 12 months
 Incarcerated for more than 72 hours in the past 12 months.
 Males only: had sex since 1977 (even once) with another man
 Ever injected illegal drugs into yourself
 Had sex in the past 12 months (even once) with a hemophiliac, I.V. drug user, anyone taking
clotting factor concentrates, or a man who had sex with another man
 Engaged (even once) in prostitution
 Had sex (even once) with a person who has AIDS or tested positive for the AIDS virus (HIV)
 Ever been notified of a positive Hepatitis B or C test, HTLV-I/II, or elevated ALT (liver enzyme)
A sample of blood will be processed to meet all FDA required testing. The blood will be tested for
antibodies to HIV and other infectious disease markers. If this testing indicates that you no longer should
donate blood, or blood products, your name will be entered on a list of indefinitely deferred donors and
you will be notified by mail.
Cancer patients cannot easily fight even the most common infections. Therefore it is critical that our
blood supply is safe for their needs. Any information that you give us is STRICTLY CONFIDENTIAL
and will not be disclosed to anyone.
The credit program allows a patient to receive one $10.00 credit for each donation made in their name, to
be applied to their blood charges. This donation credit for a particular patient does not allow the platelets
to be saved until needed, nor does it guarantee available platelets at a future date.
We thank you for your donation and welcome any questions that you might have in regard to the donor
screening or your donation.

BLOOD BANK
** (713)-792-7777**
BLOOD BANK
INFORMATION FOR POTENTIAL BLOOD/PLATELET DONORS
LOCATIONS & IMPORTANT TELEPHONE NUMBERS:
Please note appointment times are only mentioned as a guideline.

The exact times may vary as necessary.

BLOOD BANK ** 713-792-7777**
7000 Fannin - Suite 170
University Center Tower
University of Texas Health Science Center
Previously the Doctors Center Building

Platelet Donor Appointments Times
Monday - Friday 9:30 A. M. - 5:30 P.M.
Saturday, Sunday & Holidays 8:00 A.M. - 1:30 P.M.
No appointment necessary for Whole Blood Donations

Parking garage designated area - validation by Blood Bank
M. D. Anderson free shuttle service is available from Clark Clinic Entrance to the Blood Bank.
Runs every 30 minutes between the hours of 8:30 A. M. to 5:30 P.M., Monday - Friday.
Exact departure times are available at the entrance guard desks
or by calling transportation at 713-792-7491.

CLINIC SERVICES FACILITY - APHERESIS ROOM - R2.1014
Located in the Diagnostics Center
** 713-792-4531 **
Appointments -- Monday - Friday 8:00A.M. - 2:30 P.M.
Single Donor Platelet Collection Only -- No parking validation available

Exxon Co., USA Platelet Apheresis Room
Exxon Baytown Refinery
2800 Decker Drive - Room NW13; Baytown, Texas
** 281-834-4194 **
Appointment Times: Tuesday - Thursday 8:00 A.M. - 1:30 P.M.

TRANSFUSION SERVICE 1515 Holcombe
** 713-792-8630 **
Only to say "DO NOT USE MY DONATION"
BLOOD BANK HOSPITAL REPRESENTATIVE

** 713-792-6158 **
Also for your convenience, we have mobile coaches that are available to schedule blood drives in the community. If
you would like more information about scheduling a drive at your church, place of business, or school, please call a
community representative at 713-792-7788 or the hospital representative at 713-792-6158. Thank you for your
interest and donation.

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III Encuentro de Inmunohematología y

1.00 DONOR SELECTION

1.11 Donor Confidentiality

1.20 Consent Forms

1.31 Obtaining Donor Medical History and Final Donor Selection

1.33 Use of Davis's Drug Guide

1.41 Blood Pressure & Pulse

Donor and Product Safety 56

1.51 Donor Arm Preparation

1.61 Routine Venipuncture

1.71 Preparation of Donor Registration Log

3.00 SINGLE DONOR PLATELET COLLECTION

Platelet Donor Selection & Documentation 86

3.11 Donor Selection and Registration

COBE BCT Spectra 110

3.21 COBE Spectra Blood Cell Separator - Dual Needle Operation

Fenwal CS3000® PLUS Blood Cell Separator 137

3.31 CS3000® PLUS - Dual Needle Operation

Other Equipment 156

3.61 Use & Care of SEBRA Hand-held sealer

4.00 GRANULOCYTE CELL COLLECTION

Donor Selection and Preparation 161

4.11 Leukapheresis Pre, Post, and Donation Procedures

4.21 Leukapheresis Using the COBE Spectra

Fenwal CS3000 Plus® 182

4.31 Leukapheresis Using the Fenwal Model CS3000 Plus®

10.00 OPERATION POLICIES & PROCEDURES

Operational Policies & Procedures 186

10.21 Management of Hearsay Information about Blood Donors

A(S) UTMDACC Blood Bank Donor Card (Spanish)

Este taller práctico y de observación se concentrara en el proceso de recolección de

1.11 DONOR CONFIDENTIALITY

1. All donor interviews are to be conducted in an area that

2. All donor interviews must be conducted in a soft voice to assure

3. All donor records will be maintained in file cabinets and secure

4. File cabinets of donor records will be locked each evening by the

5. Donor information will not be given out over the telephone.

6. All phone conversations with donors will be conducted in

7. All deferral lists must be maintained in areas that are only

8. No donor records are to be left on the Apheresis room cabinets,

9. All confidential donor information in the laboratory information

1.12 DONOR REGISTRATION

1. Donor Information and Instructions Sheet

1. In order to be as efficient as possible, Mobile Operations

2. Greet donor. Give donor the information about AIDS (Acquired

3. Refer any questions about AIDS information to the History

5. Instruct donor to read, sign, and date the "Donor Release

1.12b - Donor Registration

6. If applicable, instruct donor to read "Blood Assurance Plans", if

7. Circle type of plan selected and instruct donor to complete

a. Blood Assurance: List the names of the individuals being

b. Donor Club: Write group name and circle DC.

c. Replacement (Repl) or Directed (DD): List patient's name,

d. Gift Donation: Circle Gift and list hospital name.

8. If the donor requests a blood type card, have him/her self-

9. Check age of donor; it must be from 17 to 75 years. At a high

NOTE: 75 year olds: If a donor is 75 years of age and has been a

11. The donor may answer history questions up to the designated

13. The technician in registration may also perform the following

1.12c Donor Registration

14. Each technician performing any donor activity must indicate

1. Code of Federal Regulations, Title 21, 1997.

2. AABB Standards, 18th Edition, 1997.

3. AABB Technical Manual, 12th Edition, 1996.