Quality Systems

1
Quality Systems
Q
UALITY, IN ALL ASPECTS of care Amendments to the 1967 Clinical Laboratory
and services, is the primary goal of Improvement Act, also known as “CLIA ’88,”
blood centers and transfusion ser- requires laboratories to establish and follow a
2
vices. A quality system is the organi- quality assurance program. In addition to the
zational structure, responsibilities, policies, blood product requirements in 21 CFR 606,
processes, procedures, and resources estab- the requirements in 21 CFR 211.22 describe
lished by executive management to achieve an independent quality control or quality as-
and ensure quality.1(p97) Many discrete activi- surance unit that has responsibility for the
ties, such as competence assessment of per- overall quality of the finished product and au-
sonnel, participation in laboratory proficiency thority to control the processes that may affect
testing programs, quality control (QC) of re- this product4 (see frequently used Code of Fed-
agents, procedures for equipment maintenance, eral Regulations quality-related citations in
and documentation of blood product deviation Appendix 1-1). As accrediting organizations,
investigations, are standard practice. Thus, for the American Association of Blood Banks
many organizations the foundation for a quality (AABB),1 the Joint Commission on Accredita-
system has been in place for some time. tion of Healthcare Organizations (JCAHO),6
The Centers for Medicare and Medicaid and the College of American Pathologists
7
Services (CMS)2 [formerly the Health Care Fi- (CAP) have also established requirements
nancing Administration (HCFA)] and the Food that address quality issues. The National Com-
and Drug Administration (FDA)3-5 have regu- mittee for Clinical Laboratory Standards
latory requirements for quality assurance. The (NCCLS) has developed a guideline on a qual-
1988 Clinical Laboratory Improvement ity system for the clinical laboratory.8
1
Copyright © 2002 by the AABB. All rights reserved.
2 AABB Technical Manual
A quality system includes QC, quality as- structure in any format that suits its opera-
surance (QA), and quality improvement, but is tions. Organizational trees or charts that show
broader in scope than these activities alone. the relationships, including operational indi-
The broader-based systems approach ensures viduals responsible for quality functions, are
application of quality principles throughout helpful.
the organization. Use of such an approach is The facility must define executive manage-
changing the focus of quality issues from de- ment and its responsibilities and authority.
tection to prevention. These include: facility operations, establish-
Business and industry have recognized the ment of and changes to the quality system,
benefit of a quality system approach for many compliance with regulatory and accreditation
years. They use the standards of the Interna- requirements, and assessment of the effective-
tional Organization for Standardization (ISO ness of the quality system. Such assessment
standards) to describe the elements of a qual- must be conducted through scheduled reviews.
ity system.9 The AABB Quality System Essen- The quality system must address all mat-
tials (QSEs)10 define the minimum aspects that ters related to compliance with federal, state,
must be addressed in a blood bank or transfu- and local regulations and accreditation stan-
sion service quality system. The AABB QSEs dards applicable to the organization. Manage-
were developed to be compatible with ISO ment must demonstrate active support of the
9000 standards and the FDA Guidelines for goals, objectives, and policies of the quality
Quality Assurance in Blood Establishments.5 function. There should be active participation
Implementation of the AABB QSEs is a good by management in the review and approval of
starting point for any facility interested in ac- quality and technical policies, processes, and
quiring ISO registration. Table 1-1 shows a procedures. The facility’s mission or vision
comparison of the AABB QSEs and ISO statement must show support of its quality
9000:2000 requirements. functions.
The remainder of this chapter discusses the A designated person who reports to man-
10 AABB QSEs and provides important infor- agement should oversee the quality functions.
mation a facility should consider when devel- This person has the responsibility to coordi-
oping its quality system. nate, monitor, and facilitate quality system ac-
tivities,5 but need not perform all of the quality
functions personally. Ideally, this person
should be independent of the operational
functions of the donor center or transfusion
service. However, in small facilities, this may
Organization not always be possible. The quality oversight
The first QSE relates to facility management. function has the authority to recommend
The facility must be organized in a manner and/or initiate corrective action when appro-
that promotes the implementation of an effec- priate.5 Depending on the size and scope of
tive quality system. The structure of the orga- the organization, the designated oversight per-
nization must be defined and documented son may work within a department (eg, trans-
and the responsibilities for the provision of fusion service), may have responsibilities cov-
blood, components, products, and services ering several areas (eg, laboratory-wide), may
clearly identified. The relationship of the posi- have a staff of workers (eg, quality unit), or
tion(s) responsible for key quality functions to may be part of an organization-wide unit (eg,
the rest of the organization must also be hospital quality management). Individuals act-
clearly defined. Each facility can define its ing in this oversight capacity, hereinafter re-

Chapter 1: Quality Systems 3
Table 1-1. Comparison of the AABB Quality System Essentials and the ISO
9000 Categories*
AABB Quality System Essentials ISO 9001:2000
Organization 5.1 Management Commitment

5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.5 Administration
5.6 Management Review
Resources 6.1 Provision of Resources
6.2 Human Resources
Equipment 6.3 Facilities
7.6 Control of Measuring and Monitoring Devices
Supplier and Customer Issues 7.2 Customer-Related Processes
7.4 Purchasing
Process Control 7.1 Planning of Realization Processes
7.3 Design and/or Development
7.5 Production and Service Operations
Documents and Records 5.5 Administration
Deviations, Nonconformances, and 8.3 Control of Nonconformity
Complications
Assessments: Internal and External 8.1 Planning
8.2 Measuring and Monitoring
8.4 Analysis of Data
Process Improvement 8.4 Analysis of Data
8.5 Improvement
Facilities and Safety 6.3 Facilities
6.4 Work Environment
*This table represents only one way of comparing the two systems.
ferred to as quality oversight personnel, ■ Review and approval of document con-

should not have final oversight of work they trol and record-keeping systems.
have performed (21 CFR 211.194). ■ Audit of operational functions.
Quality oversight functions may include the ■ Development of criteria for evaluating
5
following : systems.
■ Review and approval of the operational ■ Review and approval of suppliers.
units’ standard operating procedures ■ Review and approval of product specifi-
(SOPs) and training plans and/or devel- cations, ie, requirements to be met by
opment of the procedures. the products used in the manufacturing,
■ Review and approval of validation and distribution, or transfusion of blood and
revalidation plans and results. components.

■ Approval of lot release, ie, the review of all

operational or manufacturing records and
Resources
the decision whether to distribute, quaran- This QSE addresses the management of per-
tine, or discard blood and components. sonnel. Each blood bank, transfusion service,
■ Review of reports of adverse reactions, or donor center must have a process in place to
deviations in the manufacturing process, hire adequate numbers of personnel who have
nonconforming products and services, appropriate education, training, and experience
and customer complaints. to perform, verify, and manage all activities
■ Participation in decisions to determine within the facility.1(p3) For laboratory testing
blood and component suitability for use, staff, the personnel requirements must be com-
distribution, or recall. patible with the established “CLIA ’88” person-
■ Review and approval of corrective ac- nel qualifications and training requirements.2
tion plans. The selection process for personnel should be
■ Surveillance of problems (eg, error re- based on the applicant’s qualifications for a par-
ports, Form FDA 483 observations, cus- ticular position as determined by education,
tomer complaints) and the effectiveness training, experience, certifications, or licensure.
of corrective actions implemented to Job descriptions should exist for all personnel
solve these problems. involved in any aspect of the processes and pro-
■ Use of information resources to identify cedures that affect the quality of blood, compo-
trends and potential problems before a nents, tissues, and services. Effective job
situation worsens and products or pa- descriptions clearly define the qualifications for
tients are affected. the job and the responsibilities and reporting
■ Preparation of periodic (as specified by relationships of the position.
the organization) reports of quality is- Once hired, employees must participate in
sues, trends, findings, and corrective and a well-defined program that introduces them
preventive actions. to their position. This orientation program
Quality oversight personnel need not nec- should include facility-specific requirements
essarily perform all quality oversight functions and an introduction to facility programs for
themselves. Such functions may be shared safety, quality, computers, security, confidenti-
among existing staff, between departments, ality, etc. The job-related portion of the orien-
between facilities, or, in some instances, con- tation program should cover the specific as-
tracted to an outside firm. The goal is to pro- pects of the job. The ultimate result of this
vide as much of an independent evaluation of orientation is to deem new employees compe-
the facility’s quality activities as possible. Pol- tent to work independently in performing the
icies, processes, and procedures must exist to duties and responsibilities defined in their job
define the roles and responsibilities of all indi- descriptions. Time frames should be estab-
viduals in the development and maintenance lished to accomplish this goal. The employee
of these quality goals. Quality policies should should be given the opportunity to ask ques-
define quality processes (ie, the QSE or ISO el- tions and seek additional help or clarification.
ements) because these processes transcend All aspects of the training must be docu-
departments or work areas. A blood bank or mented and the facility trainer or designated
transfusion service need not develop its own facility management representative and the
quality policies if it is part of a larger entity employee should mutually agree upon the de-
whose quality policies address all of the mini- termination of competence.
mum requirements (ie, the 10 QSEs and their To ensure that skills are maintained, the fa-
intent). cility must have regularly scheduled compe-

tence evaluations of all staff whose activities ployee training and competence is re-
1(p76)
affect the quality of blood, components, tis- quired.
sues, or services.2,6 Depending upon the nature The quality oversight personnel should as-
of the job duties, such assessments should in- sist in the development, review, and approval
clude, but are not limited to: written evalua- of training programs, including the criteria for
tions; direct observation of activities; review of retraining.5 Quality oversight personnel also
work records or reports, computer records, monitor the effectiveness of the training pro-
and/or QC/QA records; testing of unknown gram and competence evaluations, review
samples; and evaluation of the employee’s proficiency testing results, and make recom-
5
problem-solving skills. mendations for changes as needed.
A formal competency plan that includes a
schedule of assessments, defined minimum ac-
ceptable performance, and remedial measures
is one way to ensure appropriate and consis- Equipment
tent competence assessments. Assessments
need not be targeted at each individual test or Equipment, instruments, measuring devices,
procedure performed by the employee; in- and computer systems (hardware and soft-
stead, they can be grouped together to assess ware), hereinafter referred to as equipment,
like techniques or methods and the specific are considered critical when used in the provi-
tests or procedures rotated. During routine re- sion of blood, components, tissues, and ser-
cord reviews, an exception log may be created vices.1(p4) This QSE addresses qualification,
to serve as a reference of employee compe- calibration, maintenance, and monitoring,
tence, rather than reviewing records for each which, when applicable, must be performed
specific employee. Written tests can be used for all critical equipment. Such activities help
effectively to evaluate problem-solving skills to ensure that equipment performs according
and to rapidly cover many topics by asking to the specifications (ie, requirements) defined
one or more questions for each area to be as- by the facility. Schedules for equipment moni-
sessed. For those personnel who participate, toring, calibration, and preventive mainte-
proficiency testing can be used to fulfill some nance provide a framework to conduct and
of the competence assessment requirements. review these activities. The diversity and com-
Assessments for testing personnel must be plexity of blood bank equipment require
compatible with “CLIA ’88,” which requires well-developed plans and procedures for qual-
that employees who perform testing be as- ification, implementation, and monitoring to
sessed 6 months after hire and annually there- ensure optimal and consistent performance.
after [42 CFR Part 493.1451(b)(9)]. For new equipment, policies and proce-
Prior to the introduction of a new test or dures should include a requirement to define
service, personnel must be trained to perform criteria for selection and requirements for in-
their newly assigned duties and deemed com- stallation, calibration, and qualification. After
petent. Annual reassessment of competence is installation, there must be documentation of
required thereafter.2 Although not required, any problems and the follow-up actions taken.
assessment of competence 6 months after the Recalibration and requalification may be nec-
introduction of these new duties may be pru- essary if repairs are made that affect the criti-
dent as well, particularly if the duties are com- cal operating functions of the equipment.
plex. Such early reassessment may prevent the Recalibration and requalification should also
inadvertent introduction of variation into the be considered when existing equipment is re-
process. Documentation of all aspects of em- located.

The facility must develop a mechanism to quirements.1(p7) The facility must have policies,
uniquely identify and track all critical equip- processes, and procedures to evaluate the sup-
ment. The version of software used in critical pliers’ abilities to meet these requirements.
equipment should also be tracked. The unique The three elements in this QSE focus on: sup-
identifier may be facility-specific or the manu- plier qualifications; agreements; and receipt,
facturer’s serial number can be used. If the fa- inspection, and testing of incoming supplies.
cility is part of a larger organizational struc- The quality oversight personnel play a major
ture, the mechanism may be part of a role in approving supplier requirements and
laboratory-wide or organization-wide identifi- the criteria for accepting supplies or services
cation system. A listing of all critical equip- and providing input into supplier contracts.
ment and its unique identifier serves as a tool
to assist in the control function of scheduling Supplier Qualification
and performing monitoring, calibrations, and The facility’s critical supplies and services and
preventive maintenance. Records of such ac- the functional requirements and expectations
tivities, as well as repairs, must be kept and pe- for each must be defined. The facility must
riodically reviewed. The equipment listing can also clearly define requirements or expecta-
be used to ensure that all appropriate records tions for the suppliers of these critical materi-
have been created and reviewed. Evaluation als and services and share these requirements
of equipment records and trends will assist the with staff and the supplier. Supplier names for
facility in assessing the functionality of the each critical supply or service should be docu-
equipment, allow for better control in manag- mented, as well as acceptable alternates for
ing defective equipment, and assist in identify- contingencies. Based on these defined expec-
ing equipment that may need replacement. tations, the facility can document a supplier’s
ability or inability to meet them. The greater
the potential risk to patients or to the safety of
Supplier and Customer the blood supply, the more emphasis should
be placed on evaluation and qualification of
Issues supplies, services, and their providers.
Each facility should identify which supplies Examples of factors that could be consid-
and services it considers critical and define re- ered to qualify suppliers are:
quirements for these critical supplies and ser- ■ Licensure, certification, or accreditation
1(p7)
vices, as well as requirements for the suppliers. (as required by AABB Standards ).
Examples of critical supplies are blood compo- ■ Supply or product requirements.
nents, blood bags, test kits, and reagents. Ex- ■ Review of supplier-relevant quality doc-
amples of critical services are infectious uments.
disease testing, blood component irradiation, ■ Results of audits or inspections.
transportation, and equipment calibration and ■ Review of quality summary reports.
preventive maintenance. Suppliers can be in- ■ Review of customer complaints.
ternal (eg, other departments within the same ■ Review of past experience with supplier.
organization) or external. Supplies and ser- ■ Cost of materials or services.
vices used in the collection, testing, processing, ■ Delivery arrangements.
preservation, storage, distribution, transport, ■ Financial security, market position, and
and administration of blood, components, and customer satisfaction.
tissue that have the potential to affect quality ■ Support after the sale.
should be qualified before use and obtained A list of approved suppliers should be
from suppliers who can meet the facility’s re- maintained. Critical supplies and services

should be purchased only from those suppliers gally responsible for the work performed by
who have been qualified. Once a supplier has the contractor.
been qualified, there should be periodic evalu- The blood bank or transfusion service
ation of performance to ensure continued abil- should participate in the evaluation and selec-
ity to meet requirements. Documented fail- tion of suppliers prior to agreement accep-
ures of supplies or suppliers to meet defined tance. They should be able to review contracts
requirements should result in immediate ac- and agreements and make suggestions to en-
tion by the facility. These actions should in- sure that all important aspects for their critical
clude notification of the supplier, quality over- materials and services are clearly covered. Ex-
sight personnel, and management with amples of issues that could be addressed in an
contracting authority, if applicable. Quaran- agreement or contract include: a definition of
tine or replacement of supplies until all quality the responsible party during shipment of the
issues are resolved may also be required. product; the responsibility of the supplier to
Tracking the supplier’s ability to meet ex- promptly notify the facility when changes that
pectations gives the facility valuable informa- could affect the safety of blood, components,
tion about the stability of the supplier and the or patients have been made to the materials or
supplier’s commitment to quality. services; and the responsibility of the supplier
Careful review of the documentation will to notify the facility when information that a
alert management to trends in the supplier’s product may not be considered safe is discov-
qualifications and should result in early detec- ered, such as during look-back procedures.
tion of supplier problems. Continued surveillance of the materials and
services, as discussed above, is critical.
Agreements Receipt, Inspection, and Testing of

Contracts or other agreements must define all Incoming Supplies
parties’ expectations and reflect that the par- Prior to acceptance and use, incoming critical
ties agree.1(p7) Periodic review of agreements materials (ie, critical supplies, blood, and com-
should also occur in order to ensure that both ponents) must be inspected and tested (if nec-
parties’ expectations continue to be met. essary) to ensure that they are satisfactory for
Changes to agreements must be mutually their intended use and meet specified require-
agreed upon and incorporated as needed. ments.1(pp7-8),4 It is essential that supplies used in
A commonly encountered contract is be- the collection, processing, preservation, test-
tween a blood supplier and the consignee. An- ing, storage, distribution, transport, and ad-
other type of agreement involves manufactur- ministration of blood and components meet or
ing steps, such as irradiation, compatibility exceed FDA regulations.
testing, or infectious disease marker testing of Documentation of important information
blood and components, performed by other upon receipt (see Appendix 1-2) and inspec-
departments within the facility or by another tion of these materials allows the facility to
facility under contract (eg, contract manufac- trace them from the time that control is as-
turer). The contracting facility assumes re- sumed by the facility. Policies and procedures
sponsibility for the manufacture of the prod- should define acceptance criteria for incoming
uct, ensuring the safety, purity, and potency of critical supplies, blood, components, deriva-
the product, and ensuring that the contract tives, etc, in terms of packaging, appearance,
manufacturer complies with all applicable shipping, testing, labeling, expiration, and stor-
product standards and regulations. Both the age requirements. Materials not meeting the
contracting facility and the contractor are le- acceptance requirements must be controlled

to prevent inadvertent use until further action components, tissues, and services and for
is determined. Corrective actions could result making changes to existing ones. Medical and
in the return or destruction of these materials. technical policies, processes, and procedures
Receipt and inspection records provide the fa- must be reviewed by the quality oversight per-
cility with evidence of ongoing supplier quali- sonnel, technical management (medical direc-
fication regarding shipping and packaging of tor, or physician designee, of transfusion
critical materials. service or donor center), and executive man-
Facility policies and procedures should de- agement, if applicable, prior to implementa-
fine which materials and products require test- tion. Changes made to policies, processes, or
ing before their addition to the facility’s usable procedures must be documented, validated,
inventory. Generally, reagents used in critical reviewed, and approved. Additional informa-
procedures such as ABO, Rh, and infectious tion on policies, processes, and procedures can
disease marker testing must be checked be- be found in the Documents and Records
fore use in patient or donor testing. These tests section.
will give a measure of assurance that shipping Once process control has been imple-
and storage of the reagents did not adversely mented, the facility must have a mechanism to
affect their potency. ensure that processes and procedures are per-
formed as defined and that critical equipment
and supplies are used in conformance with
manufacturers’ written instructions and facil-
Process Control ity requirements. Table 1-2 lists elements that
Process control is the most encompassing of constitute sound process control.
the QSEs. Full compliance with this QSE al-
lows the facility to be in control of its operating Validation
processes. Policies, processes, and procedures Validation is the prospective development of
must exist for all critical functions in the facil- process requirements and documented verifi-
ity and be carried out under controlled condi- cation that they have been consistently met.
tions. Each facility must have a defined One of the most important aspects of valida-
mechanism for identifying, planning, and im- tion is the validation plan. The plan may out-
plementing new policies, processes, and proce- line prospective validation (most often used
dures that affect the quality of blood, for new or revised processes) or retrospective
Table 1-2. Elements of a Sound Process Control System

■ Process to develop new, or control changes, to policies, processes, or procedures.
■ Development and use of standard operating procedures.
■ Equipment qualification processes.
■ Staff training and competence assessment.
■ Validation of policies, processes, and procedures.
■ Acceptance testing for new/revised software involved in blood bank procedures.
■ Establishment of quality control, calibration, and preventive maintenance schedules.
■ Monitoring of quality control, calibration, preventive maintenance, and repairs.
■ Monitoring and control of production processes.
■ Processes to determine that supplier qualifications and product specifications are maintained.
■ Participation in proficiency testing appropriate for each testing system in place.
■ Processes to control nonconforming blood, components, products, and critical materials.

validation (used for processes implemented be appended to the approved validation plan
before the validation requirement). Concur- or recorded in a separate document. This doc-
rent validation (used when required data can- umentation typically contains the following el-
not be obtained without performance of a ements:
“live” process) may also be performed if pro- ■ Results
spective validation is not an option. If concur- ■ Conclusions and limitations
rent validation is used, data are reviewed at ■ Approval signatures
predefined periodic intervals before final ap- ■ Supporting documentation
proval for full implementation occurs. ■ Implementation time line
Should the validation process not result in
Validation Plan the expected outcome, those data and the cor-
It is suggested that an organization develop a rective actions must be documented as well.
template for a validation plan. Development of The responsible quality oversight personnel
a validation plan is best accomplished after ob- should have final review and approval of the
taining an adequate understanding of the sys- validation plan, results, and corrective actions,
tem, which is the framework within which the and determine whether new or modified pro-
process will occur. Although no single format cesses and equipment may be implemented,
for a validation plan is required by regulation, or implemented with specified limitations.
the following elements are common to most: When there are significant changes to a pro-
■ System description cess, such as a change of equipment, revised
■ Purpose/objectives SOP, or change of supplies or reagents, the
■ Risk assessment need for revalidation must be evaluated.
■ Responsibilities
■ Validation procedures Computer System Validation
■ Acceptance criteria The FDA recently issued guidance for com-
■ Approval signatures puter software validation.12 This guideline de-
■ Supporting documentation fined a computer system to include: “hard-
Validation of new processes that include ware, software, peripheral devices, personnel,
equipment should include installation qualifi- and documentation.” Thus, validation plans
cation, operational qualification, and product for computer systems in blood banking must
qualification.11 include all of the areas referenced above.
■ Installation qualification focuses on the Computer systems may be custom-developed,
capability of the equipment to operate vendor-developed, or a hybrid. The develop-
within the established limits and specifi- ment of a validation plan specific to computers
cations supplied by the manufacturer. depends on the type of system to be used.
■ Operational qualification demonstrates Testing performed by the vendor or supplier
that the process will produce the desired of computer software is not a substitute for
result or defines the process limits. computer validation by the user. It should be
■ Product qualification provides assurance remembered that a computer is typically used
that the process results in acceptable within a process. Depending upon the nature
measurable or quantifiable specifica- of the computer functionality, changes to the
tions attributed to the product. computer system may result in changes to
Once the validation plan is approved, the how a process is performed. If this occurs, pro-
staff who are experienced in the process per- cess validation, conducted by personnel who
form the approved validation plan activities. will perform the process and use the computer
Results and conclusions of these activities may system, must also be performed. As with pro-

cess validation, quality oversight personnel mined by each facility in accordance with the
should review and approve validation plans, appropriate CLIA, FDA, AABB, state, and
results, and corrective actions, and determine manufacturer’s requirements. QC results must
whether implementation may proceed with or be documented concurrently with perfor-
without limitations. mance.3,4 Records of QC testing must include
identification of personnel, identification of re-
Proficiency Testing agent (including lot number, expiration dates,
etc), identification of equipment, testing date
Proficiency testing (PT) is one of several and time (when applicable), results, interpreta-
means for determining that test methods (in- tion, and reviews. Policies should be estab-
cluding supplies and equipment used in those lished for repeat QC testing when results fall
test methods) are working as expected and outside acceptable parameters. These should
that test outcomes are meeting predetermined include documentation of results for all initial
standards. Controlling the PT process, by hav- and repeat testing, as well as evaluation for
ing clearly defined SOPs, ensures that all staff trends. Corrective action for unacceptable QC
who perform both routine and backup test results should also be carefully documented
methods have a consistent process to follow. and reviewed. See Appendix 7 and Methods
SOPs should cover how to handle PT samples Section 8 for suggested QC testing frequencies
from receipt through testing and how to report and specific QC procedures.
the results. The review process for the sum-
mary evaluation should include how to per-
form and document corrective action when
applicable. Quality oversight personnel review Documents and Records
and monitor PT results, periodically evaluate
the proficiency program, and approve correc- The Documents and Records QSE sets the
tive action plans when PT results are unac- groundwork for many of the processes in the
ceptable. “CLIA ’88” requires in 42 CFR Process Control QSE. To comply with this es-
493.1213 that test performance be verified sential, facilities must have a process to ensure
for each analyte and defines consequences for that documents, which provide guidance for
failed proficiency testing.2 Blood centers and or evidence of performance of the job, are
transfusion services are required to participate controlled. This means that policies, process
in a CMS-approved proficiency testing pro- descriptions, procedures, and forms are identi-
gram.1(p9) fied, approved, implemented, and re-
tained.1(p68) Forms must be designed to effec-
tively capture outcomes and support process
Quality Control
traceability. Records (completed forms) must
QC is the testing routinely performed to en- be created concurrently with the performance
sure the proper functioning of materials, of each significant step and clearly indicate the
equipment, and methods. QC of reagents, identity of individuals who performed each
equipment, and methods used in collecting, step and when it occurred.13 When critical re-
testing, modifying, or otherwise affecting cords are generated, it is necessary to ensure
blood or component quality is essential. QC that they are reviewed by a second person for
performance characteristics and acceptable completeness and accuracy and are approved.
ranges should be readily available so that un- Records must be stored and archived in a de-
acceptable variations or results can be fined manner that meets the facility’s needs
promptly detected and appropriately handled. and is consistent with local, state, and federal
The frequency for QC testing should be deter- regulations. They must be maintained in us-

able condition, retained for specified periods, reasonable, provide staff with useable instruc-
a n d o rg a n i z e d f o r t ra c e a b i l i t y a n d tions and forms, and satisfy regulations.
retrievability. The facility’s documents and re- Documents should provide staff and others
cords management system may be manual with a clear idea of how objectives are accom-
and/or electronic. plished. Although there are many ways to de-
velop and maintain documents, the approach
Documents embraced by the AABB and the NCCLS14 is
The goal of the documents management sys- based on the ISO 9001 model.15 The NCCLS
tem is to achieve control of the facility’ docu- offers detailed instructions on how to write
ments. This requires a well-defined structure documents.14
that should be capable of linking policies, pro-
cess descriptions, procedures, forms, and re- Level I Documents
cords together in an organized and workable Document control based on the ISO 9001
system. model is best described as the pyramid shown
Document development within an organi- in Fig 1-1. At the top of the pyramid is Level I,
zation should be based on methods that are which consists of the facility’s quality policies
Figure 1-1. Documentation hierarchy—representing the levels of documents in an organization.16

compiled into a quality manual or quality pro- tasks and are step-by-step directions on how to
gram. These documents are time-independent perform those tasks. The SOPs should be de-
and describe the facility’s overarching quality tailed enough to provide the information
policy, or mission statement, and the facility’s needed to perform the task, but not so detailed
policies regarding the 10 QSEs. The docu- as to make it difficult to find the directions for
ments also contain the facility’s policies that the task. Procedures should be in a standard-
conform to federal, state, and local regula- ized format to assist staff and management in
tions. Individuals from top-level management their control and implementation.1(p68) Proce-
and the quality oversight function usually dures must be written for QA, QC, clerical,
write these documents. These policies may be and operational functions. Procedures may
briefly stated in a single document and refer- also be incorporated by reference, such as
ence other, more detailed documents for addi- those from a manufacturer’s manual. Relevant
tional information. Alternatively, each policy procedures must be available to staff at each
can be addressed in a separate document con- site where the corresponding job tasks are per-
taining more detailed information, such as a formed.
1(p68)
policy for a specific QSE, a statement of au-

thority and responsibility for that QSE, and
copies of the supporting documents as attach- Level IV Documents
ments. For example, the Organization QSE Level IV documents are aligned closely with
might include a copy of the organizational Level III documents and provide evidence of
chart and the Resources QSE might include SOP performance. The most common Level
copies of the job descriptions. IV document is an electronic or a paper tem-
plate upon which to capture information,
called a form, datasheet, or worksheet. These
Level II Documents documents specify the data requirements
called for in the various SOPs and processes.
Level II documents describe the overall qual-
ity system processes and operational processes Completed forms become records. Reports
within the organization. Table 1-3 lists exam- can also provide evidence of the completion of
ples of process documents that might be in Level III procedures.
place to support a quality system. Level II doc- Blood component labels are a kind of criti-
uments define how the process occurs and cal material subject to many of the require-
typically involve several functional units ments in a document management system. For
within a facility (eg, departments). These pro- this reason, they are frequently considered to
cess documents should define what happens, be a type of Level IV document. A master set
by whom, when, where, and how the policies of labels is usually kept by the facility. Because
are to be managed. These documents should they must conform to regulatory require-
provide the reader with an idea of the flow of ments, it is important that quality oversight
information from area to area or department personnel review and approve labels before
to department, as well as the responsibilities of their use. Change-out of old stock and replace-
each in the process. ment with new stock must be achieved with
100% accuracy, so that blood components are
not misbranded. Many facilities choose to ar-
Level III Documents chive a copy of obsolete labels. With the ad-
Level III documents are known as standard vent of on-demand label printers, a change
operating procedures. These documents are control process for these special types of docu-
used by individuals expected to perform job ments must also be specified.

Table 1-3. Examples of Quality System Process Documents

Organization ■ Management review process
Resources ■ Personnel hiring process
■ Training process
■ Competence assessment process
Equipment ■ Equipment management process
■ Installation qualification process
Supplier and Customer Issues ■ Supplier qualification process
■ Contract review process
■ Process for qualification of critical materials
■ Ordering and inventory control of critical materials
■ Receipt, inspection, and testing of incoming critical
materials
Process Control ■ Change control process
■ Validation process
■ Process for acceptance testing of computer software
■ Process for handling proficiency testing
■ Process for handling, storage, distribution, and transport of
blood components
Documents and Records ■ Process for creation and approval of documents
■ Document management process
■ Records management process
Deviations, Nonconformances, ■ Event management process
and Complications ■ Process for handling customer complaints
■ Process for notification of external sources
Assessments ■ Internal audit process
■ Process for quality monitoring
■ Process for handling external assessments
Process Improvement ■ Corrective and preventive action process
Facilities and Safety ■ Process for handling disasters
■ Employee safety management process
The Process for Document Development ment distribution and superceded documents;
and Management and the process for archiving, protecting, and
retrieving obsolete documents. There must be
Each facility must have a process that defines
a description of the process for changing poli-
its approach for developing and maintaining
documents. This Level II process (sometimes cies and procedures and how to document
called the “SOP for SOPs”) should define: the and track the changes, as well as to review and
chosen structure for SOPs; the process for re- validate those changes when needed. The re-
view and approval of new or revised docu- view process should define who performs the
ments by quality oversight personnel and review, how the review is documented, and
management; annual review; control of docu- how often the review is performed.

Because supplies, reagents, and critical Requirements for Level IV document con-
equipment must be used in a manner consis- trol are similar to those for Level II and III
tent with the manufacturer’s directions (21 documents. Although Level IV documents
CFR 606.65), incorporating the manufac- may be blank forms, they must be reviewed
turer’s directions into the SOPs is advisable. In- prior to implementation to determine if they
corporation of these directions requires that the will capture the needed information and com-
facility have a mechanism to detect changes to ply with regulations. There must be a mecha-
a manufacturer’s package insert or user man- nism to control these forms, ie, validate their
ual so that corresponding changes to SOPs can accuracy and completeness, track their distri-
be made. If incorporated by reference, then bution, ensure their removal when super-
the facility must include these external docu- ceded, and control changes made to them.
ments in the document management process Included in the document management
(eg, review and approval prior to use, annual process is a master copy of each policy, pro-
review, and archiving of obsolete documents). cess description, and procedure; an index of
A facility using reagents, supplies, or critical all current policies, process descriptions, and
equipment in a manner that is different from procedures; and an archive of obsolete docu-
the manufacturer’s directions must have vali- ments.5 The number of policies, process de-
dated such use and may be required to re- scriptions, and procedures in circulation
quest a variance from the FDA under 21 CFR (working copies) should be controlled to en-
640.120. If a facility believes that changes to sure that none are overlooked when changes
the manufacturer’s directions would be appro- are implemented. To facilitate their replace-
priate, they should encourage the manufac- ment, it maybe also be helpful to include the
turer to make such changes in the labeling (ie, location of copies as well. It is essential to in-
package insert or user manual). clude the date of writing a policy, process, or
Many regulatory and accreditation bodies procedure and the dates of implementation
suggest that SOPs include examples of the and revision. Another helpful practice is to
forms used to record data. Inclusion of current keep a log of changes to documents and the
blood and component labels in SOP manuals rationale for the change.
is also desirable. Procedures for the review,
maintenance, and disposition of records must Document Review and Revision
be available. Written and/or pictorial descrip- After publication of each new edition of volun-
tions of how to read, score, and record all test tary standards, such as the AABB Standards
results and interpretations, when applicable, for Blood Banks and Transfusion Services,1 or
are helpful. Directions for managing possible upon receipt of any change in federal, state, or
problems should be included, as well as the local requirements, relevant documents
limits placed on an individual’s independent should be examined for conformance with the
judgment and criteria for consulting a supervi- new requirements. Review and approval of
sor. new or changed documents must occur before
Before implementation, procedures should their use.1(p68)
be validated, ie, tested for accuracy and com- When new or revised policies, process de-
pleteness, and evaluated for their confor- scriptions, procedures, or forms are added to
mance to regulations and for their potential or replaced in the facility manual, the docu-
impact on other systems. Procedures are to be ments must be marked with the effective date.
reviewed and approved by quality oversight One copy of retired documents must be re-
personnel and management before their im- tained as defined by existing and applicable
plementation. standards and regulations. Regulatory agen-

cies require appropriate demonstrable control fined by job responsibility and administered
of SOPs (no unauthorized, antiquated, or in- by the use of security codes and passwords.
consistent SOPs in use); however, those in If records are electronically maintained, ad-
charge are free to delegate such responsibili- equate backup must exist in case of electronic
ties. 21 CFR 211.100 requires SOPs to be system failure. Records must also be easily re-
drafted, reviewed, and approved by the appro- trieved for reference or review. It should be
priate organizational units and reviewed and noted that “easily retrieved” has various defi-
approved by the quality control unit (ie, qual- nitions depending on the organization re-
ity oversight personnel). questing retrieval.
Each facility should have a policy for alter-
ing or correcting records. A common practice
Records in use is to indicate the date, the change, the
When forms are used for capturing data or re- identity of the person making the change, and
cording steps or test results, the forms become evidence of review by a responsible person.
records. Each facility must define the content The original recording must not be obliterated
for each form and how to complete it. The fa- in written records; it may be circled or crossed
cility must also define the record review pro- out with a single line, but it should remain legi-
cess and time frames for the review. The ble. Computer records should permit tracking
policies, processes, and procedures must de- of both original and corrected data to include
scribe how reports and records are archived the date and the user identification of the per-
and their retention period. (See Appendices son making the change. There must be a pro-
1-2 to 1-7 for details on record-keeping re- cess for controlling changes.1(p70) A method for
quirements.) Obsolete computer software, referencing changes to records, linked to the
necessary to reconstruct or trace records, must original records, and a system for reviewing
also be archived appropriately. When copies changes for completeness and accuracy are es-
of records are retained, there must be a pro- sential. Audit trails for changed data in comput-
cess to verify that the copy contains complete, erized systems are required by the FDA.17 The
legible, and accessible content of the original information must be maintained electronically.
record before its destruction. The following are issues that might be con-
Electronic media such as magnetic tapes, sidered when planning record storage:
optical disks, or on-line computer data storage ■ Storage of records in a manner that pro-
are widely used for archiving documents. Re- tects them from damage and from acci-
cords kept in this manner must meet FDA re- dental or unauthorized destruction or
quirements for electronic record-keeping.17 modification.
The potential also exists to use microfiche and ■ Degree of accessibility of records in pro-
optical character-reading devices to archive portion to frequency of their use.
written records. The medium selected should ■ Method and location of record storage
be appropriate for the retention requirements. related to the volume of records and the
Confidentiality of blood bank records, as all amount of available storage space.
medical information, must be addressed. Or- ■ Availability of properly functioning
ganizations should establish policies and pro- equipment/hardware/software to view
cedures to maintain the security and confiden- archived records.
tiality of records. An appropriately maintained ■ Documentation that microfiched re-
computer access security system that will records legitimately replace original docu-
strict unauthorized use must be described. ments that may be stored elsewhere or
This system may include levels of security de- destroyed.

■ Retention of original copies of color- other computer-related identifying methods

coded records, which lose meaning in are generally accepted in lieu of written signa-
black-and-white reproduction. tures (provided they meet electronic re-
Considerations for computer-maintained cord-keeping requirements).
records include:
■ A method of verifying the accuracy of
data entry. Deviations,
■ Prevention of unintended deletion of
data or access by unauthorized persons. Nonconformances, and
■ Adequate protection against inadvertent Complications
data loss (eg, when a storage device is This QSE requires a process for capturing, as-
full). sessing, investigating, and monitoring events
■ Validated safeguards to ensure that a re- that deviate from accepted policies, processes,
cord can be edited by only one person at and procedures or failures to meet require-
a time. ments, as defined by the donor center or trans-
■ Security and access of confidential data. fusion service, AABB standards, or applicable
A backup disk or tape should be main- regulations.1(p79),18 This includes the discovery
tained in the event of unexpected loss of infor- of nonconforming products and services, as
mation from the storage medium. It would be well as adverse reactions to blood donation
wise to store magnetic media used to back up and transfusion.1(pp79-80),2 Facility policies, pro-
or archive computer records and databases cesses, and procedures should define how to:
off-site under appropriate conditions, in accor- ■ Document, classify, and analyze all of
dance with the manufacturer’s recommenda- these occurrences.
tions and instructions. An archival copy of the ■ Prioritize the implementation of correc-
computer operating system and applications tive action.
software should be stored in the same manner. ■ Report to external agencies, when re-
Alternative systems must exist to ensure in- quired.
formation access in the event that computer- Each facility should have a mechanism to
ized data are not available. The backup sys- report and record information about these
tem(s) for computer downtime should be events. Facility personnel should be trained to
defined, with validation documentation to recognize and report such occurrences. De-
show that the backup system works properly. pending upon the severity of the event and
The associated processes must be periodically risk to patients, donors, and products, as well
checked to ensure that the backup system re- as the likelihood of recurrence, investigation
mains effective, including aspects of staff fa- into contributing factors and underlying
miliarity and readiness. cause(s) may be warranted. Current good
To link relevant personnel to recorded data, manufacturing practice (cGMP) regulations re-
a record with inclusive dates of employment, quire an investigation and documentation of
signatures, and identifying initials or identifi- the results if a specific event could adversely
cation codes of personnel authorized to sign, affect patient safety or the safety, purity, po-
initial, or review reports and records must be tency, or efficacy of blood or components.2,3,18
maintained. This list should consist of full-time Tools and approaches for performing root
and part-time personnel, and include cause analysis and implementing corrective
phlebotomists, transfusionists, volunteers, action are discussed in the process improve-
medical, and contract personnel, if appropri- ment QSE. A summary of the event, investiga-
ate. Magnetically coded employee badges and tion, and any follow-up must be documented.

19
Table 1-4. Components of an Internal Event Report
WHO ■ Identity of reporting individual(s)
■ Identity of individuals involved (by name or job title) in committing,
compounding, discovering, investigating, and initiating any immediate
action
■ Patient or donor identification
■ Reviewer(s) of report
WHAT ■ Brief description of the event
■ Effects on and outcome to patient, donor, or blood component
■ Name of component and unit identification number
■ Manufacturer, lot number, and expiration of applicable reagents and
supplies
■ Immediate action taken
WHEN ■ Date of report
■ Date and time the event occurred
■ Date and time of discovery
■ Collection and shipping dates of blood component(s)
WHERE ■ Physical location of event
■ Where in the process it was detected
■ Where in the process it was initiated
WHY/HOW ■ Explanation of how event occurred
■ Contributing factors
■ Root cause(s)
FOLLOW-UP ■ External reports or notifications (eg, FDA*, manufacturer, or patient’s
physician)
■ Corrective actions
■ Implementation dates
■ Effectiveness of actions taken
18
*All blood establishments (including licensed, registered but unlicensed, and unregistered transfusion services) are
required to notify the FDA if the following occur: deviations from cGMP regulations, applicable standards, or
established specifications that may affect the safety, purity, or potency of biological products or otherwise cause the
biological products to be in violation of the FD & C Act or the PHS Act (21 CFR 600.14). The FDA has identified the
following examples as reportable events if components or products are released for distribution:
– Arm preparation not performed or done incorrectly
– Units from donors who are (or should have been) either temporarily or permanently deferred due to their medical
history or a history of repeatedly reactive viral marker tests
– Shipment of a unit with repeatedly reactive viral markers
– ABO/Rh or infectious disease testing not done per manufacturer’s package insert
– Units from donors for whom test results were improperly interpreted due to testing errors related to improper use
of equipment
– Units released prior to completion of all tests (except as emergency release)
– Sample used for compatibility testing that contains the incorrect identification
– Testing error that results in the release of an incorrect unit
– Incorrectly labeled blood components (eg, ABO, expiration date)
– Incorrect crossmatch label or tag
– Storage of biological products at the incorrect temperature
– Microbial contamination of blood components when the contamination is attributed to an error in manufacturing

Table 1-4 outlines suggested components of tion relevant to these events, to the FDA using
an internal event report. Form FDA-3486 when the event:
Included in the process for reporting must ■ Is associated with manufacturing (ie,
be events involving blood components and testing, processing, packing, labeling,
critical materials that fail to meet established storing, holding, or distributing).
requirements at the time of incoming inspec- ■ Represents a deviation from current
tion, while held in inventory, or at the time of good manufacturing practice, applicable
distribution or issue. In a transfusion service, regulations or standards, established
reporting should include issue of an incorrect specifications, or is unexpected or un-
or unsuitable blood component, sample col- foreseen.
lection or testing failures that lead to such re- ■ May affect the safety, purity, or potency
lease, as well as reports of patients experienc- of the product.
ing adverse effects as a result of transfusion. ■ Occurs while the facility had control of
Events must also be reported if computer sys- or was responsible for the product.
tems are not functioning properly. ■ Involves product that leaves the control
Suspected cases of transfusion-associated of the facility (ie, distributed).18
diseases must be evaluated; confirmed cases The JCAHO requires the reporting of senti-
must be reported to the collecting facility. nel events, which for transfusion services
FDA requirements for look-back regarding means reporting hemolytic transfusion reac-
human immunodeficiency virus (HIV) have tions involving administration of blood or
been defined in 21 CFR Parts 610.46 and components having major blood group incom-
610.47 for collection and transfusion facilities. patibilities.6 There must also be a mechanism
The CMS has defined identical look-back re- to report medical device adverse events to the
quirements for transfusion services in 42 CFR FDA (21 CFR 803). Each facility should have
482.27(c). Additional FDA memoranda ad- processes and procedures in place that ad-
dress recommendations for other transfu- dress how to report each applicable type of
sion-transmitted diseases and should be refer- event.
enced when developing look-back procedures. Each facility should track all events re-
Fatalities related to blood collection or ported and look for trends. This usually re-
transfusion must be reported promptly to the quires the development of a mechanism for
FDA Center for Biologics Evaluation and Re- numbering the reports and classifying the
search (CBER). A report must be made within events. Classification schemes typically in-
24 hours by telephone (301-827-6220), volve one or more of the following categories:
e-mail (fatality2@cber.fda.gov), or fax the nature of the event, the process (or proce-
(301-827-6748). A written report must be dure) in which the event occurred, event se-
submitted within 7 days [21 CFR 606.170(b)] verity, and causes. If several events within a
to CBER Director, Office of Compliance and relatively short time period involve a particu-
Biologics Quality, Attn: Fatality Program Man- lar process or procedure, that process or pro-
ager (H FM-650), 1401 Rockville Pike, cedure should be further investigated. The
Rockville, MD 20852-1448. The report most useful schemes involve use of multiple
should include a description of any new proce- categories for each event, which allow data to
dures implemented to avoid recurrence. be sorted in a variety of ways so that patterns,
All licensed facilities, registered facilities, previously not obvious, can emerge (see exam-
and transfusion services must promptly report ple in Table 1-5). Such sorting can result in
biological product deviations (previously identification of situations that require closer
known as errors and accidents), and informa- monitoring or of problems needing corrective

Table 1-5. Example of Event Classification

Event: Unit of RBCs from a directed donor was issued to an incorrect patient
■ Classification of event
• Type of event – patient
• Procedure involved – issuing products
• Process involved – blood administration
• Product involved – RBCs
• Other factors – directed donor
■ Investigation revealed
• Proximate cause – two patients with similar names had crossmatched blood available
• Root cause – inadequate procedure for verification of patient identification during issue
action. The amount of monitoring and length Internal Assessments

of time to monitor processes will depend on
Blood banks, transfusion services, and donor
the frequency of the occurrence and the criti-
centers must define a process for internal as-
cal aspects of the occurrences. Reporting and
sessments. Internal assessments may include
monitoring of events are essential problem
identification methods for process improve- routine, scheduled system checks (also called
ment activities in a quality management sys- quality indicators) and audits, as well as other
tem. evaluations initiated by the facility. The pro-
cesses and procedures must outline a plan and
schedule for these assessments. The details of
who performs the assessments and how they
Assessments: Internal and are performed should be addressed. Assess-
External ment plans should include the quality system
This QSE defines how facilities monitor, as- and major operating systems found in the
sess, and evaluate their processes. The AABB blood bank, transfusion service, or donor cen-
Standards1(p93) and the Accreditation Informa- ter. Quality assessments should be conducted
tion Manual 20 define assessments as a system- periodically by quality oversight personnel to
atic, independent examination that is assess the effectiveness of the quality system
performed at defined intervals and at suffi- and current programs. Although a focused as-
cient frequency to determine whether activi- sessment may be required from time to time to
ties comply with planned activities, are address a specific problem area, quality assess-
implemented effectively, and achieve objec- ments usually focus on systems.
tives. Evaluations typically include compari- In addition to a schedule for the assess-
son of actual results to expected results. ments, there must be a process for responding
Depending upon their focus, they can include to the issues raised as a result of the assess-
only the process output (eg, results), both the ment, including review processes and time
process and the output, or related processes frames. The results of the assessment should
and their outputs (ie, the system). Types of as- be documented and submitted to responsible
sessments include external assessments, inter- management personnel for review, as well as
nal assessments, quality assessments, peer to executive management.
review, and self-assessments. To comply with In order to make the best use of these as-
this QSE, there should be a process to manage sessments, there must be a process to track,
internal and external assessments. trend, and analyze the problems identified so

that opportunities for improvement can be side 1 standard deviation (SD), 2 SD, and 3
recognized.1(p85),20 Early detection of trends SD indicate a process that is out of control; the
makes it possible to develop preventive ac- root cause should be determined and correc-
tions before patient safety or blood products tive action should be initiated if indicated.
are adversely affected. Evaluation summaries
provide information useful in correcting indi-
vidual or group performance problems and
Blood Utilization Assessment
ensuring adequacy of test methods and equip-
ment. In addition to review of assessment re- The activities of blood usage review commit-
sults, executive management must review any tees in the transfusion setting are an example
associated corrective or preventive action. of internal assessment. A transfusion audit is a
defined review of policies and practices to en-
sure safe and appropriate transfusions and is
Quality Indicators based on measurable, predetermined perfor-
mance criteria. Guidelines are available from
Quality indicators are specific performance
the AABB for both adult and pediatric utiliza-
measurements designed to monitor one or
tion review.21-23
more processes during a defined time and are
Peer review of transfusion practices, re-
useful for evaluating service demands, pro-
quired by the AABB, is also required by the
duction, adequacy of personnel, inventory
JCAHO6 for hospital accreditation, by the
control, and process stability. These indicators
CMS2 for hospitals to qualify for Medicare re-
can be process-based or outcome-based. Pro-
cess-based indicators measure the degree to imbursement, and by some states for Medicaid
which a process can be consistently per- reimbursement.
formed. An example of a process-based indi- Transfusion services should investigate an
cator is measurement of turnaround time from adequate sampling of cases (ie, 5% of the
blood product ordering until transfusion. Most number of cases occurring within a defined
frequently used are outcome-based indicators, time frame or 30 cases, whichever is larger).
which measure what does or does not happen The audit should assess the facility’s effective-
after a process is or is not performed. An ex- ness in:
ample of such an indicator is counting the ■ Monitoring blood ordering practices for
number of incorrect test result reports. For all categories of blood and products.
each indicator, thresholds are set that repre- ■ Monitoring wastage of blood compo-
sent warning limits and/or action limits. These nents.
thresholds can be determined from regulatory ■ Developing and approving policies and
or accreditation requirements, benchmarking, procedures for distribution, handling,
or internally derived from data. use, and administration of blood prod-
Tools frequently used for displaying quality ucts.
indicator data are run charts and control ■ Reviewing all confirmed transfusion re-
charts. In a run chart, time is plotted on the actions.
x-axis and values on the y-axis. In control ■ Ensuring that the institution’s transfu-
charts, the mean of the data and upper and sion service adequately meets patient’s
lower control limits, which have been calcu- needs.
lated from the data, are added to the chart. ■ Informing patients and physicians in a
Single points outside the upper and lower con- timely and confidential manner when
trol limits result from special causes. Statistical look-back is required for possible HCV
rules for interpreting consecutive points out- or HIV transmission.

Currently, JCAHO incorporates the above tion of evolving technologies and products
requirements into performance improvement such as solvent/detergent-treated plasma,
standards, which are listed in Table 1-6.6 growth factors, and cytokines. Appendix 1-8
One important aspect of transfusion safety lists blood utilization assessment examples.
is monitoring the blood administration pro-
cess, ie, following a unit of blood as it is issued External Assessments
for transfusion and observing the transfusion External assessments include inspections, sur-
procedure.22 Another aspect of transfusion veys, audits, etc, performed by those not affili-
safety is the review of transfusion reactions ated with the organization, such as the FDA,
and transfusion-transmitted diseases. The re- AABB, CAP, or JCAHO. Facilities must have
view committee may monitor policies and policies and procedures that ensure external
practices for notifying recipients of recalled assessments are obtained as required and de-
products (look-back notification) and donors fine how to manage such assessments. In the
of abnormal test results. Other assessments preparation phase of scheduled assessments,
important in transfusion practice include re- there is typically some data gathering and in-
view of policies for informed consent, indica- formation to submit to the organization per-
tion for transfusion, release of directed donor forming the assessment. Coordination of the
units, or outpatient and home transfusion. Ad- assessment, which includes arranging dates
ditional assessments should include, where ap- and notification of necessary personnel, needs
propriate: therapeutic apheresis, procurement to occur. During the assessment phase, it is im-
and storage of hematopoietic progenitor cells, portant to know how to greet the assessors or
perioperative autologous blood collection, inspectors and who is responsible for these in-
procurement and storage of tissue, and evalua- dividuals during the time they are in the facil-
Table 1-6. Applicable JCAHO Performance Improvement Standards

■ There must be a planned, systematic, organization-wide approach to design, measure, assess,
and improve process performance and blood usage review.
■ New processes must be designed effectively.
■ Data must be systematically collected. The data should be collected to measure existing
processes and improvement initiatives. The data must be collected on important processes or
outcomes related to the organization’s functions and mission, including at least:
– Patient preparation
– Handling specimens
– Communication processes
– Utilization management
– Needs, expectations, and satisfaction of patients and other customers
– Staff’s views regarding performance and improvement opportunities
– Data from risk management and quality control activities
■ There must be a systematic process to assess collected data in order to determine:
– Compliance with specifications
– Level of performance and stability of existing processes
– Priorities for improvement
– Actions to improve performance
– Whether changes result in improvement
■ The organization must systematically improve its performance by improving processes.
24
Data compiled from JCAHO.

ity. Clear descriptions of what information can tion can be thought of as a reactive approach to
be given to the external assessors or inspec- reported problems that includes a preventive
tors, and in what form, will help the facility component, whereas preventive action can be
through the assessment or inspection process. thought of as a proactive approach resulting
During the postassessment phase, issues iden- from analyzing information. In contrast, reme-
tified must be addressed and usually a written dial action is defined as the action taken to
response submitted. A clear delineation of the alleviate the symptoms of existing noncon-
responsibilities of all staff members in each formances or any other undesirable situa-
phase is essential. tion.25,26 Remedial action addresses only the
visible indicator of a problem, not the actual
cause (see comparisons in Table 1-7). Effec-
Process Improvement tive corrective action, and effective preventive
action as well, cannot be implemented until a
The importance of identifying, investigating,
process is evaluated in relationship to other
correcting, and preventing problems has been
processes and the underlying cause(s) deter-
clearly established in transfusion medicine.
mined. Pending such evaluation, it may be de-
The corrective and preventive action process
sirable to implement remedial action.
includes identification of problems and their
causes, and identification and evaluation of so-
lutions to prevent future problems. To be in
Identification of Problems and Their
compliance with this QSE, the facility must
Causes
have a defined process to identify the need for Sources of information for process improve-
corrective or preventive action. The process ment activities include the following: blood
must include a mechanism for data collection product and other deviations; nonconforming
and analysis, and follow-up to evaluate the ef- products and services; customer complaints;
fectiveness of the actions taken. Statistical QC records; proficiency testing; internal au-
tools and their applications may be found in dits; quality indicators; and external assess-
publications from the American Society for ments. Preparation of an annual facility
Quality, as well as specific AABB publica- quality report, in which data from all these
tions.25,26 sources are collated and analyzed, can be a
Corrective action is defined as the action valuable tool to identify issues for process im-
taken to eliminate the causes of an existing provement. Such a report is required of li-
nonconformance or other undesirable situa- censed manufacturing facilities by the FDA.
tion in order to prevent recurrence.1(p94) Pre- Selection of problem identification mecha-
ventive action is defined as the action taken to nisms is an important quality management de-
eliminate the causes of a potential noncon- cision. Mechanisms should be representative
formance or other undesirable situation in or- of the facility processes, consistent with orga-
der to prevent occurrence.1(p97) Corrective ac- nizational goals, and reflect customer needs.
27
Table 1-7. Comparison of Remedial, Corrective, and Preventive Action
Action Problem Approach Outcome
Remedial Existent Reactive Alleviates symptoms

Corrective Existent Reactive Prevents recurrence
Preventive Nonexistent Proactive Prevents occurrence

Other important decisions include whether to localized factors. The key to successfully de-
address the identified problems. This requires termining root cause is not to stop too soon or
careful consideration so that tampering with get caught in the trap of placing blame on an
processes that are just showing normal varia- individual.
tion does not occur. Most problems, particularly those that are
Identifying underlying causes for an unde- complex, have several root causes. A method
sirable condition or problem can be done by that can be of use when this occurs is the
an individual or group. The more complex the Pareto analysis. A chart of causes, laid out in
problem and the more involved the process, order of decreasing frequency, is prepared.
the greater the need to enlist a team of individ- Those that occur most frequently are consid-
uals and to formalize the analysis. The three ered the “vital few”; the rest are considered
most commonly used tools for identifying un- the “trivial many.” This method offers direc-
derlying causes in an objective manner are tion about where to dedicate resources for
process flowcharting, use of the “repetitive maximal impact.
why,” and the cause-and-effect diagram. A
process flowchart gives a detailed picture of Identification and Evaluation of Solutions
the multiple steps and the important decision Potential solutions to problems are identified
points within that process. By examining this during the creative phase of process improve-
picture, problem-prone areas may be identi- ment. Brainstorming and process flowcharting
fied. When the “repetitive why” is used, one can be particularly helpful in this phase. Possi-
works backward through the process and re- ble solutions should be evaluated relative to
peatedly asks the question “why?” until no organizational constraints, and narrowed
new information can be gleaned, the causal down to those most reasonable. Individuals
path cannot be followed because of missing in- who perform the process are usually the most
formation, or further investigation is impracti- knowledgeable about what will work. They
cal, impossible, or outside the boundaries of should be included when possible solutions
the organization. Use of the “repetitive why” are being considered. Individuals with knowl-
prevents the mistake of interpreting an effect edge of the interrelationships of processes and
as a cause. the more “global” view of the organization
The cause-and-effect diagram, also known should also be included. Solutions may fail if
as the Ishikawa or fish-bone diagram, employs representatives with these perspectives are not
a specialized form of brainstorming that involved.
breaks down problems into “bite-size” pieces. Potential solutions should be tested before
It is a method designed to focus ideas around full implementation, with a clear plan relative
the component parts of a process, as well as to methods, objectives, timelines, decision
give a pictorial representation of the ideas that points, and algorithms for all possible results
are generated and their interactions. When us- of the trial. Large-scale solutions can be tried
ing the cause-and-effect diagram, one looks at on a limited basis and expanded if successful;
equipment, materials, methods, environment, smaller scale solutions can be implemented
and human factors. Use of these tools identi- pending an effectiveness evaluation. Regard-
fies more than active failures, those in which less, data should be collected to evaluate the
there is an immediate adverse effect. It allows effectiveness of the proposed change. Data
identification of latent failures, those more can be collected by the methods used in ini-
global actions and decisions with potential for tially identifying problems or by methods spe-
damage that may lie dormant and become evi- cially designed for the trial. Once solutions
dent only when triggered by the presence of have been successfully tested, full implemen-

tation can occur. Following implementation, 3. Code of federal regulations. Title 21 CFR Parts
600-799. Washington, DC: US Government Print-
data to support the continuing effectiveness of ing Office, 2001 (revised annually).
the change should continue to be collected, on 4. Code of federal regulations. Title 21 CFR Parts
200-299. Washington, DC: US Government Print-
at least a periodic basis, to ensure that the pro- ing Office, 2001 (revised annually).
cess continues to stay in control. 5. Food and Drug Administration. Guideline for qual-
ity assurance in blood establishments. Docket
#91N-0450. (July 11, 1995). Rockville, MD:
CBER Office of Communication, Training, and
Manufacturers Assistance, 1995.
Facilities and Safety 6. Hospital accreditation standards. Oakbrook Ter-
race, IL: Joint Commission Resources, Inc., 2002.
Multiple federal, state, and local agencies have 7. College of American Pathologists Laboratory Ac-
regulations addressed in this QSE. To comply creditation Program checklists. Chicago, IL: Col-
lege of American Pathologists, 2001.
with this QSE, the facility must provide a safe 8. A quality system model for health care; NCCLS ap-
workplace with adequate environmental con- proved guideline (GP26-A). Wayne, PA: National
trols and emergency procedures for the safety Committee for Clinical Laboratory Standards,
1999.
of the employees, donors, patients, and all 9. ANSI/ISO/ASQ Q9000-2000 series – quality
other inhabitants or visitors.1(p87) Procedures management standards. Milwaukee, WI: ASQ
Quality Press, 2000.
must be in place that cover: 10. Quality program implementation. Association Bul-
■ General safety letin 97-4. Bethesda, MD: American Association
of Blood Banks, 1997.
■ Disaster preparedness 11. Food and Drug Administration. Guidance on gen-
■ Biologic safety (blood-borne pathogens) eral principles of process validation. (May 1, 1987).
Rockville, MD: CBER Office of Communication,
■ Chemical safety Training, and Manufacturers Assistance, 1987.
■ Radiation safety, if applicable 12. Food and Drug Administration. Guidance for In-
■ Discard of blood, components, and tis- dustry: General principles of software validation:
Final guidance for industry and FDA staff. (Janu-
sue ary 11, 2002). Rockville, MD: CBER Office of
Current good manufacturing practice regu- Communication, Training, and Manufacturers As-
sistance, 2002.
lations include requirements for: 13. Code of federal regulations. Title 21 CFR Part
■ Adequate space and ventilation 606.160(d). Washington, DC: US Government
Printing Office, 2001 (revised annually).
■ Sanitation and trash disposal 14. Clinical laboratory technical procedure manual.
■ Equipment for controlling air quality NCCLS approved guideline (GP2-A3). Wayne, PA:
National Committee for Clinical Laboratory Stan-
and pressure, humidity, and tempera- dards, 1996.
ture 15. Schlickman JJ. ISO 9000 quality management sys-
tem design. Milwaukee, WI: ASQ Quality Press,
■ Water systems 1998:3-20;69-80.
■ Toilet and hand-washing facilities 16. Ziebell LW. Process control. In: Ziebell LW,
An evaluation of the physical structure and Kavemeier K, eds. Quality control: A component of
process control in blood banking and transfusion
limitations of a facility is necessary prior to im- medicine. Bethesda, MD: AABB Press, 1999:
plementation of procedures or equipment to 1-12.
17. Code of federal regulations. Title 21 CFR Part 11.
ensure maximum efficiency and safety. A Washington, DC: US Government Printing Office,
more thorough discussion of safety can be 2001 (revised annually).
18. Code of federal regulations. 21CFR 600.3, 600.4,
found in Chapter 2. 606.3, 606.171. Washington, DC: US Govern-
ment Printing Office, 2001 (revised annually).
19. Motschman TL, Santrach PJ, Moore SB. Error/inci-
dent management and its practical application. In:
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action. Bethesda, MD: American Association of
1. Gorlin JB, ed. Standards for blood banks and trans- Blood Banks, 1996:37-67.
fusion services. 21st ed. Bethesda, MD: American 20. Accreditation Program Committee. Accreditation
Association of Blood Banks, 2002. information manual. 4th ed. Bethesda, MD: Amer-
2. Code of federal regulations. Title 42 CFR Parts ican Association of Blood Banks, 2001:G-1.
493 to end. Washington, DC: US Government 21. Shulman IA, Lohr K, Derdiarian AK, et al. Moni-
Printing Office, 2001 (revised annually). toring transfusionist practices: A strategy for im-

proving transfusion safety. Transfusion 1994;34: Kelley DL. How to use control charts for healthcare. Mil-
11-15. waukee, WI: ASQ Quality Press, 1999.
22. Guidelines for blood utilization review. Bethesda,
MD: American Association of Blood Banks, 2001. Maffei L, ed. Evaluation of new equipment and systems.
23. Strauss RG, Blanchette VS, Hume H. National ac- Bethesda, MD: American Association of Blood Banks,
ceptability of American Association of Blood 1997.
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24. Comprehensive accreditation manual for hospi- McCurdy K, Wilkinson S, ed. CLIA and transfusion med-
tals: The official handbook. Oakbrook Terrace, IL: icine: A guide to total compliance. Bethesda, MD:
Joint Commission on the Accreditation of Health- AABB Press, 1996.
care Organizations, 2000.
National Committee for Clinical Laboratory Standards.
25. Anderson TD. Tools for statistical process control.
Approved guidelines. Wayne, PA.
In: Ziebell LW, Kavemeier K, eds. Quality control:
A component of process control in blood banking (GP5-A) Clinical laboratory waste management,
and transfusion medicine. Bethesda, MD: AABB 1993.
Press, 1999:13-48.
26. Russell JP, Regel T. After the quality audit. 2nd ed. (GP6-A) Inventory control systems for laboratory
Milwaukee, WI: ASQ Quality Press, 2000. supplies, 1994.
27. Motschman T. Corrective versus preventive action. (GP9-A) Selecting and evaluating a referral labora-
AABB News 1999;21(8):5,33. tory, 1998.
(GP17-A) Clinical laboratory safety, 1996.
(GP19-A) Laboratory instruments and data manage-
ment systems: design of software user interfaces
Suggested Reading and end-user software systems validation, opera-
tion, and monitoring, 1995.
Andersen B, Fagerhaug T. Root cause analysis: Sim-
plified tools and techniques. Milwaukee, WI: ASQ Qual- (GP21-A) Training verification for laboratory per-
ity Press, 2000. sonnel, 1996.
Berte LM, ed. A model quality system for the transfu- (GP22-A) Continuous quality improvement: essen-
sion service. Bethesda, MD: American Association of tial management approaches, 1999.
Blood Banks, 1997.
(GP27-A) Using proficiency testing to improve the
Berte LM. Managing quality in hospital transfusion clinical laboratory, 1999.
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Rhamy J, ed. Error management: An important part of
Bozzo P. Implementing quality assurance. Chicago: quality control. Bethesda, MD: AABB Press, 1999.
American Society of Clinical Pathologists, 1991.
Russell H, Wallhermafechtel M, eds. AABB quality pro-
Clark G. Continuous quality improvement. Chicago: gram: An introduction. Bethesda, MD: American Asso-
American Society of Clinical Pathologists, 1992. ciation of Blood Banks, 1997.
FDA workshop for licensing blood establishments. Umiker W. The customer-oriented laboratory. Chicago:
Bethesda, MD: American Association of Blood Banks, American Society of Clinical Pathologists, 1991.
1995.
Validation guidelines. Microprocessor-controlled test
Holliman SM, ed. Validation in blood establishments instruments. Association Bulletin 93-2. Bethesda, MD:
and transfusion services. Bethesda, MD: AABB Press, American Association of Blood Banks, 1993.
1996.
Ziebell LW. Process control. In: Ziebell LW, Kavemeier
Holliman S, ed. Supplies, suppliers and contract review. K, eds. Quality control: A component of process control
Bethesda, MD: American Association of Blood Banks, in blood banking and transfusion medicine. Bethesda,
1997. MD: AABB Press, 1999:1-12.

Appendix 1-1. Code of Federal Regulations Quality-Related References

21 CFR Citation Topic
606.14 Biological product deviations
606.20 Personnel
606.40 Facilities
606.60 Equipment QC
606.65 Supplies, reagents
606.100 SOPs
606.160 Records
606.170 Adverse reactions
606.171 Biological product deviations
211.22 QC/QA unit responsibilities
211.25 Personnel qualifications
211.28 Personnel responsibilities
211.160 Laboratory controls
211.192 Production record review
211.194 Laboratory records and reviews

Appendix 1-2. Minimum Record Requirements (Quality Assessment and Quality

Control)
■ Dated and signed or initialed temperature record- ■ Record of employee participation in quality sys-
ing charts for each refrigerator and freezer or tem, computer, safety, and job-specific training
central monitor record, temperature records of or education with inclusive dates, subjects, and
refrigerated centrifuges, heat-regulated devices evaluation, if appropriate; documentation of staff
(ie, blood warmers, incubators) qualifications and annual competency review
■ Record of quality control tests performed on re- ■ Records of proficiency testing. The Centers for
agents for infectious disease marker tests, Medicare and Medicaid (formerly HCFA) have de-
antihuman globulin, blood typing serum, and re- fined proficiency testing requirements for blood
agent red blood cells as specified by the proce- banks and transfusion service laboratories.* It is
dures manual recommended, therefore, that the following doc-
■ Results of tests to evaluate the performance of umentation be available:
other reagents (eg, copper sulfate) and equip-  Sources of samples and expected answers
ment  Frequency and number of tests related to each
■ Results of equipment calibration, validation of laboratory category
equipment software (see also Appendices 1-5  Identity of personnel performing the profi-
and 1-6), and equipment maintenance logs ciency testing assays and relevance to their
■ Record of quality control tests of components work assignments
prepared  Mechanism by which responsibility for profi-
■ Record of periodic checks on sterile technique if ciency testing assays is rotated or other as-
components are prepared in an open system, un- surance that the competence of all employees
less an equivalent method has been approved by is ensured
the FDA  Dates of testing and evaluation of perfor-
■ Record of sterilization of supplies and reagents mance
prepared within the facility, including date, time  Corrective action, if necessary, and monitor-
interval, temperature, and mode; records of bio- ing to ensure effectiveness of corrective ac-
logical indicator tests to determine the effective- tion, if indicated
ness of sterilization  Training and retraining of personnel, when in-
■ Record of incoming critical supplies and re- dicated
agents, manufacturer, lot numbers, date re-  Notification of state or federal agency, if re-
ceived, and results of inspection and testing (if quired
applicable)  Records of parallel studies performed
■ Record of disposition of rejected supplies or re- ■ Records of biological, chemical, and radiation
agents used in collection, processing, and com- safety monitoring
patibility testing of blood and blood components ■ Record of internal quality system and operational
■ Record of supplies and reagents used, including audits, quality indicators, management review,
manufacturer, lot numbers, inclusive dates of corrective or preventive action, and follow-up for
use, and expiration date effectiveness
*Code of federal regulations. Title 42 CFR Part 493.801. Washington, DC: US Government Printing Office, 2001
(revised annually).

Appendix 1-3. Minimum Record Requirements (Patients)

Laboratory Tests fication number, ABO, and Rh; donor unit or pool
■ Patient’s first and last name and identification identification number and donor ABO and Rh;
number, or two unique identifiers, and sample and interpretation of crossmatch tests, if per-
collection date formed
■ Phlebotomist’s identification ■ Identification of personnel issuing component
■ Testing date and identification of testing person-
nel Transfusion
■ The test performed, results observed, and final ■ A signed statement that the information on the
interpretation container label and the compatibility record has
■ Results and interpretation of ABO and Rh testing, been matched with the wristband or other identi-
including control for autoagglutinins and weak D fication of intended recipient, item by item
testing, if performed ■ Documentation of vital signs
■ Results and interpretation of tests for unex- ■ Transfusionist’s identification and date/time of
pected antibodies transfusion
■ Difficulty in blood grouping, clinically significant
unexpected antibodies, and serious adverse ef- Emergency Issue of Blood
fects of transfusion ■ Label or tie-tag clearly identifying the required
tests that have not been completed
Compatibility Tests ■ A statement of the requesting physician indicat-
■ Patient’s ABO and Rh type ing that the clinical situation is sufficiently urgent
■ Comparison of the patient’s current ABO and Rh to require release of blood before completion of
types with results of previous tests performed in testing
preceding 12 months ■ Depending on local procedures, the requesting
■ Review of the patient’s records during the past 5 physician’s statement concerning the abbrevi-
years for difficulty in determining ABO or Rh ated testing before issuing the blood component
types, presence of clinically significant unex- - OR -
pected antibodies, severe reactions to transfu- ■ The compatibility label must clearly state that
sions, and special transfusion requirements tests routinely performed in that facility have not
■ Identification numbers for the patient and for do- been completed
nor unit(s) ■ All other record requirements apply as usual
■ ABO and Rh types of donor unit(s)
■ Testing date and identification of testing person- Adverse Effects of Transfusion
nel ■ Patient’s full name and identification number
■ Results and interpretation of compatibility tests ■ Patient’s diagnosis
■ Component being tested or prepared ■ Description of adverse effect
■ The date of occurrence
Transfusion Requests ■ The date of report
■ Patient’s first and last name ■ The name of the blood component(s) or prod-
■ Patient’s identification number uct(s) involved
■ Requesting physician’s identification ■ The donor unit number(s) of the blood compo-
■ Component requested nent(s) or lot number(s) of the blood product(s)
■ Date and time component needed implicated and the manufacturer (ie, collecting or
processing facility if not the same as reporting fa-
Issue for Transfusion cility)
■ Time and date of issue or reissue ■ Amount of component or product transfused
■ Donor unit number of blood or component, or lot ■ Whether or not the patient’s physician was made
number of product aware of the adverse effects
■ Pool number and unit number for each compo- ■ A copy of the notification of appropriate authori-
nent in the pool ties, when applicable (eg, blood component or
■ Inspection of blood component and final check of product manufacturer, FDA, JCAHO, etc)
records prior to issue for: patient’s name, identi-

Appendix 1-4. Minimum Record Requirements (Donors and Donor Units)

Collection and Deferral Information Special Collections Information
■ Donor unit number ■ Donors under age 17: Written permission from a
■ Donor’s first and last name and middle initial parent or guardian if it is required by state law.
■ Donor’s address and phone number (Minors who are in the military or legally married
■ Donor’s date of birth are generally exempt from this requirement.)
■ Donor’s social security number or other equiva- ■ Autologous Donations:
lent unique permanent identifier that will ensure  Written consent of the patient’s physician, the
accurate maintenance of donor deferral registries blood bank physician, and the patient (or, if in-
■ Date of donation dicated, the patient’s parent or guardian)
■ Date of last donation  Physician examination of the donor and certif-
■ Record of physical examination (temperature, ication of good health if the donation interval
blood pressure, pulse, hemoglobin or hemat- is less than 8 weeks. (The physician’s written
ocrit, arm examination) order requesting autologous collections is an
■ Identification of the examiner acceptable alternative.)
■ Documentation that the donor weighs at least 110  A US Supreme Court decision makes it illegal
pounds or that a low-volume unit was collected to offer autologous blood services without of-
■ Medical history with answers recorded as “yes” fering those services to individuals protected
or “no” for each question, with any pertinent ex- under the Americans with Disabilities Act.2
 Documentation that the attending physician
planation
■ Identification of the interviewer has been notified if the units are positive for
■ Record of whether the donor was accepted evidence of infection due to a communicable
■ If the donor is deferred, reason and deferral pe- disease
 Documentation of destruction of blood not re-
riod, with notation about temporary, indefinite,
or permanent deferral leased
■ Informed consent: ■ Apheresis (Cytapheresis and Plasmapheresis):
 Consent to have blood drawn and tested The following record-keeping requirements are
 An opportunity to exclude use for transfusion in addition to those that apply to Whole Blood do-
(if applicable) nation:
 A statement that AIDS educational material is  The name of the manufacturer and the lot
understood and an accurate medical history numbers and volumes of all solutions, soft-
has been given ware, and drugs used
 The results of laboratory tests that qualify the
 Permission for the blood bank to use blood as
it deems fit if unsuitable for transfusion and donor, time the procedure begins and ends,
signature of the donor the volume of blood processed, the volume of
■ Identification of the phlebotomist each component harvested, the estimated
■ The name of the manufacturer and lot number of blood cell loss, and any adverse events
 Description of the procedure and informed
the container/anticoagulant
■ Record of whether the phlebotomy was satisfac-
consent
 For apheresis donors who are given medica-
tory or unsatisfactory
■ Record of any donor reaction; symptoms, treat-
tions or are immunized, a separate informed
consent, as well as complete information on
ment, condition of the donor upon release; and
the drug or antigen source; the schedule, dos-
notation about whether the donor can be ac-
age, and route of administration; adverse
cepted again
 Identification of person attending the donor
events; and response (eg, antibody titer) to
 Time donor is released
the stimulating agent as measured by labora-
 Notation if the donor refuses treatment or ad-
tory tests
 All initial and periodic physical examinations
vice by a physician, including medical history in-
■ Documentation of postdonation information re-
terviews
ports  Physician’s acceptance or rejection of the do-
 Identity of the source of the information (eg,
nor, based on the accumulated laboratory data
from the donor, competent health-care pro- ■ Therapeutic Apheresis/Hematopoietic Progeni-
fessional) tor Cells:
 Documentation of evaluation, investigation,
 Physician’s order
and follow-up on these reports1  Patient identification
■ Documentation of implications in posttrans-
 Diagnosis
fusion disease transmission

Appendix 1-4. Minimum Record Requirements (Donors and Donor Units) (cont’d)
 Type of procedure performed ■ Name and volume of anticoagulant
 Method used ■ Name of component
 Extracorporeal blood volume ■ Date and time each component was prepared. (If
 Nature and volume of component removed the preparation involves multiple steps such as
 Nature and volume of replacement fluids separation, freezing, and thawing, documenta-
 Any occurrence of adverse events tion of the time each step was performed.)
 Medication administered ■ Date and time of component expiration
 Informed consent ■ Volume of component, except for Cryoprecip-
■ Therapeutic phlebotomy: itated AHF and Red Blood Cells (RBCs) prepared
 A record that the patient’s physician has or- in a routine manner from Whole Blood
dered phlebotomy ■ When recovered plasma is pooled for further
 Volume of blood drawn manufacture, the donor unit number and the
 Final disposition of unit identification of the collecting facility for each
 If transfusion components are prepared, all unit in the pool
information required for blood donors ■ For pooled component labels:
 Name of the pooled component
Tests on Donor Blood Samples  Final volume of the pooled component
■ Donor unit number  Name of the facility preparing the pooled com-
■ Reagents used, manufacturer, lot number, expi- ponent
ration date, control values and calculations if ap-  Unique numeric or alphanumeric identifica-
plicable, and evidence that reagents have been tion
subjected to performance checks  Number of units in the pool
■ Results and interpretation of ABO and Rh testing,  ABO and Rh type of units in the pool
including the test for weak D if indicated
■ Results of tests for expected antibodies in the Labeling and Lot Release
ABO system ■ Documentation that ensures current, accurate
■ Results of positive and negative controls run with donor deferral registries have been checked and
the donor samples necessary action has been taken to prevent dis-
■ Results and interpretations of tests for the detec- tribution of unsuitable products
tion of unexpected antibodies, if indicated, in- ■ Documentation that verifies all records of test re-
cluding use of IgG-coated control cells if used sults are reviewed for completeness and accu-
■ Results and interpretation of serologic test for racy prior to labeling
syphilis ■ Identity of each component in quarantine to pre-
■ Results and interpretation of screening and sup- vent unsuitable units from being released
plemental tests for all infectious disease markers ■ Prior to release, documentation that the com-
and surrogate tests pletely labeled product has been examined for
 Relevant calculations to define control and correct labeling. (This examination must be veri-
positive results. (The record of these calcula- fied by a second process.4)
tions may be kept separately from the results
of donor samples but must be readily associ- Disposition of Blood and Components
ated with specific sample records.) ■ Documentation and confirmation that all compo-
 Record of incubation times and temperature nents from a unit have been quarantined, as indi-
 Record of reason for invalidating a test result, cated; documentation of appropriate release
details of the investigation, records of super- from quarantine
visory review, outcome of the investigation, ■ When destruction is necessary, the identification
and, if indicated, any corrective action taken. of each of the components destroyed, reason for
(These records should be completed before destruction, date and method of destruction
any donor samples are retested.3) ■ When units are shipped, the shipping facility
■ Results and interpretation of tests that are per- must record the following information:
formed by outside testing laboratories, with the  Name and address of receiving facility
name and location of the testing laboratory on  Date and time of shipment
the record  A list of each donor unit number, ABO and Rh
type, and expiration date
Component Preparation  Name of each blood component
■ Donor unit number  Results of final inspection of Whole Blood and
■ Date and, if appropriate, time drawn, and docu- components
mentation of method used (manual or automated)

Appendix 1-4. Minimum Record Requirements (Donors and Donor Units) (cont’d)
 Name of person filling order tected; for reissued Whole Blood or components,
 Periodic tests documenting that shipping a record that proper temperature has been main-
containers maintain an acceptable tempera- tained, that container and closure are intact and
ture range that inspection for abnormal color or appearance
is satisfactory
Blood and Components Received from Other Facil- ■ Notation of quarantine of unsatisfactory units,
ities record of any tests performed, and final disposi-
■ Name and address of shipping facility. (It is not tion of each unit
necessary to record the address with each unit if
this information is readily available.) Irradiated Blood and Components5
■ Name of blood component ■ Identification number of unit(s) irradiated
■ Donor unit number assigned by collecting facility ■ Identity of the source and strength, duration, and
■ Accession or inventory number, if any, assigned level/dose of irradiation
by receiving facility ■ Total dose of irradiation. If a product is irradiated
■ ABO and Rh type more than once, document the steps taken, indi-
■ Component expiration date and time, if indicated vidual irradiation dose, and the total (additive) ir-
■ Date component was received radiation dose
■ For blood that is received already crossmatched, ■ Temperature and length of time unit(s) out of
the name and identification number of the in- controlled storage
tended recipient and interpretation of results of ■ Identification of the operator and the date and
compatibility tests time of irradiation
■ Results and interpretation of tests done by the re- ■ New expiration assigned to component, when ap-
ceiving facility plicable
■ Inspection of incoming blood or components ■ Site of irradiation if the facility irradiating is dif-
■ Identification of receiving personnel ferent than the collecting facility
■ Quality control of the irradiating device, includ-
Storage and Inspection of Blood Components ing: results of irradiator indicator check for each
■ Central monitor listing every 4 hours of tempera- batch irradiated, calibration and monitoring of
tures, refrigerator identification, date, and time; dose delivered to the center of the container (cor-
or continuous monitoring chart for each piece of rected for air-liquid differences), turntable
equipment being monitored; or manual record- checks, timer checks, length of time required to
ing of time, temperatures, and staff identification deliver the radiation, records of calibration stud-
every 4 hours for each piece of equipment being ies conducted annually and after repairs, and ra-
monitored diation leak tests (eg, Geiger counting or wipe
■ Explanation of abnormal temperatures and ac- tests)
tion taken, and initials of personnel ■ Personnel training, including safety procedures
■ If components are stored in an open storage area, and radiation monitoring
ambient temperature recorded at least every 4 ■ Written agreement if product irradiation is to be
hours performed in a different facility (eg, hospital radi-
■ Records of periodic testing of alarm systems and ation therapy department) that specifies that the
backup power supply; comparisons of central irradiation of blood products is under the control
monitor readings with a calibrated reference of the blood establishment, and permits review of
thermometer training and audit by the blood establishment
■ Preissue inspections, date performed, unit num- ■ Monitoring personnel exposure to radiation
ber, and description of any abnormalities de-
1. Food and Drug Administration. Memorandum: Guidance regarding post donation information reports. (December
10, 1993). Rockville, MD: CBER Office of Communication, Training, and Manufacturers Assistance, 1993.
2. Pub. Law No. 101-336, 104 Stat. 327 (1990) codified at 42 U.S.C. §12101-12213.
3. Food and Drug Administration. Guidance for Industry: Revised recommendations regarding invalidation of test
results of licensed and 510(k)-cleared blood-borne pathogen assays used to test donors. (July 11, 2001). Rockville,
MD: CBER Office of Communication, Training, and Manufacturers Assistance, 2001.
4. Food and Drug Administration. Current good manufacturing practice in manufacturing, processing, packing, or
holding of drugs; revision of certain labeling controls. Final rule. Fed Regist 1993;58:147.
5. Food and Drug Administration. Guidance for Industry: Gamma irradiation of blood and blood components: A pilot
program for licensing. (March 15, 2000). Rockville, MD: CBER Office of Communication, Training, and

Appendix 1-5. Minimum Record Requirements (Computer Systems)*

System Documentation Change Control
■ Instruction manuals (eg, user’s manual, opera- ■ System name
tions manual, training manual, and a program ■ Version, release or model number
maintenance manual if the user will be maintain- ■ Modules affected
ing the software) ■ Description of change and reason for the change;
■ Hardware configuration diagrams and system all changes explained both in complete technical
flowcharts; descriptions that define the interac- detail and in language understood by users
tions between software modules (including inter- ■ Person authorizing the change
faces) ■ Person making the change
■ Installation requirements and instructions, in- ■ Date and time of change
cluding environmental specifications ■ Records documenting that procedures for hard-
■ User’s requirements ware and software change controls are being fol-
■ Detailed description of system’s intended func- lowed
tions
■ Description of test database Validation
■ Location and the means of access to the source ■ Validation protocol that describes functions to be
code tested and test cases with expected results and
■ Documentation of in-house programming meth- actual results
odology, program development, and system ■ Records of acceptance testing to demonstrate
modifications that the intended functions performed as ex-
■ Records demonstrating that the system met its pected; records of testing of integrated hard-
predetermined specifications and requirements ware, software, and peripheral devices
prior to implementation ■ Log of problems and corrective actions taken
■ Summary of validation review and approval for
Training and Procedures implementation
■ Training and continuing competency of person-
nel Audit Trail
■ SOPs that reflect current standards, integrate ■ Identification number of donor, sample, or unit
computer functions into operations, and clearly ■ Original value
explain system use ■ New value
■ Policies and procedures for system maintenance ■ Originator identification, person, or device that
and operation; maintenance schedules (includ- created the record
ing preventive maintenance); system backup; ■ Modifier identification, person, or device that
hardware and software change control; valida- changed the record
tion and monitoring of data integrity; periodic au- ■ Date and time of change
dits ■ Authorization signature
*Food and Drug Administration. Guidance for Industry. General principles of software validation: Final guidance for
industry and FDA staff. (January 11, 2002). Rockville, MD: CBER Office of Communication, Training, and

Appendix 1-6. Minimum Record Requirements (Automatic, Mechanical, or

Electronic Equipment)1
■ Name and identification of equipment (including ■ Documentation of change to implement new
software version number), inclusive dates of use, blood typing equipment, including written ap-
links to other equipment proval from CBER when licensed facilities plan to
■ Installation qualification, process validation, and deviate from the manufacturer’s instructions.
revalidation Records to include:
■ Schedule of cleaning, preventive maintenance,  Calibration
quality control, calibration, and recalibration,  Validation
and the results of such activities  Parallel testing (minimum of 500 samples
■ Problem log: over 3 days under representative conditions)
 Down time  Complete history of the instrument during the
 Problem descriptions preimplementation phase
 Error/alarm messages  Discrepancies
 Corrective actions (eg, hardware upgrades,  NTD (no type determined) rate ≤ 6%
repairs)  Lot numbers and manufacturer of all reagents
 Results of any diagnostic tests performed used2
 Analysis for trends
 Staff and reviewer initials and dates
1. Food and Drug Administration. Guideline for quality assurance in blood establishments. (July 11, 1995). Rockville,
MD: CBER Office of Communication, Training, and Manufacturers Assistance, 1995.
2. Food and Drug Administration. Memorandum: Changes in equipment for processing blood donor samples. (July 21,
1992). Rockville, MD: CBER Office of Communication, Training, and Manufacturers Assistance, 1992.

Appendix 1-7. Minimum Record Requirements (Occupational Safety and Health)*

■ Medical record for each employee with occupa- pand information in the log, such as how an inci-
tional exposure, which includes: dent happened, what part of the body was af-
 Name and social security number of the em- fected
ployee ■ Training records will include:
 Hepatitis B vaccination status and dates  Dates of training session
 Results of testing and examinations  Summary of training session
 Health-care professional’s written opinion  Name and qualifications of person conduct-
 Information provided to the employee ing training
■ OSHA No. 200, “The Log and Summary of Occu-  Names and job titles of all persons attending
pational Injuries and Illnesses,” used to classify the training
and record illnesses and injuries
■ OSHA No. 101, “The Supplementary Record of
Occupational Injuries and Illnesses,” used to ex-
*Code of federal regulations. Title 29 CFR Part 1904. Washington, DC: US Government Printing Office, 2001 (revised
annually).

Appendix 1-8. Assessment Examples: Blood Utilization1,2

A blood usage review committee should consider the following areas of practice and develop specific measure-
ments for monitoring blood transfusion processes. Some measurements provide data for several processes.
Ordering of Appropriate Blood Components

1. Preanalytical errors. Errors in specimen collection, verbal orders, transfusion orders.
2. Units transfused. Figures for Whole Blood; Red Blood Cells, including liquid-stored, washed, leuko-
cyte-reduced, deglycerolized, and reconstituted with plasma; Platelets, including Platelets, Platelets
Pooled, Platelets Pheresis, Platelets Pheresis Leukocytes Reduced; Plasma, including Fresh Frozen
Plasma, cryoprecipitate reduced, 24-hour, and other variants; Cryoprecipitated AHF; coagulation factor
concentrates; RhIG. Use of autologous and directed donor collections. Analyze by clinical service or by
prescriber.
3. Patients transfused. Total number of patients receiving each of the components or products listed in item 2.
4. Units transfused per patient transfused. Average number of units of each component or product given to
patients receiving that component. May be useful to analyze by diagnosis or surgical/medical procedure.
5. Special components prepared and transfused. Number and relative percent of leukocyte-reduced, irradi-
ated, cytomegalovirus-negative units; aliquots prepared and transfused; outpatient and home transfu-
sions.
6. Units returned unused. Number and percent of units issued and later returned unused. Analyze by ward, by
clinical service, or by prescriber.
7. Crossmatch-to-transfusion (C:T) ratio. Number of units crossmatched divided by the number of units
transfused. Analysis could be by institutional total, by emergency vs routine requests, or by specific de-
partments, clinical services, surgical procedures, or prescribers, as needed. Although no longer required
by JCAHO, these data can still provide helpful information on appropriate use of blood and component
resources.
8. Transfusion guidelines. Are guidelines current, appropriate for the patient population being treated, and
readily available to physicians? Is there a surgical blood order schedule or type and screen protocol? Are
they current and appropriate?
Distributing, Handling, and Dispensing Blood Components

1. Turnaround time. Interval between the time a transfusion request is received and time the unit is available
for transfusion and/or is transported to the patient’s bedside. May analyze by emergency, routine, or oper-
ative requests.
2. Emergency requests. Number and percent may be analyzed by department, clinical service, prescriber,
and diagnosis. Distribution of requests by day, week, shift, or hour may be revealing. C:T ratios can give an
indication of appropriateness.
3. Uncrossmatched units. Number and percent of units issued uncrossmatched or with abbreviated
pretransfusion testing. May analyze by department, clinical service, or prescriber.
4. Age distribution of units. Age of inventory units and crossmatched units by ABO and Rh type, age of units
when received from the supplier, age at the time of transfusion, age when returned to the supplier. May be
analyzed by statistical methods and/or frequency histograms.
5. Surgical cancellations due to unavailability of blood. Number and percent of cases delayed due to unavail-
ability of blood; number of hours or days of delay, analyzed by surgical procedure and by cause (eg, anti-
body problem in an individual patient, general shortage, or shortage of particular ABO or Rh type).
6. Significant type switches due to unavailability of blood. Number of Rh-negative patients given Rh-positive
RBCs or platelets; transfusions with ABO-incompatible plasma.
7. Outdate rate. Total number of units outdated (expired unused) divided by the number of units received;
should be monitored for all blood components and derivatives. Analysis by ABO and Rh type may prove in-
formative.
8. Wastage rates. Number of units wasted due to breakage, improper preparation, improper handling or stor-
age; units prepared and held for a patient but not used; number of units that failed to meet inspection re-
quirements.
9. Adequacy of service from the blood supplier. Number of orders placed that could be filled as requested; av-
erage time between the order and receipt of emergency delivery; number of orders associated with an er-
ror such as improper unit received or units improperly shipped.
10. Compatibility testing requirements. Adequacy, currency, and appropriateness of policies and procedures.
11. Quality control policies and procedures. Number of records of temperature, equipment, component prep-
aration, or testing that are incomplete or have deviations.

Appendix 1-8. Assessment Examples: Blood Utilization1,2 (cont’d)
Administration of Blood and Components

1. Blood issue/delivery errors. Number of wrong units issued; number of units delivered to wrong pa-
tient-care area or improperly transported.
2. Blood administration policies and procedures. Adherence to facility-specific requirements when monitor-
ing patients for signs and symptoms of adverse reactions. Availability of copies of current policies and
procedures and of current Circular of Information for the Use of Human Blood and Blood Components.
3. Blood administration audits. Summary of on-site performance reviews, to include number of deviations
by category (eg, identification of patient and donor unit, documentation and completeness of medical re-
cord). May include audit for documentation of transfusion order and indication for transfusion or in-
formed consent.
4. Transfusion equipment / devices. Review of quality control documentation for equipment, including blood
warmers, infusion pumps, special filters or administration sets; documentation in the medical record that
devices were used; number of situations where their use was inappropriate.
5. Special transfusion situations. Review of compliance with policies for out-of-hospital transfusions and
perioperative and postoperative collection of autologous blood.
Monitoring Transfusion Results

1. Compliance with transfusion guidelines. Number of inappropriate transfusions, as determined by the
blood usage review committee; analysis of reasons for inappropriate transfusion.
2. Transfusion reactions. Number and percent of reported transfusion reactions; turnaround time for com-
plete investigation; documentation of transfusion service and committee review; documentation in the
medical record. May review medical record audits to ensure proper reporting.
3. Transfusion-transmitted disease. Number of cases by agent; turnaround time of investigation; complete-
ness of review and recording.
4. Look-back/case investigations. Number of cases by agent; turnaround time of investigation; complete-
ness of case-finding, notification, review, and recording.
5. Annual review of policies and procedures. Adequacy, currency, and appropriateness of policies and proce-
dures for detection and reporting of adverse effects of transfusion.
Management Data that May Prove Useful When Assessing Transfusion Services
1. Workload and productivity. Evaluation of activities and efficiency of the laboratory; may be analyzed by day
of week and by shift. Hours worked per unit transfused or patient transfused may be more valuable as an
efficiency measure than data obtained from traditional productivity calculations.
2. Event reports. Number of events dealing with laboratory processes (eg, labeling, preparation, testing, is-
sue); procedural events in blood administration; errors, accidents, and recalls by blood supplier(s).
3. Staff training and competency. Documentation of training and continuing competency of laboratory and
nursing staff to perform transfusion-related procedures and policies.
1. Comprehensive accreditation manual for hospitals: The official handbook. Oakbrook Terrace, IL: Joint Commission
Resources, Inc., 2002.
2. Guidelines for blood utilization review. Bethesda, MD: American Association of Blood Banks, 2001.

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Organization 5.1 Management Commitment

ferred to as quality oversight personnel, ■ Review and approval of document con-

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■ Approval of lot release, ie, the review of all

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Agreements Receipt, Inspection, and Testing of

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Table 1-2. Elements of a Sound Process Control System

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Figure 1-1. Documentation hierarchy—representing the levels of documents in an organization.16

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policy for a specific QSE, a statement of au-

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Table 1-3. Examples of Quality System Process Documents

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■ Retention of original copies of color- other computer-related identifying methods

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Table 1-5. Example of Event Classification

action. The amount of monitoring and length Internal Assessments

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Table 1-6. Applicable JCAHO Performance Improvement Standards

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Remedial Existent Reactive Alleviates symptoms

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Appendix 1-1. Code of Federal Regulations Quality-Related References

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Appendix 1-2. Minimum Record Requirements (Quality Assessment and Quality

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Appendix 1-3. Minimum Record Requirements (Patients)

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Appendix 1-4. Minimum Record Requirements (Donors and Donor Units)

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Appendix 1-5. Minimum Record Requirements (Computer Systems)*

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Appendix 1-6. Minimum Record Requirements (Automatic, Mechanical, or

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Appendix 1-7. Minimum Record Requirements (Occupational Safety and Health)*

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Appendix 1-8. Assessment Examples: Blood Utilization1,2

Ordering of Appropriate Blood Components

Distributing, Handling, and Dispensing Blood Components

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Appendix 1-8. Assessment Examples: Blood Utilization1,2 (cont’d)

Administration of Blood and Components

Monitoring Transfusion Results

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