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University of Colorado Hospital Policy

Introduction:

This policy and procedure describes the process for patients to receive safe and effective
administration of parenteral opioid analgesics via the Alaris patient controlled analgesia (PCA)
infusion syringe module. The goals are:
1. To provide procedures for initiating, checking, and verifying PCA orders.
2. To provide procedures for PCA opioid use, dosage, and safe practice.
3. To standardize monitoring parameters.
4. To standardize documentation.

Scope:

I. A physician or allied health care provider must order PCA infusions. Initial orders
must be written using an electronic health record (EHR) order set, which includes
standard concentrations, dose settings and monitoring parameters.

II. Opioids or sedatives ordered in addition to a PCA should be authorized by the health
care provider that wrote the PCA orders before they are administered. This is required
to prevent excessive sedation from other systemic controlled substances or sedatives.

III. New PCA orders will be written by the health care provider when a patient is
transferred to another level of care (e.g., transfer in/out of Intensive Care Unit (ICU)).
PCA orders will be rewritten or renewed every 14 days.

IV. All health care providers are accountable for verifying and checking PCA orders for
accuracy. Physicians and registered nurses (RNs) are accountable for checking the
intravenous (IV) site for patency prior to starting an infusion and may initiate PCA
pumps only if appropriately instructed. Post Anesthesia Care Unit (PACU) nurses are
accountable for initiating PCA infusions for postoperative patients prior to sending the
patient to another nursing unit.

Patient Controlled Analgesia (PCA)

Effective Date: 6/1999

Replaces Policy:


Revised Date: 1/2011, 7/2014 Policy Owner: Acute Pain Service (APS)
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V. Pharmacists are accountable for supplying opioids for PCA in pre-mixed syringes/bags.
Any drug wastage from the PCA pump must be witnessed and appropriately
independently documented by two nurses, physicians and/or pharmacists as per the
University of Colorado Hospital (UCH) Controlled Medication Management policy.

Table of Contents
Policy Details: ................................................................................................................................. 3
I Verification of Orders. .................................................................................................................. 3
II PCA Opioid Use, Dosage, and Safe Practice. ............................................................................. 3
A. Suitable Candidates for PCA.3
B. Demand Dosing.3
C. Basal Infusions...3
D. Opioid-Induced Respiratory Depression3
E. PCA by Proxy4
F. Initial and Ranges of PCA dosages4
G. Loading Dose.4
H. Basal Rates.4
I. Optimal Dosing..4
J. Opioid-Tolerant Dosing.4
K. Palliative Care Dosing...4
L. Nurse Setting Adjustments and Boluses5
M. Dual RN Verification.5
N. Demerol..5
O. Morphine Dosing...5
P. Subcutaneous PCA Infusions.5
Q. Changing PCA Solutions and Tubing6
R. PCA Keys..6
S. Adverse Events..6
III Initiation of PCA Therapy. ........................................................................................................ 6
A. Infusion Medication and Labeling.6
B. PCA Initiation7
IV Recommended Monitoring8
A. Recommended Monitoring and Sedation Scales...8
B. Increasing Somnolence..9
C. Pain Assessment.....9
D. Side Effects....9
E. Parameters for Provider Notification.....9
F. Parameters for Stopping the PCA and Administering Naloxone...9
G. Increasing Monitoring..10
V Documentation...10
VI Education..10
Related Policies:............................................................................................................................ 10
Definitions: ................................................................................................................................... 11
References: .................................................................................................................................... 11

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Policy Details:
I. Verification of Orders
All health care professionals who are administering PCA must verify and check PCA orders
for accuracy and ensure that the patient is not allergic to the prescribed drug. The physicians
order should contain the following:

A. Name and concentration of drug (mg/ml or mcg/ml)
B. Bolus or loading dose (mg or mcg)
C. Basal or continuous rate (mg/hr or mcg/hr)
D. Demand or PCA dose (mg or mcg)
E. Lockout or delay time (minutes)
F. Monitoring instructions (respiratory rate, sedation, pain intensity, etc.)

II. PCA Opioid Use, Dosage, and Safe Practice

A. Suitable candidates for PCA include patients with pain who are mentally alert and able
to comprehend and comply with instructions and procedures regarding its use. Patients
who may not be suitable candidates include: infants and young children, patients with
altered mental status (confusion, agitation, restlessness), patients with decreased level
of consciousness, patients who are not psychologically stable, and patients without
intellectual capacity to understand and operate the PCA.

B. Demand dose (PCA) only is the safest mode for opioid nave patients and is normally
used initially in the majority of patients with post-surgical, post-procedure, or acute
pain.

C. A basal infusion dose is normally only used in the opioid-tolerant patient, as needed.
Opioid-tolerant is defined as those patients who have been receiving opioids regularly
for approximately 7 days or more. A basal dose should not be increased more
frequently than every 12 hours, preferably 24 hours, to allow steady state to be reached
and the full effects of the dose increase to felt/observed.

D. To reduce the risk of opioid-induced respiratory depression, monitoring of oxygenation
by continuous pulse oximetry may be required by providers order. Risk factors for
opioid-induced respiratory depression have been recognized in the literature and are
noted in the box below. These risk factors should be considered when determining who
might benefit from the use of mechanical monitoring via continuous pulse oximetry.
Having a risk factor does not automatically require continuous pulse oximetry; the
severity of the factor(s) and the patients condition should guide the decision to use
continuous pulse oximetry. It should be noted that continuous pulse oximetry may be
automatically required by specific nursing unit protocols.

Risk Factors for Opioid-Induced Respiratory Depression Continuous Pulse
Oximetry
1. Use of a basal infusion dose in the non opioid-tolerant patient.
2. Obstructive Sleep Apnea (OSA), or suspected of having OSA.
3. Pulmonary disease or dysfunction (e.g., Chronic Obstructive
The severity of these
factor(s) and the
patients condition
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Pulmonary Disease (COPD)).
4. Obesity, Body Mass Index (BMI) 35 kg/m
2

5. Greater than 64 years old.
6. Receiving other opioid or sedative drugs in addition to PCA.
7. Impaired renal or hepatic function.
should guide the
decision to use
continuous pulse
oximetry

E. PCA by Proxy is not allowed. Unauthorized administration of a PCA dose by anyone
other than the patient, i.e., family members, caregivers, clinicians, can lead to over
sedation, respiratory depression, and even death. If a patient is unable to self-
administer their PCA dose, notify the physician service managing the PCA.
Consideration should be given to discontinuing PCA therapy and utilizing alternate
therapy such as IV push. Under no circumstances should anyone else push the PCA
button for the patient. If the patient asks a health care provider to push their PCA button
for them (e.g., patient cannot reach button), the provider should provide the button to
the patient to administer their own dose.

F. Initial and Ranges of PCA dosages for acute/postoperative pain in opioid nave adults:


Opioid
(Concentration)

Loading
Dose
(repeat PRN)

Basal Dose

Demand (PCA)
Dose

Lockout
(min.)

Morphine (5 mg/ml)
Hydromorphone (1 mg/ml)
Fentanyl (50 mcg/ml)

2-4 mg
0.4-0.8 mg
10-25 mcg

0-1mg/hr
0-0.2mg/hr
0-10mcg/hr

0.5-2 mg
0.1-0.4 mg
10-25 mcg

8-10
6-10
6-8

G. A loading dose is usually not needed in patients already receiving opioids prior to
starting the PCA.

H. A basal rate is not routinely recommended in opioid nave patients and should be used
with caution. Demand dose only is the safest starting mode (especially for high risk
patients); start with demand only and add basal as needed. If a basal rate is ordered for
an opioid nave patient, the ratio of continuous (basal) dose to demand (PCA) dose
should remain approximately 1:2.

I. Optimal opioid analgesic dose varies widely among opioid-nave patients: adjust
dosing based on patient response.

J. PCA dosage ranges in the opioid-tolerant patient can be much higher than those listed
in the above table. The Acute Pain Service (APS) or the Palliative Care Team (see on-
call schedule for pager numbers) may be consulted to determine appropriate PCA
dosages in this population.

K. In addition to opioid nave and opioid tolerant, UCH has a third category of dosing
parameters for the Palliative Care patient. The doses used in the Palliative
Care/Oncology IV PCA order set are generally much larger than those for opioid nave
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and tolerant patients, and may require the use of special high concentration
syringes/premixed bags of medication. Using this order set results in an automatic
consult to the Palliative Care Team; this consult is required to use this order set.

L. Nurses may adjust pump settings within ranges and give bolus doses as ordered.

M. Two RNs must independently verify drug, volume, concentration, and rate including
all pump settings against the orders when:
1. Initiating the PCA infusion
2. Accepting patient from another floor
3. Changing shift (with off-going RN to oncoming RN)
4. Changing any settings or changing drug
5. Hanging a new syringe/bag of drug

N. Meperidine (Demerol) is not available for PCA due to accumulation of an active
metabolite, normeperidine, which can cause seizures and tremors.

O. Morphine should be used with caution in patients with renal insufficiency due to its
more potent active metabolite, morphine-6-glucuronide (M6G). M6G has decreased
clearance and increased elimination half-life in these patients.

P. PCA opioids may be administered via a subcutaneous infusion in special circumstances
when IV access is not possible. A Palliative Care Team consult is recommended when
using the subcutaneous PCA order set (this is a physician to physician consult). This
team will assist in determining appropriate candidates and PCA dosages. The following
applies:

1. A single subcutaneous infusion site can usually accept 2-3 ml/hour.

2. Highly concentrated solutions (e.g., hydromorphone 1 or 10 mg/ml,
morphine 5 mg/ml, or fentanyl 50mcg/ml) are used for subcutaneous
infusion, and rates are in tenths of a millimeter (0.1 ml/hour).

3. A subcutaneous needle is placed according to manufacturers instructions
in anatomical sites used for subcutaneous injections, bilateral subclavicular
chest wall, or posterior scapular area; the site should allow a fat fold of at
least 1 to be pinched between thumb and index finger. Avoid areas that are
scarred, infected, irritated, edematous, bony, highly vascular, or near the
waistline. Cachexia is not a contraindication for subcutaneous access,
although available sites may be limited. The site is prepped in the same
manner as placing an IV catheter and should be covered with a transparent
dressing. Aspiration should NOT result in blood return. The site should be
monitored according to the same parameters as an IV site for erythema,
induration, leaking, bleeding, edema, infection, or tissue slough. The site
should be changed by the nurse per the manufacturers recommendations,
or more often if necessary (erythema, edema, leaking).

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4. A carrier line is not required with a subcutaneous PCA. The pigtail
extension on the PCA tubing where the carrier line would normally be
inserted should instead be primed with normal saline and then capped to
avoid air being pulled into the subcutaneous space.

5. The administration set and pump should be clearly labeled subcutaneous
infusion to prevent mistaking for an intravenous line.

6. Dosing is the same as for IV infusion; however, a longer PCA lockout
interval (20 minutes) must be allowed for slower absorption (peak effect)
via the subcutaneous route.

Q. Change PCA bag/syringe every 24 hours for UCH mixed solutions and every 96 hours
for pre-mixed solutions. Change the tubing every 96 hours.

R. The key to the PCA pump will be kept within a secured designated area, e.g., Pyxis
machine on each unit.

S. If a patient experiences an adverse event related to sedation or respiratory depression,
examine the medication concentration and pump settings to assure they are correct. If
no human errors are discovered: 1) Return the PCA pump with tag to Biomed for
inspection. The pump must not be returned to use or to Central Supply. 2) The IV bag
and tubing must be returned to the Pharmacy. Contact the Pharmacy Manager on call
for instructions on disposition of the IV bag and tubing, based on time of day and day
of the week.

III. Initiation of PCA Therapy

A. Infusion medication and labeling

1. UCH pharmacy batched morphine syringes (30 ml, 5 mg/ml),
hydromorphone syringes (30 ml, 1 mg/ml), and fentanyl syringes (30 ml,
50 mcg/ml) are stocked in the Pyxis machine. These syringes are used for
both the opioid nave and opioid tolerant PCA therapies.

2. Higher concentration hydromorphone syringes (30ml, 10 mg/ml) are only
available as a patient specific medication and must be ordered using the
Palliative Care order set. The use of the Palliative Care order set requires a
Palliative Care Consult order (this is a physician to physician consult order).
This order set may be appropriate for patients who are extremely opioid
tolerant, are nearing the end of life, or are undergoing an extreme pain crisis.
The Palliative Care order set may also be appropriate if the patient is
requiring greater than one full syringe of medication every four hours. (See
the Alaris tip sheet, located on the Alaris Multidisciplinary website, for
detailed instructions on setting up a high-dose infusion.)

3. Verify compatibility of other drugs being administered before connecting
the PCA line.
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4. A continuously running maintenance intravenous fluid (IVF) or carrier IVF
must be connected into the PCA tubing.

B. PCA Initiation:
1. Verify physician order

2. Ensure patient meets criteria for use of PCA

3. Gather equipment:
a. Alaris Brain/Point of Care Unit (PCU) with one Large Volume Pump
(LVP) module and one PCA syringe module
b. Alaris PCA key
c. PCA tubing with Y connector
d. Syringe with ordered medication

4. If the UCH Palliative Care/Oncology IV PCA order set is being used with a
continuous rate infusing via the Alaris LVP, the following additional
equipment is required:
a. Alaris PCU with one LVP module (see Kaizen Bulletin: How to Administer
Controlled Substance Infusions in Non-ICU Care Areas)
b. Alaris controlled substance tubing
c. Computerized Ambulatory Drug Delivery (CADD) lockbox
d. CADD lockbox key

5. Wash hands

6. Verify IV or subcutaneous site patency.

7. Follow the manufacturers instructions for setting up, loading, priming the
tubing, and programming the PCA pump.

8. UCH Alaris pumps use Guardrails safety software to help ensure correct
dosing of all IV medications administered to patients. These Guardrails
include hard and soft maximum and minimum ranges for PCA basal rates,
demand doses, boluses, loading doses, and lockout times. There are three
different categories of patient under these Guardrails: opioid nave, opioid
tolerant, and Palliative Care/Oncology. (Please refer to a UCH pharmacist or a
smart pump technology team member for a list of current Guardrails
standards.) When programming the pump, the correct category of patient must
be selected in order for the appropriate Guardrails to apply.

9. Label tubing with date and time and sticker.

10. Two RNs must independently verify drug, volume, concentration, and rate
including all pump settings against the orders.

11. After ensuring that PCA tubing is completely primed (including Y site
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connection) and attaching the maintenance IV fluid to the PCA tubing,
connect the PCA tubing to the patient, lock the PCA pump, and then start the
pump.

12. Instruct the patient and family/significant other on the use of PCA.

IV. Recommended Monitoring

A. Recommended patient monitoring includes assessment and documentation of vital
signs, sedation level, and pain intensity per PCA orders. Recommended monitoring
parameters are:

1. Heart rate, blood pressure, temperature and pulse oximetry every 4 hours

2. Respiratory rate and sedation level every 1 hour x 12 hours, then every 2 hours
x 12 hours, then every 4 hours until the PCA is discontinued. For a patient with
a protected airway in the ICU, monitor respiratory rate hourly with vital signs
and monitor sedation level every 4 hours (with physical assessment) or as
needed.

3. If the PCA dose is increased (basal rate started or increased, demand dose
increased, lockout frequency decreased, RN bolus given), temporarily increase
the respiratory rate and sedation level monitoring to every 30 minutes x 2.

4. Assessment of the sleeping patient (non-protected airway):
a. Respiratory status should be observed without awakening the patient.
Arousal will stimulate respiration and potentially mask pending problems.
b. Observation should include the depth and regularity of respirations and
listening for snoring.
c. Shallow respirations, periods of apnea, or snoring may be a sign of over
sedation or respiratory trouble and the patient should be awakened to further
assess.
d. If there is any question about whether the patient is sleeping normally or is
sedated, they should be awakened to further assess.
e. If respiratory rate and status are assessed as normal as noted above, it is not
required to awaken the patient to assess sedation.

Moline-Roberts Pharmacologic Sedation Scale
Use for Non-ICU Patients
1None to minimal sedation
Awake, aware, alert; spontaneous sustained interaction
2Anxiolysis
Restful, drowsy, dozing, lightly sleeping; soft voice, no tactile stimulus required or
light touch, sustains interaction
3Moderate Sedation
Sleeping, soft to normal voice, light touch, limited interaction
4Moderate Sedation
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Sleeping, normal to loud voice, light touch, follows simple commands
5Deep Sedation
Sleeping, airway and ventilation may be impaired, loud voice, intense to noxious
tactile stimulus, purposeful response or non-purposeful movement
6General Anesthesia
Sleeping, airway and ventilation likely impaired, loud voice, noxious stimulus, no
response/unarousable


Richmond Agitation Sedation Scale (RASS)
Use for ICU Patients
+4 Combative--Overtly combative, violent, immediate danger to staff
+3 Very agitated--Pulls or removes tube(s) or catheter(s); aggressive
+2 Agitated--Frequent non-purposeful movement, fights ventilator
+1 Restless--Anxious but movements not aggressive vigorous
0 Alert and calm
-1 Drowsy--Not fully alert, but has sustained awakening (eye-opening/eye contact)
to voice (>10 seconds)
-2 Light sedation--Briefly awakens with eye contact to voice (<10 seconds)
-3 Moderate sedation Movement or eye opening to voice (but no eye contact)
-4 Deep sedation--No response to voice, but movement or eye opening to physical
stimulation
-5 Unarousable--No response to voice or physical stimulation


B. Increasing somnolence can be a key indicator of pending opioid induced respiratory
depression.

C. Assess the patients pain intensity at least every 4 hours and within 1 hour after bolus
doses or rate/medication changes. Note that sedation scales are not an appropriate
measurement of pain intensity. (Refer to the Pain Management policy for more
information regarding pain intensity monitoring and appropriate pain scale use, such as
behavioral vs. self-report.)

D. Assess the patient for the following side effects and treat as needed:
1. Nausea and/or vomiting
2. Pruritus
3. Urinary retention
4. Constipation

E. Immediately notify the ordering service for respiratory rate less than 10 per minute,
sedation level of difficult to arouse (4 or more on the Moline-Roberts scale, -3 or less
on RASS), or inadequate pain relief.

F. If respiratory rate less than 8 per minute or sedation level of not able to arouse (5 or
more on the Moline-Roberts scale, -4 or less on RASS), stop infusion and administer
naloxone 0.1 mg IV STAT, may repeat every 3-5 minutes x 3 doses to a total of 0.4 mg
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per PCA orders.

G. The above monitoring parameters are minimum standards and should be increased as
warranted by patient condition and orders.

V. Documentation

A. The nurse is responsible to document the following on the appropriate patient
information record:

1. Heart rate, blood pressure, temperature and pulse oximetry every 4 hours.

2. Respiratory rate and sedation level every 1 hour x 12 hours, then every 2 hours
x 12 hours, then every 4 hours.

3. Two RNs must independently verify drug, volume, concentration, and rate
including all pump settings against the orders when:
a. Initiating the PCA infusion
b. Accepting patient from another floor
c. Changing shift (with off-going RN to oncoming RN)
d. Changing any settings or changing drug
e. Changing an empty syringe to a full one

4. Two RNs must witness and document wasting of controlled substances.

5. The number of PCA button demands/deliveries and the total amount of
medication (mg or mcg) used every 4 hours. After documenting these amounts
in the electronic health record, clear the 4 hour shift total to reset the pump for
the next 4 hour total.

6. Pain intensity at least every 4 hours and within 1 hour after bolus doses or
rate/medication changes, side effects/complications.

7. Patient and family education on the Interdisciplinary Teaching Sheet.

VI. Education

A. Where appropriate, provide patient education sheet Patient Controlled Analgesia
(PCA) (DOD# PED00105-0902 available in Spanish). Review with patient and family the
principles of PCA therapy and proper use. Identify that no one but the patient is to
administer a PCA dose.

Related Policies:
Central Venous Lines
Peripheral Venous Lines
Pain Management
Pyxis Medication System
Controlled Medication Management
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Epidural and Intrathecal Infusion Analgesia
Equipment Failure and Safety Hazard Reporting
High Alert Medications

Definitions:
Healthcare Professional: Any individual who is licensed and/or qualified to practice a health care
profession (for example, physician, nurse, social worker, clinical psychologist, pharmacist,
PT/OT/ST, or respiratory therapist) and is engaged in the provision of care, treatment, or services
as defined by their job description.

Healthcare Provider: A credentialed or licensed practitioner who has ordering privileges and
prescribing authority.

Bolus or Loading Dose: One time dose of medication that may be given at the start of a PCA
infusion, or that may be given as an additional dose to supplement PCA therapy.

Basal or Continuous Rate: The amount of medication automatically infused per hour.

Demand or PCA Dose: The amount of medication infused when the patient presses the control
button.

Lockout or Delay Time: Period of time that must pass between the completion of one PCA dose
and the initiation of the next.

Patient Controlled Analgesia (PCA): Delivery of opioids via an electronic pump which enables
the patient to self-administer small doses (usually IV) at frequent intervals, maintaining blood
levels of opioids within an effective range.

PCA by Proxy: Unauthorized administration of a PCA dose by anyone other than the patient,
i.e., family members, caregivers, clinicians. This form of PCA therapy is not allowed at UCH.

References:
1. American Pain Society (2008). Principles of Analgesic Use in the Treatment Of Acute Pain
And Cancer Pain (6th Ed.). Skokie, IL: American Pain Society (LOE 6)
2. Institute for Safe Medication Practice Newsletter (2009). Beware of basal opioid infusions with
PCA therapy. Retrieved from https://www.ismp.org/newsletters/acutecare/articles/
20090312.asp. (LOE 8)
3. Jarzyna, D., Jungquist, C.R., Pasero, C., Willens, J.S., Nisbet, A., Oakes, L., Dempsey, S.J.,
Santangelo, D., & Polomano, R.C. (2011). American Society for Pain Management Nursing
Guidelines on Monitoring for Opioid-Induced Sedation and Respiratory Depression. Pain
Management Nursing, 12(3), 118-145. (LOE 8)
4. Lehmann, K. (2005). Recent developments in Patient-Controlled Analgesia. Journal of Pain
and Symptom Management. 29(5S) S72-S89. (LOE 5)
5. Macintyre P. (2005). Intravenous patient-controlled analgesia: One size does not fit all.
Anesthesiology Clinics of North America. 23, 109-123. (LOE 8)
6. Moline, B. & Roberts, M. (2012). Validity and interrater reliability of the Moline-Roberts
Pharmacologic Sedation Scale. Clinical Nurse Specialist. 26(3):140-148. (LOE 6)
7. Parker, M. & Henderson, K. (2010). Alternative Infusion Access Devices. In M. Alexander,
University of Colorado Hospital
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A. Corrigan, L. Gorski, J. Hankins, & R. Perucca (Eds.), Infusion Nursing: An Evidence-Based
Approach St. Louis, MO: Saunders Elsevier. (LOE 8)
8. Pasero, C. (2009). Assessment of sedation during opioid administration for pain management.
Journal of Perianesthesia Nursing. 24(3):186-190. (LOE 8)
9. Pasero, C. & McCaffery M. (2005). Authorized and unauthorized use of PCA pumps.
American Journal of Nursing, 105(7), 30-32. (LOE 8)
10. Pasero, C. & McCaffery, M. (2011). Pain Assessment and Pharmacologic Management. St.
Louis: Mosby. (LOE 8)
11. Patient controlled analgesia by proxy. Sentinel Event Alert Issue 33. Dec 20, 2004. Retrieved
from http://www.jointcommission.org/assets/1/18/SEA_33.PDF. (LOE 8)
12. Safe use of opioids in hospitals. Sentinel Event Alert Issue 49. August 8, 2012. Retrieved from
http://www.jointcommission.org/assets/1/18/SEA_49_opioids_8_2_12_final.pdf. (LOE 8)

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