U.S. Department of Justice
Federal Bureau of Prisons

OPI:
NUMBER:
DATE:
SUBJECT:

Program
Statement

HSD/HPB
P6360.01
1/15/2005
Pharmacy Services

1. PURPOSE AND SCOPE. To guide a broad spectrum of operations
in the Bureau pharmacy program.
2. PROGRAM OBJECTIVES.
are:

The expected results of this program

An inmate’s access to quality, necessary, cost-effective
pharmaceutical care will be provided.
3.

DIRECTIVES REFERENCED
P4100.04
P4500.04
P6010.02
P6013.01
P6027.01
P6031.01
P6090.01
P6340.04
P6541.02

BOP Acquisitions Manual (5/19/04)
Trust Fund/Warehouse/Laundry Manual (12/15/95)
Health Services Administration (1/15/05)
Health Services Quality Improvement Program
(1/15/05)
Health Care Provider Credential Verification,
Privileges, and Practice Agreement Program
(1/15/05)
Patient Care (1/15/05)
Health Information Management (1/15/05)
Psychiatric Services (1/15/05)
Over-the-Counter Medications (11/17/04)

21 CFR Chapter II, Part 1300
4.

STANDARDS REFERENCED

a. American Correctional Association 4th Edition Standards for
Adult Correctional Institutions: 4-4378(M), 4-4379(M),
4-4397(M), 4-4401(M), and 4-4402

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b. American Correctional Association 3rd Edition Standards for
Adult Local Detention Facilities: 3-ALDF-4E-17(M),
3-ALDF-4E-12-1(M), 3-ALDF-4E-18, 3-ALDF-4E-39, 3-ALDF-4E-42, and
3-ALDF-4E-43
5. STAFFING. Each institution will maintain a pharmacy
directed by a professionally and legally qualified pharmacist and
staffed by a sufficient number of trained personnel, in keeping
with the size of the institution and the scope of medical
services provided.
Consultant/contract pharmacists, if used, will provide the Health
Services Administrator (HSA) with a written monthly report of
pharmacy activities. The HSA will maintain this report on file.
6. STANDARDS OF OPERATION. Each institution will provide
space, equipment, and supplies for the professional and
administrative functions of the pharmacy to promote patient
safety through the proper storage, preparation, dispensing, and
administration of drugs.
a. The Chief Pharmacist will maintain up-to-date reference
materials (computer-accessible or print), specifically:
(1)
(2)
(3)
(4)
(5)
b.

Drug Information reference (e.g. Facts and Comparisons,
American Hospital Formulary Service, MicroMedex, etc.);
Pharmacology/Pharmacotherapeutics reference (e.g.
Goodman/Gilman's, Applied Therapeutics, Harrison’s
Internal Medicine, Dipiro);
Drug Interactions;
Drug Information for Patients; and
Internet access in the pharmacy.

Equipment in the pharmacy will include at least:
(1)

Adequate computer equipment including GroupWise access;
!

The Chief Pharmacist will be the owner of the
institution pharmacy mailbox with proxy rights to
a designee for leave purposes.

(2)

A refrigerator dedicated to and appropriately labeled,
for the storage of medications and biologicals;

(3)

Adequate lighting and ventilation;

(4)

A sink with running water;

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(5)

A system to monitor temperature control that meets
compendia/Food and Drug Administration (FDA) standards.
Medications are considered distressed and must be
discarded if temperature controls are not maintained
over a 48 hour time frame.
!

(6)

There must be either daily temperature control
documentation or an electronic temperature control
system that alerts staff to values outside
standards.

The Bureau Correctional Institution Pharmacy System
(CIPS) computer software system.

c. Key Control And Accountability. Only pharmacy staff
(pharmacists and pharmacy technicians) and the off-shift duty
provider will have keys to the pharmacy. Only the Chief
Pharmacist and/or pharmacist-designee(s) will have access to the
main stock of controlled substances.
!

The key ring for the off-shift duty provider will have
a key to the pharmacy, but not to the pharmacy
storeroom or any key which would allow them access to
main stock medications.

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Access to the controlled substances sub-stock is
limited to the staff member who is responsible for the
shift inventory of sub-stock. This staff member will
sign the "sub-stock inventory certification sheet" for
each shift.

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Each institution will develop local procedures for
conducting the sub-stock shift inventory.

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The use of automated medication administration cabinets
(e.g. SureMed, Pyxis) negates the need for shift
inventories and proof of use (disposition) sheets for
controlled substances, needles, and syringes.

7. PROCEDURES AND OPERATIONAL PRACTICES. The Chief Pharmacist
will develop and maintain written procedures and operational
practices pertaining to pharmaceutical services, in concert with
the medical staff and, as appropriate, with representatives of
other disciplines.
a. Pharmacy and Therapeutics (P&T) Committee. The Clinical
Director (CD) will establish a Pharmacy and Therapeutics (P&T)
Committee that will meet at least quarterly. Membership of the
P&T Committee will be defined in institution policy and will

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include, at a minimum, representatives from the medical
(physician), psychiatric (if available), pharmacy, dental, and
nursing staff, as well as Health Services Administration.
(1) Meetings. The required minimum agenda for this
committee meeting includes:
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Determine what drugs on the National Formulary
will be available locally;
Determine what strengths and dosage forms will be
available locally;
Determine if any drugs on the National Formulary
should be restricted further (i.e. designated as
"Pill Line");
Discuss and evaluate errors in prescribing,
dispensing, and administering medications in the
institution;
Discuss and evaluate Adverse Drug Reactions that
occur in the institution;
Approve Drug Use Evaluations (DUEs) used in the
institution;
Review DUE data and track problems over time;
Review changes in the National Formulary;
Present drug information;
Recommend that a "Request for Addition to
Formulary" be completed for a specific drug; and
Discuss Quality Improvement measures.

(2) Minutes. Local P&T Meeting minutes will be made
available to all institution health services staff. An
electronic copy of the minutes will be sent to the BOP Chief
Pharmacist within 30 days of the end of the quarter. Institution
P&T Committee Meeting minutes will contain:
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Date of meeting;
List of attendees;
Reading and acceptance of previous minutes;
Policy and Procedure Review;
Review of past issues;
Formulary issues;
Investigational drugs;
Drug related research projects;
Monitoring and enforcement activities;
Medication recalls;
Medication errors;
Adverse drug reactions and monitoring;
Quality Improvement activities;
Pharmacy interventions;
Floor stock medications;

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1/15/2005
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Drug Utilization Review;
Completed DUEs;
DUE proposals; and
Overall and specific pharmaceutical cost trends.

b. National Drug Formulary. Each institution will use the
Bureau’s National Drug Formulary. The National Formulary will be
issued following the publication of the National Pharmacy and
Therapeutics and Formulary Meeting Minutes.
Authorization for use of items not in the national formulary
must be requested from the Medical Director through the BOP Chief
Pharmacist, using the "Non-Formulary Drug Authorization" form
(BP-S802).
!

The form will be completed and sent to the Chief
Pharmacist for each medication order requesting a
non-formulary item.

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The completed “Non-Formulary Drug Authorization” form
will be sent electronically upon receipt of this module
from the pharmacy software vendor.

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Emergency requests may be made by phone.

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The institution pharmacy will maintain a copy of all
approved and disapproved non-formulary requests. The
original will be filed in section 6 of the Health
Record.

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Prescribing a formulary medication against a
restriction placed on it during the National P&T
meeting requires a non-formulary drug authorization
unless otherwise stated in the formulary.

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A new non-formulary request is not required for intrasystem transfers who previously had a non-formulary
medication approved. The approved form, located in
Section 6 of the Health Record, will be copied and
retained in the pharmacy of the current institution.

The "Request for Addition to Formulary" form (BP-S804) must be
used to request a drug item be added to the National Formulary.
This form should be routed through the local P&T Committee and
then sent to the BOP Chief Pharmacist.
!

All requests will be reviewed at the annual National
Pharmacy and Therapeutics (P&T) Meeting.

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!

Recommendations for formulary deletions, restrictions,
etc., must also be submitted on this form.

Updates to the National Formulary will be published regularly
following National P&T review. Comments and suggestions should
be directed to the BOP Chief Pharmacist.
Unless indicated as a non-substitutable product (i.e. negative
formulary), proprietary (brand) names are used as examples for
identification purposes only. All institutions will use the
least expensive A/B rated generic when possible. “Dispense as
Written” (DAW) orders will be processed as a non-formulary
medication order and must include appropriate justification from
the prescriber.
The institution P&T Committee may use a local formulary based
on the National Formulary.
!

A local formulary can only be more restrictive than the
National Formulary. Medications may not be added or
restrictions removed.

!

Local formularies will be made available to all of the
institution’s health services staff and consultants.

c. Training and Education. Pharmacy personnel will
participate in relevant education programs, including orientation
of new employees, in-service, and outside continuing education.
The institution Chief Pharmacist will maintain participation
documentation.
All health care providers performing pill line, physicians,
and pharmacy technicians will complete pharmacy orientation as
part of the Health Services Orientation. These staff will have
documentation in their credentialing file indicating they have
completed the Pharmacy Services Orientation, before beginning
work in the Pharmacy.
!

After completing this orientation, these providers can
administer medication doses, or distribute medication
orders to inmates, but they cannot dispense medication
orders.

d. Patient Safety. The institution Chief Pharmacist will
ensure there are written procedures in place for patient safety
and the control, accountability, and distribution of drugs.
These procedures will be reviewed/revised annually, as necessary,
and are subject to local negotiation.

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Page 7
!

All drugs will be labeled adequately, including the
addition of accessory or cautionary statements, and the
expiration date, if appropriate.

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Discontinued and outdated drugs and containers with
worn, illegible, or missing labels will be returned to
the pharmacy for proper disposition.

e. Dispensing Medication Orders. Before a medication order is
dispensed, a pharmacist will review it prospectively for the
following:
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drug/drug interactions;
drug/disease interactions;
drug/food interactions;
therapeutic duplications;
over use/under use;
allergies;
therapeutic appropriateness;
appropriate dose;
appropriate route of administration;
duration of therapy;
adverse drug reactions;
proper laboratory monitoring;
appropriate clinical outcomes; and
provide the final check of the medication order to
ensure it contains the correct drug.

The label will contain the correct directions and patient
information pursuant to the medication order. Proper cautionary
statements will be included on the vial.
Any items which are changed must be documented in the Health
Record justifying the need for the change.
A practitioner with "independent status" (i.e. physician or
pharmacist) must check each medication order before it is
dispensed to the patient, ensuring the appropriate prospective
review has been completed.
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Although dentists have “independent status” they are
not allowed to dispense as a majority of medications
fall outside the scope of their practice.

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Health care providers, such as MLPs, EMTs, nurses,
medical technicians, and pharmacy technicians do not
have independent status. As such, health care
providers will not be assigned Pharmacist duties.

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(1)

(2)

In order to satisfy these requirements during evenings
and weekends, each institution will use a "drug
administration cabinet". This may be as sophisticated
as a Pyxis Medstation, a Meditrol, or a Documed
Station, or as simple as a locked, metal cabinet in the
urgent care room, or a designated area in the pharmacy.
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This cabinet will contain a limited number and
supply of urgently needed drugs that are commonly
used after hours in the institution.

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These drugs should be in single dose or single day
packages but in some cases may be in a three day
supply to ensure coverage for weekends and
holidays.

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These medications will be pre-labeled with
standard directions and the name and strength of
the drug.

When the after-hours health care provider needs to give
an inmate a medication, the following options will be
used.
(a)

The inmate may be placed on pill line to be
administered single doses of the prescribed
medication until a medication order can be
dispensed.

(b)

The health care provider may access the off-shift
drug administration cabinet, remove a pre-packaged
container, and:
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write the inmate's name and number;
the date;
the provider’s name;
the expiration date on the package; and
distribute it to the inmate.

(c)

A medication order will be written for the
pharmacist to review retrospectively.

(d)

A log book will be maintained for the off-shift
medication cabinet, to record drugs and doses that
are distributed from the cabinet. The log book
will contain:
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date;
time;

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inmate name;
register number;
drug;
amount dispensed; and
provider's signature.

(e)

Where an automated medication distribution system
is used as the drug administration cabinet, the
distribution/administration report will provide
documentation of these occurrences in lieu of the
log book.

(f)

The next working day, the pharmacist will:
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(g)

The practice agreement for MLPs will state
specifically they may access the drug
administration cabinet and pill line stock. Pill
line stock will not be bulk stock containers.
Local procedures will specify the system in use at
each institution. Pill line stock may include:
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(h)

enter the order into the pharmacy computer;
review the order retrospectively;
fill the order for the amount written less
the dose(s) distributed or administered by
the health care provider;
provide a "final check" of the medication
order; and
dispense the completed order to the inmate.

unit-dose packaging appropriately labeled;
medication order labeled vials with a seven
to 30 day supply of the inmate’s medication;
heat-sealed blister cards filled or checked
by the pharmacist; and
automated medication administration cabinets
(e.g. Pyxis Envoy).

Non-pharmacist health care providers will not have
access to bulk stock packages that would permit
them to actually dispense a medication order or
administer doses.
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The only exception to the above is described
in Section 9.c.

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(3)

Inmates transferring to other institutions in/out of
the Bureau will have their medications listed on a
Medical Summary of Federal Prisoner/Alien in Transit
(BP-S659) form, which is delivered in a timely manner
to the pharmacy for processing.

f. Inspections. The Chief Pharmacist or designee will conduct
at least quarterly inspections of all areas where medications are
dispensed, administered, or stored. The Chief Pharmacist will
maintain a record of quarterly inspections for at least two
years.
g. Drug Monitoring. The Chief Pharmacist will provide drug
monitoring services keeping with each patient’s needs, FDA and
manufacturer recommendations, and practices recommended through
drug information references.
8.

DEA CONTROLLED SUBSTANCES

a. Applicability of Federal Law. Drug Enforcement
Administration (DEA) controlled substances are drugs and drug
products under jurisdiction of the Controlled Substances Act of
1970 and are divided into five schedules (I, II, III, IV, and V).
!

Nothing in this chapter will be construed as
authorizing or permitting any person to engage in any
act that is not authorized or permitted under existing
federal laws, or that does not meet regulations
published in the most recent edition of Title 21,
Chapter II, of the Code of Federal Regulations (21 CFR,
Part 1300 to end).

Application for a new or renewed registration number under the
Controlled Substances Act includes the following procedures.
(1)

To obtain an initial DEA registration number, each
Chief Pharmacist will complete and forward a New
Application for Registration form (DEA-224), to the BOP
Chief Pharmacist for certification.
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For renewal, Form DEA-224a will be sent to the
Central Office, Attn: Chief Pharmacist, BOP, 320
First Street NW, Washington, DC 20853 for
certification (there is no cost for new or renewal
registration).
The BOP Chief Pharmacist will verify fee exemption
status.
The phone number for DEA registration and renewal
is 1-800-882-9539.

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(2)

"Registration Classification" on Form DEA-224 will be
checked as "hospital/clinic." There will be only one
official registration number for each Bureau
institution.

(3)

The DEA registration number will be used only for
official federal business.

(4)

The BOP Chief Pharmacist will forward the certified
form to the DEA, which will send the new or renewed
registration number to the institution.

(5)

The institution Chief Pharmacist will complete and
submit these forms. At institutions without a
pharmacist on staff, the HSA will retain this
responsibility.

b. Responsibility. The Chief Pharmacist will be the
responsible authority for all DEA controlled substances. The
main stock will be kept locked and stored in a vault or safe to
which only the Chief Pharmacist and/or pharmacist designee(s) has
the combination or keys.
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The HSA will ensure that a duplicate set of keys or
combinations of all vaults and safes in the HSU will be
sealed in separate envelopes, plainly marked with
contents, and filed in the Warden's or security
officer's vault or safe.

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The Chief Pharmacist or designee must be present for
any inventories, inspections, searches, or shakedowns
of the storeroom, vaults or safes.

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The Chief Pharmacist will ensure that all combinations
or locks to main stock vaults or safes storing DEA
controlled substances are changed:

(1)

At transfer, reassignment, or termination of
applicable HSU administrative or pharmacy personnel, or

(2)

When unusual circumstances dictate increased internal
control measures.

c. Purchasing/Receiving. Purchase orders for controlled
substances will be prepared by a designated employee without the
knowledge or assistance of inmates.
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Controlled substances will be stocked in single-dose
packaging when available.

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The Chief Pharmacist will establish a proper system of
security for their receipt.

d. Records. The pharmacist will maintain adequate main stock
records for each controlled substance. Headings will indicate:
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sub-stock unit;
date;
record number/P.O. number;
quantity received;
quantity issued to sub-stock; and
balance on hand.

Sub-stock records address the administration of medication on
medical/nursing units or on pill line. Sub-stock will have
records maintained for proof of use for each DEA controlled
substance on hand. Each proof of use sheet will contain:
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name and strength of drug;
date issued;
amount issued;
pharmacy control number;
department location (if applicable);
date and amount returned;
date and time of administration;
name and number of inmate;
dosage administered;
corresponding medication order number (CIPS);
signature of person administering; and
balance on hand.

The completed proof of use sheet will be returned to the
pharmacy, and kept with controlled substances records.
At the start of each shift, staff will conduct a complete DEA
sub-stock inventory in accordance with local procedures. If the
inventory is not correct, staff will attempt to resolve the
differences immediately.
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The staff member discovering the discrepancy will write
a memo to the Chief Pharmacist explaining the event.

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If the discrepancy is not resolved, the Chief
Pharmacist or designee, will notify the HSA, to ensure
that its possible cause(s) is identified.

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For institutions using a computer driven medication
station, the pharmacist will generate sub-stock
discrepancy reports daily.

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!

The pharmacist will review and sign these reports and
file them with the controlled substance main stock
records.

The staff member completing the sub-stock inventory
certification sheet will return it to the pharmacy. The
pharmacist will review and retain the forms for two years prior
to the last federally mandated biennial inventory. The change of
shift record will include:
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date and time of the count;
signature of off going and oncoming staff; and
exact quantity of all controlled substances on hand in
that sub-stock at that time.

The use of automated medication administration cabinets (e.g.
SureMed, Pyxis) negates the necessity for shift inventories,
proof of use sheets, and disposition sheets for DEA controlled
substances, needles, and syringes.
All inventories and listings in the controlled substance
records will be exact using tablets, capsules, vials, etc., not
in units of bottles or other bulk measurements.
When a Chief Pharmacist permanently departs from an
institution, he/she and the oncoming Chief Pharmacist (or the
acting Chief Pharmacist or the HSA) will complete an immediate
inventory of:
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main stock controlled substances;
perpetual inventory;
purchase orders;
federal order forms;
receivers; and
invoices.

When a newly selected Chief Pharmacist arrives at an
institution, he/she and the HSA will complete a similar inventory
immediately.
Controlled substances in sub-stocks are to be used for
administration only. Any dispensing of controlled substances
will be accomplished through main stock.
e. Security. The DEA, per 21 CFR Part 1301.72, requires
safeguarding and accounting for all controlled substances.

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!

Main stock controlled substances will be stored in a
vault or safe.

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Sub-stock controlled substances will be stored in a
stationary, approved steel cabinet with two separately
key-locked steel doors, a safe with a keyed padlock, or
an automated medication cabinet (e.g., SureMed, Pyxis).

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When a controlled substance requires refrigeration, the
medication must be secured in a locked refrigerator or
in a locked drawer within the refrigerator.

f. Biennial Inventory. The Controlled Substances Act requires
each registrant to make a complete and accurate record of all
controlled substance stock on hand every two years. The Chief
Pharmacist will complete the biennial inventory on the date
mandated by federal law (May 1 of odd-numbered years for
institutions registered before May 1, 1971; for institutions
registered after May 1, 1971, every two years on the date of the
initial inventory).
The actual taking of the inventory will not vary more than four
days from the biennial inventory date. The Chief Pharmacist will
maintain the inventory with the controlled substances records.
The inventory record must:
(1)

List the registrant’s name, address, and DEA
registration number;

(2)

Indicate the date and time the inventory is taken
(i.e., opening or close of business);

(3)

Be signed by the person or persons responsible for
taking the inventory;

(4)

Be maintained at the location appearing on the
registration certificate for at least two years prior
to the last federally mandated inventory;

(5)

List the name of each controlled substance;

(6)

List the dosage form and unit strength of each
controlled substance;

(7)

List the number of units in each container of each
controlled substance;

(8)

List the number of each container of each controlled
substance;

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(9)

Separate Schedule II controlled substances from all
others; and

(10) Include main stock and all sub-stocks.
g. Additional Auditing Requirements. Corrected or amended
medication orders may not be processed for controlled substances.
A new medication order will be written.
Any record keeping error will be corrected by the person who
made the error by drawing one line through the error, writing an
explanation directly below, and initialing. Errors may not be
"blacked out.”
(1)

Theft or Loss. Any incident of theft or loss must be
documented by the individual discovering it. A copy of
the documentation will be sent to the Chief Pharmacist
for review and filing. The Chief Pharmacist will in
turn send a memo to the HSA, with a copy to the Warden.
The Warden will notify the DEA via DEA Form 106.
In accordance with 21 CFR 1301.76(b), the DEA Form 106
must contain:
(a)
(b)
(c)
(d)
(e)
(f)
(g)

Name and address of the facility;
DEA Registration Number;
Date of the theft;
The fact that the local police department was
notified;
The type of theft;
A list of the symbols or cost code (if any) used
by the facility; and
A list of the controlled substance(s) missing.

The report is made in triplicate. The pharmacy keeps
the original copy, and forwards the other two copies to
the Regional DEA Office.
(2)

Controlled Substances Inventory Team. The HSA will
designate, in writing, a Health Services supervisor as
Chair of the Quarterly Controlled Substances Inventory
Team. The Controlled Substances Inventory Team will
consist of the chair and at least one other supervisor.
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The Chief Pharmacist will be a technical advisor
and will be present during the inventory, but may
not be a team member.

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(3)

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The team will conduct a quarterly count of all
main stock controlled substances.

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Each team member will then sign the Quarterly
Controlled Substance Audit Team Certificate form
to be filed with the controlled substance records.
A copy of this form does not need to be sent to
the BOP Chief Pharmacist.

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This count may be done at anytime within the time
frame of the quarter.

Quarterly Report. At the end of each quarter, the
Chief Pharmacist will complete a Quarterly Report for
Narcotics and other Controlled Substances inventory
form. An electronic copy will be submitted to the BOP
Chief Pharmacist within 30 days of the end of the
quarter. Each quarterly report will reflect the usage
pertaining to the following dates (variance from these
dates will not be allowed):
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1st Quarter = October 1 to December 31
2nd Quarter = January 1 to March 31
3rd Quarter = April 1 to June 30
4th Quarter = July 1 to September 30

h. Disposal. The Chief Pharmacist or designee will dispose of
controlled substances when necessary, in the manner prescribed by
the DEA in 21 CFR 1307.21.
This disposal will be accomplished in one of two methods:
(1)

Request from the Special Agent-in-Charge at the
Regional DEA Office, in writing, that permission be
granted for the facility to self-dispose of controlled
substances; or

(2)

By transfer to a DEA approved vendor that is certified
to dispose of controlled substances.

DISPENSING AND ADMINISTRATION

9.

a.

Definitions
(1)

Administration is defined as providing one dose of
medication to be applied or consumed immediately.

(2)

Dispensing is defined as placing multiple doses in a
properly labeled container for use over a period of

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Page 17
time, i.e., filling a medication order. Dispensing is
the act of prospectively reviewing the medication order
as described in Section 7.e.
!

(3)

Only pharmacists may dispense medications.

Distribution is defined as physically handing a filled
medication order or OTC (over-the-counter) product to
an inmate. Any health care provider who has completed
the Pharmacy Training and Orientation Program can
distribute or administer medications.

b. Prescribing Restrictions. All DEA controlled substances,
psychiatric medications, and other medications restricted to
“physician use only” by the BOP National Formulary prescribed by
a MLP must be countersigned by a staff physician before the
medication order may be processed and dispensed.
!

Local policies will address a process of review in the
absence of a full time physician.

c. Options During the Absence of the Pharmacist. During
periods when a pharmacist is not available (e.g. annual refresher
training, CME, etc.) one of the following options will be used:
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Contracting (Amend Existing Contract).
Incorporate a requirement for pharmacist back-up
coverage in the comprehensive medical contract.

!

Contracting (Establish Separate Contract).
Contract with a firm that is capable of providing
temporary pharmacist services using open market
procurement procedures or existing Federal Supply
Schedules (FSS). The Bureau of Prisons
Acquisition Policy (BPAP), Part 37, stipulates
various requirements relating to using private
sector temporary services. The Chief Executive
Officer and Regional Director must approve a
written justification prior to the acquisition.

!

Interagency Agreements. Establish an interagency
agreement with another government agency (e.g., VA
or DOD) to provide pharmacist coverage on an “as
needed” basis.

!

TDY Within the Bureau. Arrange/plan for TDY
pharmacist assistance from another Bureau
institution with more than one pharmacist.

P6360.01
1/15/2005
Page 18
!

Use PHS Officers from Outside the Bureau. Secure
TDY assistance from PHS officers assigned to other
government agencies. (The institution needing the
pharmacist is responsible for travel, lodging, and
per diem.) The BOP Chief Pharmacist can help
identify pharmacists in this category or use a PHS
inactive reserve corps officer through the BOP-PHS
liaison and the PHS Inactive Reserve Coordinator.

!

Obtain the Services of a Second Pharmacist for
larger institutions, particularly those with a
satellite camp or FDC. In this situation,
pharmacy hours of operation could be extended,
vacations, training, and sick leave covered, and
quality services can be maintained.

Physicians are responsible for diagnosing and treating patients
and may only dispense medications in emergency situations. All
of the above options must be actively pursued and exhausted.
Institutions without the services of a pharmacist for more than
three days will contact the Medical Director for guidance.
d. Administration. To ensure that medications are actually
consumed at pill line, the following procedures will be followed.
!

The pharmacist or pharmacy technician will prepare a
CIPS-generated Medication Administration Record (MAR)
sheet for use at pill line.

!

The person administering the medication will identify
each inmate by examining two forms of identification
(e.g. photo ID, DOB, registration number, name, etc.)
of anyone who arrives to receive medication.

!

The inmate will swallow the dose of medication and the
water while being observed directly by the staff
member.

!

The inmate will then show the empty dose cup and water
cup to the person conducting pill line before disposal.

!

The inmate will be asked to open his/her mouth to show
that the medication has not been “cheeked” before
leaving the window.

!

Medications should not be removed from their packaging
or labeling until being administered.

P6360.01
1/15/2005
Page 19
!

The administration of medication should be documented
in the MAR after it is completed.

!

When an inmate refuses to take a prescribed pill line
or inpatient administered medication, or is a
“no-show,” that decision will be documented on the MAR.

Unless local institution security requirements dictate
otherwise, medication dispensing will be in light-resistant,
moisture-resistant vials and not plastic bags.
e. DEA Controlled Substances. The physician or dentist will
initiate or countersign the medication order in the health record
which will include:
!
!
!
!
!

controlled substance;
DEA number;
strength;
directions; and
duration of therapy.

Health Services staff may accept a verbal order, but the
physician or dentist must countersign the verbal order within 24
hours or by the close of the next workday.
Schedule II controlled substance orders will be valid for 72
hours only (with the exception of detox medications). Schedule
III, IV, and V orders may be written for not more than 30 days.
!

An exception to this requirement is when DEA controlled
substances are used for seizure disorders unless
otherwise restricted in the BOP National Formulary.
Then, medication orders can be written for up to 180
days.

!

All orders for controlled substances used for hypnotic
purposes will be valid for not more than seven days.

!

All orders for substances (Schedule II - V) used in
cases of chronic or terminal illness resulting in
unremitting pain not likely to abate in the short term
and drugs used for narcolepsy or ADHD will be valid for
up to 30 days.

!

All such orders must be supported by on-going
documentation in the health record or inpatient record.

P6360.01
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Page 20
Accountability. Consistent with 21 CFR, Part 1300, Section
1304.4, the Chief Pharmacist will maintain all records
pertaining to purchase, administration, inventory, and
audits for at least two years prior to the most recent
federal biennial inventory. These records will be kept in a
vault, safe, or other secure area. No other items may be
stored with DEA controlled substances or their records.
!

Daily, the pharmacist will generate a CIPS
controlled substance report. The report will be
maintained with other controlled substance
documentation in accordance with DEA regulations.

Controlled substances that are damaged, expired, or
retrieved from inmates through R/D will be segregated in the
safe from other controlled substances.
!

A separate “Outdate & Confiscate” log will serve
as an inventory as long as the medications are in
the facility.

Ordinarily, all DEA controlled substances taken by mouth
will be crushed or administered in liquid form. Pharmacy
staff will issue crushed medication in single dose packaging
already crushed.
f. Restricted Drugs. Restricted drugs are defined as non-DEA
controlled drugs that may be abused or those that require
Directly Observed Therapy (DOT). Ordering, prescribing,
dispensing, and accounting for restricted medications will be in
accordance with local and Bureau procedures.
The Chief Pharmacist will ensure that medication is not subject
to excessive exposure to heat, light, and moisture.
All restricted drugs to be taken by mouth will be administered
in single doses, and swallowed in the presence of an employee to
ensure that the medication is ingested, in accordance with the
procedures outlined in Section 9.d.
g. Medication Orders. A medication order is any medication a
health care practitioner orders for a patient. A health care
practitioner will reevaluate each medication order prior to
writing a renewal order.

P6360.01
1/15/2005
Page 21
!

All medication orders for chronic care medications are
valid for no more than 30 days with five refills
totaling 180 days (except for controlled substances
unless used for seizure control and other medications
specifically restricted by the BOP National Formulary).

!

When available, the Prescriber Order Entry (POE) will
be used to prescribe and process all medication orders.
This does not negate the need for the pharmacist to
have access to the patient’s health record.

!

Local CIPS data will be backed up each work day.

All institutions will have a system(s) in place for ensuring
medications not picked up by inmates are logged into the CIPS
computer system along with documentation in the inmate health
record.
The distribution of drug samples within the institution is
prohibited.
A staff physician will review and cosign orders written by
consultant physicians.
!

The pharmacy department will have a means to identify
the signatures of all staff practitioners authorized to
prescribe.

When an inmate is hospitalized, undergoes surgery, or is
transferred from outpatient to inpatient status, or inpatient to
outpatient status, current drug orders are to be discontinued
automatically.
!

Local procedures will determine automatic stop orders
for drugs in other circumstances. (Stop order dates
for DEA controlled substances are addressed in
Section 9.e.

All medications arriving with inmates through receiving and
discharge as new commitments will be given to the Chief
Pharmacist or designee.
!

The Chief Pharmacist will dispose of all DEA controlled
substances in a manner prescribed by the DEA.

!

Pharmacy staff will dispose of all other medications
according to local procedures.

P6360.01
1/15/2005
Page 22
!

During the intake screening process, health care staff
will determine the need for any medication orders. The
Pharmacy will ensure that adequate supplies are on hand
prior to disposal. These medications, if appropriate,
will be administered on pill line until the pharmacy is
able to obtain the drug(s).

!

An inmate may retain medications prescribed by another
Bureau institution if they are not otherwise restricted
by policy (e.g. controlled substance).

h. Medications for Inmates in Special Housing Units (SHU).
Every workday, the Chief Pharmacist will obtain a list of all
inmates placed in a SHU during the previous 24 hours (e.g.
SENTRY, Operations Lieutenant). Using this list, the pharmacist
will issue current medication(s) and ensure the MAR is available
for administration of all restricted medications during SHU
rounds.
!

Local procedures will be developed and negotiated to
retrieve the inmate’s confiscated medication. Health
Services staff will determine if the medication should
be administered or redistributed to the inmate, if
appropriate.

!

Local policies and procedures will stipulate the
medication(s) and amount (number of days) an inmate in
SHU may maintain in their cell.

!

Under no circumstances will medication be locked up
with the inmate’s property, thrown in “hot trash,” or
distributed or administered to an inmate by anyone
other than a health care provider.

i. Psychiatric Medication. Refer to Program Statement on
Psychiatric Services for procedures on obtaining informed
consent, non-compliance, and patient counseling.
Informed consent will be obtained and documented before
dispensing or administering psychiatric medication. Ordinarily,
the prescribing physician will be responsible for obtaining the
informed consent.
!

Psychiatric medication for a current DSM Axis III
diagnosis does not require an informed consent (e.g.
amitriptyline for trigeminal neuralgia or headache
disorder), but does require routine patient counseling
procedures.

P6360.01
1/15/2005
Page 23
(1)

Continuity of Care. All institutions will have a
system(s) in place for ensuring continuity of care for
all inmates receiving psychiatric treatment. This
system will include:
!
!
!
!

(2)

Review of psychiatric history prior to
incarceration;
Review of psychiatric treatment prior to
intra-system transfer;
Monitoring compliance with psychiatric
medications; and
Maintaining documented informed consent in the
health record.

Non-Compliance. All institutions will have a system(s)
in place for timely notification of noncompliance.
Such notification will be made to the CD and other
relevant mental health staff, such as the Chief of
Psychology, treating staff, or contract psychiatrist.
!

At Psychiatric Referral Centers (PRCs), the
treating psychiatrist and Chief Psychiatrist will
be informed of any noncompliance issues.

j. OTC Medications.
Counter Medications.

See the Program Statement on Over-the-

k. Outdated Medications. The Chief Pharmacist will maintain
adequate records and procedures to ensure that outdated
medications are not used.
!

Expired medications must be stored separately.

!

Expiration dates will be the last day of the month
unless otherwise specified.

!

Local procedures will be written for disposal of
expired medications.

When multi-dose vials of injectable medications are opened, the
expiration date will be regarded as the manufacturer’s expiration
date as long as aseptic technique is used, unless otherwise
stated by the manufacturer in the package labeling.
l. Hormone Maintenance Drugs.
on Patient Care.

Refer to the Program Statement

m. Investigational/Experimental Drugs.
Statement on Patient Care.

Refer to the Program

P6360.01
1/15/2005
Page 24
10.
a.

MEDICATION ERRORS
Definitions
(1)

A medication error is a dose of medication that
deviates from the physician’s order as written in the
inmate’s health record or from the expected standard of
care, or institution policy and procedures.
!

(2)

With the exception of errors of omission, the
patient must actually receive the drug for the
incident to be classified as a medication error.

A potential error is a mistake in prescribing,
dispensing, or planned medication administration that
is detected and corrected through intervention, by
another health care provider or the inmate, before
actual medication administration.
!

Documentation of instances in which an individual
has prevented the occurrence of a medication error
will help identify system weaknesses and reinforce
the importance of multiple checks in the
medication use system.

b. Types of Medication Errors. Based on the American
Society of Health Systems Pharmacists (ASHP) Guidelines,
medication errors will be categorized as follows:
!

Prescribing Error. An incorrect drug selection (based
on indicators, contraindications, known allergies,
existing drug therapy, and other factors), dose, dosage
form, quantity, route, concentration, rates of
administration, or instructions for using a drug
product ordered or authorized by a physician (or other
legitimate prescriber). This includes illegible
medication orders that lead to errors that reach the
patient.

!

Omission Error. The failure to administer an ordered
dose to a patient before the next scheduled dose, if
any.

!

Wrong Time Error. Administration of a medication
outside a predefined time interval from its scheduled
administration time.

P6360.01
1/15/2005
Page 25
!

Unauthorized Drug Error. Administration to the patient
of medication not authorized by a legitimate prescriber
for the patient.

!

Improper Dose Error. Administration to the patient of
a dose that is greater than or less than the amount
ordered by the prescriber or administration of
duplicate doses to the inmate.

!

Wrong Dosage Form Error. Administration to the patient
of a medication in a different dosage form than ordered
by the prescriber (e.g., intramuscular instead of
intravenous).

!

Wrong Drug-Preparation Error. Medication incorrectly
formulated or manipulated before administration.

!

Wrong Administration Technique Error. Inappropriate
procedure or improper technique in the administration
of a drug.

!

Deteriorated Drug Error. Administration of a
medication that has expired or for which the physical
or chemical dosage form integrity has been compromised.

!

Monitoring Error. Failure to review a prescribed
regimen for appropriateness and detection of problems,
or, failure to use appropriate clinical or laboratory
data for adequate assessment of patient response to
prescribed therapy.

!

Compliance Error. Inappropriate patient behavior
regarding adherence to a prescribed medication regimen.

!

Other Medication Errors. Any medication error that
does not fall into one of the above predefined
categories.

c. Applicability and Procedures. Listed below are the
required elements of the institution’s Medication Error Program.
The Pharmacy Technical Reference Manual (TRM) should be used as a
reference for the institution program.
!

The monitoring and reporting of medication errors will
be conducted in a blame-free manner and focus primarily
on systems and continuous quality improvement
activities rather than on individuals.

P6360.01
1/15/2005
Page 26
(1)

Organizational Responsibilities. Sufficient personnel
must be available to perform tasks adequately and a
suitable work environment must exist for preparing drug
products.
!

Lines of authority will be clearly defined for
medication ordering, dispensing, and
administration.

A formal Drug Use Evaluation (DUE) program will be
integrated and coordinated with the overall institution
Quality Improvement Program (QIP). The institution's
QIP will include monitoring, evaluation, and resolution
of problems in the area of quality and appropriateness
of patient care services the pharmacy department
provides.
!

Pharmacists and others responsible for processing
medication orders will have routine access to
appropriate clinical information and patients
(including medication, allergy and
hypersensitivity profiles; diagnoses; pregnancy
status; and laboratory values) to help them
evaluate the appropriateness of medication orders.

Pharmacists will maintain medication profiles for all
patients, both inpatients and ambulatory patients, who
receive care at the institution. This profile will
include adequate information to allow monitoring of the
following:
!
!
!
!
!
!

medication histories;
allergies;
potential drug interactions and Adverse Drug
Reactions (ADRs);
duplicate drug therapies;
pertinent laboratory data; and
other information.

The Pharmacy Department must be solely responsible for
procuring, distributing, and controlling all drugs used
within the organization.
!

The preferred administration method is the unit
dose drug distribution and control system.

P6360.01
1/15/2005
Page 27
!

Comprehensive policies and procedures that provide
for efficient and safe distribution of all
medications and related supplies to patients will
be established.

!

Except in emergencies, all sterile and non-sterile
drug products will be dispensed from the pharmacy.

!

The storage of non-emergency floor stock
medications on the nursing units or in other
patient care areas will be limited to OTCs and
stat dose quantities of selected drugs.

!

Only abbreviations approved in the Program
Statement on Health Information Management may be
used.

The telephone number of the local poison control center
will be displayed prominently in the pharmacy and
readily available in areas where medications are
dispensed/administered.
The pharmacy department, in conjunction with nursing,
risk management, QIP, and the medical staff, will
conduct ongoing educational programs to discuss
medication errors, their causes, and methods to prevent
their occurrence.
(2)

Prescriber Responsibilities. Prescribers will evaluate
the patient’s total status and review all existing drug
therapy before prescribing new or additional
medications.
!

Prescribers will be familiar with the medication
use system in place within the institution (e.g.,
the formulary system, DUE programs, allowable
delegation of authority, procedures to alert
nurses and others to new drug orders, standard
administration times, and approved abbreviations).

Medication orders written in the health record and
inpatient record, must be complete and will include:
!
!
!
!
!
!

drug name;
route and site of administration;
dosage form;
dose;
strength;
frequency of administration;

P6360.01
1/15/2005
Page 28
!
!

duration of therapy; and
prescriber’s name.

In some cases, a dilution, rate, and time of
administration should be specified.
Prescribers will write legible medication orders. An
illegible handwritten order will be returned to the
prescriber and regarded as a potential error.
Medication orders will include specific instructions
rather than using non-standard or ambiguous
abbreviations. Specific instructions help
differentiate among intended drugs.
!

Medication orders will include standard
nomenclature, using the drug’s name. Avoid
locally coined names (e.g., Dr. Doe’s compound);
chemical names; unestablished abbreviated drug
names; acronyms; and apothecary or chemical
symbols.

!

Always use a leading zero before a decimal
expression of less than one (e.g., 0.5 ml).

!

A terminal zero will not be used (e.g., 5.0 ml).

Ordinarily, verbal orders will be reserved for
emergency situations. When it is impossible for the
provider to write the order, the following must occur:

(3)

!

The health care provider will read the order back
to the prescriber to confirm it.

!

The health care provider receiving the verbal
order will write the order in the patient’s health
record.

!

The prescriber will confirm the order by signing
the chart entry within 24 hours or the next
working day.

Pharmacist Responsibilities. Pharmacists will
participate in drug therapy monitoring and DUE
activities to help achieve safe, effective, and
rational use of drugs.
Pharmacists must be familiar with the medication use
system in place within the institution, including:

P6360.01
1/15/2005
Page 29
!
!
!
!
!

the formulary system;
DUE programs;
allowable delegation of authority procedures;
procedures to alert health care providers and
others to new drug orders;
standard administration times;

Each institution will have a local policy outlining
procedures to be followed for “hold” orders.
Before dispensing medications in non-emergency
situations, the pharmacist will review an original copy
of the written medication order. Pharmacists will have
a system for self-checking the reading of medication
orders, labeling, and dosage calculations.
!

When possible, for high risk drug products, all
work should be double checked by another member of
the pharmacy staff (e.g., injectable/IV
admixtures, cancer medications).

Pharmacists will dispense medications in ready-toadminister dosage forms whenever possible. Pharmacists
will ensure timely delivery of medications to the
patient care area after receipt of the orders.
!

If medications doses are not delivered or therapy
is delayed pending resolution of a detected
problem (e.g., allergy or contraindications), the
pharmacist will inform the health care staff of
the delay and the reason.

Pharmacy staff will review medications that are
returned to the department. Such review processes may
reveal system breakdown or problems that resulted in
medication errors (e.g., omitted doses and unauthorized
drugs).
c. Monitoring and Managing Medication Errors. The staff
member identifying the error will report potential and actual
medication errors on the Medication Error form (BP-S795). The
electronic version of this form will be used when available.
(1)

Physician notification will be made when clinically
indicated.
The Medication Error form will be submitted to the
institution Chief Pharmacist who will report this
information to the QIP Coordinator.

P6360.01
1/15/2005
Page 30
(2)

The QIP coordinator will furnish a copy of the
Medication Error Report or a summary of all reports, to
the HSA.

(3)

After reviewing the available information, the HSA,
Clinical Director, and Chief Pharmacist may determine
that immediate intervention (e.g. further education) is
necessary to prevent further repeats of the same or
similar error, rather than wait on the conclusions of
the P&T Committee.
Medication Error Severity Ratings

Level 0

No medication error occurred (potential errors rated
Level 0))

Level 1

An error occurred that did not result in patient harm

Level 2

An error occurred that resulted in the need for
increased patient monitoring, but no change in vital
signs and no patient harm

Level 3

An error occurred that resulted in the need for
increased patient monitoring with a change in vital
signs but no ultimate patient harm, or,
Any error that resulted in the need for increased
laboratory monitoring

Level 4

An error occurred that resulted in the need for
treatment with another drug or an increased length of
stay

Level 5

An error occurred that resulted in permanent patient
harm (sentinel event)

Level 6

An error occurred that resulted in patient death
(sentinel event)

The QIP coordinator and the Chief Pharmacist will meet at least
quarterly to review the forms collected, analyze, and classify
the errors, and prepare a Medication Error Review Summary
(BP-S796) to report at the P&T Committee.
!
!

This summary will not identify those making the error
by name.
An electronic copy of this summary will be sent to the
BOP Chief Pharmacist for informational purposes.

P6360.01
1/15/2005
Page 31
The P&T Committee will suggest process improvements that result
from the review. Suggestions may include:
!
!
!
!

Conducting organizational staff education;
Making recommendations for staffing levels;
Revising policies and procedures, or
Changing facilities, equipment, or supplies.

d. Error Resolution. All errors will be reviewed and
researched by the QIP coordinator or Chief Pharmacist.
!

The P&T Committee will research errors for correctable
administrative and clinical issues and report
medication errors in the meeting minutes.

In the large majority of cases, one or more of the following
actions are appropriate:
!
!
!

Error discussion;
Staff training; and
Local peer review. (Refer to Program Statement on
Credentialing, Privileging and Practice Agreements)

Reviews should focus on the improvement of performance by
recognizing errors and developing a plan to minimize future
errors.
!

A Focus Review Team should evaluate errors resulting in
permanent patient harm or death (e.g. sentinel events).

11. ADVERSE DRUG REACTION REPORTING AND DRUG RECALL. The Health
Services Division participates in adverse reaction reporting
programs sponsored by the Food and Drug Administration (FDA) of
the Department of Health and Human Services (DHHS).
!

Institutions will use the Adverse Drug Reaction Monitoring
and Prevention Program outlined in the Pharmacy TRM.

!

Drug product defects will be reported in accordance with the
FDA drug product problem reporting program.

!

A drug recall procedure that can be implemented readily,
including provisions for documenting results, will be
initiated.

!

Adverse Drug Reactions and drug recalls will be reported in
the institution P&T Minutes.

P6360.01
1/15/2005
Page 32
12. RELEASE/TRANSFER MEDICATION. When an inmate is transferred
to a CCC, up to a 90 day supply of current medication will be
provided pursuant to a new medication order. The number of days
supplied will be determined on a case-by-case basis, dependent
upon clinical justification and release planning for the inmate
(i.e., insurance, Medicaid, Aids Drugs Assistance Programs (ADAP)
availability).
!

Unless properly justified, a minimum of 30 days supply of
chronic medications will be provided.

!

Inmates requiring DEA controlled substances may be
considered for transfer to a CCC after institution staff
consult with the Community Corrections Manager (CCM) to
determine if the respective CCC can accommodate the inmate’s
special medication needs.

An inmate releasing from custody will be provided a 30 day supply
of medication. The medication, with directions, will be given to
the releasing officer as indicated by local procedure.
!

All release medications will be dispensed in an approved
child-resistant container unless waived by the inmate or
clinically justified (e.g. disability, etc.).

All intra-system transfers will be provided with a minimum seven
day supply of all clinically necessary medications as noted on
the Medical Summary of Federal Prisoner/Alien in Transit form
(BP-S659).
!

On a case-by-case basis, additional medication may be
necessary en route to the next institution, with
consideration given to length of time, mode of travel, and
availability of medication at the next institution.

!

All DEA controlled substances and other items subject to
abuse will be restricted to minimum quantities.

!

An inmate brought in from another Bureau institution
(intra-system transfer) may use medication at the receiving
institution in accordance with local policy.

A copy of the Medical Summary of Federal Prisoner/Alien in
Transit (BP-S659) form may be used to transcribe current
medications.

P6360.01
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Page 33
13. PRIME VENDOR CONTRACT. The national contracts for
medications and pharmaceutical products are mandatory. All
institutions will order from these contracts, which are
applicable for Federal Supply Schedule (FSS), General Services
Administration (GSA), and Blanket Purchase Agreement (BPA)
contract pharmaceutical items.
!

If the items are identified on the computer database as noncontract items, normal procurement procedures will be used;
i.e., purchase from FSS, mandatory source, or open market.

The Chief Pharmacist will implement the prime vendor contract at
the institution. Procedures for delivery and receipt of
medications will be developed locally in conjunction with the
warehouse.
!

Questions that cannot be resolved by the Prime Vendor
regarding the contract will be directed to the BOP Chief
Pharmacist.

!

The Chief Pharmacist will ensure institution compliance with
the Prime Vendor Procedural Guide. A current guide can be
obtained from the Prime Vendor.

Mandatory national contracts exist for selected medications
listed in the National Formulary. In these cases, institutions
must use only the specified brand of the product under contract,
when available.
!

In order to receive the beneficial contracted price, no
institution is authorized to vary from this requirement.

All medications indicated for treatment or manifestations of HIV
and AIDS will be listed separately on a purchase order under
project number 84-U if purchased from a vendor other than the
Prime Vendor. HIV/AIDS medications purchased from the Prime
Vendor will use the project number designated to their respective
region:
NER
SER
NCR

73L
75L
77L

MAR
SCR
WXR

74L
76L
78L

Medications used to treat Hepatitis C Virus (HCV) infection, such
as Interferon Alfa 2B, Interferon Alfa con-1, and ribavirin, will
be ordered using project number 31-J.

P6360.01
1/15/2005
Page 34
Medications other than those to treat HCV or HIV/AIDS will be
ordered from the Prime Vendor using the following project number
designated to their respective region:
NER
SER
NCR

72I
74I
76I

MAR
SCR
WXR

73I
75I
77I

14. NEEDLES AND SYRINGES. The HSA or designee will be
responsible for the control of needles and syringes. The
importance of proper control and use cannot be overstated.
!

All unused needles and syringes in sub-stocks will be
inventoried on each medically staffed shift. For
institutions using computer driven medication stations (e.g.
SureMed or Pyxis) for needle and syringe accountability, the
shift inventories and disposition sheets are not required.

!

Local procedures will specify responsibility for conducting
the inventory.

!

The time the inventory is conducted will be documented.

The only exceptions to the shift inventory requirement are
properly sealed emergency carts or kits or the automated
medication cabinets (e.g. SureMed or Pyxis).
!

Each institution will develop a policy for inventorying
sealed carts on a quarterly basis.

When a discrepancy is noted, a thorough search will be conducted
by the finder of the discrepancy, after attempting to resolve the
discrepancy, for the missing item(s).
!

The finder will report all unresolved discrepancies
immediately to the HSA and the Operations Lieutenant.

!

After the search, a written memorandum to the HSA and
Operations Lieutenant will be prepared by the finder
explaining the details.

Local procedures will identify the party responsible for storing
needles and syringes. All unused sub-stock needles and syringes
will be stored in a separate locked cabinet or drawer, within a
room locked at all times when staff are not present.

P6360.01
1/15/2005
Page 35
!

All main stock inventories of sterile needles and syringes
will be stored in a secure area, and have a perpetual
inventory.

!

Each facility will have suitable storage space.

The HSA will ensure a Certificate of Disposition for Control of
Needles and Syringes is provided for all areas accountable for
these items. The HSA will also ensure local procedures indicate
responsibility for requisition of needles and syringes and for
recording additions to and uses of inventory.
!

Each area of use will have an individualized inventory.

!

For institutions using a computer driven medication station,
the Activities Report will take the place of the Certificate
of Disposition.

The practitioner using or obtaining new supplies of needles and
syringes will subtract or add, as appropriate, from the
inventory.
!

The employee using the needle or syringe will designate on
the form the patient’s name or reason that the item(s) was
used, and sign for the item(s), indicating date and time.

!

Employees will not handle disposed/contaminated syringes,
needles, scalpels, and other accountable items to conduct a
physical count.

!

Staff may check out needles/syringes in small quantities for
specific indications (e.g. lab, insulin line). All unused
needles/syringes will be returned to stock or sub-stock.

Needles and syringes obtained from main stock will be added to
the sub-stock inventory and the new totals brought forward. Substock needles and syringes will be requested from main stock via
a requisition form.
!

Under no circumstance will needles and syringes be stored
with controlled substances.

The Certificate for Disposition for Control of Needles and
Syringes will be collected by the HSA. This documentation will
be retained for two years.
!

The HSA will review and maintain each form for spot-check
inventories of used needles and syringes.

P6360.01
1/15/2005
Page 36
15. PATIENT COUNSELING. The Chief Pharmacist will develop
written procedures to address patient counseling by a pharmacist.
Physical plant considerations will be factored into this plan.
All inmates, whether in the parent institution, SHU, or a
satellite facility, will be provided information on their
medication. Patient counseling will comply with federal and
state regulations.
!

This information may take the form of a written medication
information sheet and/or oral counseling. Every effort
should be made to provide oral counseling when possible.

!

Written medication information sheets may be those developed
by Bureau pharmacists or those available from pharmacy
software program.

!

Oral counseling may be done at the pharmacy window, a
designated counseling area, or the inmate's cell always
being mindful of patient confidentiality.

!

The patient counseling will also consider literacy and
primary language.

The opportunity for oral counseling by a pharmacist will be
offered when new medication is distributed. If not logistically
possible, local procedures will provide an avenue for inmates to
request counseling.
Patient information to be furnished with new medication orders
may include:
!
!
!
!
!
!
!

Name of the Drug;
Indications;
Dosage Instructions;
Significant or common Adverse Effects;
Drug-drug or Drug-food interactions;
What to do if a dose is missed; and
Special instructions (i.e. take with food, will discolor
urine, etc.)

It is not necessary to furnish patient counseling for each
medication refill. However, this provides the pharmacist with an
excellent opportunity to check on patient compliance, drug
effectiveness, and adverse drug reactions.
Patient information for OTC drugs dispensed by a pharmacist may
be on a sheet with other OTC products, and made available in the
Health Services Unit.

P6360.01
1/15/2005
Page 37
16. CHRONIC MEDICATION/SUMMARY SHEET. The chronic medication/
summary sheet is filed under the problem list in Section 2 of the
health record. The chronic medication/summary sheet lists
current medications.
!

Each institution will determine the appropriate format to
meet this requirement (i.e., computerized pharmacy records
available to the prescriber, etc.).

17. METHADONE. The regulations on purchasing, prescribing, and
storing of methadone vary depending on the clinical reason for
its use. There are currently only three approved uses for
methadone within BOP institutions. These uses are:
!
!
!

Treatment of opiate addicted pregnant inmates;
Detoxification of opiate addicted inmates; and
Treatment of severe pain.

a. Treatment/Detoxification. Title 42 CFR 8 requires that any
healthcare facility using methadone for detoxification or
maintenance of opioid addicted patients must have an accredited
behavioral health program in order to maintain a valid license
for the use of methadone. The responsibility for opioid
treatment centers falls under the Substance Abuse and Mental
Health Services Administration (SAMHSA).
There are several options available to institutions regarding
the use of Methadone.
(1)

Institutions may participate in the DEA Narcotic
Addiction Treatment Program by obtaining a methadone
license. This license allows institution physicians to
treat narcotic addicts with a tapering or withdrawal
schedule of methadone for an extended period.
!

Inmates will not be maintained on methadone with
the exception of pregnant inmates.

Institutions which have a methadone license must store
bulk stock methadone in a separate safe from that used
to store other controlled substances.
!

Methadone ordered under this license may only be
used for detoxification purposes. It may not be
used for other diagnoses (e.g. pain management).

!

All records pertaining to purchasing, prescribing,
and administering must be stored separate from
other controlled substance records.

P6360.01
1/15/2005
Page 38

(2)

(3)

(4)

!

If the institution chooses this method, an
application to SAMHSA must be submitted.

!

If the institution chooses to maintain a methadone
license the Chief Pharmacist will be responsible
for the accreditation process. The institution
will be responsible for the corresponding fee.

For institutions without a methadone license, the DEA
allows physicians to prescribe methadone for up to 72
hours, in an emergency, to narcotic addicts.
!

The medication order may not be extended or
renewed for that individual under any
circumstances.

!

This 72 hour window allows for rapid tapering when
an inmate coming into the institution has been
maintained on methadone in the community.

!

In this instance, the main stock of methadone may
be stored with other controlled substances.

!

Documents pertaining to purchase, prescribing, and
administering do not have to be stored separately
from other Schedule II controlled substances.

A contract with a local methadone clinic may be pursued
to supply methadone for detoxification. All
institutions which do not have a methadone license and
could conceivably receive a pregnant female on
methadone will have a contingency plan, such as this,
in place.
!

Any pregnant female arriving at the institution on
methadone needs to be maintained on methadone
until the baby is delivered.

!

Detoxification should be done after delivery.
CD will seek guidance from the BOP Medical
Director.

The

Institutions may choose non-methadone alternative
detoxification protocols either after the 72 hour
window explained in subsection 2. above or upon receipt
of the inmate.

P6360.01
1/15/2005
Page 39
b. Treatment of Pain. Bureau physicians may prescribe
methadone for inmates with severe pain for an extended period.
The procedures for prescribing methadone for pain are the same as
those described in 9.e.
!

When prescribed for severe pain, methadone may be
purchased without a methadone license.

!

Bulk stock methadone may be stored with other
controlled substances.

!

Documents pertaining to purchase, prescribing, and
administering do not have to be stored separately from
other Schedule II controlled substances. However, they
must be "readily recoverable."

!

Ensure that medication orders for methadone clearly
indicate the use for severe/chronic pain in the health
record to avoid any confusion or problems during a DEA
audit.

!

Institutions with a methadone license are not allowed
to order methadone used for pain under the methadone
detoxification license. These inventories must be kept
completely separate.

18. URGENT CARE CARTS. An adequate supply of urgent care drugs
will be maintained in the pharmacy and in designated areas. The
Chief Pharmacist is responsible for all medications located in
the urgent care carts and kits, and for the inspection procedures
used.
!

Approved DEA controlled substances may be maintained on
urgent care carts and will be inventoried by pharmacy staff
at least quarterly or whenever the urgent care cart seal is
broken.

!

Information regarding supplies and medication for the
urgent care carts, based on the level of emergency care
provided, is available from the BOP Chief Pharmacist.

/s/
Harley G. Lappin
Director


U.S. Department of Justice
Federal Bureau of Prisons

Program
Statement

OPI:
NUMBER:
DATE:
SUBJECT:

HSD/HPB
P6370.01
1/15/2005
Laboratory Services

1. PURPOSE AND SCOPE. To ensure medical laboratory services
will be regularly available to meet the needs of inmates at all
Bureau institutions.
Laboratory services are classified into one of three categories;
waived, moderate complexity, or high complexity.
!

Each institution's category will reflect its mission and the
inmate population.

!

The Medical Director will make the initial laboratory
category designation when an institution opens.

2. PROGRAM OBJECTIVES.
are:

The expected results of this program

a. Testing will be performed by qualified health care
personnel.
b. Medical laboratory test reports will be accurate and
timely.
c. Laboratory test results will be reported to inmates as
necessary and incorporated into the inmate’s health record.
Accurate records will be maintained.

e.

Safety and quality control procedures will be enforced.

3.

d.

DIRECTIVES REFERENCED
P4100.04
P6010.02
P6031.01
P6090.01
P6360.01

BOP Acquisitions Manual (5/19/04)
Health Services Administration (1/15/05)
Patient Care (1/15/05)
Health Information Management (1/15/05)
Pharmacy Services (1/15/05)

P6370.01
1/15/2005
Page 2
Clinical Laboratory Improvement Act of 1988 (CLIA`88)
STANDARDS REFERENCED

4.

a. American Correctional Association (ACA) 4th Edition
Standards for Adult Correctional Institutions: 4-4378, 4-4384,
4-4424, and 4-4427
b. American Correctional Association (ACA) 3rd Edition
Standards for Adult Local Detention Facilities: 3-ALDF-4E-04,
3-ALDF-4E-07, 3-ALDF-4E-9, and 3-ALDF-4E-17
5. APPLICABILITY. Institutions other than Medical Referral
Centers (MRCs) will operate only Waived Category laboratories.
!

Institutions currently operational may petition the Medical
Director for review of the current classification.

!

Only upon the Medical Director's approval will the category
of laboratory services be increased or reduced.

6. BUREAU LABORATORY SERVICES AND CLASSIFICATIONS. Use of the
Medical Reference Laboratories (MRL) is mandatory for all Bureau
institutions for initial, routine, and non-emergency patient
management testing.
!

Commercial laboratories will be used only for those tests
not available at the MRLs and for emergency laboratory
services, or in extenuating circumstances if the Medical
Director has approved a waiver.

!

Current documentation will be maintained from the contract
lab demonstrating certification and availability of services
to include a copy of CLIA certification.

!

Laboratory service contracts negotiated with commercial
laboratories will require a provision that the contract
vendor will send a copy of the monthly billing statements
for review to the Bureau’s National Health Systems
Administrator. This copy will be sent at the time the
institution is billed.

Health Services Administrators (HSA) will ensure that all current
national contracts for special laboratory studies, such as CD4
and viral load testing for HIV infection, are used for these
studies.

P6370.01
1/15/2005
Page 3
Each of the regions will be assigned to one of the MRLs by the
Medical Director.
The MRLs will provide collection and packing supplies. Failure
to use MRL provided supplies will result in rejection of
specimens.
!

Specimens must be shipped on the day of collection and can
only be shipped Monday through Thursday using the nationally
contracted overnight service (i.e. Federal Express).

!

Specimens should not be shipped the day before a Federal
holiday.
DEFINITIONS

7.

a.

Specimen Collection procedures include:
!
!
!
!
!

b.

venipuncture using appropriate anticoagulant and/or
additive for required analysis;
capillary puncture;
collection of urine specimens for urinalysis and
chemistry analysis;
collection of parasitology specimens (feces and blood);
and
collection of bacteriology specimens for culture for
procedures referred to Reference Laboratories.

Specimen Processing procedures include:
!
!
!

specimen preservation;
specimen processing and separation; and
preparation for transportation for procedures referred
to appropriate Reference Laboratories.

8. LABORATORY MANUALS. The director of the laboratory must
approve, sign, and date any policies and procedures manuals. All
laboratory policy and procedures will be reviewed annually and
revised as necessary. Local laboratory policy and procedure
manuals will be negotiated in accordance with the Master
Agreement.
a. Laboratory Policy Manual. There will be a written policy
manual for laboratory services. This policy manual must be
reviewed annually. Policy will include, but not be limited to:
!
!

scheduling of tests;
required records and reports;

P6370.01
1/15/2005
Page 4
!
!
!
!
!

safety;
infection control;
chemical hygiene plan;
OSHA Bloodborne Pathogen guidelines; and
Quality Assurance.

b. Laboratory Procedure Manual. A written procedure manual
for performing all analytical methods the laboratory uses must be
readily available and followed by laboratory personnel. This
manual will be reviewed annually.
!

Textbooks may be used as supplements to these written
descriptions, but may not be used in lieu of the
laboratory's written procedures for testing or
examining specimens.

!

Manufacturers' package inserts or operator manuals may
be used, when applicable, to meet the requirements of
this section.

c. Technical Reference Manual (TRM). The TRM lists all tests
available at the MRLs, the procedures for specimen collection and
processing, packing and shipping instructions, and procedures for
reporting test results. MRL supervisors will conduct an annual
review of the TRM.
9. LABORATORY FORMS. MRLs will format their own laboratory
report forms. Laboratory reports must be legible, accurate,
timely, and results must be reported in clearly designated units
of measurement. Reference values are to be provided with each
laboratory test result.
All laboratory analyses must be ordered in writing (by electronic
or manual methods) on the appropriate forms. Requests will
include the following information, clearly and legibly typed,
stamped, or printed:
!
!
!
!
!
!

Inmate's full name and complete registration number;
Name of the requesting individual;
Full name and address of the institution;
All tests required;
Date the specimen was collected and the time of collection
if relevant; and
Source of the specimen (e.g., culture, site, etc.).

All MRLs will have compatible Laboratory Information Systems
(LIS) approved by the Medical Director. MRLs with LIS may
maintain some or all of this required information electronically.

P6370.01
1/15/2005
Page 5
10. REPORTS. Test reports will include all of the information
on the request form listed above (Section 9). Information will
be available regarding:
!
!

Date and time received by the MRL; and
Date and time analysis reported by the MRL.

Authenticated, dated reports of all examinations performed by the
pathology and medical laboratory services will be made a part of
the patient's health record.
!

The name, address, and phone number of the laboratory
performing the analysis will be included on each report.

Each institution will develop a local procedure for reviewing and
acting upon abnormal laboratory values. Qualified health
personnel will use good clinical judgement to determine the need
to personally inform an inmate of an abnormal laboratory value.
Notations regarding significant laboratory or pathology
abnormalities will be made in the Chronological Record of Medical
Care (SF-600).
!

A physician will review, initial, and date all laboratory
reports prior to filing in the health record.

Each institution pathology and medical laboratory service will
maintain a daily accession record of specimens collected,
specimens processed, and an appropriate identification system for
each. The accession record will include at least:
!
!
!

Patient identification;
Identification of the practitioner ordering the test; and
Test or evaluation performed.

The daily accession record may be maintained electronically.
The performing laboratory will maintain duplicate copies of all
pathology and medical laboratory services testing and
examinations in a readily retrievable manner. Requirements for
record retention are determined by Federal, state, and local
regulations. All laboratory records and patient reports will be
maintained according to the following table:
Record/Material
Test requisitions
Test records
Immunohematology

Period of Retention
2 years
2 years
5 years

P6370.01
1/15/2005
Page 6
Test reports
Pathology
Proficiency testing

2 years
10 years
2 years

11. CLASSIFICATIONS. In accordance with the CLIA`88, all Bureau
institution laboratories must meet strict laboratory testing
standards. The Bureau's laboratories are subject to inspection
by surveyors from the College of American Pathology (CAP) and/or
the Joint Commission on the Accreditation of Healthcare
Organizations (JCAHO).
Classifications are as follows:
!
!
!

Waived
Moderate Complexity
High Complexity

The following indicates the Laboratory Services generally
provided in each of the classification categories.
a.

Classification Category:
!

Specimen Collection

!

Specimen Processing for referral to MRLs or contract
laboratories

!

Waived Tests as defined by CLIA`88 as Classification
Category Waived to meet the needs of the institution’s
health services program. Examples of waived tests
include:
•
•
•
•
•
•

b.

Waived

dipstick urinalysis;
finger stick glucose testing;
erythrocyte sedimentation rate (ESR) testing;
fecal occult blood testing;
spun hematocrit testing; and
Hgb Ac (if equipment is available).

Classification Category:

Moderate Complexity

!

Specimen Collection

!

Specimen Processing for referral to MRLs or commercial
laboratories.

!

Waived tests as defined in Classification Category
Waived

P6370.01
1/15/2005
Page 7
!
c.

12.

Moderate Complexity tests as defined by CLIA `88
regulations and updates.

Classification Category: High Complexity
!

Specimen Collection

!

Specimen Processing for referral to MRLs or commercial
laboratories

!

Waived tests as defined in Classification Category
Waived

!

Moderate Complexity tests as defined by CLIA 88
regulations and updates.

!

High Complexity tests as defined by CLIA 88 regulations
and updates.

!

Accredited by the College of American Pathologists
(CAP).

PERSONNEL REQUIREMENTS AND RESPONSIBILITIES

a. Category Waived. There are no CLIA requirements for a
Laboratory Director, Technical Consultant, or Clinical Consultant
for Waived Category laboratories.
b.

Category Moderate Complexity

(1) Laboratory Director. The laboratory director, if
qualified, may perform the duties of the technical consultant,
clinical consultant, and testing personnel, but can direct no
more than five laboratories.
Individuals with the following qualifications may be
laboratory directors:
!
!

Pathologist
Other licensed Medical Doctor (MD) or Doctor of
Osteopathic Medicine (DO) with:
(1)
(2)
(3)

one year experience directing/supervising
non-waived tests; or
by August 1993, have at least 20 CME credit hours
in laboratory practice commensurate with director
responsibilities; or
laboratory training during residency equivalent to
above (2), or certification in hematology or
hematology/oncology.

P6370.01
1/15/2005
Page 8
!

Doctor of Philosophy (PhD) in science with:
(1)
(2)

!

Master's in science with:
(1)
(2)

!

laboratory related board certification; or
one year full-time experience supervising
non-waived testing.

one year laboratory training or experience; and
one year supervisory experience.

Bachelor's in science with:
(1)
(2)

two years laboratory training or experience; and
two years supervisory experience.

!

On or before February 28, l992, qualified or could have
qualified as a laboratory director under
March 14, 1990, Medicare/CLIA 67 rules; or

!

On or before February 28, 1992, qualified under state
law to direct a laboratory in the state.

(2) Technical Consultant. The technical consultant is
responsible for the laboratory’s technical and scientific
oversight. Technical consultant requirements for laboratory
training or experience may be acquired concurrently in more than
one of the specialties (e.g., the pathologist or medical
technologist with experience can consult in each specialty).
The technical consultant is not required to be on-site at
all times, but must be available to the laboratory as needed.
Individuals with the following qualifications may be technical
consultants:
!

Pathologist;

!

Other MD or DO with one year of laboratory training or
experience in the specialty or subspecialty for which
they are responsible;

!

PhD or Master's degree in science and one year
laboratory training or experience in specialty for
which they are responsible; or

!

Bachelor's degree in science or medical technology with
two years laboratory training or experience in the
specialty for which they are responsible.

P6370.01
1/15/2005
Page 9
(3) Clinical Consultant. The clinical consultant provides
consultation to the laboratory's clients concerning the
diagnosis, treatment, and management of patient care including
appropriateness of testing ordered. The clinical consultant must
prepare a written report after each visit to the institution.
Individuals with the following qualifications may be clinical
consultants:
!
!

MD, DO, or PhD who qualifies as a laboratory director;
or
Licensed MD or DO.

(4) Testing Personnel. Testing personnel must be at least
a high school graduate or equivalent with "documented training"
appropriate for the testing the laboratory performs. Knowledge
about specimen collection, proper instrument use, and the
assessment of validity of patient test results is required.
c.

Category High Complexity

(1) Laboratory Director. Individuals with the following
qualifications may be a laboratory director:
!

Pathologist;

!

Other MD or DO with:
(1)
(2)

!

one year laboratory training or residency (e.g.,
physicians with board certification in
hematology); or
two years experience directing or supervising high
complexity testing.

PhD with:
(1)
(2)

(3)

(4)

certification in one of the laboratory
specialties; or
until September 1994, have two years laboratory
training or experience, and two years experience
directing or supervising high complexity testing.
By the end of two years must become
board-certified; or
On or before February 28, 1992, be serving as a
laboratory director and previously qualified or
could have qualified under March 14, 1990, rules
(Medicare/CLIA 67); or
On or before February 28, 1992, qualified under
state law to direct a laboratory in the state.

P6370.01
1/15/2005
Page 10
(2) Technical Supervisor. The laboratory must employ one
or more individuals qualified by education and either training or
experience to provide technical supervision for each of the
specialties and sub-specialties of service in which the
laboratory performs high complexity testing. Requirements for
laboratory training or experience in each of the specialties or
sub-specialties may be acquired concurrently.
The technical supervisor is not required to be on-site at
all times but must be available to laboratory as needed. Time in
the laboratory must be adequate to supervise the technical
operation.
If the pathologist director is not board certified (or
eligible for certification) in both anatomic and clinical
pathology and the laboratory performs tests in the specialties of
Microbiology (bacteriology, mycobacteriology, mycology,
parasitology, virology), Diagnostic Immunology, Chemistry,
Hematology, and Radiobioassay, the qualifications for technical
supervisor are:
!

Pathologist, board certified or eligible for
certification in clinical pathology; or

!

Other MD or PhD in science with one year laboratory
training or experience within the specialty (e.g.
Microbiology), with at least six months of experience
in the applicable subspeciality (e.g., bacteriology,
mycology); or

!

Master's degree in science with two years laboratory
experience or training in the specialty and a minimum
of six months spent acquiring proficiency in the
applicable subspecialty; or

!

Bachelor's degree in science with four years training
or experience in the specialty, with a minimum of six
months experience in the applicable subspecialty.

(3) Clinical Consultant. The clinical consultant provides
consultation on appropriateness of tests ordered and
interpretation of test results.
Individuals with the following qualifications may be
clinical consultants:
!

MD, DO, or PhD qualified as a laboratory director for
high complexity testing or

P6370.01
1/15/2005
Page 11
!

Licensed MD or DO.

(4) General Supervisor. The general supervisor must be
accessible to testing personnel whenever testing is performed and
provide on-site supervision of testing personnel and reporting of
test results.
For blood gas analysis, the general supervisor must have at
least a bachelor's degree in respiratory therapy and one year of
training or experience; or have an associate degree related to
pulmonary function and two years of training or experience.
Individuals with the following qualifications may be a general
supervisor:
!

MD, DO, or PhD, master's, or bachelor's degree in
science and with one year of laboratory training or
experience in high complexity testing; or

!

Associate degree in a laboratory science or medical
laboratory technology and two years laboratory training
or experience in high complexity testing; or

!

Previously qualified or could have qualified as a
general supervisor under March 14, 1990, rules
(Medicare/CLIA 67) on or before February 28, 1992.

(5) Testing Personnel. Individuals with the following
qualifications may be testing personnel:
!

MD, DO, or PhD, master's degree or bachelor's degree in
science;

!

Associate degree in laboratory science;

!

Previously qualified or could have qualified as a
technologist under March 14, 1990, rules (Medicare/CLIA
67) on or before February 28, 1992;

!

Until September 1, 1997, individuals with a high school
diploma or equivalent and documented training
appropriate for the testing performed are qualified;

!

For blood gas analysis, within five years either be
number one or number two (above) or bachelor's degree
in respiratory therapy or associate degree related to
pulmonary function;

!

For histopathology, tissue examinations must be
performed by an MD or DO certified in anatomic

P6370.01
1/15/2005
Page 12
pathology (or eligible for certification). For
dermatopathology, an MD or DO certified in
dermatopathology or dermatology can also perform
examinations; and
!

There must be sufficient qualified personnel with
documented training and experience to conduct the work
of the laboratory as specified by the current
Classification Category.

13. QUALITY CONTROL. Quality control systems and measures of
the pathology and medical laboratory services will be designed to
ensure both the quality and appropriateness of the laboratory
service. All categories of laboratories will adhere to the
minimum guidelines as currently mandated by CLIA 88 regulations.
The quality control program will include, but not be limited to,
the following:
!

Preventive maintenance, periodic inspection, and
performance testing of all equipment and automated
instruments will be performed with documentation maintained
for the test equipment’s life.

!

Emergency power will be available to meet the needs of the
medical services provided. The emergency power will be
sufficient to maintain all essential refrigeration,
equipment, and instruments required for emergency testing.

!

Documented monitoring of temperature controlled instruments
will be performed daily.

!

Labeling of reagents and solutions will include:
•
•
•
•
•
•

!

identity;
strength;
precautions and special handling information;
preparation date;
expiration date; and
the initials of the person preparing the reagent.

Written procedures will be established for the preparation
of patients and for the collection, preservation,
transportation, and receipt of specimens to ensure
satisfactory specimens are available or used for the
analysis to be performed.

P6370.01
1/15/2005
Page 13
14. PROFICIENCY TESTING. All MRLs are required to participate
successfully in an approved proficiency testing (PT) program.
Recommended source for proficiency testing material is the
College of American Pathologists (CAP).
15. LABORATORY STANDARDS. There will be sufficient space,
equipment, and supplies within the medical laboratory service to
perform the required volume of work with optimal accuracy,
precision, efficiency, and safety. Equipment and instruments
will be appropriate for the services specified for each
classification category.
Special precautions will be taken to avoid unnecessary physical,
chemical, and biological hazards. The routine use of laboratory
instruments, equipment and the performance of laboratory analysis
must be evaluated frequently to ensure quality and appropriate
laboratory support is provided to meet the needs of the
institution medical service.
16. BLOOD TRANSFUSION SERVICE. MRCs that operate a blood
transfusion service will comply with the following specific
requirements:
!

Under no circumstances will facilities operate a blood bank
service (donor collection, blood or blood components
processing); services will be strictly limited to
transfusion services.

!

Personnel in the transfusion service will have sufficient
training and/or experience and demonstrate technical
competence in the performance of immunohematologic
procedures performed.

!

Institutions performing blood transfusions will have written
policies and procedures which conform to the American
Association of Blood Banks, Standards for Blood Banks and
Transfusion Services.
These policies and procedures will be readily available to
staff and will be reviewed at least annually by the Director
of the Service and revised as necessary.

!

Blood or blood components will be stored and handled in such
a manner that they retain their maximum efficacy and safety.
They will be properly processed, tested, and labeled.

P6370.01
1/15/2005
Page 14
!

Refrigerators used for the routine storage of blood will
conform to all specifications of the American Association of
Blood Banks. The proper functioning of the refrigerator
will be constantly monitored by a system of audible and
visible alarms (including remote alarms for use when there
is no one in attendance) that are either battery operated or
are on a circuit powered by the institution’s emergency
generator.

!

A written procedure will be established for obtaining
necessary blood and blood components at all times. It will
be documented that stored blood is inspected daily for
evidence of hemolysis and for possible bacterial
contamination.

!

The blood center source where blood or blood components are
obtained will be recommended by the Laboratory Director and
approved by the medical and administrative staff. The blood
center must be certified by the American Association of
Blood Banks (AABB).

!

Required Bench Reference. MRCs which operate a blood
transfusion service will have the most recent edition of the
AABB Standards and AABB Technical Manual for Blood Banks and
Transfusion Services available for reference.

17. INMATE WORKERS. Due to the confidentiality and sensitivity
of diagnostic test results, inmate workers will not be allowed to
work in clinical laboratories, other than in orderly positions
and then only under direct supervision.
18. NEEDLES AND SYRINGES. When needles and syringes are
maintained in the laboratory, an accountability system will be
established in accordance with the Program Statement on Pharmacy
Services.

/s/
Harley G. Lappin
Director