Basic Documentation

 May 25, 2005–FDA issued 21 CFR Part 1271
CGTP for Human Cells, Tissues, and Cellular
and Tissue-based Products (HCT/Ps),
representing the last of three FDA rules that
have been developed to improve the safety of
HCT/Ps.
 July 1, 2005–With the CGTP rule, JCAHO
revised its standards for Laboratory
Accreditation Program (QC5.300, QC5.310 and
QC5.320) and adopted the three standards for
the Ambulatory Care, Office-Based Surgery,
Critical Access Hospital and Hospital
Accreditation programs (new standards
PC17.10, PC17.20 and PC17.30), these
standards apply to accredited organizations that
store or issue tissue.
Who enforces the Guidelines?
The U.S. Food & Drug Administration (FDA), Center
for Biologics Evaluation and Research (CBER)
regulates biological products. The CBER is
responsible for ensuring the:
 Safety of the Nation’s blood supply
 Production and approval of childhood vaccines
 Oversight of human tissue used for
transplantation
 Supply of allergenic materials and antitoxins
 Safety and efficacy of all biological therapeutics.
The Joint Commission on Accreditation of
Healthcare Organizations (JCAHO) and College of
American Pathologists (CAP) has also adopted the
CGTP as part of their standards, which means that
hospitals seeking accreditation through JCAHO or
CAP must meet the prescribed Guidelines.
Laboratory
The College of American Pathologists (CAP)
accredits over 6,400 hospital laboratories. CAP has
Centers for Medicare & Medicaid Services (CMS)
authority to accredit all Clinical Laboratories
Improvement Amendments (CLIA) specialties and
subspecialties as well as recognition by JCAHO as
an equivalent program in JCAHO-accredited
institutions.
CAP requires that all Phase II deficiencies MUST
be corrected before accreditation is granted.
The CAP process uses the following questions as a
way of identifying Phase II deficiencies:
 Are temperatures monitored daily and recorded
for appropriate types of equipment: refrigerators,
freezers, incubators, ovens, water baths and dry
baths?
 Is there evidence that corrective action would be
taken if acceptable temperature ranges were
exceeded, including evaluation of contents for
adverse effects?
 Is the temperature sensing device NIST-certified
or guaranteed by manufacturer to meet NIST
standards?
 Are all non-certified temperature sensing
devices in use checked against an appropriate
NIST standard device before use?
 Are alarms systems checked at specified
periodic intervals and results recorded?
 Is there an audible alarm for each storage unit,
and is the alarm monitored 24-hours per day (in
laboratory or remotely)?
 Will alarms continue to function if the power is
interrupted?
 Does the laboratory have a policy in place for
implementing backup capability for refrigerators,
freezers and incubators?
Pharmacy
USP <797>, JCAHO EC6.20.14, and MM2.20
require documentation verify that medications are
stored under necessary conditions to ensure stability
(monitoring controlled temperature areas).
Controlled environment areas in compounding
facilities include the following: controlled room
temperature, 15°C to 30°C (59°F to 86°F) within
mean kinetic temperature (MKT) of 25°C (77°F);
cold temperature, 2°C to 8°C (36°F to 46°F);
freezing temperature, -20°C to -10°C (-4°F to 14°F).
The temperature sensor used to monitor controlled
temperature areas must be NIST-certified or
guaranteed by the manufacturer to meet NIST
Standards. A controlled temperature area should be
monitored at least once per day and the results
documented on a temperature log. Additionally,
pharmacy personnel should note the storage
temperature when placing products into or removing
products from the storage unit in order to monitor
temperature deviations.
During a recent JCAHO survey at one hospital,
refrigerator checks were identified as a concern
because entries were missing and temperatures
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