Basic Documentation

Siemens Industry, Inc. Page 3 of 6
Document No. 149-208
were outside the required range without evidence of
action.
1
When storing vaccines it is important to maintain
records for at least three years.
2
Human Cells and Tissue Banks
CGTP for HCT/Ps requires that appropriate
temperature and temperature limits for storage be
established at each step of the manufacturing.
Storage temperature for HCT/Ps must be
maintained, recorded, and periodically reviewed to
ensure that temperatures have been within
acceptable limits.
3
All records must be retained for
10 years after their creation date. Records may be
maintained electronically, as original paper records,
or as true copies such as photocopies, microfiche, or
microfilm.
JCAHO has adopted FDA HCT/Ps ruling into the
new patient care requirements for hospitals:
PC17.10, PC17.20, and P17.30. Information can be
obtained from the Joint Commission Resources Web
site:
4
http://www.jcrinc.com/
Blood Bank
Hospitals may have dual accreditation by CAP and
the American Association of Blood Banks (AABB).
The AABB assessment ensures that the quality
systems and operational systems must be in
compliance with:
 AABB Standards
 21 CFR Part 600 and Part 606
 CLIA 88
 Federal guidelines and documents
The FDA
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requires equipment to be observed,
standardized and calibrated on a regularly schedule
basis as prescribed in the Standard Operating
Procedures Manual. Temperatures shall be
recorded daily and calibrated as necessary. Records
of storage temperature and proper maintenance will
be kept for a retention period of no less than five
1. FacilityCare Email Report, May 24, 2005 a newsletter
from FacilityCare magazine.
2. Immunization Action Coalition #P3036 (8/04)
3. FDA 21 CFR Part 1271.260(a-d).
4. Joint Commission Perspectives, July 1, 2005.
5. FDA 21 CFR Part 606 and Part 640.
years.
6
Storage temperatures for blood bank
products are shown in Table 1.
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Table 1. Storage Temperature for Blood Bank
Products.
Blood Product Type Storage Temp (°C)
Whole Blood 1°C to 6°C (34°F to 43°F)
Red Blood Cells 1°C to 6°C (34°F to 43°F)
Red Blood Cells–Frozen -65°C (-85°F) and colder
Platelets 1°C to 6°C (34°F to 43°F)
Plasma -18°C (-0.4°F) and colder
Source Plasma -5°C (23°F) and colder
Source Plasma–Liquid 10°C (50°F) and colder
Plasma–Liquid 1°C to 10°C (34°F to 50°F)
Plasma–Platelet Rich 1°C to 6°C (34°F to 43°F)
American Institute of Architects (AIA) 2006
Guidelines requires refrigerators used for holding
blood for transfusions shall be equipped with
temperature-monitoring and alarm signals.
8
Morgue
AIA 2006 Guidelines requires refrigerators used for
holding bodies shall be equipped with temperature-
monitoring and alarm signals.
9
Temperature control of Morgue Refrigerators
typically provides: digital readout, high/low alarms
with audio and/or visual indication, and contacts for
remote alarm connection. Temperature Range
should be maintained from 2.2°C to 4.4°C (36°F to
40°F).
Food Services
The core of any HACCP plan is accurate records of
time and temperature. HACCP principles:
 Identify critical control points
 Establish preventive measures with critical limits
for each control point
 Establish procedures to monitor critical control
points
6. FDA 21 CFR Part 606.160(b) (3) and (d).
7. FDA 21 CFR Part 600.15 (Table).
8. AIA Guidelines, 2006 Part 2.1 General Hospitals, Section
5.11.2.4(4), p. 98
9. AIA Guidelines, 2006 Part 2.1 General Hospitals, Section
5.12.2.1, p. 99