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ASHI Governance
Standards for Histocompatibility Testing Section C - General Comments and Quality Assurance C1.000
Facilities C1.100
Laboratory space must be sufficient so that all procedures can be
carried out without crowding to the extent that errors may result. C1.200
Lighting and ventilation must be adequate. C1.300
Refrigerators and freezers must be maintained at temperatures optimal
for storage of each type of sample or reagent. They must be monitored
daily. Recording thermometers are recommended for mechanical
refrigerators or freezers. These should be coupled to alarm systems
with an audible alarm where it can be heard 24 hours a day. In
laboratories where liquid nitrogen is utilized for storage of frozen
cells, the level of liquid nitrogen in the cell freezers must be
monitored at intervals which will ensure an adequate supply at all
times. Ambient temperature and/or the temperatures of incubators in
which test procedures are carried out must be monitored daily to
ensure that these procedures are carried out within temperature ranges
specified in the laboratory’s procedure manual. C1.400
Laboratories performing mixed lymphocyte cultures, HLA-D, or cellular
Class II typing should have a laminar flow hood or other appropriately
aseptic work area. Counters should be standardized according to the
manufacturer’s instructions at regular intervals. The incubator
should be monitored daily in relation to temperature (37°C) and CO2
concentration (5% +/- 1%) and should be appropriately humidified. C1.500
Laboratories using radioactive materials must store radioactive
materials and conduct procedures using radioactive materials in a
designated section of the laboratory. Radioactive materials must be
disposed of at locations designated by local institutions. C1.600
Equipment Maintenance and Function Checks C1.610
The laboratory must establish and employ policies and procedures for
the proper maintenance of equipment, instruments and test systems by
1) defining its preventive maintenance program for each instrument and
piece of equipment, and by 2) performing and documenting function
checks on equipment with at least the frequency specified by the
manufacturer. C1.700
Adequate facilities to store records must be immediately available to
the laboratory. C1.800
The laboratory must be in compliance with all applicable Federal,
State and local laws which relate to laboratory employee health and
safety; fire safety; and the storage, handling and disposal of
chemical, biological and radioactive materials. C1.900
Computer assisted analyses must be reviewed, verified and signed by
the Supervisor and/or Laboratory Director before issue. C1.910
The computer software program used for analyses must be documented. C2.000
Specimen Submission and Requisition C2.100
The laboratory must have available and follow written policies and
procedures regarding specimen collection. C2.110
The laboratory must perform tests only at the written or electronic
request of an authorized person. The laboratory must assure that the
requisition includes: 1) the patient’s name or other method of
specimen identification to assure accurate reporting of results; 2)
the name and address of the authorized person who ordered the test; 3)
date of specimen collection; 4) time of specimen collection, when
pertinent to testing; 5) source of specimen. Oral requests for
laboratory tests are permitted only if the laboratory subsequently
obtains written authorization for testing within 30 days of the
request. C2.120
Blood samples must be individually labeled as to the name, or other
unique identification marker for the donor and the date of collection.
When multiple blood tubes are collected, each tube must be
individually labeled. C2.130
The laboratory must maintain a system to ensure reliable specimen
identification, and must document each step in the processing and
testing of patient specimens to assure that accurate test results are
recorded. C2.140
The laboratory must have criteria for specimen rejection and a
mechanism to assure that specimens are not tested when they do not
meet the lab’s criteria for acceptability. C2.200
Blood samples must be obtained using a location which does not
compromise aseptic techniques. The donor’s skin must be prepared by
a technique which ensures minimal possibility of infection of the
donor or contamination of the sample. All needles and syringes must be
disposable. C2.210
All blood samples should be handled and transported in accordance with
the understanding that they could transmit infectious agents. C2.220
The anticoagulant/preservation medium used must be shown to preserve
sample viability, antigens and distributions of
markers/characteristics of cells tested for the (maximum) length of
time and under all the specified storage conditions the laboratory
permits, on the basis of documented or published stability tests,
between sample collection and testing. C2.300
Reagents C2.310
All reagents must be properly labeled and stored according to
manufacturers’ instructions. Each serum or monoclonal antibody or
typing tray must be stored at a temperature appropriate to maintaining
its reactivity and specificity. C2.320
Reagents, solutions, culture media, controls, calibrators and other
materials must be labeled to indicate 1) identity and when
significant, titer, strength or concentration; 2) recommended storage
requirements; 3) preparation and/or expiration date and other
pertinent information. C3.000
All procedures in use in the laboratory must be detailed in a
procedure manual which is immediately available where the procedures
are carried out. The procedure manual must be reviewed at least
annually by the Director and written evidence of this review must be
in the manual. Any changes in procedures must be initialed and dated
by the Director at the time they are initiated. C4.000
Quality Assurance C4.100
The laboratory must participate in at least one external proficiency
testing program, if available, in each category for which ASHI
accreditation is sought. C4.200
If a laboratory’s performance in an external proficiency testing
program is unsatisfactory in any category for which ASHI accreditation
is sought, the laboratory must participate in an enhanced proficiency
testing program in that category until performance is deemed
satisfactory. C4.300
Proficiency test samples must be tested in a manner comparable to that
for testing patient samples. C4.400
The laboratory must, at least once each month, give each individual
performing tests a characterized specimen as an unknown to verify his
or her ability to reproduce test results. The laboratory must maintain
records of these results for each individual. C4.500
The laboratory must establish and employ policies and procedures, and
document actions taken when 1) test systems do not meet the
laboratory’s established criteria including quality control results
that are outside of acceptable limits; and when 2) errors are detected
in the reported patient results. In the latter instance, the
laboratory must promptly a) notify the authorized person ordering or
individual utilizing the test results of reporting errors; b) issue
corrected reports, and c) maintain copies of the original report as
well as the corrected report for two years. C5.000
Records and Test Reports C5.100
The laboratory must maintain a legally reproduced record of each test
result, including preliminary reports, for all subjects tested for a
period of two years or longer, depending on local regulations. C5.110
These records must include log books, and at least a summary of
results obtained. C5.120
Work sheets must clearly identify the subject whose cells were tested,
the typing sera which were used, the date of the test and the person
performing the test. C5.130
For each cell-serum combination, the results must be recorded in a
manner which indicates the approximate percent of cells killed. The
numerical codes used in the ASHI Laboratory Manual are recommended. C5.140
Reports or records, as appropriate, should include a brief description
of the specimen (blood, lymph node, spleen, bone marrow, etc.) used
for testing. C5.150
Membranes or autoradiographs from nucleic acid analysis must be
retained as a permanent record. C5.160
Records may be saved in computer files only, provided that back-up
files are maintained to ensure against loss of data. It is recommended
that legal advice be sought to be certain that computer files meet
requirements in case of legal actions. C5.170
For marrow transplantation, the donor must give his informed consent
before blood is taken for typing and before the donor is placed on a
list of donors available to be called. C5.180
For marrow transplantation, donor records should be maintained so that
donors can be rapidly retrieved according to HLA type. C5.190
The laboratory must have adequate systems in place to report results
in a timely, accurate and reliable manner. C5.200
The report should contain: a.
The date of collection of sample. b.
The Laboratory and/or Institution’s unique identifier/
number. c.
The name of the individual tested. d.
The date the individual was tested. e.
The date of the report. f.
The test results. g.
Any appropriate control value/normal ranges, where appropriate. h.
Appropriate interpretations and the signature of the Laboratory
Director, or designate in his/her absence. C5.210
The laboratory must indicate on the test report any information
regarding the condition and disposition of specimens that do not meet
the laboratory’s criteria for acceptability. C5.220
The laboratory must maintain permanent files of all internal and
external quality control tests. C5.230
Laboratories should have a mechanism in place for resolving any tissue
typing discrepancies that may occur between laboratories. C6.000
The Laboratory Director and technical staff must participate in
continuing education relative to each category for which ASHI
accreditation is sought. C7.000 An accredited laboratory may engage another laboratory to perform testing not done by the primary laboratory. In that event, the subcontracting laboratory must be accredited by the American Society for Histocompatibility and Immunogenetics, if the testing is covered by ASHI Standards. If genetic systems not covered by ASHI Standards (ABO, RBC enzymes etc.) are subcontracted, the subcontracting laboratory must document expertise and/or accreditation in those systems. The identity of the subcontracting laboratory and that portion of the testing for which it bears responsibility must be noted in the reports.
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