CHAPTER 9
PATIENT TEST MANAGEMENT FOR MODERATE COMPLEXITY (INCLUDING THE SUBCATEGORY),
HIGH COMPLEXITY TESTING, OR ANY COMBINATION OF THESE TESTS
9-1. Condition: Patient test management; moderate complexity testing
(including the subcategory), high complexity testing, or any combination
of these tests (§493.1101)
Each laboratory performing moderate complexity (including the subcategory),
or high complexity testing, or any combination of these tests, must employ
and maintain a system that provides for proper patient preparation; proper
specimen collection, identification, preservation, transportation, and processing;
and accurate result reporting. This system must assure optimum patient specimen
integrity and positive identification throughout the preanalytic (pre-testing),
analytic (testing), and postanalytic (post-testing) processes and must meet
the standards of this chapter as they apply to the testing performed.
9-2. Standard: Procedures for specimen submission and handling (§493.1103)
a. The laboratory must have available and follow written policies and procedures
for each of the following, if applicable: methods used for the preparation
of patients; specimen collection; specimen labeling; specimen preservation;
conditions for specimen transportation; and specimen processing. Such policies
and procedures must assure positive identification and optimum integrity
of the patient specimens from the time the specimen(s) are collected until
testing has been completed and the results reported.
b. If the laboratory accepts referral specimens, written instructions must
be available to clients and must include, as appropriate, the information
specified in paragraph a above.
c. Oral explanation of instructions to patients for specimen collection,
including patient preparation, may be used as a supplement to written instructions
where applicable.
9-3. Standard: Test requisition (§493.1105)
The laboratory must perform tests only at the oral, written, or electronic
request of an authorized person. Oral requests for laboratory tests must
be documented in a retrievable manner. The laboratory must make an attempt
to obtain written authorization for oral requests. Records of test requisitions
or test authorizations must be retained for a minimum of two years. The
patient's chart or medical record will not be used as the only record of
a laboratory test requisition. The laboratory must assure that the requisition
or test authorization includes:
a. The patient's name or other unique identifier.
b. The name or other suitable identifiers of the authorized person requesting
the test and, if appropriate, the individual responsible for utilizing the
test results or the name and address of the laboratory submitting the specimen,
including, as applicable, a contact person to enable the reporting of imminent
life threatening laboratory results or panic values.
c. The test(s) to be performed.
d. The date of specimen collection.
e. For Pap smears, the patients's last menstrual period, age or date of
birth, and indication of whether the patient had a previous abnormal report,
treatment or biopsy.
f. Any additional information relevant and necessary to a specific test
to assure accurate and timely testing and reporting of results.
9-4. Standard: Test records (§493.1107)
The laboratory must maintain a record system to ensure reliable identification
of patient specimens as they are processed and tested to assure that accurate
test results are reported. These records must identify the personnel performing
the testing procedure. Records of patient testing, including, if applicable,
instrument printouts, must be retained for at least two years. Immunohematology
records must be retained for no less than five years in accordance with
21 CFR Part 606, Subpart I. The record system must provide documentation
of information specified in paragraphs 9-3a through 9-3f and include:
a. The patient identification number, accession number, or other unique
identification of the specimen.
b. The date and time of specimen receipt into the laboratory.
c. The condition and disposition of specimens that do not meet the laboratory's
criteria for specimen acceptability.
d. The records and dates of all specimen testing, including the identity
of the personnel who performed the test(s), which are necessary to assure
proper identification and accurate reporting of patient test results.
9-5. Standard: Test report (§493.1109)
The laboratory report must be sent promptly to the authorized person, the
individual responsible for using the test results or laboratory that initially
requested the test. The original report or an exact duplicate (paper or
electronic copy) of each test report, including final and preliminary reports,
must be retained by the testing laboratory for a period of at least two
years after the date of reporting. Immunohematology reports must be retained
by the laboratory for a period of no less than five years in accordance
with 21 CFR Part 606, Subpart I. For pathology, test reports must be retained
for a period of at least ten years after the date of reporting. This information
may be maintained as part of the patient's chart or medical record which
must be readily available to the laboratory and to OASD(HA), TSG, or their
designee upon request.
a. The laboratory must have adequate systems in place to report results
in a timely, accurate, reliable and confidential manner, and, ensure patient
confidentiality throughout those parts of the total testing process that
are under the laboratory's control.
b. The test report must indicate the name and address of the laboratory
location at which the test was performed, the test performed, the test result
and, if applicable, the units of measurement.
.
c. 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.
d. Pertinent "reference" or "normal" ranges, as determined
by the laboratory performing the tests, must be available to the authorized
person who ordered the tests or the individual responsible for utilizing
the test results.
e. The results or transcripts of laboratory tests or examinations must be
released only to authorized persons or the individual responsible for utilizing
the test results.
f. The laboratory must develop and follow written procedures for reporting
imminent life-threatening laboratory results or panic values. In addition,
the laboratory must immediately alert the individual or entity requesting
the test or the individual responsible for utilizing the test results when
any test result indicates an imminent life threatening condition.
g. The laboratory must, upon request, make available to clients a list of
test methods employed by the laboratory and, in accordance with paragraph
10-7, as applicable, the performance specifications of each method used
to test patient specimens. In addition, information that may affect the
interpretation of test results, such as test interferences, must be provided
upon request. Pertinent updates on testing information must be provided
to clients whenever changes occur that affect the test results or interpretation
of test results.
h. The original report or exact duplicates of test reports must be maintained
by the laboratory in a manner that permits ready identification and timely
accessibility.
9-6. Standard: Referral of specimens (§493.1111)
A DoD laboratory located within the United States must refer specimens for
testing only to a laboratory possessing a valid certificate authorizing
the performance of testing in the specialty or subspecialty of service for
the level of complexity in which the referred test is categorized.
a. The referring laboratory must not revise results or information directly
related to the interpretation of results provided by the testing laboratory.
b. The referring laboratory may permit each testing laboratory to send the
test result directly to the authorized person who initially requested the
test. The referring laboratory must retain or be able to produce an exact
duplicate of each testing laboratory's report.
c. The authorized person who orders a test or procedure must be notified
by the referring laboratory of the name and address of each laboratory location
at which a test was performed.
d. Medical laboratories located outside of the United States will select
referral laboratories meeting acceptable quality assurance standards as
determined by the local commander or the TSG. Test results must be returned
to the referring laboratory.
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