Subpart J--Facility Administration for Nonwaived Testing
Sec. 493.1100 Condition: Facility administration
Each laboratory that performs nonwaived testing must meet the
applicable requirements under Sec. Sec. 493.1101 through 493.1105,
unless HHS approves a procedure that provides equivalent quality
testing as specified in Appendix C of the State Operations Manual (CMS
Pub. 7).
Sec. 493.1101 Standard: Facilities
(a) The laboratory must be constructed, arranged, and maintained to
ensure the following:
(1) The space, ventilation, and utilities necessary for conducting
all phases of the testing process.
(2) Contamination of patient specimens, equipment, instruments,
reagents, materials, and supplies is minimized.
(3) Molecular amplification procedures that are not contained in
closed systems have a uni-directional workflow. This must include
separate areas for specimen preparation, amplification and product
detection, and, as applicable, reagent preparation.
(b) The laboratory must have appropriate and sufficient equipment,
instruments, reagents, materials, and supplies for the type and volume
of testing it performs.
(c) The laboratory must be in compliance with applicable Federal,
State, and local laboratory requirements.
(d) Safety procedures must be established, accessible, and observed
to ensure protection from physical, chemical, biochemical, and
electrical hazards, and biohazardous materials.
(e) Records and, as applicable, slides, blocks, and tissues must be
maintained and stored under conditions that ensure proper preservation.
Sec. 493.1103 Standard: Requirements for transfusion services
A facility that provides transfusion services must meet all of the
requirements of this section and document all transfusion-related
activities.
(a) Arrangement for services. The facility must have a transfusion
service agreement reviewed and approved by the responsible party(ies)
that govern the procurement, transfer, and availability of blood and
blood products.
(b) Provision of testing. The facility must provide prompt ABO
grouping, D(Rho) typing, unexpected antibody detection, compatibility
testing, and laboratory investigation of transfusion reactions on a
continuous basis through a CLIA-certified laboratory or a laboratory
meeting equivalent requirements as determined by CMS.
(c) Blood and blood products storage and distribution. (1) If a
facility stores or maintains blood or blood products for transfusion
outside of a monitored refrigerator, the facility must ensure the
storage conditions, including temperature, are appropriate to prevent
deterioration of the blood or blood product.
(2) The facility must establish and follow policies to ensure
positive identification of a blood or blood product recipient.
(d) Investigation of transfusion reactions. The facility must have
procedures for preventing transfusion reactions and when necessary,
promptly identify, investigate, and report blood and blood product
transfusion reactions to the laboratory and, as appropriate, to Federal
and State authorities.
Sec. 493.1105 Standard: Retention requirements
(a) The laboratory must retain its records and, as applicable,
slides, blocks, and tissues as follows:
(1) Test requisitions and authorizations. Retain records of test
requisitions and test authorizations, including the patient's chart or
medical record if used as the test requisition or authorization, for at
least 2 years.
(2) Test procedures. Retain a copy of each test procedure for at
least 2 years after a procedure has been discontinued. Each test
procedure must include the dates of initial use and discontinuance.
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(3) Analytic systems records. Retain quality control and patient
test records (including instrument printouts, if applicable) and all
analytic systems activities specified in Sec. Sec. 493.1252 through
493.1289 for at least 2 years. In addition, retain the following:
(i) Records of test system performance specifications that the
laboratory establishes or verifies under Sec. 493.1253 for the period
of time the laboratory uses the test system but no less than 2 years.
(ii) Immunohematology records, blood and blood product records, and
transfusion records as specified in 21 CFR 606.160(b)(3)(ii),
(b)(3)(v), and (d).
(4) Proficiency testing records. Retain all proficiency testing
records for at least 2 years.
(5) Laboratory quality systems assessment records. Retain all
laboratory quality systems assessment records for at least 2 years.
(6) Test reports. Retain or be able to retrieve a copy of the
original report (including final, preliminary, and corrected reports)
at least 2 years after the date of reporting. In addition, retain the
following:
(i) Immunohematology reports as specified in 21 CFR
606.160(b)(3)(ii), (b)(3)(iv), and (d).
(ii) Pathology test reports for at least 10 years after the date of
reporting.
(7) Slide, block, and tissue retention--
(i) Slides.
(A) Retain cytology slide preparations for at least 5 years from
the date of examination (see Sec. 493.1274(f) for proficiency testing
exception).
(B) Retain histopathology slides for at least 10 years from the
date of examination.
(ii) Blocks. Retain pathology specimen blocks for at least 2 years
from the date of examination.
(iii) Tissue. Preserve remnants of tissue for pathology examination
until a diagnosis is made on the specimen.
(b) If the laboratory ceases operation, the laboratory must make
provisions to ensure that all records and, as applicable, slides,
blocks, and tissue are maintained and available for the time frames
specified in this section.
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