68 FR 3703, Jan. 24, 2003, unless otherwise noted.
Each laboratory that performs nonwaived testing must meet the applicable requirements under §§ 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).
(a) Reporting of SARS-CoV-2 test results. During the Public Health Emergency, as defined in § 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a “SARS-CoV-2 test”) must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe.
(b) [Reserved]
[68 FR 3703, Jan. 24, 2003, as amended at 85 FR 54873, Sept. 2, 2020]
(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.
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 beneficiary.
(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.
(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.
(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in §§ 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 § 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)(iv), (b)(3)(v) and (d).
(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years.
(5) Quality system 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(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 § 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 retained and available for the time frames specified in this section.
[68 FR 3703, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003]