Summary:
Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the polymerase chain reaction (PCR) testing worksheets and interview with the general supervisor (GS), the laboratory failed to ensure that a specimen stability study was performed to establish that a treated specimen could be frozen, thawed, retested and provide accurate test results after the initial PCR testing was performed and failed. Findings: 1. During the review of the PCR worksheets, the GS stated that sometimes the PCR testing for one of the four genes will fail and they will defrost the frozen specimen and retest that particular gene the next day. 2. The GS was asked if a stability study had been performed for freezing, thawing, and retesting the PCR specimen to verify that the test results would still be accurate. According to the GS, the laboratory had not performed a stability study for freezing, thawing, testing the treated specimen for PCR testing. 3. During the exit interview on 01/09/2025 at 3:30 PM, the GS confirmed that a stability study had not been performed to establish that a specimen could be frozen, thawed, retested and the effects would not impact patient results that were reported and interpreted. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)