Summary:
Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on hematology written procedure manual review, lack of sperm count quality control records and laboratory general supervisor interview on March 21, 2023 at 12: 15 P.M. , it was determined that the laboratory failed to ensure compliance with the analytic system requirements for sperm cell counts. The findings include: 1. The hematology written procedure manual did not include written control procedures for perform sperm count analysis. Refer to D5403. 2. The laboratory failed to include one control material each 8 hours of operation when 25 of 25 patients specimens were processed for sperm count by the Cell -VU system from March 2, 2022 to March 15, 2023. Refer to D5543. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 493.1253. (7) Control procedures. (8)