Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(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. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to maintain manual cell count test records for at least 2 years in 2021, 2022, and 2023. Findings include: 1. Review on 7/21/2023 of manual cell counts in July revealed 1 cell count reported in the laboratory's information system (LIS). The laboratory was not able to provide a copy of the corresponding worksheet used for the patient's manual cell count or for the quality control testing. 2. Interview on 7/21/2023 at 8:15 a.m. with a Lead Technologist and the Hematology Technical Supervisor revealed that after the results on the worksheet are reviewed the cell count worksheets and control sheets are discarded. 3. The laboratory performed 60 cell counts annually; a combination of both automated cell counts and manual. 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) 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 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)