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 review of coagulation records and interview with the Laboratory Operations Manager 10/4/22 - 10/6/22, the laboratory failed to retain the raw data used to calculate the reference (normal) range of prothrombin time (PT) when a new lot number of innovin, Lot #549717, was put into use on 1/12/20. Findings: Review of coagulation records revealed the laboratory had retained the "Executive Summary" for innovin Lot #549717, but failed to retain the raw data used to calculate the new reference (normal) range. Interview with the Laboratory Operations Manager on 10/6 /22 at approximately 11:00 am confirmed the laboratory failed to retain the raw data used to calculate the reference (normal) range for innovin, Lot #549717. He stated he was not employed when the new innovin was put into use and could not locate the raw data. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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)