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 Unity Interlaboratory Quality Assurance Program (IQAP) reports and immunoassay analyzer information and interview with the chemistry lead, staff B, the laboratory did not retain the quality control (QC) information when the QC range was updated for troponin analyte for one of one event reviewed. Findings include: 1. Review of Unity IQAP reports showed the laboratory reviewed and updated the QC range for the troponin analyte after receipt of the IQAP peer group data. 2. Review of the Abbott i1000 immunoassay analyzer showed the updated quality control range had changed all previous data to the new QC range. Further review showed no indication of the previous QC range or the time and date the change was made. 3. Interview with staff B on June 8, 2023, at 9:30 AM confirmed the laboratory did not retain QC range information when the troponin QC range was updated. 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 3 -- 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)