Summary:
Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on08/12/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of laboratory's submitted form "Listing of Laboratory Personnel", proficiency testing (PT) records, policies/procedures and staff interview, the laboratory failed to incorporate PT into regular patient workload for 2 of 3 personnel who routinely performed complete blood count (CBC) testing in the laboratory in 2023, testing person (TP) number 2 and TP number 4. Findings included: 1. Review of laboratory's submitted form "Listing of Laboratory Personnel" revealed there were 3 testing personnel in 2023 (TP1, TP2 and TP4) that routinely performed CBC testing. 2. Review of laboratory's American Proficiency Institute PT records from 2023 revealed all testing events were performed by the same personnel, TP number 1. There was no documentation of PT performance with routine patient testing for TP number 2 or TP number 4 (as indicated on submitted form "Listing of Laboratory Personnel"). 3. Review of laboratory's policies/procedures revealed there were no protocols in place for ensuring that PT is incorporated into regular patient workload with rotation among laboratory's testing personnel. 4. In an interview on 08/12/2024 at 1010 hours in the laboratory, TP number 1 (as indicated on submitted Form CMS 209) confirmed the findings. 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 -- 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 493.1253. (7) Control procedures. (8)