Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review, the laboratory did not maintain proficiency testing attestation statements for testing personnel. Findings: 1. Proficiency testing attestation statements were not signed by the testing person(s) for the 2022 API (proficiency test provider) second event (UTI panel). D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: I. Based on record review the laboratory did not evaluate unsuccessful proficiency test (PT) results (individual proficiency test failures) for bacteriology. Findings: 1. The laboratory performs proficiency testing for molecular UTI bacteria/yeast testing; 2. PT Event 032521 split sample molecular testing. The laboratory passed the overall test event, but did not investigate test results that were unacceptable for sample U121 and sample U221; and 3. The laboratory did not detect the bacteria E. coli that was present in sample U121, and did not detect VRE VAN B (vancomycin resistant enterococcus) present in sample U221. The laboratory did not investigate the cause of the unsuccessful performance and determine if patient testing may have been affected. 4. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- There was no explanation or investigation into these unsatisfactory results and no determination if patient results around this time may have been affected. II. Based on record review, the laboratory did not have the directors evaluations for proficiency test events 62221 and 91321 (split samples). Findings: 1. The laboratory performed the split sampling for proficiency testing of molecular microbiology testing; 2. The laboratory did not have the test results (summary of acceptable performance) and scores provided by the proficiency test provider for each sample tested; and 3. The laboratory did not have records showing the director's review for either proficiency test event. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review, the laboratory did not take