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 of proficiency testing performance evaluations and interview with the technical supervisor (TS), the laboratory failed to attest that proficiency testing (PT) samples were tested in the same manner as patient specimens for proficiency samples in 2023 for College of American Pathology (CAP) PT testing events 1 and 2 for bacteriology and virology. Findings include 1. A review of the proficiency testing performance evaluations on 10/25/23 revealed that the laboratory director or designee and testing personnel performing testing failed to sign the attestation statements for the CAP 2023 Microbiology - 1st and 2nd events and the CAP 2023 Virology - 1st and 2nd events. 2. In an interview on 10/25/23 at 1:55 PM, the TS confirmed that the laboratory director or designee and testing personnel performing testing failed to sign the attestation statements. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) documentation and an interview with the Technical Supervisor (TS), the laboratory failed to maintain documentation of each step in in the testing and reporting of results for proficiency testing samples the CAP 2023 Microbiology - 1st and 2nd events and the CAP 2023 Virology - 1st and 2nd events. Findings include: 1. Record review of PT documentation of the CAP 2023 Microbiology - 1st and 2nd events and the CAP 2023 Virology - 1st and 2nd events on 10/25/23 failed to produce signed attestation statements, instrument printouts, PT program report forms, and documentation of who handled, prepared, processed, ran, and resulted each step of the PT submissions, instrument printouts, and PT forms. 2. In an interview on 10/25/23 at 2:00 PM, the TS confirmed that the laboratory did not retain required PT documentation for CAP Virology and Microbiology 2023 events. D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on patient test record review and interview with the QA Manager, the laboratory failed to retain test requisitions for at least 2 years for samples received by the laboratory for one of five patient records reviewed. The laboratory performed approximately 810,000 tests annually. Findings include: 1. Review of patient test records on 10/25/2023 failed to include requisitions for one of five samples that were received and analyzed by the laboratory. 2. The QA Manager confirmed during interview on 10/25/2023 at approximately 4:00 PM, that test requisitions are not always retained for at least 2 years. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on Record review and interview with the Technical Supervisor (TS), the laboratory failed to twice annually evaluate the accuracy of analytes of molecular panels that were not included in subpart I since the laboratory began operation in April 2022. The laboratory performed approximately 300,000 molecular tests annually. Findings include: 1. Record review on 10/25/2023, revealed a lack of documentation to verify twice annually the accuracy of analytes not included in subpart I of molecular respiratory pathogens panel, urinary tract infection panel, gastrointestinal pathogen panel, sexually transmitted infections panel, wound infections panel, nail, fungal panel, and women's health panel. 2. In an interview with -- 2 of 5 -- the TS on 10/25/2023 at 2:20 PM, it was confirmed that the laboratory failed to twice annually evaluate the accuracy of analytes in molecular panels that were not included in subpart I. 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)