Summary:
Summary Statement of Deficiencies 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 a review of laboratory American Proficiency Institute (API) proficiency testing (PT) records, testing personnel records, patient test records, and interviews with the laboratory director (LD) and testing personnel 1 (TP1), the laboratory failed to ensure every testing personnel who performs KOH testing examined or tested proficiency samples. Findings: 1. A review of the laboratory records revealed the laboratory enrolled in commercial PT for KOH testing thru API in 2018 and 2019. 2. A review of 2018 and 2019 patient test records identified 3 laboratory testing personnel who performed and documented KOH testing of patient specimens. 3. A review of 2018 and 2019 API PT records identified 1 testing personnel who examined or tested all proficiency samples for 6 of 6 Microbiology KOH testing events. 4. An interview with TP1, on 12/17/19 at approximately 11:25 AM, confirmed that 1 laboratory testing personnel, of the 3 who perform patient KOH testing, had been the only testing personnel performing KOH PT in 2018 and 2019. 5. An interview with the LD, on 12/17/19 at approximately 11:45 AM, confirmed that only one testing personnel had performed KOH proficiency testing in the API Microbiology KOH testing events in 2018 and 2019. 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 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 -- laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory American Proficiency Institute (API) proficiency testing (PT) records and an interview with testing personnel 1 (TP1), the laboratory director and the testing personnel failed to sign the attestation statements for PT events. Findings: 1. A review of 2018 and 2019 API PT records identified that 3 of 3 2019 Microbiology KOH testing events had no signed attestation statements, attesting to the routine integration of the samples, from the laboratory director and testing personnel. 2. An interview with TP1, on 12/17/19 at approximately 11:25 AM, confirmed that there were no signed attestation statements for the 3 API 2019 Microbiology KOH testing events by the laboratory director and testing personnel. 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: Based on a review of laboratory American Proficiency Institute (API) proficiency testing (PT) records and an interview with testing personnel 1 (TP1), the laboratory failed to document evaluations of proficiency testing performance for KOH testing. Findings: 1. A review of 2018 and 2019 API PT records identified no documentation of review and evaluation of results for 3 of 3 API Microbiology KOH testing events in 2019. 2. An interview with TP1, on 12/17/19 at approximately 11:25 AM, confirmed that no review and evaluation of PT results for KOH testing had been performed and documented. -- 2 of 2 --