Summary:
Summary Statement of Deficiencies 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 review of the laboratory's procedures, review of 2019, 2020, and 2021 laboratory test logs, the absence of documentation, and interview with staff 5/17/21, the laboratory failed to verify the accuracy of the KOH (potassium hydroxide) prep test results at least twice a year. Findings: Review of the laboratory's procedures and review of the 2019, 2020, and 2021 laboratory test logs revealed: 1. The laboratory's procedure "Testing for Fungus" does not indicate how the laboratory is verifying accuracy of the KOH testing. During interview at approximately 10:50a.m, the histology technician confirmed the providers are reading the slides behind each other to verify accuracy of testing. 2. There was no documentation available to indicate that the laboratory verified the accuracy of the KOH preps in 2019. Approximately 49 patients were tested in 2019 by testing personnel #4(physician assistant). The histology technician confirmed at approximately 10:55a.m that the laboratory failed to verify accuracy of KOH testing twice a year in 2019. She stated that TP#4 was the only provider that was performing KOH testing at the laboratory location currently, and confirmed that the laboratory director read slides behind TP#4 in 2020 to verify the accuracy of testing. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and 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 -- identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of random patient test reports and interview with staff on 5/17/21, the laboratory failed to ensure the test reports included all required information. Findings: a. Review of random patient KOH(potassium hydroxide) test report (#573350) in the EMA EMR(electronic medical record) revealed the address of the laboratory location where the test was performed included an incorrect street and suite number. Interview at approximately 11:00a.m, the clinical staff member confirmed the street and suite number in EMA EMR for the KOH test report was the laboratory's previous location across the street before they moved into the current laboratory space. b. Review of random patient MOHS(micrographic) surgery test reports(#PV21- 43, #PV21-76, #PV21-88, #PV21-90) in the EMA EMR revealed the laboratory location where the tests were performed was the address of the laboratory's sister clinic. Interview at approximately 11:05a.m, the Histology technician and nurse supervisor stated the sister clinic's location is where the MOHS surgeon finalizes the reports. They confirmed the address on the MOHS surgery test reports should be the laboratory location where the tests are performed. -- 2 of 2 --