Associated Skin Care Specialists Pa

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 document review and interview with laboratory personnel, the laboratory failed to perform and document testing accuracy verification activities at least twice annually for one of three microscopic examinations in 2020 and two of three microscopic examinations in 2021. Findings are as follows: 1. The laboratory performed microscopic examinations for fungus, parasites, and viruses under the specialty of Microbiology as confirmed by the Laboratory Specialist (LS) during a tour of the laboratory at 10:15 a.m. on 05/20/22. 2. Requirements for twice annual verification of accuracy testing for Scabies parasite preparations (S), and Tzanck virus preparations (T) were established in the laboratory's Proficiency Testing for Provider Performed Microscopic Examinations procedure found in the KOH, Tzanck, Scabies, Pregnancy UA manual. 3. One verification of testing accuracy document for Scabies preparations was found during review of 2020 laboratory records. The laboratory was unable to provide a second accuracy verification from 2020 for Scabies preparations upon request. 4. Verification of testing accuracy documents for Scabies and Tzanck preparations were not found during review of 2021 laboratory records. The laboratory was unable to provide accuracy verification documents from 2021 for Scabies and Tzanck preparations upon request. 5. The laboratory's Scabies test log indicated patient samples received microscopic examinations for parasites in 2020 and 2021. The Tzanck test log indicated a single patient sample received microscopic examination for viruses in 2021. See below. 2020 Test Number of patients S 1 2021 Test Number of patients S 1 T 1 6. In an interview at 12:25 p.m. on 05/20/22, the LS confirmed the above finding. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to ensure a stain used for Histopathology tissue processing was not used after the expiration date had been exceeded in 2020. Findings are as follows: 1. The laboratory performed Mohs micrographic surgery and Histopathology slide examination as confirmed by the Laboratory Specialist (LS) during a tour of the laboratory at 10:10 a.m. on 10/01/20. 2. A requirement to inspect all date sensitive products was established in the Equipment Maintenance - Linistainer and Stains procedure found in the Policy and Procedure manual. 3. Expired Thermo Scientific Eosin-Y stain was observed as present and available for use during the tour. See below for detailed information. Stain Exp. Lot number Eosin-Y 05/2020 475731 3. The laboratory used the expired stain June through September 2020. 4. In an interview at 10:15 a.m. on 10/01/20, the LS confirmed the above finding. . 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 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 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 -- 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 observation, document review, and interview with laboratory personnel, the laboratory failed to ensure 1 of 2 test reports reviewed on date of survey included complete test results. Findings are as follows: 1. The laboratory performed Mohs micrographic surgery and Histopathology slide examination as confirmed by the Laboratory Specialist (LS) during a tour of the laboratory at 10:10 a.m. on 10/01/20. 2. Case E-M-345, performed on 08/20/18, was 1 of 2 cases reviewed on date of survey. The Mohs map and associated slide labeling indicated the surgery was performed in two stages. Mohs map documentation indicated the tissue margins were clear of tumor after the second surgical stage. 3. The operative report (test report) included a description of the first surgical stage and indicated residual tumor was seen. The report did not include a description of the second surgical stage nor a statement indicating the final result of the surgery. 4. In an interview at 12:05 p.m. on 10/01/20, the LS confirmed the above finding. -- 2 of 2 --