Associated Skin Care Specialists Pa -Coon Rapids

Summary Statement of Deficiencies 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 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 document review and interview with laboratory personnel, the laboratory failed to retain testing accuracy verification records for three of three microscopic examinations performed in 2021 for at least two years. Findings are as follows: 1. The laboratory performed microscopic examinations for fungus, parasites, and viruses under the specialty of Microbiology as confirmed by the Histotechnician (HT) during a tour of the laboratory at 10:05 a.m. on 09/15/22. 2. Requirements for twice annual verification of accuracy testing for KOH fungal preparations (K), 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 manual. 3. Verification of testing accuracy documents for KOH, Scabies, and Tzanck preparations were not found during review of 2021 laboratory records. The laboratory was unable to provide testing accuracy verification documents from 2021 for KOH, Scabies, and Tzanck preparations upon request. 5. The laboratory's KOH test logs indicated 16 patient 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 -- samples received microscopic examinations for fungus in 2021. The Scabies and Tzanck test logs indicated no patient testing for parasites or viruses occurred in 2021. See below. 2021 Test Number of patients K 16 S 0 T 0 6. In an interview at 11:50 a. m. on 09/15/22, the HT confirmed the above finding. The HT indicated verification of microscopic examination accuracy had been performed for the three tests in 2021 per information obtained from the providers, but the documents could not be found. -- 2 of 2 --

Summary Statement of Deficiencies 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 observation, document review, and interview with laboratory personnel, the laboratory failed to document instrument temperatures for a cryostat for two of three dates on which Mohs surgery was performed. Findings are as follows: 1. The laboratory performed Mohs micrographic surgery testing as confirmed by the Nurse Manager (NM) during the entrance interview on 12/01/20 at 10:05 a.m. 2. A Leica model HM550 (S/N: 28140) and a Leica model HM550P (S/N: 53456) cryostat were observed as present and available for use during a tour of the lab. 3 A requirement to record the operating temperature of the cryostats each day of patient testing was established in the Procedure for Equipment / Daily Cryostat (MICROM), located in the Laboratory Manual. 4. During a review of the Cryostat Daily / Weekly / Monthly QA Log, cryostat temperature documentation was not found in laboratory records for two of three days on which Mohs surgery was performed during the timeframe reviewed, 08/20/18 through 12/01/20. Date of service: Mohs Case # performed: 9/12 /19 CM19-357 10/15/20 CM20-423 5. The laboratory was unable to provide the missing records upon request. 6. During an interview on 12/01/20 at 11:15 a.m., the NM confirmed the above findings. . 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 --