Skin Care Doctors Pa

Summary Statement of Deficiencies D0000 . The Skin Care Doctors PA laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the initial survey performed on November 1, 2024. The following standard-level deficiency was cited: 493.1291 Test report . 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 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 one of two test reports reviewed on date of survey included complete test results in 2024. Findings are as follows: 1. The laboratory performed Mohs micrographic surgery which included tissue inking and Histopathology slide interpretation as confirmed by the Practice Administrator (PA) during a tour of the laboratory at 10:06 a.m. on 11/01/24. The laboratory began testing on May 1, 2024. 2. The following equipment was observed as present and available for use during the tour: Leica Autostainer XL Leica ST4020 autostainer Leica CV5030 coverslipper Leica CM1850 cryostat (2) Olympus CX41 microscope 3. Mohs case 24-091, performed on August 22, 2024, was one of two cases reviewed on date of survey. The Mohs map, the Skin Care Doctors Mohs log, and associated patient slides indicated the surgery was performed in two stages. The Mohs map 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 -- documentation indicated the tissue margins were clear of tumor after the second surgical stage. 4. The operative report (test report) included a description of the first surgical stage. The report did not include results of the first stage nor a description indicating the second and final result of the surgery. 5. In an interview at 12:35 p.m. on 11/01/24, the PA confirmed the above finding. -- 2 of 2 --

Summary Statement of Deficiencies D5006 MYCOLOGY CFR(s): 493.1203 If the laboratory provides services in the subspecialty of Mycology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1263, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on observation, document review and an interview with laboratory personnel, the laboratory failed to meet all requirements specified in 493.1230 through 493.1256, 493.1263, and 493.1281 through 493.1299 for the sub-specialty of Mycology. The laboratory performs approximately 10 non-waived mycology tests per year. Findings are as follows: 1. The laboratory failed to perform and document fungal microscopic examination testing accuracy verification activities at least twice annually. See D5217 2. The laboratory failed to establish required procedures for fungal microscopic examinations and associated required activities. See D5403 3. The laboratory failed to ensure solutions used for fungal microscopic examinations were not used after the expiration date had been exceeded. Dee D5417 4. The laboratory failed to maintain an information or record system (patient testing log) for fungal microscopic examinations. See D5787 5. The Technical Consultant failed to ensure testing personnel were evaluated for fungal microscopic examination competency. See D6046 . 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. 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 -- This STANDARD is not met as evidenced by: . Based on observation, 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 one moderate complexity microscopic examination procedure performed by the laboratory. Findings are as follows: 1. The Mycology Subspecialty was removed from the laboratory's Clinical Laboratory Improvement Amendments (CLIA) certification on 08/02/19 as indicated on the Form CMS-116 submitted by the laboratory during the routine CLIA survey performed on 08/02/19. 2. The following fungal microscopic testing materials were observed as present and available for use during a tour of the laboratory with the Clinical Operations Manager (COM) at 11:20 a.m. on 11/30/22: Omano microscope and Olympus BX-41 microscope Potassium Hydroxide (KOH) solution - 1 bottle Chlorazol Black stain - 1 bottle Glass slides and cover slips Butane lighter The KOH and Chlorazol Black were expired - see D5417 3. Laboratory Testing Personnel 1 indicated she performed approximately 2 fungal microscopic examinations each of the last 5.5 years during an interview at 11:32 a.m. on 11/30/22. 4. Laboratory Testing Personnel 2 indicated she performed approximately 2 fungal microscopic examinations each of the last 2 years during an interview at 11:50 a.m. on 11/30/22. 5. The laboratory's fungal microscopic patient testing log, found the KOH Log, Burnsville manilla folder, indicated patient samples received fungal microscopic examinations in 2018 and 2019. See below. Year Number of tests 2018 35 2019 3 Fungal testing records were not found for 2020, 2021, or 2022. See D5787. 6. A procedure for twice annual verification of fungal testing accuracy was not found in laboratory documents. The laboratory was unable to provide this procedure upon request. See D5403 7. Verification of fungal testing accuracy documents from 2019 through 2022 were not found during review of laboratory records. The laboratory was unable to provide the testing accuracy verification records upon request. 8. In an interview at 11:52 a.m. on 11/30/22, the COM confirmed the above finding. . 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)