Skincare Drs Pa

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 XX 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 procedures performed by the laboratory. Findings are as follows: 1. The Mycology Subspecialty was removed from the laboratory's CLIA certification on 10/11/18 as indicated on the Form CMS-116 submitted by the laboratory during the routine CLIA survey performed on 10/11/18. 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 1:10 p.m. on 11/28/22: Micromaster microscope and Olympus CX-41 microscope Potassium Hydroxide (KOH) solution - 2 bottles Chlorazol Black stain Glass slides and cover slips Butane lighter Waste container labeled KOH Slides containing 141 unlabeled slides with milky or gray residue The KOH solution and Chlorazol Black stain were expired - see D5417 3. Laboratory Testing Personnel 1 indicated she performed approximately two fungal microscopic examinations each of the last 5.5 years during a telephone interview at 1: 33 p.m. on 11/28/22. 4. The laboratory's fungal microscopic patient testing log, found the the KOH Log, Edina manilla folder, indicated patient samples received fungal microscopic examinations in 2018, 2019, and 2020. See below. Year Number of tests 2018 5 2019 2 2020 1 Testing records were not found for 2021 or 2022. See D5787. 5. 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 6. Verification of fungal testing accuracy documents from 2018 through 2022 were not found found during review of laboratory records. The laboratory was unable to provide testing accuracy verification records upon request. 7. In an interview at 1:40 p.m. on 11/28/22, 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)

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 XX 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 procedures performed by the laboratory. Findings are as follows: 1. The Mycology Subspecialty was removed from the laboratory's CLIA certification on 10/11/18 as indicated on the Form CMS-116 submitted by the laboratory during the routine CLIA survey performed on 10/11/18. 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 1:10 p.m. on 11/28/22: Micromaster microscope and Olympus CX-41 microscope Potassium Hydroxide (KOH) solution - 2 bottles Chlorazol Black stain Glass slides and cover slips Butane lighter Waste container labeled KOH Slides containing 141 unlabeled slides with milky or gray residue The KOH solution and Chlorazol Black stain were expired - see D5417 3. Laboratory Testing Personnel 1 indicated she performed approximately two fungal microscopic examinations each of the last 5.5 years during a telephone interview at 1: 33 p.m. on 11/28/22. 4. The laboratory's fungal microscopic patient testing log, found the the KOH Log, Edina manilla folder, indicated patient samples received fungal microscopic examinations in 2018, 2019, and 2020. See below. Year Number of tests 2018 5 2019 2 2020 1 Testing records were not found for 2021 or 2022. See D5787. 5. 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 6. Verification of fungal testing accuracy documents from 2018 through 2022 were not found found during review of laboratory records. The laboratory was unable to provide testing accuracy verification records upon request. 7. In an interview at 1:40 p.m. on 11/28/22, 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)

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 and interview with laboratory personnel, the laboratory failed to ensure 1 of 2 Histopathology tissue marking materials was not used after the expiration date had been exceeded. Findings are as follows: 1. The laboratory performed Mohs Micrographic Surgery under the subspecialty Histopathology as confirmed by the Histology Technician (HT) during a tour of the laboratory at 1:05 p. m. on 01/08/21. 2. An expired tissue marking material was observed as present and available for use during the tour of the laboratory. See below. Cancer Diagnostics Tissue Marking Dye Lot 7137 Expiration 08/18 3. The laboratory performed approximately 257 Mohs procedures annually as indicated on the Form CMS-116 completed for the 01/08/21 survey. 4. In an interview at 1:05 p.m. on 01/08/21, the HT 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to retain Mohs Micrographic Surgery quality control (QC) slides for at least 2 years. The laboratory performed approximately 350 Mohs Micrographic Surgery procedures annually. Findings are as follows: 1. The laboratory performed Mohs Micrographic Surgery as confirmed by the Histotechnician (HT) during a tour of the laboratory on 10/11/18 at 1:05 p.m. 2. During the tour, the HT stated separate Mohs QC slides were created using excess tissue from the first patient case of the day. 3. Mohs QC slides associated with cases 17-033 from 05/15/17 and 18-065 from 05/14 /18 were not available on date of survey. The laboratory was unable to provide the Mohs QC slides upon request. 4. In an interview on 10/11/18 at 1:20 p.m., the HT indicated the QC slides were discarded after surgeon review on each day of patient testing. 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 --