Associated Skin Care Specialists Pa - Maple Grove

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 activities used to verify the accuracy of the single Histopathology test performed in the laboratory at least twice annually in 2021. Findings are as follows: 1. The laboratory performed Mohs micrographic surgery with microscopic examination under the specialty of Histopathology as confirmed by the Laboratory Specialist (LS) during a tour of the laboratory at 1:05 p.m. on 01/25/22. 2. Cases completed by each Mohs surgeon were sent for evaluation twice annually to verify accuracy as established in the Proficiency Testing for Mohs Surgery procedure located in the Mohs Logs/Quality Assurance manual. The Maple Grove office had one Mohs surgeon in 2021 as indicated laboratory records. 3. Documentation of one Mohs case review completed in 2021 was found during review of laboratory records. The laboratory was unable to provide a second Mohs case review from 2021 upon request. The laboratory was given 3 days to locate and forward the required documentation. 4. The laboratory performed approximately 907 Mohs micrographic surgery procedures annually as indicated in laboratory records and listed on Form CMS-116 Clinical Laboratory Improvement Amendments (CLIA) Application for Certification provided by the laboratory on date of survey. 5. In an interview at 3:05 p.m. on 01/25/22, the LS confirmed the above finding. In an email received at 2:40 p.m. on 01/27/22, the LS indicated a second Mohs case review for 2021 was not found. . D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) 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 -- (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory staff, the laboratory failed to retain lot number and expiration date records for 2 of 2 stains used for Histopathology testing. Findings include: 1. The laboratory performed Mohs micrographic surgery with microscopic examination under the specialty of Histopathology as confirmed by the Laboratory Specialist (LS) during a tour of the laboratory at 1:05 p.m. on 01/25/22. 2. Laboratory policies and procedures did not include instruction to record and retain Hematoxylin and Eosin (H&E) stain lot numbers and expiration dates. 3. H&E stain lot numbers and expiration dates were not found during review of laboratory records from March 2020 through January 2022. 4. The laboratory was unable to provide the required documentation upon request. 5. In interviews at 1:10 p.m. and 3:30 p.m. on 01/25/22, the LS confirmed the above finding. -- 2 of 2 --

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 Histopathology testing material 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 Laboratory Specialist (LS) during a tour of the laboratory on 02/28/18 at 1:05 p.m. 2. One bottle of Mounting Medium, lot 350525 and expiration date 10/2017, was observed as present and available for use during the tour of the laboratory. 3. In an interview on 02/28/18 at 1:06 p.m., the LS confirmed the Mounting Medium was used after the expiration date had been exceeded. 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 --