Advanced Dermatology

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on the surveyor's observation during the laboratory's tour and interviews with the area practice manager (AM), and administration personnel (AP), the laboratory failed to label reagents used in the laboratory to indicate the received date, opening, preparation, and expiration dates when such materials are used. The findings include: 1. Based on the surveyor's observation during the laboratory's tour on October 16, 2025, at approximately 3:30 p.m. no received date, opening date, and preparation labels were used or documented for reagents used in the laboratory. 2. There was not a reagent log available for the date received, lot number, expiration date and, and opening date. 3. The laboratory's AM and AP affirmed by interview conducted on October 16, 2025, at approximately 3:45 p.m. that the reagents used in the laboratory for Mohs procedure were not labeled with the received date, opening, preparation, and /or expiration date and that a reagent log was not available at the time of the survey. 4. Based on the laboratory's annual testing declaration submitted at the time of the survey, the laboratory analyzed approximately 200 samples for Mohs test procedure using reagents not labeled as regulated. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 the surveyor's examination of laboratory reagents and interview with the laboratory's area practice manager (AM) and other laboratory administration personnel (AP); the laboratory failed in not using reagents when they have exceeded their expiration date. The findings include: 1. Based on the surveyor's examination, the laboratory stored expired reagent: tissue marker Lot # 23214 Expired 08/31/2025. No other non-expired tissue marker was available for replacement. 2. The AM and AP affirmed on October 16, 2025, at approximately 3:30 p.m., that the laboratory only had at the time of the survey expired tissue marker reagent used for sample staining for microscopic examination. 3. Based on the laboratory's submitted testing declaration test volume, the laboratory stained and tested and reported approximately 200 samples for Histopathology microscopic examination for some of which they might have used expired staining reagents. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the surveyor's direct observation during the laboratory tour, review of the laboratory's policies and procedures, preventive maintenance (PM) documentation, four (4) patient records, and interviews with the laboratory's area practice mnager (AM); the laboratory failed to establish and follow a policy and procedure in place for the calibration of the thermometers as defined by the manufacturer, with at least the frequency recommended for the laboratory's equipment prior to patient testing. The findings include: 1.The laboratory failed to provide PM documentation for the year 2024 and 2025 for the digital thermometers used in the laboratory according to manufacturer's requirements, to be performed annually. 2. No

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the lack of laboratory current written policies and procedures and interview with the laboratory personnel, it was determined that the laboratory failed to have available and follow written procedures for Histopathology (Mohs testing) test procedure performed in the laboratory. The findings included: 1. On the day of the survey on October 28, 2021 at approximately 11:00 a.m. the laboratory failed to provide written policies and procedures for Histopathology test procedures currently performed in the laboratory. 2. For five (5) out of five (5) random patient test results reviewed covering period from 09/30/2019 to 09/28/2021 all the patients had Mohs test ordered, analyzed, and reported for which the laboratory had no written policies and procedures available for the current practice. 3. The laboratory staff confirmed on October 28, 2021 at approximately 11:30 a.m.. that the laboratory did not have written policies and procedures available for the current Mohs test performed in the laboratory. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures manual and interview with the laboratory personnel (LP); it was determined that the laboratory failed to update protocols in place when changes in the practice occurred in the laboratory and the effective date and signature of approval by the laboratory director of such changes. The findings included: 1. On the day of the survey October 28, 2021 at approximately 11:30 a.m. the procedure manual in place had not being updated to reflect current Mohs procedure performed in the laboratory. 2. The existing protocols presented to the surveyor included testing no longer perfomed in the laboratory. 3. The LP affirmed on October 28, 2021 at approximately 12:00 p.m. that the laboratory failed to update protocols for the current testing performed in the laboratory and that the effective date and the laboratory director's signature were missing. 4. The laboratory's testing declaration form stated that the laboratory processes approximately 1,000 Histopathology samples annually including the Mohs procedure. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on interview with the laboratory staff on October 28, 2021 at approximately 12: 00 p.m., the laboratory director failed to ensure that an approved, signed, and dated, procedure manual reflecting the current practice is available to all personnel responsible for any aspect of the testing process. Findings include: D5401 and D5407. -- 2 of 2 --