Hull Dermatology

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 upon observation, review of Mohs surgery log, review of cryostat temperature records and interview with laboratory staff the laboratory failed to document proper cryostat operating temperatures for 550 Mohs surgery procedures performed in 2025. Findings follow: A) During a tour of the laboratory on 11/18/25 at 1:15 p.m. a cryostat with an manufacturer defined acceptable temperature range of -21 degrees C. to -35 degrees C. was observed in the tissue processing area. B) In an interview on 11 /18/25 at 01:15 p.m., the laboratory staff member (identified on the entrance conference attendance record) stated that Mohs surgeries are performed on Mondays in the clinic and that 550 Mohs surgery procedures were performed in 2025. C) Review of the cryostat temperature log revealed that no operating temperature was recorded on any date in 2025. D) In an interview on 11/18/25 at 03:00 p.m. the laboratory staff member (identified on the entrance conference attendance record) confirmed that Mohs surgeries were performed in 2025 and the cryostat was used to prepare slides used for diagnosis on those surgeries, and there was no documentation of the proper cryostat operating temperatures in 2025. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- CFR(s): 493.1252(d) (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 staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 11/18/25 at 2:45 pm, one (of 1) bottle of Toluidine Blue O, 1% lot# 0027-00, expiration date 2021-08-31 was observed in the laboratory cabinet, available for use beyond the expiraton date. C) In an interview on 11/18/25 at 3:00 pm the laboratory staff member ( identified on the entrance conference attendance record) confirmed that the item, identified above, had exceeded the expiration date and was available for use in the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Through a review of the KOH patient log, a review of 12 patient medical records, and interviews with laboratory staff, it was determined the laboratory failed to have a record system that included the identity of the personnel who performed the test. Survey findings include: A. During a review of the KOH patient log for 2020 through 2022, it was noted that the log failed to have a documentation of the testing person who performed the testing on each patient sample. B. The surveyor reviewed 12 patient medical records in the Electronic Medical Record system. Five medical records reviewed, had documentation of KOH microscopic examinations. One of the five medical records, with KOH microscopic exams, included the name of the individual who performed the test. C. In an interview at 3:17 on 3/2/2022, employee #6 (as listed on the Personnel Identification Worksheet) confirmed there was no documentation of the person performing the testing on four of five KOH microscopic examinations reviewed. 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 D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of the laboratory procedures, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to document the quality of the Hematoxylin and Eosin (H and E) stain each day of use which has a potential to affect all histopathology slides reviewed. Survey findings include: A. A review of laboratory procedure manual failed to include a policy for documenting the quality of H and E staining of the slides. B. The surveyor requested documentation of stain quality but none was provided. C. In an interview, at approximately 08:45 a.m. on 3/4 /20, laboratory employee #seven (as listed on the CMS 209 form) confirmed the laboratory failed to document slide and stain quality each day of 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 --