Sills Dermatology

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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: Through observation, review of Mohs surgery log, review of cryostat temperature records and interview with laboratory staff it was determined that the laboratory failed to document proper cryostat operating temperatures for 6 of 125 Mohs surgery procedures performed in 2022. Findings follow: A) During a tour of the laboratory on 9/13/22 at 12:50 p.m. two cryostats, designated QS11 and QS12, both with an acceptable temperature range of -21 degrees C. to -35 degrees C. were observed in the tissue processing area. B) Review of the Mohs surgery log for 2022 revealed that Mohs surgery procedures were performed on six patients (specimen numbers 22m- 0274, 22m-0275, 22m-0276, 22m-0277, 22m-0278 and 22m-0279) on 7/19/22 C) Review of the cryostat temperature log for cryostat QS12 revealed that no operating temperature was recorded on 7/19/22. D) In an interview on 9/13/22 at 1:40 p.m. the laboratory staff member (#2 on the CMS 209 form) stated that she was not present on 7/19/22 and other personnel would have used cryostat QS11 to process Mohs surgery patients on that day and that temperature records for cryostat QS11 were hanging on the side of the instrument since that unit was rarely used. E) Review of the temperature records on the side of cryostat QS11 revealed that no operating temperature was recorded on 7/19/22. F) In an interview on 9/13/22 at 1:40 p.m. the laboratory staff member (#2 on the CMS 209 form) and the laboratory director 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 -- confirmed that Mohs surgery was performed on 7/19/22 and there was no documentation of the proper cryostat operating temperature on that day. -- 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: Through obseration and interview it was determined that the laboratory failed to assure that supplies were not used when they have exceeded their expiration date. Findings follow: A. During a tour of the laboratory on 3/20/18 at approximately 1545 one of one bottle of Potassium Hydroxide Solution Lot # 1578-00 with an expiration date of September 2015 was observed in a cabinet next to cover slips and slides. B. In an interview on 3/20/18 at approximately 1545 the office manager identified as number one on the "Entrance and/or Exit Conference Attendance Record" verified that the bottle was available for use and had exceeded the expiration date. 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 --