Sun Dermatology

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Sun Dermatology on 03 /07/24. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures manual and interview with the Mohs Technician (MT), the laboratory failed to have a documented complaint investigation procedure that allows individuals to report concerns to or about the laboratory. Findings included: -Review of the policies and procedures manual signed by the Laboratory Director on 01/08/24, showed that no documented complaint investigation procedure was approved for the laboratory staff to follow. - Interview with the MT on 03/07/24 at 10:50 a.m., confirmed that the laboratory did not have a documented complaint investigation procedure to follow. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: 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 -- Based on review of laboratory records and interview with the Mohs Technician (MT), the laboratory failed to perform annual competency assessment for KOH and Scabies for 2 (#A and #B) out of 3 (#A, #B, and #C) Testing Personnel (TP) reviewed. Findings included: -Review of laboratory records revealed that TP #A and #B did not receive annual competency assessment for KOH and Scabies. -Interview with the MT on 03/07/24 at 10:33 a.m., confirmed that TP #A and #B were not competency assessed for KOH and Scabies testing. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with the Mohs Technician (MT), the laboratory had no written job descriptions for the Clinical Consultant, Technical Consultant, Technical Supervisor, General Supervisor, and Testing Personnel. Findings Included: -Review of the policies and procedures manual signed by the Laboratory Director on 01/08/24, revealed that the roles and responsibilities for the Clinical Consultant, Technical Consultant, Technical Supervisor, General Supervisor, and Testing Personnel were not documented. - Interview with the MT on 3/07/24 at 10:50 a.m., confirmed that the laboratory had no written job descriptions for Clinical Consultant, Technical Consultant, Technical Supervisor, General Supervisor, and Testing Personnel. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on February 3, 2022. Sun Dermatology clinical laboratory was not in compliance with 42 CFR 493, Requirements for Laboratories. 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 record review and interview with lab staff #A, the laboratory failed to verify the accuracy of wet mounts for Scabies and Potassium Hydroxide (KOH) at least twice annually for 2 of 2 (2020 and 2021) years reviewed. The findings included: Record review revealed only one KOH/Scabies Prep Sheet in 2020 dated 10/28/2020. The document was for KOH testing only. The Consult line was incomplete and the second signature was the original provider's signature, not a consulting provider. The KOH/Scabies Prep Sheet dated 1/20/2021 was for KOH testing only. The Consult line was incomplete and the second signature was the original provider's signature, not a consulting provider. The KOH/Scabies Prep Sheet dated 7/7//2021 was for KOH and Scabies testing. The Consult line was incomplete and the second signature was the original provider's signature, not a consulting provider. During an interview with lab staff #A on 2/03/2022 at approximately 1415, lab staff #A confirmed that wet mounts and KOH preps were not verified for accuracy at least twice annually. 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 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 -- 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: Based on record review and interview with lab staff #A, the laboratory failed to establish and document acceptable reference ranges for laboratory humidity, laboratory temperature, 3050 Leica Cryostat temperature, and 1850 Leica Cryostat temperature for 2 of 2 (2020 - 2021) years reviewed and January of 2022. Findings included: Record review of temperature and humidity logs discovered that the reference ranges were missing from the log sheets for: 1. Laboratory humidity and room temperature for all of 2020, 2021, and January of 2022 2. 3050 Leica Cryostat temperature for all of 2021 and January of 2022 3. 1850 Leica Cryostat temperature for January of 2022 Interview with lab staff #A at 1415 on February 3, 2022, confirmed the reference ranges for humidity and temperatures were not established and documented. 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 lab staff #A, the laboratory failed to have an in-date working bottle of Potassium Hydroxide (KOH). The findings include: During the lab tour on 2/03/2022, it was observed that the KOH reagent bottle in use (lot #K15213) was expired on February 2018. During interview on 2/03/2022 at 1415 with lab staff #A, it was confirmed that the KOH reagent bottle was dated to expire February of 2018. It was revealed that thirteen (13) patients had KOH testing done from 7/27/2018 through 10/14/2021. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Sun Dermatology on March 18, 2020. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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: Based on record review and interview with laboratory staff, the laboratory failed to document humidity for 2 of 2 (2018 - 2020) years reviewed. Findings Included: Review of temperature logs revealed no humidity documented from March 2018 through March 2020. During an interview on March 18, 2020 at 11:00 AM, the laboratory supervisor confirmed that the humidity was not documented and the laboratory was not aware of the requirement to check the humidity daily. 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 --