Spring Hill Dermatology, Plc

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: Based on observation of the laboratory, review of the manufacturer's instruction manual, environmental records, annual test volumes reported on Form CMS-116, and staff interview, the laboratory failed to monitor ambient room temperature and humidity where patient tissue processing occurred in 2022, 2023, and 2024. 1. Observation of the laboratory on 06/10/24 at 08:15 a.m. revealed an Intelsint RVG/1 Histology Vacuum Tissue Processor (SN1344/172) in use for processing patient dermatopathology tissue samples. 2. A review of the Intelsint RVG/1 - Histology Vacuum Tissue Processor Installation, Use and Maintenance manual revealed a running ambient temperature requirement of 10 / 35 C and a relative humidity requirement of Max 80% (not condensing). 3. A review of the laboratory environmental records revealed no room temperature or humidity records were available for the area where the laboratory processed tissues using the Intelsint RVG/1 Tissue Processor in 2022, 2023, or 2024. 4. A review of the Form CMS-116 annual test volume estimates revealed approximately 18,500 tissue sample results reported in 2022, 2023, and 2024 (06/01/2022-06/10/2024). 5. An interview on 06/10/2024 at 11: 45 a.m. with the laboratory director and the laboratory manager confirmed the laboratory did not monitor laboratory room temperature or humidity in 2022, 2023, or 2024. 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 D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on review of laboratory corrected patient reports and Laboratory Director interview determined the laboratory failed to indicate the corrected results on corrected patient reports for January through July 2018. The findings include: 1. Review of 22 (accession numbers: 69, 144, 366, 367, 602, 5847, 3420, 745, 746, 748, 845, 1046, 1318, 1240, 1620, 2079, 2197, 2198, 2180, 2852, 2853, 3123) laboratory corrected patient reports revealed the laboratory failed to include the corrected information on the final laboratory corrected patient reports. 2. Interview with the Laboratory Director on August 1, 2018, at 12:20 PM confirmed the laboratory failed to include the information that was corrected on the 22 final laboratory corrected patient reports for January through July of 2018. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each 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 -- consultant and 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 results reporting, and whether consultant 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 personnel job descriptions and interview with the laboratory manager determined the Laboratory Director failed to ensure the laboratory had a written job description for the Technical Supervisor in 2018. The findings include: 1. Review of the laboratory job descriptions failed to include a job description for the laboratory Technical Supervisor. 2. Interview with the laboratory manager on August 1, 2018, at 9:55 AM confirmed the Laboratory Director failed to include a job description for the position of Technical Supervisor in 2018. -- 2 of 2 --