Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dermatology Associates & Surgery Center Beckley on 11/14/2024 by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess for compliance with the CLIA regulations under 42 CFR 493. Specific deficiencies are cited, as follows: 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 tour of the microscopic testing area, review of the Leica DM750 microscope manufacturer's instructions, lack of environmental monitoring equipment, lack of documentation, and interviews with the laboratory manager, the laboratory failed to monitor and document the temperature and humidity in one of two patient testing areas. Findings: 1. During interview on 11/14/2024 at 11:06 am, the laboratory manager stated there were two separate areas for patient testing and that the microscope used for analyzing patient samples was located in a different room. 2. During a tour of the separate laboratory area on 11/14/2024 at 12:10 pm, the surveyor identified the microscope as a Leica DM750. No thermometer or hygrometer could be located. No documentation that the temperature and humidity had been monitored through the date of survey (11/14/2024) could be located. 3. During interview on 11/14 /2024 at 12:10 pm, the laboratory manager verified there was not a thermometer or hygrometer in that room. 4. Review of the Leica DM750 manufacturer's instructions 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 -- for use identified temperature and humidity requirements as follows: a. Temperature for use: 10-40 degrees Celsius b. Storage temperature: -20-52 degrees Celsius c. Humidity during use and storage: 20-90% 5. During exit interview on 11/17/2024 at 12:26 pm, the laboratory manager confirmed that the temperature and humidity were not being monitored in the microscopic testing room. 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 policies and procedures, lack of documentation, and interview with the laboratory manager, the laboratory director failed to ensure that job duties and responsibilities were specified in writing for individuals occupying four of five CLIA positions. Findings: 1. Review of the laboratory's Mohs policies and procedures identified written job descriptions for the laboratory director (LD), clinical consultant (CC), technical supervisor (TS), general supervisor (GS), and testing personel (TP) positions as located in the "Beckley Mohs Log 2024" binder. All job descriptions had been approved and signed by the laboratory director. 2. The job descriptions for the CC, TS, GS, and TP were not signed by the individuals occupying the positions. No documentation that personnel had signed their respective job descriptions through the date of survey could be located. 3. During interview on 11/14 /2024 at 11:52 am, the laboratory manager confirmed that no job descriptions were assigned to or signed by individuals in the CC, TS, GS, and TP positions. -- 2 of 2 --