Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on May 26, 2022. J Matthew Knight MD PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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, the laboratory failed to record the temperature of the Avantik cryostat from 01/03/2022 to 05/26/2022. Findings: Review of the 2022 Cryostat temperature log showed that on the days of laboratory testing, only the Mohs technician's initials were recorded. There were no temperature readings recorded on the log. Review of the laboratory's policy titled "Quality Control Policies and Documentation" in the section for the cryostat, "Temperature is recorded daily and documented." On 05/26/2022 at 9:54 AM, the Practice Manager stated the log was initialed indicating the temperature were in range for the cryostat in 2022. 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 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 -- 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 procedure manual and interview, the Laboratory Director failed to specify in writing, the responsibilities and duties (job descriptions) of Testing Personnel (Mohs Surgeon) from 9/8/21 to 5/26/22. Findings: Review of the laboratory's procedure manual, signed by the Laboratory Director on 9/8/21, showed there was no job descriptions for the Mohs Surgeon. On 05/26/2022 at 10:18 AM, the Practice Manager stated they did not have a job description for the Mohs Surgeon. -- 2 of 2 --