Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a surveyor review of the Mohs laboratory's procedure manual and an interview with the practice manager, the laboratory failed to have a procedure manual that is comprehensive, up-to-date, and accurate. FINDINGS: On December 18, 2019 at approximately 10:30 AM the practice manager confirmed surveyor's finding that Mohs procedure manual still lists the former laboratory director as the current laboratory director. The laboratory must have an accurate and up to date procedure manual signed by the current laboratory director. 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 a lack of room temperature and humidity records an and interview with the 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 -- practice manager, the laboratory failed to follow the manufacturer's instructions to monitor and document the room temperature and humidity where testing is performed. Findings Include: It was confirmed by the practice manager, on December 18, 2019 at approximately 10:30 AM that the laboratory failed to follow the manufacturer's written criteria to monitor and document the temperature and humidity of the room where Mohs testing is performed from January 2018 through the date of this survey. -- 2 of 2 --