Summary:
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 a lack of humidity records an and interview with the Practice manager, the laboratory failed to follow the manufacturer's instructions to monitor and document the room humidity where testing is performed. Findings Include: It was confirmed by the practice manager, on October 2, 2018, approximately 1:30 pm that the Moh's technician failed to follow the manufacturer's written criteria to monitor and document the humidity of the room where Moh's testing is performed from July 10, 2017 through the date of this survey. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of the laboratory's records and an interview with the practice 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 -- manager, the laboratory director failed to ensure that the laboratory failed to followed the manufacturer's instruction to monitor and document the humidity of the room where testing is performed. Refer to D5413 -- 2 of 2 --