Summary:
Summary Statement of Deficiencies D0000 A routine recertification inspection was performed on May 8th, 2018 and May 9th, 2018. The laboratory is in compliance with all Conditions of Participation found in the CLIA regulations at 42 CFR part 493. 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 review of analyzer operator manuals, laboratory environmental records, and interview with facility personnel, the laboratory failed to monitor the humidity of the operating environment for 4 of 4 months reviewed between January 1, 2018 and May 9, 2018. The findings included: 1. Based on review of analyzer operator manuals, the following equipment have relative humidity requirements for the operating environment: Microm HM 525 Cryostat - "Operating Conditions 5 degrees Celsius to 35 degrees Celsius at a max relative humidity of 60 percent (page 14 of the operator's manual) Vitros 5600 automated chemistry analyzer -15 percent to 75 percent humidity between the temperatures of 15 degrees Celsius and 25.6 degrees Celsius, decreasing to 15 - 60 percent relative humidity for temperatures between 25.6 and 30 degrees Celsius. 2. Based on review of laboratory environmental records for 4 of 4 months reviewed between January 1, 2018 and May 9, 2018, the laboratory did not monitor the relative humidity in the operating environment. 3. In an interview at 11:00 hours on 5/9/2018 in the office, the General Supervisor stated the laboratory had previously Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- monitored relative humidity levels of the operating environment but had ceased documenting humidity levels when the previous chemistry analyzer was removed. D5783