Summary:
Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on the attached notice of determination of noncompliance, the laboratory did not meet state Law 23-16.2-6. The Rhode Island Department of Health took adverse action against the laboratory. See attached. 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 staff interview the laboratory failed monitor and document of refrigerator temperatures. Findings include: 1. Record review of the laboratory's "Daily Temperature Chart" logs for specimen storage on 12/7/18 revealed, no recorded specimen refrigerator temperatures for the months of November and December 2018 and no temperature charts available for the testing months of August and September 2018 2. Interview with the Laboratory Director (LD) on 12/7 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- /18 at 11:00 a.m. revealed that technical staff failed to record temperature data for the clinical specimen refrigerator; in addition, the LD acknowledged that the quality assurance policy failed to identify and ensure correction of this oversight. D5781