Summary:
Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on the surveyor's review of College of American Pathologists (CAP) Proficiency Testing (PT) reports and an interview with the laboratory supervisor, the laboratory failed to evaluate, perform and document remedial action for the PT scores of less than 100% for the following specialty in 2017: 2017 third event: Bacteriology = 60% 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 surveyor's review of laboratory's temperature documentation and interview with the laboratory supervisor, the laboratory failed to follow the manufacturer's temperature requirement for the laboratory testing. FINDINGS: 1. The laboratory performs throat culture. The manufacturer of the throat culture media used for testing 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 -- and the laboratory's temperature policy require that the incubator temperature to be in the range of 35-37 degree Celsius. On June 7, 2018 at approximately 2:00 PM the laboratory supervisor confirmed surveyor's findings that the incubator temperature was out of range, when patient samples were incubated for throat culture for 5 days in 2017 and was out of range for 12 days from January 2018 thru the survey date. 2. Approximately 60 patient samples were tested and reported for throat culture during this time frame. -- 2 of 2 --