Summary:
Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of coagulation reagent verification records, observations of the coagulation analyzer and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 12:00 pm on 05/28/2021, the laboratory failed to program the correct normal patient mean for the current prothrombin time reagent in use (lot 255916, expiration 07/31/2021) into the Stago Compact Max coagulation analyzer. The findings include: 1. The laboratory established a normal patient mean of 12.7 seconds for prothrombin time reagent lot 255916 (expiration 07/31/2021). 2. At the time of the survey, observation of the Stago Compact Max analyzer revealed that the laboratory had programmed a normal patient mean of 12.8 seconds into the instrument. 3. Observation of prothrombin time reagent in the laboratory's refrigerator confirmed current use of lot 255916 (expiration 07/31 /2021). 4. Laboratory personnel identifier #2 confirmed that the laboratory did not have the correct established normal patient mean programmed into the coagulation analyzer. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --