Summary:
Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the ACL Elite coagulation reagent verification records from January 2019, observations of the coagulation analyzer and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 1: 00 pm on 09/12/2019, the laboratory failed to meet the hematology (coagulation) requirements for test system/equipment/reagent verification as specified in the standard D5411. 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 ACL Elite coagulation reagent verification records from January 2019, observations of the coagulation analyzer and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 09/12/2019, the laboratory failed to program the correct normal patient mean for the current thromboplastin reagent in use (lot N0789332, expiration 07/2020) into the 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 -- ACL Elite coagulation analyzer. The findings include: 1. The laboratory established a normal patient mean of 11.04 seconds for thromboplastin lot number N0789332 (expiration 07/2020) in January 2019. 2. At the time of the survey, observation of the ACL Elite coagulation analyzer revealed that the laboratory had programmed a normal patient mean of 11.55 seconds into the instrument. 3. Observation of thromboplastin reagent in the laboratory's refrigerator confirmed current use of lot N0789332 (expiration 07/2020). 4. Laboratory personnel identifier #3 confirmed that the laboratory did not have the correct established normal patient mean programmed into the coagulation analyzer. -- 2 of 2 --