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: Review of Ortho MTS ID-Tipmaster pipetor A63006231 blood bank function check, manufacturer's instructions, and staff interview revealed that the laboratory failed to assure that the pipetor used for Immunohematology testing with the Ortho MTS Gel system was operating within the manufacturer's specification. Findings were: 1. Review of January 2, 2018 Ortho MTS ID-Tipmaster pipetor A63006231 verification record from Streck of the 12.5 microliter (ul) setting showed the percent recovery was 106.94%, which Streck recommends an acceptable limit of 100% +/- 3%. In addition, the Streck record documented a correlation verification (c. v.) of 11.44% with a mean (average) volume of 13.4 ul. For this pipette, no