Summary:
Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Through a review of the new instrument validation for the AcT Diff 2 put into service in March 2019, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to verify the manufacturer's normal ranges were appropriate for the laboratory's patient population. Survey findings include: A. A review of the validation documentation for the AcT Diff 2 Hematology Analyzer, which was put into service in March 2019, revealed that there was no documentation of verification of the manufacturer's normal values for patient testing. B. In an interview at 2:45 pm on 10/1/2019, laboratory employee #2 (as listed on the form CMS-209) confirmed the laboratory had no documentation of verifying the normal patient ranges in use for the AcT Diff 2. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. 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 -- This STANDARD is not met as evidenced by: Through a review of the Coulter AcT diff 2 Operator's Manual, a review of quality control and patient results from the Coulter AcT diff 2, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to document function checks as defined by the manufacturer. Survey findings include: A. A review of the Coulter AcT diff 2 Operator's Manual revealed that Instrument Startup is required daily. The Instrument Startup includes a background count for WBC, RBC, Hemoglobin, and Platelet which is recorded as Pass or Fail. The manual lists required