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: Based on review of verification data and interview with the technical consultant, the laboratory did not verify performance specifications for the Bayer DCA Microalbumin /Creatinine cartridge prior to reporting patient test results. Findings: 1. A review of the verification documentation showed the Bayer DCA 2000 was put into use testing patient specimens on 11/2/2018. 2. The verification did not include precision and reportable range for Microalbumin, and did not include accuracy, precision, and reportable range for Creatinine. 3. The laboratory does approximately 2 microalbumin /creatinine tests per month. 4. The technical consultant confirmed these findings at 11: 15 am on 4/22/19. 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 --