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 observation, document review, and interview with laboratory personnel, the laboratory failed to ensure 4 of 4 reportable ranges obtained during performance verification activities completed in 2019 were adopted by the laboratory. Findings are as follows: 1. The laboratory performed Endocrinology testing as confirmed by the Technical Supervisor (TS) during a tour of the laboratory at 10:10 a.m. on 08/11/21. 2. A Roche Cobas e411 chemistry analyzer was observed as present and in use during the tour of the laboratory. 3. Performance verification (PV) activities on the Cobas e411 analyzer for Estradiol (EST), Progesterone (PRG), Human Chorionic Gonadotropin (HCG) and Luteinizing Hormone (LH) were completed in September 2019. The Laboratory Director approved the PV activities on 10/2/19. 4. The upper and lower limits of the reportable range for EST, PRG, HCG, and LH listed in the following Chemistry Procedure Manual procedures did not reflect the actual reportable range value obtained by the laboratory during the PV. See below. Chemistry Procedure Manual procedures Estradiol COBAS e-411 Progesterone COBAS e-411 B-HCG Total COBAS e-411 Luteinizing Hormone (LH) COBAS e- 411 Analyte PV Procedure EST 25.017-2602.00 5-3000 PRG 0.598-59.013 0.05-60 HCG 3.817-9951.00 0.100-10000 LH 0.795-194.667 0.100-200.00 5. Documents provided by the TS indicated the reportable range values listed in the procedures were 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 -- also used in the Cobas e411 analyzer and in the laboratory information system, Artworks. 6. The annual estimated Endocrinology test volume was 2994 as indicated on the Form CMS-116 obtained during the survey. 7. In an interview at 1:25 p.m. on 08/11/21, the TS confirmed the above finding and indicated the manufacturer's analytical measurement range had been used as the reportable range for the analytes. . D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure test reports included the address of the laboratory location. Findings are as follows: 1. The laboratory performed Endocrinology and Hematology testing as confirmed by the Technical Supervisor (TS) during a tour of the laboratory at 10:10 a. m. on 08/11/21. 2. A complete and accurate address of the laboratory location was not included on the external test report reviewed on date of survey. The street address was not present and the city indicated was Saint Paul, MN while the laboratory was located in Lilydale, MN. 3. In an interview at 2:00 p.m. on 08/11/21, the TS confirmed the above finding. -- 2 of 2 --