Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) initial survey was completed on April 10, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on review of laboratory records, review of the laboratory's policy and procedure manual (SOP) and interview with the technical supervisor, the laboratory failed to establish a procedure for evaluating the accuracy of all toxicology testing performed by Liquid Chromatography (LC). Findings include: 1. Review of the laboratory's SOP revealed the laboratory is enrolled with American Proficiency Institute (API) for testing performed on the Biolis 50 analyzer used for screening but no mention of proficiency testing enrollment or a procedure for parallel testing with another laboratory in order to determine accuracy of toxicology testing performed by LC. 2. Review of laboratory records revealed a one page report with values listed for 5 samples. The report indicates samples were tested by this laboratory as well as two other labs. No supporting documents are available. The analytes listed does not include all analytes tested in this laboratory. 3. During an interview with the technical supervisor (TS) on April 10, 2018 at approximately 4 pm in the laboratory area, the TS provided and envelope with results and stated the lab is in the process of performing parallel studies. 3. Interview with the technical supervisor (TS) on April 10, 2018 at 4:20 pm in the room next door to the testing personnel's office confirmed the laboratory has not enrolled in a proficiency testing program which includes testing 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 -- performed by LC, there is no supporting documentation for the one page report mentioned above, the laboratory has not completed parallel testing and the SOP does not include a policy and procedure for verifying accuracy through proficiency testing or parallel testing of tests performed by LC . 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 the laboratory's validation records for testing performed on the Biolis 50i analyzer used for toxicology screening, creatinine and pH as well as interview with the technical supervisor, the laboratory failed to verify performance specifications for creatinine and pH. Findings include: 1. Review of performance specification validation records for testing performed on the Biolis 50 i analyzer revealed no documentation for validation of creatinine and pH. 2. Interview with the technical supervisor on April 10, 2018 at 4:20 pm in the room adjacent to the testing personnel's office confirmed no documentation of performance specification validation is available for creatinine and pH. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of the laboratory's validation records for testing performed on the Biolis 50i analyzer used for toxicology screening, creatinine and pH as well as interview with the technical supervisor, the laboratory director failed to ensure performance specifications for creatinine and pH were performed and failed to document approval of performance specifications for toxicology testing before patient testing began. Findings include: 1. Review of performance specification validation records for testing performed on the Biolis 50 i analyzer revealed no documentation for validation of creatinine and pH. 2. Review of performance specification validation records for toxicology testing revealed no documentation that the records were reviewed and approved by the laboratory director. 2. Interview with the technical supervisor on April 10, 2018 at 4:20 pm in the room adjacent to the testing personnel's office confirmed no documentation of performance specification validation is available for creatinine and pH and validation records for toxicology testing have not been signed by the laboratory director. -- 2 of 2 --