Randy D Walker Md Pllc

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Through observation and interview with laboratory staff it was determined that the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 10/24/24 at 12:27 pm, one (of eight) opened container of Insure One One Day Fecal Immunochemical Test (lot L5647, 16300, expiration date 8/22/24) was observed in the laboratory, available for use beyond the expiraton date. B) In an interview on 10/24/24 at 12:27 pm the technical supervisor, confirmed that the item, identified above, had exceeded the expiration date and was available for use. 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 --

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 validation studies for the Alere Triage Cardiac analyzer performed on November 27, 2019, lack of documentation, and interview with staff, it was determined the laboratory failed to validate the method correlations for Alere Triage Cardiac analyzer to verify that the manufacturer's reference intervals (normal ranges) are appropriate for the laboratory's patient population. Survey finding follow: A. The laboratory utilizes the Alere Triage Cardiac analyzer to process the following analytes: D-Dimer and Cardiac panel. B. A review of the validation studies for the Alere Cardiac analyzer revealed no data was present (at time of survey) to verify the manufacturer's reference intervals (normal ranges) are appropriate for the laboratory's patient population. C. Upon request, the laboratory was unable to provide method correlation studies performed for the validation of the Alere Triage cardiac analyzer. D. In an interview on 02/04/2021 at 11:30, the technical consultant confirmed that method correlation studies were not performed as part of the validation of the Alere Triage analyzer. D5785