Mcgehee Family Clinic

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 a review of package instruction for Roche Coagucheck, laboratory patient logs, patient medical records, lack of documentation, as well as interviews with staff, it was determined the laboratory failed to follow manufacturer's instructions when performing the Coaguchek test system for evaluating Prothrombin Test (PT) and International Ratio (INR) as evidenced by. A. A review of Roche Coagchek package insert revealed the purpose of the test system "The purpose of Coaguchek test system is intended for use by professional healthcare providers for quantitative Prothrombin Time (PT) Testing for monitoring Warfin therapy." B. A review of Coaguchek patient logs from May- August 2019 (4 of 4 months) revealed patient #0027054 (eleven years old) had a PT (12.1) /INR (1.0) performed on 5/3/2019. C. A review of fifteen patient medical records revealed patient #0027054 (1 of 15 patients) was not on Warfin Therapy. D. In an interview on 8/14/2019 at 1300, the laboratory director confirmed the PT/INR was performed on patient #0027054 and this patient was not on Warfin Therapy. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Through a review of laboratory's policy and procedure manual, Quality Control (QC) data and Levy-Jennings graphs for January-June of 2019, lack of documentation, as well as interviews with staff, it was determined the laboratory failed to monitor the accuracy and precision of the QC process and test performance over time as evidenced by: A. A review of the policy and procedure manual revealed the laboratory did not have a policy for addressing shifts and trends in quality control data. B. A review of quality control data and Levy-Jennings graphs for January-June of 2019 ( six of six months) for nine of eighteen analytes revealed shifts and trends in QC data, without

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 performed on 07/25/2017 for the Siemens Dimension ExL, MVP summary data, as well as interviews with staff, it was determined the laboratory failed to validate the reportable range established by the manufacturer for one of twenty-five chemistry tests validated on the Dimension ExL. As evidenced by: A. A review of the validation documentation for Siemens Dimension ExL Chemistry analyzer dated 7/25/2017 revealed the manufacturer's analytic range for Triglycerides as 15.00 to 585. B. A review of the MVP Summary dated 07/25/2017 include the following range validated by testing standard solution: Triglycerides 0.00 to 483.60. The Laboratory did not validate the full analytic range claimed by the manufacturer. C. In an interview at 1145 on 4/12/2018, the Laboratory Director (as listed on the form CMS-209) confirmed the Laboratory did not validate the full reportable range claimed by the manufacturer of the Siemens Dimension ExL. 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 --