Hendrix Medical Clinic

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of the 2021 CMS Casper Reports 0155D, 0153 D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analyte Total Bilirubin. Survey Findings follow: Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of 2021 CMS Casper Reports 0155D and 0153 D and American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte Total Bilirubin (TB). Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 40% for the analyte TBILI in the second proficiency testing event of 2021. B. A review of the proficiency testing results revealed the laboratory received a score of 40% for the analyte TBILI in the third proficiency testing event of 2021. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: . Based on review of 2021 proficiency testing results, it was determined the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: . Based on review of 2021 proficiency testing event, it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Analyte Total Bilirubin. Refer to D2096 -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Through a review of manufacturer's instructions for the Medonic M Series hematology analyzer, a review of the laboratory policy and procedure manual, a review of five randomly selected patient complete blood count reports, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to follow manufacturer's instructions, and laboratory policies for Medonic analyzer flags on complete blood count (CBC) results. Survey findings include: A. Manufacturer's instructions for the Medonic M Series hematology analyzer state that if the WBC differential is flagged with "OM" the action required is to follow the laboratory's protocol for verification of results. B. The laboratory protocol for verifying differential results flagged by the Medonic analyzer, as listed in the policy and procedure manual, is as follows: 1. Check there specimen for clots or agglutination. Recollect if clots are found; 2. If no clots are detected, the specimen will be re-mixed and re-tested; 3. If flags persist, at the discretion of the physician, send the specimen to the reference lab. C. In a review of five randomly selected patient CBC reports, it was determined that two of the five reports included OM flags present on the WBC differential. It was further determined that there was no documentation that the laboratory protocol had been followed on two out of two CBC reports with flags. D. In an interview, at 3:11 p.m. on 1/19/2021, lab employee #4 (as listed on the form CMS-209) confirmed the lack of documented actions for the flagged CBC results. 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 -- 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 new instrument validation documentation for the Vitros 350 Chemistry analyzer and interviews with staff, it was determined the laboratory failed to validate the reportable range in use for eight of sixteen chemistry tests reviewed. Survey findings include: A. The surveyor reviewed new instrument validation documentation for the Vitros 350 Chemistry Analyzer dated 10/30/2019. In a review of the validation documentation for reportable range, it was determined eight chemistry tests out of sixteen reviewed, failed to have the reportable range in use validated. The following test reportable ranges were not validated: Alanine Aminotransferase (ALT) - the reportable range in use is 6 - 100 but was only validated from 21 to 919; Chloride - the reportable range in use is 50 - 175 but was only validated to 142.5; Glucose - the reportable range in use is 20 - 625 but was only validated to 583.5; Potassium - the reportable range in use is 1 - 14 but was only validated to 10.55; Sodium - the reportable range in use is 75 - 250 but was only validated to 203.5; Total Bilirubin - the reportable range in use is 0.1 - 27 but was only validated to 18.35; Urea - the reportable range in use is 2 - 120 but was only validated to 106; and Triglyceride - the reportable range in use is 10 - 525 but was only validated to 473. B. In an interview at 1:12 p.m. on 1/19/2021, laboratory employee #4 (as listed on the form CMS-209) confirmed the reportable ranges in use by the laboratory had not been fully validated. -- 2 of 2 --