Randy D Roberts, Md

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 four patient complete blood count reports which were flagged by the instrument, 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" or "TM" 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 the 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 four patient complete blood count reports which were flagged by the instrument, it was determined that three of the four reports included OM flags present on the WBC differential and one of the reports included TM flags on the WBC differential. It was further determined that there was no documentation that the laboratory protocol had been followed on four of four CBC reports with flags. D. In an interview, at 11:25 a. m. on 3/2/2021, lab employee #2 (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 1 --

Summary Statement of Deficiencies D0000 . This is the CLIA recertification survey of the Laboratory conducted on 08/08/2018. At the time of recertification survey the laboratory was not in compliance with the following conditions: 42 CFR 493.803(a)(b)(c): Successful Participation 42 CFR 493.807: Reinstatement of Nonwaived Laboratories 42 CFR 493.1403: Moderate Complexity- Laboratory Director 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 a review of the 2016 and 2017 CMS Casper Reports 153D, 155D and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory had unsuccessful performance in proficiency testing for the tests of White Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Blood Cell Differential (WBC DIFF), Granulocytes (GRANS), Lymphocytes (LYMPHS) and Monocytes (MONO) as evidenced by: Failure to achieve satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2130. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: . Based on review of 2017 and 2016 CMS Casper Reports 155D, 153D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory had a subsequent unsuccessful performance for the test White Blood Cell Differential, Lymphocytes, Granulocytes, and Monocytes as cited at 2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . A. Based on review of the 2017 and 2016 CMS Casper Reports 155D and 153D, and the American Proficiency Institute proficiency testing results, it was determined the laboratory failed two out of three proficiency testing for the tests of White Blood Cell Differential (WBC DIFF), Granulocytes (GRANS), Lymphocytes (LYMPHS) and Monocytes (MONO) as evidenced by: 1. The laboratory recieved a score of 0% for the test of WBC DIFF in the third proficiency event of 2016 and in the first proficiency event of 2017. 2. The laboratory received a score of 0% for the test of LYMPHS in the third proficiency testing event of 2016 and in the first proficiency event of 2017. 3. The laboratory received a score of 0% for the test of MONOs in the third proficiency testing event of 2016 and in the first proficiency event of 2017. 4. The laboratory recieved a score of 0% for the test of GRANS in the third proficiency testing event of 2016 and in the first proficiency event of 2017. B. Based on the review of the 2017 and 2016 CMS Casper Reports, it was determined the laboratory had three out of four consecutive failures which constitutes unsuccessful performance for the test White Blood Cell Differential (WBC DIFF), Granulocytes (GRANS), Lymphocytes (LYMPHS) and Monocytes (MONO) as evidenced by: 1. The -- 2 of 4 -- laboratory received a score of 0% for the test of WBC DIFF, 0% for the test of GRANS, 0% for the test of LYMPHS and 0% for the test of MONO in the third proficiency testing event of 2016. 2. The laboratory received a score of 0% for the test of WBC DIFF, 0% for the test of GRANS, 0% for the test of LYMPHS and 0% for the test of MONO in the first proficiency testing event of 2017. 3. The laboratory received a score of 0% for the test of WBC DIFF, 0% for the test of GRANS, 0%for the test of LYMPHS and 0% for the test of MONO in the third proficiency testing event of 2017. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: . Through a review of Quality Assessment Plan for Proficiency's testing, Proficiency Testing (PT) records for 2016, 2017 and 2018,