Novant Health Meadowlark Pediatrics

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of 2021, 2022, and 2023 API (American Proficiency Institute) proficiency testing records and interview with testing personnel (TP) #1 on 4/5/24, all proficiency samples for 6 of 8 proficiency testing events reviewed were tested by 1 of 3 testing personnel (TP #1). Findings: Review of 2021, 2022, and 2023 API proficiency testing records revealed TP #1 had tested all samples for 6 of 8 testing events during 2021 (3rd Hematology test event), 2022 (1st and 3rd Hematology test events), and 2023 (1st, 2nd, and 3rd Hematology test events). During interview at approximately 12:45 p.m., TP #1 confirmed that she had routinely performed the proficiency testing. She stated one of the other testing personnel works part time, so she is not always working when it is time to test the proficiency samples. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assessment plan, review of 2021, 2022, and 2023 quality assessment monitors, and interview with the TC (technical consultant) 4/5/24, the laboratory director failed to ensure the quality assessment program was maintained to assure the quality of the laboratory services offered. Findings: Review of the laboratory's quality assessment plan revealed the plan included monitors to be completed by the laboratory on a quarterly basis. Review of 2021, 2022, and 2023 quality assessment monitors revealed the 2021 2nd and 3rd quarter monitors and the 2023 2nd, 3rd, and 4th quarter monitors were missing from the records. During interview at approximately 1:45 p.m., the TC stated the 2021 2nd and 3rd quarter monitors and the 2023 2nd, 3rd, and 4th quarter monitors were missing from the records because the laboratory did not complete them. -- 2 of 2 --

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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2022 and 2023 API (American Proficiency Institute) proficiency testing results 11/20/23, the laboratory failed to successfully participate in proficiency testing for WBC (white blood cell) Differential on two of three consecutive testing events. Findings: See the deficiency cited at D2130. D2130 HEMATOLOGY 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 -- 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: Based on desk review of CMS Casper reports 153D and 155D and desk review of 2022 and 2023 API proficiency testing results 11/20/23, the laboratory failed to achieve satisfactory performance for WBC Differential on two of three consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper reports 153D and 155D and 2022 API proficiency testing results revealed the laboratory received a score of 40% for WBC Differential on the 2022 API Hematology/Coagulation 3rd event. 2. Desk review of CMS Casper reports 153D and 155D and 2023 API proficiency testing results revealed the laboratory received a score of 0% for WBC Differential on the 2023 API Hematology/Coagulation 2nd event. 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 desk review of CMS Casper reports 153D and 155D and desk review of 2022 and 2023 API proficiency testing results 11/20/23, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. Findings: See the deficiency cited at 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 desk review of CMS Casper reports 153D and 155D and desk review of 2022 and 2023 API proficiency testing results 11/20/23, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: See the deficiency cited at D2130. -- 2 of 2 --