Nea Baptist Clinic - Trumann

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Through a review of proficiency test documentation for 2023, the laboratory policy and procedure for the external quality control program, the listing of "NEA Baptist Alert Values", the data log for the Sysmex XP300 complete blood cell (CBC) analyzer, and interview, the surveyor determined the laboratory failed to test proficiency samples the same number of times that it routinely tests patient samples. Survey findings include: A) The Surveyor reviewed the Proficiency Test documentation for the Second Hematology Events of 2023 . Five of five proficiency test samples were tested in duplicate. B) Review of the laboratory policy and procedure for external quality control program revealed "the laboratory must test the proficiency testing samples in the same manner as it tests patient specimens". C) Review of the NEA Baptist Alert Values policy and procedure revealed that "all alert values should be rerun for confirmation" and it defined alert values for the components of CBC testing. D) Review of the Sysmex XP 300 hematology analyzer data log revealed that on 7/13/23 all five of the proficiency testing samples were tested in duplicate and samples, HSY-06, HSY -09, and HSY-10 did not have any results that were considered to be "alert values" according to the laboratory's Alert Value policy and procedure. Further review of the data log revealed that all patients were run a single time unless results were such that they should be run in duplicate according to laboratory policy and procedure. E) In an interview, at 03:30 p.m. on 2/6 /24, laboratory employee ( #3 on the CMS 209 form) confirmed all proficiency samples were run in duplicate, including those whose results would not be required to be run in duplicate according to laboratory policy and procedure. 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 D6006 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(d) 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. (d) Each individual may direct no more than five laboratories. This STANDARD is not met as evidenced by: Through a review of laboratory policies and procedures, personnel records, lack of documentation, and interviews with laboratory personnel it was determined the laboratory director failed to ensure the competency of the consultants in the laboratory. Survey findings follow: A. Through a review of quality control, quality assessment, laboratory maintenance, and personnel records, it was determined there was no documentation of the laboratory director being on-site since 4/7/2017. B. Although there is no documentation that the laboratory director had been in the facility since 4/7/2017 the director signed competency documentation for the clinical consultant and technical consultant (two of two consultants) on 6/13/2017 and 6/1 /2018. C. In an interview at 10:15 a.m on 6/27/2019 the technical consultant confirmed that the laboratory director had not been present in the laboratory but had been taken competency assessment forms to sign. D. In an interview at 10:45 on 6/27 /2019 the laboratory director confirmed that he had signed the competency assessment forms without reviewing documentation to confirm that the consultants were performing their duties competently. 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 --