Mana Family Medicine Springdale

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Through review of the CMS 209 form, review of laboratory documentation of competency assessment, lack of documentation and interview with laboratory staff it was determined that the laboratory failed to assess testing personnel competency on an annual basis for one of two testing personnel listed on the CMS 209 form. Findings follow: A) Review of the CMS 209 form revealed that two testing personnel were employed by the laboratory. B) Review of competency assessment records revealed that the employee (# 4 on the CMS 209 form) had competency assessments documented on January 2019, January 2020, February 2021, January 2022, and March 2023 but no competency assessment was documented since 3/7/2023, a perod of 18 months. C) Upon request, the laboratory was unable to provide competency assessments for the period of March 2023 through July 2024 for employee (# 4 on form CMS 209). D) In an interview on 8/20/24 at 3:30 pm, the laboratory staff member (# 3 on form CMS 209) stated that competency assessments for the dates and employee identified above may have been discarded and were not available. She further confirmed that the employee had performed testing in the laboratory in the period of 8/5/24 through 8/19/24 during the vacation of testing personnel (# 3 on form CMS 209). 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 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: Through a review of proficiency testing attestation sheets for 2021 and 2022, a review of patient results and through interviews with laboratory staff, it was determined one of two testing personnel who perform patient testing, did not perform proficiency testing. Survey findings include: A) The laboratory retains attestation sheets for each proficiency testing event. The attestations are signed by testing personnel and laboratory director as documentation that the testing was performed in the same manner as patient samples. The laboratory performed proficiency testing in three testing events in 2021 and three testing event in 2022. All attestation sheets for 2021 and 2022 were signed by laboratory employee #3 (as listed on the form CMS-209) except for the second testing even in 2021 on which there were no signatures on the attestation form. Laboratory employee #4 never attested to performing proficiency testing during 2021 and 2022 (six events). B) Review of patient results for CBC testing performed in November 2022 revealed that the testing personnel (#4 on the CMS 209 form) performed and reported 13 CBC tests. C) In an interview, at 4:05 p. m.. on 12/6/22, laboratory employee #3 confirmed that she was the only laboratory employee performing proficiency testing. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using 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 2 -- laboratory's routine methods. This STANDARD is not met as evidenced by: Through a review of documentation for the six proficiency testing events completed by the laboratory in 2021 and 2022, lack of documentation, and interviews with staff, it was determined the laboratory testing personnel and director failed to sign the attestation statements for one of six proficiency testing events completed by the laboratory. Survey findings include: A) A review of the proficiency test documentation for 2021 revealed the laboratory performed proficiency testing API Hematology/Coagulation event #2 and the attestations for the event was not signed by the testing personnel or the laboratory director or designee. B) Laboratory employee ( #3 on the CMS 209 form) confirmed, in an interview at 4:05 p.m. on 12/6/22, that the attestation form lacked the required signatures. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Through review of the CMS 209 form, personnel records, and the

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Through review of the CMS 209 form, personnel records and confirmed by interview it was determined that the competency of the technical consultant was not assessed by the laboratory director on an annual basis and the competency of one of two testing personnel was not performed at least twice during the first year of employment. Findings follow: 1. The competency of the technical consultant was not evaluated on an annual basis. A) Review of personnel files revealed that documentation of the annual evaluation of the competency of the technical consultant identified as number four on the CMS 209 form was not present. B) Upon request, the laboratory was unable to provide the competency evaluations of the technical consultant identified as number four on the CMS 209 form. C) In an interview on 11/17/20 at approximately 10:30 AM, the technical consultant, identified as number four on the CMS 209 form, said that the competency of the technical consultant was not performed.. 2. The competency of one of two testing personnel was not evaluated at least twice during the first year of employment. A) Review of personnel files revealed documentation of annual evaluation of the competency of the testing personnel, identified as number two on the CMS 209 form, was dated 9/6/18 and no other competency evaluation of the personnel was present until 1/1/19. B) In an interview of 11/17/20 at approximately 01:00 PM, the laboratory staff member, identified as number four on the CMS 209 form. stated the the date of hire of the testing personnel, identified as number two on the CMS 209 form, was in September of 2018. C) Upon request, the laboratory was unable to provide an additional competency evaluation of the testing personnel, identified as number two on the CMS 209 form, performed during the first 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 -- year of employment. D) In an interview on 11/17/20, the technical consultant, identified as number four on the CMS 209 form, stated that the competency of the testing personnel, identified as number two on the CMS 209 form, was only performed once during the first year of employment. -- 2 of 2 --