Affinity Physician

Summary Statement of Deficiencies D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of Personnel records, a review of the Laboratory Personnel Report (CMS-209), and an interview with Testing Personnel #1, the Technical Consultant failed to perform and document competency assessment for Urine Sediment exams. This was noted for one of two competency assessment opportunities reviewed from the date of the last survey, 11/8/2022, to the date of the current survey, 6/27/2024. The findings include: 1. A review of Personnel records revealed Testing Personnel #1 to only have a completed competency assessment dated 6/3/2024. 2. A review of the CMS-209 confirmed Testing Personnel #1 was previously qualified since the last survey conducted on 11/8/2022. 3. During an interview 6/27/2024 at 10:30 AM, Testing Personnel #1 confirmed the absence of a 2023 competency assessment. 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 D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of a patient report and an interview with the Clinic Manager and the Testing Personnel, the laboratory failed to ensure one of five required parameters was included on a test report. The test report included the previous name of the facility, and the facility had failed to correct this deficiency since the previous survey on 11/20 /2020. The findings include: 1. During the post analytical review on 10/27/2022 at 1: 00 PM, the surveyor requested a patient test report. The laboratory provided one patient report printed from the Athena EMR (Electronic Health Record). However, the surveyor noted the name of the facility performing the test was incorrect. It did not match the name on the laboratory's CLIA Certificate, or the name of the practice in which the laboratory was located. The surveyor further noted the same problem was discussed during the previous survey on 11/20/2020, when the Clinic Manager stated the laboratory would fix it. 2. During an interview on 10/27/2022 at 1:15 PM, the Clinic Manager explained the name on the test report, "Medicine Montclair" was the previous name of the facility, and Athena was unable to change the name set up in the "corporate office table". The laboratory provided a letter dated December 22, 2020, mailed to the CLIA State Agency with the same information. The surveyor explained 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 -- the name of the laboratory performing the test was required by CMS (Center for Medicare and Medicaid Services). If Athena was unable to change the name of the laboratory in the EHR, the laboratory must implement another mechanism to ensure the correct laboratory name was on the test report. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 2 of 2 --

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the 2018 - 2020 API (American Proficiency Institute) Proficiency Testing records and an interview with the Technical Consultant, the laboratory failed to document