Erlanger Health

Summary Statement of Deficiencies D0000 A desk review survey conducted on 05/12/2025 of proficiency testing scores resulted in the following deficiencies. The laboratory was found to be out of compliance with the following conditions: D2016- 493.803 Condition: Successful participation D6000- 493.1403 Condition: Laboratories performing moderate complexity testing; 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 desk review survey of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) (0155) report and the American Association of Bioanalysts Medical Laboratory Evaluation (AAB/MLE) 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 -- proficiency testing records, the laboratory failed to successfully participate in the platelet (PLT) analyte. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 a proficiency testing desk review of the CASPER 0155 report and the AAB /MLE 2024 and 2025 PT records, the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte in two consecutive testing events in the specialty of Hematology for the platelet (PLT) analyte. The findings include: 1. A review of the CASPER 0155 report revealed the following results: 2024 Event Three: The laboratory received a 0% score for Platelets. 2025 Event One: The laboratory received a 40% score for Platelets. 2. A review of the AAB/MLE 2024 and 2025 proficiency testing records (Nonchemistry M3 2024 and Nonchemistry M1 2025) confirmed that the laboratory received the above results. 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 a proficiency testing desk review of the CASPER 0155 report and the AAB /MLE 2024 and 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure that proficiency testing samples were tested as required. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and the AAB /MLE 2024 and 2025 records, the laboratory director failed to ensure proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2131. -- 2 of 2 --

Summary Statement of Deficiencies D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on a review of the Laboratory Quality Assurance (QA) Plan, laboratory personnel records, and staff interview, the laboratory director failed to perform competency assessment for the technical consultant in 2023 and 2024. The findings include: 1. The laboratory's "Quality Assurance Plan" policy states: - At least annually, the Laboratory Director will review the performance of each laboratory employee to ensure competency. - Competency will be evaluated initially, at 6 months, and annually thereafter. - Competency will be defined and documented and kept on file. 2. A review of the laboratory personnel records revealed that: - The Technical Consultant (TC) was appointed to the laboratory in February 2023. - No records for documentation of 6-month or annual technical consultant competency by the laboratory director were available for 2023 and 2024. 3. An interview with the office manager, the technical consultant, and testing personnel #1 on 1/30/2025 at 1: 15 p.m. confirmed the laboratory director failed to perform competency assessments for the TC in 2023 and 2024. D6018 LABORATORY DIRECTOR RESPONSIBILITIES 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): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

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: Based on review of the CMS Laboratory Personnel Report (CLIA) (CMS 209), laboratory quality assurance plan, testing personnel (TP) records, and interview with the office manager, the laboratory failed to follow the quality assurance plan for personnel training/competency assessment for five of five testing personnel in 2021 and 2022 The findings include: 1. Review of CMS 209 report revealed five testing personnel performing moderately complex patient testing for complete blood count. Testing personnel one, two, three and five were established and testing personnel four a new testing personnel since last survey with documented hire date of 02.07.2022). 2. Review of the laboratory's quality assurance plan "Personnel" section, revealed, "competency will be evaluated initially, at 6 months and annually thereafter". 3. Review of testing personnel competency assessments revealed no annual competency assessments for testing personnel one, two, three, and five in 2021 and 2022. 4. Review of testing personnel training/competency assessments revealed no initial training and no 6 month competency assessment performed on testing personnel four since documented hire date of 02.07.2022. 5. Interview with the office manager on 01.17.2023 at 12:00 pm confirmed the laboratory failed to follow the quality assurance plan for personnel training/competency assessment in 2021 and 2022. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)