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Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 23, 2023. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory director (LD) failed to specify, in writing the duties and responsibilities of each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of laboratory testing. Findings include: 1. SOP review revealed the LD failed to specify, in writing, the duties and responsibilities of each person engaged in the performance of all phases of laboratory testing. 2. During an interview with Testing Personnel#2(CMS-209) in the basement of the breakroom on February 23, 2023 11:40 AM, confirmed the laboratory SOP did not contain a duties and responsibilities 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 2 -- 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 review of Ttesting Personnel(TP) documents and staff interview, the Technical Consultant(TC) failed to perform annual competency on all testing personnel. The Findings include: 1. Competency record review revealed that the Technical Consultant(TC) failed to perform an annual competency for all Testing Personnel (TP) for 2022 (January-December). 2. During an interview with Testing Personnel#1(CMS-209) on February 23, 2023 at approximately 11:00 AM, in the basement of the breakroom, confirmed that the Technical Consultant (TC) did not perform competency for the Testing Personnel for 2022. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 4, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: After a review of the procedure manual, personnel records and an interview with the laboratory director, it was determined that the laboratory did not have a comprehensive competency assessment policy with CLIA six(6) standards for its testing personnel specific to the specialty of Hematology. Findings include: 1.) Testing Personnel (TP) record review revealed that competency assessment was performed in 2019 and 2020. However, the policy did not clearly contain the six (6) CLIA criteria for personnel competency assessment. 2.) The laboratory director and office manager confirmed after an interview on 02/04/2021 at approximately 12:45 pm, in the break room that the laboratory competency assessment policy needs upgrading with the current six (6) CLIA standard criteria. 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 D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 17, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) document review and staff interviews, the lab director (LD) failed to ensure the laboratory is enrolled in a proficiency testing program. Findings include: 1. Review of American Proficiency Institute (API) documents revealed the lack of documents for 2018 testing events #1 and #2. 2. Interviews with staff #3 (CMS 209 form) and the LD on 10/17/18 at 11:14 am in the file/crash cart office confirmed the lab did not enroll in 2018 PT until 10/16/18. 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 --