Reagan Medical Center

Summary Statement of Deficiencies D0000 On September 11, 2024 an off site follow-up review was completed. The report revealed that the

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 27, 2024. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 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 -- report and review of the American Proficiency Institute (API) reports, the laboratory failed to successfully participate in proficiency testing (PT) in 2 of 3 events for Creatine Kinase, Isoenzyme (CK, Iso) resulting in the initial unsuccessful participation for CK, Iso. Refer to D2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CMS CASPER 155 report and review of API PT reports, the laboratory failed to demonstrate satisfactory performance in 2 of 3 testing events for CK, Iso, resulting in the initial unsuccessful participation for CK, Iso. Findings: 1. A review of Casper Report 155 disclosed the laboratory failed CK, Iso on the following: 2023 Event 2 Score 0% 2024 Event 1 Score 60% 2. A review of the laboratory's API Reports confirmed the laboratory failed CK, Iso with the aforementioned scores. 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 review of the CMS CASPER 155 report and review of the API reports, the laboratory director failed to provide overall management and direction for successful participation in PT. The laboratory director failed to ensure PT samples were tested as required. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the CMS CASPER Report 155 and the API 2023 event 2 and 2024 event 1 PT evaluation reports, the laboratory director failed to ensure successful PT participation in 2 of 3 testing events. Refer to D 2096 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 21, 2022. 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: 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 the review of the Testing Personnel Competency and an interview with the Office Manager, the Technical Consultant(TC) failed to perform annual competencies for the Testing Personnel for the subspecialty Hematology. The Findings include: 1. An annual competency assessment was not performed for the following staff for Hematology 2020, 2021, and 2022 thus far for Testing Personnel #1 and Testing Personnel #8 (CMS-209), at the time of the survey. 2. An interview on September 21, 2022, with Testing Personnel#1 (CMS-209), at approximately 2:00 PM, confirmed that competencies were performed for Testing Personnel #1 or #8 for 2020, 2021, and thus far 2022. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when 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 -- appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the general laboratory standard operating procedure manual (SOP) and staff interview, the laboratory failed to establish written instructions for sending specimens to an outside reference laboratory for testing. The findings include: 1. A review of the SOP confirmed that a written policy and procedure (to include collection, preservation, storage, transport, testing schedule times, or how to obtain additional assistance) was not available for staff to follow when sending specimens to reference laboratory (Quest Diagnostics). 2. During an interview on September 21, 2022 at 1:10 PM with the Office Manager in the breakroom, confirmed that the laboratory did not have a written policy and procedure for staff to follow when sending specimens to reference laboratories. 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: Based on review of the laboratory's testing personnel competency assessment records and an interview with the Office Manager, the Technical Consultant (TC) failed to ensure the competency assessment was performed for all Testing Personnel. The Findings include: 1. Annual competency records revealed that the TC did not perform competency for the following Testing Personnel for 2020, 2021, and thus far 2022: Testing Personnel #1- Testing Personnel #8(CMS-209), at the time of the survey. 2. During an interview with Testing Personnel#1(CSM-209) on September 21, 2022 at approximately 2:30 PM, confirmed that the Technical Consultant did not perform competencies for all Testing Personnel. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 23, 2020. 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: 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 laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency test (PT) records and staff interview, the testing personnel (TP) and laboratory director (LD) failed to attest to the routine integration of PT samples into the patient workload as required. Finding include: 1. API (American Proficiency Institute) PT document review revealed the LD and TP failed to sign the following attestation statements: 2019 Hematology/Coagulation (Event 1); 2020 Chemistry (Event 2). 2. API (American Proficiency Institute) PT document review revealed the LD failed to sign the attestation statement: for 2020 Hematology /Coagulation (Event One). 3. An interview with TP #8 (CMS 209 Form) on 9/23/2020 at approximately 1:30 PM in the breakroom confirmed the aforementioned PT attestation forms were not signed. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to maintain a copy of all PT records as required. Findings include: 1. American Proficiency Institute (API) PT document review revealed the lack of an attestation statement for 2020 PT Chemistry (Event 1) at the time of survey. 2. An interview with Testing Personnel #8 (CMS209) on 9/23/2020 in the breakroom at approximately 2:00 p.m. confirmed the lack of the aforementioned PT attestation statement at the time of survey. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of