Arklatex Children's Clinic

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted April 15, 2025 at ArkLaTex Children's - CLIA ID # 19D0463834. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (b)(7) 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 review of the laboratory's College of American Pathologists (CAP) proficiency testing records and interview with personnel, the laboratory failed to ensure the laboratory director and testing personnel signed the original evaluation and attestation form for four (4) of four (4) proficiency testing events in the specialty of Hematology reviewed in 2024 and 2025. Findings: 1. Review of the laboratory's College of American Pathologists (CAP) proficiency testing records from 2024 and 2025 revealed the original evaluation and attestation statement was not signed by the laboratory director/designee and/or testing personnel for the following four (4) of four (4) proficiency testing (PT) events reviewed: a) FH16-A 2024: Laboratory Director and (4) Testing Personnel did not sign attestation form b) FH16-B 2024: Laboratory Director and (4) Testing Personnel did not sign attestation form; Laboratory Director /designee did not sign the original evaluation form c) FH16-C 2024: Laboratory Director and (3) Testing Personnel did not sign attestation form; Laboratory Director /designee did not sign the original evaluation form d) FH16-A 2025: Laboratory Director and (3) Testing Personnel did not sign attestation form 2. In interview on April 15, 2025 at 2:30 pm, Testing Personnel 1 confirmed the attestation forms identified were not signed by the appropriate personnel. 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 D0000 A Certification survey was performed on June 21, 2023 at ArkLaTex Children's Clinic, CLIA ID 19D0463834. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level 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: ***REPEAT DEFICIENCY from previous survey 11/04/2021*** Based on review of CMS-209 (Laboratory Personnel Report), laboratory policy, personnel records, and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for Clinical Consultant were complete. Findings: 1. Review of the laboratory's CMS-209 form provided to surveyor revealed the following five (5) Clinical Consultants: a) Personnel 1 (Laboratory Director, Clinical Consultant and Technical Consultant) b) Personnel 2 (Clinical Consultant) c) Personnel 3 (Clinical Consultant) d) Personnel 4 (Clinical Consultant) e) Personnel 5 (Clinical Consultant) 2. Review of the laboratory's policy for competency assessment revealed "Competency assessment of all clinical consultants is performed by the Laboratory Director upon verification of CLIA requirements. This will be repeated only if the CLIA requirements or Policy/Procedure requirements change". 3. Review of personnel records from 2022 and 2023 revealed the laboratory did not perform a competency assessment for duties as Clinical Consultant for the following four (4) of five (5) consultants: Personnel 2 through Personnel 5 4. In interview on June 21, 2023 at 11:54 am, Personnel 6 stated that the laboratory added a policy for clinical 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 -- consultant competency after the last survey but the laboratory director did not perform competencies for the identified personnel. Personnel 6 confirmed competency assessments were not performed for the above identified personnel. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test 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)