Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Initial survey was completed on September 10, 2026. 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) (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 interview, facility document review, and facility policy review, the laboratory failed to obtain the required signatures on proficiency testing attestation statements/forms for 7 of 10 events reviewed. Findings included: A laboratory policy titled, "Proficiency Testing Policy," implemented 03/01/2025, revealed, "C. The testing person and laboratory director must attest to the routine integration of the samples into the patient workload." Per the policy, "5. The testing person must sign /date the attestation statement. 6. Have the attestation statement signed by the laboratory director or delegated designee." The "Attestation Statement" for the "2025 Hematology / Coagulation - 2nd Event" electronically submitted 07/26/2025, revealed no evidence to indicate the Attestation Statement was signed by the Laboratory Director (LD). The "Attestation Statement" for the "2025 Chemistry - Core - 3rd Event" electronically submitted 09/10/2025, revealed no evidence to indicate the Attestation Statement was signed by the LD. The "Attestation Statement" for the "2025 Hematology / Coagulation - 3rd Event" electronically submitted 11/11/2025, revealed no evidence to indicate the Attestation Statement was signed by the LD or the person(s) who performed the test. The "Attestation Statement" for the "2026 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 -- Hematology / Coagulation - 1st Event" electronically submitted 03/26/2026, revealed no evidence to indicate the Attestation Statement was signed by the LD. The "Attestation Statement" for the "2026 Chemistry - Core - 2nd Event" electronically submitted 06/10/2026, revealed no evidence to indicate the Attestation Statement was signed by the LD or the person(s) who performed the test. The "Attestation Statement" for the "2026 Hematology / Coagulation - 2nd Event" electronically submitted 07/14/2026, revealed no evidence to indicate the Attestation Statement was signed by the person(s) who performed the test. The "Attestation Statement" for the "2026 Chemistry - Core - 3rd Event" electronically submitted 09/08/2026, revealed no evidence to indicate the Attestation Statement was signed by the LD or the person(s) who performed the test. During an interview on 09/10/2026 at 11:40 AM, the Technical Consultant stated it was an oversight as to why the attestation statements were not signed. During an interview on 09/10/2026 at 3:15 PM, the LD stated he did not realize the attestation statements had to be signed. 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 interview, facility document review, and facility policy review, the laboratory failed to follow ensure competency evaluation/assessments were completed and signed per the laboratory policy for 2 of 2 personnel files reviewed. Findings included: A laboratory policy titled, "Competency Assessment - Testing Personnel," implemented 03/01/2025, revealed, "B. Evaluating and documenting the performance of testing personnel must be conducted initially at post training and prior to testing and reporting test results, semiannually during the first year the individual tests patient specimens, and annually thereafter." A laboratory policy titled, "Technical Consultant Job Description/Personnel Records Checklist/Competency Evaluation," implemented 03/01/2025, revealed, "A. It is the responsibility of the laboratory director to review and approve the duties and responsibilities described below for CLIA [Clinical Laboratory Improvement Amendments] personnel Moderate complexity testing." Review of Testing Personnel (TP) #2's personnel file with a hire date of 12/16/2024 revealed evidence of only an annual "Testing Personnel Competency Assessment Form" dated 01/29/2026 and signed by TP #2, the Technical Consultant (TC), and the Laboratory Director (LD). The "Technical Consultant Competency Evaluation Form" dated 12/01/2025 and signed by the TC revealed no evidence to indicate the form was signed by the LD. During an interview on 09/10/2026 at 11:30 AM, the TC was asked to provide documentation of initial and semi-annual competency for the testing personnel. The TC stated those competencies were not performed. The TC was asked to provide a copy of her competency signed by the LD and she stated the LD did not sign her competency assessment. During an interview on 09/10/2026 at 3:15 PM, the LD stated he did not realize the competency forms had to be signed. 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