Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on January 21, 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: D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: A review of 2024 - 2026 Quality Assurance Records, 2024 - 2026 Quality Control records, 2024 - 2026 Maintenance & Temperature Records, and 2024 - 2026 Proficiency Records confirmed that the Laboratory Director failed to maintain the quality assessment program to assure the quality of laboratory services. THE FINDINGS INCLUDE: 1. A review of the aforementioned 2024 - 2025 laboratory records revealed that there was no documention confirming complete oversight of the clinical laboratory by the Laboratory Director. 2. An exit interview, with Office Manager, on January 21, 2026, at 11:30am, confirmed that the Laboratory Director failed to maintain the quality assessment program to assure the quality of laboratory services. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform 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 -- test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: A review of 2024 - 2026 Personnel Records confirmed that Laboratory Director failed to perform all required competencies. THE FINDINGS INCLUDE: 1. A review of 2024 - 2026 Personnel Records confirmed that the Laboratory Director failed to complete competencies for the Technical Supervisor and the General Supervisor. 3. An exit interview, with Office Manager, on January 21, 2026, at 11:30am confirmed that Laboratory Director failed to perform all required competencies. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (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: A review of current laboratory procedure manual confirmed that the Laboratory Director failed to provide, in writing, the qualifications, responsibilities, and duties of all laboratory personnel. THE FINDINGS INCLUDE: 1. A review of the current laboratory procedure manual confirmed that the Personnel Procedure did not contain the qualifications, responsibilities, and duties for the Clinical Consultant, Technical Supervisor, General Supervisor, and Testing Personnel positions in the laboratory. 2. An exit interview, with Office Manager, on January 21, 2026, at 11:30am, confirmed that the Laboratory Director failed to provide, in writing, the qualifications, responsibilities, and duties of all laboratory personnel. -- 2 of 2 --