Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on August 20, 2025. 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: D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: A review of 2023 - 2025 Maintenance Records, 2023 - 2025 Quality Control Records, 2023 - 2025 Temperature Records, and a tour of the laboratory confirmed that Laboratory Director (LD) failed to provide proper oversight of the operation and administration of the laboratory operations. THE FINDINGS INCLUDE: 1. The finding of the review of the 2023 - 2025 Maintenance Records, 2023 - 2025 Quality Control Records, 2023 - 2025 Temperature Records, and a tour of the laboratory confirmed that the LD failed to provide proper oversight of laboratory operations. 2. Please refer to D6020 and D6063 for details. 3. An exit interview conducted with the Laboratory Team on August 20, 2025 at 11:00am confirmed that LD failed to provide proper oversight of the operation and administration of the laboratory operations. 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 -- 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 2023 - 2025 Maintenance Records, 2023 - 2025 Quality Control Records and 2023 - 2025 Temperature Records, confirmed that the Laboratory Director (LD) failed to ensure that the quality control and quality assessment programs were established and maintained to assure the quality of laboratory services provided. THE FINDINGS INCLUDE: 1. A review of the Maintenance Records, 2023 - 2025 Quality Control Records and 2023 - 2025 Temperature Records, records revealed that the maintenance, quality control, and temperature documentation, was not reviewed by the LD, to ensure the quality services of the laboratory. 2. An exit interview, with the Laboratory Team, on August 20, 2025, at 11:00am, confirmed that the LD failed to ensure that quality control and quality assessment plans were established. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: A review of the 2023 - 2025 Personnel Records confirmed that the Histology Technician failed to meet the required minimum qualifications. THE FINDINGS INCLUDE: 1. A review of 2023 - 2025 Personnel Records for the Histology Technician (see Personnel Form CMS-209 )confirmed that the Histology Technician (HT) did not meet the CLIA personnel qualifications. 2. An interview with the Laboratory Director confirmed that the HT had a high school diploma without laboratory training. The Laboratory Director was instructed to immediately remove the individual from the testing bench. 3. An exit interview, with the Laboratory Team, on August 20, 2025, at 11:00am confirmed that the Histology Technician failed to meet the required minimum qualifications. -- 2 of 2 --