Summary:
Summary Statement of Deficiencies D0000 Based upon findings made during an onsite validation survey completed May 7, 2024 the laboratory failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493. 1421 Condition: Laboratories performing moderate complexity testing; testing personnel. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the CMS Report 209 Laboratory Personnel Report, personnel records and interview of facility personnel found that the laboratory director failed to ensure one of eight testing personnel met minimum education requirements for performing moderate complexity testing in Chemistry. (See D 6065) 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. 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 -- This CONDITION is not met as evidenced by: Based on review of the CMS Report 209 Laboratory Personnel Report, personnel records and interview of facility personnel found that one of eight testing personnel failed to have documentation available for review to ensure they met minimum education requirements for performing moderate complexity testing in Chemistry. (See D 6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of the CMS Report 209 Laboratory Personnel Report, personnel records and interview of facility personnel found that one of eight testing personnel failed to have documentation available to ensure they met minimum education requirements for performing moderate complexity testing in Chemistry. Findings included: 1. Review of the CMS report 209 Laboratory Personnel Report identified eight testing personnel performing moderately complex testing. 2. Review of personnel records for testing person four found a certificate of achievement for having completed the respiratory therapy technician program dated August 12, 1982. 3. During interview of the administrator conducted on May 7, 2024 at 9:16 AM, she confirmed that there were no other records of education for testing person four available for review. -- 2 of 2 --