Summary:
Summary Statement of Deficiencies 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: Based on laboratory observation, review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), lack of documentation and staff interview, three of five testing personnel listed on the FORM CMS-209 did not qualify as testing personnel (Refer to D6065). 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: 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 -- Based on observation of the laboratory, review of the (FORM CMS-209), lack of documentation, and staff interview, testing personnel listed on the FORM CMS 209 did not qualify as testing personnel due to lack of documentation of the highest level of education. The findings include: 1. Observation of the laboratory on 10/14/24 at 8: 40 a.m. revealed the Beckman Coulter DxH 520 CBC instrument on the counter that was used for patient testing for Complete Blood Count with White Blood Cell Differential (CBC w/Diff). 2. A review of FORM CMS 209 revealed five persons who performed moderately complex patient testing for CBC w/Diff. 3. Personnel records did not contain evidence of the highest level of education for three of five testing personnel (testing persons two, three and four). 4. The laboratory director confirmed during an interview on 10/14/24 at 1:00 p.m. that testing persons two, three, and four who performed patient testing for CBC w/Diff did not qualify due to a lack of documentation of the highest level of education. -- 2 of 2 --