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 surveyor review of personnel records and interview with the Technical Consultant, four of twenty testing personnel do not have credentials available showing they meet the qualification requirements for moderate complexity testing personnel. Findings include: 1. Four of twenty testing personnel do not have credentials showing they meet the qualification requirements for moderate complexity testing. See 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 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 STANDARD is not met as evidenced by: Based on surveyor review of personnel records, interview with the Technical Consultant and email correspondence with the Technical Consultant, four of twenty testing personnel do not have documented evidence showing they meet the minimum qualification requirements to perform moderate complexity testing. Findings include: 1. Review of personnel records showed the laboratory did not have sufficient documentation to show Staff A, Staff B, Staff C and Staff D meet the minimum qualification requirements to perform moderate complexity testing. 2. Interview with the Technical Consultant on September 8, 2020 at 10:25 AM, confirmed Staff A, B, C and D perform moderate complexity testing. 3. Email correspondence from the Technical Consultant on September 15, 2020 at 9:24 AM confirmed Staff A, B, C and D were awaiting documentation showing the minimum qualification requirements for moderate complexity testing personnel is met. -- 2 of 2 --