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 review of personnel records 4/19/18 and the deficiency cited at D6065, the laboratory failed to verify that 1 of 25 testing personnel (TP #6) met the minimum education requirements for performing moderate complexity testing. 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 review of personnel records and interview with the office manager 4/19/18 the laboratory failed to verify that 1 of 25 testing personnel (TP # 6) met the minimum education requirements for performing moderate complexity testing. To be qualified to perform moderate complexity testing, personnel must have a minimum of a high school diploma or a GED (high school graduation equivalency diploma). During a review of testing personnel records during the onsite recertification survey on 4/19/18 the laboratory did not have records to indicate testing personnel #6 had earned at least a high school diploma or equivalent. During the onsite recertification survey the laboratory only had documentation of education obtained in the Philippines for TP #6. -- 2 of 2 --