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 record review and staff interview on 8/20/2018, the laboratory failed to ensure one of four new personnel hired in 2017 and 2018 met educational qualification requirements for moderately complex hematology testing. Refer to tag 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 record review and staff interview, the laboratory failed to ensure one of four new personnel hired in 2017 and 2018 met educational qualification requirements for moderately complex hematology testing. Findings include: 1) Review on 8/20/2018 of personnel records from 2017 and 2018 revealed one (Staff A) of four new testing personnel records failed to have documentation of educational qualification requirements for Staff A who performed complete blood cell counts (CBC). Further review revealed Staff A completed training and began testing patient CBCs in January 2018. 2) Interview on 8/20/2018 at 12:15 p.m. with the laboratory director confirmed Staff A's personnel record did not include documentation that educational qualifications had been met prior to performing patient CBC testing. -- 2 of 2 --