Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review on competencies, competency policy and interview with testing personnel # 13 on May 15, 2018 the laboratory failed to follow policy to assess competency for testing personnel #22, #25, #28, #3, #13 and #9. Findings: 1. Review of policy shows "a competency test every 12 months-semiannually during the first year that the person tests samples and annually thereafter". 2. Review of competencies shows no annual competency for testing personnel #22 and # 25 for 2016. 3. Review of competencies shows no competency semiannually for testing personnel # 28, #3, #9 and #13 during first year of testing. 4. Review of competencies shows no initial competency for testing personnel # 9. 5. Interview with testing personnel # 13 on May 15, 2018 at 3:15 PM confirmed the laboratory failed to follow policy to assess competency. 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 revealed and interview with the testing 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 -- personnel #13 confirmed, the laboratory failed to have academic credentials required to qualify two of thirty seven new testing personnel for the speciality of chemistry for moderate complexity testing (refer to tag #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 personnel records and interview with testing personnel #13, the laboratory failed to have documentation of academic credentials to qualify two of thirty seven testing personnel for moderate complexity testing. Findings: 1. Review of the personnel records of testing personnel #21 and #29 for the speciality of chemistry revealed the laboratory failed to have academic credentials to qualify them. 2. Interview with testing personnel #13 on May 15, 2018 at 1:30 PM confirmed, the laboratory failed to have the required documentation to qualify two testing personnel for moderate complex testing. -- 2 of 2 --