Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Through a review of proficiency test documentation for 2021 and 2022, lack of documentation, and interview with laboratory staff, it was determined the laboratory failed to maintain copies of proficiency test instrument print-outs for one of five proficiency test events surveyed. Survey findings follow: A) Review of proficiency testing documentation for API Hematology/Coagulation 2022 event #1 revealed that original instrument result print-outs were not included in the documentastion. B) Upon request, the laboratory was unable to produce the instrument print-outs for the events identified above. C) In an interview on 10/11/22 at 12:05 a.m., the laboratory staff member (#2 on the CMS 209 form) confirmed that the instrument print-out for the event identified above was not available. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the 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 -- 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: Through a review of personnel files for four of four laboratory testing personnel listed on the CMS 209 form, through a lack of documentation, and through interviews with staff, it was determined that one of four laboratory testing personnel failed to meet qualification requirements as testing personnel as evidenced by: D6065 - one of four laboratory testing personnel lacked documentation of appropriate education to qualify as a testing personnel 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: Through a review of laboratory personnel records for seven testing personnel, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to document that laboratory employee one of seven testing personnel (#5 as listed on the CMS 209 form) met educational requirements to perform moderate complexity testing. Survey findings follow: A) In an interview, at 11:55 a.m. on 10/11 /22, employee #2 (as listed on the CMS 209 form) confirmed employee #5 performs Complete Blood Cell testing on the moderately complex Sysmex hematology system. B) Review of the personnel files for the testing personnel, identified as number 5 on the CMS 209 form, revealed that the employee began employment in August 2021. The educational documentation was a certificate issued by the Gujarat Secondary & Higher Secondary Education Board Certification from Paramguru Pathshala English Medium School which the surveyor was unable to understand. C) In the interview, at 11:55 a.m. on 10/11/22, laboratory employee, identified as #2 on the CMS 209 form, stated that she did not know what the educational certificate indicated, and there was no documentation of the educational equivalency evaluation present. -- 2 of 2 --