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Title
Personnel Policies for Individuals Directing or Performing Non-waived Tests
Memo #
16-18-CLIA
Posting Date
2016-04-01
Fiscal Year
2016
Summary
REVISED 05.03.16: ***Revised due to typographical error under citation of §493.1443(b)(3)*** This policy memorandum supersedes S&C-10-07-CLIA “Consolidation of Personnel Policies for Individuals Directing or Performing Non-waived Tests under the Clinical Laboratory Improvement Amendments (CLIA).” • CLIA surveyors will now accept Primary Source Verification (PSV) as evidence of compliance with the personnel qualifications mandated in Subpart M of the Clinical CLIA Regulations. • If there are required elements in the personnel regulations that the PSV company does not verify, it is the laboratory director’s (LD) responsibility to ensure that these personnel qualifications are met by other means. • CLIA personnel regulations and the policy on mandatory citations are not changing. • Laboratories may choose to submit primary source verification for LD qualifications. • Bachelor’s and Associate’s degrees in nursing meet the requirement for earning a degree in a biological science for, respectively, high complexity testing personnel and moderate complexity testing personnel. the laboratory director’s (LD) responsibility to ensure that these personnel qualifications are met by other means. • CLIA personnel regulations and the policy on mandatory citations are not changing. • Laboratories may choose to submit primary source verification for LD qualifications. • Bachelor’s and Associate’s degrees in nursing meet the requirement for earning a degree in a biological science for, respectively, high complexity testing personnel and moderate complexity testing personnel.
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