Primary Source Verification - Laboratory and Point-of-Care Testing Personnel

What is primary source verification and is it required for laboratory and point-of-care testing personnel?

Any examples are for illustrative purposes only.

Primary source verification of an employee's credentials refers to verifying a state or federally required license, certification, or registration with the issuing agency or the designated agent, both upon hire and when the credential is renewed .. This can be accomplished by mail, secure electronic communication (including secure websites), or by telephone if the details of the verification are documented. When primary source verification is required, an organization cannot accept evidence of the required credential directly from the employee.

Primary source verification has limited applicability to individuals performing non-waived laboratory and point-of-care testing and does not apply to individuals performing waived testing unless there is a state law specifying otherwise. Applicability of primary source verification for non-waived testing is as follows:
  • License - Yes. Primary source verification is expressly required for licensure, certification, and registration when there is a state or federal regulation requiring the specific license, certification or registration to perform testing. Thus, primary source verification applies in states that have a licensure or registration requirement for testing personnel. Testing personnel licensure is currently required in 12 states and one territory: California, Hawaii, Florida, New York, North Dakota, Rhode Island, Tennessee, Louisiana, Nevada, West Virginia, Montana, Georgia, and Puerto Rico. Registration by a national certification agency is required by Georgia.
  • Education - No. While the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA) at Subpart M, the standards requirement for primary source verification does not apply to education and the CLIA regulations are silent. Thus, education can be verified in the manner the organization determines appropriate. CMS document S&C-10-07-CLIA indicates that appropriate documents substantiating the education must be provided within "a reasonable time frame (the time it takes to complete the survey or within one week afterwards). These will include: diplomas, certificates, licenses, degrees, transcripts, training, experience, continuing education (CE), competency assessment, duties and responsibilities."
  • Professional credentials - No, with the exception of the state of Georgia, certifications and registrations, such as MT(ASCP) or CLS(NCA), are usually voluntary credentials not required by state or federal regulation. For employers that specify a certification or registration as a requirement for the position, the credentials may be verified according to the organization's policy. However, there may be exceptions. Primary source verification is applicable if the credential is required by state or federal regulation. As example, cytotechnologists and cytology general supervisors qualifying under CLIA at 42 CFR 493.1483(b)(2) are required to have a certification (i.e. American Society of Clinical Pathology (ASCP) certification). As a regulatory requirement, the credential must be primary source verified.
Last updated on April 30, 2020
Manual: Laboratory
Chapter: Human Resources HR

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