Lab work no longer requires paper records of credentials; CMS allows use of PSV

CMS recently updated its Clinical Laboratory Amendments (CLIA) for lab work at critical access hospitals and regular hospitals. CMS surveyors will now accept primary source verification (PSV) as proof of laboratory qualification for laboratory directors, technical consultants, clinical consultants, technical supervisors, general supervisors, and all testing personnel. The change also applies to nurses who conduct moderate complexity testing or high complexity testing.

To show compliance, facilities must have documentation to prove that those working in a lab have the necessary qualifications under 42 CFR, Part 493, Subpart M. Until this April, that meant facilities had to keep paper records of all their employees’ lab qualifications on site, including degrees, certificates, diploma, licenses, and prior work history.

The new change means that facilities can use PSV—verification from the organization that issued a specific credential—to show that their employees have the qualifications they claim. The process can be done via email, phone, or fax, and healthcare facilities can hire third party companies to conduct PSVs for them.

Many laboratories, accreditation organizations, and other healthcare facilities had asked for the policy change, hoping to reduce the amount of paper documentation they had to collect and maintain. After reviewing several PSV companies, CMS’s decided to do the following:

• CLIA surveyors will accept PSV as evidence of compliance with the personnel qualifications.

• If a PSV company doesn’t offer a verification service for a particular type of certification, it’s the laboratory director’s responsibility to ensure that documentation is provided.

• Laboratories may choose to submit PSV for lab director 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 changes are effective immediately, though the agency clarified that none of the CLIA personnel regulations have changed. Click here to read CMS’s letter on CLIA compliance, complete with examples of the practical application of the new verification rules.