CMS urged to scrap policy letting nurses evaluate lab tests

Hospital lab workers are urging the CMS to do away with an Obama-era regulation that allowed nurses to analyze clinical lab tests.

The policy in question was issued in 2016 over concerns there was a shortage of testing personnel, especially in rural areas. However, lab personnel say that nurses don't have the training necessary to analyze such tests and are asking the Trump administration to junk the policy.

"Clinical judgment of results cannot be made if the laboratory scientist has no understanding about molecular biology; genetics and polymerase chain reaction testing," Byron Serna, director of laboratory services at Baylor Scott & White Health said in a comment. "There is already enough risk with patient safety within the field of transfusion medicine. Why increase that risk by placing under-educated staff members in that area of the laboratory?"

The remarks are in response to the CMS' request for information on whether regulations governing clinical laboratories need to be updated. Comments were due March 12. Specifically, the CMS is interested in whether personnel requirements, testing standards and industry fee structures need to be updated.

There has been an increased reliance by clinical labs on undertrained staff to do and analyze increasingly complicated tests.

"I am aware of workforce shortages in the laboratory; these should not be solved by employing individuals from another healthcare discipline that has its own shortage situation," Samuel Ryan Galorport, senior clinical laboratory scientist at Bartlett Regional Hospital in Alaska said in a comment. "Patient safety demands quality laboratory testing performed by qualified individuals."

Officials at Allina Health, a Midwestern health system with 12 hospitals, said the 2016 guidance represents an erosion of laboratory education standards.

"This ultimately creates a significant patient safety issue which would not become apparent until several years after proposed changes have been instituted," Tracey Witherow, director of organizational integrity and regulatory affairs at Allina Health, said in a comment.

Major trade groups like the American Society for Clinical Laboratory Science and American Society for Clinical Pathology have also been lobbying the CMS to reverse course, arguing that nurses do not take the same amount of scientific coursework necessary to conduct and analyze complex laboratory tests.

But some nurses and staff disagree with that assertion. Ruth Blackman, a nurse in New York, said in comments that she had extensive biological science education and supported others in her profession being able to read lab tests.

Vicki Lehrman, a compliance and safety executive for Avera Queen of Peace hospital in South Dakota, said she too supported nurses performing such tests. However, she specifically expressed support for RNs, as she felt they had adequate training.

"A bachelor degree RN may be able to handle requirements for a waived or moderately complex lab if there is appropriate laboratory training provided," Lehrman said in a comment. "Without that, nursing does not have the same level of understanding of what constitutes laboratory quality."