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Help Stop CMS’ Proposal Classifying Nursing as a Biological Science

Bring Histotechnology Processes Under CLIA’s Oversight

Flawed Proposal Would Allow Individuals with a Degree in Nursing to Supervise Labs,
Perform High Complexity Testing!!!

Histotechnology Pre-Examination and Examination Processes are Highly Complex and
Should be Under CLIA’s Oversight!!!

Help is needed to STOP a highly flawed proposal from the Centers for Medicare and Medicaid Services (CMS) to allow individuals with a bachelor’s degree in nursing to supervise clinical laboratories and to perform all CLIA complexity levels of laboratory testing.

The proposal, published in a CMS Request for Information on Jan. 9, 2018, outlines a new policy that undermines the Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel standards. The new policy would allow individuals with a bachelor’s degree in nursing to perform high complexity testing and to serve as technical consultants (supervisors), which would require them to assess the competency of skilled laboratory professionals.

The proposal reflects the Agency’s nonsensical position, outlined in a controversial April 1, 2016 memorandum, that nursing is a biological science. The 2016 policy allows individuals with a nursing degree to perform and supervise high complexity testing and may even allow these degree holders to direct clinical laboratory testing. It is unclear whether CMS would disallow a nursing degree from being used to meet other supervisory roles apparently allowed under current Agency policy.

A typical baccalaureate degree in the biological sciences generally requires three to four times OR MORE biological coursework than a degree in nursing. The laboratory medicine community has great respect for the nursing profession and the important healthcare services they provide to patients. Still, a nursing degree is not equivalent to a biological sciences degree. In response to the 2016 policy, the laboratory community, and NSH, have advocated repeatedly for changes to the policy. CMS has received several letters and a petition signed by 35,000 concerned individuals challenging the Agency’s interpretation and even met with representatives of the laboratory community in September 2016. For more information on these efforts, click here.

In addition, Histotechnology Pre-Examination and Examination processes are Highly Complex and should be under CLIA’s oversight. CR §493.25 states that a laboratory must obtain a certificate for tests of high complexity if it performs one or more tests that meet the criteria for tests of high complexity as specified in 493.17

Review of the CLIA categories of tests by complexity indicates that many tasks and tests performed in the histopathology laboratory are in fact of high complexity (CFR 42 §493.5, CFR 42 §493.17). Many of the functions and tests (outside the scope of patient result interpretation) are not only routinely performed by histologists but are also validated and acted upon by histologists in their day-to-day operational responsibilities. From a medical perspective, accurate diagnosis is directly related to patient outcome and therefore the principle goal in diagnostic histopathology.

Many of the “CLIA definitions and regulations” are outdated and based on methods and technology that are over 30 years old. There have been significant advances in science and medicine that have and will continue to transform laboratory medicine. Efforts to reduce healthcare costs have also changed the landscape from a “fee for service model” to an integrated team of health care professionals geared towards patient outcomes using the “Total Test Approach.” It is essential that education and training in medical laboratory sciences keep pace with the transition toward personalized medicine to provide high quality; outcome-based patient care.

In the interests of quality care, we urge all CONCERNED INDIVIDUALS, I.E., laboratory professionals, pathologists, Patients and the General Public, to contact CMS and tell the Agency to put patients first. Individuals that don’t have the appropriate scientific knowledge should not be allowed to perform high complexity testing or supervise laboratory testing. And, HISTOTECHNOLOGY PRE-EXAMINATION AND EXAMINATION PROCESSES ARE HIGHLY COMPLEX AND SHOULD BE UNDER CLIA’s OVERSIGHT TO ENSURE QUALITY PATIENT OUTCOMES

Click here to download instructions in a Word document to add the histotechnology specific language to your comments. Use this link to access the ASCP eAdvocacy Center.

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