The laboratory community is being presented a once-in-a-generation opportunity to guide the updating of CLIA regulations to reflect the current and future practices in clinical laboratories that support clinical decision-making in an ever-evolving healthcare system. In advance of a March 12, 2018 deadline, CMS is requesting information, comments, information, evidence, research, and trends related to CLIA personnel regulations that the Agency intends to use to update the existing CLIA personnel regulations in the future.  This will be the first time since 1992 that there has been a comprehensive review of the regulations.

ASCLS is preparing detailed comments for CMS on all of the issues raised, with a central focus on strengthening laboratory personnel standards and ensuring the ongoing, invaluable contributions of laboratory professionals in the healthcare system.

More Information: ASCLS In Depth Analysis and Issue Brief (PDF)

High Standards Better Care

Nursing Degrees Are Not Equivalent to Biological Sciences Degrees

In April 2016, CMS released a memo updating its interpretation of the personnel regulations allowing surveyors to consider a bachelor’s degree in nursing as equivalent to a bachelor’s degree in a biological science for high complexity testing personnel. After CMS published the previously “unwritten rule” in April 2016, ASCLS, working through the Board of Certification, raised deep concerns with the agency. The societies presented more than 30,000 signatures from laboratorians, physicians, nurses and other healthcare professionals demanding that CMS reverse its decision, expressing their deep concern about patient health and welfare in those institutions that placed unqualified people in key positions in the laboratory. 
The ASCLS position has not changed. Nursing and biological sciences degrees are not equivalent and creating a regulatory framework where they are, puts the lives of patients at risk. CMS claimed that this previous unwritten rule was necessary for areas where there were not enough qualified laboratory personnel to perform the necessary work. Equating a bachelor’s degree in nursing with a degree in biological sciences would allow nurses to:
  • Perform high complexity testing without any additional training. 
  • Serve as a technical consultant for high complexity laboratories or as lab director or technical consultant for a moderate complexity laboratory with defined laboratory experience.
Nurses seem to have no interest in taking on these roles, understanding their training best prepares them to contribute to patient health in other ways. The fear is that nurses will be forced into roles for which they do not have adequate training by short-sighted administrators.
In both scope and depth, the natural science coursework required for a biological sciences degree vastly outweighs the natural science coursework required as part of a nursing degree. Typical coursework requirements for a bachelor of sciences degree in biological sciences includes a total of at least 63 hours of natural sciences, including at least 39 hours of major requirements in the biological sciences and 32 hours of prerequisites. In contrast, nursing degrees include only a quarter of the course hours in the natural sciences. 
Comparisons from some leading universities with both nursing and medical laboratory science programs illustrate the entirely different degree programs.
Louisiana State University Health Science Health Science Center
University of North Carolina at Chapel Hill
University of Mississippi Medical Center
University of Wisconsin Milwaukee

More Information: Detailed analyses comparing nursing, biological science, and medical laboratory science degrees (pdf)

While ASCLS and laboratory professionals have great respect for our nursing colleagues and believe that existing educational programs in nursing provide outstanding training for professionals in the nursing field, the nursing degree is not intended to be, nor should it be viewed as adequate to direct moderate complexity or perform high complexity diagnostic testing. 

Review Comments

More than 8,600 comments were submitted to CMS in response to their request for action. All comments to CMS are public and can be reviewed online.

Sign a Petition

Use the ASCLS Action Center to sign onto a petition supporting key issues on CLIA personnel regulations.

Personnel Qualifications-Alternate Pathways

CMS seeks comment on whether it should add nursing degrees as a separate qualifying degree (as opposed to the equivalent of a biological science degree) to the current list of qualifying degrees for moderate and high complexity testing personnel requirements. The Agency also is seeking to define what is considered a “physical science degree” for regulatory purposes, and whether any physical science degree(s) should meet the CLIA educational requirements.
In all cases, the Board of Certification has clear alternate pathways for those not trained as laboratorians. Nurses holding a BSN or those holding degrees in physical sciences should be able to undergo a standard evaluation of their degree programs to determine if they are prepared to perform these tests.
Rather than focus on specific degrees, which may not be entirely descriptive of the coursework, CMS should define the educational requirements for non-laboratory science bachelor degree holders instead of relying on the label of their degree. 

Lowering Standards Is Risky, Ineffective, and Not Patient-Centric

The motivation for CMS to expand qualifying criteria is unclear. If this action is to address concerns about adequately staffing clinical laboratories, there are more effective approaches. Lowering standards is risky and is not supported by data. Expanding a regulatory role for nursing and non-biological science degree holders is unlikely to overcome difficulty finding personnel to properly perform testing. The average salary for a nurse is substantially higher than a credentialed MLS or MLT professional. 
If institutions are unable to fill necessary positions with qualified personnel, lowering standards is not an efficacious solution. These institutions should consider increasing compensation and benefits to attract appropriately trained and credentialed personnel or choose to forgo providing those services in ways that clearly put patients’ lives at risk
In its 2015 report on diagnostic errors in health care, the Institute of Medicine focused on the causes of harm in our healthcare system, placing sufficient and accurate diagnostic testing at the center of a healthy diagnostic process. Forcing or allowing unqualified personnel to perform laboratory tests weakens the entire diagnostic process and harms patients. 
“When errors occur, the “deficiencies” of health care providers (e.g., insufficient training and inadequate experience) and opportunities to circumvent “rules” are manifested as mistakes, violations, and incompetence. Violations are deviations from safe operating procedures, standards, and rules, which can be routine and necessary or involve risk of harm.” 
- Patient Safety and Quality: An Evidence-Based Handbook for Nurses.” Agency for Healthcare Research and Quality 2008 
As testing has moved closer to the patient and utilization of point of care testing (POCT) has increased, it is common for preanalytical errors to occur and inaccurate results reported. In most of those cases, these tests are performed by non-laboratory professionals, giving a glimpse into what lowering qualifications for performing high complexity testing may hold. Both the scientific literature and the experiences of most laboratorians are filled with examples of mistakes impacting testing. Reviews by CMS and other laboratory accrediting authorities document the frequency of these kinds of errors in moderate complexity and physician office laboratories. If performance in those environments can already be considered unsatisfactory, it is inappropriate to expand similar qualifications to high complexity laboratories.

Addressing Workforce Shortages

While there are clearly shortages of qualified laboratory personnel, current CLIA regulations fail to recognize improvements in technology that allow for the more efficient deployment of qualified laboratory professionals. Updates to the CLIA regulations should anticipate changes in practice, management of clinical knowledge, advancing technology, and expansion of testing capabilities. 
In some cases, CLIA regulations already provide for a single person to serve in roles for multiple laboratories simultaneously. Improved technology and its utilization in clinical laboratories should allow the Agency to expand that allowance to a wider range of positions, effectively expanding the workforce and providing typically hard to reach institutions with access to qualified personnel. For technical consultants, supervisors, and clinical consultants, CLIAC has been interpreted to only allow individuals in those positions to work in one laboratory, since wording of the responsibilities suggest they need to be physically present. 
Considering what is possible with current technology, that interpretation is no longer necessary.  ASCLS encourages CMS to reconsider the interpretation of those position responsibilities and allow individuals to appropriately serve in those roles for multiple laboratories. 

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