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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