PAP/NGC Program Review
Ann T. Moriarty, MD
Barbara DuBray-Benstein, SCT(ASCP), PhD
State-mandated licensure for laboratory personnel has recently
become a hot and hotly contested topic. As professionals, we need to be informed.
We need to explore the issues facing us as we evaluate licensure. We need to
know the arguments that proponents and opponents of licensure make. In this
article, we do not intend to advocate for or against licensure; rather, we will
provide facts so that cytologists can make informed decisions and ask the right
questions when the issue of licensure arises in their own states.
What is licensure?
Licensure is a process by which a state government grants permission to an individual to engage in a specific occupation provided the person has met certain qualifications. Licensure is mandatory once it has been established in a particular state. Whether it’s by testing, educational standards, or enforcing standards of practice, licensure controls who can practice the profession. Having a license usually entails paying a fee and may be coupled with regulatory personnel standards and continuing education requirements. Cytology is a nationally regulated profession with personnel standards stipulated by CLIA ’88. State licensure for cytotechnologists must be at least as vigorous in state requirements to have an effect. Other laboratory personnel do not have the strict standards that cytotechnologists have, and state licensure may raise the personnel requirements for other laboratory professionals.
Does licensure ensure quality?
Proponents of licensure claim it eliminates back-door entry into the profession because applicants must meet criteria established by the state board of clinical laboratory personnel. It guarantees that all who perform laboratory testing meet minimum standards of competence. By protecting the public from incompetent and unqualified personnel, licensure therefore promotes and protects the health and safety of the public.
Opponents of licensure argue that a license does not necessarily ensure quality; compliance with CLIA ensures quality, they say. In fact, the personnel standards for cytotechnologists outlined in CLIA with respect to education, training, and certification can be construed to mandate quality. However, this may not be true for other laboratory professionals. Those in favor of licensure cite studies that show there is a link between the qualifications of the personnel who perform the laboratory testing and the accuracy of the test result. Others state these studies are largely flawed and that no adequate relationship between licensing and quality can be demonstrated.
Licensure gives the state control over its laboratory personnel. It may provide a framework or mechanism to remove incompetent personnel from practice. It may also hinder the lab’s ability to remove incompetent personnel if state requirements are not violated. It may lead to poor use of personnel because some individuals may be restricted in their work or may require an excessive degree of supervision.
Licensure often requires taking an exam or participating in continuing education. Thus, one of the benefits of licensure is to encourage continuous learning, enabling professionals to keep up with advances in their field. Those who challenge this benefit cite the high cost of implementing a testing program and the expense of maintaining a bureaucracy to oversee the monitoring of individuals. Opponents say the benefit does not outweigh the cost.
What does licensure mean to scope of practice?
Licensure is often viewed as a mechanism to improve upon the inadequacies of
the federal regulations—that is, CLIA—which currently allow individuals
with only a high school diploma to perform many laboratory tests. While state
licensure may not have an impact on the personnel requirements and practice
of classic cytology, cytotechnologists should recognize that licensure of other
medical lab personnel may have an indirect effect on the expanding practice
of modern cytology. Requiring licensure is often viewed as a method to make
the profession legitimate because it defines the scope of practice for a particular
profession, which is a description of the activities that a health care professional
is permitted to perform within a profession. Those activities are based on the
professional’s education, training, and experience. If the scope of practice
defines what laboratory test may be performed by whom, then if a cytotechnologist
is not licensed or if the test is not defined in the cytotechnologist’s scope
of practice, the cytotechnologist may be prohibited from performing testing
he or she is capable of. Case in point: molecular testing of human papillomavirus,
or HPV. If medical technology requires state licensing and technologists are
allowed to perform HPV testing as part of their scope of practice, but cytotechnologists
are not licensed in the same state, cytotechnologists will be excluded from
performing this complex test that they are qualified to perform by national
What other licensure requirements could affect cytology?
While licensure usually addresses who can perform tests (minimum personnel standards) and what tests can be performed (scope of practice), oftentimes how that test is performed (regulation of testing) may be included. When licensed, a medical technologist may be required to have a minimum educational requirement and may be able to perform complex testing, but may be restricted from high biologic risk testing unless additional qualifications are met. Likewise, a cytotechnologist may be required to have a minimum educational requirement and be able to screen slides, but may be restricted to a lower workload limit than federal standards mandate. State licensure may require more stringent standards than do federal regulations.
Depending upon the cost of a license, moving to a state that requires licensure may limit the mobility of laboratory professionals. Given the critical shortage of laboratory professionals, this may have an unexpected impact on the work force. While most states with licensure require only those laboratory professionals physically practicing in the state to hold a license, some states require state licensure of all those who examine patient specimens from that state.
What do you want?
To be included or disenfranchised? Because state licensure is a local issue, anyone who practices cytology must be tuned in at the local level. Make it your business to be aware of impending licensure issues in your state. Alert your colleagues through state and regional cytology and pathology societies. Alert the CAP when licensing is being considered in your state. Communicate with the proponents of licensure in your state. Make sure that bills to be considered do not exclude you from practice. Even if state licensure does not extend to cytotechnologists in your state, licensing will affect you. Be active—or risk losing your practice.
- Gatscha RM. More about cytotechnologist licensure. ASCT Journal of
- Gross SJ. Of Foxes and Hen Houses: Licensing and the Health Professions.
Westport, Conn.: Greenwood Press (Quorum Books); 1984.
- State mandated licensure of laboratory personnel: What are the pros and
cons? What is the current legislation? Laboratory Medicine. 2004;
- Young SD. Occupational Licensing. Available at http://www.econlib.org/library/Enc/OccupationalLicensing.html.
Accessed Sept. 22, 2004.
- California Code of Regulations, Title 17, Division 1, Chapter 2, Subchapter
1, Group 2, SB 165.
- The Tennessee Medical Laboratory Act: SB No. 2051 (HB No. 1990), enacted
- The Clinical Laboratory Practice Act: New York State Bill S03762/A0498,
enacted June 19, 2004.
Dr. Moriarty, a member of the CAP Cytopathology Committee, is with AmeriPath-Indiana, Indianapolis. Dr. DuBray-Benstein, a cytotechnologist consultant to the committee, is a professor in the Department of Clinical Laboratory Sciences and program director for the cytotechnology program, University of Tennessee Health Science Center, Memphis.