38 US states may want to be more like California – Reasons for Licensing Medical Laboratory Professionals.
When your healthcare provider orders lab tests, are they performed and analyzed by licensed medical laboratory professionals? If you live in the United States, chances are the answer is no. Medical laboratory scientists (MLS also known as Clinical Laboratory Scientists (CLS) in CA) and medical laboratory technicians (MLT) are licensed in just 12 states (California, Hawaii, Florida, New York, North Dakota, Rhode Island, Tennessee, Louisiana, Nevada, West Virginia, Montana and Georgia) and Puerto Rico1,2. Yet State Governments require licenses for hundreds of other professionals. Among healthcare occupations and professionals licensed by states are physicians, physician assistants, dentists, nurses, midwives, respiratory care professionals, radiologic technicians, chiropractors, optometrists, physical therapists, and pharmacists. Among the non-healthcare related occupations licensed are plumbers, painters, general contractors, school bus drivers, bartenders, cosmetologists, dogcatchers, insurance agents and realtors1,2.
Clinical laboratory tests take human biological samples such as whole blood, urine, spinal fluid and other body fluids and perform various analytical tests ranging from urine pregnancy through DNA analysis requested by physicians and other providers. Laboratory tests are classified as waived, moderate or high complexity based on the necessary skill and educational level of the testing personnel needed to perform a particular test. Why is it important to maintain high quality laboratory tests? Over 70% of clinical and diagnostic decisions are based on the results of laboratory testing. Accurate and timely laboratory test results directly correlates with better patient outcomes. Maintaining the integrity of the lab personnel standards is essential for accurate and timely laboratory test results1.
Clinical laboratory practice is one of the few health professions not licensed in the US. Although national certification is available, in the 38 non-licensure states, there is no requirement for employers to hire certified personnel. In such states, federal regulation enforced by Centers for Medicare and Medicaid Services (CMS) known as the Clinical Laboratory Improvement Act (CLIA) of 1988 permit laboratories to hire high school graduates to perform moderately complex tests with nothing more than on the job training. A very lenient standard indeed, considering the critical role of laboratory testing in diagnosis and treatment of patients2.
CLIA regulations are minimal, yet annually, nearly a hundred labs are closed nationwide as a result of continued deficiencies. More importantly, CLIA’s personnel standards only address the minimal requirements2. In California, we agree with the American Society for Clinical Laboratory Science (ASCLS), the American Society for Clinical Pathology (ASCP) and the College of American Pathologists (CAP) that these are insufficient to protect patient and public health2,3. For example, CLIA requires only an Associate degree and minimal laboratory training to perform tests of high complexity. In light of the increasing complexity of new test requirements, especially for genetic and molecular testing, CLIA standards are inadequate. State licensure laws can and should provide higher standards. The adoption of higher standards will ensure that patient and public health are better protected2.
Licensure is the most well-known type of occupational regulation. Licensure refers to the right bestowed by a governmental agency or entity to engage in a legally defined occupational scope of practice. Licensure in California addresses the maintenance of a licensee’s skill through continuing education and/or competency requirements. It also provides a statewide benchmark for entry-level personnel. It is clear that laboratory operations, including testing, have a major role in assessing and managing patient health; nevertheless, most states do not license laboratorians1,2.
Patients in California have benefited from the higher standards (when compared to CLIA) required of our clinical laboratory professionals for more than 50 years largely due to the efforts of the California Association for Medical Laboratory Technology (CAMLT) and their legislative advocates. The 12 states that mandate licensure for medical laboratory professionals have their scopes of practice clearly defined and delineate what is required of laboratorians. These state mandated standards must be stricter than the rules and regulations mandated by CLIA. As CLIA personnel standards continue to decline, states with laboratory personnel standards such as California are relatively immune from such detrimental policy changes for now. However, special interest groups (e.g., optometrists, chiropractors, pharmacists, nurses, etc.) in California and the other 11 states and Puerto Rico with laboratory personnel licensure continuously lobby their statesmen to lower laboratory personnel standards to allow them to perform laboratory tests or to supervise laboratories without requisite education and training. Therefore, states like California through CAMLT must fight each and every day to maintain appropriate licensing standards for laboratory personnel1.
Concerned laboratorians in Texas, South Carolina, Virginia, Minnesota, Massachusetts and Missouri are actively pursing licensure but have met with opposition. The opposition claims that licensure will increase costs for labs, make it harder to hire out-of-state personnel and increase the shortage. But when compared to the hidden costs related to misdiagnoses, delayed therapies and poor patient outcomes, it is just a drop in the bucket1,2.
It is ironic that many of the 38 states without medical laboratory personnel laws long for what California currently has (licensure of clinical laboratory personnel and a strong professional society (CAMLT) directly funding lobbyists who can be on heightened alert at all times to safeguard our high standards and quality patient care) yet only a fraction of California’s population is aware of the benefits or contributions of CAMLT. This is one of the many reasons why we as clinical laboratorians need to encourage support and active membership in our professional societies with active education of those outside our profession (e.g., legislative representatives, hospital administrators, nursing, patients…) that it takes more than just a college degree or high school education to do what we do on a daily basis – much specialized education and training is necessary to do the job and what is best for all Americans1.
California Association for Medical Laboratory Technology, Board of Directors. California Nurses Spared Extra Laboratory Workload. Newsline 2016;42;3:8.
Rohde R, Falleur D, Ellis J. Almost anyone can perform your medical laboratory tests – wait, what? Posted March 10, 2015.
College of American Pathologists, Office of Government and Professional Affairs. College Announces Revision in its Position on State Legislation Requiring Licensure of Laboratory Personnel. News Release posted December 18, 2008.