Classification: Position Paper
Status: Approved by the ASCLS House of Delegates approved July 2006, Revisions adopted June 2023

Introduction

Medical laboratory professionals provide clinical information and services that contribute to the effective delivery of care in today’s complex healthcare environment, as stated in the American Society for Clinical Laboratory Science (ASCLS) position paper “Value of Medical Laboratory Science Personnel and Clinical Laboratory Services in Healthcare (2021).”1 Medical laboratory professionals must provide accurate, and reliable information using state-of-the-art technology to facilitate evidence-based patient care decisions. This clinical information has a direct impact on patient diagnosis, treatment, health maintenance, safety, hospital length of stay, as well as resource utilization, and patient satisfaction. In addition, such information provides an essential foundation for patient-centered care, improved health outcomes, and overall public health. Thus, licensure of medical laboratory professionals is essential to protect the public from substandard laboratory services and potentially misleading information by assuring that only appropriately educated and qualified individuals perform testing. Licensure not only benefits and protects the public but also medical laboratory professionals themselves. Advantages of medical laboratory professional licensure include the following:

  • Enables improved quality of laboratory testing through entry level certification and ongoing competency requirements
  • Defines and protects scope of practice
  • Formalizes and elevates professional status by:
    • Enhancing public visibility
    • Increasing recognition from the public and other healthcare professionals
    • Balancing opportunities with other licensed healthcare professionals when competing for resources
  • Improves recruitment and retention for the profession
  • Aids in advocacy for the profession due to ability to collect data on the workforce

Background

ASCLS has long supported licensure of medical laboratory professionals to assure high quality laboratory services for the public. When the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) developed into a facility regulation with personnel standards inadequate to protect the public, ASCLS renewed its efforts to advocate for state personnel licensure to accomplish that goal.

Traditionally, several mechanisms exist to credential medical laboratory professionals:

  • Personnel Licensure: the process by which an agency of a state government grants permission to an individual to engage in a given occupation upon finding that the applicant has attained the minimal degree of competency necessary to ensure that the public health, safety, and welfare will be reasonably protected. Personnel licensure is required by law and defines the profession’s scope of practice. Medical laboratory professionals practicing in a state with a licensing statute are required to be licensed to perform work within the defined scope of practice.
  • Facility Licensure: the process by which an agency of a state government grants authorization to operate a clinical laboratory after all required standards are met as determined by onsite inspection. Personnel standards/requirements may be included in a facility licensure statute. State facility licensure is required to begin operation of a new facility in states with such statutes.
  • Certification: the process by which an association or non-governmental agency grants recognition to an individual who has met certain predetermined qualifications specified by that agency or association. Certification is a voluntary process, both for medical laboratory professionals and employers. In non-licensure states there is no governmental requirement that medical laboratory professionals be certified, and employers are not required to employ only certified professionals.
  • Title Protection: the process by which an agency of a state government grants permission to an individual to use a specific title upon finding that the applicant has met the educational requirements of the specific title. Title protection is mandated by law for individuals using a specific title; however, it does not preclude anyone from performing tasks within the same scope of practice while using a different title.
  • Registration: the process by which a professional association or governmental agency identifies an individual by listing (maintaining) the individual’s name on a roster. Registration may be mandatory; however, it generally has neither educational nor competency requirements.

Most other health care professionals, including physicians, nurses, pharmacists, physical therapists, respiratory care professionals, radiologic professionals, etc. instituted state licensing statutes to protect the public from unlicensed individuals who do not meet pre-determined competencies. Licensing statutes have successfully ensured that only individuals meeting those standards are allowed to practice. Only a small number of states (https://ascls.org/licensure/) have medical laboratory personnel licensure laws. Therefore, most states have only voluntary certification available to regulate competency of medical laboratory professionals.

CLIA ’88 is a federal statute that grants a facility or testing location a certificate(s) instead of a practitioner license and is inadequate alone to ensure testing personnel competency. CLIA ‘88, however, mandates that testing personnel must meet any state personnel licensure requirements that exist.

Rationale

Proponents of medical laboratory personnel licensure advocate that licensure will accomplish the following:

  • Protect the public from substandard care and consequences of inaccurate results
  • Set standards that must be followed to assure quality and consistent laboratory testing
  • Define and protect the scope of practice of the profession
  • Improve access to accurate medical laboratory workforce data
  • Facilitate an effective response in disaster preparedness by assisting in the identification, location, and mobilization of needed medical laboratory professionals
  • Address practitioners who lack professional competence

Patient Safety

In November 1999, the Institute of Medicine (IOM), now the National Academy of Medicine (NAM), released a report, “To Err is Human: Building a Safer Health System,”2 which estimated that 49,000-98,000 Americans die annually from preventable healthcare errors. Since the IOM’s subsequent report, “Crossing the Quality Chasm”, a nationwide and state-by-state movement to prioritize the importance of patient safety in all healthcare processes has occurred. As stated in the 2022 ASCLS position paper “Patient Safety and Clinical Laboratory Science”3, because of their vital role in patient care, medical laboratory professionals have identified the need to incorporate NAM aims as the framework for evaluating and improving their services.

Medical laboratory professionals are responsible for implementing processes that manage the entire scope of laboratory practice: pre-analytic, analytic, and post-analytic. To ensure the best possible outcomes for patients, they must collaborate with all other health care professionals to reduce medical errors. In order to do this effectively, medical laboratory professionals should meet defined educational requirements, be certified, participate in required continuing education, and demonstrate continued competency. Employing individuals without the appropriate education, certification, and training creates the potential to place every patient and every caregiver in harm’s way. Licensure of medical laboratory professionals provides a means to assure that these requirements are maintained in all patient care environments.
Quality

CLIA ’88 was enacted by the Centers for Medicare and Medicaid Services (CMS)4 so that all citizens would be assured of receiving quality laboratory results regardless of the testing site. We now know that CLIA ’88 regulations, as implemented, are inadequate to assure the intended and required level of consistent quality. Although CLIA ’88 regulations have some standards for academic and clinical training, many in the clinical laboratory profession consider them to be the minimum level required. Medical laboratory personnel standards that are significantly higher than those required by CLIA are necessary to assure the highest level of quality.

Reliable laboratory test results are central to quality health care delivery and competent medical laboratory professionals are central to providing quality laboratory testing. CMS reports have demonstrated that the accuracy and precision of laboratory testing is inconsistent across different sites of care, with CLIA reports linking failures in quality to untrained personnel. Often the personnel performing testing have not been formally and appropriately educated to provide reliable testing. This lack of education compromises their ability to properly perform and interpret laboratory procedures. Appropriately educated medical laboratory professionals are the single group of healthcare professionals who are knowledgeable in quality assurance and management for the entire testing process.

Scope of Practice

Personnel licensure defines and protects the scope of practice for medical laboratory professionals and consequently will prevent individuals lacking the required education and certification from assuming laboratory practice.

As ASCLS defined in its 2023 “Scope of Practice and Personnel Standards”5 position paper, medical laboratory professionals, as members of the health care delivery team, are responsible for assuring reliable and accurate laboratory test results which contribute to the diagnosis, treatment, prognosis, and prevention of physiological and pathological conditions in humans. The most suitable healthcare professionals provide the most appropriate level of care required. ASCLS recognizes that there is some overlap with the scope of practice of other licensed health care professionals, and that point of care testing may be performed by non-licensed individuals under the direction of a qualified CLIA laboratory director. Ultimately, by having medical laboratory professionals assume the role for which they were educated, the total care provided for the consumer will be superior, resources will be more effectively utilized, and unnecessary procedures will be avoided. The current economic and regulatory healthcare environment benefits when medical laboratory professionals function in their designated role to achieve high quality, cost-effective assessment, diagnosis, treatment, and prevention to meet the needs of a changing healthcare consumer.

Laboratory Workforce Data

In the absence of licensure, lack of reliable clinical laboratory workforce data for medical laboratory professionals precludes the profession from participating in a variety of opportunities including educational scholarships and government funding. In addition, this lack of data locks the profession out of opportunities developed to address the workforce shortages for other professional groups. Licensure will facilitate the collection and utilization of accurate workforce data, which will be more reliable than current sources of data, such as the Bureau of Labor Statistics. This relevant information will facilitate the ability to address manpower shortages and geographic distribution, to effectively respond during a bioterrorism or other public safety threat by mobilizing the appropriate medical laboratory professionals, and addressing other specific workforce needs.

Disaster Preparedness

An effective response to bioterrorism, pandemics, and natural disasters requires state public health departments and emergency preparedness agencies to identify, locate and mobilize the required educated medical laboratory professionals in a timely manner.6 Personnel licensure provides a means to identify and locate qualified medical laboratory professionals in times of a disaster. The medical laboratory professional serves as a first line of surveillance of infectious disease agents and is responsible for the early detection and identification of the etiology of biologic agents.

  • Medical laboratory professionals are critical players in planning strategies for early detection and prevention of further disease spread
  • Prevention and control strategies depend on the ability of the medical laboratory professional to adequately provide and communicate critical information to public health and law enforcement agencies
  • In the event of a biological attack, the medical laboratory professionals will be expected to provide information on proper collection, processing, handling, and/or transport of samples to the appropriate laboratory
  • During recovery from a national disaster, medical laboratory professionals are essential for accurate and timely patient triage, diagnosis, and treatment

Ability to Address Incompetent Practitioners

Personnel licensure statutes include provisions to investigate the actions of any person holding a license to engage in the practice of clinical laboratory science. A license can be temporarily suspended or revoked upon violations of any provision of a licensure statute and/or charges that a medical laboratory professional’s continuation in practice would constitute an imminent danger to the public. Such violations/charges can include:

  • Professional incompetence
  • Violation of any standard of professional conduct including falsification of records or data or HIPAA violations
  • Engaging in dishonorable, unethical, or unprofessional conduct of a character likely to deceive, defraud or harm the public
  • Providing professional services while mentally incompetent, under the influence of alcohol or narcotic or controlled dangerous substance that exceeds therapeutic amounts or without valid medical indication
  • Conviction or violation of any state or federal law, rule, or regulation that specifically relates to the discipline for which the individual is licensed

There are no data trends that support opposition concerns that arise regarding salary impact, vacancy rates, or impact to the cost of healthcare.

  • Salaries are market driven; therefore, no direct correlation exists between implementation of medical laboratory personnel licensure and increased levels of compensation. ASCP wage survey data7 is updated every two years and reflects a more market driven impact on wages on a regional level.
  • There is no evidence that regions in the US with more licensure states have higher vacancy rates. ASCP vacancy survey data8 does not reflect any trends for vacancy rates when reviewed against states/regions with licensure laws.
  • Healthcare is not more costly due to licensure. Quality laboratory testing performed by appropriately educated medical laboratory professionals results in more cost-effective health care for the American public.

ASCLS Position Statements

Medical laboratory professionals provide essential services to physicians and other healthcare providers by furnishing vital information critical to the diagnosis, treatment, and prevention of disease or impairment, and the assessment of health. Therefore, it is essential that medical laboratory professionals are appropriately educated and competent to perform and interpret laboratory testing and produce consistently accurate and timely information necessary to ensure optimal patient outcomes. ASCLS reaffirms its intent to continue a leadership role and to remain steadfast in advocacy efforts to enact and implement personnel licensure laws in all states.

  1. Personnel licensure assures that clinical laboratory services are performed with an appropriate level of professional competence by requiring entry level qualifications for individuals engaged in the practice of clinical laboratory science.
  2. Minimum requirements for licensure should include both educational (academic and clinical) requirements and passage of a validated competency-based national certification examination.
  3. Personnel licensure renewal should require documentation of continuing education as a means of demonstrating continuing competence.
  4. Public health and safety are enhanced through competency requirements established by licensure for medical laboratory professionals.
  5. Personnel licensure is essential to define the clinical laboratory science scope of practice and protect it by excluding those who have not acquired the appropriate requisites for licensure.
  6. Personnel licensure provides for the creation of an essential mechanism to identify and collect data on the laboratory workforce.
  7. Personnel licensure provides the ability to contact and mobilize medical laboratory professionals for disaster response.
  8. Personnel licensure provides the only legal basis to bar incompetent practitioners from providing services to the public.

References

  1. American Society for Clinical Laboratory Science Position Paper: Value of Medical Laboratory Science Personnel and Clinical Laboratory Services in Healthcare. July 2021.
  2. Institute of Medicine (IOM). 2000. To err is human: building a safety health system. Washington, DC: National Academy Press.
  3. American Society for Clinical Laboratory Science Position Paper: Patient Safety and Clinical Laboratory Science, 2023.
  4. CLIA Regulations and Federal Register Documents; https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents
  5. American Society for Clinical Laboratory Science Position Paper: Scope of Practice and Personnel Standards, 2023.
  6. American Society for Clinical Laboratory Science Position Paper: Role of Clinical Laboratories in Bioterrorism Preparedness, 2002.
  7. Garcia E, Kundu I, Fong K. The American Society for Clinical Pathology 2021 Wage Survey of Medical Laboratories in the United States. Am J Clin Pathol 2022;XX:1-21.
  8. Garcia E, Kundu I, Kelly M, Soles R. The American Society for Clinical Pathology 2020 Vacancy Survey of Medical Laboratories in the United States. Am J Clin Pathol 2022;157:874-889.

Resources

  1. Passiment Elissa, Quality Systems – The Role of People, Laboratory Medicine, September 2005.