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Document: Laboratory Personnel Licensure
Classification: Position Paper
Status: Approved by the ASCLS House of Delegates
Date: July 2006

Introduction

Clinical laboratory services are a vital component of health care, ensuring optimal patient outcomes, as stated in the 2005 position paper of the American Society for Clinical Laboratory Science (ASCLS) "Value of Clinical Laboratory Services in Health Care." Laboratory professionals must provide accurate, specific and reliable information using state-of-the-art technology to facilitate evidence-based patient care decisions. The laboratory information, they provide, has a direct impact on patient diagnosis, treatment, health maintenance, safety, length of stay, as well as resource utilization, and patient satisfaction. Thus, laboratory personnel licensure is essential to protect the public from substandard laboratory services and possibly misleading information, by assuring that only adequately educated and qualified individuals perform testing. Background

ASCLS, as well as its predecessor, the American Society for Medical Technology (ASMT), has long supported licensure of laboratory professionals to assure high quality laboratory services for the public. The 1977 ASMT position paper "State Licensure" was followed by numerous supportive publications, including the 1982 position paper "Personnel Credentialing," the 1989 ASMT Model Licensure Bill, and the 1989 ASMT State Licensure Planning Manual. When the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) developed into a facility regulation with personnel standards inadequate to protect the public, ASMT renewed its efforts to press for state licensure to accomplish that goal.

Traditionally, several mechanisms exist to credential laboratory professionals and, to varying degrees, identify competencies:

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 or competency necessary to ensure that the public health, safety, and welfare will be reasonably protected. Licensure is required by law and defines the profession's scope of practice. Laboratory professionals practicing in a state with a licensing statute are required to be licensed to perform work within the defined scope of practice. Employers are required to employ only licensed individuals.

Certification - the process by which a non-governmental agency or association grants recognition to an individual who has met certain predetermined qualifications specified by that agency or association. Certification is a voluntary process, both for practitioners and employers. There is no governmental requirement that 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 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, ie. physicians, nurses, pharmacists, physical therapists, respiratory care practitioners, radiologic technologists, etc. instituted state licensing statutes to protect the public from unlicensed individuals', who do not meet pre-determined competencies, practicing. Licensing statutes have successfully ensured that only individuals meeting those standards are allowed to practice. With the exception of thirteen states/territories that have laboratory personnel licensure laws, most states have only voluntary certification available to regulate competency of clinical laboratory professionals.

CLIA '88 is essentially a federal facility licensure statute, inadequate alone to ensure testing personnel competency. It does, however, mandate that testing personnel must meet any state licensure requirements that exist. Rationale

Proponents of clinical laboratory 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
  • Facilitate an effective response in disaster preparedness by assisting in the identification, locating and mobilization of needed clinical laboratory professionals
  • Improve access to accurate laboratory workforce data

Despite allegations of licensure opposition, experience in states that have licensure statutes has demonstrated:

  • No direct correlation exists between implementation of laboratory personnel licensure and increased levels of compensation
  • No correlation exists between implementation of laboratory personnel licensure and exacerbation of the personnel shortage
  • Healthcare is not more costly. Quality laboratory testing performed by appropriately educated clinical laboratory professionals should result in more cost effective health care for the American public.

Patient Safety

In November 1999, the Institute of Medicine (IOM) released a report "To Err is Human: Building a Safer Health System," which estimated that 49,000-98,000 Americans die annually as a result of 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. Consistent with this movement, a variety of initiatives have gained prominence, focusing on and rewarding patient safety initiatives. These include:

  • Leapfrog
  • Safest in America
  • JCAHO patient safety goals
  • National and state patient safety legislation

Clinical 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, clinical laboratory professionals should meet defined education requirements, be certified, continually update their education, and demonstrate continued competency. Employing individuals without the appropriate education and training creates the potential to place every patient and every caregiver in harm's way. Licensure, of clinical laboratory professionals, provides a means to assure that these requirements are maintained in all patient care environments. Quality

CLIA '88 was enacted 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 by the Centers for Medicare and Medicaid Services (CMS), are inadequate to assure the hoped for 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. Personnel standards 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 clinical 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 clinical laboratory professionals are the single group of healthcare professionals, who are educated in the quality assurance and management for the entire testing process.

Disaster Preparedness

An effective response to bioterrorism and natural disasters requires state departments of health and emergency preparedness agencies to identify, locate and mobilize the required educated clinical laboratory professionals in a timely manner. Personnel licensure provides a means to identify and locate qualified clinical laboratory professionals in times of a disaster. The clinical 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.

  • Clinical 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 clinical laboratory professional to adequately provide and communicate critical information to public health and law enforcement agencies.
  • In the event of a biological attack, the clinical 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, laboratory professionals are essential for accurate and timely patient triage, diagnosis and treatment

Scope of Practice

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

As ASCLS defined in its 2001 "Scope of Practice" position paper, clinical 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. We believe the most suitable healthcare professionals should provide the most appropriate level of care required. Ultimately, by having clinical laboratory professionals assume the role for which they were educated, the total care provided for the consumer will be superior and unnecessary procedures will be less likely. Resources will be more effectively utilized and expertise valued for the contributions made. The current economic and regulatory healthcare environment benefits when clinical 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 clinical 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. Position

Clinical laboratory practitioners provide essential services to physicians and other healthcare providers by furnishing vital information critical to the diagnosis, prevention, and treatment of disease or impairment and the assessment of health. Therefore, it is essential that clinical laboratory practitioners 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. ASCLS believes that state personnel licensure provides the best mechanism to assure that clinical laboratory services are performed with an adequate level of professional competence by requiring appropriate entry level qualifications for individuals engaged in the practice of clinical laboratory science in all settings.
  2. ASCLS believes that through the competency requirements established by licensure for clinical laboratory practitioners, the public health and safety is enhanced.
  3. ASCLS believes that state personnel licensure provides the only legal basis to bar incompetent practitioners from providing services to the public.
  4. ASCLS believes that personnel licensure is essential to define in state statute the clinical laboratory science scope of practice and protect it by excluding those who have not acquired the appropriate requisites for licensure.
  5. ASCLS believes that minimum requirements for licensure should include both educational (academic and clinical) requirements and passage of a validated competency-based national certification examination.
  6. ASCLS believes that licensure renewal should require documentation of continuing education as a means of demonstrating continuing competence.
  7. ASCLS believes that licensure will provide for the creation of a much-needed mechanism to identify, collect data on, and provide access to the state's laboratory workforce. This relevant information will facilitate the ability to address manpower shortages and distribution, to effectively respond during a bioterrorism or other public safety threat by mobilizing the appropriate clinical laboratory professionals, and address other specific workforce needs.


REFERENCES
1. ASCLS Role of Clinical Laboratories in Bioterrorism Preparedness Position Paper, 2002.
2. ASCLS Scope of Practice Position Paper, 2001.
3. Passiment Elissa, Quality Systems - The Role of People, Laboratory Medicine, September 2005.
4. ASCLS Value of the Profession Position Paper, 2005.
5. Institute of Medicine. To Err is Human: Building a Safer Health Care System. National Academy Press. 1999.