Classification: Position Paper
Revision Dates: 2012 and 2022
Status: Approved by the ASCLS House of Delegates June 30, 2022

Introduction/Background

Clinical Laboratory Science is a profession that practices independently as well as collaboratively with other healthcare professions. Clinical Laboratory Science as an autonomous profession has its own Body of Knowledge, Scope of Practice, and certifies its own practitioners. This profession requires its practitioners to demonstrate scientific, technical, managerial, and scholarly competencies, as well as high standards of performance and professional conduct. Its practitioners have ethical responsibilities to patients, colleagues, society, and to the advancement of the profession.

Rationale

Clinical laboratory science is the defined practice of qualified medical laboratory professionals which encompasses the design, performance, evaluation, reporting, interpretation, and clinical correlation of clinical laboratory testing. In addition, this includes the management of all aspects of this medical specialty. Through completion of accredited educational programs and national certifications, medical laboratory professionals have the required knowledge, autonomy, and skills to not only perform, interpret, and report clinical laboratory testing, but also consult with and educate medical laboratory professionals, other healthcare professionals, patients, and the public.

Patient care, economic and regulatory healthcare environments benefit from expanded roles for non-physician medical laboratory professionals. These expanded roles and ethical responsibilities1 include, but are not limited to:

  • Serving on healthcare teams to supply clinical laboratory expertise and scientific information to improve healthcare outcomes
  • Eliminating barriers to access laboratory services
  • Assuring delivery of timely diagnostic information
  • Promoting equitable distribution of healthcare resources
  • Directing moderate-complexity laboratories and with appropriate graduate education and certification by a board approved by CMS directing high-complexity clinical laboratories*
  • Placing primary focus on the welfare of the patient, healthcare outcome, and assuring that all clinical laboratory services are safe, effective, efficient, timely, equitable and patient-centered
  • Upholding the dignity and respect of the profession and maintaining a reputation of honesty, integrity, competence, and reliability
  • Establishing cooperative, collaborative, and respectful working relationships within the profession of clinical laboratory science and with all healthcare professionals
  • Contributing from their defined sphere of professional competence to advance the well-being of society and serving as patient and public advocates in clinical laboratory science

ASCLS Position Statements

  1. Clinical laboratory science is the defined independent practice of qualified medical laboratory professionals, who provide essential healthcare services.
  2. Medical laboratory professionals have the required knowledge and expertise to educate and consult with medical laboratory professionals, other healthcare professionals, patients, and the public.
  3. Medical laboratory professionals in accordance with all state or federal agency regulations are qualified to direct clinical laboratories at varying levels.
  4. Medical laboratory professionals have ethical responsibilities to patients, colleagues, society, and to the advancement of the profession of clinical laboratory science.

* CLIA 88’ Exempt Status laboratories would abide by their program standards as they relate to Laboratory Director qualifications if different than the CLIA 88’ regulations. States with State licensure programs that have exemption from CLIA program include New York and Washington. Government agency laboratories that have exemption from CLIA program include the Department of Defense and Veterans Health Administration.

References

  1. The American Society for Clinical Laboratory Science, Code of Ethics, https://ascls.org/code-of-ethics/

Resources

  1. CLIA 88’ Certification Boards for Laboratory Directors of High-Complexity Testing; https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Certification_Boards_Laboratory_Directors
  2. CLIA Regulations and Federal Register Documents; https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents