CLASSIFICATION: Position Paper
STATUS: Approved  by the ASCLS House of Delegates, 2012, Revised by the ASCLS House of Delegates July 2024

Introduction/Background

The value of clinical laboratory testing in disease prevention, detection, and monitoring has been estimated by various measures.1-4 In early 2000, 73% of examined evidence-based clinical practice guidelines (CPG) for leading causes of death and 80% of such guidelines for most clinically and economically burdensome conditions in the United States included using laboratory testing as a standard of care,5 pointing to the unprecedented contribution and essential role of the medical laboratory professionals in healthcare. As laboratory medicine has grown in complexity due to advances in scientific discovery, medical research, and emergence of new methodologies triggering rapid progress in patient care management, these values are anticipated to increase.

Laboratory stewardship programs are effective means to improve the quality of patient care and control health care costs as laboratory testing, inherent of many care pathways, is considered the highest volume medical activity.6,7 The National Healthcare Expenditures (NHE) in the United States were 18.3% of the Gross Domestic Product (GDP) in 2021 and grew 2.7%.8 Congress commissioned the Office of Inspector General (OIG) to implement a new payment system for laboratory tests to reduce healthcare spending. The Protecting Access to Medicare Act of 2014 (PAMA) was passed in 2014, and its implementation in 2018 resulted in the reduction of Medicare payments from the government for laboratory testing in the private market. Despite cuts in reimbursement levels for laboratory services due to PAMA, laboratory spending increased by $459 million (6%) to $7.6 billion in 2018. While reimbursement for higher volume, more routine tests decreased, utilization increased. Reimbursement and utilization for more esoteric and molecular and genetic testing also increased. The OIG predicted a savings of $670 million, but the cost for laboratory services continued to increase. This is the largest expenditure on laboratory tests since the passage of PAMA in 2014.9

While the cost of healthcare continues to rise, there are significantly increased expectations from clinicians and healthcare consumers to deliver information in a manner that will facilitate rapid diagnosis and treatment. The long-standing, documented laboratory workforce shortages, exacerbated by COVID-19 pandemic, burnout and supply chain issues, motivate the Clinical Laboratory Science profession to advocate for its increased visibility, appreciation and support enabling better job satisfaction, employment growth and retention.10-12 This advocacy requires continuous reassessment of the professional scope of practice, reflecting the dynamic changes in the scientific, economic, and regulatory environment, and the resulting evolution of the career ladder to expand personnel standards and establish the Doctorate in Clinical Laboratory Science (DCLS) as the terminal degree equally qualifying to serve as High Complexity Laboratory Director (HCLD) as PhD and MD.13,14

The Clinical Laboratory Science Profession

In previous statements of opinion, policy and positions, the American Society for Clinical Laboratory Science (ASCLS) has established that Clinical Laboratory Science is a profession: distinct from the practice of medicine; characterized by its own Body of Knowledge and Scope of Practice15,16; which certifies its own practitioners; and requires of its practitioners competency in scientific, technical, managerial and scholarly principles, and high standards of performance and professional conduct.17

ASCLS defines the profession of Clinical Laboratory Science as encompassing the design, performance, evaluation, reporting, interpreting, and clinical correlation of clinical laboratory testing, and the management of all aspects of these services.18 The profession includes practitioners (DCLS, PhD, Masters, Bachelors, and Associate level individuals as well as other certified individuals) qualified in a number of discipline-specific areas of expertise including, but not limited to microbiology, virology, hematology, immunology, cytometry, transfusion medicine, clinical chemistry, endocrinology, toxicology, cytogenetics, cytology, histology, histocompatibility and molecular diagnostics. Integral features of each of the specialties include diagnostic testing, research, consultation, education, laboratory informatics, marketing, and administration.

Description of the Scope of Practice

Medical laboratory professionals (MLP), as members of the healthcare team, contribute to the prevention of disease, and the diagnosis, treatment, and prognosis of pathophysiological conditions in humans.

  • Quality clinical laboratory testing is evidenced by performing the appropriate laboratory testing for the correct patient at the right time and producing accurate test results, in the most cost-effective manner. This is accomplished by participating in multi-disciplinary diagnostic care teams to ensure that appropriate clinical laboratory tests are ordered,
  • Procure test samples in an efficient, safe, and timely manner,
  • Produce accurate, precise and timely test results,
  • Correlate and interpret laboratory test data,
  • Disseminate laboratory test information to clinicians and patients in a timely manner,
  • Evaluate the impact of clinical laboratory services and testing on patient outcomes,
  • Evaluate the impact of clinical laboratory services and testing on healthcare system outcomes,
  • Utilize qualified medical laboratory personnel as described in ASCLS Levels of Practice Model.21

The practice of Clinical Laboratory Science requires:

  • Assessing, designing, evaluating and implementing new clinical laboratory test methods
  • Evaluating the appropriateness of existing and new clinical laboratory methods for clinical utility, cost-effectiveness and cost-benefit analysis
  • Developing, implementing, and reporting results of clinical laboratory research
  • Designing and implementing cost-effective delivery models for clinical laboratories, including services and personnel
  • Developing and implementing an effective Quality Management System to include the twelve (12) Quality System Essentials19:
    • Organization and Leadership
    • Facilities and Safety Management
    • Supplier and Inventory Management
    • Process Management
    • Information Management
    • Assessments
    • Customer Focus
    • Personnel Management
    • Equipment Management
    • Documents and Records Management
    • Nonconforming Event Management
    • Continual Improvement
  • Incorporating appropriate educational skills and five (5) competencies in academic curricula to prepare current and future practitioners to prevent gaps in delivery of care, improve healthcare quality and patient safety20:
    • practicing evidence-based medicine
    • employing quality improvement methodologies
    • using appropriate information technology
    • delivering patient-centered care
    • working as part of an interdisciplinary team
  • Incorporating required continuing education and career growth opportunities for medical laboratory professionals,
  • Promoting awareness and understanding of the value of clinical laboratory tests, services, and professionals.

Description of Current Practice

The levels of practice as defined by the ASCLS Levels of Practice Model (LOP) are hierarchical and differentiate the technical practice skills required for each level of practice based on education, certification, and experience.21 Medical laboratory professionals can practice as generalists or in specific disciplines within the clinical laboratory profession depending on their education, certification, and experience.

The following scenarios describe specific examples of the scope of practice of Clinical Laboratory Science.

Providers of Clinical Laboratory Services: MLP qualified by education, experience and certification may perform sample collection and processing, laboratory tests, and provide test results to clinicians and to consumers upon request or upon clinician referral. These services can be used to assess wellness and identify disease risk factors, as well as assisting in the diagnosis, monitoring and treatment of disease. MLPs exercise prudence and judgment to ensure that such services are consistent with good practice and sound professional ethics.17

Directors of Clinical Laboratories: Qualified MLPs may fill the roles of administrative director, high complexity laboratory director, or moderate complexity laboratory director.22,23 While the requirements of an administrative laboratory director are defined by organizations, MLPs may direct high and moderate complexity clinical laboratories in accordance with Clinical Laboratory Improvements Amendments of 1988 (CLIA) regulations. MLP may serve in the CLIA-defined roles with the appropriate education, experience, and certification.24,25 Below is a description of the roles as they pertain to Medical Laboratory Scientist qualifications:

Education

Experience

Certification
High Complexity Laboratory Director Doctoral degree in chemical, biological or Clinical Laboratory
Sciences (DCLS)		 2 years of supervision over a high complexity laboratory Certification by Health and Human Services (HHS) approved board
Moderate Complexity Lab Director Doctoral degree in chemical, biological or Clinical Laboratory
Sciences (DCLS)		 1 year supervising non-waived laboratory testing Not required by CLIA.
Moderate Complexity Lab Director Master’s degree in a chemical, biological or Medical Laboratory
Science from an accredited institution		 1 year of training and /or experience in non-waived testing and 1
year supervising non-waived laboratory testing		 Not required by CLIA.
Moderate Complexity Lab Director Bachelor’s degree in a chemical, or biological science or Medical
Laboratory Science from an accredited institution		 2 years of training and/or laboratory experience, or both in
non-waived testing and 2 years supervising non-waived testing		 Not required by CLIA.

 

CLIA defines specific educational requirements for Technical Consultants, Technical Supervisors, General Supervisor, and Testing Personnel. This function is firmly grounded in (a) applicable state law, and/or (b) federal regulations governing clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 and laboratory participation in Medicare and Medicaid.21,22,23

Consultants for Clinical Laboratory Services: MLPs provide support to clinicians, manufacturers, and consumers of clinical laboratory testing services about the:

  • Design and service scope of clinical laboratories,
  • Appropriate utilization, selection and sequencing of clinical laboratory tests,
  • Clinical correlations and interpretations of the quality and utility of specific laboratory results in collaboration with clinicians,
  • Design and development of clinical laboratory instruments, test kits and other component,
  • Appropriate use, maintenance, quality assurance and other procedural and informational requirements.

MLPs can be categorized as practitioners, educators, and laboratory leaders, both: administrative and technical. Although specific knowledge and experience is common to all three of these areas, none is mutually exclusive of the other. Demands of the medical laboratory profession often require individuals to practice in more than one area and therefore may perform at various levels of practice depending on their unique qualifications.

Practitioners perform the scientific function. The scientific function includes:

  • Production and dissemination of test data
  • Monitoring the accuracy, precision, and utility of laboratory testing
  • Correlation and interpretation of test data
  • Design, development, evaluation, and implementation of new laboratory test methods, contributing to evidence-based medicine (EBM), evidence-based practice (EBP), and comparative effectiveness research (CER).26
  • Test utilization/laboratory stewardship

Educators perform the educational function. The educational function includes the establishment and management of educational programs for:

  • New and current medical laboratory professionals
  • Other healthcare providers
  • Healthcare consumers

Laboratory leaders perform the managerial function. The managerial function includes managing and administrating all aspects of the following laboratory operations:

  • Technical
  • Fiscal
  • Workflow
  • Human resources
  • Interdepartmental communication and practice

Qualifications for Practice

Personnel standards should be prescribed for ALL laboratory personnel, including directors, supervisors and other laboratory technical personnel to ensure the accuracy and reliability of test performance. Qualifications to perform testing at CLIA defined regulatory complexity levels should determine personnel standards at the technical level.22,23

  • The individual qualified to perform CLIA waived tests must demonstrate competency and would perform simple tests requiring little to no independent judgement and interpretation.
  • The individual qualified to perform CLIA moderately complex tests must demonstrate, at a minimum, competency as a Medical Laboratory Technician (MLT) and would perform, under direct supervision, more technically demanding tests with some degree of independent judgement and interpretation.
  • The individual qualified to perform CLIA highly complex tests must demonstrate, at a minimum, competency as a Medical Laboratory Technician (Level IV as described in the ASCLS Levels of Practice Model)21, Medical Laboratory Scientist, or discipline certified scientist/technologist or specialist (BB, SBB, C, SC, H, etc.) and would perform more technically complex tests requiring considerable amounts of independent judgement and interpretation.

Validated competency-based credentialling examinations should be required for all medical laboratory professionals performing moderate and high complexity testing. Waived testing should be performed by personnel who have been properly trained by a certified Medical Laboratory Technician, Medical Laboratory Scientist, or other certified scientist as defined by ASCP BOC.28

Education and certification benchmarks should be used to define positions at various levels of work and different types of work presently performed by professionals in the clinical laboratory. Benchmarks are defined as the standards by which others may be measured according to the established levels of practice.21 The benchmarks in the table below are defined by ASCP BOC Route 1. Other eligibility routes defined by ASCP BOC are acceptable.28

 

Practitioner

Benchmarks
Personnel performing CLIA waived testing High School diploma/GED and successful completion of appropriate training for testing at this level. It is within the scope of practice of a certified Medical Laboratory Scientist and/or technician to provide this training.
Phlebotomist High school diploma/GED and successful completion of a phlebotomy program accredited by an agency recognized by the U.S. Department of Education or completion of a phlebotomy program/clinical experience in an acceptable clinical laboratory.
Medical Laboratory Assistant High school diploma/GED and successful completion of a medical laboratory assistant program accredited by an agency recognized by the U.S. Department of Education or completion of a medical laboratory assistant/clinical experience in an acceptable clinical laboratory.
Medical Laboratory Technician Associate degree as awarded by a regionally accredited college/university, including successful completion of a Medical Laboratory Technician program accredited by an agency recognized by the U.S. Department of Education.
Medical Laboratory Scientist and categorical scientist (C, BB, H, etc.) Baccalaureate degree as awarded by a regionally accredited college/university, including or in addition to successful completion of a Medical Laboratory Science program accredited by an agency recognized by the U.S. Department of Education.
Laboratory Specialist (ex. SBB, SH, SM, etc.) Baccalaureate degree or higher, valid certification, and acceptable clinical experience.
High Complexity Laboratory Director (HCLD) Doctoral degree in a chemical, biological, or clinical laboratory science from an accredited institution, certification by a board approved by the department of Health and Human Services (HHS), and two years of experience directing or supervising high complexity testing. Acceptable doctoral degrees are the Doctorate in Clinical Laboratory Science (DCLS) and the Doctorate in Philosophy (PhD) with at least three years high complexity testing experience and board certification.

 

The current economic and regulatory healthcare climate benefits from the roles described for medical laboratory professionals. These roles achieve high quality, cost-effective assessment, diagnosis, treatment, and prevention of disease to meet the needs of a changing healthcare environment. It is time for the appropriately qualified MLPs to participate more actively in interdisciplinary teams and play their appropriate role, so the total care provided to the patient is optimized.

Position Statements

  • Personnel standards to include educational benchmarks and competency requirements should be prescribed for ALL Medical laboratory personnel including directors, supervisors, Medical Laboratory Scientists, Medical Laboratory Technicians and other laboratory personnel to ensure the accuracy and reliability of test performance.
  • ASCLS supports and advocates for state licensure for medical laboratory professionals.27
  • In combination with CMS approved board certification, a Doctorate of Clinical Laboratory Science degree provides eligibility to serve as a High Complexity Laboratory Director (HCLD).
  • Minimum personnel standards must be defined in terms of qualifications needed to perform testing at the CLIA defined complexity levels.
  • Validated competency-based credentialing examinations are critical for all laboratory practitioners at all levels of testing.
  • Waived and Point of Care testing must be performed by competency-assessed personnel who have been properly trained by a certified medical laboratory professional.
  • Key elements for the career mobility (ladder) include competency-based credentialing examinations, clinical experience, and documentation of continuing education to determine competency of personnel at all levels of responsibility.21
  • There is a need for educational programs and certification in critical support roles such as phlebotomists and medical laboratory assistants as defined by the BOC.28
  • Certification eligibility routes as defined by the BOC are acceptable.
  • All practitioners should demonstrate continued competence through ongoing recertification.
  • Medical Laboratory Science professionals should serve on interdisciplinary healthcare teams to prevent diagnostic error and improve patient safety and health outcome.

References

  1. Ngo A, Gandhi P, Miller WG. Frequency that Laboratory Tests Influence Medical Decisions. J Appl Lab Med. 2017 Jan 1;1(4):410-414. doi: 10.1373/jalm.2016.021634. PMID: 33636802.
  2. Rohr UP, Binder C, Dieterle T, Giusti F, Messina CG, Toerien E, Moch H, Schäfer HH. The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report. PLoS One. 2016 Mar 4;11(3):e0149856. doi: 10.1371/journal.pone.0149856. Erratum in: PLoS One. 2016;11(4):e0154008. PMID: 26942417; PMCID: PMC4778800.
  3. Commission on Office Laboratory Accreditation (COLA). Integrating Laboratories into the Patient Centered Medical Home Model of Health Care Delivery. Accessed October 2023. http://www.cola.org/wp-content/uploads/2015/06/COLA_14194-PCMH-Whitepaper.pdf.
  4. The American Society for Clinical Laboratory Science. Value of Medical Laboratory Science Personnel and Clinical Laboratory Services in Healthcare. January 2021. Accessed October 2023. Available at: https://ascls.org/value-of-clinical-laboratory-services/
  5. The Lewin Group. The value of diagnostic innovation, adoption, and diffusion into healthcare. Jul 2005 Accessed from: https://dx.advamed.org/sites/dx.advamed.org/files/resource/Lewin%20Value%20of%20Diagnostics%20Report.pdf.
  6. Dickerson JA, Fletcher AH, Procop G, Keren DF, Singh IR, Garcia JJ, Carpenter RB, Miles J, Jackson B, Astion ML. Transforming Laboratory Utilization Review into Laboratory Stewardship: Guidelines by the PLUGS National Committee for Laboratory Stewardship. J Appl Lab Med. 2017 Sep 1;2(2):259-268. doi: 10.1373/jalm.2017.023606. PMID: 32630981.
  7. Zhi, M., Ding, E. L., Theisen-Toupal, J., Whelan, J., & Arnaout, R. (2013). The landscape of inappropriate laboratory testing: a 15-year meta-analysis. PloS one, 8(11), e78962.
  8. Centers for Medicare & Medicaid Services (CMS.gov). National Health Expenditure (NHE) Fact Sheet. 2021. Accessed from https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NHE-Fact-Sheet.
  9. U.S. Department of Health and Human Services Office of the Inspector General. Medical Laboratory Test Expenditures Increased in 2018, Despite New Rate Reductions. August 6, 2020. Accessed October 2023. Available at: Medicare Laboratory Test Expenditures Increased in 2018, Despite New Rate Reductions, OEI-09-19-00100 (08/07) (hhs.gov)
  10. Edna Garcia, Iman Kundu, Melissa Kelly, Ryan Soles, The American Society for Clinical Pathology’s 2018 Vacancy Survey of Medical Laboratories in the United States, American Journal of Clinical Pathology, Volume 152, Issue 2, August 2019, Pages 155–168, https://doi.org/10.1093/ajcp/aqz046
  11. Edna Garcia, Iman Kundu, Melissa Kelly, Ryan Soles, The American Society for Clinical Pathology 2020 Vacancy Survey of Medical Laboratories in the United States, American Journal of Clinical Pathology, Volume 157, Issue 6, June 2022, Pages 874–889, https://doi.org/10.1093/ajcp/aqab197
  12. American Society for Clinical Laboratory Science. Addressing the Clinical Laboratory Workforce Shortage. 2020. Accessed October 2023. Available at: https://ascls.org/addressing-the-clinical-laboratory-workforce-shortage/
  13. American Society for Clinical Laboratory Science Position Paper. Advanced Practice: Doctorate of Clinical Laboratory Science, 2016. Accessed September 2022. https://ascls.org/advanced-practice-doctorate-in-clinical-laboratory-science/
  14. American Society for Clinical Laboratory Science. ASCLS Applauds CMS Proposed Rule Interpretation Making DCLS Eligible for High Complexity Laboratory Director. Accessed: October 2023. Available at: https://ascls.org/ascls-applauds-cms-proposed-rule-interpretation-dcls/
  15. American Society for Clinical Laboratory Science. Body of Knowledge. 2022. https://members.ascls.org/store_product.asp?prodid=63
  16. American Society for Clinical Laboratory Science Position Paper. Scope of Practice. 2012. Accessed on Oct 2, 2023. Available at: https://ascls.org/scope-of-practice
  17. American Society for Clinical Laboratory Science Code of Ethics. Accessed: October 2023. Available at: https://ascls.org/code-of-ethics/
  18. American Society for Clinical Laboratory Science. Independent Practice. Accessed: October 2023. Available at: https://ascls.org/independent-practice/
  19. A Quality Management System Model for Laboratory Services; Approved Guideline – Fifth Edition, CLSI document QMS01
  20. Committee on the Health Professions Education Summit, National Academies Press. Greiner AC, Knebel E. eds. Health Professions Education: A Bridge to Quality. Washington DC: National Academies Press; 2003.
  21. American Society for Clinical Laboratory Science Position Paper. Levels of Practice and Model Career Ladder, 2022. Accessed October 2023. https://ascls.org/levels-of-practice-and-model-career-ladder/
  22. Code of Federal Regulations. Title 42, Chapter IV, subchapter G part 493. 2022. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-M/subject-group-ECFR2640b368593bdb0/section-493.1443, Accessed 8/20/22.
  23. Code of Federal Regulations. Title 42, Chapter IV, subchapter G part 493. 2022. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-M/subject-group-ECFR10813e8157e2976/section-493.1405, Accessed 8/20/22.
  24. Center for Disease Control and Prevention. Clinical Laboratory Improvement Amendments (CLIA) Test Complexities. 2018. https://www.cdc.gov/clia/test-complexities.html, Accessed 8/20/2022.
  25. U.S. Food & Drug Administration. CLIA Categorizations. 2020. https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations, Accessed 8/20/22.
  26. American Society for Clinical Laboratory Science DCLS Body of Knowledge. https://ascls.org/wp-content/uploads/2022/08/DCLS_BOK_ADOPTED_20220630.pdf
  27. American Society for Clinical Laboratory Science Position Paper. Laboratory Personnel Licensure. July 2006. Accessed October 2023. Available at: https://ascls.org/laboratory-personnel-licensure/
  28. American Society for Clinical Pathology (ASCP) Board of Certification (BOC). 2022. https://www.ascp.org/content/board-of-certification#, Accessed 8/20/22.