Classification: Position Paper
Status: Adopted by the ASCLS House of Delegates August 2016. Revision Adopted July 2024

Introduction

The concept of interprofessional patient care teams to provide more effective medical care for patients has been promoted for decades.1-5 These teams usually consist of the admitting physician, hospitalist physicians, nurses, doctoral pharmacists, health profession therapists, and social workers. Professionals from the clinical laboratory are conspicuously absent from these teams, yet many medical decisions (diagnosis, therapy, discharge, etc.) rely on laboratory test results.6 With a plethora of clinical laboratory tests and new molecular methodologies being added to the clinical laboratory test menu, clinicians are challenged with keeping abreast of the latest developments in clinical laboratory sciences.7,8 Technological advancements in laboratory informatics, patients’ ready access to laboratory test results, and personalized/precision medicine place the clinical laboratory in the center of patient-centered care. 9-13 Thus, an advanced practice medical laboratory professional, the Doctor of Clinical Laboratory Science (DCLS), should be a key member of the interprofessional health care team.

The DCLS practitioner brings a unique skillset and perspective that enhances the delivery and utilization of laboratory services. The DCLS practitioner increases efficiency, facilitates patient management outcomes, and improves timely access to accurate and appropriate laboratory information by participating directly in patient care decisions, monitoring laboratory utilization, and conducting research on the diagnostic process.3,16,28

In the 2022 Clinical Laboratory Improvement Amendment (CLIA) Personnel Standards update, the Center for Medicare Services states that “the DCLS contributes to increasing laboratory efficiency and improves timely access to accurate and appropriate laboratory information. A graduate of a DCLS program will be able to: provide appropriate test selection and interpretation of test results; monitor laboratory data and testing processes; improve the quality, efficiency, and safety of the overall diagnostic testing process; and direct laboratory operations to comply with all state and Federal laws and regulations”.18

Background

Institute of Medicine (IOM) studies identified 210,000 to over 400,000 preventable patient deaths in U.S. hospitals each year in addition to billions of health care dollars wasted annually on medical errors.14,15 In 2001, the IOM specified six aims to improve the delivery of health care so that it is safe, timely, efficient, equitable, patient-centered, and effective based on scientific knowledge.2 In 2003, the IOM specified five core competencies for health care professionals, namely, the ability to provide patient-centered care, work in interdisciplinary teams, employ evidence-based practice, apply quality improvement, and utilize informatics.3 The IOM further expanded recommendations in 2015 to reduce diagnostic errors that included promoting teamwork with health care professionals, patients, and families; improving the use of information technologies; developing processes to detect and reduce diagnostic errors; and providing more funding for research on the diagnostic process.16

The Centers for Disease Control and Prevention (CDC), Division of Laboratory Systems, convened a professionally facilitated meeting “The 2007 Institute: Managing for Better Health.” This Institute addressed the wide-ranging goal of improving the integration of laboratory medicine within the health care system. Four main goals were identified at this meeting.27 One of the goals identified was: “to institutionalize new models of clinical consultation provided by laboratory medicine professionals to clinicians to guide their decisions about utilization of laboratory tests or services.”27 This goal addresses the CDC’s vision of a collaborative, consultative relationship between medical laboratory professionals and clinicians, thus integrating laboratory medicine into patient care.

The American Society for Clinical Laboratory Science (ASCLS) strongly supports the IOM’s recommendations to improve patient safety.17 Although initiatives in clinical laboratory quality improvement, informatics, and evidence-based practice continue to be addressed to improve health care quality and safety, these efforts need to be expanded, coordinated, standardized, and linked to patient outcomes. 11,19-25 To accomplish this, ASCLS supports having a DCLS professional as a member on interprofessional healthcare teams and collaborating in patient-centered care.17,25,26 The Inclusion of the DCLS practitioner in the interprofessional health care team positively impacts quality patient care, outcomes, and safety. In addition, the DCLS practitioner contributes to healthcare cost-savings by providing valuable evidence-based clinical knowledge regarding laboratory testing that fosters accurate and timely diagnoses and treatment, thus supporting the IOM’s recommendations.2

For the last 20 years, ASCLS has advocated for the role of advanced practice non-physician laboratory scientists in promoting improved patient outcomes.25

  • 2004: The ASCLS House of Delegates accepted a model career ladder for the profession. The highest practice level in the career ladder includes the DCLS role, which requires a doctorate degree with skills in consulting, evaluating laboratory testing outcomes, and evaluating research designs. This paper was most recently revised/approved in 2022 as the “Levels of Practice and Model Career Ladder”.25
  • 2005: ASCLS established the DCLS Oversight Taskforce, which ultimately became an official committee and was charged with the direction and oversight for the development, implementation, recognition, integration, and evaluation of the new advanced practice Doctorate in Clinical Laboratory Science.
  • 2006: The ASCLS DCLS Oversight Committee collaborated with the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) Graduate Task Force. The committees produced a “Joint Educational Statement”, which included guiding competency statements, and Standards framework. A curriculum was drafted, externally reviewed, and amended.30 The basic curriculum model included scientific/medical knowledge and professional practice. Course work included advanced theory, clinical correlations, healthcare knowledge, laboratory stewardship, research methods, statistics, epidemiology, pathophysiology, advanced clinical laboratory science content areas, education, leadership, management, and interprofessional communication. Clinical training included patient care rounding and participation on interprofessional healthcare teams. An applied or translational research project was required.
  • 2009: The ASCLS House of Delegates approved a position paper, which expanded the practice levels and educational requirements for medical laboratory professionals and specified requirements for a doctoral-prepared clinical laboratory practitioner (Doctor of Clinical Laboratory Science or PhD). Practice skills included clinical assessment, evidence-based practice/research, laboratory services clinical consultation, patient counseling, grant-funded research as principal investigator, and test utilization/assessment/protocol development. This paper was most recently revised/approved in 2022 as the “Levels of Practice and Model Career Ladder”.25
  • 2014: The first student was accepted into the newly established DCLS program at Rutgers University in New Jersey. This was followed in 2016 with DCLS programs at the University of
    Texas Medical Branch in Galveston, Texas and in 2019 at the University of Kansas Medical Center in Kansas City, Kansas. In 2018, the first DCLS practitioner graduated from Rutgers University.
  • 2022: The Body of Knowledge for the Doctor of Clinical Laboratory Science was approved by the ASCLS House of Delegates.31
  • 2023: ASCP Board of Certification formed an exam committee for the development of the DCLS certification exam.
  • 2024: Effective 1/28/2024, CMS confirms that the DCLS degree is accepted as qualifying for High Complexity Laboratory Director (HCLD).18

The DCLS Practitioner Role

While medical laboratory professionals at all levels of practice have valuable knowledge regarding laboratory tests and data and can contribute to interprofessional health care teams, the DCLS is the advanced practitioner for the medical laboratory. The advanced doctoral education and experience prepares the DCLS practitioner to:

  • Provide patient-centered, customized consultation services on appropriate test selection and interpretation for the purpose of clinical decision-making among the interprofessional healthcare team and the patient.
  • Monitor laboratory data, test utilization, and diagnostic testing processes in individual patients and populations using informatics and analytics to reduce diagnostic errors, improve efficiency, and reduce costs.
  • Conduct research and apply evidence to demonstrate the clinical utility of laboratory tests and algorithms and to improve the quality, efficiency, and safety of the overall diagnostic testing process.
  • Educate health care providers, patients, their families, and the general public about the indications, best evidence, patient preparation, and interpretation of clinical laboratory testing, including home self-testing.
  • Direct laboratory operations at all levels of complexity to comply with all state and federal laws and regulations, as well as guidelines determined by professional boards of licensure, and certification/accreditation agencies.
  • Participate in public and private health policy decision-making at all organization and government levels using best evidence.

The DCLS practitioner is being utilized in various practice settings, serving as laboratory directors, consultants, quality assurance specialists, research scientists, educators, and the voice of the laboratory. Examples include (but are not limited to):

  • Private and public hospital laboratories
  • Academic medical centers
  • Veteran’s Health Administration
  • Defense Health Agency
  • Reference laboratories
  • Clinics
  • Biotechnology companies
  • Research
  • Pharmacies
  • Public health / Government agencies

Rationale

Pathologists and other health care providers recognize the need for greater clinician access to laboratory consultants for clinical decision support and appropriate utilization of laboratory services.7,29 The advanced clinical laboratory practitioner is in a unique position to improve patient outcomes while developing and strengthening collaborative relationships among laboratory professionals and other health care providers. Improper test selection and patient preparation and misinterpretation of laboratory tests cost patients in time, treatment, and money, and jeopardize their safety.20 The advanced clinical laboratory practitioner is also instrumental in coordinating the utilization of laboratory test data to actionable outcomes that can improve patient care and reduce medical errors.

The DCLS practitioner contributes to financial improvement in a variety of ways, serving as a member of interprofessional healthcare teams and more specifically as a member of daily patient care rounding teams and diagnostic management teams. The DCLS practitioner provides critical input on appropriate tests/testing algorithms leading to a faster, focused diagnosis, decreased patient length of stay, and ultimately improved patient care. Due to the relatively recent entry of the DCLS practitioner into the healthcare system, most data at this time have been presented in oral format and are awaiting formal publication. As more DCLS practitioners enter the field, comprehensive surveys of employers and colleagues on healthcare teams will provide data to support the added value DCLS practitioners provide to patient care and utilization of laboratory services.

ASCLS Position Statements

The following represents the most recent position of ASCLS on the Doctorate in Clinical Laboratory Science.

  1. Continued development and implementation of a professional Doctorate in Clinical Laboratory Science degree in institutions of higher learning is encouraged.
  2. Doctorate in Clinical Laboratory Science programs should seek accreditation by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS).
  3. Baccalaureate level education leading to certification as a generalist Medical Laboratory Scientist provides an essential foundation for success in the graduate curriculum and for building the advanced DCLS practitioner competencies.
  4. Interprofessional health care teams should include DCLS practitioners.
  5. The DCLS practitioner is an expert in laboratory testing and should be leading laboratory stewardship efforts.
  6. The DCLS practitioner is an expert who can recommend and interpret diagnostic tests and therefore a process should be established to allow for DCLS practitioner reimbursement.
  7. DCLS practitioners must earn doctoral-level board certification specific to the unique scope of practice of the DCLS (e.g., via the ASCP Board of Certification DCLS exam under development).
  8. Board Certified DCLS practitioners are qualified to serve as laboratory directors at all levels of complexity.
  9. With the continued growth in the number of DCLS practitioners, published, evidence-based research into the impact and value of the role is encouraged.
  10. Professional licensure laws, ideally with nationwide reciprocity, should be created in all states to regulate the practice of DCLS practitioners.

References

  1. World Health Organization. Learning Together to Work Together for Health. Report of a WHO Study Group on Multiprofessional Education for Health Personnel: The Team Approach. Technical Report Series 769:1-72. Geneva: World Health Organization, 1988.
  2. Institute of Medicine. Crossing the quality chasm: A new health system for the 21st Century. Washington, DC: National Academies Press, 2001.
  3. Institute of Medicine. Health professions education: A bridge to quality. Washington, DC: National Academies Press, 2003.
  4. Wiecha J, Pollard T. The interdisciplinary eHealth team: Chronic care for the future. J Med Internet Res 2004;6:e22. doi:10.2196/jmir.6.3.e22.
  5. Nandiwada DR, Dang-Vu C. Transdisciplinary health care education: Training team players. Journal of Health Care for Poor and Underserved 2010;21:26-34.
  6. Forsman RW. Why is the laboratory an afterthought for managed care organizations? Clin Chem 1996;42:813-816.
  7. Hickner J, Thompson PJ, Wilkinson T, Epner P, Sheehan M, Pollock AM, Lee J, Duke CC, Jackson BR, Taylor JR. Primary care physicians’ challenges in ordering clinical laboratory tests and interpreting results. J Am Board Fam Med 2014;27:268-274.
  8. Kotzer KE, Riley JD, Conta JH, Anderson CM, Schahl KA, Goodenberger ML. Genetic testing utilization and the role of the laboratory genetic counselor. Clin Chim Acta 2014;427:193-195.
  9. Snyder CF, Wu AW, Miller RS, Jensen RE, Bantug ET, Wolff AC. The role informatics in promoting patient-centered care. Cancer J 2011;17:211-218.
  10. Campbell B, Linzer G, Dufour DR. Lab Tests Online and consumer understanding of laboratory testing. Clin Chim Acta 2014;432:162-165.
  11. Shirts BH, Jackson BR, Baird GS, Baron JM, Clements B, Grisson R, Hauser RG, Taylor JR, Terrazas E, Brimhall B. Clinical laboratory analytics: Challenges and promise for an emerging discipline. J Pathol Inform 2015:6:9.
  12. Giardina TD, Callen J, Georgiou A, Westbrook JI, Greisinger A, Esquivel A, Forjuoh SN, Parrish DE, Singh H. Releasing test results directly to patients: A multisite survey of physician perspectives. Patient Educ Couns 2015;98:788-796.
  13. Schmidt KT, Chau CH, Price DK, Figg WD. Precision oncology medicine: The clinical relevance of patient specific biomarkers used to optimize cancer treatment. J Clin Pharmacol 2016; 17 JUN 2016, DOI: 10.1002/jcph.765.
  14. Institute of Medicine. To Err is Human: Building a safer health system. National Academies Press, 2000.
  15. James JT. A new, evidence-based estimate of patient harms associated with hospital care. J Patient Saf 2013;9:122-128.
  16. Institute of Medicine. Improving diagnosis in health care. Washington, DC: National Academies Press, 2015.
  17. American Society for Clinical Laboratory Science Position Paper. Patient Safety and Clinical Laboratory Science 2023. https://ascls.org/patient-safety-and-clinical-laboratory-science-position-paper, Accessed 9/14/23.
  18. Provisions of the Proposed regulations for CLIA Requirements for Histocompatibility, Personnel, and Alternative Sanctions for CoW Laboratories B. Proposed Changes to Personnel Requirements 1. Definitions c. Doctoral Degree, 87 Fed. Reg. 44910-44911 (July 26, 2022) (to be codified at 45 C.F.R. pts 493.2 definitions, 493.1443 Laboratory director qualifications)
  19. Grzybicki DM, Shahangian S, Pollock AM, Raab SS. A summary of deliberations on strategic planning for continuous quality improvement in laboratory medicine. Am J Clin Pathol 2009;131:315-320.
  20. Smith ML, Raab SS, Fernald DH, James KA, Lebin JA, Grzybicki DM, Zelie C, West DR. Evaluating the connections between primary care practice and clinical laboratory testing. Arch Pathol Lab Med 2013;137:120-125.
  21. Price CP, St John A. Innovation in healthcare. The challenge for laboratory medicine. Clin Chim Acta 2014;427:71-78.
  22. Scotten M, Manos EL, Malicoat A, Paolo AM. Minding the gap: Interprofessional communication during inpatient and post discharge chasm care. Patient Educ Couns 2015;98:895-900.
  23. Centers for Disease Control and Prevention, Division of Laboratory Systems, Clinical Laboratory Integration into Healthcare Collaborative (CLIHCTM). https://www.cdc.gov/cliac/docs/addenda/cliac0812/12_TAYLOR_clihc_CLIAC_Aug2012-2.pdf, Accessed 9/14/23
  24. Centers for Disease Control and Prevention, Division of Laboratory Systems, Laboratory Medicine Best Practices (LMBP™) Initiative: Systematic Evidence Review and Evaluation Methods for Quality Improvement. https://www.cdc.gov/labbestpractices/index.html. Accessed 9/14/23
  25. American Society for Clinical Laboratory Science Position Paper. Levels of Practice and Model Career Ladder, 2022. https://ascls.org/levels-of-practice-and-model-career-ladder, Accessed 9/14/23
  26. American Society for Clinical Laboratory Science Position Paper: Scope of Practice and Personnel Standards, 2024. Position Papers – ASCLS.
  27. Centers for Disease Control and Prevention. Division of Laboratory Systems. The 2007 Institute: Managing for Better Health. Executive Summary of Action Plan Priorities, 2007.
  28. Walz SE, Darcy TP. Patient safety & post-analytical error. Clin Lab Med 2013;33:183-194.
  29. Laposata ME, Laposata M, Van Cott EM, Buchner DS, Kashalo MS, Dighe AS. Physician survey of a laboratory medicine interpretive service and evaluation of the influence of interpretations on laboratory test ordering. Arch Path Lab Med 2004;128:1424-1427.
  30. American Society for Clinical Laboratory Science: History of the DCLS Task Force. https://ascls.org/wp-content/uploads/2014/09/02_History_of_the_DCLS_Task_