Introduction/Background

Medical laboratory professionals provide clinical information and services that contribute to the effective delivery of care in today’s complex healthcare system. They are indispensable partners in providing patient-centered care and in improving health outcomes and overall public health.
Clinical laboratory services are one of the most cost effective, least invasive sources of objective information used in clinical decision-making. Clinical laboratory services have a direct impact on many aspects of patient care including, but not limited to, inpatient length of stay, patient safety, resource utilization, innovation in care, customer satisfaction and ultimately patient outcome. 1
Emerging and re-emerging diseases, pandemics, and bioterrorism agents with global impact showcase the crucial importance of identifying, tracking, and monitoring public health threats. Public health response and the need for ongoing surveillance highlights one of many critical needs for clinical laboratory services and qualified laboratory professionals.

Rationale

There are five common domains in which clinical laboratory services provide value within the healthcare system. 2-3 While the most commonly known is the provision of laboratory test results for clinicians, the other domains are of no less importance or value in improving the overall quality of healthcare in the United States.
Clinical Decision Support – Providing Test Results: 
Medical laboratory professionals produce objective clinical data using state of the art technologies to guide clinical decision making. This information has a significant impact on patient diagnosis. Tests, whether classified as screening or diagnostic, are essential elements of protocols used to prevent, diagnose, and manage specific diseases and conditions. Algorithmic testing models, designed with other healthcare team member input, are used to guide the diagnostic process to obtain the right information at the right time for a given patient. Additionally, clinical laboratory testing advancements allow for faster provision of results including options that are available at the patient bedside (inpatient settings) or within ambulatory locations. These patient-centered models assist in rapid identification of disease, assessment of severity of disease, creation of a therapeutic plan, and management/monitoring of treatment outcomes.
Clinical Decision Support – Consultation and Collaboration: 
Medical laboratory professionals consult and collaborate with other healthcare professionals to ensure informed decision-making in patient care.1 Medical laboratory professionals at all levels of the practice, including the DCLS (Doctor of Clinical Laboratory Science) decrease medical errors and improve patient outcomes through service on diagnosis (diagnostic) management teams, quality improvement committees, and by participating in direct patient care activities related to clinical laboratory testing. Through these partnerships, medical laboratory professionals:
  • explain the advantages and limitations of specific tests, to assure that the right test is selected at the right time
  • provide guidance in the correct interpretation of test results
  • develop clinical laboratory evidence-based practice guidelines
  • utilize data to improve therapeutic practices through individualized precision medicine
  • collaborate with other healthcare professionals regarding patient treatment options
  • collaborate with specialty teams in bridging the gap between research and clinical application
  • provide clinical data and support for risk management and patient safety
  • support the professional development process of other healthcare professionals by assisting with education and guidance relating to laboratory medicine
Patient Safety and Health Outcomes:
Clinical laboratory services are one of the leading diagnostic services in healthcare.  Medical laboratory professionals are stewards of patient safety and are key healthcare team members in promoting a culture of patient safety and quality defined by the National Academy of Medicine (NAM) (formerly the Institute of Medicine) as “safe, effective, patient-centered, timely, efficient, and equitable” practice.4
Primary emphasis is placed on providing clinical laboratory services that improve the diagnostic process in medicine and health outcomes for patients served.  This is achieved by preventing:
  • delayed diagnosis through the provision of timely services
  • wrong diagnosis through clinical laboratory testing accuracy and the generation of laboratory data that supports the diagnostic process
  • missed diagnosis through appropriate clinical laboratory consultation support
Patient safety competencies are practiced in the provision of all clinical laboratory services.4 Medical laboratory professionals:
  • provide patient-centered care, recognizing the patient is the focus of the practice
  • employ evidence-based laboratory practice to facilitate and support change
  • apply quality improvement principles to processes to reduce opportunities for error and improve service delivery
  • use informatics as an essential component of the practice to enhance communication and provide safe healthcare delivery
  • participate on interprofessional healthcare teams to provide laboratory medicine expertise in developing innovative and improved healthcare services.
Financial Value: 
Clinical laboratory services provide needed information to assure correct clinical decisions that influence patient outcome and healthcare cost. Improved patient outcomes will ultimately lead to decreased medical treatment costs, decreased inpatient length of stay as well as reduced inpatient readmissions. Decreased time to establishing a correct diagnosis and implementation of the most appropriate care for a patient will lead to decreased costs of care. Effective and efficient clinical laboratory services maximize low cost, high quality, timely delivery for operational efficiencies of the parent organization that contribute to:
  • preventing disease
  • detecting disease early
  • establishing an accurate diagnosis
  • selecting the right treatment
  • avoiding delays in treatment
  • improving care pathways
  • facilitating recovery
  • reducing disability
  • preventing relapse or retarding disease progression
  • reducing the need for long term care
Public Health & Policy – Research and Development Support:
Clinical laboratory services provide clinical data to support public health decision making and healthcare policy development. Additionally, clinical laboratory services have an impact on the evolution of analytical technology, molecular epidemiology, and bioinformatics. Clinical laboratory data provides core clinical information analytics to improve:
  • public health and regulatory policy
  • public health surveillance programs (e.g. newborn screening, lead toxicity screening, infectious disease tracing, foodborne illness tracing, bioterrorism threats, antibiotic resistance)
  • population health policy and global health strategies
  • health disparities through provision of screening services in underserved communities (colorectal cancer, prostate cancer, infectious disease)

ASCLS Position Statements:

  1. ASCLS believes that medical laboratory professionals provide clinical information and services that contribute to the safe and effective delivery of care.
  2. ASCLS believes that clinical laboratory services contribute to patient-centered care by providing information to allow diagnostic and therapeutic decision making by clinicians, other healthcare professionals, and patients.
  3. ASCLS believes that medical laboratory professionals, at all levels of practice, are essential to communicating evidence-based clinical information that drives test utilization with the highest efficacy and efficiency in given clinical conditions.
  4. ASCLS believes that medical laboratory professionals have the knowledge, expertise, and responsibility to serve on multi-disciplinary quality improvement and patient safety healthcare teams.
  5. ASCLS believes that medical laboratory professionals provide essential contributions that support healthcare systems in meeting national patient safety goals, improving health outcomes and raising the safety standards for healthcare professionals.
  6. ASCLS believes that medical laboratory professionals and the services they provide are critical in protecting the public’s health.

References

  1. Price CP, McGinley P, St John A. Where is the value of laboratory medicine and how do you unlock it? J Appl Lab Med. 2020 Sep;5(5):1050-60. https://doi.org/10.1093/jalm/jfaa116.
  2. Nadder T, Davis D, Sandhu PK, Uettwiller-Geiger D, Zibrat S. A review of published studies on the value of laboratory medicine. Clin Lab Sci [Internet]. 2018 Oct [cited 2020 Dec 14]. ascls.118.000729. Available from: http://clsjournal.ascls.org/content/early/2018/09/04/ascls.118.000729 Subscription required.
  3. Christenson RH, Grenache DG, Oellerich M. Special collection on the value of laboratory medicine. J Appl Lab Med. 2020 Sep;5(5):841-43. https://doi.org/10.1093/jalm/jfaa120.
  4. American Society for Clinical Laboratory Science, House of Delegates. ASCLS Position Paper: Patient Safety and Clinical Laboratory Science [internet]. 2015 Jul [cited 14 Dec 2020].
  5. https://ascls.org/position-papers/185-patient-safety-clinical-laboratory-science

Adopted by the ASCLS House of Delegates on January 17, 2021

 

Document: Value of Clinical Laboratory Services in Health Care
Classification: Position Paper
Date: July 2005
Status: Approved by the ASCLS House of Delegates, July 2005

Background

Clinical laboratorians provide information and services that contribute to maximizing the effective delivery of care in today’s complex healthcare system by assuring that the correct test is performed on the right person, at the right time, producing accurate test results that enable providers to make the right diagnostic and therapeutic decisions using the right level of health care resources.

Laboratory information enables physicians and other healthcare professionals to make appropriate evidence-based diagnostic or therapeutic decisions for their patients. Clinical laboratory services are the most cost effective, least invasive source of the objective information used in clinical decision-making. Clinical laboratory services have a direct impact on many aspects of patient care including, but not limited to, length of stay, patient safety, resource utilization, and customer satisfaction.

While technology continues to improve the productivity of today’s laboratories, new technologies, new diseases, and disease strains continue to drive the need for more tests and testing. Changes in the world, such as bio-terrorism and the speed with which diseases spread globally drive the need for rapid diagnosis.

Thus, the clinical laboratory professional is an indispensable partner in providing patient care, and making direct improvements in the lives of patients, in the maintenance of the public’s health, and in the effectiveness of individual health care providers

Rationale

Impacting diagnosis, identifying abnormalities: Laboratory professionals produce accurate, sensitive and specific information using new age technologies to guide clinical decision making. It is the role of laboratory professionals to inform physicians about which tests have the highest effectiveness in given clinical conditions. Through this partnership, the overall cost of testing and patient care is controlled and the quality of care is improved.

Laboratory information has a profound impact on patient diagnosis. Tests, whether classified as screening or diagnostic, are essential elements of protocols used to diagnose and manage specific diseases and conditions. Algorithmic testing models, designed with clinicians, are used to guide the diagnostic process to obtain the right information at the right time for a given patient, shorten the time to diagnose, the length of stay and improve utilization of laboratory services.4 These models assist in rapid identification of disease, assessment of severity of disease, creation of a therapeutic plan, and management/monitoring of treatment outcomes. The more efficient the testing protocol, the shorter the length of inpatient stay or outpatient encounter, the faster the implementation of therapy, and the lower the overall cost of care.

Change in patient management: The ability of a physician or other patient care provider to consistently make timely and evidence-based decisions which result in a change in care management is directly related to the availability of accurate, reliable and timely laboratory testing and reporting of results. A few examples that illustrate the laboratory professional’s ability to be the primary enabler of therapeutic efficacy are:

  • Monitor the effectiveness of parenteral nutritional treatment
  • Ensure proper dosing of medication
  • Monitor harmful effects of therapeutic drugs
  • Identify the causes of infection
  • Determine effective antibiotic therapy
  • Monitor the effectiveness of cancer therapy
  • Provide real-time decision support

Clinical laboratory services provide the information required by a physician to start, adjust and also to stop a course of treatment. This allows for the most appropriate, cost effective use of expensive drugs and other therapies, and allows the patient to be treated at the most appropriate level of care for the most appropriate period of time. Without laboratory information, these decisions would be compromised at best.

Patient Safety and Impacting Patient Outcome: Clinical laboratory services are a vital component of ensuring optimal outcomes for all patients accessing health care, whether for simple situations or for complicated, potentially life threatening situations; including end-of-life care. Laboratory professionals impact patient safety by providing pre-surgical or pre-procedural testing that determines the current ability of the patient to undergo those treatments. Patient outcomes are influenced by providing the needed information for clinicians to monitor the effectiveness of ongoing treatments and therapies. Patient outcomes can also be measured by how well chronic illnesses are managed. Diabetics rely on laboratory support to monitor the long-term effectiveness of their home monitoring systems. Laboratory professionals provide vital information to assist clinicians in making decisions that affect quality of life for their patients.

Position

  1. ASCLS believes that clinical laboratory services are a vital component for ensuring optimal patient outcomes.
  2. ASCLS believes that the appropriate utilization of laboratory services by clinicians will result in efficient and effective clinical decision-making. Clinical laboratory professionals contribute to efforts to maximize effective and efficient healthcare delivery by assuring that the correct test is performed on the right person at the right time, producing accurate test results with the best outcome in the most cost effective manner. Laboratory professionals should inform healthcare providers about which tests have the highest efficacy and efficiency in given clinical conditions.
  3. ASCLS believes that clinical laboratories contribute to patient centered care by providing information for evidence based decision making. Laboratory test results are one objective measurement by which abnormalities may be identified, specific diagnoses may be ruled in or out, and decisions to start, adjust, or discontinue a course of treatment may be reached.
  4. ASCLS believes that it is vital to continue efforts to assure that laboratory professionals meet the high standards necessary to protect the public’s health.
  5. ASCLS believes that laboratory professionals contribute important elements towards meeting the patient safety goals of the” Quality of Health Care in America” project and supports IOM’s recommendation to raise the standards for health care professionals.
  6. ASCLS supports the continued efforts to establish, in all states, licensure (or state personnel standards) of clinical laboratory professionals as a means of assuring that only appropriately educated and qualified persons perform laboratory tests. This will require that all practitioners demonstrate continued competence through recertification and documentation of clinical competence in the workplace.
  7. ASCLS believes that it is vital to develop relationships with other state and national healthcare organizations to assure that there is an adequate workforce to meet the increasing demands of clinical laboratory testing.

References

  1. Forsman Rodney S. Why is the laboratory an afterthought for managed care organizations? Clinical Chemistry. 42: (5): 813-816. 1996.
  2. Forsman Rodney S. The Value of the Laboratory Professional in the Continuum of Care. Clinical leadership and management review, 370-373. Nov/Dec 2002.
  3. ASCLS Scope of Practice Position Paper, 2001.
  4. http://www.mgh.harvard.edu/labmed/ser/interp.htm visited June 10, 2005