The practice of laboratory medicine is undergoing rapid change, both leading as well as reflecting changes in our healthcare system. These changes are driven by new technologies that now enable molecular and genomic testing, electronic data collection and integration; personalized and evidence-based medicine, and the vertical and horizontal integration of all health care. The laboratory is in the center of these massive changes, with clinical laboratory test results a key factor in 70% or more of all medical decisions.

As testing has expanded into new specialties and grown more complex, the assumption that most requesting physicians are fully capable of interpreting all laboratory test results is no longer valid. Laboratories have been transformed from a passive clinical service provider to an active partner in patient diagnosis, treatment, and management. Clinical laboratory consulting is now becoming an integral and necessary part of routine laboratory services, and the role and responsibilities of the Clinical Consultant have grown along with this.

Several studies have shown the value of laboratory assistance to attending physicians with test selection and interpretation. The lack of clinical involvement is associated with significant consequences: 15% – 54% of primary care medical errors are related to the testing process; 17% of healthcare spending in the U.S. is due to test overutilization; and nearly a third of total healthcare spending may be due to potentially avoidable clinical care[i].

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, such as clinical consultants, provide vital information to assist clinicians in making decisions that affect the quality of life for their patients.

The development of personalized medicine, as well as increased patient rights to directly request tests, and access their test results, further impacts the need for clinical consultation.

What are the qualifications and responsibilities of a Clinical Consultant?[ii]

This is a CLIA required and defined position for all moderate and high complexity laboratories.

Qualifications include having an MD/DO/DPM license, or a doctoral degree in laboratory science AND board certified in the specialty/subspecialty of service.

CLIA defined responsibilities include: providing consultation regarding the appropriateness of the testing ordered and interpretation of test results. The clinical consultant must—

(a) Be available to provide clinical consultation to the laboratory’s clients;

(b) Be available to assist the laboratory’s clients in ensuring that appropriate tests are ordered to meet the clinical expectations;

(c) Ensure that reports of test results include pertinent information required for specific patient interpretation; and

(d) Ensure that consultation is available and communicated to the laboratory’s clients on matters related to the quality of the test results reported and their interpretation concerning specific patient conditions.

How do changes in laboratory medicine impact the role of the Clinical Consultant?

Personalized medicine / Genomic Medicine[iii]

Personalized medicine is beginning to transform the practice of medicine. It is allowing health care providers to:

  1. Shift the emphasis in medicine to prevention and prediction of disease rather than reaction to it;
  2. Focus on susceptibility to disease, improve disease detection, preempt disease progression;
  3. Ability to make more informed medical decisions; earlier disease interventions than was possible in the past;
  4. Customize disease-prevention strategies;
  5. Prescribe more effective drugs and avoid prescribing drugs with predictable side effects;
  6. Have a higher probability of desired outcomes thanks to better targeted therapies;
  7. Reduce the time, cost, and failure rate of pharmaceutical clinical trials, and
  8. Eliminate trial-and-error inefficiencies that inflate health care costs and undermine patient care

Points c) d) and e) all involve assistance from the clinical consultant.

Evidence-based medicine[iv]

Laboratory information has a profound impact on patient diagnosis. 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. 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

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:

  1. Monitor the effectiveness of parenteral nutritional treatment
  2. Ensure proper dosing of medication
  3. Monitor harmful effects of therapeutic drugs
  4. Identify the causes of infection
  5. Determine effective antibiotic therapy
  6. Monitor the effectiveness of cancer therapy
  7. Provide real-time decision support

Points b) e) and g) all involve assistance from the clinical consultant.

Direct Access To Test Results

Societal changes, focused on individual empowerment and personalized medical care, created the momentum for revisions to the traditional way that laboratory results were made available to patients. Direct access by patients to their own test results was made official policy in 2014.

Physicians recognized that patients have a right to their medical information; that by providing the information (directly) patients could be more engaged, be better partners, and be more compliant in their healthcare.

While the rule does not require laboratories to interpret test reports, this may result in more direct interaction between laboratory professionals and the patient. Laboratories can always refer an individual back to their health care provider for this information as well.


Among current themes of medical practice today are evidence-based medicine, patient-centered care, and quality management. Running through all of these is the integration and organization of information. Acting within these themes are societal forces altering the culture of medical practice, an economic evolution from cost-centered to value-centered management; changing government regulations, transformations in medical and graduate school curricula, rapidly developing, often disruptive technologies, and personnel shortages. It is in this environment of interacting interests and forces, that the laboratory and its professional personnel are redefining their roles, including how to provide relevant clinical consultation to attending physicians.

Today, it is acknowledged that quality laboratory service is not just about providing accurate, useful and timely information to the attending physicians; it must be provided within the context of the particular patient’s circumstances. It is clinical consultants who have the contextual background to fully and optimally assist the clinician[v].

[i] The Role of Pathologists in the Clinical Laboratory. Labs Are Vital. Sept. 30, 2013
[ii] CLIA Requirements and Responsibilities for Clinical Consultants
[iii] The Jackson Laboratory: Genetics and Your Health/ Personalized Medicine and You. 2014.
[iv] The Value of Clinical Laboratory Services in Health Care. An ASCLS Position Paper . July 2005.
[v] The Role of Pathologists in the Clinical Laboratory. Labs Are Vital. Sept. 30, 2013

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