- CLIA88 defines the role of a Clinical Consultant in subpart M of the regulations. The Clinical Consultant must be qualified and able to render opinions to laboratory clients regarding the diagnosis, treatment and management of patients; be a doctor of medicine, osteopathy, or podiatric medicine; and have a license in the state where the laboratory is located. Responsibilities include:
- Being available for consultation
- Assisting clients in ordering appropriate tests for clinical expectations
- Assuring that reports include pertinent information for test interpretation
- Assuring that consultations related to the quality of test results and interpretation specific to patient concerns are communicated to clients
- This person does not need to be the Laboratory Director, but the role of Laboratory Director is greatly enhanced by also being a pathologist Clinical Consultant who both understands and provides administrative, clinical and technical leadership.
- The qualifications for Clinical Consultants are listed in 42 CFR 493.1417
- The general duties of a Clinical Consultant are listed in 42 CFR 493.1419
- In the role of a Clinical Consultant the pathologist acts primarily in his or her capacity as a physician, interacting with other physicians and clinical staff to ensure appropriate test utilization, interpretation and follow-up. This is a valuable service that the pathologist as a physician can uniquely provide. For POCT, this includes responding to requests for new POC tests.
- The initial Clinical Consultant duties of the pathologist take place when determining whether POCT should be deployed in a particular clinical setting. Questions that should be asked and answered during this period include:
- Who will be performing testing (physicians, nurses, others)?
- What population will be tested (e.g., age, sex, known diagnosis)?
- How will the test result be used (e.g., screening, diagnosis, monitoring)?
- Will the result be incorporated into a treatment algorithm?
- What are the requirements of the test result (e.g , qualitative versus quantitative, reportable range, low end sensitivity, accuracy, precision)?
- What are the advantages and disadvantages to performing this testing at the POC rather than in a centralized laboratory?
- Will follow up testing be required with another test and/or by the central laboratory?
- The answers to these questions will help determine:
- If proposed POCT is appropriate in a given clinical setting
- The characteristics of the test that will be required
- Developing test/treatment algorithms:
- The Clinical Consultant can significantly impact the appropriate utilization of POC tests, as well as the appropriate use of the results, by working with the clinical team to develop testing/treatment algorithms that incorporate the results of the POC test. Through the use of such algorithms, the user should understand when it is appropriate to use a POC test and what they should do with the result. Such algorithms foster consistent and appropriate test utilization and may provide data useful in the post-implementation follow-up.
- When will the test be used?
- For diagnosis:
- What (if any) clinical findings or prior test findings should be present prior to performing the test?
- What is the follow-up of a positive test? For example, are confirmatory tests required by either manufacturer recommendations, by regulations, or for medical reasons?
- What is the follow-up for a negative test?
- For screening:
- What (if any) clinical findings or prior test findings should be present before performing the test?
- What is the follow-up of a positive test? For a negative test?
- For monitoring:
- What will the frequency of monitoring be? Is this dependent on clinical findings or merely time delineated?
- Does monitoring need to occur at a specific point in time (e.g., post therapy)?
- Does the test have important decision levels? How accurate is the test at those levels?
- Are critical values needed?
Are repeat or follow up values required?
- How do these relate to critical values in the central laboratory?
- What are the actions to be taken when such a value is identified?
Developing testing aids:
- Once there has been a determination that POCT is appropriate and a specific test has been identified and validated, the role of a Clinical Consultant becomes more educational. Non-laboratorians may not be cognizant of important differences between POC and centralized laboratory tests. In order to assure the results of POC tests are used appropriately, it is incumbent upon the Clinical Consultant to make sure that the users are aware of and understand any potential issues or problems that may occur when using a POC test. These may include but are not limited to:
- Potential problems in reading the results of the test (internal controls, color discrimination, etc.)
- Appropriate interpretation of the test result
- Limitations in test sensitivity
- Limitations in the dynamic range of the test
- Test specificity and potential interferences
- Effects of other clinical conditions on the test result (e.g., anemia, hypoxia)
- The effect of sample collection problems
- Appropriate follow-up of a positive and/or negative test result
- Many of the above issues can be addressed through the use of a well-written test procedure, appropriate staff training and competency assessment. However, it is also important to provide as many tools and reminders for the testing staff regarding these issues as possible. Remember that the testing staff will largely be non-laboratorians with many other duties and therefore may not understand the potential for a test to produce an erroneous result unless it is performed in strict compliance with the procedural steps. Providing testing aids will help standardize testing and result reporting practices. These may include but are not limited to:
- Preprinted forms or stickers to document POC test results that contain action reminders (e.g., “Glucose values < 50 mg/dL or > 250 mg/dL should be confirmed by the clinical laboratory”, “Testing should not be performed in any patient with a hematocrit less than 25%”)
- Automated reminders pre-programmed into a testing device
- Preprinted stickers for use either on the instrument or in the patient’s chart reminding users of a potential problem (e.g., “Falsely elevated glucose results may be seen in patients receiving parenteral solutions or medications containing maltose, galactose or xylose.”)
- Reminders programmed into the LIS or HIS if POC test results are entered into the systems
Benefits of being a Clinical Consultant:
- A final but equally important role of the Clinical Consultant is assisting when problems in POC testing are encountered. Troubleshooting a POC test that is producing apparently erroneous results can be a challenge even for laboratorians. For end-users, who may have a limited understanding of what may impact a POC result, such troubleshooting may be impossible. Therefore, the Clinical Consultant must be prepared to apply his or her understanding of the methodology employed in each POC test to investigate the cause of erroneous results. Sources of error include:
- User error in performing the test (e.g., sample application, timing of reading)
- User error in interpreting the test result (e.g., inattention to control results, color discrimination problems, incorrect assumptions of what a positive or negative test result looks like)
- Sample problems (e.g., contamination, aged sample, inappropriate sample type, inappropriate collection device)
- Interfering substances (e.g., skin cleansers, IV solutions, medications)
- Patient’s clinical conditions that might impact the test result (e.g., anemia, hypoxemia)
- Reagent and/or device storage conditions (e.g., heat, humidity, sun exposure, expired components)
- Instrument problems (e.g., contaminated, dirty, out-of-control, improper programming)
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- Through the role of the Clinical Consultant, the POC pathologist Laboratory Director establishes himself or herself as a valued member of the care team and an important resource to the clinical staff. It demonstrates the expertise and value that the pathologist can bring to implementing POCT. The relationships that develop through this process can produce positive impacts in other areas of pathologist-clinician interactions. However, this role is best fulfilled in partnership with a POCT Coordinator. The director provides leadership and may make many of these determinations, but the coordinator also has an essential role in providing information and direct support to POCT sites and operators. The most successful POCT program is one in which there is a true partnership between director and coordinator. Best programs also include strong partnerships with clinical and other healthcare colleagues.