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CAP Home > CAP Committees and Leadership > Point of Care Testing Topic Center > Pathologist as Technical Consultant > Pathologist as Technical Consultant: Selection of Appropriate Test Methods
 
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Point of Care Testing Toolkit
 
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  • Give us your feedback on this sectionPathologist as Technical Consultant:
    Selection of Appropriate Test Methods

    1. Considerations pertaining to test selection are also addressed in the Laboratory Director and Clinical Consultant sections. What follows is a more detailed approach to considering and selecting a POCT test and methodology from a Technical Consultant perspective.
    2. Process change
      1. The process of selecting an appropriate POCT method is similar to selection of central laboratory methods or instrumentation. One needs to consider clinical, financial, and operational needs, along with expected outcomes, in order to select the POCT method that best fits those needs.
      2. To obtain the maximal benefit from the use of the POCT, it is absolutely vital that implementation of POCT be accompanied by process changes. The POC test should answer a clinical question that can lead to a decision to change treatment and assess outcome of the intervention in a shorter time frame than if the test were performed in the central laboratory. Alternatively, having POCT may improve patient disposition and workflows that make the health system more cost effective and improve patient or provider satisfaction. If these are not the case, then that test is probably not needed at the POC.
      3. Even with potential outcome or process changes, POCT may also not be indicated if the physical site cannot accommodate it, there is not sufficient staff, the technology is not appropriate (i.e., greater accuracy or analytic sensitivity is required for clinical decision-making than is available with current POC technologies), there will not be adequate oversight, operating staff rejects the responsibility, or the cost is too great.
      4. There are very few POC tests that do not have a laboratory counterpart that is almost universally less expensive (i.e., reagent costs) and has better performance characteristics (i.e., accuracy and precision) than the POC test. Sometimes central laboratory processes can be changed so that better turnaround times or service levels are achieved and POCT may not be needed, especially in some hospital settings. Alternatively a patient care site may re-evaluate its work processes to see if patient visit schedules or specimen transport can be changed so that tests can be run and resulted from the central laboratory in time for care decisions or patient disposition. This may relieve the patient care site from having to manage POCT but still achieve desired outcomes. Even if POCT is indicated, there is little purpose to its implementation unless process improvements are targeted. Those improvements can be grouped as medical, resource, operational or financial outcomes.(1)
    3. Prioritizing and reassessing needs
      1. The feasibility and impact of POCT varies from institution to institution. What works at one facility may not be possible or valuable at another.
      2. It is equally important to keep an open mind to the potential for POCT. A historical failure of POCT rarely means that POCT cannot be implemented. Changes in POCT technology, institutional processes, and clinical needs such as patient volumes and acuity may justify reassessing the viability of a specific POC test.(1)
      3. Similarly, the local culture, motivation, or leadership may change and with that, the need to reassess POCT. A common scenario is a request for POC test to support a discrete clinical pathway (i.e., POC for lactate as part of a sepsis bundle) even when POCT may have been tried and found not valuable previously. In these instances the evidence and institutional support behind the clinical protocol should be weighed more heavily than a previous failure for POCT in a similar situation.
    4. The flowing is a systematic checklist of considerations for selecting specific POCT options.
      1. What are the benefits of the requested POCT?
        1. Improve patient treatment and outcomes by shorter turnaround times? Improve patient throughput and disposition?
        2. Improve patient or provider satisfaction?
        3. Allow new treatment services or regimens?
        4. Improve work-flow and logistics?
        5. Financial considerations?
      2. How will the test be used and what is the accuracy needed?
        1. For making diagnoses?
        2. Screening?
        3. Trending or monitoring?
        4. Are different levels of performance/accuracy sufficient at the POC for this test?
      3. What is the patient population served and are there special needs or considerations for that population?
        1. Adults?
        2. Pediatrics?
        3. Is the test approved for each population?
        4. Different disease prevalence and sensitivity issues?
        5. Specimen requirements or limitations?
      4. Can the central laboratory improve services to provide the need or is POCT the best alternative?
      5. What test methodologies, kits, or devices are available?
        1. Are they sufficiently accurate and reliable for the need?
        2. Are the vendors reliable, able to meet user site needs?
        3. Are there performance comparison reports for test systems?
        4. Are limitations or sources of error known for the systems?
      6. Are the test systems of the right complexity level for the site?
        1. Waived versus non-waived?
        2. Are there qualified personnel at the site?
        3. Oversight and organization required?
      7. Are there exclusions or obstacles for performing the test at the site or for the patient population?
        1. Staffing, physical limitations, etc?
        2. Are the test options convenient and user friendly for the site to perform?
        3. Staff training requirements and learning curve?
        4. Receptive versus resistant operator staff?
        5. Who is requesting the test?
        6. Is there uniform site agreement that the test should be performed at the POC?
      8. Does the test system have special physical requirements?
        1. Testing space, ventilation, temperature control, utilities, storage space, infection control, etc?
        2. Can these be accommodated?
      9. What are projected test volumes?
        1. Are these realistic?
        2. Expected to increase?
        3. Will the POC testing affect central laboratory volumes?
        4. Are volumes time related?
        5. What will be maximum or peak testing capacity or through put required of a device/system/and staff?
      10. How many devices, etc. are needed per site?
      11. What are reagent, supply, and other consumables required?
        1. Who will purchase or supply them? Budgeted to whom? Storage and environmental conditions suitable?
        2. Safety issues?
      12. Connectivity considerations?
        1. Device and site capabilities?
        2. Include results in medical record electronically?
        3. Does information technology (IT) staff need to be involved in selection and implementation?
      13. Costs and revenues examined?
        1. Cost/test, cost/billable or reportable?
        2. Higher unit costs compensated by better outcomes, through put, etc?
        3. All costs considered, to include reagents, consumables, quality control, proficiency testing, IT, etc.?
        4. Who bears costs and who records revenues, (i.e., the central laboratory or testing site)?
        5. Billing codes available?
        6. Reimbursement?
        7. Capacity to bill?
      14. Projected outcomes defined?
        1. Metrics or capacity to track these?
        2. Reporting and accountability?
        3. System in place to modify the testing process, etc. to achieve or re-visit goals?
      15. Oversight, performance, and regulatory responsibility?
        1. Central laboratory
        2. POC site
        3. Quality plan
        4. Safety issues
    5. Identifying potential POCT options
      1. A number of resources can be used to assist in the identification of potential POCT systems. Examples include:
        1. laboratory periodicals and buyer’s guides
        2. medical alert websites that list complaints, field corrective actions, and potential adverse events
        3. vendor websites
        4. external quality assessment (i.e., proficiency testing) performance reports
        5. peer-reviewed literature
        6. regulatory and accrediting body websites
        7. online product searches
        8. professional trade shows
        9. local vendor fairs
        10. peers, colleagues, or ListServs
    6. Assessment Grid: The Request for Proposal (RFP)
      1. An assessment grid outlines all the technical and performance characteristics of potential devices or kits.
      2. The information to consider can be extensive. A formal RFP can be initiated. The RFP includes a list of those requirements identified when completing the assessment grid.(1)
      3. To use the grid, minimal performance acceptance criteria should be established before different POC methods or equipment are compared. These minimal performance criteria should be based upon both manufacturers’ stated performance claims and intended use of the device.
        1. For example, if a POC lactate method will be used in a sepsis bundle with a cut-off of 4 mM (lactate values above 4 mM trigger further clinical actions and follow-up), and the manufacturer’s stated performance criteria indicate that the POC method matches reference methods within 20% but only up to lactate values of 2-3 mM, then the user may question whether the technology will be appropriate for the intended use.
      4. The following are two tools developed by the CLSI
        1. Assessment Grid
        2. Clinical Needs Assessment Tool

    Items to Consider When Comparing Point-of-Care Testing System Specifications

    These items may also be considered when soliciting vendors for contract/bidding information.

    Criteria

    POCT A

    POCT B

    POCT C

    System Name

     

     

     

    Ease of Use

     

     

     

    Operator training required

     

     

     

    Complexity rating

     

     

     

    Device Description/Physical Features

     

     

     

    Instrument dimensions (height × length × width)

     

     

     

    Instrument weight

     

     

     

    Power requirements

     

     

     

    Start-up/warm-up considerations

     

     

     

    Other utilities (air/vacuum)

     

     

     

    Maintenance requirements

     

     

     

    Environmental requirements

     

     

     

    Network/computer connectivity

     

     

     

    System Performance Characteristics

     

     

     

    Analytes that can be tested by this system

     

     

     

    Clinical sensitivity for each analyte (from regulatory submission/package insert)

     

     

     

    Clinical specificity for each analyte (from regulatory submission/package insert)

     

     

     

    Analytical sensitivity for each analyte (from regulatory submission/package insert)

     

     

     

    Analytical specificity for each analyte (from regulatory submission/package insert)

     

     

     

    Cross-reacting analytes

     

     

     

    Interfering substances

     

     

     

    Storage requirements

     

     

     

    Analytical accuracy for each analyte

     

     

     

    Analytical precision (within-run) for each analyte

     

     

     

    Analytical precision (between-run) for each analyte

     

     

     

    Analytical range for each analyte

     

     

     

    Throughput or turnaround time

     

     

     

    System Calibration and Quality Control

     

     

     

    Instrument calibration frequency

     

     

     

    Reagent calibration frequency

     

     

     

    Calibration mode(s): automatic or manual

     

     

     

    Instrument internal Staff Training

     

     

     

    Reagent internal quality control

     

     

     

    Software/Firmware Features

     

     

     

    Operator ID entry

     

     

     

    Patient ID entry

     

     

     

    Ability to enter patient demographic information

     

     

     

    Time/date

     

     

     

    Result presentation (qualitative/quantitative)

     

     

     

    Result recording (printed/electronic/display)

     

     

     

    LIS connectivity

     

     

     

    Onboard data storage (patient/QC/EQA [proficiency testing]), including storage capacity

     

     

     

    Operator security levels

     

     

     

    QC lockout

     

     

     

    Reagent expiration lockout

     

     

     

    Clinical Needs Assessment Comparison Worksheet


    Name of Diagnostic Test:______________Existing Service or New (circle one)

     

    Current
    Service

    POCT
    Option #1

    POCT
    Option #2

    Manufacturer-Supplied Information

     

     

     

    Name of test

     

     

     

    Manufacturer

     

     

     

    Address

     

     

     

    Contact numbers

     

     

     

    Support services

    • Installation
    • User training
    • Maintenance
    • Service

     

     

     

    Patient safety history
     a. Medical device reporting search
     b. Recalls/Withdrawals/Safety Alerts

     

     

     

    Test Use Characteristics

     

     

     

    Number of tests performed per month (current)

     

     

     

    Number of tests performed per month (expected)

     

     

     

    Technology proven and robust?

     

     

     

    Technology new and innovative?

     

     

     

    Patient Demographics

     

     

     

    Patient population expected to benefit from POCT

     

     

     

    Is population listed in device Intended Use? (Y/N)

     

     

     

    Expected increase or decrease in incidence of disease

     

     

     

    New treatment regimens or therapies on horizon (Y/N)

     

     

     

    New competing technologies on horizon (Y/N)

     

     

     

    Urgency of result availability and perceived benefit of improved turnaround time

     

     

     

    Impact on Clinical Benefit or Medical Outcomes Expected

     

     

     

    Application of test SC = Screening;
    TR = Triage; or TH = Therapeutic Monitoring

     

     

     

    Fewer visits? (Y/N) Quantity

     

     

     

    Fewer call-backs? (Y/N) Quantity

     

     

     

    Shorter length of stay? (Y/N) Quantity

     

     

     

    Decreased mortality? (Y/N) Quantity

     

     

     

    Decreased morbidity? (Y/N) Quantity

     

     

     

    Lower readmission rate? (Y/N) Quantity

     

     

     

    Increased clinician/patient satisfaction? (Y/N)

     

     

     

    Improvements in workflow/turnaround time? (Y/N) Quantity

     

     

     

    Lower readmission rate? (Y/N) Quantity

     

     

     

    Improved compliance with therapies? (Y/N) Quantity

     

     

     

    Reduced risk of toxicity to therapies? (Y/N) Quantity

     

     

     

    Improved patient quality of life expected? (Y/N) Explain.

     

     

     

    POCT committee summary assessment of clinical needs: _________________________

    POCT committee recommendation: __________________________________________

      1. POCT cost analysis:
        1. Although an assessment of the value of POCT to the institution (increased patient throughput, cost avoidance due to delay in therapy or instituting inappropriate therapies, etc.) is an essential function for a pathologist as a Laboratory Director, as the Technical Consultant, the pathologist also plays a central role in this process. Based on knowledge gained in the evaluation and selection process, the Technical Consultant is the individual best situated to estimate the overall cost of implementing a proposed POC test.
        2. Decisions on whether or not to adopt POCT should not be based on cost alone, but understanding the costs associated with POCT is important. In general, due to economies of scale, cost of testing supplies, etc. POCT is often more costly than performing the testing in a central laboratory. Therefore, in order to have a positive impact on the institution, the perceived benefits of POCT should offset any difference between POCT and central laboratory testing costs. While a formal cost/benefit analysis may be impractical or impossible to perform prior to making the decision to implement POCT, understanding the magnitude of the costs involved is essential to making a well-informed decision.
        3. This tool may help to assess the overall costs involved in bringing in a new POC test. (Word, 78 KB)

    See Tools section for POC references

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