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 Point of Care Testing Toolkit

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Point of Care Testing Toolkit

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  • Introduction & Definitions
  • Advantages & Disadvantages
  • History
  • Current & Projected Technology
  • References
  • Tools
  • Toolkit Authors
  •  
  • Pathologist Roles
  • Pathologist as Laboratory Director
  • Pathologist as Clinical Consultant
  • Pathologist’s Regulatory Role
  • Pathologist as Technical Consultant
  • Give us your feedback on this sectionIntroduction

    Worldwide, one of the fastest growing aspects of clinical laboratory testing is point of care testing (POCT), estimated to be increasing at least 10-12% per year overall and upwards to 30% per year in some testing areas. In contrast, central laboratory testing has grown approximately 6-7% annually.

    When first widely introduced, POCT was largely for home use or physician office laboratory (POL) testing. In hospitals, it was considered as supplementary to central laboratory testing. It was not generally regarded as a primary responsibility of centralized pathology services and was often treated by central hospital laboratories with indifference, benign neglect, or frank hostility, and considered as substandard or second tier testing that was unmanageable. Some laboratorians considered POCT to be a potentially disruptive competitor to their services. POCT was also an added responsibility that many laboratories or nursing services found difficult to assume. The attitude of POCT as an inferior stepchild or orphan testing has changed with government regulations, the growth of the technology, an expanding perspective and spectrum of healthcare services, and different expectations from healthcare providers and consumers. Decentralized patient care and access to testing in under-served areas are key elements in the evolving expansion of POCT.

    POCT continues to mature both as a technology and in the eyes of healthcare providers, laboratorians, regulators, administrators, and vendors. While the technology has become more varied and robust and performance has improved, the various groups associated with POCT have grown more realistic and demanding about its potential. No longer does the Everest theory prevail — just because it exists does not mean POCT should be used in all situations. The need for comparability with central laboratory testing, efficacy, operational device and kit fail-safes, management and oversight requirements, operator performance standards, economic indicators, and patient outcome data are all now considerations when deciding whether to employ POCT in specific situations.

    POCT is increasingly being seen as a testing modality with performance expectations similar to traditional laboratory testing and requiring the same high standards. Rather than inferior testing or a nuisance, it is increasingly seen as a complementary or alternate type of testing that meets specific care needs and is an integrated part of clinical laboratory services, either; under the formal direction of the central laboratory or with consultation or guidance by laboratory services. POCT should be considered as a part of the continuum of the clinical laboratory’s contribution to healthcare and a fundamental responsibility of laboratory services. It needs to be regarded with the same expectations of quality involving the total testing process, covering the pre-, intra-, and post-analytic phases of testing. As healthcare reform changes the perspective from fee for service to the optimization of over all patient care, POCT can be a critical factor in streamlining and improving laboratory services.

    The Laboratory Director is a mandated and fundamental position required for any clinical laboratory to function. As POCT is now frequently a component of laboratory services, it is essential that pathologist Laboratory Directors see it as their responsibility to be actively involved in all aspects of POCT.

    This Tool Kit for Laboratory Directors of POCT testing has been developed by the CAP POCT Resource Committee as a service to CAP members and the laboratory community. It is intended to be a resource for any pathologist who wants to learn about POCT or who has responsibility to guide or direct POCT. It may be used by pathology residents, pathologists who have been long- time directors of POCT programs, or by pathologists who have been recently assigned to lead POCT programs. Pathologists may also use the Tool Kit to guide other members of their POCT teams. We hope that this Tool Kit encourages more active and effective pathologist involvement in POCT and also serves as a useful resource for those who are already active advocates and leaders in POCT. We see POCT as a prime opportunity for pathologists to truly be “transformational” members of the health care team, demonstrating pathology’s rich value in promoting and ensuring quality laboratory testing, whether it is from a central or decentralized site.

    We recognize that this Tool Kit is heavily weighted toward the perspective and experience in the United States. References to international experiences and priorities are included and over time it is the intention to expand that perspective. Clearly, international needs drive the expansion of POCT and will probably influence its use in the United States.

    As a web based resource, the Tool Kit is meant to be a living document. This “second edition” of the Tool Kit and much of the material is an orientation to POCT. It will be actively augmented and edited over time to remain current and focused on practical contents. Some sections are brief now but will be expanded, e.g. POCT technology, a broad and rapidly evolving discipline. Additional “tools” will be continually added and updated. This second edition has been re-formatted as an outline format to make the text less dense and key points more accessible. Readers are urged to provide feedback on this format and whether it makes the Tool Kit easier to use.

    The POCT Resource Committee hopes that find the Tool Kit to be a rich and useful resource. We also hope that will offer comments, suggestions, case materials, and questions to keep the document a vital tool. It is our hope that the tools and perspective of this Tool Kit will reflect the best practices and experiences of the CAP membership that is most involved in POCT. The website will instruct on how to participate in this feedback and contribute insights and materials.

    Reflecting the essential collaborative nature of POCT, this Tool Kit is also a collaborative venture. The CAP POCT Resource Committee is a multidisciplinary group with membership across all specialties of pathology, representatives from industry and other major laboratory organizations, nurse, technologist, and physician administrator membership. The Tool Kit has all these voices as authors, so the document reflects different perspectives and has different tones. It also is necessarily redundant, because the same considerations need to be reflected in different aspects of POCT. As a web-based document, the reader can access different parts of the document as needed, but some basic information may be repeated. Finally, the Clinical Laboratory Improvement Amendments of 1988 (CLIA88) categories of leadership and responsibilities have much overlap.

    The Tool Kit is organized in sections to give a general orientation to POCT and then, using the United States’ CLIA88 framework, it follows the roles and responsibilities of a Laboratory Director for POCT. In depth discussion of specific functions, e.g. test selection and competency assessment, can be accessed as needed in applicable sections.

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    Give us your feedback on this sectionA. Definition of POCT

    To fully understand and appreciate POCT, it is necessary to understand its breadth, encompassing varied sites, uses and technical options.

    Note: Although some definitions of POCT include devices such as portable ultrasound, nerve conduction stimulators, etc., this Tool Kit will limit the discussion to laboratory tests inherent in the CLIA ’88 definition of a laboratory, e.g. “performed on material derived from the human body”, rather than on the body itself. http://edocket.access.gpo.gov/cfr_2009/octqtr/42cfr493.2.htm

    1. POCT is referred to by many different terms. Each may specify an aspect of the more general POCT term. Alternate terms for POCT include:
      1. Bedside testing
      2. Near-patient testing
      3. Ancillary testing
      4. Satellite testing
      5. Remote testing
      6. Physician’s office laboratory (POL) testing
      7. Patient self-management


    2. POCT has several definitions based on geographical, functional, technological, or operational context:
      1. Geographical context– where the test is conducted (outside of the main or core laboratory)
        1. Hospitals (ED, OR, ICU, neonatal care, etc.)
        2. Ambulatory care settings (clinics, physician office laboratories, rural clinics, student health clinics)
        3. Health fairs
        4. Pharmacies
        5. Prisons
        6. Military operations
        7. Visiting nurses
        8. Nursing homes
        9. Patient self-management
        10. Disaster and medical relief
        11. Remote clinics, under developed sites or countries
        12. Transport vehicles (ambulances, helicopters, trains, cruise ships, airliners)
        13. Mobile health vans – blood mobiles, clinics, public events
        14. Corporate healthcare operations
        15. Definitions based on location include:
          1. The analysis of clinical specimens as close as possible to the patient, including bedside, patient care unit or stat response labs that service specified areas- e.g. the “ER or ICU”.1
          2. Laboratory and other services provided to patients at the bedside. POCT is defined as tests designed to be used at or near the site where the patient is located, that do not require permanent dedicated space, and that are performed outside the physical facilities of the clinical laboratories. Examples include kits and instruments that are hand carried or otherwise transported to the vicinity of the patient for immediate testing at that site (e.g., capillary blood glucose) or analytic instruments that are temporarily brought to a patient care location (e.g., operating room, intensive care unit). POCT does NOT include limited service satellite laboratories with fixed dedicated testing space.3


      2. Functional context– rapid or fast turnaround of test results which are readily accessible for patient care;
        1. POCT is defined as diagnostic testing at or near the site of patient care.4 The driving notion behind POCT is to bring the test conveniently and immediately to the patient. This increases the likelihood that the patient will receive the results in a timely manner
        2. Near patient testing is defined as any investigation carried out in a clinical setting or the patient's home for which the result is available without reference to a laboratory and perhaps rapidly enough to affect immediate patient management.5
        3. Rapid test turnaround times (TATs) and access to results are assumed to improve patient care and healthcare delivery. Sometimes the central laboratory may assume a POC function and produce very rapid turnaround times but more frequently testing at the point of care produces an overall shorter TAT.


      3. Technologic context– testing is usually, but not always, conducted with small, portable devices or manual kits. POCT is accomplished through the use of transportable, portable, and handheld instruments (e.g., blood glucose meter,) and test kits (e.g., HIV salivary assay). Cheaper, smaller, faster, and smarter POCT devices have increased the use of POCT approaches by making it cost-effective for many diseases, such as diabetes and acute coronary syndrome
        1. POCT may be performed on platforms that are also found in central laboratories. These are usually small to midsized instruments amenable to be transported to the patient’s location
        2. Conversely, the central laboratory may use small POCT devices when these make sense for the volume or type of testing a laboratory provides.


      4. Operational context– usually performed by non-laboratory personnel who may include:
        1. Nurses
        2. Physicians
        3. Emergency medical technicians
        4. Medical office assistants
        5. Pharmacists
        6. Medics
        7. Patients (self-testing)
        8. Definition of POCT based on testing personnel:
          1. Clinical laboratory testing conducted close to the site of patient care, typically by clinical personnel whose primary training is not in the clinical laboratory sciences or by patients (self-testing). http://www.aacc.org/SiteCollectionDocuments/NACB/LMPG/
            POCTLMPG.pdf
            6,7
          2. POCT may be performed by laboratory staff who work in POLs, small decentralized laboratories, clinics, or other non-central laboratory sites


      5. POCT is a dynamic discipline. With the evolution of technology and changing medical needs, sites, and operators, the definition and spectrum of POCT is expected to change over time.

    REFERENCES

    1. McGraw-Hill Concise Dictionary of Modern Medicine. 2002. McGraw-Hill Companies, Inc.
    2. United States National Library of Medicine. Medical Subject Headings. Point of care systems. 2009 MeSH.
    3. Commission on Laboratory Accreditation, Laboratory Accreditation Program. Point-of-Care Testing Checklist. June 15, 2009. College of American Pathologists.
    4. Kost GJ. Goals, guidelines and principles for point-of-care testing. In: Kost GJ, ed. Principles and practice of point-of-care testing. Philadelphia: Lippincott Williams and Wilkins. 2002, Chapter 1, pp3-12.
    5. Delaney BC, Hyde CJ, McManus RJ, Wilson S, Fitzmaurice DA, Jowett S, Tobias R, Thorpe GH, Hobbs FDR. Systematic review of near patient test evaluations in primary care. BMJ 1999;319:824-827.
    6. National Academy of Clinical Biochemistry. Laboratory Medicine Practice Guidelines: Evidence-Based Practice for Point-of-Care Testing. (Nichols JH, editor) 2007. Washington, DC. AACC Press. 187 pgs.
    7. Nichols JH, Christenson RH, Clarke W, Gronowski A, Hammett-Stabler CA, Jacobs E, et. al. Executive summary: The National Academy of Clinical Biochemistry laboratory medicine practice guideline: Evidence-based practice for point-of-care testing. Clin Chem Acta 2007;379:14-28.
    8. Nichols JH, Kickler TS, Dyer KL, Humbertson SK, Cooper PC, Maughan WL, Oechsle DG. Clinical outcomes of point-of-care testing in the interventional radiology and invasive cardiology setting. Clin Chem 2000;46(4):543-50.
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