• D'Orazio P, Fogh-Andersen N, Okorodudu A, Shipp G, Shirey T, Toffaletti J. Critical care. In: Laboratory medicine practice guidelines: evidence-based practice for point-of-care testing. Washington (DC): National Academy of Clinical Biochemistry (NACB); 2006. p. 30-43. [178 references]

This is the current release of the guideline.

High-acuity disorders/conditions that require life-sustaining care, including:

• Major organ dysfunction
• Severe trauma
• Major surgical wounds
• General anesthesia
• Severe sepsis

Assessment of Therapeutic Effectiveness
Evaluation

Cardiology
Critical Care
Emergency Medicine
Internal Medicine
Pediatrics
Surgery

Advanced Practice Nurses
Allied Health Personnel
Clinical Laboratory Personnel
Emergency Medical Technicians/Paramedics
Health Care Providers
Hospitals
Nurses
Physician Assistants
Physicians

• To examine the application of evidence-based medicine (EBM) to the form of diagnostic testing known as point-of-care testing (POCT)

  Note: For the purpose of this document, POCT is defined as "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). POCT refers to any testing performed outside of the traditional, core or central laboratory."

• To systematically review and synthesize the available evidence on the effectiveness of POCT, with specific focus on outcomes in the areas of:
  1. Patient/health
  2. Operational/management
  3. Economic benefit
• To provide guidelines on the use of point-of-care testing (POCT) of arterial blood gases (PO₂, PCO₂, pH), glucose, lactate, magnesium, cooximetry (O₂ saturation, carboxyhemoglobin [HbCO], methemoglobin [MetHb]), sodium, potassium, chloride, and ionized calcium in critical care

Patients in critical care

Point-of-care testing (POCT) of the following analytes:

1. Arterial blood gases (ABG) in the intensive care unit (ICU), emergency department (ED), and during cardiac surgery (adult and neonatal)
2. Glucose
3. Lactate
4. Oxygen saturation by pulse oximetry
5. Carboxyhemoglobin and methemoglobin
6. Potassium in ED
7. Ionized calcium in ED and ICU

Note: The following point-of-care (POC) tests were considered but not recommended: magnesium testing, electrolyte testing in ICU, ionized calcium testing in operating room.

• Patient outcomes such as mortality and length of hospital or emergency department stay
• Staff satisfaction
• Therapeutic turnaround time (TTAT)
• Economic benefit

Hand-searches of Published Literature (Primary Sources)
Searches of Electronic Databases

For a specific clinical use, pertinent clinical questions were formulated and key search terms were ascertained for the literature search. Searches were conducted through online databases (e.g., PubMed, MEDLINE) and private libraries maintained by members of the focus group. Peer-reviewed articles from private libraries were used in the systemic review only if the citations and abstracts could be found in the online databases. The search strategy started with the general terms (e.g., point-of-care testing, bedside testing) and concluded in specific settings, disease states, and outcomes (e.g., emergency department, blunt trauma, mortality). Method comparison studies that only compared a point-of-care testing (POCT) system to a central laboratory system for analytical performance were excluded from the review.

The 2 clinical questions that the guideline developers sought to address for each analyte and for a given clinical setting, disease state, and outcome measure were:

1. Is there evidence in the peer-reviewed literature that more rapid therapeutic turnaround time (TTAT) of a (analyte) result leads to (outcome) improvement in the (setting) for patients with (disease)?
2. Does POCT of (analyte) for patients with (disease) in the (setting) improve (outcome) when compared to core laboratory testing?

Not stated

Weighting According to a Rating Scheme (Scheme Given)

Levels of Evidence

1. Evidence includes consistent results from well-designed, well-conducted studies in representative populations.
2. Evidence is sufficient to determine effects, but the strength of the evidence is limited by the number, quality, or consistency of the individual studies; generalizability to routine practice; or indirect nature of the evidence.
3. Evidence is insufficient to assess the effects on health outcomes because of limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information.

Review of Published Meta-Analyses
Systematic Review with Evidence Tables

Abstracts identified by the literature searches were reviewed by 2 individuals to determine initial eligibility or ineligibility for full-text review, using Form 1 (Appendix A - see the "Availability of Companion Documents" field). If there was not consensus, then a third individual reviewed the abstract(s). To be included in the full systematic review of the clinical question, articles selected for full text review were examined for at least 1 relevant outcomes measurement. The systematic review consisted of creating evidence tables using Form 2 (Appendix A - see the "Availability of Companion Documents" field) that incorporated the following characteristics:

1. Study design—Prospective or retrospective, randomized, and controlled, patient inclusion/exclusion criteria, blinding, number of subjects, etc.
2. Appropriateness of controls
3. Potential for bias (consecutive or nonconsecutive enrollment)
4. Depth of method description—full-length report or technical brief
5. Clinical application—screening, diagnosis, management
6. Specific key outcomes and how they were measured
7. Conclusions are logically supported

For the assessment of study quality, the general approach to grading evidence developed by the US Preventive Services Task Force was applied (see the "Rating Scheme for the Strength of the Evidence" field). Once that was done, an assessment of study quality was performed, looking at the individual and aggregate data at 3 different levels using Forms 3 and 4 (Appendix A - see the "Availability of Companion Documents" field). At the first level, the individual study design was evaluated, as well as internal and external validity. Internal validity is the degree to which the study provides valid evidence for the populations and setting in which it was conducted. External validity is the extent to which the evidence is relevant and can be generalized to populations and conditions of other patient populations and point-of-care testing (POCT) settings.

The synthesis of the volume of literature constitutes the second level, Form 5 (Appendix A - see the "Availability of Companion Documents" field). Aggregate internal and external validity was evaluated, as well as the coherence/consistency of the body of data. How well does the evidence fit together in an understandable model of how POCT leads to improved clinical outcome? Ultimately, the weight of the evidence about the linkage of POCT to outcomes is determined by assessing the degree to which the various bodies of evidence (linkages) "fit" together. To what degree is the testing in the same population and condition in the various linkages? Is the evidence that connects POCT to outcome direct or indirect? Evidence is direct when a single linkage exists but is indirect when multiple linkages are required to reach the same conclusion.

Expert Consensus

The field of point-of-care testing (POCT), diagnostic testing conducted close to the site of patient care, was divided into disease- and test-specific focus areas. Groups of expert physicians, laboratorians, and diagnostic manufacturers in each focus area were assembled to conduct systematic reviews of the scientific literature and prepare guidelines based on the strength of scientific evidence linking the use of POCT to patient outcome.

Final guidelines were made according to Agency for Healthcare Research and Quality (AHRQ) classification (see the Rating Scheme for the Strength of the Recommendations field). The guidelines are evidence based and require scientific evidence that the recipients of POCT experience better health outcomes than those who did not and that the benefits are large enough to outweigh the risks. Consensus documents are not research evidence and represent guidelines for clinical practice, and inclusion of consensus documents was based on the linkages to outcomes, the reputation of the peer organization, and the consensus process used to develop the document. Health outcomes, e.g., benefit/harm, are the most significant outcomes in weighing the evidence and drafting guidelines.

Strength of Recommendations

A - The National Academy of Clinical Biochemistry (NACB) strongly recommends adoption; there is good evidence that it improves important health outcomes and concludes that benefits substantially outweigh harms.

B - The NACB recommends adoption; there is at least fair evidence that it improves important health outcomes and concludes that benefits outweigh harms.

C - The NACB recommends against adoption; there is evidence that it is ineffective or that harms outweigh benefits.

I - The NACB concludes that the evidence is insufficient to make recommendations; evidence that it is effective is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.

The guideline developers reviewed published cost analyses. With decision analysis methods, 3 models of postoperative point-of-care (POC) blood gas testing for coronary artery bypass graft (CABG) patients were developed and evaluated for economic value. These were (1) a STAT laboratory in a large tertiary-care medical center with 15-min turn-around-time (TAT); (2) STAT testing in a central laboratory of a large community hospital with a 30-min TAT; and (3) STAT testing in a central laboratory of a medium-large community hospital with a 45-min TAT. The cost savings related to faster TAT were primarily due to fewer adverse events or earlier detection of these adverse events. Some adverse clinical events benefited greatly by faster TAT (ventricular arrhythmias and cardiac arrests), whereas others were relatively independent of TAT (postoperative bleeding and iatrogenic anemia). This study used clinical experts to define probabilities of adverse events leading to a mathematical analysis instead of a prospective clinical study.

Although blood gas testing was a small part of the testing evaluated, one report describes the process, the economics, the attitudes, and the clinical and economic benefits of implementing POC testing in a large medical center that previously had a variety of STAT-type laboratories. Although considerable cost savings ($392,000 per year) were reported, the majority of these were in labor savings ($495,000 per year), which more than made up for the otherwise increased cost ($145,000 per year) of POCT. POCT is especially cost-effective when it allows closure of a pre-POCT laboratory that is extremely inefficient, as one described here that averaged less than 1 test/day per full-time equivalent (FTE) (5.0 FTEs worked in this laboratory).

Peer Review

The guidelines were presented in open forum at the American Association for Clinical Chemistry (AACC) Annual Meeting (Los Angeles, CA, USA) in July 2004. Portions of these guidelines were also presented at several meetings between 2003 and 2005. Participants at each meeting had the ability to discuss the merits of the guidelines and submit comments to the National Academy of Clinical Biochemistry (NACB) Web site for formal response by the NACB during the open comment period from January 2004 through October 2005.

None provided

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

It is hoped that these guidelines will be useful for those implementing new testing, as well as those reviewing the basis of current practice. These guidelines should help sort fact from conjecture when testing is applied to different patient populations and establish proven applications from off-label and alternative uses of point-of-care testing (POCT). These guidelines will also be useful in defining mechanisms for optimizing patient outcome and identify areas lacking in the current literature that are needed for future research.

Not stated

• The material in this monograph represents the opinions of the editors and does not represent the official position of the National Academy of Clinical Biochemistry or any of the cosponsoring organizations.
• Point-of-care testing (POCT) is an expanding delivery option because of increased pressure for faster results. However, POCT should not be used as a core laboratory replacement in all patient populations without consideration of the test limitations and evaluation of the effect of a faster result on patient care.

An implementation strategy was not provided.

Getting Better

Effectiveness
Timeliness

• D'Orazio P, Fogh-Andersen N, Okorodudu A, Shipp G, Shirey T, Toffaletti J. Critical care. In: Laboratory medicine practice guidelines: evidence-based practice for point-of-care testing. Washington (DC): National Academy of Clinical Biochemistry (NACB); 2006. p. 30-43. [178 references]

Not applicable: The guideline was not adapted from another source.

2006

National Academy of Clinical Biochemistry - Professional Association

National Academy of Clinical Biochemistry

Guidelines Committee

Committee Members: Robert H. Christenson, Ph.D., FACB, University of Maryland School of Medicine, Baltimore, Maryland, USA; William Clarke, Ph.D., Johns Hopkins Medical Institutions, Baltimore, Maryland, USA; Ann Gronowski, Ph.D., FACB, Washington University, St. Louis, Missouri, USA; Catherine A. Hammett-Stabler, Ph.D., FACB, University of North Carolina Chapel Hill, Chapel Hill, North Carolina, USA; Ellis Jacobs, Ph.D., FACB, New York State Department of Health, Albany, New York, USA; Steve Kazmierczak, Ph.D., FACB, Oregon Health and Science University, Portland, Oregon, USA; Kent Lewandrowski, M.D., Massachusetts General Hospital, Boston, Massachusetts, USA; Christopher Price, Ph.D., FACB, University of Oxford, Oxford, UK; David Sacks, M.D., FACB, Brigham and Women's Hospital, Boston, Massachusetts, USA; Robert Sautter, Ph.D., Carolinas Medical Center, Charlotte, North Carolina, USA; Greg Shipp, M.D., Nanosphere, Northbrook, Illinois, USA; Lori Sokoll, Ph.D., FACB, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA; Ian Watson, Ph.D., FACB, University Hospital Aintree, Liverpool, UK; William Winter, M.D., FACB, University of Florida, Gainesville, Florida, USA; Marcia L. Zucker, Ph.D., FACB, International Technidyne Corporation (ITC), Edison, New Jersey, USA

Not stated

This is the current release of the guideline.

None available

This NGC summary was completed by ECRI Institute on August 10, 2007. The information was verified by the guideline developer on September 24, 2007.

National Academy of Clinical Biochemistry's (NACB) terms for reproduction of guidelines are posted with each set of guidelines.