Point-of-care tests produce rapid, reliable results that aid in identification and monitoring of acute infections or chronic disease. Point-of-care connectivity; Approved standard. Patient results must be recorded in the medical record and associated with a physician order for billing and insurance compliance. This validation is especially important for POCT sites where multiple operators with varying levels of education and experience are performing POCT analysis. Glucose (92, 122): Multiple studies have conclusively demonstrated that improved glycemic control in the inpatient population decreases morbidity and improves outcome, provided that the glycemic threshold is not too low (140180 mg/dL); however, the data in those studies are CL based. J Pathol Inform 2011;2:22. Electrical requirements: None, battery, or line power. With data management, this kind of abuse will be caught during chart and database audits (68). The membership of the interdisciplinary POCT committee should include representation from all the stakeholders, including but may not be limited to the following: director of POCT, POCT manager, POCT coordinator, physicians (typically from emergency medicine, critical care medicine, and/or family medicine), nurses, nurse practitioners, nurse manager, infection prevention/control/public health, supply chain, risk management consultant, information technology, and clinical/biomedical engineering. 2 days of "and the lord heard me - i have my answers" || nsppd || 6th july 2023 Was the impact of POCT compared against comparable central lab processes with respect to specific patient populations and disease states to see if patient care improved in terms of, outcome, prognosis, morbidity or mortality. Executive summary. Clin Chim Acta 2001;307:15968. Science & Research Clin Chem 2016;62:147481. Many home use devices include software capabilities enabling patients to share important health information with health care providers using a computer. Point-of-care testing ( POCT ), also called near-patient testing or bedside testing, is defined as medical diagnostic testing at or near the point of care that is, at the time and place of patient care. Use of POCT in an Emergency Department triage documented a reduction in turnaround time for test results (26.5 min for POCT compared to 83 min for laboratory cardiac marker testing) that allowed a faster rule-in/rule-out strategy for patients with suspected acute myocardial infarction and negative electrocardiogram (78). Ideally oversight of a POCT program should be provided by individuals with experience in clinical laboratory sciences and quality management. Training: The extent of training depends upon the complexity of the system. Point of care technology or standard laboratory service in an emergency department: is there a difference in time to action? Economic impact of a new rapid PCR assay for detecting influenza virus in an emergency department and hospitalized patients. Diagnosing heart failure with NT-proBNP point-of-care testing: lower costs and better outcomes. Experience from the EXCEL throat culture module. Department of Health | Definitions - Point-of-care testing In this group, 202 individuals tested positive for influenza. This included comprehensive programs in education, training, quality assurance, and ongoing management support. Emory University School of Medicine Point-of-care testing (POCT): Current techniques and future collected, please refer to our Privacy Policy. Standard Operating Procedures Clinical and Translational Research Center Purpose: This procedure defines guidelines for Point of Care Testing (POCT) Point of Care Testing refers to those analytical patient testing activities provided under the clinical laboratory's CLIA certificate, but performed outside the physical . Nichols, The Journal of Applied Laboratory Medicine, AACC; D. Alter, College of American Pathologists; T.S. Choice of glucose meter was found to be the most important variable required for good EQA performance (54). PLoS One 2016;11:e0146620. Reconciliation rates increased from 20.2% in the second month post implementation of a POCT management system to 48.6% by the 13th month post POCT implementation (70). Despite the growing role of POCT, there have been only a few studies that have been able to assess the impact of operator training and ongoing competency on test performance (12, 2123); however, there are several studies that assess POCT test performance via multiple simultaneous interventions, of which operator education and training is one component (14, 16, 17, 24). Point of Care Research (POC-R) - Veterans Affairs Point-of-Care Ultrasound: A Practical Guide for Primary Care Through a more critical review of POCT data, operational errors of nursing staff emerged, indicating the need to enhance the awareness of POCT operators to preanalytic variables (33). POCT was able to improve outcome by stratifying patients requiring, and not requiring, transfer for sophisticated cardiac care. Does it have QC lockout, preventing test performance if QC has not been successfully performed within the prescribed time frame? In general, these imaging modalities are used by specialists in radiology and pathology; however, there exists a more general need for all physicians and health care providers the world over to visualize tissue, cells, and molecules to aid in diagnosis at the point of care (PoC) or to guide surgical and medical procedures at the point of . Arch Pathol Lab Med 2010;134:7518. CLSI guideline POCT09-A-selection criteria for point-of-care testing devices; approved guideline. Barriers to hospital-based clinical adoption of point-of-care testing (POCT): a systematic narrative review. For example, a recent survey of 42 family physicians, resident family physicians, and nurse practitioners in the United States identified hemoglobin A1c for diabetes and HIV, and gonococcus/chlamydia for sexually transmitted infections (STIs) as the most desired POCTs (8). Patients were given therapeutic interventions such as leg ulcer dressings while being monitored for PT/INR and electrolytes coordinated with a lab information system. (See related publication GP21-A.) Analysis of common failures suggest that investigation of the pathway for testing could reduce unexplained failures and correct sources for the failure (53). Future studies are required to identify the ideal number of POC management personnel needed relative to the scope of the POCT program (POC test menu, number of devices, number of operators). What is the value of an interdisciplinary committee to oversee POCT? Amniotic Fluid Testing Using Amniotest Swabs. Seven Q-Tracks monitors of laboratory quality drive general performance improvement: experience from the College of American Pathologists Q-Tracks program 19992011. [108] Jang J Y, Shin S D, Lee E J, Park C B, Song K J, Singer A J. Am J Clin Pathol 2008;129:796801. Lab Med 2008;39:5603. Reduction of antibiotic prescriptions for acute respiratory tract infections in primary care: a systematic review. Explore fellowships, residencies, internships and other educational opportunities. Acad Emerg Med 2012;19:52534. In one study, use of POCT cardiac markers as part of remote risk stratification reduced 30-day mortality by better determination of which patients should be transferred to tertiary care centers for invasive treatment. Management of data is thus an integral part of the delivery of POCT. Failures noted on the linearity survey forewarn of linear range and calibration problems before they are experienced with PT failures, allowing time to make appropriate corrections before the next PT challenge (58). Patient data may be printed out on paper strips and results manually transcribed in case notes (with a 6% error rate). POCUS: definition, examples and benefits | Philips While data management does not directly improve patient outcomes, data management provides the tool to collect information that allows clinicians to better manage their patients, and this subsequently helps to improve patient care. In general, point-of-care testing encompasses any tests that are performed at or near a patient and at the site where care or treatment is provided. J Diabetes Sci Technol 2018;12:7719. Ann Emerg Med 2013;61:14551. Implementation of point-of-care testing in a pediatric healthcare setting. The impact of an interdisciplinary/multidisciplinary team including endocrinologists, intensivists, hospitalists, nurse practitioners, pharmacists, dietitians, and laboratory medicine specialists, has been investigated on inpatient glucose control (11). The need for a point of care testing: an evidence-based appraisal. Accuracy of HbA1c has also improved over the past 20 years due to efforts to standardize the measurements by manufacturers in relation to their device performance on PT/EQA programs (46). Instrument performance must be verified before use in patient care. Presentation title: Management of Point-of-Care Testing: An AACC Academy Guidance Document Length: 1.5 hours AACC Guidance on Management of Point-of-Care Testing [121] Singer A J, Williams J, Taylor M, Le Blanc D, Thode H C.Jr., Comprehensive bedside point of care testing in critical ED patients: a before and after study. [129] Yang H L, Lin Y P, Long Y, Ma Q L, Zhou C. Predicting cardioembolic stroke with the B-type natriuretic peptide test: a systematic review and meta-analysis. Conception, regulations, and usage. It is up to the site to determine the analytical performance requirements needed to assure that a system is fit for purpose. Ann Clin Biochem 2017;54:42031. [54] Bietenbeck A, Geilenkeuser W J, Klawonn F, Spannag l M, Nauck M, Petersmann A, etal. Staffing needs, both for actual test performance as well as labor needed for management and oversight. Procedures will posted anonymously if preferred. The advantages of PT/EQA are not insignificant considering the thousands of operators, hundreds of devices, and multiple locations involved in POCT within a healthcare institution. An interdisciplinary committee helps laboratory medicine to better understand clinical needs, and this forms the basis of a quality POCT program. Blood gases/electrolytes (Intraoperative) (92): No outcome studies for POCT intra- or peri- operatively were identified. Arch Endocrinol Metab 2018;62:51422. POCT can enhance patient care by expanding the opportunities for healthcare services at different patient and population levels. Through the capture of patient results, POCT data management provides the opportunity to generate reports that are utilized for data trending, documentation of clinical quality measures, and evidence of patient outcomes. Laboratory medicine practice guidelines: Evidence-based practice for point-of-care testing. [87] Briggs C, Guthrie D, Hyde K, Mackie I, Parker N, Pope k M, etal. Performance of point-of-care HbA1c test devices: implications for use in clinical practice: a systematic review and meta-analysis. The Point of Care Testing Procedure Manual contains the approved procedures for safe and effective operation of POCT procedures by MGH POCT providers. [122] Schnell O, Crocker J B, Weng J. While data management does not directly improve patient outcomes, data management provides the tool to collect information that allows clinicians to better manage their patients, and this indirectly improves patient care. One study showed that clinical decision time increased; however, without any changes in LOS, mortality or rate of hospital admission due to other inherent hospital barriers (availability of physician or bed space). ment of a point-of-care testing program, the Clinical and Labora-tory Standards Institute (CLSI) recommends multidisciplinary representation from performing sites to serve on the POCT committee (3). Does data management improve POCT outcomes? Information technology assessment: What will be the mechanism for the capture of patient testing and Quality Control data and how will it be recorded in laboratory records and the medical record? Sepsis (Lactate) (92): Lactate was found to reduce ICU admission rates and mortality in one study, as well as to increase time to administer IV fluids but not antibiotics. S Afr Med J 2019;109:1125. See Table 2 for the typical responsibilities associated with oversight of a POCT program. Leveraging the real value of laboratory medicine with the value proposition. They observed that users who performed fewer QC tests generated results with greater imprecision, subsequently concluding that user competency was a significant factor affecting analytical performance (21). Point-of-care testing (POCT) is a laboratory-medicine discipline that is evolving rapidly in analytical scope and clinical application. 900 Seventh Street, NW Suite 400 An operational and clinical needs assessment should be performed, as well as a review of facilities and material management requirements to identify the test use characteristics required in the potential POCT devices. to analyze our web traffic. Clinical utility studies require data on the influence of POCT on outcomes. Improve Efficiency and Accuracy of Documentation Learn More Minimize Risk to Resident Safety Learn More The specifics of these requirements will be dependent on the clinical use, such as screening, diagnosis or monitoring, of the POCT results, as well as to whether other systems are available for the performance of the analysis. Connectivity is at the core of POCT growing pains. [68] Cvitkovic M. Point-of-care testing. BJGP Open 2018;2:bjgpopen18X101596. Intuitively, it makes sense that an understanding of (i) how to operate the POCT device, (ii) troubleshooting instrument errors, and (iii) understanding the importance of using QC material and (iv) proper handling and storage of quality control material and patient samples, would lead to improved test performance. Many of the point-of-care testing procedures are identified by CLIA as waived while others are moderately complex. Indeed, laboratories with more experience participating in PT have fewer failures (43), and laboratories that participate in multiple surveys, such as the CAP linearity (LN) survey, perform better on PT surveys (58). [100] Lewandrowski K, Flood J, Finn C, Tannous B, Farris A B, Benzer T I, etal. Connectivity standards have created uniform interfaces to interconnect computerized POCT devices with data management systems (66), and several data management system vendors currently offer connections to dozens of different devices and manufacturers. Respiratory tract infections (RTIs) are also potential priority areas for POCTs (8). [85] Soto M, Sampietro-Colom L, Vilella A, Pantoja E, Asenjo M, Arjona R, etal. EQA is an important part of a quality improvement system and is used to monitor the participant performance and to assess the methods used (39). [61] Humbertson S K. Management of a point-of-care program. Point-of-Care Ultrasonography | AAFP [126] Ryan R J, Lindsell C J, Hollander J E, O'Neil B, Jackson R, Schreiber D, etal. The effects of a lack of adequate connectivity are most readily seen in large institutions or within multi-site systems where a dispersed set of devices can create data management issues. AACC Guidance Document on Management of Point-of-Care Testing, The Journal of Applied Laboratory Medicine, Commission on Accreditation in Clinical Chemistry. On average, 1%2% of participants failed in the central lab, compared to 9%10% for POCT EQA, and the central 95% of all glucose measurements in a central lab deviated less than 10% from the assigned target, whereas POCT central 95% of results exceeded 15% deviation from the target value (54). Arch Pathol Lab Med 2005;129:1869. Instead this guideline will focus on how clinicians can get the most efficacy and highest quality results from implementing best practices for POCT. They are often easy to use and contain filtered information. Improved outcomes were noted in remote/rural settings. Second-generation glucose systems introduced rudimentary data management software, which permitted manual downloading of quality control results to a personal computer. POCT is a now proven approach that can provide faster turnaround (TAT) of laboratory test results. The Point of Care Testing Procedure Manual contains the approved procedures for safe and effective operation of POCT procedures by MGH POCT providers. Director of Clinical Chemistry and POCT Participating in a PT/EQA program can thus improve the quality of a variety of POCT methods by increasing precision, enhancing accuracy, decreasing the number of errors or unsuccessful challenges, and documenting result agreement with peers. Acad Emerg Med 2015;22:3846. What is point of care (POC) testing? | Definition from TechTarget Room Temperature Monitoring Information and Log sheet Urine Dipstick QC Logs Another study identified a lack of evidence for the use of lactate in community settings. St. Louis, MO; Ellis Jacobs [ Download pdf] The following video is a presentation on this Guidance Document, recorded during the virtual AACC Annual Scientific Meeting in December 2020. Point of care ultrasonography (POCUS) is advanced diagnostic ultrasonography that is performed and interpreted by the attending physician as a bedside test [ 1 ]. Point of Care (POC) - PointClickCare Crit Rev Clin Lab Sci 2019;56:23946. [42] Bukve T, Roraas T, Riksheim B O, Christensen N G, Sandberg S. Point-of-care urine albumin in general practice offices: effect of participation in an external quality assurance scheme. 6. However, it is the recommendation of this expert panel that the number of operators needed should be proportional to the volume of POC performed to ensure that each operator maintains competency via experience with the device. Am J Emerg Med 2018;36:91621. EJIFCC 2018;29:196200. The Cleveland Clinic Foundation. Hospitals and independent laboratories have fewer PT failures than all other testing sites (57). Crit Care Clin 2000;16:62339. Wayne, PA: Clinical and Laboratory Standards Institute; 2006. Updated regularly, this comprehensive online physiotherapy resource integrates leading physical therapy textbooks, procedure and exercise videos, image galleries, self-assessment tools . AACC Guidance Document on Management of Point-of-Care Testing Arch Pathol Lab Med 1995;119:30711. Participation in PT/EQA is therefore recommended for all tests and locations where POCT is conducted. A systematic survey. If you would like to participate, send in your procedure. Some are lyophilized and require reconstitution and accurate dilution before analysis, while others require thawing and calibration to room temperature. Crit Rev Clin Lab Sci 2017;54:47194. The same group performed a follow-up study comparing trained and untrained nurses using the same type of instrument and same lot of glucose strips. Manual POCT results may not get documented, as this is an added step, which presents a risk that clinical staff may act based on a result that is never recorded in the patients chart. Primary care practice (92): Limited data on whether POCT affected outcomes in primary care practices. In this study, user competency was evaluated by the number of QC tests performed by each operator, and the imprecision associated with the measurements was a surrogate marker of analytical performance. Operators must be trained and have regular competency checks. Point of Care Testing Toolkit. Teaneck, NJ; Norman Moore It concluded that in locations without laboratory testing, POCT Tn testing reduced transfer to central locations. Data management systems automate the ordering and billing of results, generation of control statistics and patient reports, trending of instrument error codes, and documentation of operator training/competency that assist POCT programs in ensuring regulatory compliance. Operators responsible for generating results from POCT devices are usually non-laboratory trained personnel with backgrounds in various disciplines, such as but not limited to nursing, pharmacy, medical assistants, and emergency medicine services (e.g., Emergency Medical Technicians). Blood gases/electrolytes (ICU/ED) (92): Multiple studies identified that showed quicker result turnaround time with varying responses as to whether they impacted LOS or prognosis. Milan: International Federation of Clinical Chemistry and Laboratory Medicine (IFCC); 2014. Consideration should be given to having ad hoc members contribute when there is a need for additional subject matter expertise such as the laboratory; chemistry, coagulation, hematology, or microbiology, depending on the specific test request discussed, as well as clinicians from the site implementing the test. Setting up a point-of-care testing service in a Greenfield, Quaternary Hospital: an implementation review. 3rd Ed. Impact on test turnaround time and patient emergency department length of stay. Nashville, TN, The American Association for Clinical Chemistry (AACC) Academy (formerly known as the National Academy of Clinical Biochemistry, NACB) formed a committee of experts on point-of-care testing (POCT) to revise the Laboratory Medicine Practice Guidelines (LMPG) Evidence-Based Practice for Point-of-Care Testing published in 2006 (1, 2). Several factors impact laboratory performance on PT/EQA surveys. Unacceptable results by a PT provider is an unexpected outcome for a laboratory. Dr. Everett Chalmers Regional Hospital Horizon Health Network Consultant or Advisory Role: E. Jacobs, Quidel Corp. Stock Ownership: E. Jacobs, Abbott Diagnostics; N. Moore, Abbott. The intent of this discussion was to review existing literature to determine what available evidence, if any, exists to support the hypotheses that faster TATs secondary to POCT; improve outcomes (decreased morbidity and mortality) or patient care processes (decreased admissions or shortened length of stay (LOS). Practical challenges related to point of care testing. [131] Wu Z, Yang L, Guo Q, He M, Li K. Experiences and the use of BNP POCT platform on suspected ischemic stroke patients in the emergency department setting. Point of care diagnostics and networks. POCUS has been widely used in many disciplines as a rapid diagnostic tool, especially in emergency medicine. // Department of Pathology and Laboratory Medicine // Previous studies have indicated that point-of-care ultrasonography (POCUS) of the gastric antrum can predict the adequacy of fasting before surgery and anesthesia. Table 2 Responsibilities of POC administration. Sufficient concordance between POCT results and results obtained in a comparative laboratory (the hospital or central laboratory) must be guaranteed within acceptable tolerance limits when POCT is implemented. Bedside glucose monitoring. MLO Med Lab Obs 2000;32:448, 501. Chairholder: Gerald A. Hoeltge, M.D. Crit Care Nurs Q 2011;34:11627. POCUS has been used to aid the diagnosis of multiple medical . [67] Quinn A D, Dixon D, Meenan B J. What are Point-of-Care Tools? Clin Biochem 2004;37:8117. Laboratorians appreciate the value of electronic gathering of information as an essential asset for doing business, especially when it comes to quality control/quality assurance, billing/compliance, and regulatory requirements. Guidance Documents are brought to you by the. POCT devices should generate results that are comparable to those of the local laboratory (87). PDF Subject: Lab 23 Point of Care Quality Management ISO 22870:2016 (E): Point-of-Care TestingRequirements for Quality and Competence. ISBN 1-56238-315-9. Agenda . PT/EQA is a surrogate marker for POCT performance. BMC Fam Pract 2016;17:149. [6] Lewandrowski K, Gregory K, Macmillan D. Assuring quality in point-of-care testing: evolution of technologies, informatics, and program management.