Assuring Quality in Point-of-Care Testing: Evolution of Technologies, Informatics, and Program Management

Lewandrowski, Kent; Gregory, Kimberly D.; MacMillan, Donna

doi:10.5858/arpa.2011-0157-ra

Cited by 76 publications

(50 citation statements)

References 9 publications

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“…Investigations should address the adequacy of POCT oversight; provide education regarding the importance of QC for both regulatory compliance and patient care; establish institutional policy and training of both POCT personnel and supervisors; ensure competency in POCT instrumentation, software, and design regarding QC; and monitor QC performance and compliance, as well as any other variables that may affect the POCT program at an institution. Some authors 2,6 have suggested solutions such as increased oversight by a dedicated POCT supervisor, improved or reeducation of POCT personnel, and enhanced QC design features, such as instrument locks in the event of a QC failure.…”

Section: Commentsmentioning

confidence: 99%

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confidence: 99%

“…However, achieving compliance with regulatory guidelines and ensuring the quality of POCT has proved challenging in many institutions. 6 In the authors' experience, performance of traditional QC is a misunderstood and undervalued concept for many nonlaboratory personnel because they are largely unfamiliar with laboratory operations, standards, and limitations. Although proficiency testing provides a periodic audit of testing accuracy, periodic audits of testing documentation can provide valuable information regarding the operational performance of the POCT program.…”

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confidence: 99%

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Documentation of Quality Control and Operator Training at Point-of-Care Testing: A College of American Pathologists Q-Probes Study of 106 Institutions

Dyhdalo

Howanitz

Wilkinson

et al. 2014

Archives of Pathology &Amp; Laboratory Medicine

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Context.-Operator training, quality control, and proper follow-up for out-of-range quality control (QC) events are crucial steps that must be adequately performed and documented to ensure excellent patient care and regulatory compliance.Objective.-To examine point-of-care testing (POCT) personnel training and QC documentation/compliance.Design.-Participants in a POCT documentation study of the College of American Pathologists Q-Probes program collected data retrospectively for glucose and urine dipstick testing regarding test operators, operator competency assessment, and QC documentation. Documentation was assessed for participant adherence to 4 quality indicators: (1) whether test operator training was up to date, (2) whether the test operator names were noted in the test records, (3) whether QC was performed, and (4) whether out-of-range QC events were followed up. Data were analyzed for associations with institutional demographic and practice variables.Results P oint-of-care testing (POCT) is defined as testing that occurs at or near the site of patient care, with the goal of providing rapid information and improving patient outcomes.1,2 Point-of-care testing is growing several times faster than is central laboratory testing in the United States 2,3 and has become ubiquitous in both hospitals and outpatient care settings. Because POCT is typically performed by nonlaboratory personnel, many health care workers are now performing a wide variety of tests. Quality patient care is dependent on accurate laboratory results, necessitating assurance that POCT is well documented, equipment is well maintained, and testing operators are qualified to perform the tests. It is also important to ensure that quality control (QC) procedures are run consistently and that documentation of QC performance and follow-up of out-of-range QC results are recorded to ensure accurate results and high-quality patient care. Additionally, POCT is subject to regulatory requirements that, if ignored, can lead to loss of accreditation. 4 The College of American Pathologists (CAP) POCT accreditation checklist requires that (1) POCT instruments have defined QC ranges, (2) QC results are evaluated daily, (3) corrective action is taken when results exceed defined tolerance limits, and (4) QC results are verified before patient results are reported. 5A complete POCT program includes organization, supervision, written procedures, operator training and competency, instrument evaluation, quality control, proficiency testing, and appropriate recording of result and notification, all with the necessary documentation. However, achieving compliance with regulatory guidelines and ensuring the quality of POCT has proved challenging in many institutions. 6 In the authors' experience, performance of traditional QC is a misunderstood and undervalued concept for many nonlaboratory personnel because they are largely unfamiliar

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Documentation of Quality Control and Operator Training at Point-of-Care Testing: A College of American Pathologists Q-Probes Study of 106 Institutions

Dyhdalo

Howanitz

Wilkinson

et al. 2014

Archives of Pathology &Amp; Laboratory Medicine

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“…Managed by the central laboratory this executive group is committed to fulfilling the regulations for quality management and improving the whole process. 77 The POCT committee is the right place for actively fulfilling the spirit of partnership and should meet at least once a year. It is important that clinical POCT users have participation in decision making.…”

Section: Organization Related Issues Hpoct Coordinationmentioning

confidence: 99%

Central Laboratory Service and Point-of-Care Testing in Germany—From Conflicting Notions to Complementary Understandings

Bietenbeck¹,

Junker²,

Luppa³

2015

Point of Care: The Journal of Near-Patient Testing &Amp; Technology

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Point-of-care testing (POCT) enables health care personnel to perform laboratory medicine tests near the patient. The underlying technology and the range of test parameters available are evolving rapidly. Thus, a series of clinical applications are possible that can shorten the time for clinical decision-making about additional testing or therapy, as delays are no longer caused by preparation of clinical samples, transport, and central laboratory analysis. The idea of conventional and POCT laboratory services presiding within a hospital seems contradictory; yet, they are, in fact, complementary: together POCT and central laboratory are important for the optimal functioning of diagnostic processes. They complement each other, provided that a dedicated POCT coordination integrates the quality assurance of POCT into the overall quality management system of the central laboratory. We describe here the clinical, organizational, and economic issues of hospital POCT from the European point of view. The advantages of POCT are to be combined with the core competences of the central laboratory to significantly improve the overall patient outcome. This review also portrays novel developments for POCT due to the fact that future utilization of POCT globally will depend on health care trends and new areas of application.

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“…The calibration activities for the devices and confirmation of the measurable range of the instrument must also be performed for each device before clinical use. 10 Quality control is another key challenge. Organizations are required to perform and maintain documentation for the calibration activities based on the manufacturer's recommendations for the product.…”

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confidence: 99%

Managing the Challenges in Point-Of-Care Testing

Gramz

Koerte

Stein

2013

Point of Care: The Journal of Near-Patient Testing &Amp; Technology

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As adoption of point-of-care (POC) testing increases and becomes more widespread, POC coordinators face increasing challenges in effectively managing their POC testing program. Operator management, device management, quality control, and compliance reporting are a few of the challenges being faced beyond the generation of results. An integrated ''POC ecosystem'' consisting of eight core components has the potential to improve a POC coordinator's ability to meet the challenges. The eight core components include device management, operator management, quality control, compliance reporting, competency management, inventory management, remote monitoring, and mobile access. Although solutions for each of the components exist today in one form or another, efficiently managing all aspects of a POC program requires close collaboration among health care institutions, device manufacturers, and information technology vendors in the future.W ith the ultimate goal of improving patient care, adoption of point-of-care testing (POCT) continues to grow at a high rate. 1 The ability to deliver fast and reliable results near the patient is a key driver for improving patient outcomes and optimizing clinical workflow. Key factors that contribute to the successful expansion and standardization of POCT include the role of the point-of-care (POC) coordinator, clinical requirements together with accreditation agencies, and the commercialization of new technology for devices and informatics.The POC coordinator's role and establishment of dedicated resources responsible for managing POC programs within hospitals have advanced from initial popularization in the late 1980s to a requirement and necessity for managing today's decentralized testing programs. 2 Requirements established by clinical standards agencies such as the International Standard, ISO 22870:2006 from the International Organization of Standardization, numerous standards from the Clinical and Laboratory Standards Institute, and the RiliBÄ K guidelines issued by the German Federal Medical Council have been pivotal in standardizing the way POCT is performed. 3 Accreditation agencies such as the College of American Pathologists in the United States and the Clinical Pathology Accreditation in the United Kingdom have helped health care institutions aggressively implement structured programs for POCT and ensure requirements are met. 4 Practitioners in the field frequently request improved devices and reagents, expanded menu, and connectivity. 5 These requirements are being addressed by 3 major technological trends in POCT, miniaturization, parallelization of tests, and networking. 6 In addition, as device connectivity becomes widely available even for smaller devices, informatics solutions provide additional functionality and workflow improvements. 7 Although the present growth of POCT is strong, further adoption of POCT depends on how well the industry manages to overcome the challenges POC coordinators face in managing their POC programs. KEY CHALLENGES IN POCTWith POC devices ...

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Assuring Quality in Point-of-Care Testing: Evolution of Technologies, Informatics, and Program Management

Cited by 76 publications

References 9 publications

Documentation of Quality Control and Operator Training at Point-of-Care Testing: A College of American Pathologists Q-Probes Study of 106 Institutions

Documentation of Quality Control and Operator Training at Point-of-Care Testing: A College of American Pathologists Q-Probes Study of 106 Institutions

Central Laboratory Service and Point-of-Care Testing in Germany—From Conflicting Notions to Complementary Understandings

Managing the Challenges in Point-Of-Care Testing

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