Table 3.
POC curriculum and learning objectives for public health schools.
| Section and topics | Learning objectives |
|---|---|
| Part I. | Getting Started—The Mission |
| Goals, objectives, and overview of uses in public health | • Define POCT as testing at or near the site of care and appreciate that the definition does not depend on the instrument format or size • Understand the fundamental goals and objectives of POCT for rapid and effective evidence-based decision making at points of need • Introduce situations where POCT has proven benefits for public health • Understand the importance of generating fast results, so that triage can be performed efficiently and immediately |
| Part II. | Fundamental Principles and Practice of POC Testing |
| A. TECHNICAL | |
| Needs assessment | • Develop competency in needs assessment for POC diagnostics in public health • Apply to healthcare settings limited-resource countries |
| Instrument formats, selection, and validation | • Recognize basic formats for disposable, handheld, portable, and transportable POC technologies that perform in vitro testing • Describe disposable POC tests, including smartphone modules, and their advantages, disadvantages, and marginal cost-effectiveness • Have the ability to select and validate the correct instruments |
| Non-invasive monitoring vs. in vitro diagnostic testing | • Consider the operating principles of non-invasive devices, namely pulse oximetry for monitoring of oxygen saturation, and continuous hemoglobin monitoring • Compare in vivo, ex vivo, and in vitro approaches and advantages |
| Specimen processing | • Contrast whole-blood vs. plasma analysis, also dry blots • Outline specimen processing and suitable sample types for testing in the field, primary care, and emergency room • Review special requirements associated with isolation laboratories |
| Quality assurance (QA), quality control (QC), and proficiency testing (PT) | • Identify “waived tests” under CLIA'88 and compare other POC tests • Know the definition and importance of quality assurance, including internal quality control and external quality assessment • Learn the five basic elements of the individualized quality control plan (IQCP), including environmental stress; how to customize QA, QC, and PT; and the importance of continuous quality improvement • Recognize confounding factors in diagnostic testing |
| Environmental stresses | • Overview the effects of environmental stresses on POC instruments and reagents, and how to avoid adverse consequences • Study methods for modulating environmental conditions for POC reagent storage and transportation |
| Multiplex molecular diagnostics | • Gain a basic appreciation of multiplex assays used for the detection of viruses, bacteria, and fungi, that is, pathogen detection • List advantages, disadvantages, costs, and limitations • Show examples of current POC disposable tests and instruments commercially available |
| B. DESIGN AND BUILD | |
| Design criteria | • Read WHO and other POC device performance specifications |
| Commercialization | • Understand custom POC test clusters, basic manufacturing requirements, commercialization processes, and timelines |
| Regulatory oversight | • Review routine FDA 510(K) clearance and pre-market approval (PMA) • Outline the FDA system of classification of diagnostic tests (i.e., CLIA-waived, moderately complex, and complex) and the criteria for home testing. • Assess the ramifications for implementation, personnel, and use |
| FDA and WHO emergency use declarations | • Study the process, legal requirements, and terms of FDA emergency use authorizations (EUAs) and WHO emergency use assessment and listings (EUALs) • Locate EUA and EUAL listings and documentation of tests on the web |
| Accreditation options | • Understand the definition of accreditation and why an organization would engage in it • Discuss the main considerations and steps leading to accreditation • Consider inspections options for POCT [e.g., College of American Pathologists, Joint Commission, and CMS (for waived testing)] |
| C. PRACTICUM | |
| Device hands-on experience | • Demonstrate CLIA'88 waived and moderately complex POC tests • Learn how to perform common POC tests, how to operate mobile POC instruments, and security features (e.g., UN and PW) • Watch demonstration videos of transportable whole-blood analyzers and test clusters for critical care and support of patients in isolation |
| Results interpretation | • Use case studies to demonstrate how to interpret basic test results |
| Performance evaluation | • Attend a workshop illustrating POC performance evaluation, such as regression analysis, Bland-Altman plots, and locally-smoothed (LS) median absolute difference (“LS-MAD”) curves and maximum absolute difference (“LS-MaxAD”) curves |
| Trouble shooting | • Gain experience at trouble shooting POC tests and devices • See examples of error codes and how to respond to them |
| Establishing a POC program | • Understand the steps necessary to establish a successful POC testing program |
| Part III. | Integration of POC and Public Health Expertise |
| Roles of public health personnel and POC Coordinators | • Recognize the benefits of teamwork among public health practitioners, POC Coordinators, reference laboratories, and clinical laboratories • Develop personnel resources and a database of skill sets in advance of disasters, emergencies, complex crises, and epidemics • Understand that public health students and professionals could become POC Coordinators |
| Training, credentialing, and assuring competency | • List and analyze approaches to multidisciplinary credentialing • Specify requirements for maintaining competency and annual reviews • Learn how to document competency of Disaster Medical Assistance Teams (DMATs) and other first responders |
| Part IV. | Health Maintenance and Non-communicable Diseases (examples) |
| Pregnancy | • Explore sensitivity, timing, and interferences, and the technical differences in disposable urine tests vs. plasma assays |
| Prediabetes and diabetes | • Appreciate why plasma glucose standardization is necessary for consistent performance of blood glucose meters • Understand the role of POC HbA1c testing in the diagnosis and monitoring of prediabetes vs. diabetes • Develop patient plans for self-testing of capillary whole-blood glucose • Correlate prevalence, demographics, and public health implications of evidence-based POC diagnosis in poor and rich nations |
| Acute coronary syndromes and acute myocardial infarction | • Study Spatial Care Paths™ (SCPs) for rapid home rescue of patients with acute chest pain • Apply evidence-based medicine (EBM) and learn why current POC cardiac troponin (cTn) tests are limited to ruling in (not ruling out) acute myocardial infarction • Read about prehospital diagnosis using POC cTn on ambulances • Strive to use POC cTn in rural areas to eliminate social inequity by rapidly diagnosing acute myocardial infarction and starting intervention |
| Part V. | Communicable Diseases (examples) |
| HIV | • Appreciate the POC methods of screening for HIV, including pregnant women for prevention of transmission and algorithms for newborns • Study the advantages of simultaneous multiplex testing for concurrent diseases, such as TB |
| Influenza A and B | • Apply EBM principles to influenza testing and understand predictive values and their use from the viewpoint of the primary care physician • See examples of portable CLIA-waived instruments (Liat, Roche Diagnostics; Alere-i, Abbott) useful during flu season |
| Malaria | • Review new POC tests (e.g., fingerprick Ag Plasmodium falciparum) and uses in Africa and other endemic areas |
| Strep throat screening | • Review primary care practices related to screening • Understand necessary follow-up testing |
| Tuberculosis and resistance testing | • Cover instrumentation for TB diagnosis and resistance testing [e.g., the GeneXpert MTB/RIF test as a marker for multidrug resistant TB (MDR TB)], by drawing on the foregoing instruction in molecular diagnostics • Establish appropriate settings and conditions for testing • List and abate environmental stresses (e.g., temperature and dust) |
| Part VI. | Geospatial Science and Geographic Information Systems (GISs) |
| Small-world networks (SWNs) | • Define, illustrate, and analyze healthcare SWNs •Set the stage for community public health practice using POCT in optimized SWN healthcare delivery systems |
| GIS applications to health systems | • Explain how to set up and analyze a GIS • Establish SCPs within SWNs for rapid diagnosis and treatment •Assess the impact of GIS analysis of SWNs and SCPs •Integrate smartphone POCT-GIS for sentinel case tracking |
| Part VII. | Preparedness for Outbreaks, Epidemics, and Isolation |
| A. LECTURES | |
| Dynamic evidence-based medicine | • Present sensitivity, specificity, and predictive values of POC tests •Point out that the false negative rate, FN(t), is a function of time, and therefore, sensitivity and the ability to rule out disease are dynamic when testing patients with evolving infections |
| Ebola virus and other highly infectious diseases | • Document how the 2014–16 Ebola virus disease epidemic and cases entering the U.S. proved unequivocally the need for POCT •Overview how POCT could have curtailed the 2014–16 epidemic •Delineate POCT effectiveness in curtailing recurrent outbreaks in the DRC and the potential for empowering field response in war zones •Survey POC technologies available for Ebola virus disease and other high risk pathogens |
| B. WORKSHOPS | |
| Personal protective equipment (PPE) | • Don PPE and practice performing POC tests, then doff the PPE and show that work was performed without personal exposure |
| Isolation laboratory and quarantine | • Be able to read floor plans, design an isolation laboratory, equip it with POCT, and route specimen workflow •Understand specifications for biosafety cabinets and limits to performing molecular diagnostics and POC tests within them •Identify special aspects of personnel training and protection |
| Spatial care paths™ | • Demonstrate sentinel case discovery, 911 intent, and fastest rescue routes in healthcare SWNs •Place POCT to optimize efficiency and effectiveness |
| IQCP, its five key components, and plan design | • Practice designing individualized quality control plans (IQCP) • Remember the five components of the testing process: specimen, test system, reagent, environment, and testing personnel • Sketch out an IQCP for POCT in an isolation laboratory associated with a hospital and in an alternate care facility |
| Part VIII. | Disasters, Emergencies, and Rapid Response |
| Disaster caches | • List the test clusters in DMAT POCT caches, the three US sites of storage, personnel training, and regional deployment, including Alaska and Hawaii • Recognize necessary steps in opening and using the compact and larger laboratory caches, test clusters, and their different purposes • Review the basics of specimen collection and sample preparation, including for infectious diseases, under challenging field conditions • Recognize the analytical limitations of POCT under disaster conditions |
| Performance standards | • Establish QC criteria necessary to complete before using POC devices from caches in the field during emergencies and disasters • Develop backup procedures in case of QA failures • Know National Disaster Medical System routines for maintaining high levels of performance when using POCT from caches in the field |
| Telehealth | • Gain familiarity with field connectivity and telecommunications |
| Alternate care facilities | • Integrate DMAT resources with community alternate care facilities |
| Bioterrorism | • Be aware of major threats, methods of detection, containment |
| Emergency management and emergency operations centers | • Relate POC concepts to public health emergency management systems and structures • Integrate public health emergency operations centers as critical tools for responding to crises near points of need •Formulate appropriate POC test clusters to enhance local community resilience and coordinate them with regional POC resources, personnel, and caches |
| Part IX. | Global Health and Limited-resource Settings |
| Community resilience | • Present key published literature that shows how POCT adds to community resilience and value every day and during emergencies |
| Bedside and beyond | • Map the starting and ending points for public health ownership of POC diagnostics, monitoring, and therapeutics responsibilities |
| National essential diagnostics lists | • Strategize national essential diagnostics lists that concentrate on disease-specific resources • Study which diagnostics listed can be delivered at points of need • Identify how to use POCT to implement diagnostics lists cost-effectively from the standpoint of value for global health challenges |
| POC culture | • Appreciate the assimilation of point-of-need diagnosis into the daily lives of people as technologies permeate personalized medicine • Scan the spectrum of POCT from the home to primary care, to concierge medicine, and on to the ER, labor room, OR, and ICU |
| Case studies | • Illustrate value propositions for POCT in limited-resource countries in Asia, Africa, and other settings |
| Part X. | POCT Standards, Policy, and Guidelines |
| A. LECTURES | |
| ISO framework | • Outline the purpose and contents of the International Organization for Standardization (ISO) 22870:2016, “Point-of-care testing: Requirements for quality and competence,” and associated standards (e.g. ISO 15189:2012, Medical laboratories) |
| CDC and WHO | • Review the guidelines and documents published by the CDC and WHO for POC needs, technologies, and public health response |
| General Accountability Office (GAO) | • Analyze recent General GAO reports, webcasts, and documents regarding POC technologies for epidemics, molecular diagnostics, and cost-effective healthcare systems in the U.S. and abroad |
| Global status | • Compare and contrast national POCT policy and guidelines that have been established in Malaysia and Thailand, and their advantages and shortcomings (e.g., lack of disaster POC) |
| B. WORKSHOPS | |
| Procedures | • Understand the necessity for a set of written policies and procedures for POC testing • Be able to identify the core content of a policy or procedure |
| Policy and guidelines workshop | • Give learners the opportunity to draft an outline of the contents of national POCT policy and guidelines for a limited-resource country |
| Part XI. | Project Management and POC Value Propositions |
| Project management and the POC committee | • Understand the basic principles of project management • Consider how to analyze and effectively manage stakeholders • Understand the importance of the POC committee, anticipatory planning, and preparation for community projects |
| How to write a business case and develop value propositions | • Understand what information should be included in a business case • Be able to analyze the cost-effectiveness and value of POC testing • Identify key issues to address when implementing a new POC service |
| Part XII. | Conclusions and Future Trends: The POC Vision |
| Course summary | • Recap what we have learned and what we can do with our knowledge to improve public preparedness, response, and health outcomes |
| Learner presentations | • Have teams of learners share studies of POC applications with which they have personal experience or have gleaned from literature |
| Future vision | • Understand the role of POC technologies in future public health initiatives, disaster preparedness, and stopping spread of outbreaks of highly infectious diseases in America and other countries |