Monday, July 09, 2018

by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

It has been one of the primary goals in the reformation of our healthcare system to have patients more involved in managing their own health. The Affordable Care Act (ACA) promotes the shift from curative to preventive medicine by focusing on early detection and management of chronic disease, along with a more patient-centered approach to health care. POCT promotes these goals with rapid test results that providers can use to immediately inform patients of their condition or progress, and modify their treatment on-site. This provides a face-to-face opportunity to ensure understanding and discussion of future goals, thus more directly involving the patient in their own care.

POCT is defined by the College of American Pathologists 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 clinical laboratories”.  POCT also streamlines the testing process by obviating the need to collect a specimen, transport it to the lab, then perform testing, and transmit the results back to the provider. This speed and efficiency often improves both patient outcomes and patient satisfaction.

Increasing Demand for POCT

These advantages are further enhanced by continuous technological innovation, improving the quality, convenience, connectivity, speed, and range of applications.  Emerging technological innovations include smartphone apps, biosensors, lab-on-a chip, and wearable devices.  The transmission of POC test results in Electronic Health Records (EHR) further enhances the advantages of POCT. These results can be shared instantaneously with all members of the medical team, enhancing immediate patient assessment and treatment as well as making POC data available for analysis. 

Additional factors in our society that are enhancing the demand for rapid, on site, decentralized, personalized and automated laboratory testing include:

• The push for patient centered care (rise of personalized medicine)
• Chronic laboratory staff shortages
• Rapidly increasing older population, leading to increased incidence of chronic diseases
• Rising incidence of lifestyle diseases (e.g. cardiac, diabetes)
• Increased demand for home-based POC usage (facilitated by technological innovations)
• Increasing trend toward healthcare decentralization (linked to rise of mobile technology)
• Long-term savings / cost benefit analyses (preventive vs. curative medicine)
• Rural locations with limited laboratory services (linked to laboratory staff shortages).

POC Testing:  What,  Where and Who?

In light of the many factors leading to the increased demand for POCT, manufacturing companies are pushing the envelope to make POCT devices faster, easier, and more reliable. The global POC diagnostics market is forecasted to grow at a compound annual growth rate (CAGR) of 9.3% from 2013 to 2018, and to reach $27.5 billion by the end of 2018.  

Hundreds of tests once considered too complex for POC are now routinely performed outside the laboratory. Sensor technologies enable the rapid analysis of blood samples for many critical care assays, including:

• Blood gases/electrolytes
• Cardiac markers
• Cholesterol/lipids
• Coagulation monitoring (INR;  ACT, Heparin; Hemostasis Assessment)
• Drugs of abuse testing (DAT)
• Fecal occult blood
• Food pathogens
• Glucose monitoring; Hemoglobin A1C
• Hematology
• Infectious diseases (such as Influenza and Rapid Strep)
• Pregnancy and fertility
• Tumor/cancer markers
• Urinalysis testing
• Other Chemistries (Magnesium, Lactate, Micro-albumin, Creatinine)
• D-dimer for thromboembolism

Future: Tests Trending

• Microbiology
• Outbreaks / epidemics
• Methicillin resistant staph aureus
• Endocrine testing to guide surgical therapy
• Parathyroid hormone

ACTH

• Gastrin
• Growth hormone
• Sepsis markers
• Stroke markers
• DNA  testing

POCT is performed in many non-laboratory sites such as urgent care centers, outpatient clinics, physician office laboratories, retail clinics (such as CVS and Walgreen Pharmacy Minute Clinics), ERs, nursing homes, ambulatory coagulation clinics, the patient bedside, and in patient homes.   Each of these environments has different testing needs, variability in staff available for testing, different data processing procedures, and different regulatory requirements.

Point of Care Testing may be performed by nurses, MAs, EMTs, paramedics, pharmacists, or any combination of trained healthcare workers, as well as laboratory professionals.   

Benefits of POCT

Operational benefits of POCT may include rapid decision making and triage, as well as the assurance of optimal use of professional time. POCT sets the stage for rapid diagnosis in the physician's office, ambulance, home, the field, or in the hospital room. Clinicians become empowered to make decisions at the point-of-care and this can have significant positive impact on healthcare delivery and address some of the challenges of health disparities.

There are other potential benefits depending on the specific situation and testing:

• Less sample volume (pediatric, neonatal, ICU venues)
• Decreased pre-analytic concerns related to processing of specimens (i.e. clotting, centrifugation, preservation)
• Optimized drug treatments
• Reduced post-op care time
• Reduced hospital admissions
• Reduced hospital stays

Challenges of POCT

Although POCT provides rapid results and the opportunity for faster medical decisions, the risk of errors with POCT often raises concern over the reliability of test results. In contrast to the core lab, where errors occur most frequently in the pre- and post-analytic phases, POCT errors occur primarily in the analytic phase of testing. This can be related to a lack of understanding or training of non-laboratory staff who are typically involved in POCT, or as a result of test limitations and misuse of POCT in extreme environmental conditions.  While the laboratory offers a structured, controlled testing environment, testing conditions for POCT can vary tremendously. Additionally, the connectivity needed to get POCT results into the EHR fast enough to effect a change in patient care is challenging.

Management of POCT can also be challenging for these reasons as well:

• Required documentation of training, QC, QA, PT activities, as well as competency assessments.
• Error management  
• IQCP requirements, if applied
• Calculating the Cost-benefit ratio. The cost-per-test may actually be higher for a POC test (as compared to the same test in a centralized lab), but if the total patient episode of care cost is reduced, this better meets the patient needs and improves patient outcomes while lowering overall costs. 

For certain POC tests, other concerns may include:

• Only adequate for screening; needs follow up with confirmatory testing
• May not be FDA approved for all uses that the similar test in the lab is approved for (e.g., PT/INR approved for Coumadin monitoring but not for diagnosis of other coagulation disorders)
• Less precise testing may result in the need for further testing
• Poor quality control and/or improperly trained workers can mean even less accurate tests
• Use in settings where the POC tests have not been properly validated (e.g., handheld glucose meters in intensive care units for patients on tight glycemic control)

Managing Your POCT:  Ensuring Quality and Compliance

POCT Management Team

Management of POCT can be challenging. Testing may include multiple sites, many different POCT devices/kits, and dozens of operators that have to be managed in order to assure quality. Interdisciplinary POC management teams that include the laboratory, physicians, and nurses, are considered as the most effective way to ensure the quality of work performed. They would be responsible for:

• Determining the test menu
• Selecting methodologies
• Establishing policies and procedures
• Confirming proper training and competency assessment
• Overseeing regulatory compliance
• Documenting corrective action where necessary
• Providing advisory assistance to the end users of POC technologies

However, regulatory standards hold the laboratory director ultimately responsible for managing and supervising POCT quality. 

Critical Areas of Consideration

Regulatory Requirements

Ensuring highest quality performance and proper regulatory compliance requires that correct processes and procedures are followed including specimen acquisition and labeling; quality control; instrument calibration and maintenance; results reporting; proficiency testing; personnel training;, competency assessments; and safety.  Documentation of all work must be complete and accessible.

Testing Performed by Non-laboratory Personnel

Clinical personnel with minimal laboratory knowledge, such as nurses or medical assistants, often perform the majority of POCT. They are often unfamiliar with routine laboratory procedures regarding the importance of proper patient preparation, sample collection, calibration, instrument maintenance, and quality control.   A related concern is that POCT equipment will not be used and maintained properly, or will not include appropriate quality control and quality assessment procedures.   

Training and Competency Assessments

There is often confusion between training requirements and ongoing competency assessments. For CLIA and all accrediting organizations, initial training is required prior to POC device operation, followed by documented competency assessments at specific intervals. 

Conclusion:  Growing Acceptance, Growing Use, Growing Importance

Technical advances are making POCT more accurate, less expensive, and easier to use. In fact, many new POC devices are beginning to include QA and documentation features. Demand will continue to increase as economic needs for rapid patient turnaround and reduced hospital length-of-stay intensify. Add to that an increasing need for medical support at remote, diverse sites and outpatient centers, and for underserved populations. And to top it off, there is a chronic shortage of qualified clinical laboratory scientists.

Convenient patient access to healthcare, and real-time lab results are now the goals and expectations.  POCT should be considered as part of the continuum of the clinical laboratory's contribution to healthcare and a fundamental responsibility of the laboratory, regarded with the same expectations of quality throughout the total testing process. POCT can be a critical factor in streamlining and improving laboratory services.

IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

Irwin Z. Rothenberg is a Technical Writer/Quality Advisor for COLA’s Educational subsidiary, COLA Resources, Inc. (CRI), a leader in online continuing education for physicians, laboratory personnel, and allied health professionals.  CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars on cutting-edge technology and regulatory issues, and CRI on-site Symposia for Clinical Laboratories, providing live educational sessions and interactive workshops with leading industry organizations. For more information, visit their website at www.criedu.org or call 1-800-981-9883.