Saturday, June 09, 2018

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

With emerging technological innovations in healthcare, including smartphone apps, biosensors, lab-on-a-chip, and wearable devices—all of which offer a closer connection to the patient—point-of-care (POC) technologies are quickly becoming part of the transformation of the healthcare landscape. The driving concept in support of point-of-care testing (POCT) is to bring testing closer to the patient and results conveniently and quickly to the provider to expedite diagnosis and subsequent treatment. POCT allows for faster clinical decisions in hospitals, physicians’ offices, ambulances, patient homes, and in the field. 

The College of American Pathologists (CAP) defines POCT as “testing that is performed near or at the site of a patient with the result leading to a possible change in the care of the patient.” 

POCT’s popularity has risen in recent years due to its convenience, timeliness, and potential to improve patient outcomes. In fact, POCT is estimated to be increasing at 10-12% annually, compared to a 6-7% annual increase for other clinical laboratory testing. Used appropriately, POCT can be a key component in meeting the goals of simultaneously improving patient outcomes and reducing healthcare costs.  

Hundreds of tests once considered too complex for POCT 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 (DOA)
• Fecal occult blood
• 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

Challenges inherent in managing point of care testing:

In the core lab, errors occur most frequently in the pre- and post-analytic phases, however, POCT errors occur primarily in the analytic phase of testing.  This is related to a lack of understanding or training of non-laboratory staff who are involved in POCT. In addition, 

there are possible test limitations and misuse in a particular environment. This often raises concern over the reliability of test results.  

More than ever, the laboratory must be proactive in monitoring all aspects of POCT, if quality care is to be maintained.  These actions include:

• All Point of Care (POC) testing personnel must be properly trained, and have their competency periodically assessed, even if all their testing is waived  
• All instruments involved should be used in accordance with manufacturer’s requirements with quality control, calibration, and maintenance records monitored;  
• Test results must be verified as to accuracy and (if previously patient tested) consistent with a patient’s history  
• Reagent storage and handling must be monitored
• Utilization of split sampling and proficiency testing is recommended for monitoring quality.

Managing POCT:  the Laboratory Liason

Mindful that POC testing may be performed by non-laboratory staff, laboratories often have a staff tech responsible for monitoring this testing, acting as both a liason, as well as a technical resource for the POC testing staff.  

This is an important responsibility, as feedback from the field to the laboratory is needed to identify potential communication problems, complaints, and the needs of both patients and staff.

The bottom line is that there should be no difference in the quality of patient care provided by the laboratory, whether performed within the confines of the laboratory itself, or anywhere else. Ultimate responsibility lies with the laboratory administration and staff.

An alternative model:   POCT Management Teams

Interdisciplinary POC management teams that include the laboratory, physicians, and nurses are considered as the most effective way to ensure the best oversight.  This model increases the probability of inter-departmental cooperation and buy-in by non-lab staff of all the procedures required to assure quality POCT. 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 users of POC technologies

However, regulatory standards hold the Laboratory Director ultimately responsible for managing and supervising POCT

Compliance strategies in the digital age: The Use of Data Management Systems

Technology has now enabled us to monitor all aspects of POCT remotely, from test requests to test results; from QC to maintenance records to documentation of competency to operate instruments.  When possible, use digitalized monitoring to ensure quality work. Here is a sampling of the capabilities of remote monitoring:

Training & Competency Assessments

• Documentation of the initial training, as required by CLIA and Accreditation organizations,  prior to POC testing, followed by documented competency assessments at specific intervals. 

Quality and Compliance

• QC limits and frequency intervals can be configured on the test instrument or managed remotely through a data management system. 
• Data systems can prevent an operator from using the instrument once the QC interval has been exceeded or the result is not within acceptable limits. 
• QC results for each test instrument and operator can be reviewed and evaluated remotely by laboratory personnel
• Documentation of comments describing corrective action for unacceptable QC results
• Some data management systems allow incorporation of manual QC results.

Instrument Use 

• Monitoring instrument use through access control and electronic communication with a laboratory information system (LIS) or other network system. This communication also allows the LIS to download quality control and patient results. 
• POC testing can be set up and configured remotely from a single central location with software updates manually or automatically downloaded to the instruments. 
• The data management system can serve as a repository for testing locations, instrument serial numbers, and instrument service history and software versions. 
• The data management system can also track the status of the connected test instruments so that communication and connectivity issues can be addressed promptly.

POCT Operator Management

• Access to a POCT device can be authorized via operator list downloads when the instrument queries the data management system to determine whether a particular operator is authorized. 
• If an unauthorized operator attempts to use the POCT instrument, he or she will be locked out, preventing use. 

Data Monitoring

• In order to comply with accreditation standards, POCT coordinators can monitor data from activities such as correlation testing, linearity and analytical measurement range verification, proficiency testing, calibration, and patient identification.
• Data systems can automatically capture this data and document it for review. This data also can be entered by hand from manual tests (e.g. fecal occult blood, dipstick urine, pregnancy tests as well.

Inventory Management 

• Reagent and control lot numbers, and established QC ranges, can be entered into the data system and uploaded to the POCT instruments. 
• Alarms can be set to alert the POCT coordinator when new lots are in use that may require validation
• Many POCT devices include barcode scanning capabilities that allow reagents and controls to be scanned by operators to verify the current lot number and prevent use of expired or un-validated reagents. 
• The current lot numbers may reside in the data management system.

Remote Access 

• Enables POCT data management from any computers within or outside of the organization, based on how the system is configured. 

Note:  to ensure quality management of POCT results, and earn the confidence of the medical staff, each of these activities must be continuously monitored, whether accomplished manually, or through the use of data management systems.

Summary

Technological advances have resulted in an explosion in the number of tests that can be performed outside the laboratory setting; locations include operating rooms, nursing homes, the workplace, private homes, retail settings, and remote field sites.  More than ever, the laboratory must be proactive in monitoring this, if quality care is to be maintained.  

This means that all Point of Care (POC) testing personnel must be properly trained (and the training documented), have their competency periodically assessed, even if all their testing is waived; all instruments involved should be used in accordance with manufacturer’s requirements with quality control, calibration, and maintenance records monitored; and test results verified as to accuracy and (if the patient has been previously tested) consistent with a patient’s history.  Monitor reagent storage and handling as well.  Recommended is the utilization of split sampling as well as proficiency testing, as part of Good Laboratory Practice.

Many laboratories, mindful that POC testing may be performed by non-laboratory staff, often have a staff tech responsible for monitoring this testing, acting as both a liason to the laboratory as well as a technical resource for the POC testing staff.  The alternative is the utilization of POCT Management Teams.

The bottom line is that there should be no difference in the quality of patient care provided by the laboratory, whether performed within the confines of the laboratory itself, or anywhere else. Ultimate responsibility lies with the laboratory administration and staff.

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.