The introduction of point of care testing (POCT) as an example of technology improving health care is a good illustration. For instance, when a diabetic goes to the clinic, he/she will have access to his/her blood glucose level within less than one minute. In addition, a nurse can use a blood gas test result in a hospital ward to assist a physician in determining whether or not a patient requires oxygen. All of the test results described above were obtained at the point of care rather than being sent to a central laboratory for processing. Therefore, it is simple to understand why laboratory managers view POCT as important to them as well, regardless of whether or not the laboratory staff is actually performing the tests.
What Is Point-of-Care Testing (POCT)?
Point of Care Testing (POCT) refers to those laboratory based tests performed directly on the patient, either at the bedside or very near to it; and not in a large central lab. POCT uses small, hand held or compact instruments that usually require only a minuscule quantity of biological material (such as a single drop of blood from a finger prick or urine sample). Since results are available in a matter of minutes, clinicians have the ability to make immediate decisions about how best to treat the patient while he/she is still in the clinic.
POCT should not be used in place of central laboratory testing. Central laboratory testing is supported by POCT. Most POCT results will need further testing or confirmation from the main laboratory.
How Does POCT Work?
A typical POCT workflow is short, which is both its strength and its risk:
- The staff (nurse, doctor) will find the patient and take the sample.
- A sample may be put on a test cartridge, strip, or cassette. The sample will then be read with a reading device or by eye for certain quick tests.
- The result is interpreted, acted on and recorded.
The laboratory staff can make errors when labeling, testing procedures or documenting, and they will go unnoticed unless there is a set procedure in place for testing, because the staff will have less work to do.
Common Types and Examples of POCT
- Blood glucose meters in wards, clinics and home-care settings
- Blood gas and electrolyte analyzers in ICUs and emergency departments
- Rapid antigen and antibody tests, such as dengue, malaria or pregnancy tests
- Cardiac marker tests used in emergency assessment
- Coagulation (INR) monitors for patients on anticoagulant therapy
- Haemoglobin and HbA1c devices in outreach camps and clinics
- Urine dipsticks for quick screening
Benefits of POCT for Diagnostic Laboratories
The use of Point-of-Care Testing (POCT) may reduce the time required to arrive at a clinical diagnosis. POCT is especially valuable in emergency care settings; at health camp outreach programs; and in cases where sampling must occur in remote locations. POCT requires only minimal volumes of sample, making it possible to collect samples from pediatric patients and those with difficult-to-locate veins. POCT is not limited to utilization within diagnostic laboratories but rather may be utilized as part of health camp programs; during home visits; or as part of corporate screening programs, all while utilizing a smaller analyzer than what would typically be needed.
Common Challenges in POCT Management
In general, the difficulty is rarely caused by the equipment. It is usually due to the amount of people, locations and files that are involved.
- There are many types of operators, and there is no standard for their training. Each type of operator (nurse, technician or physician) may use a different method of performing tests.
- There are gaps in quality control. When no staff is working at the laboratory, controls can either be ignored or undocumented.
- There is a proliferation of devices (meters and analyzers) used across several departments and branches of hospitals, however there is no specific person responsible for each device nor are any records kept regarding their calibration or maintenance.
- Patient identification errors. Results get attached to the wrong record.
- The lack of documentation means that findings documented on paper or in notes have not been formally recorded into the patient's record.
- The data are inconsistent. Since POCT results do not interact with the LIS, there is no way to identify patterns and/or inconsistencies in the data.
How Should Laboratories Coordinate POCT?
A good point-of-care testing (POCT) program is an integral part of a laboratory's quality program, and does not treat POCT as a completely separate function within the laboratory. Although the laboratory will not perform every test that is done at the patient's bedside, the laboratory defines which types of tests may be performed at the bedside and makes sure they are done correctly.
Set clear ownership
The responsibility for monitoring the performance of point-of-care testing (POCT) at various locations may rest on a single person or a small team of people. For example, this person could be a pathologist or other senior laboratory staff member. The types of POCT that can be performed by different categories of personnel should be defined along with the identification of those responsible for reviewing the performance of those individuals.
Train and assess operators
The operator must have received appropriate training before he/she can begin to operate the equipment, and also receive periodic assessment. All operators that are capable of performing all of the tests associated with the equipment and when they will lose competency in these areas should be documented. Testing cannot take place if the operator has not been trained to use the equipment, or if the operator's training is no longer valid.
Run and record quality control
Define when quality control procedures are to be performed (i.e., at the start of every shift before the first patient test; when you switch to a new lot of strips or meter; etc.) and what will happen if a control fails. If a control fails, you cannot use that device to test patients until the issue is fixed. For example, a ward's blood glucose meter can be tested with control solution at the beginning of each shift before testing any patients, and also when they open a new box of strips. You must document all controls, failures and corrective actions. Quality control in POCT is only successful if it is documented correctly.
Manage devices as assets
Create a continuous record of each item of equipment: where it currently resides physically, what is the serial number of each item of equipment, when each item of equipment is due to be calibrated and/or receive routine maintenance, and the manufacturer's expiration date for the reagent. You will need to develop some method of identifying a piece of equipment that has gone missing (or has missed its scheduled calibration/maintenance) so that you can take corrective action prior to a problem developing.
Make patient identification and documentation consistent
Every time you scan or input data, please use two identifiers. You must use the exact same two identifiers each time. Additionally, please clearly define what will occur after you obtain the results of your scanning/inputting activity; who is going to enter the results into the patient's record; and how long after the results are available to enter them into the patient's record. Finally, please establish an escalation procedure when you identify critical values.
Keep communication open with the central laboratory
Share performance appraisals with each other and engage in open dialogue regarding mistakes that occurred during testing. Establish the conditions under which a POCT result should be verified by the primary laboratory (e.g., if any of the results obtained do not align with prior testing).
Role of LIS and Laboratory Management Software in POCT
To continue to meet the needs of POCT across wards, branches and camps, manual record keeping systems such as paper registers and spreadsheets will not suffice. Laboratory Information Systems (LIS) or Laboratory Management Software will assist in creating a structured environment for POCT related activities. This includes but is not limited to: patient records, test orders, results, reporting, quality control, inventory management, and audit trails.
In practice, this can support POCT coordination in several ways:
- Keeping patient identity consistent across tests, reports and visits
- Maintaining quality and compliance records for audits
- Tracking reagent and consumable stock and expiry
- Keeping an audit trail of who entered or changed a result
- Giving managers a single view of laboratory workflow management across branches
MargLabz is an Cloud-Based Pathology Software application (Lab OS) that has more than 40 separate applications that provide solutions for tracking/managing patients & samples, testing & reporting, laboratory equipment interfaces/analyzer integrations, quality control/assurance & compliance, financial billing/invoicing, inventory control/digital health. Organizations considering options for Point of Care Testing (POCT) systems should evaluate how well each piece of equipment and result types are handled by the system they are evaluating using their own scenario.
Best Practices for Better POCT Coordination
- Start with a written policy listing approved tests, devices and locations.
- Limit device models to simplify training and maintenance.
- Keep a live competency list and stop lapsed operators from testing.
- Review QC records and device logs on a fixed schedule, not only before audits.
- Compare POCT results with central laboratory results at set intervals.
- Record the operator and device with every result in the patient record.
- Audit a few cases each month, from sample to documentation.
Conclusion
The use of POCT can help provide clinicians with fast results on-site, but obtaining fast results does little good unless those fast results are both accurate and properly documented. Laboratories which have taken over the operation of POCT equipment, provided training to personnel on how to use the equipment, documented the quality control of the equipment, and maintained connectivity of the data generated from the equipment will be able to successfully incorporate POCT into the overall laboratory testing program (central laboratory) without compromising patient safety. It is suggested that you begin with a single type of equipment or a single area/unit within your facility, establish the proper procedures for utilizing the equipment, and once those procedures are working as expected, expand your POCT operations.