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Point-of-care testing and accreditation

Point-of-care testing (POCT) refers to the testing of patients’ samples, such as blood or urine, at the location where the patient is being treated, rather than sending the samples to a centralized laboratory. POCT can provide rapid results, allowing healthcare professionals to make quicker and more informed decisions about a patient’s treatment.

Accreditation is a process in which a facility, program, or service is evaluated against established standards by a third-party organization. In the case of POCT, this means that the equipment, processes, and personnel involved in testing are evaluated to ensure that they meet the standards for accuracy, reliability, and quality.

One key reason for POCT accreditation is to ensure patient safety. Accurate and reliable test results are essential for the proper diagnosis and treatment of patients. Inaccurate results can lead to misdiagnosis, inappropriate treatment, and even harm to the patient. POCT accreditation helps to ensure that test results are accurate and reliable.

In India, accreditation is voluntary; many hospitals opt for NABH and laboratories opt for NABL accreditation based on ISO 15189. Recently in 2022, ISO 15189 has been modified to include POCT in the scope of accreditation where ISO 22870 has been added. This is a welcome move, which will be immensely beneficial for patient safety and hospital managements.

POCTs are operated by nurses. OT/anesthesia technicians, emergency technicians, who in their own capacity are proficient but may not be aware or even amenable to the discipline of laboratory equipment-related quality-management system. Lab QMS involves daily maintenance, daily internal controls, EQAS, training, competency evaluation, risk management, service contract, inventory, etc. It may be beyond the capacity of nursing and non-lab technicians to keep track of these.

In the past, lack of a guiding framework kept the lab personnel away from taking the responsibility of POCT quality-management system. The ISO 15189 now states that the quality assurance system of the POCT should rest with the lab where duly trained personnel will supervise and train the end users, the competency mapping, the equipment maintenance, and track the non-conformities.

Hospitals, which have implemented the ISO 15189 and ISO 22870, have found immense benefit.

Data management in POCT is a huge challenge as vast majority of POCT are not connected to hospital information system. Documentation of results in patient files, critical alerts, and inventory management all can be satisfactorily approached with accreditation and laboratory oversight. All POCT devices, if connected to HIS, the benefits reaped will be immense for patient care and safety.

It has been amply illustrated that pre- and post-analytical errors form 60 to 70 percent of laboratory errors. For POCT, such studies, if extrapolated, make them fraught with risks considering the lack of oversight and follow up. On the contrary, if such errors are detected due to QMS they will certainly be addressed and minimized with training and competency mapping.

As the system matures choosing appropriate quality indicators for POCT ensures that quality is monitored on an ongoing basis, and offers insight into areas requiring improvement.

As a lab head and NABH assessor, personally I look forward to this exciting development which will shape up in the next 1–2 years. 

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