ISO accreditation for laboratory services (ISO 15189) is gaining widespread acceptance and adoption internationally. Indeed, many jurisdictions are making ISO accreditation mandatory for their pathology services to ensure quality and competence.
For example, Daman (Abu Dhabi Insurance Provider) has instructed that all medical laboratories in the Emirate of Abu Dhabi must have ISO 15189 accreditation status for laboratory test payments to occur. In the Irish Republic, all laboratory transfusion activities must be accredited to the standard. Many more are adopting it voluntarily as a sign of quality and commitment to the highest standards.
One pathology discipline that has been left behind in this accreditation renaissance is Point of Care Testing (POCT). The reasons for this are many, varied and complex. The challenges associated with POCT accreditation and potential solutions are the subject of this editorial piece. The attitudes towards POCT and its management need to change by all those involved, inside and outside the laboratory. Nowadays it would be unthinkable for a reputable laboratory not to undergo ISO 15189 accreditation, but yet for POCT, it is seen as “an impossible dream”. This viewpoint is held because the discipline falls between two stools (hospital and laboratory) making management difficult with no effective organisation/governance structure in place. Resources are typically ring fenced for the main laboratory with POCT usually at the end of the line.
Cleveland Clinic Abu Dhabi is the first hospital in the Middle East to gain accreditation status (ISO 22870) for its POCT services with the United Kingdom Accreditation Service (UKAS). ISO 22870 is an annex document to 15189 and both standards are assessed in parallel by the accreditation agency. Our experience shows that the obstacles facing POCT services to gain accreditation are not insurmountable if the commitment from laboratory and hospital leadership exists. Its benefits once implemented are obvious. Accreditation provides a framework to structure the service, establishes quality benchmarks in a challenging pathology discipline and gives independent and international recognition of competence.
The following impediments need to be addressed before a decision to undergo accreditation is made.
Commitment across the organisation
POCT involves stakeholders across the entire hospital organisation: nursing, perfusionist, physicians, and respiratory therapists amongst many others. The successful implementation of accreditation requires commitment from all of them. It also requires commitment from the highest level: hospital and nursing leadership. At the outset of our accreditation journey for POCT, meetings were held with the chief nursing officer of CCAD. Support and 100% assistance required was offered and given.
Subsequent meetings were held with nursing management and floor staff across the hospital. The Chief Nursing Officer was present at some of these meetings seeking support from everyone. Without this public endorsement and engaged commitment from the top, the quality culture and accountability required for a successful POCT programme would not permeate through middle management and patient facing health personnel.
The engagement of busy nursing, physician and allied health personnel is a constant challenge. Staff are focused on the clinical management of patients and not the technical limitations of instrumentation and pre-analytical variables which can cause wrong results. It requires the “soft skills” to build good relations with our nursing colleagues, ensuring that quality outcomes are always assured. Without this collaboration and mutual respect, root causes of quality issues may not be identified to ensure corrective actions are put in place.
Governance and management
The governance and management of POCT in hospitals is frequently misunderstood, ineffective or not in place at all! When establishing a POCT programme it is important to identify and involve the key stakeholders and to initiate a well-defined organisational structure which includes a POCT Committee. Membership should include clinical engineering, hospital risk management, nursing leadership, Information Technology (IT), clinicians, POCT manager, pathologists, hospital quality, finance and nursing educators to ensure a multi-departmental approach is adopted.
Essential documents include the POCT Charter and POCT policy which are developed by the POCT committee and endorsed by the hospital executive.
Developing the POCT policy, which is a high-level document outlining the core principles and rules applicable to the discipline, was the first step in clarifying the role of the POCT programme. It also defines what POCT is in CCAD. This provides clarity if questions are raised about certain testing or devices. Every hospital will have their own definition outlining the scope of testing in their local institution.
The charter details the committee membership, rules and procedures governing the group. It also highlights the reporting relationships with other committees in the hospital, in particular the Medical Executive Committee (MEC) or governing committee of the hospital. The POCT committee reports directly to the MEC, the management committee of the hospital. The strategic role of the POCT committee is described in the POCT committee charter signed by the Chief Executive Officer (CEO) of the hospital. This endorsement is very important as it gives legitimacy and recognises the central role the POCT committee plays as the gatekeepers of POCT in the organisation.
How the service is managed on a day to day level is another key challenge. POCT is often a sub-discipline of clinical chemistry. However, POCT incorporates other disciplines such as haematology, coagulation, microbiology and molecular biology. Technologies involve a wide variety of different analytic principles: reflectance, lateral flow, electrochemistry and multi wavelength spectrophotometry amongst others. Hospitals with a large POCT programme in place, may decide not to subsume it under another discipline where it might not receive the attention or resources it deserves.
CCAD took the view that POCT is a unique pathology discipline and it should be treated as such. A separate POCT department was established, led by a POCT medical director and POCT manager with dedicated staff. The POCT Medical Director is responsible for the overall operation and administration of the POCT programme whilst the POCT manager is responsible for the technical and scientific oversight, training and competence assessment of testing personnel. The manager also plays a key role in selecting the testing methodologies appropriate for the clinical demand and verifying its performance. This is not the only model for POCT management. Other approaches can be taken (such as that outlined above) and responsibilities can be shared, but adequate resources to provide quality oversight and control must be given!
IT Connectivity
Managing hundreds of devices and 1,000s of operators effectively whilst ensuring quality on a daily basis is beyond the means of any POCT Coordinator or management team. We cannot be everywhere all the time, over everyone’s shoulder. IT management solutions are vital for enabling the oversight and day to day control needed to ensure patient safety and meaningful quality oversight. An integrated system allows for electronic patient identification, operator traceability, reporting of results to the patient’s permanent medical record, real time device monitoring, remote maintenance and that all-important day to day management!
There are many solutions available now from vendors with frequently no cost associated with the software itself. Resources are needed to integrate it with the hospital IT system and ideally patient results flowing to the Electronic Medical Record (EMR). Frequently the best devices come from different vendors. With this in mind, it’s better to procure vendor neutral software that does good things for all devices rather than vendor support software which frequently have limitations with connecting other vendor device types to it.
Training and competency
Most errors relating to POCT are usually not related to the analytical performance of the instrument itself but occur during the pre-analytical phase, i.e. operator associated. The cause of these errors typically includes inadequate training, miscommunication and misunderstanding. An effective well-structured and standardised training and competency programme is vital to ensure quality and patient safety. In a large organisation, this challenge is magnified due to the variety of staff, different mind sets, different skill sets and experiences.
The volume of caregivers requiring training is frequently beyond the capability of POCT coordinators. Support is needed from nursing administration and education to assist and complete these important tasks. Having this kind of multidisciplinary support and collaboration is key to successfully training significant numbers of staff. It is extremely important that laboratory and nursing leadership have a mutual understanding and appreciation of one another’s departmental operations and requirements to ensure cooperation and success.
Documentation of training is another challenge. A paper-based system detailing all the concomitant requirements such as patient sampling, QC and exams, posed significant administrative demands.
Tracking and monitoring competency records for many of our devices is performed manually which is very challenging, particularly when competency periods expire. Paperwork is kept centrally and all details recorded and tracked on a spreadsheet.
Software solutions are available now that can automate the process, capturing all the requirements as they are done, simplifying the process. This can transform the management of this perennial problem but requires financial resources which are not always available. CCAD has procured software to manage our glucometer and coagulation instruments. This has ensured we are able to provide all training and competency requirements for these devices more efficiently. Such a system is known as auto certification. More software has now been recently procured and CCAD intends to implement a similar auto certification system to the glucometers, for as many other instruments as possible in the future
Continual Improvement
One of the most challenging aspects of introducing any quality management system, is establishing an effective system of identifying, reporting and managing non-conformities. This is very challenging with hundreds of devices and thousands of operators.
CCAD uses an online incident reporting and risk management system for our nursing and allied health colleagues. Intuitive software with different icons direct hospital staff to the appropriate drop down menu with specific fields to record the event information. Instructions on how to report any events are included in an online mandatory POCT course for staff when they begin working at CCAD. This course includes how POCT is governed, managed and expectations of responsibilities from clinical staff. As part of this hospital wide event reporting system, a specific POCT option was created as part of the menu to allow hospital staff to report events. This is directed to the POCT manager and the department for follow up.
The POCT department also has its own internal event reporting system, which is part of the quality department system in the laboratory. A dedicated person in the POCT department manages this day to day. This generates a lot of information which gives meaningful data by location, caregiver type, instrument type and testing phase: pre-examination, examination, post examination. We also have a comprehensive audit schedule in place covering all our devices, locations and instrument operator types. This satisfies our ISO obligations. The object of performing audits is to identify non-conformities and address them. The POCT department also wants to identify potential non-conformities-situations identified that may cause future issues. Non-conformities are written up with a close out target of 30 working days. The audit cycle is completed annually.
The POCT department constantly strives to improve our service to the end users and so a POCT email address was created to allow the end users an easier and more convenient way of communicating with the team. The department also periodically seeks input from hospital staff as to how the POCT service and training can be improved. For example, suggestions from our nursing educators and POCT users have led to a simpler and shorter knowledge test for POCT glucose. We have an annual online survey where we seek feedback from our colleagues working on the floors. This generates a lot of feedback on valuable information which we follow up on.
Addressing the myriad of challenges that POCT typically suffer from require resources. Without adequate financial and human capital resources, best practice, quality and competence cannot be assured and remains an impossible dream. With widespread acceptance of ISO 15189 in the main laboratories, attention will inevitably fall on POCT. Health authorities will seek the same standards to be applied to POCT. So, change is coming sooner or later. Let the renaissance of POCT accreditation begin! More importantly, accreditation ensures the goals of best practice and patient safety are realised for the discipline of POCT. The impossible dream will become a reality. Let’s get to work!