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Point-of-Care Testing

The Evolution of a Training and Competency Program at Cleveland Clinic Abu Dhabi

Fitzmaurice, Emma BSc, MSc; Harris, Jonathan BSc, BSc Biochem, MSc; AbdelWareth, Laila MB BCh, FRCPc, FCAP, EMHCA; Kumar, Chandan BTech

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Point of Care: The Journal of Near-Patient Testing & Technology: June 2020 - Volume 19 - Issue 2 - p 25-32
doi: 10.1097/POC.0000000000000201
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Abstract

Cleveland Clinic Abu Dhabi (CCAD) is a contemporary 365-bed, state-of-the-art quaternary facility, which opened in April 2015. The greenfield build was a collaborative effort between the investment arm of the Abu Dhabi government (Mubadala) and the US-based hospital Cleveland Clinic in Ohio. It was developed to address the medical treatment and critical care deficiencies that existed in the emirate of Abu Dhabi and United Arab Emirate population.

The point-of-care testing (POCT) department was established upon opening and is now seen as a reference site for POCT governance, organization, and management in the region (Harris et al, 2018).1 The CCAD POCT program has the broadest scope accredited internationally to International Organization for Standardization (ISO) 22870 2016 with the United Kingdom Accreditation Service.

The objective of this article is to provide a review of the evolution of CCAD's approach to meeting the training and competency requirements for its POCT program. It will discuss when the hospital opened to the present and plans for the future. The POCT team believes that the experiences and lessons learned will be of benefit to those who will embark on a greenfield project in the future and/or those who are working within an established system currently.

Creating and maintaining a successful recertification (competency renewal) program is one of the biggest challenges for any POCT program. In CCAD, the scope of POCT is broad, complex, and growing. Since opening, the scope (Table 1) has reached 16 test types, with further applications in review. With patient census figures rising and expansions planned within the hospital, the demand for initial training and competency renewal increases. The department has addressed the recertification challenge with some novel approaches, which have brought about challenges initially but ultimately successes. Using the hospital information technology (IT) infrastructure and POCT middleware applications available, the POCT department has migrated from a hardcopy system to electronic management for training and competency records. This facilitates compliance to local regulations and international accreditation requirements.

TABLE 1
TABLE 1:
Cleveland Clinic Abu Dhabi POCT Program

The concept of personnel training for POCT is not a recent development. As far back as 1987, an article in Diabetes Care stated “The usefulness of blood glucose monitoring depends on the accuracy of results. Accuracy depends on proper technique and proper technique depends on the adequacy of training.”2 Unlike the traditional laboratory setting, where there is a centralized system for overseeing training, POCT coordinators have the added challenges of managing hundreds or thousands of staff across multiple disciplines throughout the hospital. Ensuring that staff is trained correctly is a collaborative approach between nursing and laboratory.

Restricting access to only those who are fully trained and competent is the objective of any successful POCT program. In a US study conducted in 1999 by the Institute of Medicine (Kohn et al, 2000),3 100% of participants advocated that untrained staff or those whose competency had expired should have access removed from a POCT device. This supports the idea that to ensure quality of test results in the near patient setting, advances in ongoing training and continuous education are necessary. Since 2015, POCT at CCAD has achieved College of American Pathologists (CAP), Joint Commission International, and ISO 22870 accreditation. One of the CAP requirements is that the 6 elements of competency assessment (Table 2) will be used. The number of elements that needs to be covered is dependent on the classification of the test as waived or nonwaived. A minimum of 2 must be covered for waived testing, whereas all 6 must be met for nonwaived. These requirements also complement the ISO standards (section 5.1), which also alludes to the 6 elements.

TABLE 2
TABLE 2:
The CAP 6 Elements of Competency

Hospital expansion and extensions to the POCT scope created challenges in managing and overseeing staff competencies. Initially, it was a completely manual system (Table 3). Retaining hardcopy training documentation for hundreds of staff created clerical demands and logistical problems. In the traditional POCT setting, documentation for training is handled by nursing staff or human resources (HR), meaning that individual units and/or HR will take ownership for compliance and control of records. In CCAD, the responsibility resides with the POCT manager and coordinator. Mass onboarding of caregivers, as the hospital opened, meant that some staff were being trained on several devices during their first weeks of orientation throughout the first year of opening. The impact of this was obvious in the following year when there were endless expiries of competencies monthly. Failures to recertify on time meant access management for devices became increasingly harder to manage and regulate. Some of the POCT devices in use have operator “lock out,” allowing POCT coordinators to control access. This is to ensure that only those who have recertified can perform patient testing. This is an invaluable compliance tool. However, there still are many devices, which do not offer this function. Frequent reminders from POCT staff to nursing to recertify and locking out of caregivers (those who did not recertify) caused frustrations for both nursing and POCT staff. With recurrent recertification demands (as mandated by CAP), it became obvious that this ad hoc approach was not sustainable.

TABLE 3
TABLE 3:
Progression of Training and Recertification in the CCAD POCT Department

It was decided that dedicated recertification months (Fig. 1, Table 3) would be more beneficial in governing the competency of staff. This formed part of continuous improvement (CI) initiative, which included annual review of policies, nonconformances, audits, and caregiver feedback for each device. All of this quality data are reviewed and improvements are implemented as part of annual recertification. Training issues identified through the quality management system from the previous year become key learning points for the year ahead.

FIGURE 1
FIGURE 1:
The CCAD POCT recertification months.

A key performance indicator (KPI) of 90% for completed recertification was established during the final quarter of 2017 (Table 3). Having successfully achieved this during 2018, the decision was made to increase it to 92.5% for 2019. Meeting and exceeding this target is a constant focus. This was possible because of the support and active participation of superusers (local nurse trainers), nurse management, and nursing leadership.

During these dedicated months, the status of recertification by caregiver is reported weekly to local managers. Through sharing of this information and accountability taken by the responsible manager, CCAD achieves and sometimes exceeds its KPI target.

Development of software that could interface devices and support initial training and ongoing recertifications became a primary focus for improvement and system evolution. One of the biggest obstacles that CCAD continues to face is a meaningful capture of competency elements with devices and Middleware applications (Roche Cobas IT and Siemens Poccelerator). In the context of recertification, Roche Cobas IT offers a valuable tool in the form of observed test sequence (OTS; Fig. 2, Accuchek Inform II Operators Manual, 2014).4 The OTS function allows an observer (superuser) to review and confirm an end-user patient testing competency by witnessing a patient test to ensure that procedures are being adhered to. They then document the performance with a pass/fail result. The audit trail is captured electronically. The entire process is saved alongside the final result with any additional comments. The POCT team at CCAD considers this approach transformative and best practice. It is our view that such solutions should be available for all POCT instruments used in all hospital settings. An OTS style function remains unavailable from non-Roche vendors currently, meaning that an auto recertification approach is not possible for most of our scope. This is a serious limitation that needs to be addressed by most POCT manufacturers.

FIGURE 2
FIGURE 2:
Observed test sequence workflow. This figure can be viewed online in color at www.poctjournal.com.

The OTS function along with Cobas Academy (educational software that complements Cobas IT)—a platform for creating examination material—initially offered a hybrid solution for recertification requirements for Accuchek glucose and Coaguchek prothrombin time/international normalised ratio by facilitating auto recertification (Fig. 3, Table 3). Poccelerator offers a similar platform, E-Trainer, as a potential solution to the training requirements for devices, which are connected to that. However, despite of the software, the functionality and accessibility of the training application proved more complex than first envisaged. Training material needed to be SCORM (share content object reference model) compatible, which would require all training material to be either converted or recreated in this particular format. None of the vendor material available to CCAD was SCORM compliant; consequently, this valuable resource could not be used. For that reason, Cobas Academy proved to be the best alternative to accommodate examination questions and generate examination certificates for all our scope including the Roche devices.

FIGURE 3
FIGURE 3:
Auto recertification for Roche Accuchek glucose and CoaguChek prothrombin time/international normalised ratio. This figure can be viewed online in color at www.poctjournal.com.

In early 2018, Roche announced that Cobas Academy would no longer be available as a portal for online examinations. The major setback from this was the fact that (a) examination completion would no longer feed into Cobas IT and auto-update staff certification tasks and (b) completion certificates would not be generated for staff. Completion certificates reflect the fulfillment of all tasks for initial and ongoing assessment (Fig. 4), and it is this that essentially prompts auto recertification in Cobas IT. As part of a nursing lead initiative, these completion certificates (along with other mandatory nursing competencies) will contribute to staff appraisals at CCAD. With an emphasis on CI, the POCT team treated the obstacle of the loss of Cobas Academy as an opportunity to examine alternative solutions for examination completion and auto recertification.

FIGURE 4
FIGURE 4:
Recertification stages for initial and ongoing assessment. This figure can be viewed online in color at www.poctjournal.com.

A Learning Management System (LMS) in use by the nursing education team offered an alternative platform to manage initial training and competency renewal. One-to-one instructor training is invaluable for both waived and nonwaived devices, and we did not seek to replace this with e-learning alone, but rather support it. With mixed reviews over the value of e-learning to staff during routine work hours as a sole source of training (Bietenbeck et al, 2019),5 CCAD requires all staff to undergo face-to-face training initially, with support material and examination questions being available on LMS (Table 3).

An LMS is a software program that supports the design, documentation, reporting, and distribution of training courses and material. Because it is a web-based application, courses can be customized and assigned remotely to end users via e-mail notification with instructions for use. However, it is a standalone application, and there is currently no direct interface between LMS and Cobas IT. During the last quarter of 2018, the POCT department met with the laboratory IT team, Roche representatives, and a CCAD Learning Technologies Specialist to examine the possibility of integrating the LMS module with Cobas IT. The concept was tested for Accuchek recertification month (POCT glucose) in March 2019. With more than 1200 end users, the Accuchek is by far the most widely used device at CCAD. Glucose recertification would be greatly affected with the loss of Cobas Academy and its auto recertification capabilities.

Having used LMS for other non-Roche devices, the proposal was to build an examination in LMS and then export completed results to Cobas IT to fill the missing link for auto recertification. Although the concept seems simple, the reality proved more complex. Unique usernames in LMS are a different format to operator ID used in Cobas IT. Examination status in LMS (completed, in progress, failed) differ from numerical values (0 or 1) built in Cobas IT. There was no way of reflecting examination completion in LMS in real-time on Cobas IT. Staff assignment by location on LMS was not 100% accurate, meaning that mass enrolment was hindered. Finally, no auto-generated completion certificates were issued to staff on completion of tasks as the integration between Cobas IT and LMS was lacking. Completion certificates need to be issued from the LMS for nursing record purposes.

Our IT team played an important role in overcoming some of these shortfalls. The POCT coordinator generated scheduled reports from LMS of completion status of examinations with LMS usernames. This was then translated by the IT team into a Cobas IT compatible format using scripted reports. These scripted reports were then imported into Cobas IT, acting in a similar way to the link Cobas Academy played, closing the loop of auto recertification. The POCT coordinator then produced regular reports from Cobas IT of end-user recertification completion status and shared to nurse managers. To generate electronic completion certificates, the coordinator used these exported Cobas IT reports, converted them into comma-separate value files and once again imported this information into LMS, producing a completion certificate for end users to have (Fig. 5). This could then be uploaded manually by nursing to our in-house HR portal, Mawared, to reflect end-user compliance.

FIGURE 5
FIGURE 5:
Recertification cycle integrating LMS with Cobas IT. This figure can be viewed online in color at www.poctjournal.com.

Cleveland Clinic Abu Dhabi successfully surpassed our KPI for recertification for Accuchek in March 2019, with the final figure for completion exceeding 96%. This was a significant achievement considering the cumbersome and lengthy workflow created to achieve our target. However, the concept worked, lessons were learned, and further improvements were sought.

Each month brings a different recertification and, with that, unique challenges. Forward planning means we can be fully prepared and anticipate where problems may arise and address them ahead of time. Continuous improvements in our training program remain a key focus. However, the vision for uniform training solutions is hindered by software and vendor restrictions. For the purposes of auto recertification, Table 4 gives a breakdown on how limitations in software mean that the process remains cumbersome and nonstandardized. Ideally, OTS capabilities would be at our disposal for all tests, capturing end user and trainer operator ID for a fully traceable process.

TABLE 4
TABLE 4:
Components of Training Courses

It has to be acknowledged, however, that the use of LMS has transformed the management of the training and competency renewal program. Documentation uploading is now the responsibility of the caregiver rather than the POCT coordinator. The POCT manager has a bird's eye view of who has completed what and when virtually. Those who have not completed their training are quickly identified and follow-ups can be made. In time, the LMS will be an alternative to the manual spreadsheet of training and recertification history for all caregivers (CAP requirement and best practice). Another manual task will be eliminated.

Nursing education identified “technical skills” in the form of courses, which are associated with each clinical area in the hospital (Fig. 6). These are considered mandatory and POCT (after discussions between laboratory and nursing education) was included in this. Nurse educators sought to streamline the management of skills documentation and make the process that existed more effective and efficient. After assigning each course to a specific job description (mapping of skills to each caregiver position), this criterion has been built into LMS: auto assigning of courses to caregivers via LMS. Upon arrival of new staff or recertification for current end users, a notification will be sent to the individuals with their customized requirements for training and ongoing assessment. This is another transformation, whereby the coordinator no longer has to assign courses manually. Caregivers are identified for each POCT device via LMS automatically. This was only possible through a collaborative effort of nursing managers, directors, and educators.

FIGURE 6
FIGURE 6:
Technical skills integration project for POCT. This figure can be viewed online in color at www.poctjournal.com.

Nursing educational leadership is currently working on a technical skill integration project, which will see a bidirectional interface being established between LMS and Mawared (HR Portal) (Table 3). The objective of this is to (1) satisfy Joint Commission International requirements to have a centralized site for staff competency, (2) align with CCAD HR initiatives to use Mawared as the source of truth for staff competency, (3) provide end users and managers with access to technical skills status, and (4) promote accountability of end users for their own professional development. This project is underway and will be completed by June 2020. By establishing an interface between LMS and Mawared, end-user compliance, and historical records of recertification can be archived and available from a central catalog (Mawared). Point-of-care testing competency records will be stored here with all other mandatory skills.

Finally, the POCT teams have incorporated a real-time feedback survey on LMS for all caregivers who have completed their recertification. This is mandatory for a completion certificate to be created. This will feed into CI activities for the next year.

2019 has been a year of great progress for the POCT training and education program at CCAD. We will implement further improvements in 2020. With the planned upgrade of Cobas IT 1000 to version 2.09 and by ensuring all POCT servers are active directory (AD) compliant, the anticipation is to minimize manual input by IT and POCT teams as much as possible; streamlining what was once a hardcopy system to a fully automated platform. The 2.09 version will facilitate interfacing between Cobas IT 1000 and the LMS. Another transformation will automate the documentation of competency right through to the HR portal Mawared.

Cleveland Clinic Abu Dhabi will transfer some non-Roche devices onto the Cobas IT platform to further use the certificate system that exists on that platform and integration with LMS/Mawared.

Achieving compliance with AD means that the authentication and authorization of end users will be a largely automated and centralized process (Table 3). For example, when an end user logs into a desktop that is part of a Windows domain, AD verifies the submitted password and determines whether the user has access or not and allows auto login to the application. This essentially means that only one password is required to manage their profile. It also means that it will be possible to automatically revoke access from the application once an end user leaves the organization. To use the functionality of AD to its full potential, the POCT department, alongside IT and the Roche team, are currently exploring the possibility of having 2 identifiers for staff in Cobas IT 1000, the first being their operator ID and the second being the username used by Mawared and LMS. Essentially, this would mean that information can easily migrate between the 3 platforms (Fig. 7). Operator ID would enable access to devices, whereas standardization of the user name would facilitate communication between the 2 software applications. This means the system will automatically be interfaced with auto generation of completion certificates from LMS. Staff whose job description fall into the category of clinical and nursing and a select group from allied health will automatically have profiles created in Cobas IT from AD after information feeds from Mawared.

FIGURE 7
FIGURE 7:
Future workflow for recertification. This figure can be viewed online in color at www.poctjournal.com.

The POCT department will still be required to manually provide access to devices through an activation step; however, the rest of the process will be automated, from auto enrollment of courses in LMS, creation of completion certificates, and the final update in Mawared to reflect end-user compliance.

In April 2019, the laboratory at CCAD was transferred to the National Reference Laboratory, another Mubdala entity. The structure of the POCT service has changed from a dedicated department to a traditional collaborative model between laboratory and nursing. A clinical instructor under nursing education has been assigned to support the POCT training and competency renewal efforts. This arrangement is working well, and an excellent relationship exists between nursing education and the laboratory.

In collaboration with our nursing education colleagues, the POCT team plan more enhancements and innovations in the year ahead. This includes simulation, game-based learning, and the concept of gamification (which is an available functionality on LMS). Discussions will take place with the other Middleware provider with a view to integrate that with LMS also. The POCT team will also look at different methods of assessing competency, which will add value to experienced staff as well as new ones to promote deeper learning. Error detection reports will be pulled annually from middlewares and analyzed before recertification. Key learning points will be derived from this analysis. Any caregiver identified with multiple errors will be retrained.

The evolution of the POCT training and recertification program has been one of discovery and deep learning. This has only been made possible through collaboration with IT service, nursing education, and superusers on the floors. The training program that exists now is more sophisticated and superior than what existed at the outset. This is a credit to the tenacity and passion of the POCT team (manager and coordinators), IT team, nursing colleagues, and nursing leadership.

REFERENCES

1. Harris J, AbdelWareth LO, Lari S, et al. Setting up a point-of-care testing service in a greenfield, quaternary hospital: an implementation review. Arch Pathol Lab Med. 2018;142(10):1223–1232.
2. American Diabetes Association. Consensus statement: self-monitoring of blood glucose. Diabetes Care. 1987;10:95–99.
3. Kohn LT, Corrigan JM, Donaldson MS, eds. Committee on Quality of Health Care in America, Institute of Medicine. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press; 2000.
4. Accuchek Inform II Operators Manual, version 5.0, 2017–04. Basel, Switzerland: Roche Diagnostics; 2014.
5. Bietenbeck A, Wust K, Luppa P. Users Regard Operator Training as Critical for Successful POCT Applications. Clinical Laboratory; 2019.
Keywords:

point-of-care testing; training; competency; Abu Dhabi

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