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Further development of the Australian Point-of-care Practitioners Network for point-of-care Testing for INRA project funded under the Australian Government’s Quality Use of Pathology Program

Final Performance Report – February 2015

© Australasian Association of Clinical Biochemists Inc. 2015

Further development of the Australian Point-of-care Practitioners Network for point-of-care Testing for INR

Australian Point-of-care Practitioners Network www.appn. net.au

Australasian Association of Clinical Biochemists [email protected]

Editing: Andrew St John and Rosy Tirimacco

Contents

Background iv Introduction v Executive Summary vi1.0 Activity work to develop a quality framework for PoCT 12.0 The development of guidelines to support the use of PoCT for INR to improve warfarin monitoring. 63.0 Collaboration undertaken with the NPS to support common goals related to the optimal use of oral anticoagulants 84.0 Collaboration undertaken with RCPA QAP in the development of an EQA programme for PoCT 95.0 Difficulties related to performing the above activities.

106. Conclusion

11References

12Appendix 1. Distribution of APPN Members across Australia (as of 28/1/15)

13Appendix 2. APPN competency tests

15Appendix 3. Webinar participation rates

17

Final Performance Report 3

Appendix 4. EQA Case Study

18Appendix 5. Reprint from Australian Family Physician Vol.44 Jan-Feb 2015

21Appendix 6. Article from Australian Presciber Vol. 34 (in press)

23

Background

The aim of this project was to continue the development of point-of-care testing (POCT) in Australia and to ensure that POCT is performed within an appropriate quality framework. Since the establishment of the Australian Point-of-care Practitioner Network (APPN) in 2010 two important developments have taken place which are likely to expand the need for POCT and the supporting resources of APPN.First, the Sansom report on the Review of Anticoagulant Therapies for Atrial Fibrillation (AF)1 recommended the use of POCT for INR to improve access to warfarin monitoring. The report identified several major barriers to the greater adoption of warfarin as a treatment of AF including lack of monitoring and uniform guidelines for warfarin therapy. In preparing for this project we carefully studied the recommendations of the Sansom review and then designed several sub- projects to address those recommendations. In addition we collaborated with representatives of the National Prescribing Service (NPS) to enhance their educational campaign related on the optimal use of all oral anticoagulants.In addition we sought to resolve the ongoing issue of a user-friendly External Quality Assurance (EQA) for POCT in the community and have developed an EQA programme that addresses both analytical and interpretation performance.A further need for consumers or patients who want to self-monitor their INR levels has also been addressed. While the number of such users is relatively low in Australia, experience in other countries has shown the effectiveness and safety of self-monitoring. This report will demonstrate how APPN can play a role in expanding the numbers of people self-monitoring and therefore address a key recommendation of the Sansom report which is to improve access to INR testing.


Introduction

This report includes the following aspects on each of the 5 major activities associated with the complete project and listed below:

• Activity work to develop a quality framework for PoCT including an education and training program for all POCT operators

• The development of guidelines to support the use of PoCT for INR to improve warfarin monitoring

• Collaboration undertaken with the NPS to support common goals related to the optimal use of oral anticoagulants

• Collaboration undertaken with RCPA QAP in the development of an EQA programme for

PoCT• Commentary on any issues, problems or delays that our organisation

experienced in its performance of the activity and an explanation of how your organisation dealt with those issues, problems or delays.

Executive Summary

During the 18 months of this project we have refreshed and upgraded the content of the website so that it continues to represent the most up to date information to support those providing point-of-care testing (POCT) in the community and provide a quality framework for testing. This has contributed to a steady stream of new website registrations/users, a significant portion of which have used the website to test their competency for POCT.In addition we have completed a number of new tasks related to INR testing at point-of-care including:

• Development of an electronic INR quality management program• Development of an online protocol to guide the initiation and monitoring

of warfarin treatment in patients with Atrial Fibrillation (AF).• Development of a case-based external quality assurance programme.

We have collaborated with a number of organisations to assist with the overall goals of this project. The most successful of the collaborations has been with the National Prescribing Service who have contributed to the generation of consensus guidelines for INR therapy for dosing and they have overseen the development and testing of an online protocol to guide the initiation and monitoring of warfarin treatment in patients with Atrial Fibrillation (AF).Collaboration with a number of General Practice organisations in order to recruit GP practices to test out the POCT tools developed as part of this project has not been as successful. Likewise collaboration with the RCPA Quality Assurance Program to test the case-based External QA program has not been achieved in the time of this grant. However, more recent discussions indicate that this situation will change and we are now exploring how APPN can be developed in collaboration with RCPA QAP.Furthermore, APPN is currently collaborating with the Pharmacy Guild to identify pilot sites where the full range of APPN tools can be tested, primarily in conjunction with INR testing.Over the time of the two grants received from QUPP to develop APPN we have shown that it can provide the tools required to deliver safe and effective POCT according to the required standards. This model is different to what we understand QAAMS provides in that little if any face to face contact with POCT operators is required through APPN. Therefore we believe that the APPN model is likely to be more cost effective at delivering the same standard of testing as QAMMS.The work of APPN has been described in two recent publications which are referenced below.3,5


1.0 Activity work to develop a quality framework for PoCT

The activities in this part of the project have been guided by the need to conduct all POCT in a way that conforms to required standards, in particular, to the AACB guidelines for PoCT in Australia2 and to those stipulated in the Commonwealth endorsed standards.A key part of the work has been the development of an Electronic INR Quality Management (QM) Program but it is important to emphasise that this program can be applied to all other POC tests. The program provides an easy to use but formal electronic quality framework to ensure PoCT is performed to an appropriate standard.Via the ‘Quality Management’ tab on the APPN website, health care practitioners registered withAPPN can log into the QM module and perform a number of tasks including (Fig 1 - 2):

• Allocate a ‘name’ for the instrument for ease of identification• Manage lot numbers for consumables and their Quality Control (QC)

results for each instrument.• Select the type of QC test they intend to perform on the instrument.• Action or review QC results and add any comments as necessary.

The QC results are demonstrated in both table and chart format and the system will indicate if the results are within the expected range (highlighted in green) or if they fall out of the expected range (highlighted in red), as shown in Fig 3. Results out of the expected range will be flagged to the user and a reason must be provided for the out of range result. The system will generate a corresponding action to the reason provided, which will need to be performed by the user. There is an option to request help from an APPN scientist if needed. A poster of the QM Program depicting its functionalities has been displayed at the Australasian Association of Clinical Biochemists (AACB) 52nd annual scientific conference (Fig 4).Other functionalities for the electronic QM includes a help page which contains step by step instructions on how to navigate the QM program for first time users and an export function to download the QC results in an excel spreadsheet or graph as a PDF document. The QM module also incorporates a system of reminder emails which are automatically sent to the user when a QC is overdue.With this program GPs and other healthcare practices can use it to confirm that their POCT devices are performing to the manufacturer’s specifications and producing correct patient results. This web-based system and its deployment will represent a major step forward in ensuring that PoCT is conducted in a similar quality framework to that which operates in central pathology laboratories.


While the APPN model is consistent with the principles of training and education employed bythe QAAMS program, it differs in several aspects:

• There is no requirement for face-to-face or video linked training as all the resources and assessments are online

• The QM module is applicable to all approved PoC devices and QC material• The QM module can be adapted to any suitable External QA program and

is integrated into the online module• The APPN model can be applied across a broad range of PoCT operators.

Figure 1. Entering Quality Control Results into the QM Module

2 AACB APPN Project

Figure 2. Reviewing QC results, ensuring results are within the acceptable range.

Figure 3. Graph and table representation of the Quality Control results performed


Figure 4· Electronic INR Quality Management Program Poster displayed at the AACB 52nd Annual Scientific Conference

While an important activity for this project has been the development of an Electronic Quality Management System, there was also significant activity around the ongoing maintenance and update of the APPN website to ensure it continues to be an education and competency resource for all POC operators. Thus an important process at the start of the project was a software update to improve the functionality of the website together with a facelift to allow easier navigation and increase user-friendliness.In addition there have been regular updates of the content, provision of online education webinars, a presence at key professional meetings such as RACGP – GP14 and ACRRM – RMA14Conference and the continuing availability of a POCT Help line. Together these have facilitated APPN reaching and assisting 2466 members as of Jan 2015 (Appendix 1) with successful completion of 1862 competencies to date. Further details of the APPN members are shown in Appendices (1-3). All the education modules and webinars on the APPN website have been accredited by the Australian College of Rural and Remote Medicine (ACRRM) and the Royal Australian College of General Practitioners (RACGP) for the 2014-2016 triennium.APPN continues to offer and develop a quality framework for POCT, including:

• Instrument evaluations• Training videos• Online competency assessments• Online QC/QA• Webinars

The role of APPN in supporting PoCT in the community is described in a Viewpoint article just published in the Australian Family Physician Journal3

(Reprint of this article is listed in Appendix 5).


2.0 The development of guidelines to support the use of PoCT

for INR to improve warfarin monitoring.The need for better management of the monitoring of warfarin was highlighted in several key recommendations of the Sansom Report1. In particular the Report recommended:

• The need for more convenient, timely, systematic and coordinated monitoring of warfarin including INR testing to guide better dosing.

• Greater use of PoCT for INR testing in the community.• Nationally endorsed dosing and management algorithms for all available anticoagulants.

These recommendations have driven a key part of this project namely the development of an online protocol to guide the initiation and monitoring of warfarin treatment in patients with Atrial Fibrillation (AF). The age adjusted warfarin initiation protocol was implemented as the background algorithm to determine warfarin dosing with PoCT embedded as the clinical contributor. After the healthcare practitioner inputs the patient’s Date of birth and PoCT INR result, the background algorithm derives the recommended warfarin dose. Contraindications are listed and must be checked before proceeding on warfarin therapy. High baseline results are flagged and advice is given on managing these patients. Patient details are captured and the recommended follow up date and warfarin dose are prescribed. A printable calendar showing warfarin dose and time of next INR test is displayed along with a graph plotting all INR results. Time in therapeutic range (TTR) is calculated for each patient and for the practice overall to determine effectiveness of treatment. The tool has now been fully tested and reported on at the scientific conference of the Australasian Association of Clinical Biochemists (AACB) and shown in Fig 5.It was hoped that during the timeframe of this project a pilot study of this tool would be completed. A before and after study would involve 10-20 GPs who are already using PoCT for warfarin management in their practices. They would be asked to monitor and dose their patients using existing guidelines over a period of six months, recording the time in INR therapeutic range (TTR) as the main outcome. After this six month period the same GPs would be asked to use the APPN online monitoring and dosing tool and record the TTR over the next six months. Comparison of the TTR results before and after use of the online tool will reveal whether the tool has improved warfarin management through an increased TTR.

6 AACB APPN Project

Figure 5. Electronic Management of Warfarin Poster displayed at the AACB 52nd AnnualScientific ConferenceA major challenge associated with the project has been the difficulty in recruiting sufficient GPs to conduct the pilot study; this issue will be dealt with more fully below. Since a significant number of pharmacies are also conducting INR testing it might also be possible to conduct a pilot study with this group and we have commenced discussions with the Pharmacy Guild to explore this possibility. In particular we submitted a joint application for a BUPA research grant to continue this work.The pilot study is critical in order to show the effectiveness of the online tool. With evidence of its effectiveness it will be possible to encourage GPs to use the dosing guidelines incorporated in the tool and improve warfarin management. However, this will require a change in practice which is generally not easy in medicine even when good evidence is available to support the change. Thus the magnitude of the required task here is not underestimated and this will require extensive education and follow-up once the pilot trial is completed.


3.0 Collaboration undertaken with the NPS to support

common goals related to the optimal use of oral

anticoagulants

A key part of the online tool described above is the incorporation of warfarin dosing guidelines. Many such guidelines exist which, as acknowledged in the Sansom Report, have contributed to general confusion as to how to dose warfarin patients and this has led to less than optimal patient management. Agreement on which guidelines to use and the details contained within them was thus a key part of this project and it was achieved in collaboration with the National Prescribing Service (NPS).NPS has considerable experience with drug prescribing including advising GPs on warfarin management including its program “Decision tool for anticoagulants” which follows the Warfarin Reversal Guidelines of 20134. To this end a working party (APPN, NPS and haematologist) was established and through regular discussions including face to face meetings over the term of the project, agreement was obtained as to an appropriate set of guidelines for warfarin dosing.While the NPS indicated that the information contained in the agreed guidelines is also suitable for consumers who undertake self-monitoring for INR, no other information specific to patient self-monitoring has yet been added to the APPN website.The collaboration with NPS has continued throughout this project with agreement on the recommendations and guidelines on the optimal use of oral anticoagulants. These guidelines have been incorporated into the electronic warfarin tool discussed above in1 and are a testament to the successful collaboration with NPS. They are also keen to see its wider deployment in the GP community and thus we foresee the collaboration between APPN and NPS continuing after this project is completed. We believe this collaboration has been productive and the future incorporation of uniform dosing guidelines into the APPN training model will be an important part of the POCT quality framework to ensure that POC results are used correctly for patient management.The importance of regular monitoring of INR, including the use of PoCT, has been described in a recent publication by members of this project5 (A copy of this article is listed in Appendix 6).

8 AACB APPN Project

4.0 Collaboration undertaken with RCPA QAP in the

development of an EQA programme for PoCT

Quality management of INR testing requires both an internal QC component and external quality assurance or EQA where individual GP practices can compare their results to their peers using samples distributed by APPN. While such programs are already provided by the RCPA QAP they are primarily for laboratory based POCT users. For GPs the program needs to be provided on an affordable basis and furthermore it needs to go beyond just comparing INR results and assess the GPs ability to interpret the results and take the appropriate clinical actions such as correct dosing of warfarin.Thus we developed an External Quality Assurance (EQA) INR program for PoCT which included integrating a clinical patient warfarin management case with the analysis of two external quality control samples. The first INR case study for the APPN EQA INR program was based on a patient presentation to a GP practice and was reviewed by Dr Philip Tideman (Cardiologist), Professor Alex Gallus (Haematologist) and a South Australian GP. All are supportive of this type of electronic QA program. Details of the case history are shown in Appendix 4.Expressions of interest and registration for the case study were distributed at the Rural Medicine Australia 2013 Conference, sent to APPN members and made available to some existing users of the RCPA-QAP Point-of-Care Program. While the development of this program was initially supported by the RCPA-QAP subsequent discussions indicated that the they were unwilling to provide details of existing QAP users to whom we could have sent the case history and associated samples. It is clear from discussions with the new More recent discussions with the new management indicate there will be an opportunity for APPN to collaborate more productively with the RCPA-QAP in the future.Another problem was limited feedback from GPs – only 4 participated in the case studies – but expressed that they were happy with the program and found it very useful and informative. Despite this we believe that the concept is an important part of quality management. Our view is based on the experiences of a similar POCT support organisation in Norway called NOKLUS who regular use such external QA programs for a variety of analytes including INR. The head of NOKLUS Prof Sverre Sandberg, has regularly visited Australia and in discussing the results of external QA programs, has emphasised that such case histories are important but there is no need to distribute such samples more than twice per year. This is a very different model to the existing INR program within RCPA-QAP which may explain their previous lack of support and collaboration.


5.0 Difficulties related to performing the above

activities.

We have made considerable efforts to liaise with key stakeholders in the area of PoCT including Australian General Practice Accreditation Limited (AGPAL) and the Australian College of Rural and Remote Medicine (ACRRM). This has included several teleconferences and meetings with senior members of both organisations. We have sought their assistance to identify GPs who can trial the tools the APPN is offering in relation to providing a quality framework for testing. One specific need has been the trial of our case history based EQA program and the CEO of AGPAL indicated he could identify 25 practices that would trial this program.Unfortunately, despite our repeated requests, he has been unable to recruit these practices and therefore more rigorous testing of the program has not been possible. Likewise, the initial interest of ACRRM has not translated into practices volunteering to help trial our programs.The underlying issue here is the limited time that GPs have to devote to trialing APPN initiatives. GP practices are busy with limited resources and while many express an interest in POCT and some are indeed carrying out POCT. They often choose to continue doing this without wishing to get involved in what they perceive as POCT research. It is unlikely there will be any improvement in GP engagement without consideration of some form of incentive programBased on preliminary discussions we believe that it may be easier to recruit pharmacies who are currently conducting POCT to engage in trials of APPN tools and we have identified a small number of pharmacies who are willing to act as pilot sites to test the full range of APPN tools as part of conducting INR testing. While this will be useful we would still like to demonstrate these tools within general practice and ways need to be found in the future to achieve this goal.

10 AACB APPN Project

6. Conclusion

This project has further confirmed that the provision of internet support for POCT is popular with many POCT providers and can effectively provide the quality framework for safe and effective POCT. In addition we have shown through the tools developed for INR testing that the key recommendations of the Sansom report in relation to POCT can be achieved.Further, this model can now be adapted for wider use in POCT with the successful development of a user friendly EQA program and the enhancement of the competency and training modules on the APPN website.The future development of APPN, including the testing of the INR tools developed as part of this grant will rely on the continuing collaboration with key organisations. Recent discussions with both the RCPAQAP and the Pharmacy Guild have been productive and have confirmed their interest in using the capabilities of APPN to drive safe POCT in the community. A trial of the INR testing tools including the dosing software remains a priority project for AAPN. A grant application to the BUPA organisation for such a trial was unsuccessful but a small pilot study in several pharmacies is about to start. In addition the establishment of an INR database through the APPN website may also attract the interest of those already conducting POCT for INR and encourage them to use the quality management tools developed in this grant.


References

1. Commonwealth of Australia 2012. Review of Anticoagulation Therapies in Atrial Fibrillation.http://www.pbs.gov.au/reviews/atrial-fibrillation-files/report-anticoagulation.pdf2. Australasian Association of Clinical Biochemists 2008. Point of Care Testing ImplementationGuide. http://www.aacb.asn.au/documents/item/155.3. St John A, Tirimacco R, Badrick T, Siew L, Simpson P, Cowley P, Ullah S, Tideman P. Internet support for point-of-care testing in primary care. Aus Fam Physician 2015;44:10-11.4. Tran HA, Chunilal SD, Harper PL, Tran H, Wood EM, Gallus AS. An update of consensus guidelines for warfarin reversal. Med J Aust. 2013; 198 (4): 198-1995. Tideman P, Tirimacco R, St John A, Roberts GW. How to manage warfarin therapy. AustralianPrescriber 2015;38:44-48 (in press)


Appendix 1. Distribution of APPN Members across Australia (as of 28/1/15)

Figure A1. Graph displays number of registered APPN members from each state


Table A1. Shows occupation of registered APPN members

PositionNumber of members

(as of 28/1/15)

Medical Specialist 46Medical Director 18Pathologist 29GP 292GP Registrar 49Intern 23Practice Manager 35Nursing. GP Practice 286Nursing. Hospital 667Nursing. Community 86Nursing. Flight 7Nursing. Educator 84Scientist/Lab Tech 182Specimen Collector 75PoCT Coordinator 69Industry 130Pharmacist 79Allied Health 30Dentistry 8Student 65Other 206Total 2466


Appendix 2. APPN competency tests

Table A2. Shows the breakdown of competency tests performed and passed

Competency Assessments(as of 28/1/15)

CompletedCompetencies

Albumin:Creatinine Ratio - Penny Coates 9Arterial Sample Collection 10

4Basal-bolus Insulin for Hyperglycaemic Inpatients â€“ Greg Roberts

34BNP Abbott i-STAT 1

2BNP Alere Heart Check 2BNP Alere Triage MeterPro 2Capillary Sample Collection 20

2D-Dimer Alere Triage MeterPro 3D-Dimer Radiometer AQT90 FLEX 3D-Dimer Roche cobas h 232 2Drug Treatment of Type II Diabetes - Steve Stranks 28Glucose Abbott FreeStyle Lite 7Glucose Abbott Optium Omega 2Glucose Abbott Optium Xceed Hospital 1

1Glucose Abbott Optium Xceed Patient 6Glucose HemoCue 201 DM 2Glucose HemoCue 201 DM RT 2Glucose HemoCue 201 RT 1Glucose HemoCue 201+ 4Glucose Johnson & Johnson OneTouch Verio 1Glucose Life Bioscience CareSens 1Glucose Life Bioscience CareSens N 1Glucose Nipro TRUEtrack 1Glucose Nova StatStrip GLU/KET Connectivity 1Glucose Nova StatStrip GLU/KET Xpress 5Glucose Nova StatStrip Glucose Connectivity 1Glucose Nova StatStrip Glucose Xpress 6Glucose POCD SensoCard 2


Glucose POCD SensoCard Plus 1Glucose Roche Accu-Chek Active 4Glucose Roche Accu-Chek Go 2Glucose Roche Accu-Chek Inform II 10Glucose Roche Accu-Chek Mobile 2Glucose Roche Accu-Chek Performa 18Glucose Roche Accu-Chek Performa Nano 2HbA1c AMSL Quo-Test 3HbA1c Clinical Targets, Units and Goals for Precision 36HbA1c POCD Afinion 1

5HbA1c Siemens DCA Vantage 30INR Abbott i-STAT 65INR Alere INRatio2 39INR Clinical Competency 23

5INR Coaguchek Competency 28INR Over- Anticoagulation 18

8INR Roche CoaguChek XS 101INR Roche Coaguchek XS Plus 94

INR Roche CoaguChek XS Pro 88Interference with Blood Glucose Measurements 44Lipids Alere Cholestech LDX 2Lipids POCD CardioChek PA 2Lipids REM Systems Piccolo Xpress 2NT-proBNP Alere Triage MeterPro 2NT-proBNP Radiometer AQT90 FLEX 2NT-proBNP Roche cobas h 232 2Quality Assurance 13

6Role of HbA1c in Diabetes Management - Mr Greg Roberts 32Troponin I Abbott iSTAT 28Troponin I Alere Triage MeterPro 1Troponin I Radiometer AQT90 FLEX 1Troponin T Roche cobas h 232 4Urinary Albumin POCD Afinion AS100 8Urinary Albumin Siemens DCA Vantage 5Venous Sample Collection 17

5Total 1862


Appendix 3. Webinar participation rates

Table A3. Shows the number of APPN members that have attended the webinars. This does not include people that attended in groups.

Event GPs Total Attendees

INR Webinar 21

71AF Webinar 16 50

BNP Webinar 13

35Diabetes Webinar 20 52Heart Failure Webinar 1

351Blood Gases Webinar 3 29

INR Update on Warfarin Webinar 15

58Update on Lipids Webinar 2 28Blood Gas the Basics Webinar 3 32Warfarin Webinar 8 37


Appendix 4. EQA Case Study18 AACB APPN Project

Figure A2.Example of the External Quality Assurance INR Program Case Study


Appendix 5. Reprint from Australian Family Physician Vol.44 Jan-Feb 2015


Appendix 6. Article from Australian Presciber Vol. 34 (in


VOLUME 38 : NUMBER 2 : APRIL 2015 ARTICLE

press)Final Performance Report 23

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