Measuring patient safety: a training...

WHO-EM/HCD/066/E

Report on

Measuring patient safety: a training workshop

Cairo, Egypt 8-11 May 2006

(t7l.�) World Health �•§ Organization

.....-,.� Regional Office for the Eastern Mediterranean

© World Health Organization 2007 All rights reserved.

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Document WHO-EM/HCD/066/E/02.07 / l 50

CONTENTS

I. IN'fRODUCTION ............................................................................................................. 1

2. THE WORID ALLIANCE FOR PATIENT SAFETY ..................................................... 2

3. REVISITING THE FIRST TRAINING WORKSHOP: IMPLEMENTATION OF

PLANNED ACTIONS ...................................................................................................... 3

3.1 Introduction .............................................................................................................. 3

3.2 The focus and objectives of the second training workshop .................................... .4

3.3 Overview of some studies ........................................................................................ 5

4. COUNTRY PRESENTATIONS ........................................................................................ 6

4.1 Overview .................................................................................................................. 6 4.2 Egypt ........................................................................................................................ 7

4.3 Jordan ....................................................................................................................... 8 4.4 Kenya ....................................................................................................................... 8

4.5 Morocco ................................................................................................................... 9 4.6 South Africa ............................................................................................................. 9

4.7 Sudan ...................................................................................................................... 10

4.8 Tunisia .................................................................................................................... 10

4.9 Yemen ..................................................................................................................... I 0

5. TRAINING ON THE TOOLS ......................................................................................... I I

6. IMPLEMENTATION OF A REGIONAL PLAN OF ACTION FOR ASSESSMENT

OF PATIENT SAFETY ................................................................................................... 13

6.1 Overview ................................................................................................................ 13

6.2 Sampling ................................................................................................................ 13

6.3 Measuring reliability and validity of reviewing ..................................................... 14

6.4 Missing records ...................................................................................................... 15

6.5 Incomplete records ................................................................................................. 15

6.6 Record review ........................................................................................................ 15

6.7 Strategies for devising a national plan of action .................................................... 17

7. NEXT STEPS .................................................................................................................. 22

Annexes

I. PROGRAMME ............................................................................................................... 24

2. LIST OF PARTICIPANTS .............................................................................................. 25

3. SUMMARY REPORT ON THE FIRST TRAINING WORKSHOP: ASSESSING

UNSAFE PRACTICE ..................................................................................................... 29

4. COUNTRY PLANS OF ACTION .................................................................................. 38

5. REVIEW FORMS ........................................................................................................... 51

1. INTRODUCTION

WHO-EM/HCD/066/E

On 8 May 2006, a training workshop on implementation of patient safety plans of action was convened at the WHO Regional Office for the Eastern Mediterranean in Cairo. The workshop represented the continuation of a previous workshop held at the same location in December 2005. The main objectives of the training workshop were to:

• review progress in implementing agreed upon plans of action in Egypt, Jordan, Kuwait, Morocco, Sudan, Tunisia and Yemen;

• guide country teams on improving their assessment techniques of adverse events and finalize the findings of the patient safety assessment;

• train participants in more advanced techniques in patient safety assessment; • develop new plans of action for root cause analysis and improvement in patient safety;

and • agree on mechanisms of follow-up and technical support by consultants and WHO.

The meeting was inaugurnted by Dr Mohamed A. Jama, Deputy Regional Director, WHO/EMRO, on behalf of Dr Hussein A. Gezairy, WHO Regional Director for the Eastern Mediterranean. In his message, Dr Gezairy addressed the problem of assessment of patient harm inflicted by health care delivery systems, noting that such hann was of potentially immense magnitude and remained largely uninvestigated and poorly documented.

He referred to the f'irst training workshop on patient safety, which had fulfilled two components of the regional patient safety strategy: assessing the magnitude of the problem and understanding causes of error. ln addition, the Regional Office was developing an accountability framework to develop and test methods of preventing adverse events and was helping to organize operational patient safety programmes. He noted that the second workshop was coming at the right time as an operational arm of efforts to address patient safety in the Region. The seriousness and enthusiasm with which the workshop was being approached was a strongly positive indication of potential success in implementing previously agreed upon plans of action. That the Eastern Mediterranean Region was keeping up with the global momentum was additionatly recognized as an encouraging factor. Along with the available skills and expertise of the trainers, these factors drew the broad lines for a successful inter-regional collaboration as part of the overall resolution to implement patient safety and avoid patient hann.

Dr Ahmed Abdellatif. Regional Adviser, Health Care Delivery, WHO/EMRO provided a brief introduction to the workshop and reviewed the objectives and workshop methodology. He explained that during the workshop the participants would assess absorption and application of research tools provided by training experts, rigorously apply previously taught concepts to country projects, and address specific needs of, and hindrances faced by, participating countries. Dr Riham Saher (Egypt) was appointed as Rapporteur. The workshop programme and list of participants are attached as Annexes 1 and 2, respectively. A summary of the proceedings of the first workshop is attached in Annex 3. National plans of action developed by each country in the first training workshop are attached as Annex 4. Review forms are attached as Annex 5.

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2. THE \VORLD A LLIANCE FOR PATIENT SAFETY

The World A11 iance for Patient Safety was l aunched in October 2004 in \Vashington DC in response to a 2002 Health Assembly resolution (WHA55. l 8) urging WHO and Member States to pay the closest possible attention to patient safety. This worldwide endeavour brought together the heads of agencies. health policy-makers, WHO and patient groups to advance the fundamental goal of "First do no harm .. and reduce the potential unwarranted harm innicted on patients. The fundamental purpose of the World All iance for Patient Safety is to faci l i tate the development of a patient safety pol icy and practice through the fulfilment of a number of core functions and other short term ini tiatives. Several in tellectual and pol icy documents pertaining to patient safety have been published, i ncluding "To Err is Human" and ·'An Organization with Memory". Such documents are descriptive of the problems and provide approaches for solutions, outl ining a framework for thi nking about patient safety.

Several action areas are implemented by the World All iance, incl uding the "Patient for Pat ient Safety .. designed to ensure that the perspective of the pat ients and their fami l ies is a central reference point in shaping the focus of the work. A second perspective. that of the health care workers, i s supported by the work of Albert Wu in the United States. In addition, WHO has issued guidel ines on hand hygiene in health care (which wil l be publi shed in i ts final fonnat in 2007). Such guidelines represent a consensus of i nternational experts and upto-date technology information on hand hygiene within the health care context.

The World Alliance for Patient Safety has given priori ty to the development of a taxonomy for patient safety and adverse event reporting, which aims to define, harmonize and group patient safety concepts into an i nternational l y agreed upon classi fication. Other priority actions of the World Al l iance include addressing health care-associ ated in fections worldwide through a campaign entit led: "Clean care is safer care", idcnt if ying and disseminating "best practices for i mproving patient safety" and developing a reporting system for medical errors and "near misses" to faci l itate the analys is of root causes of errors. The development of baseline studies pertaining to patient safety and adverse event measurement in developing countries is also of high priority to The World Alliance for Pat ient Safety.

WHO has drafted guidel ines for adverse event reporti ng and learning systems. A set of these document have been generated through the World Al l iance for Patient Safety under the guidance of Dr Lucian Leape. These documents represent an attempt to work out where the reporting system l ives and what should be done i n the field of patient safety, h ighl ighting the current state of knowledge that needs to be tested.

There are multi ple ways to learn from adverse events to drive change and prevent hann including the following.

Analysis of single incidents, in which root cause analysis is applied.

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Analysis of pooled Incident data, in which an aggregation of incidents is studied. Currently , the tools available to perform this form of analysis are primitive. '

Data mining techniques. which hold promise but have delivered little a s yet; these apply to countries which accumulate computerized information and communicate.

Proactive hazard analysis

Ana1ysis of near miss data. which is important, but should not occur at the cost of real harm.

Generally, the techniques are early and untested. It is crucial that we learn from these techniques and improve them to become part of the world community i nvolved in enhancing the measurement of patient safety and avoiding patient hann.

Finally, it will be important to learn from other industries which h ave succeeded in improving their quality e.g. aviation . Complexity has been added to the health care system, which may have precluded improvements. The World Alliance for Patient Safety is a platform to bring countries, organizations and individuals together with the purpose of promoting the health care system and avoiding preventable harm.

3. REVISITING TIIE FI RST TRAINING \VORKSHOP: Jl\lPLEMENTATION OF PLANNED ACTIONS

3.1 Introduction

The proceedings. purpose and outcomes of the fi rst training workshop (Cairo, 2005) were briefly touched upon by Dr Ross Wilson. An overview of the ai ms. agenda and expected outcomes of the current workshop were similarly outlined. i n an attempt to pick up from where the project was left. On doing so, Or Wi lson delivered a rohust and motivational start to the meeting, gathering all participants around the central goal of assessment of the magnitude of patient harm in the Region and developing the keystones of a framework that organizes a patient safety programme.

There are 192 Memher States of WHO, the majority of which are s igned up in the World Alliance for Pat ient Safety. However. very few of these countries have shown data related to assessment of patient harm induced by the health care system. It is particularly sign i ficant that most data have heen provided by developed countries, while developing countries are lagging hchind. The work adopted by the patient safety workshops (Cairo. December 2005 and May 2006) is thus groundbreaking and is expected to have profound impact on the regional and international health care systems.

1 Kohn LT. Corrigan JM. Dnnalt.lson MS. ctls. Tn f.'rr i.t l/11111011: Ruifdi,rg a safer lrmltli JyMrm. Wa.�hingtnn DC,

Institute of Medicine, National At-at.lcmy Press. 1 999.

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The notion that "preven!able patient harm i s completely unacceptable .. is a fundamental concept. The magnitude of !he problem may be undereslimatcd by patients, health care providers and policy-makers. This is particularly true for events that are highlighted in mass media, e.g. newspapers (Weingart SN et al., 2000). Such events usual ly reflect rare (although probably catastrophic) events. More common events that culminate in patient hann, however, remain poorly represen!ed and should be the focus of attention by researchers. The levels of hann inflicted upon patients are consistently h igher than expected. Indeed, .. the more one measures, the more one finds". Measurement is thus key to an effective response. Whi le val idated tools for measurement are avai lable, putting such tools into practice and enhancement of their efficiency is of utmost importance particularly where medical resources are inadequate.

3.2 The focus and objedives of the second training workshop

The focus of the training workshop is to use available measurement tools to understand the size and nature of patient hann in developing countries. To assist in comprehension and application of such tools, an expert group supported by the World Al l iance for Patient Safety. have dedicated their expertise. The main objectives of the workshop are to:

• complete the training process initial ized in the first workshop (see the summary report i n Annex 3)

• raise the level of confidence hy trainees in the application of the research tools in a robust manner

• discuss the local use of generated d.ita to dri ve change.

Key acliievement.,·

The key achievements of 200:'i include the successful engagement of countries from each WHO region in the proposed project on patient safety and assessing patient hann. This included Benin, China. Costa Rica, Egypt. Estonia. Kenya. Malaysia, Myanmar, Peru. Poland, South Africa, Thai land and Tunisia. The first meeting on the glohal research programme for patient safety (Washington 2005) was another successful milestone that specifical ly addressed the management of a global research programme. The first tr.i ining workshop marked the commencement of the implementation of patient safety measurement i n 9 countries. comprising countries of the African and Eastern Medi terranean Regions. The participat ing countries included Egypt. Jordan. Kenya. Kuwait. Morocco. South Africa, Sudan. Tunisia and Yemen. Final ly. the World Al l iance Research Counci l was set up in Washington in Apri l 2006 to oversee the research agenda through a l ive process, fed hy constant input and analysis.

Patient safety represents one of the domains of quality. which include appropriateness, efficiency, effecti veness, acceptabi lity and accessibi l i ty. Whi le the input in the patient safety domain may be di fferent from that in other domains, they all are intertwined and lead to each other and are thus inseparable. Patient safety should he regarded from the patient's perspective, which underscores the importance of creating a .. patient-driven .. system. While the latter Tepresents a complex system encompassing several circles, such as patients, cl inicians. medical teams. organizations, financial and pol i tical governance environs, it should


be noted that achievement of success is only possible when work involves all circles inclusively.

3.3 Overview of some studies

Several studies have been conducted addressing the issue of patient safety measurement. The fo11owing is a brief overview of some presented by Dr Wilson and is not intended as an exhaustive in-depth analysis of such articles.

An observational study (Andrew LB, Lancet, 1997. 349:309) was performed on a tertiary referral office in 1997. The uniqueness of the study derives from the fact that the researchers obtained permission to act as physicians, allowing active involvement and accurate perception of on-going events and hence assessment of desired measurements. Studies involving this technique are act ively adopted by Charles Vincent (among other researchers) who is dynamically attempting to combine available techniques and place them where they can be rigorously tested.

Another study performed in the United Kingdom in 2005 (Shaw R et al, Quality and

safety in health care, 2005, 14(4):279-83) analysed approximately 30 000 reports. The study demonstrated that reporting systems may not necessari ly be accurately reflective of medical record reviewing. For example, the latter study demonstrated that over 40% of reported adverse events (AE) were slips, trips and falls , which are underestimated in the record documentation. This study highlighted that reporting and investigational systems go hand-inhand to provide an accurate perception of AE occurrence.

An A ustralian study performed in 1 995 (Wilson R ct al, Medical joumal of Amtralia,

1995. 163(9):458-7 1 } showed that the majori ty ( -40%) of AE were detected in association with operations. rather than. for example, in the area of sl ips. trips and falls ( 1 .7%). The findings of the latter study explicitly demonstrated that the data wil) determine the aspects of patient safety that require attention. Furthermore. the study highlighted that simple basic fundamental medical issues (such as surgery-related AE) are superior to isolated events in order of priority and warrant attention.

Sources of data

Data indicative of patient harm may he derived from various sources:

• Large data sets. which are not always available • Reporting systems: including complaints. sentinel reports, litigation proceedings. • Retrospective record review, which is currently the only validated tool. Although not

sophisticated, it represents the best available and most rigorously tested tool. • Observation/interview, which is important but underdeveloped.


Elements/or improving patient safety tlmmgh developing lrealth services

An effective governance system, demonstrating explicit transparency, i s an essential prerequisite for the improvement of health services. Indeed, such improvement is contingent upon the existence of a governance system that recognizes responsibility and accountability in health care del ivery. Simi larly. efficient and effective leadership is an indispensable tool in the process of improving health care delivery.

Another important component is measurement, which is critical in providing feedback to health care providers. Peer competition is l ikely to fuel a driving force towards health service improvement. Thus measurement of the quality of health services i s a good indicator of achievement, progress and areas of weakness that need to be worked on.

Cultural issues need to be seriously considered and addressed before a change can be made. Ignoring culture i s as painful as lacking efficient leadership. Change i s driven by people who are profoundly affected by culture.

Conclusion

There are several hierarchical levels in the path to provision of quality health care: obtaining and analysing research findings, impact on policies. impact on cl inical practice and impact on health care outcomes respectively. We are currently at the first level. The measurement of patient harm and assessment of the magni tude and nature of the problem along with representation of such data in a scientifical ly accurate research format, wil l therefore be critical before change is induced.

4. COUNTRY PRESENTATIONS

4.1 Overview

A delegate from each of the countries presented a summarized progress report in the form of a presentation on a template provided by the training team prior to the meeting. The template includes a tabulated description of proposed components of the action plan and an indication of the current status of the team on each item. The conclus ion of the presentat ion provided a description of the major chal lenges faced by the team and specific needs that require attention during the workshop. The main objective of this exercise was to share the experiences of the different participating groups, get an overall feel on the progress of the project and, importantly, highlight the chal lenges faced by each country. Unvei ling the obstac les and exposing the needs of each country was important to guide the training team members towards a targeted train i ng approach, specifically directing attention to individual country needs while covering the overall components of the training agenda.

In general, a h igh level of enthusiasm, commitment and progress were perceived. Dr Ross Wilson and Ms Sisse Bjorn Olsen acknowledged and ident ified a great level of leadership engagement and support, thus reflecting a wide-scale appreciation of the


fundamental concept of patient safety. While slightly different approaches were undertaken by different countries, all participants demonstrnted competence in active planning, dissemination of awareness and in steering their project towards a successful start. Specific needs and hindrances were underscored, briefly discussed and flagged for further discussion in subsequent training sessions. Emphasis was placed on comprehension, validation and practical application of the project tools (review fonn 1 , RFl and review form 2, RF2) provided by the training team.

While each team tackled the ini ti at ion of their project from a slightly different angle that was appropriately consistent with their culture and national system, all teams abided by the rules and guidelines set by the training team during the first workshop held in Cairo (December, 2005). Absorption of previously taught approaches was clearly demonstrated. There seemed to be a consensus that incompleteness of many patient records as well as f inancial restraints represented the major hurdles.

Each presentation was finalized with an overview by Dr Wilson of the progress made and challenges met with, along with emphasi s on the specific needs that would be addressed in subsequent training sessions. Overall , countries seemed to be well-positioned to provide data from selected hospitals when funds are made available.

4.2 Egypt

The Egyptian team is in the initial phases of action plan implementation. Since the last workshop in December, the project team held several meetings with the purpose of fonnulating their proposal and init ializing project action plans. After obtaining the approval and support of the Ministry of Health and Population. actively involving stakeholders and selecting participating hospitals (3 hospitals: 1 teaching, I governmental and l private). the project team embarked on approaching hospital directors. Hospital officials were made aware of the purpose of the project and familiarized with the broad lines of the action plan. The role of the hospital directors and associated staff was clearly explained and a formal invitation, signed by the f irst undersecretary, was submitted. This process was performed on a one-to-one basis as this approach was more convenient than the originally-proposed awareness workshop because it accommodated conflicting t ime schedules. Overall. there was widespread support hy local leadership and stakeholders in Egypt.

The Egypti an team then considered and i nit iated revie,ver recruitment, choosing 2 senior nurses and 2 senior clinicians for that purpose. The reviewer training sessions, however, were not performed. The team then decided to embark on a small field study during which practical application of provided tools was put into action . The major challenges potentially facing the Egyptian team are financial restraints and record incompleteness. Some more targeted training was suggested. Otherwise, the team showed immense enthusiasm and optimism in reaching the targeted goal of obtaining data hefore the end of December 2006 .

4.J Jordan


The Jordanian group commenced action in the proposed project. The team engaged local leadership and stakeholders, i ncluding the Minister of Health, and the Quality Directorate. Other stakeholders identified and actively engaged include the Secretary General, the Assistant Secretary General for hospitals, the Nursing Director, the Director of Public Relations, as well as the Director of the hospital selected for the pilot study. There has been a clear rise in the level of awareness of patient safety in the Jordanian media, which seem to be actively following up on the d evelopment and progress of the project. The team additionally commenced on the process of reviewer recruitment, selecting 4 nurses and 4 physicians and performed active training during a workshop that included orientation, classroom teaching and field visits along with exercises and case discussion. Six hospitals in the middle region of Jordan have been chosen for the study and 500 records will be pulled out for each hospital.

The major challenges met by the Jordanian team include financial restraints, record inadequacy, existence of a poor record-keeping system and recruitment of highly quali fied personnel. In addition, the team expressed the need for further training, particularly pertaining to the various elements of the provided review forms, as well as the requirement for recruitment of an information technology { IT) specialist . An additional challenge facing the team in Jordan is the lack of administrative personnel.

The team seems to be otherwise confident of meeting the goal of completion of the project by December 2006.

4.4 Kenya

Although the Kenyan team was able to engage local leadership, including the Director of Medical Services and several CEOs, and raise awareness of the proposed project, however, team members have not been able to engage physicians yet. Potential funding sources have been identified. In addi t ion, project personnel have been identified. There seemed to be some uncertainty regarding recru i tment of h ighly specialized senior personnel. This was particularly true considering the uncertainty around funding and hence financial compensation for proposed reviewer time commitment . The Kenyan !,'Toup thus implied that less senior special ists may be resorted to. Participating hospitals (two major hospitals) have been selected by team members. The project team, however, d id not embark on pi lot testing, record sampling or data collection.

The major obstacles that meet the team in Kenya are the lack of funding and specialist recru i tment. The most outstanding need for the group, only second to funding, is the modi fication of research tools to accommodate the H IV/AIDS populat ion. The team is optimistic about completion of the proposed project plans before the end of 2006 if funding wi l l be made avai lable.

4.S Morocco

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The Moroccan team is in the phase of active planning. Worthy of note , the French version of the tool, on which the team is strongly dependent, was only made available a week prior to the workshop. As a result. significant delays were experienced in adherence to the initially proposed time frame. Nonetheless, the team already engaged local leadership and stakeholders, including the Ministry of Health, universities, hospital managers, phamacovigilance centre and professional associations. The team identified and engaged several stakeholders and institutions including. the Hospital Managers Association. the Directorate of Hospitals at the Ministry of Health, the National Commitee of Nosocomial Infection control, University qual ity managers. Heads of intensive care departments of 2 universities and the Department of Epidemiology at a university. A steering committee has been established (Head of Hospital Directorate at the Ministry of Health, Dean of I medical university, 2 top managers of universities hospitals). In addition, a technical committee ( I manager Ministry of Health, l statistician. 2 professors from 2 universities and 2 from the Ministry of Health) has been created.

Some funds have been received, setting the steps for the initiation of the action plan. 6 hospitals (2 university, l regional, 2 provincial and 1 private) have been chosen for the study. Although reviewers and hospitals have been selected, however, no pilot study or active training has been put into action thus far.

The major challenges that face the team include the poor quality of hospital records. financial support and active training of personnel . The team therefore, does not expect to complete the proposed project and obtain final results before December, 2006. The team, however, seems to be on the right track towards adoption and implementation of the action plan, particularly considering the much needed additional training provided by the current workshop.

4.6 South Africa

Although the South African team did not receive the tools for implementation of the action plan proposed in the first workshop, significant progress was made in the engagement of local leadership and stakeholders and the establishment of governance structure. The team successfully engaged the National Department of Health quality assurance directorate, provincial hospital directorates and the South African Medical Research Council. In fact, a programme on injection safety, stemming from the interest in patient safety as a whole, was launched in South Africa fol lowing the first workshop. With regard to obtaining ethics approval, the South African team is awaiting initial direction from WHO so that a research protocol can be developed and submitted to the Medical Research Council and provincial research ethical committees.

Project management and training in AE detection have started, but the actual process of selection of hospitals has not commenced. Recruitment of project personnel is in process. The Council of Health Service Accreditation of South A frica (COHS ASA) has developed a research and development unit that will supply field staff.

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The major challenges facing the learn include financial restrai nts, incompleteness of records and the presence of more than one record for the same patient in a single hospital. The team proposed to set a goal of completion of the proposed action plan i n two hospi tals by the end of December 2005.

4.7 Sudan

The Sudanese team engaged local I eadership and stakeholders, setting up 3 separate meetings that involved stakeholders. The meetings yielded a high level of support and commitment by the Federal Minister of Health and the Undersecretary. The steering committee was fonned by a ministerial decree (headed by the Undersecretary). The technical committee was also formed.

The team actively engaged in a 3-day workshop to raise awareness, obtain support and recrui t promising reviewers. In addition, the workshop provided an opportunity for testing the provided tools and providing i nit ial training on their use. 8 special i st physicians and 7 nurses were recruited to the team. Simultaneously, some financial support was promised through the Ministry of Finance and the WHO. although not delivered. Actions were commenced i n obtaining ethical clearance. I n addition, 5 hospi tals were selected ( 3 general and 2 specialty hospitals). orientation of selected hospital directors and staff commenced. but data co l lecti on was not started.

The major obstacles that meet the Sudanese team inc lude deficient funding, incompleteness of medical records. relati ve novelty of the problem addressed by the project and the requirement for further training on the use of the tools. The team was otherwise confident that their projecl would be nearing complet ion hy the end of ::?006.

4.8 Tunisia

The Tunisian team did not present their progress report. The team members were newcomers to the group, henc� unfami l iar with the project. Furthermore. the delay in receiving the French tool impacted on the team as was the case for the Moroccan team.

Nonetheless. the Tuni sian team actively engaged in the training provided by the current workshop, addressed many issues related to application of the project plans of action in Tunisia and displayed i mmense enthusiasm for the outcome of the proposed project . l n addi t ion. the team expressed confidence i n implementation o f the project and members were very optimistic that they wi l l be ahle to execute the plan in Tuni sia with h igh l ikel ihood of obtaining results by the proposed tentati ve date of December, 2006.

4.9 Yemen

In Yemen. the project team successfully obtained an agreement from local leadership and stakeholders to initiate the projected action plan. The team ohtained the approval of the Deputy Minister and engaged the Chairperson of Patient Sat"cty Committee encouraging h i m to work closely with t h e project team. The project management structure wil l i nclude the

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Patient Safety Committee, medical services, hospital directors and members of the

lnfonnation and Statistics department.

In addition, a provisional ethics approval was obtained. Potential recruits and

participating hospitals (5 hospitals in 3 govemorates) were selected. However, training was not performed and sampling was not initiated. A pi lot study was perfonned by the team and uncovered a huge defect in medical records acquisition and analysis. Not only were the records incomplete and devoid o f clarity, but were sometimes ambiguotts and subject to misinterpretation due to the use of d ifferent recording languages (e.g. Russian). The latter

therefore, along with the lack of a standardized record�keepi ng system are the major obstacles

facing the Yemeni team. In add ition, lack of funding, the need for personnel recruitment and

increasing local awareness of patient safety are additional factors that would need to be addressed before the project team could complete the proposed action plan.

Otherwise. the team could not foresee any major chal lenges that would preclude the

implementation of the project by the end of 2006.

5. TRAINING ON THE TOOLS

The third day of the second workshop on implementation of patient safety plan of action

was dedicated to training on the use of the research tools (review form I "RFl .. and review form 2 "RF2") (Annex 5). and discussion of pitfalls associated with their use. Project teams were divided into groups and given case summaries for discussion, analysi s and review. Case

reviews were then d iscussed i ndivi dually as well as collectively and key learning points were

highlighted by each of the trainers in a discussion forum set up on the fourth day of the

meeting.

Choice of adverse event

The choice of the adverse event (AE) is an arbitrary process based on finding the most

important aspect of pat ient safety. Whi le more than one adverse event may be detected during examination of a single record. i t i s important to choose the event that is:

• Most relevant • Most acute • Has the most severe outcome • Has the highest degree of preventabil ity.

The knowledge of other adverse events may be captured through the narrative summary

so that the information is not lost or incomplete. I f several adverse events are detected and form a chain, it is usually the first event that ini tiated the chain. and that is therefore the most

relevant.

Timing of the adverse event

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The Index Admission (IA) is the admission that leads to a particular record being sampled for the study. It is the one selected by a randomized process from the hospital l i st. The date for this admission needs to be known to detennine if the event that led to the harm occurred before or after that date. An event wil l be counted as an AE if it led to an index admission within 12 months of occurrence. For example, if an AE occurred 6 months before, and Jed to, an index admission it should be included in the study. In the section on RF2 where the timing of the disability i s to be determined (Section D; Q. # 17 ) the timing of the AE in relation to the IA ( i n this case, before the IA) should be highl ighted.

Classification of an adverse event

In section C of RF2 the reviewer is required to classify the AE. It is important that this classification should be pertinent to the occurrence itself rather than to the care that led to the event. For example. a patient with a fracture who has developed wound infection following surgery would fit into the C2 category (operative AE) rather than C3 (fractures).

Missing data

Identification of an adverse event is a fact and needs to be clearly documented in the sampled record. It i s therefore crucial that all avai lable elements in a record are appropriately harvested. A second opin ion may be sought in case of doubt. However. as tempting as it may be to fi l l in the gaps created by missing pieces of data, postu lation should he strictly avoided. Judgment of preventabi l i ty should be based on avai lable data. Information that is in ferred or that could not be deduced should be clearly stated in the narrative part of the review.

Lead-11p q11estio11.r

The lead-up que�tions described in the section of RF2 that precedes the sections on contributory factors and preventabi l i ty are designed to enhance the thinking process to help the reviewer deliberate on prevenlabi l i ty. They arc not final questions on their own . Answering these questions does not necessitate a high degree of precision.

N.B. Quest ion 20 addresses consensus about diagnosis or therapy regarding the disease or occurrence referred to in the case study in general. rather than the particu lar case studied in the index admission.

Reference to the expert panel

The expert panel should be asked the questions that would make material di fferences to the causation and/or the preventabi l i ty. It is anticipated that reference to the expert panel wi l l be minimal ( in < 5% of cases studied).

Injury versus disability

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The term •disabi J i ty' refers t o the out come of an i njury.

6. IMPLEMENTATION OF A REGIONAL PLAN OF ACTION FOR ASSESSMENT OF PATIENT SAFETY

6.1 Overview

During the first training workshop, an action plan was developed in accordance with the

guideJ ines set by international studies. The plan was formu]ated to include key elements

required for management. adoption and implementation of a research project ai med at

assessment of patient safety.

Key components in the plan included:

• Engagement of leadership • Establishment of governance structure • Identification and engagement of stakeholders • Securing funding resources • Ethical consideration • Project management and personnel structure • Reviewer recruitment • Training of potential recruits • Hospital selection and engagement • Case sampling and record acquisition • Pilot testing • Data col lection and analysis • Reporting and release of results.

The action plan was tailored to accommodate the needs of individual countries and was

tabulated to form a template for a tentative plan of action that was fi l led by each country and

presented during the final sessions of the first workshop (see Annex 4).

During individual country presentations, several issues were raised that warranted a

discussion forum, led by Dr Wi lson, in an attempt to address some outstanding questions and provide guidance in working around problems and system defects. On doi ng so. several

components of the research project were highlighted for discussion.

6.2 Sampling

There are 2 issues in the sampl ing component: a) hospital sampling and b) sampling of

records within a hospital.


a) Hospital sampling: It i s important to note that i t i s not possible to obtain a hospital sample that reflects the problem at a national level. The main objective of the project is to measure the frequency and nature of patient harm in some hospitals in a country, rather than to measure the prevalence of adverse events in a country. The project is l ike ly to capture a picture that reflects some aspects of health care and provide feedback for the use of the research tools in different worlds. In selection of hospi tals for performance of the study, it may be useful to adhere to as many of the fol lowing criteria as possible:

Criteria for hospital selection

• Hospitals that show the will ingness to work with you • Hospitals that are geographically convenient to the research team • Hospitals that have medical records and sufficient activity: usually medium/large-size

hospitals • As many hospitals as can be logistical ly managed by the research team, with a

minimum of 2. • Highly regarded hospitals that possibly renect the best care in the country • "Nested" hospitals (hospitals that are divided into smal ler, probably independent,

specialized hospi tals) are preferably avoided. Further discussion of such hospitals wi l l follow.

b) Record sampl ing: There has been an international consensus to sample approxi mately 500 records per hospital. Oversampl ing wil l probably be required. particularly since the quality of the records is not known. A master l i st, containing a complete l i st of all patients admitted to all departments of the hospital within a certain time period wil l be crucial for random sampling. Thus, every tenth patient record. for example, can be retrieved for examination using this l ist. Random sampl ing should be strict ly adhered to. The result of this process should be 500 complete sets of records. All sampled records should be accoun ted for and no record could he rejected by an arbitrary process without accountabi l i ty. 11 i s to be noted that selection by department may be problematic and needs to be com::1:ted for relati ve length of stay. Selection by department should therefore be avoided where possihle to avoid skewed results.

6.3 Measuring rel iability and validity of re,·iewing

Duplicate reviewing. for both the nurse and the medical reviews (RF! and RF2 respectively) wi l l be essential to ensure rel iabi l i ty of data. For review form I (RFI ). nurse screeners wi l l be required to duplicate review I O% of sampled records. At least 80% agreement between primary and dupl icate reviews wi l l be required. The process wil l be overseen by the site manager. Hence, a nurse reviewing a record wil l not know whether she is performing a primary or duplicate review. The direction of a record wil l be determined hy the first review, that is, if a record is scored positive for criteria on RF l by the first reviewer, but negative by the duplicate reviewer. it wi l l he considered positive and wi1 1 pass through the medical review phase (RF2).

6.4 Missing records


The fol lowing rules should be applied when deal ing with missing records:

• Every effort should be made to locate missing fi les. thus underscoring the importance of communication with the medical records department.

• All missing records should be accounted for in the report. Such records can be

statistical ly corrected if over 5%. (If the number of missing records i s less than 5% of

sampled records, i t does not alter the results significantly.) • The gaps will need to be filled by oversampling.

6.5 Incomplete rttords

Incomplete records do not inval i date the methodology. Reviewers shou ld proceed with each record as far as possible. digging out documented infonnation and using it as efficiently as possible. I t should be noted. however. that the review forms should be factual and only documented information needs to be stated. If any infom1ation is inferred, this needs to be

clearly stated.

6.6 Record review

6.6. J Selection of reviewers

The fol lowing criteria should be strongly considered during selection and recruitment of

project reviewers:

• Ideal ly, reviewers will have expertise and clinical experience (thus wil l probably be

senior). • Generalists are usually required, e.g. internist. genernl surgeon. anesthesiologist. • A reviewer should show interest in patient safety. • A reviewer should be wil ling to give the time commitment to work on the project.

A reviewer should be able to review records with accuracy and competence. Not al l good doctors are good reviewers. A project team wil l therefore need to devise a strategy to detennine who would have biases that could not be overcome (and who would thus not be

suitable as a reviewer). A reviewer audition. in which potential reviewers are tested and evaluated, may be a good idea. Reviewers who are key elements due to clinical expertise. but

who prove not to be •natural ' reviewers may be invited on the ex.pert panel to ensure their involvement in the project.

6.6.2 Reviewer training

Adequate reviewer training has been shown to directly correlate with rel iabi l i ty and

val idity of the data, hence with the success of the project as a whole. Reviewers need to be infonned of the purpose of the study, the construction of the project, their role in the study. the outcome of the study for them and their country. It should be emphasized during the training

WHO•EM/HCD/066/E Page 1 6

that rigor and abidance by the set rules are extremely important. Potential reviewers need to be thoroughly trained to use RFI and RF2 in accordance with the rules and guidelines set by the two WHO training workshops (Cairo, 2005 and 2006). The time of training should best be as close as possible to the time of data collection. However, planning for the training course (preparation of materials, presentations, course location, lectures, case preparation, and even tentative time schedule setup) should be started by the project team as soon as is feasibly possible.

The following guidelines (directed by the workshop instructors) are helpful in devising a plan for training of potential reviewers:

Functions: The main objectives of training reviewers are to: sensitize potential reviewers to the concept o f patient safety and the project; train reviewers for the use of the tools; and assess the abil ity of trainees to deal with the tools.

Timing: The training course/workshop should be planned as close to the actual project as possible. If necessary, a tentative schedule shoul d be set up to ensure that the training occurs right before the study review commences.

Targef audience: Training sessions are aimed at nurses and doctors who wil l potentially form the screeners and reviewers for the study. A common training session should be attended by both nurses and doctors together (rather than separately) . More people should be trained than is actually required for the study. This a l lows for the selection of the most promising candidates. Following evaluation and selection of nurse and doctor reviewers, alternat ive roles can be assigned to other participants who did not fulfil the criteria for successful reviewers.

Training items: Training may assume several fonns e.g. workshop sessions, site visits, lectures and/or presentations, but should include:

• famil iarizing trainees with the project and terminology • review, analysis and d iscussion of the tools (RFl and RF2) • site visits • review of case summaries for demonstration • evaluation of trainees.

6.6.3 Assessment of trai11i11g

Assessment of reviewers is not a pass/fail phenomenon. but rather opens up for discussion and further training. If possible, a committee could be arranged for to put together gold standards for reviewing. Reviewers should be given case summaries, followed by assessment of such summaries by the project team along with constrnctive and supportive comments. Further train ing and repeat assessment should be implemented i f necessary.


6.6.4 Reviewer engagement and motivation

It is of i mmense importance that reviewers are actively engaged in the project. Creating a motivational drive may be achieved by one or more of several factors, including emphasis on the scientific privileges of the project, publication potential and the impact of the project on patient safety and on the country as a whole.

6.6.5 Time commitment

An average of 2-3 weeks will be required to complete the review process for each hospital depending on the level of experience of the review team, geographical location of the hospitals, quality and legibil ity of the notes and the time commitment of the reviewers. The expert panel will need to be available for advice within reasonable time (An expert should get back with advice within 24hours).

6.6.6 Location of the review team

Most studies performed thus far had all members of the review team in one room. Although discussions are possible, only one reviewer will be responsible for examination of each record (which will have his/her reviewer ID). A "Gold Standard Reviewer" should be assigned. For reliability testing, 2 separate forms should be filled. The process should be overseen by the site manager.

6.7 Strategies for devising a national plan of action

6.7. 1 Data handling and report generation

For each hospital included in the study, it is helpful to draw a flow chart representing the records going through each phase of the review process. This ensures that each sampled record is accounted for. The process of record acquis ition and review should be overseen by the site manager to ensure that all records are accounted for and that implementation of the action plan proceeds with precision and accuracy.

Data reporting and release should assume a high degree of sensitivity. It is l ikely that the Ministry of Health, the World Health Organization and each of the individual participating hospitals will require a report. In addition, at least one publication, in which all participants should be included, should come out of thi s work. The results should not be shared until properly c leaned and analyzed. Indeed, such infonnation needs to be released in a sophisticated manner to drive local change. International dissemination wil l be a goal. While the involvement of the media may have different impact in different cultures, it is probably wise not to use the media as a dissemination vehicle until the data are cleaned and finalized.

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Records sampled

Oiarts screened Oiarts not screened

Inadequate doti.unc:nt:llion Screened positive Screened ner:ari�

Medical review Missing

No A E AE

6. 7.2. Summarized guidelines for implememation of plan of action

Action

Agreement to the study (engaging local leaden.hip)

F.stahlishing study governance strul'ture

Identifying and engaging stakeholders

St-curing r�ourtes and funding

Ethics consideration and approval

Projed management. personnel and struc-ture

Task

Overall agreemenl required.

Lo�:al leadership engagement should involve active �upport.

Usually includes members from MOI i. WHO and pmrcssi1,nal body.

!Jentifa·atinn ur slccring cummincc lo whom the project learn �hnuld report is importanl.

Governance slructure needs to be clear-draw a diagram.

Engagement and support are important

Need tu ensure that this steering cummillee is valuable and have the members act as advocates. particularly once the resuhs are nut.

Financial support will hopefully he availahle soon enough for ii lo be useful.

Work with whatever sources are currently available unti l forther supp(irt anrives.

Need for technical support. assistance with tra in ing and cnuntry co-ordinatinn are rec1 1gni1.cd.

AssMance with data entry and reP4->rt generation wil l be provided

Di fferent requirements for different cnuntries and institutions

Find from IRBs if there is a fast-track method of otitaining apprnval, particularly sim:e the project is under the quality banner.

A structure (probably including a steering and a technical commi1tee} nested into the Ministry Clf Health is appealing.

A m:mager should have manager skills, should be wmmined 10 the project and should l:ie familiar w ith navigating his way around the health care management system.

Action

Reviewer reeruitment

Training

Hospital selection and

engagement

Case sampling

Review process

Record acquisition

Pilot testing

Task


Make sure a reviewer is up to the task i n terms of �ommitment.

A good reviewer needs to be able to view the health care system analytically and objectively.

Needs to have rigor in following the rules and adhering to the guidelines

Hang on to good reviewers and try to fit in with their needs.

DO NOT use nurses and doctors from a particular hospital as reviewers for records from their own hospital.

Should be performed as close in time to the actual review as possible.

Aimed at nurses and doctors who will potentially form the screeners and reviewers for the study.

A common training session should be attended by both nurses and doctors together (rather than separately).

More people should be trained than is actually required for the study.

Training should involve case studies. site visits. group discussions and rigorous teaching of RFl and RF 2 (Annex III}

Should end with evaluation and recruitment of promising reviewers.

Make sure the hospital staff have a good knowledge of the project.

Reassure them of the anonymity of the study.

Be prepared to answer questions related to ethical approval. contacting patients and research methods.

Ensure staff of the validity and reliability of the data.

- 500 records per hospital should be sampled.

Nested and specialized hospitals are best avoided.

• Weighting individual hospitals to design a national sample depending on the involvement of the hospital i n the national health care system may be subsequently performed.

Approximately 2 nurses. 2 doctors in addition to the site manager need to be on-site during the review process.

A lockable filing cabinet is a plus.

A l ist of randomized records has to be available during the review.

Reliability testing should be performed: need to have 10% duplicate reviews for RFI and 10% for RF2.

Duplicate review structure: for example every I01h record can be placed in a filing cabinet and 2 RF ls and RF2s performed for it.

Reliability testing should be overseen by the site manager who will make sure that a) each reviewer does not know whether they are performing a primary or duplicate review and b) that the FIRST (rather than the duplicate) review is the one taken in the study.

A numerical code should be allocated to each record . That l ink is broken once the data are taken out of the hospital. 1t is critical that the data is complete and entered in the database before the l ink is broken. Identifiable data will not be stored or reported and will not be discoverab(e dow11 the track.

Site manager needs to be sure that all fields are fi lled in a legible manner and that text summery is clear.

Create a dialogue with the MR department to get their co-operation.

Give MR the necessary information, involve them in the process and be considerate of their effort and time.

To be performed on l0'l> sampled records

Action

Data collection, entry, cleaning and analysis

Report and release of data

Task


Internet-based database entry system will be created by trainers.

Expert trainers will help with data cleaning for generation of standardized data.

In the reporting: hospitals from the involved countries.

In the reporting system. participating hospitals will be identified but no data will be attributed to specific hospitals.

There will be a report to WHO. Ministry of Health. participating hospital director.

It is likely that at ]east one publication wilJ come out of the generated data.

Publications should reflect all contributors.

Information.will be released with sensitivity and with the intention to drive local change.

International dissemination. will be a goal.

Results should NOT be shared until properly cleaned and analysed.

6. 7.3. Tentative individual country plans

Participants from each of the individual participating countries provided a tentative plan for the month to follow the current workshop. The following summarizes the tasks set by each

country.

Kenya

• Revision of proposal to incorporate discussed changes: IIlV/inclusion of an extra hospital

• Discussion with potential reviewers • Exchange proposal draft with WHO Geneva & Ross for comments • Fonnulation of advisory and oversight committees • Visits to institutional records departments • To agree on logistics of data retrieval • WR briefing

South Africa

• Contact directors e.g. quality assurance director, National Department of Health director

for briefing • Contact Head of Western Cape Department of Health to inform of the project, identify 2

hospitals for inclusion in programme • Set a study protocol • Submit protocol to Medical Research Committee and provincial research committee • Develop training material for training of nurses and reviewers • Set up date for training

Egypt

Within 1 week:

• Finalize action plan


• Make calls to schedule training sessions • Report meeting outcomes of current meet ing to leaders

Within one month :

• Team meeting to accurately define member roles • Arrange for a general awareness workshop • Get feedback from the expert training team regarding final action plan • Visit hospitals to ensure the presence of a master list for records • Getting famil iar with medical records staff • Construct a pf an for training workshop: information, presentations, tools etc. • Reviewing i n July

Yemen

Report participation to officials including Patient Safety Committee (P.S.C.) Chairman (with brief expf an at ion of the proceedings and outcomes of the workshop and future plans)

Within I month :

• Finalize study proposal, including t ime frame, project management and budget • Selection of reviewers and screeners: get approval of PSC Chairman. • Hold a workshop for PSC, stakeholders and team members to update with current status

and future plans • Preparation for training

Sudan

Within a week:

• Briefing to Minister and Undersecretary • Hold meeting with steeri ng committee • Follow up on funding (Ministry of Finance and WHO)

Within one month :

• Visit first hospital and meet managers for discussion of medical records system and other logistics and appoint one focal point to assist team

• Prepare stationery and other supplies; copy RFl and RF2 • Conduct training • Sampling and data acquisi tion • Hoping to start reviewing in July

Jordan

WltO·EJ\UHCD/066/E Page 22

• Meeting with steering committee and re-selecting hospitals • Contact potential reviewers• supervisors/employers • Meeting with reviewers and discussions; updating on some issues raised from the first

workshop • Train ing • Meeting with Medical Records Department • Arrange for workshop that includes physicians • Acquisition of medical records and start data collection

Morocco

• Inform leadership (including Minister of Health} of the near future pJans • Obtain formal letter of invitation from the Ministry of Health to participating hospitals • Identification of reviewers • Case sampling • Record acquisition • Invitation of reviewers • Training workshop for reviewers (June) • Data collection (July)

Tunisia

• Within 1 week: • Prepare summary of project • Arrange meeting with policy makers • Non.formal briefi ng of hospital directors • Establish agenda for next steps • Within a month: • Establish steering committee • Constitute a working group (including stakeholders: Hospital directors, Medical

Committee President, etc.) • Identify reviewers (2 nurses. 2 doctors) • Train reviewers by end of August • Identify medical records l ist and start sampling (if authorization received to start the

project).

7. NEXT STEPS

As it stands, the health care system remains inefficient in delivering its services in accordance wi th the intuitive rule: .. do no harm". Detects in the system are largely uncharted resulting in underestimation of the problem. Patients (customers) are, in many cases. unaware of the problem and place, sometimes erroneously, a huge amount of trust in the providers. Fai lure in many other industries i s well -recognized and rigorously dealt with. It is critical that


the health care system should learn from safety measures in other industries; such as aviation and pursues a similar track. particularly considering that the outcome of this pursuit is potential improvement in human health and l ife expectancy. Health care by its nature is risk prone.

To embark on a project that assesses patient safety and identifies areas of harm is a great endeavour. This study wil l be important in prioritizing the areas in the health care system that require attention and will have tremendous impact on the research agenda that WHO and the World Al l iance for Patient Safety are building and funding. It is hoped that the participants in this project can play the leadership role, creating a degree of dissatisfaction with the health care system to instigate change.

Dr Wilson expressed his enthusiasm for this project and his confidence that the participants will display the activity and energy required to successful ly complete their mission. On behalf of the trainers, Dr Wilson vowed to provide as much help as possible and strongly encouraged feedback and dialogue among the participants and trainers. A suggestion was made to use the PowerPoint template provided for country presentations during this workshop as a detai led (possibly monthly) progress report.

Dr Abdellatif concluded the workshop by thanking tutors and participants and encouraging the replicat ion of the training workshop in each participant country to implement the agreed upon plans of action. He expressed optimism and strongly encouraged regular feedback of activities hetween the end of this workshop and the beginning of the next , scheduled for December 2006 . Dr Abdellatif pointed out that the participants had embarked on a mission which was a responsibility, and he hoped that the delegation of each participating country would be regarded as pioneers in the f ield. He final l y concluded by thanking the administrative and technical team for their support.

WHO-E�1/HCD/066/E Page 24

Annex l

PROGRAMME

Monday, 8 May 2006

08:30-09:00 09:00-1 0:30

10:30-13 :30 1 3 :30- 1 5:30 15 :30- 1 7:00

Registration Opening session Message of Dr Hussein A. Gezairy WHO Regional Director for the Eastern Mediterranean Introduction of participants and resource persons Adoption of Agenda and programme Welcome speech by Dr Ross Wilson Time to finalize country presentations by the individual counties Country presentations on progress made Summary of progress and chal lenges

Tuesday, 9 l\fay 2006

08:30- 1 3 :30 13 :30- 17 :00

Addressing challenges and needs identi fied by presentations on day l Discussions and group work

Wednesday, 10 l\lay 2006

08:30-09:00 09:00- 1 3:30 1 3 :30- 1 7 ;00

Teaching of record review and use of Review Form I and 2 Group work Assessment of record review trainers

Thursday, 11 May 2006

08:30- 1 1 :00 1 1 :00-1 3:30 1 3 :30- 1 5:30 15 :30

Praclical guidance on data handling, ownership and report generation Setting new goals and identifying the nellt steps Detai ls further support and fol low-up Close

EGYPT Dr B adr Ismail Mohamed


Annex 2

LIST OF PARTICIPANTS

Information Systems and Computers Expert Institute of National Planning Cairo

Professor Ossama S.E. Rasslan Professor and Head of Medical Microbiology and Immunology Department Ain Shams Universi ty Cairo

Prof. Mahi El Tehewy Professor of Public Health Ain Shams Uni versity Cairo

Dr Atef Badran Clinical data Manager National Cancer Institute (NCI) Cairo

Dr Aisha Ahou El Fotouh Ain Shams Uni versity Cairo

Dr Susan Desouki Ain Shams University Cairo

Dr Riham Saher Ain Sham University Cairo

Dr Ashraf Abdelkhal ik AbdeJbaki Consultant of Internal Medicine and Nephrology Air Force Hospital Cairo

JORDAN Dr Safa Qusous Director of Quality Ministry of Health Amman

Dr Samira Ezaat Quality Directorate Amman

Mr Wael Kildani El Nadeem Hospi tal Madba

KENYA Prof Wil l iam Macharia


Member of Africa Advisory Committee on Health Research and Development Focal point for patient safety research Nairobi

Dr Janet Butage Medical records officer Member of Africa Advisory Committee on Health Research and Development Focal point for patient safety research Nairobi

MOROCCO Prof Nabil Kenjaa Professeur de reanimation medicale Centre Hospital ier Universitaire de Fcs Rabat

Dr Amina Sahel Chef de Service des Soins Ambulatoircs Direction des Hopitaux et des Soins Amhulatoires (OHSA) Ministere de la Sante Rabat

SOUTH AFRICA Professor Stuart Whittaker Managing Director Council for Health Service Accreditation of South Africa (CO HS ASA) Cape Town


Dr Fikile Si thole Council for Health Service Accreditation of South Africa (COHSASA) Cape Towh

SUDAN Dr Mal ik Abdo Ali Focal point of Patient Safety Federal Mini stry of Health KhartoUtn

Dr Zahir Mohammed Khier Allah Deputy Director of Hospital Department Cur.itivc Medicine Directorate Federal Ministry of Health Khartoum

Dr Sara Hassan Mosatafa Planning and Research Office Federal Ministry of Health Khartoum

TUNISIA Professor Ben Ammar Mohamed Salah Professor of Anesthesia and Intensive Care CHV - Mongi Sl im Tunis

Professor Mondhcr Lctacif Prevenl i vc Medicine and Epidemiology unit University I lospital Tunis

YEI\IEN Dr Adel Al-Moayed Director General Hajja General Hospi tal Sana'a

Mr Nasr Ali Ahmed Head of Continuing Studies Nursing Department Ministry of Publ ic Health and Population Sana"a


Dr Ross Wilson Director Center for Health Care Improvement Royal North Coast Hospital St l..eonards AUSTRALIA

Ms Sisse Bjorn Olsen MRCS Clinical Research Fellow

Resource persons

Department of B iosurgery and Surgical Technology Faculty of Medicine Imperial College London London UNITED KINGDOM

Professor Phillip Michel Director, Health Evaluation Strategy Public Health Programme and Disease Management French National Authority for Health FRANCE

WHO Secretariat

Dr Mohamed A. Jama, Deputy Regional Director. WHO/EM RO Dr Ahmed Abdellat if, Regional Adviser. Health Care Delivery and Coordinator Health Systems. WHO/EMRO Dr lciar Larizgoit ia Jauregui , EIP/SPO/QPS, WHO/HQ Dr Amr Mahgoub, Regional Advi ser, Health Management Support. WHO/EMRO Dr M. Farag. SSA/DHS, WHO/EM RO Mrs Hoda El Sabbahy, HCD/DHS, WHO/EMRO


Annex 3

SUMMARY REPORT ON THE FIRST TRAINING \VORKSHOP: ASSESSING UNSAFE PRACTICE

Cairo, Egypt, 4-8 December 2005

Introduction

The WHO Regional Office for the Eastern Mediterranean held a training workshop on patient safety in Cairo, Egypt on 4-8 December 2005. The objectives of the workshop were to:

• assess the magnitude of unsafe practice; • develop a critical mass of patient safety surveyors and trainers; and • outl ine collaboration with WHO headquarters and Regional Office for the Eastern

Mediterranean.

The inaugural message was delivered by Dr Abdallah Assaedi , Assistant Regional Director. WHO/EMRO, on behalf of Dr Hussein A Gezairy, WHO Regional Director for the Eastern Mediterranean. In his message, Dr Gezairy highlighted the importance of the patient safety issue and stressed the pressing need for adopting safety practices in health insti tutions in the Region. The patient safety p;ogramme was one of the top priori ti es of the Regional Office and the f irst important step was to assess the magnitude of the problem in the Region.

Dr Ahmed Abdellatif, Regional Adviser, Health Care Deli very and Coordinator, Health Systems. introduced the programme of patient safety in the Region and results of the survey at mini sterial and faci l i ty level which provided a strong rationale to continue work on this issue in the Region. He also explained that the regional strategy for enhancing patient safety had been endorsed by the Regional Committee for the Eastern Mediterranean in October 2005 and had the support of ministries of health in the Region. He described the ongoing activi ties to build up public awareness and widen the regional advocacy and involvement of civic and private organizations in patient safety. WHO would provide technical support to Member States to formulate their national pol icies and strategies for patient safety.

Proceedings

Day I

Dr Ross Wilson, Director of Health Care Improvement. Royal Coast North Hospital, Austral ia, introduced the plan of the workshop and discussed di fferent i ssues related to patient safety. In order to come up with common understanding of patient safety issues, Dr Wilson involved the participants in many· exercises to share experiences and concepts of patient safety.

In the next session, Dr Wi lson asked the participants to group themselves and work on identifying data sources to assess the magnitude of the problem related to patient safety. The


groups then presented and discussed their outcomes with the rest of the participants. At the end of the day, Dr Wilson introduced many studies done on adverse effects of health care in

different countries.

Day 2

In the first session , Dr Wilson summarized the concepts discussed on the first day and

highlighted the need for more knowledge and infonnation about the magnitude of the

problem. He asked the participants to work in groups to discuss how they would use infonnation about adverse effects in their country. At the end, Dr Wilson expressed the need to involve the stakeholders earlier to trust, understand and appreciate the results. He also

advised the groups not to dramatize the results, but to dramatize the solution and stressed the role of leadership in dealing with patient safety issue.

In the second session, the participants were asked to work in groups to outline the scope and elements of an adverse effects project in their country stressing four points: 1) number of hospitals to be included; 2) leadership; 3) major obstacles; and 4) estimated starting date. Group presentations were to be continued the next day.

Day 3

In the first session, the groups presented a draft of an adverse effects project in their countries and considerable discussions took place regarding different designs presented by the

groups.

Ms Sisse Olsen, Clinical Research fe11ow, Faculty of Medicine, Imperial College

London, began the second session by giving individual tasks to the participants to identify the foliowing:

• The aim of his/her country project • What role can he/she plays in this project • What is his/her existing skills to do this • What do he/she needs to learn to be successful in his/her role in country project.

Ms Olsen then continued to discuss adverse events and gave an overview of the process of screening and in-depth medical record review. Discussions focused on methodology, selection of reviewers, criteria of reviewing, ethical issues, etc.

In the third session, Dr Wilson started to recap the topics which were discussed in the morning and stressed that the objectives of the projects are to measure the magnitude of the problem while action in response to data analysis is not considered in this workshop; however, recommendation could be given.

Each country group was then divided into two subgroups; one group was working with Dr Wilson to finalize the research protocol and the other group was working with Ms Olsen to understand the process of medical record review.

Day 4


1n the first session the subgroups continued to work; one in finalizing the research protocol and the other i n processing the medical record review.

All participants and the resource persons conducted a field visit to one hospital to simulate all range of medical record review process. On arrival, the hospital director welcomed the group and gave short introduction on the mission of the hospital. Dr Abdellati f thanked the director and the hospital staff and explained that the aim of the visit is training and assured them that alt infonnation discovered during this training i s completely confidential. A representative from each country group then joined with Ms Olsen to the medical record department to get a sample of two medical records and went back to join the rest of the group to do the screening followed by the in-depth reviewing of the positive records. The groups then presented summary of their cases and a lot of discussion took place.

In the third session. Ms Olsen continued to clarify some points related to screening and record review and stressed on rating scale of disabi lity and preventability. The participants, then, re-divided into their country groups to work on case study dealing with disabi lity and preventahili ty. Coming back from grouping, the group presented their outcomes and short discussion took place. Dr Wilson, then, introduced a checklist to help the group to manage their project and the participants re-divided again into country group to fi ll the checkli st.

Day 5

During the first session. the groups continued to work to finish their country project and fill the checklist. The participants then watched a short video show gi ving them some important messages concerning leadership, teamwork and persistence. At the end Dr Wi lson highlighted the i mportance of keeping in contact as a group of experts in this field in the Region.

In the second session, Dr Wilson then invited each country group to present the final draft of their project management checklists. The th ird session hegan by introducing how to ensure validity of the study and discussing quality i mprovement versus research. Finally Dr Wi lson infoTITied the part icipants some important websites related to pat ient safety and adverse effects.


Programme of the first workshop

Sunday, 4 December 2005

08:30-09:00 09:00-10:30

I 0:30-14:00

14 :00- 1 7:00

Registrat ion Opening session Message of Dr Hussein A. Gezairy WHO Regional Director for the Eastern Mediterranean Introduction of participants and resource persons Election of officers Adoption of Agenda and programme Objectives, expected outcome, and methodology of the meeting Highlights on Regional initiatives for Patient Safety Principles of Patient Safety and of patient safety programmes: Recognition of the need for improvement in health care and health care settings The systemic nature of failures and errors. Concepts and definitions of key terms. The response of the WHO: the World All iance for Patient Safety Principles of research for patient safety The role of research and key studies on patient safety Advantages and l imi tations of the methodologies used in the studies described above

Monday, S Decemher 2005

08:30-1 1 :00 1 1 :00-1 2:00

Overview of research methods for patient safety studies Continued

Tuesday, 6 December 2005

08:30-17:30 Study and Design and Conduct Sampling, review methods, train ing. data entry

Wednesday, 7 December 2005

08:30- 14:00 1 4 :00-16:00 1 6:00- 17:30

Practi cal training in first and second stage of record review. Participants wi l l design their own research project Participants wil l have 'hands on' practice with database software

Thursday, 8 Decemher 2005

08:30-1 3:30 1 3 :30- 15:30 1 5 :30

Work sheet on nex.t steps for each project Review of practical issues and 'next steps' Close


List of participants of the first workshop

EGYPT

Dr Badr Ismail Mohamed Information Systems and Computers Expert Institute of National Planning Cairo

Professor Ossama S.E. Rasslan Professor and Head of Medical Microbiology and Immunology Department Ain Shams University Cairo

Prof. Mahi El Tehewy Professor of Public Health Ain Shams University Cairo

Dr Atef Badran Clinical Data Manager National Cancer Institute (NCI) Cairo

Dr Abdel Aziz Shaheen Biostatistician National Hepathology and Tropical Medicine Research Institute (NHTR() Cairo

Prof. Aisha Abou El Fotouh Ain Shams University Cairo

Dr Susan Desouki Ain Shams University Cairo

Dr Riham Saher Ain Shams University Cairo

KENYA Prof Wi1 1 iam Macharia Member of Africa Advisory Committee on Health Research and Development Focal point for patient safety research Nairobi

Dr Janet Butage Medical records officer


Member of Africa Advisory Committee on Health Research and Development Focal point for patient safety research Nairobi

JORDAN Dr Safa Qusous Director of Quali ty Ministry of Health Amman

Dr Mohammed Jamil Kharabsheh Hospital Management Department Ministry of Health Amman

Dr Samira Ezaat Quality Directorate Amman

Mr Wael Kildani El Nadeem Hospital Madba

Dr Bassam Shahin Royal Mi l i tary Forces Amman

Dr Mohamed Bassam Qassem Director Patient Safety Department Amman

KUWAIT Dr Talat Abdullah Al Fadala Quality Control Department Ministry of Health Kuwait

Mrs Amal Kassem A. Al Ghadban Deputy Manager Medical Records Department Ministry of Health Kuwait

Mr Sadek Abdulhadi Al Fi l i

Nursing consultant

Kuwait

MOROCCO Prof Nabil Kenjaa

WHQ.EM/HCD/066/E Page 35

Professeur de reanimation medicale

Centre Hospital ier Universitaire de Fes Rabat

Dr Amina Sahel Chef de Service des Soins Ambulatoires Direction des Hopitaux et des Soins Ambulatoires (DHSA) Ministere de la Sante

Rabat

Mr Driss Bessar

Cadre a la DHSA

Rabat

Prof Ali Amine Zeggwagh

Professor of Higher Education

Rabat Faculty of Medicine and Pharmacy

Rabat

SOUTH AFRICA Prof Stuart Whittaker Managing Director

Counci l for Health Service Accreditation of South Africa (COHSASA)

Cape Town

Dr Albie Van Zyl Medical Surveyor

Council for Health Service Accreditation of South Africa (COHSASA)

Cape Town

SUDAN Dr Zahir Mohammed Khier Al lah Deputy Director of Hospital Department

Curative Medicine Directorate

Federal Ministry of Health

Khartoum

Dr Salma Ahmed El-Houri Medical Practitioner Head of Patient Safety Programme

Qual ity Directorate Khartoum Teaching Hospital Khartoum

Ms Ann Auma Tul lio Khartoum North Teaching Hospital Khartoum

Dr Sara Hassan Mosatafa

Planning and Research Office Federal Ministry of Health Khartoum

TUNISIA Dr Kamel Hili Director Assistant of Evaluation

Primary Health Care Direction Tunis

Mr Lotfi Ben Ghozia Technician


Pedagogic Centre for Training of Health Professionals Tunis

Mr Sarni Tazarki Programmer Mini stry of Public Heal th Tunis

YEMEN Dr Adel AI-Moayed Director General Hajja General Hospital Sana'a

Mr Nasr Ali Ahmed Head of Continuing Studies Nursing Department Ministry of Public Health and Population

Sana'a


Dr Ross Wilson Director Centre for Health care Improvement Royal North Coast Hospital St Leonards AUSTRALIA

Ms Sisse Bjorn Olsen Clinical Research Fellow

Resource persons

Department of Biosurgery and Surgical Technology Faculty of Medicine Imperial College London London UNITED KINGDOM

WHO Secretariat

Dr Abdallah Assaedi, Assistant Regional Director, WHO/EMRO Dr Ahmed Abdellatif, Regional Adviser, Health Care Delivery and Coordinator Health Systems, WHO/EMRO Dr Iciar Larizgoitia Jauregui, EIP/SPO/QPS, WHO/HQ Dr Amr Mahgoub, Regional Adviser, Health Management Support, WHO/EMRO Dr Mohamed Abdurrab, Regional Adviser, Research Policy and Cooperation, WHO/EMRO Dr M. Farag. TO/DHS, WHO/EMRO Mrs Hoda El Sabbahy, HCD/DHS, WHO/EMRO


Annex 4

COUNTRY PLANS OF ACTION

C ountry: E ;,nrp t

Project management

Ph� Tasks Who

Agreement to the task Get support of MOH. Project manager Identifying/engaging Obtain an invitation for various hospitals. local leadership

Get approval of the first undersecretary.

Approach the medical syndicate

Approach the chief executive of major hospitals for approval and raise awareness

Establishing Include stakeholders in a meeting to provide Project manager governance structure. awareness of the general concepts and the proposed

Identifying and outcome of the study

involving stakeholders Create a steering committee:

• a MOH representative • Project manager • Medical syndicate rep. • Chief executive of the major hospitals

Securing resources Create a provisional budget. Project manager and funding Seek funding from MOH, WHO.

Ethical consideration/ Consider the regulation of the ethical review board Project manager approval of each participating hospital

Project management Choose and recruit members of the project: Project manager personnel and • Manager structure • Accountant

• Epidemiologist • Two clinicians • Administrative personnel • Biostatistician

Review recruitment Two senior clinicians, one surgeon and one internist. Project team Two-four senior nurses

Expert panel

Training Train a group of potential recruits for screening and Team reviewing

Hospital selection and Three major hospitals from a group of hospitals that Project manager and engagement show desire for participation. epidemiologist

Convenient and representative sample.

When January 2006

J anuary-Fcbruary 2006

January-February 2006

February 2006

February 2006

March 2006

March 2006

February-March 2006

WHO-EM/HCD/066/E

Page 39

Project managern1?nt '" '-. ,:,: ' :'-:� : / ___ -- _ "' • � - .• - ',' - • ••.· d� � •

Case sampling 500 records/hospital chosen through a systematic random approach.

Record acquisition

Pilot testing Data collection, entry, cleaning and analysis

Go to medical records archive, may need to over sample Ensure the presence of aJI notes

Performed on 10% of sampled records in the first hospital.

• Design datasheet • Data collection • Develop database • Data entry • Data validation and cleaning • Data analysis

Reporting and release Descriptive aggregate report to the MOH of results and WHO.

Individual hospital report Controlled media report Scientific publications (if Ok)

Country: Jordan

Agreement to the task

Feedback to higher level of the MOH about the project purposes.

Identifying/engaging Official Jetter to MOH Hospital Directors local leadership Official letter to Medical Syndicate

Establishing governance structure. Identifying and involving stakeholders Securing resources and funding

Ethical consideration/ approval

Invitation (official) letter to Directors of MOH hospitals followed by orientation presentation to them through a meeting as they are main stakeholders

Communicate WHO/EMR.O for funding Use existing MOH resources

Submitted the project for approval from H. E. the Minister of Health and Ethical Committees at hospital level

Epidemiologist

Epidemiologist

Project team

• Manager • Epidemiologist • Statistician • Reviewers and scrccners • IT experts • Data entry personnel

Project manager

MOH

MOH

MOH

MOH

April 2006

April-June 2006

June-July 2006

June-August 2006

SeptemberNovember 2006




February 2006

WHO-E:M/HCD/066/E Page 40

Project management Project manager under Quality Directorate/MOH personnel and Steering Committee 56 persons from MOH higher structure level + Medical syndicate headed by secretary

General

Scientific Committee 5-6 persons. headed by Project manager

Reviewer Screening Team: qualified nurses (4). two team recruitment from outside sampling hospitals.

Reviewing team: specialists, surgeons and Internist (4) from outside sampling hospitals

Training Practical and classroom training course for the screening and reviewer teams

Hospital selection OH hospitals (frame 26 all over the kingdom) and engagement Sample (Middle Region MOH hospitals) AU

hospitals (6)

Case sampling 500 Medical records from each hospital

List of records admitted randomly chosen by sequence number using systematic Random sampling

Record acquisition All types of records will be accessed

Check quality of medical records

Project Manager and involved hospital directors responsible for this process

Pilot testing Piloting of first hospital for file completion and evaluation purposes

Data collection, Data collection by review team entry, cleaning and Data entry by statisticians analysis

Data cleaning by reviews

Reporting/ release of Scientific Committee writing a report results Engagement of press through MOH, officials

Dissemination of results and declaration is the responsibility of steering committee

Scientific publication

Country: Kuwait

Project management

Phase


Tasks

Evidence (reason)

Advantage: Benefit for country Identifying/ engaging Explaining the project local leadership

Establishing Presentation about patient Safety Project governance structure. Report to the stakeholders Identifying and

MOH

MOH

MOH

MOH

MOH

MOH

MOH

MOH

MOH

Who

MOH

Hospital directors

February 2006

February 2006

April 2006

March 2006

March-April 2006

May 2006

May-June 2006

September-October 2006

December 2006

When

December 2005

December 2005

involving stakeholders

Securing resources and funding


Financial support

WHO-EM/HCD/066/E

Page 41

With ministerial order. no need for patient consent

Project management Creating the reviewing team personnel and structure

Reviewer Screening: Head nurse recruitment Reviewing:

Physicians

Anaesthesians

Surgeons

Experts panel: Hematology. Pediatrician • • • etc.

Training Dif. Of AE

Process of Project

1 week duration

Hospital selection Six main governmental hospitals and engagement

Case sampling 500 records/hospitals

Administration index 2004

Random sampling

Record acquisition Collecting channels

List it to be available at any time

Pilot testing Examine and follow-up:

The project process

Training

Initial results

Resources

Data collection, entry, cleaning and analysis

Reporting/release of Reporting results for all involved hospitals results

Private companies

NGOs

Quality Control DepL

Quality Control Dept.

Hospital Med. Rec. Dept.

Quality Control Depart.

Quality Control Dept.

January 2006

February 06

March 2006

March 2006

May 2006

June 2006

December 2006

WHO-EM/HCD/066/E

Page 42

Country: Morocco

Project management

Phase

Agreement to the task Identifying/ engaging local leadership

Establishing governance structure. identifying and involving stakeholders



Project management personnel and structure

Reviewers recruitment

Training

Hospital selection and engagement

Case sampling

Record acquisition

Pilot test

Tasks

Inform.al contacts with potential local leaders (MOH departs� universities, hospital managers, phamacovigilance centre, professional associations (clinicians, nurses), Media?

Meetings to present the project and obtain engagement

Conduct project

Disseminate results

Elaborate recommendations

Lobbying vis A vis universities (department of research, MOH, WHO, other organizations)

Submission of protocol for approval

Manage the project

Writing protocole

Training

analysis

Monitoring

Contact

Testing/selecting

Training

Nurses/Junior training

Senior training

Expert training (who will call to phone)

10 hospitals

Contact (evaluate degree of involvememt)

Meetings

Confidentiality chart

350-500 cases/H

Random sample from all admissions of 2004

Medical files

Nurse files

Reanimation & anaesthesia files

Theatre operation files

In 2 hospitals to:

Have an idea about prevalence of AE

Evaluate the validity & reliability of French version of tools

Who

Project management team

Steering committee:

DHSA (MOH) + 2 universities

PMT

CERB (Faculty of Medicine and Pharmacy Rabat)

PMT

Secretary

Research team (RT)

RT

RT

PMT

RT

Nurses

RT

When

January 06

February 06

January-March 06

Fcbruary 06

January

December 06

February-March 06

March 06

February 06

March 06

April 06

April 06

Data collection. entry. cleaning and analysis

Reporting/release of results


Training of nurses/junior doctors; senior doctors entry operators

Coding (SPSS)

Elaborate research report

Meetings for feedback

Web site of university and ministry

Spread of"Research Report" to minister. ministry departments. universities, hospitals directors. WHO, Sissa

Mains results for media

Publication

Country: Sudan

Doctors, nurses

RT

SC

May-July 06

July 06

.Project management: I year project from January� Implementation in 10 hospitals. thal are 6 f�eral hospitals

Phase Tasks Who When

Agreement to the Meting with the higher political level in FMOH Patient safety Second week in task (Ministerial Undersecretary) programme within January 06

Identifying/ engaging local leadership

Establishing governance structure.

Identifying and involving stakeholders



Undersecretary council orientation

Formation of the steering committee (20 members involving stakeholders), Two meetings

Orientation meeting to the stakeholders reporting

Formation of the technical committee (5 members) technical. senior accepted key figures from clinicians

Project team

Contacting funding agencies

Contacting MOF

Obtain ethical clearance from the national ethical committee

Project management Steering group expert panel personnel and Project manager Technical committee structure

Reviewers

Data managers

Personnel

quality directorate

H.E. MOH

Programme

Undersecretary

Undersecretary with programme directors

Technical committee

Technical committee

January

February

January

January-March 06

End of February 06

February

Reviewer recruitment

Training


Case sampling

Record acquisition

Pilot testing

Data collection. entry, cleaning and analysis


\VHQ.EM/HCD/066/E

Page 44

Nomination and selection of 3 nurses

Nomination and selection of specialists

Training workshop 5-6 to train reviewers

Orientation Meetings and sessions with selected hospital directors

· Orientation sessions with senior clinicians

Visits of the 10 selected hospitals

Visits to IO hospitals to health information units and chief nurses

Sampling

Review of records

Data entry

Analysis

10 days data collection and review for each of the 10 hospitals

Data entry

Data analysis

To complete the report

Meeting wit higher political level in FMOH

Steering committee meeting (workshop)

Dissemination to various care providers in different stages

Publication

Stakeholders

Country: Tunisia

Project management

Phase





Tasks

Share the infonnation about the existence of the new health challenge and give a review about what was published on these aspects

Submitting project of research about AE to the ministry and approval for engaging local leadership

Design a central unit who involve:

National experts

Representative of DTH

Representative of DER

Representative ofUFC

Representative of . •. .

Representative of administration

Technical. committee

Technical committee

The programme with the support of the tech. committee

Reviewers

Reviewers

Reviewers

Reviews medical record especially data management team

Technical committee

Minister

Quality Directorate

Who

The team who participate to this meeting (National Team)

MOH

April

End of February

March-April 06

May 06

May 06

May 06

June-September 06

September-October 06

When

December OS

December OS


Representative of medical infection

Representative of CSNR.S

Securing rcsow-ces Mobilize human resources: MOH and funding Central unit Hospital

Local working group +

Material IX/HO

Financing reviewers

Financing training session

Technical support

Ethical After Ministry approval, we have to submit the MOH January 06 consideration/ project to Council national d'ethique for approval approval

Project management Central unit MOH MOH January 06 personnel and Local working group regional hospitals (Regional Regional hospitals structure Director of Public Health)

Reviewer Regional directors identified Health Council of March 06 recruitment Selection between nurses who has high skills and Regional hospital

experience designed

Training Resident of health council of the 6 regional National team April 06 hospitals identified National expert Nurses = 12

Medical officer = 6

Hospital selection Central unit MOH National team January 06 and engagement 6 Regional Hospitals

Ministry approval will facilitate the engagement of regional hospital headquarters

Case sampling Overview of existing data about Regional Central unit February 06 Hospitals = number of beds, activities MOH 6 similar socio-economic areas selected

1 regional hospital from each

5000 Medical register/year 2005

Record acquisition Local working group in the 6 regional hospitals Local working May 06 have to select the registers corresponding at the group sample required

Nurses will do the fJJ"St step to select the registrar with positive criteria

One medical officer from the local working group has to review positive registrar and identify those who present AE

Pilot testing National team has to review and control the National team May 06 ongoing of the first and the second step of the project and even have to take decision to change some procedures

Data collection, Complete data collection and recording National team June-July 06 entry, cleaning and Clear and analyze the results

analysis


'\VHO-EM/HCD/066/E Page 46

Discuss with the regional working group

The report should clarify the content of the project National team on the basis of reducing preventable AE

Resend the . . . . . . . . .. of the project and then the results

Summary about what can be planned for the future

Report wiH be anaJysed

Feedback to the regional level

If project successful: extend the project to some university hospitals and to private clinics

Country: Yemen

Project management" ·

Phase _Tasks







Project management personnel and structure

Reviewer recruitment

Training


Develop a draft of the project to be presented to the high leadership in MOH (Minister and his deputy) to get their approval

Create a political commitment from high level officers of MOH

Identify the concerned stakeholders and sectors in MOH and hospitals aimed

Preparing an action in which the budget will be clear for each part

Marketing at that project among donors (MOH, WHO and NGOs)

Present the draft of the project to the research ethical committee to get approval for starting the study

Forrning a national task force (M.S. quality assurance, community sharing department, health sector reform. hospital department, physician syndicate, strategic department)

Specialists (ex.perts)

Physicians

Nurses

Medical records

Organizing 5 days training course for the screeners and reviewers

Get the agreement from the aimed hospitals and ensure the confidentiality of the information

Who.

July 06

When

December 05

Mid December 05

1 March 06

Mid March

06

l April 06

7 April 06

15 April 06

30 April 06

Case sampling

Record acquisition

Pilot testing

Data collection. entry, cleaning and analysis


gained

WHO-EM/HCD/066/E

Page 47

Random sampling: 350 cases per hospital

Develop a format for the data collection notes that may make our task much easier and will be our documents

First hospital will be as a pilot testing

Review data recorded from each hospital:

Enter data in SPSS Analyses by the experts and directorate

Formation the assessment of the magnitude of the AE in these hospitals

Preparing a final report of the results of the study to be presented to the high level officers of MOH and making some suggestions

Organizing a meeting with the stakeholders to discuss the results and identifying the next steps.

Country: Kenya

Project Management

Phase

Agreement to the taskIdentifying/engaging local leadership

Establishing governance structw-e


T�ks ProfessionaJ association body

Stakeholders advisory forum:

Hospital CEO (private hospital)

Director of medical services

Provincial district medical Superintendents

Health care financim (insurance)

National AIDS Council

MAC of private hospitals

Consumer organizations

Medical Practitioners and Dentists board and HESAB

Kenyatta Hospital Director

MOH

Medical Practitioner and dentists board

Kenya Medical Association

CEO rep.Jhospital admin.

Consumer organizations representatives

Issues/share vision:

Decide data ownership

Consensus on ethical issues

Policy and dissemination

Who

PI

PI

IS May 06

30 May 06

30 May 06

10 June 06

1 July 06

When March 06

March 06

WHO-EM/HCD/066/E

Page 48

Securing resources and Full proposal with budget PI/WHO January-February funding Communication with potential fund 06

providers/WHO

Determination of banking arrangements. financial accounting

Explore local supplementary funding (medical insurance companies)

Ethical consideration/ Submission of proposal to ethical committees PI Fcbruary 06 approval (National and institutional)

Letter of support from WHO

N.B.: Institutional clearances critical and facilitated by director of medical services support and teaching hospital clearance.

Project management Recruitment of project manager PI and funding recipient March 06 personnel and structure Identification and e.quipment of project office organization

Financial and technical review

Reviewer recruitment Phase 1 screening (nurses) PUproject manager/data March 06

Phase 2 screening (doctors) manager

Specialist consultants identification

(co-investigators)

Training Screening (Phase 1) Pl/project manager/data March 06

Auditing (Phase 2) manager

Pilot Testing (1 week)

Hospital selection and Create sampling frame for MOH hospitals based PUProject manager/co- February 06 engagement on access and cost of identifying private investigators

hospitals

Visit and engage CEOs of private hospitals. director Kenyatta national hospital and medical superintendents of MOH hospital

Engage other staff in institutions

Case sampling Determine order of filed implementation (where Project manager/data Ear1y March 06 to start and how to work) manager/co-

Streamline transport and data collection process investigator

Random sampling of 500 cases

Record acquisition Agree on process with institutions - who? How Project data manager March - April 06 to handle and secure pulled out records.

Pilot testing Visit private hospital/teaching hospital and Full research team Early Aprir 06 nearest MOH hospital

Preset on 10 medical records for each facility

Data collection, entry, Ensure process clear and pre-tested Data manager February-March cleaning and analysis Collection, Identification, engagement of 06

Biostatistical support (Who?)

Reporting/release of Consensus on who should have access and when Oversight Committee January-February results (MOUs) Advisory Forum 06

Consensus on publication May-June 06

Scientific meetings presentations


Consensus on local (nationa]) dissemination process

Discussion on policy plan

Fol1ow-up studies towards national survey or surveillance system and National AIDS Council. ART Programme Adverse events monitoring

Preparatory phase and proposal revision: January-March 2006; Data collection: April-JuJy 2006

Country: South Africa

P,-oject management Phase Tas�: Who When

Agreement to the Provincial department s of Health COHSASAMD February 06 task National Department March 06 Identifying/ HospitaJ management teams engaging local leadership

Establishing WiU be a 2 phase approach COHSASA MD March 06 governance structure Initially meeting with provincial March-April 06 Identifying and DOH/nationa] involving

DOH/COHSASA stakeholders Second Phase: Meeting with Provincial DOH/rcprcscntatives from hospitaJs/COHSASA

Securing resources Determination of budget -COHSASA January 06 and funding Communication with WHO re potential funding + WHO

COHSASA -COHSASA + MD

Size of project dependent on available resources

Ethical Research proposa] to be substituted to ethical COHSASA/MD February 06 consideration/ committee for approval (?DOH) approval Letter of support from WHO

Project management Appoint project manager at COHSASA. Could COHSASA/MD January 06 personnel and use existing structures including data collection structure and travel arrangements

Reviewer Phase 1 (screening) Project manager February-March 06 recruitment Nursing staff (current COHSASA ful] time or part

tome staff)

Phase 2 (medical review)

Identification of either a senior family physician, physician surgeon

Appoint expert panel

Training Training to be provided in Cape Town for phase I Dr Van Zyl ± 2 weeks prior to and II reviewers pilot

Duration :t 1 week

\VHO-EM/HCD/066/E

Page 50

Hospital selection Hospitals that are currently in programme COHSASAfMD March 06 and engagement Could be selected having stratified hospitals on MRC statistician

baseline results

Meetings to be arranged with management teams

Numbers of hospitals dependent on funding 4-10 hospitals might be more rea1istic

Case sampling 500 randomly selected records per hospital Review team April-June 06

Method to be selected upon MRC statistician March 06

Record acquisition Spend first day at hospital to draw records Review team April-June 06

Ensure as many records as possible are accessed -especial1y records of deceased patients. pending litigation • . . etc.

Pilot testing Commence with Sitsi hospital (500 files x_ 2 Review team April 06 weeks)

Hospital should be easily accessible

Project manager to be included

Data collection. Data collection April-June 06 entry, cleaning and Analysis July-August 06 analysis

Collaboration with WHO

Reporting/release of Report to provincial and national DOH All COHSASA MD October 06 results Report to WHO and team

? Publication


Annex S

NURSE (RFI ) AND MEDICAL (RF2) REVIEW FORMS

0

EMRO WHO Adverse Event Study 2006

CONFIDENTIAL

NURSE REVIEW FORl\1 (RFI)

MEDICAL RECORD No. □ □ □ □ □ □

PATIENT NAME: -------------------(S11nrame) (Given Names)

DIRECTIONS: I . For all criteria refer to definitio11s in RF/ Afanual.

2. For all criteria enter the appropriate number in the box.

3. Plea."e print or write response legibly in BL UE pen. RED for corre,·tions or deletions.

4. Thi." page to he remm•ed and destroyed by team leader ONL Y after all rei•iew elements are completed and prior to remm,al ofrei•iewformsfrom the ho ... pital.

DO NOT FILE IN THE MEDICAL RECORD

EMRO AE study Nurse Review fonn RFI 050306

Reviewer ID Number: D D D Case Number: I I I I I I I Age: I Sex: D Date of Admi��lon : I I I I 1 1 I D D .M M Y J'

Time Commenced Review: (U.te 24 /,011r clock)

Time Review Finished:

Total t ime spent reviewing in minutes : {Do not include interruption t ime off)

Discharge Status: D Date of Discha� I 1 1 I I LLJ

D D M M Y Y

Brief cl inical summary: ___________________ _

l\lccl ica l record documentation adequate To support questionaire:

I . I n it ial mecl ical assC'ssment:

2. Medical progress notes:

3. N ursing progress notes:

4. Proced ure documentation:

5. Patholo�y reports:

6. Discharge summary:

□ l =\'es 2-=No (tftC'11 STOP)

□

□ □ □ □

□

l ==Yt>�

2=�o

Jc:i',/A

7. Other (gi\'e details): ___________________ _

Cr-iteria Present:

\Vas a management plan written on admission

I ADVERSE EVENT DETERMINATION: EMRO A E study Nurse Review fom1 R F ! 050:106

□

□

l =Ycs l=No( Then STOP)

l =Yes 2=No

2

Did the patient sustain an unintended i njury resulting in temporary LJ Or permanent d isabil ity and/or prolonged length of stay u a Consequence of health care management?

I. Unplanned admission (including readmission)as a result of any health care management within 1 2 months. □

l=YES 2=NO

J =Yes 2=No

2. Unplanned admission to any hospital, post this discharge. □ l=Yes 2=No-

3. Hospital-incurred patient accident or injury.

4. Adverse drug reaction.

5. Unplanned transfer from general care to intensive care/ hi�her dependency.

6. Unplanned transfer to another acute care hospital.

7. Unplanned return to the operating room on the admission.

8. Unplanned removal, injury or repair of organ or structure during surgery, invasive procedure or vaginal delivery.

9. Other patient complications to include: Al\11, C\'A, PE etc.

EMRO AE study Nurse Review fonn RF I 050306

□

□

□

□

□

□

□

l =Yes 2=No

l =Yes 2=No

l =Yes 2=No

l=Yes 2=No

l =Yes 2=No

l=\'es 2=No

3

to. Development of neurological deficit not present on admission

1 1 . Unexpected death (i.e. not an expected outcome of disease during this hospitalisation).

□ l =Yes 2=No

□ l =Yes 2=No

1 2. Inappropriate dischar�e. (This will be followed by explicit criteria in the manual (Tp>38C � 0 1� 2=No

13. Cardiac/respiratory arrest, low apgar score.

14. Injury or complications related to abortion or labour and del inr)' includinJ! neonatal complications.

15. Hospital acquired infection/sepsis.

1 6. Pat ient/family dissatisfaction with care recehed documented in the medical record and/or r,·idcnce of complaint lodged.

I 7. Documentation or corrrspondence indicating l itigation. either contemplated or actual (e.g. letter from solicitor etc. )

1 8. Any other undesirable outcomes (not co,·ered by any other criteria.

EMRO AE study Nurse Review fonn RF! 050306

□

□

□

l =Yes 2=No

l=Yes 2=No

l=Yes 2=No

□ l=Yes 2=No

□ l=\'es 2;No

4

19. h there evidence of this patient being HIV positive?

Documented known HIV =ve) (On anti retroviral therapy) (Recent TB (anytime In the past 24/12) (Known HIV exposure)

Demographic section (to come before criterion 1 )

□ I-Yes

2=No

Diagnosis on admission _____________________ _ Name of principal procedure/Operation _______________ _

Was this patient on any regular medication?

If es lease indicate which below.

k:O-MORBIDITIEij

□ 1-Yes l=No

D No co--morblditles Please tick all of the following co--morbidities that apply to this patient or Not known

Cardio-vascular Coronary artery disease Peripheral vascular d isease Cardiac insufficiency or dysrhythmia Hypertension

Resptratorr § Asthma/COPD Other serious lung problem (e.g. severe Tuberculous scarring, pneumonectomy) (Specify) __________ _

Ga.<:tro-intestinal Chronic or recurrent dyspepsia Inflammatory bowel disease Chron's/colitis Chronic liver d isorder Chronic diarrhoea

Endocrine

a Diabetes Endocrine d isorder (e.g. thyroid, adrenal) (Specify) __________ _

Neurological

�

Epilepsy Stroke Parkinson's Dementia Other serious neurological disorders (e.g. MS,MND) (Specify) ____ _

Renal 0 Chronic renal disease Haematological

EMRO AE study Nurse Review form RF! 050306

Exi.<:tin cancer Specify ________ _

Di.fahility \Vheel chair bound Blind Deaf Learn ing difficulty Other (Specify) _____ _

Ps · l,iat Schizophrenia Affective disorder Other (Specify) _____ _

P.<: ·clw.-.ocia/ Alcoholism Drug abuse S moker Homeless Other (Specify) _____ _

Infection □ HIV/AIDS

D Chronic infection (e.g. Hep C M RSA) Specify _____ _

N11tritiona/ status Obese undernourished Other (Specify) _____ _

Otl,er co-mnrhidity (Specify)

s

§ Anaemia Malaria llaematolo�ical cancer Other (Specify) _________ _

EMRO AE sludy Nurse Review form RFt 050306

Allrrgies (Specify) ________ _

6

D . .

EMRO WHO Adverse Event Study 2006

CONFIDENTIAL

MEDICAL REVIEW FORM (RF2)

CASE No.□□□□□□□

Directions:

N C H I

1. Complete this form only if RF/1 completed by RN reviewers has Identified that a screening aiterion is present.

2. Please read RF/1 Prior to reviewing the medical record of INDEX admission, prior to answering the specific questions on this form.

3. Do not write the patients name or hospital record number on this form.

4. "AE* means adverse event.

5. Please print or write responses or notes legibly, in BLUE pen, RED for corrections or deletions.

6. For all questions enter the appropriate number in the corresponding box.

7. Please return this form to the team leader on completion of Review Session.

EMRO AE study Medical Review Form (RF2} 050306.

DO NOT FILE IN THE MEDICAL RECORD

I �ECTION A - CLINICAL SUMMAR\j I

1.

la Reviewer ID Number: D D D lh Case Number! .... _._____.__.____,_--'._____.___,

le Date or Review:

D D M M Y Y

Id Time Commenced Review: I I I I j l f Total time spent reviewing in minutes: [TI

2.

le Time Review FinlshedJ..___.___,_____.___.

2a Please give brief dinkal summary (expand on nursing summar)' if necessary. you do not need to rewrite if summary is adequate).

2h Do you confirm the RN reviewers criteria finding: D

l =Yes (Go to Q.3) 2=No(,fn�"•tr 2c then STOP.)

2c If you answered .. NO .. to Q.2b please indicate why by answering one of the

EMRO AE sludy Medical Review Funn (RF!) 050.106. 2

following questions:

i. Criterion Error (criterion not fulfilled). Describe: -----------------------------

ii. Other. Describe: -----------------------------

FOR All QUESTIONS ENTER APPROPRIATE

NUMBER IN BOX

I �ECTION B - ADVERSE EVENT DETERMINATION! I

INJURY:

3,,, Was there a patient injury or complications?

3a If Yes to Q.3 describe brieny the clinical

□ l=YES 2=NO(Tlren STOP)

contnt: ______________________________ _

DISA BILITY:

Jb Did the injury or complication result in a d isability at the time of discharge and/or a prolonged hospital stay?

)=Disability l=Prolonged hospital stay 3=Both

Jc Describe the d isability and/or prolonged hospital

4-=Neither (Then STOP) (No AEJ □

stay: _______________________________ _

EMRO AE study Medical Review Fonn (RF2} 050306. 3

CAUSATION: In your best judgement, is there evidence that HealthCare management caused the patient's inju ry? I n answering th is question, consider when relevant the following questions and complete the appropriate boxes. After due consideration of the clinical details of the patient's management, what level of confidence do you have that the HEAL TIICARE l\1ANAGEI\IENT caused the injury?

CONFIDENCE SCORE: t . =Little or no evidence for management causation (Then STOP,no AE) 2. -Slight to modest evidence for management causallon. I SCORE I 3. =Management causation not likely; less than 50-50 but close call. □ 4. =.Management causation more l ikely than not, more than 50-50 but close cal l. 5. =Moderate/strong evidence for management causation. 6. =Virtually certain evidence for management causation.

Did the patients HIV/AIDS status or its treatment contribute to the A E

l=YES 2=NO □

If yes please describe in what way:

If an adverse c,,cnt has hcen identified please proceed to complete all sect ions on the rest of the form.

I �ECTION C - CLASSIFICATION OF ADVERSE EVEN11 I lrLEASE c1 1oosE o�u· O'."F. OF suRsr.cT10Ns c 1 -C1ij

I !ct - DIAGNOSTIC ERROR:! I

4. Was the adverse event the resu lt of a d iaj:!nostic error (wrong or delayed diagnosis)? l =YES □ 2=NO

4a: If yes to Q.4 then describe: _______________________ _

, 4b: If yes to Q.4 choose one of the fol lowing that best describes the diagnostic error.

t . ==There was a failure to take an adequate history and/or physical examination. 2. =There was a fai lure to employ ind icated test. 3. =There was fai lure to act upon resu lts of tests or findings. 4. =Inappropriate or outmoded diagnostic tests were used. 5. =There was avoidable delay in diaS?,nosis. 6. =Doctors or other p rofessionals were practising outside their area of expertise.

EMRO AE study Med ical Review fonn ( Rf2) 050306. 4

(GIVE DETAILS)

\Vere there other diagnostic errors? l=YES 2=NO □ 4c

4d If yes to Q.4c then describe: _____________________ _

I lc2 - OPERATIVE ADVERSE EVENjj I ENTER APPROPRIATE NUMBER IN ALL BOXES

Was the AE related to an operation or did it occur during the immediate (30 day!) Postoperative period? □ l =YES

2=NO

5a If yes to Q5 select one of the following:

ITECHNICALj

l=Technical p roblem. Specify: __________________ _

2=Bleeding. Specify: ______________________ _

3=\Vound Infection 4=Non-wound infection : S=Other wound problem: Specify: _________________ _

6=0ther Specify: _______________________ _

6b \Vere there other operative p roblems? D l=YES

6c If yes to 6b specify: ____________ 2=NO ________ _

6d Choose one of the following that best describes the adverse event. l=The operation was inefficacious (failed to relieve symptoms). 2=The patient was inadequately prepared before the operation. J=There was avoidable delay in treatment. 4=There was i nadequate monitoring/supervis ion of the patient after the operation. S=Doctors or other professionals were p ractising outside their area of expertise.

(GWE DETAILS) 6=1nappropriate or outmoded forms of therapy were used. 7=None of these apply.

EMRO AE study Medical Review Form (RF2) 050306. 5

7

8.

7=PE l O=DVT

INON-TECHNICA�

8=CVA 1 l=Al\11

9=CIIF 12=PNEUMONIA

13=0ther non tech nical Specify: ___________________ _

11¢3 -FRACTuREsl l (I ncludes non-operative treatment)

Was the adverse event related to a fracture? 6a If yes to Q.6 indicate the type of fracture: ______________ _ 6b I f yes to Q. 6 indicate one of the following: □ l =Re-do: ___________________________ _

(GIVE DETAILS) 2=Prosthesis Failure: ------------------------

3 = 0 per at iv e Care: _________________________ _ (Gf l 'E DETAILS)

4=Non-operative Care: _______________________ _ (GWE DETAILS)

5=0ther: -----------------------------(Gf l "E t>F.T,HI.S)

11¢4 - ANAESTHESIA RELATED INJURY:l l

\Vas the adn�rse ennt related to anaesthesia'?

7a I f yes to Q. 7 indicate the operation involved: ______________ _ 7h I f yes to Q 7 i nd icate one of the fol lowing:

1 =lntuhation. 2=Anaesthctic agent complication. 3=Equipment failu re. 4=Preop a ssessment. S=Other: -----------------------------

( (ill E IJlT

.-IILS)

I les -OBSTETRIC RELATED INJURY (l\1aternal�,

\Vas the adverse event related to ohstctric management?

8a If yes to Q.8 indicate at what stage the A E occurred. 1 =Antenatal. 2=Lahou r & Dclinry 3=Post-partum.

8h Describe the contributing factors to the ad\'l:rsc cnnt:

□ l =\'ES

2=�0(S1t.·1r TO Q9}

□

EMRO AE study Medical Review Funn ( RF:!} llSOJOfi.

9.

8d Mode of Delivery l=Normal Vaginal Delivery. l=ln:1trumental AHbted Delivery. 3=Caesarean Section.

□

I 1¢6 .. NEON AT AL RELATED INJUR51 I

Was the adverse event a neonatal injury?

9a If yes go to Q.9 indicate one of the following. 1 =Conduct of Delivery. l=Pre Delivery Assessment. J=Post-Delivery Care.

□ l•YES

l•NO(SK/P TO Q.1f1)

4=0ther.Speclfy: _________________________ _

9b Describe the contributing factors to the adverse event:

1 re, -NON-SURGICAL PRocEnujijj 1

10. Was this procedure,-related (Non-surgical) injury (such as endoscopy or cardiac catheterisation)?

/Oa If yes to Q.10 select one of the following:

[TECHN/t:A�

□ l•YES

2=NO(SKIP TO q.11)

!=Technical problem. Specify: ___________________ _

l=Bleeding. Specify: _______________________ _

J=Wound infection 4=Non wound Infection S=Other wound Infection. Specify: __________________ _

6=0ther Specify: ________________________ _

7=PE IO=DVT

S=CVA

I J=Al\11

9=CCF l l=PNEUMONIA

13=0ther non-technical Specify: __________________ _

EMRO AE study Medical Review Form (Rf2) 050306. 7

/Ob Were there other procedure-related problems? □ l=YES

2=NO (SKIP TO Q.IJE)

/Oc If yes to 1 0b specify: _______________________ _

/Od Choose one of the following that best describes the adverse event. □ 1 =The procedure was inefficacious (failed to relieve symptoms). 2=The patient was inadequately prepared before the procedure. 3=There was avoidable delay In treatment. 4=There was inadequate monitoring of the patient after the procedure. S==Doctors or other professionals were practising outside their area of expertise. 6==1nappropriate or outmoded forms of therapy used. 7=None of these apply.

lies . DRUG RELATED INJURY!I

11. Was this a drug related injury? □ l=YES

2=NO (.�Up In Q. 11)

I la I f yes to Q. I I then descrihe: ____________________ _

1 1 h What was the drug?

l=anti-ncoplastic 2=a ntihiotic 3=a nti-malarial 4=antiretroviral S=a nti-seizurc 6=d iahetes 7=scdatin or hypnotic.

I le Name of medication :

8:;anticoagulant 9:;ant ihypertensive

1 O=narcotic/opiod 1 ):;potass ium 1 2:;other;plrasc sprcify : ________ _

-----------------------

lld Describe the drug"s side effect: --------------------

I le Choose one of the fol lowing that best descrihes the drug related injury.

1 :;The AE resulted from an error in the method of use or dose. 2=There nas failure to recognise possihle antagonistic or complemen tary drug-drug

i nteraction. 3=There was inadequate mon itoring of d rug lc\'l'ls or othrr in adequate follow-up. 4:;The drug was used inappropriately.

EMRO AE $Ludy Mctlirnl Review Form (RF2) 05CH06.

S=There was avoidable delay in treatment. 6=Doctors or other professionals were practising outside their area of expertise. 7=None of these apply.

I If Were there other drug t reatment errors?

Please describe:

□ l=VES 2=NO

---------------------------

f 1¢9 - THERAPEUTIC ERRoRJf

12. Was this a therapeutic error (e.g. correct d iagnosis but inappropriate therapy or delay i n treatment)? □ l=\'ES

2=NO (Skip tn Q. 11) 12a If yes to Q. 12 then describe: ____________________ _

lk:10 - FALL�,

13. \Vas the injury the result of a fall? □ l :YES 2=NO (Skip tn Q.UJ

13a If yes to Q. /3 describe the circumstances: ______________ _

I �ECTION D - DISABILifyj I 14. Was a portion of. o r the entire hospitalisation, due to the adverse event?

I = No increase in hospital days. 2= Portion of hospital stay. 3= Entire hospital stay.

16. How many days are attributable to the AE? DAYS

16. Would the patient at some time be able to return to pre-hospital state with regard to Employment, independence and leisure? □ l=Yes

l=No

/6a: Bued on evidence In the medical record what is Che degree of disability attributable to the adverse event? D

EMRO AE study Medical Review Form (RF2 ) 050306. 9

I= J\linimal impairment and/or recovery in one month. 2= Moderate impairment. recovery in one to six months. 3= Moderate impairment, recovery in six months to a year. 4= Permanent impairment, disability 1 -50%. 5=Permanent impairment, d isabil i ty >50%. 6= Permanent nu rsing. 7= Institutional care. 8= Death 9= Cannot reasonably judge.

17. \Vhen d id the Healthcare management and the consequent AE occur in relation to the index hospitalisation?

I= Healthcare management occurred during hospitalisation; Ae discovered during hospitalisation.

2= Healthcare management occurred in outpatient treatment p rior to hospitalisation ; AE indication for hospitalisation or first d iscovered during hospitalisation.

3= Healthcare management occurred during hospitalisation at any institution 1 2 months prior to index h ospitalisation; A E indication for hospital isation or first d iscovered during hospitalisation.

4= Hea lthcare management occurred during index admission; AE d iscovered in suhseq ucnt hospital isation.

l �ECTION E - CLINICAL CONTEXT OF AEI I

!OUTSI DE HOS PIT AQ

18. Where did the HealthCare management causing the AE occur? (choose one) rn 0 l= l'hysicians office 02=Ambulator)· care unit

( inc.day surgery)outs ide hospital 03-=l lome

04=11ome, labour and deli\:ery 05=Nursing home 06=Other site outside of h ospital

Specify: _______ _

!I NS IDE HOSPITAQ

07=Pat ients h ospital room 08=OR 09=1CU l O=ER I l=Ambulatory care unit

I 7=Therapy/Rchabi litation 1 H=Pathology 19c::Lahoratory (cl in ical) 20=Blood bank 2 t=Pharmacy 22=Hospital Bathroom (inc. Day suq�cry) inside hospital

1 2=Rl'covery Room 1 3=Lahour and Delivery 14=Nu rscry

23=Service Area (sta irs. halls. ele\-·ator) 24=Procedure room 25=Other site in hospital

15=Radiology Specify: ___________ _ I 6=Cardiac Cathetcrisation

EMRO AE study Medical Review Form I RF:?) 050.�06. 1 0

fg. SPECIALTY responsible for AE (choose one) rn Traditional Non-doctor HealthCare worker (01 ) (Need to renumber all)

01 =Anaesthesiology Ol=Cardiac Surgery OJ=Colon/Rectal Surgery 04=General Surgery

14=Cardiology JS=Dermatology 1 6=Emergency 17=Endocrinology IS=Family Practice

SURGERY

0S=Gynaecology 06=Neurosurgery 07=Obstetrics 08=Orthopaedic Surgery

MEDICINE 23=1ntensive Care Unit (ICU) 24=1nternal Medicine (not otherwise classified) 25=1\.1edical Oncology 26=Neonatology 27=Nephrology

lO=Plastic Surgery I !=Thoracic Surgery 12=Vascular Surgery IJ=Urological Surgery

3 1=Pathology 32=Paediatrics 33=Physical medicine 34=Psychiatry 35=Pulmonary Disease 36=Radiation Therapy 37=Radiology 38=Rheumatology

l 9=Gastroenterology 20=Haematology ll=lmmunology 22=1nfectious disease

28=Neurology 29=Ophthalmology 30=Otorh inolaryngology 39=Other specify: ____ _

40=Dentistry/Oral Surgery 44=Nursing 4 1 =Dietry 45=Osteopathy

48=Podiatry 49=Transportation support

42=Hospital Psych iatry Plant 46=Pharmacy S0=Other specify: ____ _ 43=1\tidwifery 47=Physical or

20.

20a

20b

Occupational Therapy

CONSIDER AND EVALUATE THE FOLLOWING QUESTIONS REGARDING THE CLINICAL CONTEXT OF THE AE

Is there consensus about diagnosis or therapy regarding this case? l =Very Little D 2=Some 3=A great deal

How complex was this case? □ l=Very complex 2=Moderately complex 3=Uncomplicated.

Was the management in question appropriate? 1 =Definitely appropriate 3=Possibly inappropriate □ 2=Probably appropriate 4=Definitely inappropriate

EMRO AE !.tudy Medical Review Fonn (RF2) 050306. l 1

20c What was the co-morbidity of the case in which the adnrse event occurred? l =Very i ll patient 2=1\toderately i l l patient □ 3=No co=morbidity

20d What was the degree of deviation of management from the accepted norm? l =Little 2=1\toderate 3=Severe □

20e \Vhat was the degree of emergency in management of the case prior to the occurrence of adverse event? ) =Critical and very urgent

□ 2=l\1oderate 3=Not urgent

20/ What potential benefit was associated \\'ith the intervention? l =Life sa,·ing 2=!\tajor qual ity of l ife 3=1\tinor quality of l ife 4Not applicable

20g What was the chance of benefit associated with the intervention? l=High 2=!\todcrnte 3=Low 4=Not applicable

I !sECTION F - CONTRIBUTORY FACTORS! I

21. Was the injury the result of a system error? □ l =Yes 2=No

□

□

21a I f yes to Q.21. choose one of the following to dcscrihe the system error:

t =The AE resulted from defective eq u ipment or supplies: ------------

(GIJ 'E DETAILS) 2=Thc AE resulted because equipment or supplies were not available: --------

(GIJ 'E OET.·HUiJ 3=There was inadequate reporting or communication : ____________ _

(GIJ 'E DETAILS) 4=Thcre was inadequate t ra in ing or su pen·ision or doctors o r other personnel : ___ _

(GJ J 'E DETAILS) S=There was a delay in the provision or scheclu l in;! of services kl!, fah ,�,,�. U:I� \ nr follow up vlsilsl

(G/ 1 'E DETAILS)

EMRO AE !>ludy Medical Review Fonn ( R F2) 050306. 1 2

6=There was inadequate staffing: ____________________ _

(GIVE DETAILS) 7=There WH inadequate functioning of hospital sen'ices (e.11. pharm■ry,blood b■nt or h111mkttplnc>

(GIVE DETAILS) 8=No protocol/policy or failure to Implement protocol or plan: _________ _

(GIVE DETAILS) +

21b Were there other system errors? □ l=YES 2=NO

21c Ir yes to Q.1 6b then describe: __________________ _

21d Was the patient receiving limited care as defined by DNR status?

21e Was the patient i nvolved in an experimental protocol?

lfsECTION G - PREVENTABILITYll

□ □

22. Rate on a 6 point scale the strength of evidence for preventability.

1 = Virtually no evidence for preventabil ity 2= Slight to modest evidence for preventability. 3=Preventabi l ity not quite likely� less than 50-50 but close call. 4= Preventability more likely than not; more than 50-50 but close call 5= Strong evidence for preventability. 6= Virtually certain evidence for preventability.

l=YES

l=NO

l=YES

l=NO

23. Describe briefly the manner in which the AE could have been prevented.

24. In the final analysis, was this an error of commission or omission?

l= Commission 2= Omission □

25. Which areas should have efforts d irected to amid recurrence? (you may choo�e more than one)

1= communication 2= education

EMRO AE study Medical Review Fonn (RF2} 050306. 1 3

3= record keeping 4= more nursing staff 5= more clerical staff 6= protocol 7= resources 8= other __________________ _

EMRO AE study Medical Review fom1 (RF2 ) 050306.

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