1. High 5s Project for Patient Safety:
What is the Role for IHF?
In support of the work of WHO Patient Safety Programme
Karen H. Timmons President and Chief Executive Officer Joint Commission International International Hospital Federation Leadership Summit Healthcare 2 June 2010
Good afternoon! Thank you, Dr. de Roodenbeke, for giving me this opportunity to speak about the work of the High 5s Project and how members of the International Hospital Federation might participate in this project. I would like to provide a brief overview of the Project and then discuss the roles and responsibilities of the participating hospitals.

2. Introduction to High 5s Project
Launched in 2007 by the World Health Organization (WHO) to address concerns of patient safety around the world
A global patient safety collaboration of:
8 countries
WHO Collaborating Centre for Patient Safety Solutions
WHO Patient Safety Programme
Other agencies
The High 5s Project was launched in 2007 by the World Health Organization (WHO) to address concerns of patient safety around the world
It is a global patient safety collaboration involving:
8 countries: Australia, Canada, France, Germany, The Netherlands, Singapore, United Kingdom, United States
WHO Collaborating Centre for Patient Safety Solutions
WHO Patient Safety Programme
Other agencies

3. High 5s 5 problems 5 countries 5 years
Derives its name from the original intent to reduce the frequency of:
High 5s
This project derives its name from the original intent to reduce the frequency of 5 problems in 5 countries over 5 years.
The impetus for this project was borne out of concerns regarding how widespread some patient safety issues have become. We know that no matter the organization, no matter the level of resources, significant errors still occur—even in the “best” of hospitals. And the problems in addressing these errors are the same. The solutions that have been developed and implemented so far have been necessary, yet they don’t go far enough. Now the challenge lies in standardization of solutions.

4. High 5s Mission
The Mission of the High 5s Project is to facilitate implementation and evaluation of standardized patient safety solutions:
Within a global learning community
To achieve measurable, significant, and sustainable reductions in high-risk patient safety problems
The objective of the High 5s initiative is to achieve a significant, sustained and measurable reduction in the occurrence of five patient safety problems over five years in now at least seven countries, and to build an international collaborative learning network that fosters the sharing of knowledge and experience in implementing innovative standard operating protocols (SOPs). The project is best characterized as applying standardizing patient care processes to improve patient safety and in evaluating the impact of these.

5. Contributions of Members
WHO Patient Safety: Policy dialogue, technical, advocacy, country engagement
WHO Collaborating Centre: Coordinate activities, organise meetings, develop SOPs and evaluation framework, establish learning communities, undertake analyses
Countries: Coordinate activities, develop SOPs, recruit and support hospitals, implement and evaluate, support data collection
Supported by:
Participating countries (national)
WHO, WHO CC, U.S. Agency for Healthcare Research and Quality, Commonwealth Fund (global)
I would also like to discuss the roles the key stakeholders play in this initiative.
WHO Patient Safety Programme: Policy dialogue, technical, advocacy, and country engagement
WHO Collaborating Centre coordinates activities, organises meetings, develops SOPs and evaluation framework, establishes learning communities, and undertakes analyses.
The participating countries coordinate activities, develop SOPs, recruit and support hospitals, implement and evaluate, support data collection
The Project is supported by:
Participating countries (national)
WHO, WHO CC, U.S. Agency for Healthcare Research and Quality, Commonwealth Fund (global)

6. High 5s Project Design

7. The Standardization Challenge
Within one country
Across participating countries
One of the overarching goals of this initiative is implementing standardization within one country, across participating countries.

8. Major Components of the Project
Implementation of Standard Operating Protocols
Impact Evaluation Strategy
Data collection, reporting, and analysis
Collaborative Learning Community
Project report
Major components of the project include:
Implementation of Standard Operating Protocols
Impact Evaluation Strategy
Data collection, reporting, and analysis
Collaborative Learning Community
Project report

9. WHO Collaborating Centre for Patient Safety Solutions
Developed Nine Patient Safety Solutions
High 5s Project Collaboration between the Centre and WHO Patient Safety Programme
Offers proactive solutions for patient safety based on empirical evidence, hard research and best practice
Advances the entire continuum of patient safety
System design and redesign
Product safety
Safety of services
Environment of care
Facts about the Centre
A key driver for global collaboration and change has been the WHO Patient Safety Programme (previously the World Alliance for Patient Safety), created by WHO to promote safer care. JCI and The Joint Commission were recently re-designated as the Collaborating Centre for Patient Safety Solutions
The WHO Patient Safety Programme has a very powerful--but challenging—mandate: To make health care as safe as possible as soon as possible.
While global interest--and certainly national interest--in patient safety has increased in the last decade, no one country has come to grips with the problems posed by patient safety.
Certainly we have seen that the case for action is urgent and compelling. The intent of the World Alliance was to gain global commitment to glean the knowledge and better understand the contributing causes to safety problems and errors so that systems and solutions might be designed that detect risk and to design systems and standardized processes with safety in mind.
As the WHO Collaborating Centre for Patient Safety Solutions, our chief objective was to develop and disseminate solutions in cooperation with others that help mitigate the risk of adverse events from happening. However, the intent has been to do this in a collaborative way with sensitivity to regional and local issues. 9 9 9

10. World Patient Safety Programme: Ten Action Areas
Global Patient Safety Challenges : 1. Clean Care is Safer Care 2. Safe Surgery Saves Lives
Solutions to improve patient safety
High 5s
Patients for Patient Safety
Catalyse countries’ action to achieve safety of care
Technology for Patient Safety
Research for Patient Safety
Knowledge Management
International Classification for Patient Safety (ICPS)
When it started 5 years ago, there were six main strands comprising the World Alliance. Now there are 10, which I will briefly highlight.
Solutions
High 5s
Technology
Knowledge Management
Special projects
Reporting and Learning
ICPS
Research
Patients for Patient Safety
Global Patient Safety challenges
Special projects: - Education - Radiotherapy - Rewarding excellence - When things go wrong - Vincristine sulphate
Reporting & Learning 10

11. Solutions for Patient Safety
The Solutions strand is a sharing, learning and support function for the World Alliance. 11 11

12. Definition
A Patient Safety Solution is any system design or intervention that has demonstrated the ability to prevent or mitigate patient harm stemming from the processes of health care.
I’d like to talk briefly about the Patient Safety Solutions. A solution is defined as any system design or intervention that has demonstrated the ability to prevent or mitigate patient harm stemming from the processes of health care.
As you can see by the definition—patients are at the forefront of these solutions. As I discuss the first set of 9 solutions, you will notice how the impact that each of them has on patient safety. 12 12

13. The inaugural nine solutions were released in May of 2007
The inaugural nine solutions were released in May of They are available on TJC/JCI/WHO Web sites.
This solution aims to mitigate the risk of confusing drug names. The recommendations focus on protocols, legibility and use of preprinted orders or electronic prescribing.
Confusing drug names is one of the most common causes of medication errors and is a worldwide concern. With tens of thousands of drugs currently on the market, the potential for error created by confusing brand or generic drug names and packaging is significant. The recommendations focus on using protocols to reduce risks and ensuring prescription legibility or the use of preprinted orders or electronic prescribing. 13

14. The widespread and continuing failures to correctly identify patients often leads to medication, transfusion and testing errors; wrong person procedures; and the discharge of infants to the wrong families. The recommendations place emphasis on methods for verifying patient identity, including patient involvement in this process; standardization of identification methods across hospitals in a health care system; and patient participation in this confirmation; and use of protocols for distinguishing the identity of patients with the same name.
This solution mitigates the risk of failure to correctly identify patients, which often lead to medication and testing errors and sometimes to wrong person procedures. 14

15. Gaps in hand-over (or hand-off) communication between patient care units, and between and among care teams, can cause serious breakdowns in the continuity of care, inappropriate treatment, and potential harm for the patient. The recommendations for improving patient hand-overs include using protocols for communicating critical information; providing opportunities for practitioners to ask and resolve questions during the hand-over; and involving patients and families in the hand-over process.
Gaps in hand-over communications between care-givers can seriously disrupt continuity of care and result in patient harm. Solution focuses on protocols to mitigate these. 15

16. Considered totally preventable, cases of wrong procedure or wrong site surgery are largely the result of miscommunication and unavailable, or incorrect, information. A major contributing factor to these types of errors is the lack of a standardized preoperative process. The recommendations to prevent these types of errors rely on the conduct of a preoperative verification process; marking of the operative site by the practitioner who will do the procedure; and having the team involved in the procedure take a “time out” immediately before starting the procedure to confirm patient identity, procedure, and operative site.
Considered totally preventable, these errors are commonly the result of miscommunication and lack of a standard preoperative process. 16

17. While all drugs have a defined risk profile, these are especially dangerous.
While all drugs, biologics, vaccines and contrast media have a defined risk profile, concentrated electrolyte solutions that are used for injection are especially dangerous. The recommendations address standardization of the dosing, units of measure and terminology; and prevention of mix-ups of specific concentrated electrolyte solutions. 17

18. Medication errors occur most commonly at transitions
Medication errors occur most commonly at transitions. Medication reconciliation is a process designed to prevent medication errors at patient transition points.  The recommendations address creation of the most complete and accurate list of all medications the patient is currently taking—also called the “home” medication list; comparison of the list against the admission, transfer and/or discharge orders when writing medication orders; and communication of the list to the next provider of care whenever the patient is transferred or discharged.
This solution seeks to ensure medication reconciliation and suggests a number of strategies to assure medication accuracy. 18

19. The design of tubing, catheters, and syringes currently in use is such that it is possible to inadvertently cause patient harm through connecting the wrong syringes and tubing and then delivering medication or fluids through an unintended wrong route.  The recommendations address the need for meticulous attention to detail when administering medications and feedings (i.e., the right route of administration), and when connecting devices to patients (i.e., using the right connection/tubing).  
This solution seeks to reduce the potential of errors caused by current design of tubing, catheters and syringes through misconnect. 19

20. One of the biggest global concerns is the spread of Human Immunodeficiency Virus (HIV), the Hepatitis B Virus (HBV), and the Hepatitis C Virus (HCV) because of the reuse of injection needles.  The recommendations address the need for prohibitions on the reuse of needles at health care facilities; periodic training of practitioners and other health care workers regarding infection control principles; education of patients and families regarding transmission of blood borne pathogens; and safe needle disposal practices.
This solution is designed to reduce the spread of serious contagious disease through the reuse of injection devices. 20

21. It is estimated that at any point in time more than 1
It is estimated that at any point in time more than 1.4 million people worldwide are suffering from infections acquired in hospitals. Effective hand hygiene is the primary preventive measure for avoiding this problem. The recommendations address the promotion of hand hygiene adherence as a health care facility priority, requiring leadership and administrative support and financial resources, as well as adopting the WHO Guidelines on Hand Hygiene in Health Care.
This solution focuses on mitigating risk of health care-associated infections due to the failure of caregivers to wash their hands. 21

22. The Standardized Project Elements
SOPs
The critical steps
Evaluation Plan
Performance measures
Event analysis approach
On-site evaluation of SOP implementation
Culture survey
The standardized project elements are
SOPs
The critical steps
Evaluation Plan
Performance measures
Event analysis approach
On-site evaluation of SOP implementation
Culture survey

23. Standard Operating Protocol Defined
A Standard Operating Protocol (SOP) is a set of instructions for implementing a defined process in a consistent and measurable manner by multiple users.
What is a standard operating protocol?

24. Correct Site Surgery
Problem: Wrong site, wrong procedure, wrong person surgery
Scope of SOP: All cases performed in the in-patient operating rooms
Solution:
Extended preoperative verification process
Surgical site marking
Final “time out” before incision
To date, we have finalized 3 standard operating protocols:
Performance of Correct Procedure at Correct Body Site (US)
Assuring Medication Accuracy at Transitions in Care (Canada)
Managing Concentrated Injectable Medicines (UK)
2 SOPs have been deferred to a later date: Communication failures during patient handovers (late 2010) and Addressing health care-associated infections.
Here is an overview of the Correct Site Surgery SOP. As you can see, the SOP follows a defined structure, which includes
The safety problem to be addressed
The proposed solution, i.e., the process to be standardized
The implementation strategy
Work plan
Integration into existing processes
“Getting started” toolkit

25. Relationship between the Correct Site Surgery SOP and the WHO Surgical Safety Checklist
Focus on correct person, procedure, site
Seeks uniform compliance with standardized protocol
Includes comprehensive pre-op verification process
Does not include “Sign-out”
Available only to High 5s’ participating hospitals
Surgical Safety Checklist
Focus on all major surgical risks
Permits modification of process per local practice
Limited (day-of-surgery) pre-op check
Includes “Sign-out”
Available to all hospitals wishing to use it
Many of you might be familiar with the WHO’s Safe Surgery Checklist, and thus you might be concerned that the Checklist and the Correct Site Surgery SOP might be counter-effective. But, the Correct Site Surgery SOP and the WHO’s Safe Surgery Checklist have more in common than they have differences.
Where the initiatives overlap, the expectations are consistent. Both can be implemented without conflict.

26. Relationship between the SOP and the WHO Checklist
The yellow area are items on the High 5s pre-op verification check list that are not on the WHO Surgical Safety Checklist.
The blue are on the far right (labeled “sign out”) is on the WHO Checklist but not on the High 5s SOP.
This graphic is to demonstrate similarities and differences in the processes; it is not sufficiently detailed to collect all the data elements required for the High 5s evaluation.

27. Medication Reconciliation
Problem: Miscommunications about patient medications among caregivers
Scope of SOP: Patients ≥ 65 admitted through the Emergency Department to in-patient units
Solution:
“Best possible medication history” on admission
Compare with admission orders
Reconcile discrepancies
Repeat process at all patient care transitions across the care continuum
Here is the Medication Reconciliation SOP.

28. Concentrated Injectable Medicines
Problem: Inadvertent injection of undiluted concentrated medicines
Scope of SOP:
Concentrated potassium chloride solution
Sodium heparin >1000 units/milliliter
Injectable morphine preparations
Solution:
Minimize storage/preparation of concentrates on clinical units
Encourage ready-to-use products
Standardize procedure if concentrated medicines must be used on clinical units
And here is the Concentrated Injectable Medicines SOP.

29. Evaluation Plan
Identify and apply process and outcome measures for each Protocol
Evaluate Protocol implementation and, over time, modify Protocols as appropriate
Develop and apply an Event Analysis Framework, including the identification and use of Protocol-specific trigger events
Conduct baseline and periodic organization culture surveys
The evaluation plan involves
Identifying and applying process and outcome measures for each Protocol
Evaluating Protocol implementation and, over time, modifying Protocols as appropriate
Developing and applying an Event Analysis Framework, including the identification and use of Protocol-specific trigger events
Conducting baseline and periodic organization culture surveys

30. SOP Implementation Evaluation
Determine whether an SOP can be implemented as it was designed to be implemented
Determine whether the SOPs appear to be effective in preventing the targeted adverse events
Determine the potential portability of the SOPs
The SOP implementation evaluation involves
Determining whether an SOP can be implemented as it was designed to be implemented
Determining whether the SOPs appear to be effective in preventing the targeted adverse events
Determining the potential portability of the SOPs

31. Project Challenges Standardization across diverse countries
Language barriers
Competition with existing in-country project priorities
Concerns about control of project results
Project Launch
And some of the project challenges involve
Standardization across diverse countries
Language barriers
Competition with existing in-country project priorities
Concerns about control of project results
Project Launch

32. Roles and Responsibilities of Participating Hospitals
I would now like to highlight the key roles and responsibilities of participating hospitals.

33. Participating Hospital Leadership
Oversee implementation of the SOP selected by the LTA by ensuring all defined responsibilities are carried out in a timely and effective manner
Continuously work to create and sustain an organizational culture of safety
Enable implementation of the SOP within the established work environment
Encourage appropriate clinical leaders to be overt champions for the High 5s Project
Identify opportunities to pursue hospital-specific projects that build upon the basic goal of the High 5s initiative.
The mission of the High 5s Project cannot be accomplished without the ongoing visible commitment of the leadership of the participating hospitals in implementing the Standard Operating Protocols. Here are the responsibilities of leadership in overseeing a hospital’s participation:
Oversee implementation of the SOP selected by the Lead Technical Agency (LTA) by ensuring that all defined responsibilities with regard to implementation and evaluation are carried out in a timely and effective manner.
Continuously work to create and sustain an organizational culture of safety through personal involvement in the High 5s Project, including encouragement of interdisciplinary teamwork and collaboration and support of efforts to identify/prioritize opportunities to improve the efficiency and effectiveness of SOP implementation.
Enable implementation of the SOP within the established work environment by supporting relevant clinical administrative staff behavioral changes.
Encourage appropriate clinical leaders to be overt champions for the High 5s Project generally and the SOP specifically.
Identify opportunities to pursue hospital-specific projects that build upon the basic goal of the High 5s initiative.

34. Involvement in SOP Implementation
Ensure adequate resources are available and dedicated to implementing SOP
Charge an SOP team with carrying out implementation, use of High 5s information management system, and effective communication between the participating hospital and the LTA
Periodically meet with the implementation team to review progress and adherence to the SOP implementation and evaluation strategies
Regularly monitor data and progress reports from SOP implementation team
Ensure that adequate resources are available and dedicated to the implementation of the SOP, including staff time, equipment, training and financial resources.
Form an SOP implementation team and charge it with carrying out the implementation strategy described in the SOP, including development of a Project Work Plan, use of the High 5s information management system to collect and report required data, and effective communication between the participating hospital and the LTA.
Periodically meet with the implementation team to review progress and adherence to the SOP implementation and evaluation strategies, and to identify barriers or evidence of drifting and develop strategies to address these.
Regularly monitor data and reports from the SOP implementation team on their progress.

35. Communication
Promote organization’s decision to participate in the High 5s Project
Internally and externally publicize that the organization is part of a select few in the country participating in this groundbreaking international patient safety initiative
Keep the Board, staff, other key constituencies informed about the project and its progress
Publicly acknowledge successes related to the High 5s Project and staff’s contribution
Provide regular feedback regarding the progress of SOP implementation to all participating hospital leaders and staff
Promote the organization’s decision to participate in the High 5s Project by describing the rationale and expected benefits of implementing the selected SOP in the participating hospital.
Publicize, both internally and externally, that the organization is one of only a select few in the country that have been invited to participate in this groundbreaking international patient safety initiative supported by the World Health Organization, the World Health Organization Collaborating Center led by The Joint Commission and Joint Commission International, the United States Agency for Healthcare Research and Quality, the Commonwealth Fund, and the LTA.
Keep the Board, staff, other key constituencies informed about the project and its progress
Publicly acknowledge successes related to the High 5s Project and the contribution of all staff participating in the implementation of the SOP.
Provide regular feedback regarding the progress of SOP implementation to all participating hospital leaders and staff (whether directly involved in the implementation of the SOP or not); such feedback should include achievements, barriers encountered and how they were addressed, resources needed, and data showing the progress and impact of implementation

36. Information Management System
Ensure technical support is available to its staff involved in:
Use of the High 5s Information Management System
Maintenance of participating hospital demographic data
Design and use of the mechanism designed by the
Participating Hospital Leadership should ensure technical support is available to its staff involved in:
Use of the High 5s Information Management System, which is intended to support project data gathering, analyses and reports
Maintenance of participating hospital demographic data.
Design and use of the mechanism designed by the LTA for exchange of information that is not directly entered into the High 5s information management system.

37. Participating Hospitals
Determine scope of hospital implementation, including:
Selection of SOP(s) to be implemented
Determination of the number of participating units
Selection of units to implement the specific SOP(s)
Hospitals participating in the High 5s project have roles and responsibilities as well, which include
Determining the scope of implementation, including:
Selection of SOP(s) to be implemented
Determination of the number of participating units
Selection of units to implement the specific SOP(s)

38. Participating Hospitals (cont’d)
Implementation of the Project Plan as set forth in the SOP, including
Selection of members of the implementation team, including identification of the team leader and the Project champion
Implementation of the Project Plan as set forth in the SOP and evaluation plan
Collection and submission of data to the LTA or direct entry of the data into the High 5s Information Management System
Conduct of event analyses
They are also responsible for implementing the Project Plan as set forth in the SOP, including
Selection of members of the implementation team, including identification of the team leader and the Project champion
Implementation of the Project Plan as set forth in the SOP and evaluation plan
Collection and submission of data to the LTA or direct entry of the data into the High 5s Information Management System
Conduct of event analyses

39. www.high5s.org finalised: 2009
IMS: Wiki platform
Thank you for your time! For more information on this project, please visit its Web site at