Standardization in Patient Safety: The WHO High 5s Project
Standardization in Patient Safety: The WHO High 5s Project
The High 5s project is a World Health Organization (WHO) global patient safety initiative. It was launched in 2007 to facilitate the development, implementation and evaluation of SOPs that were developed to address known patient safety problems. The project has brought together multiple countries and institutions to form a global learning community with the combined aim of producing measurable, significant and sustainable reductions in the incidence of challenging hospital-based patient safety problems. The founding countries were Australia, Canada, Germany, the Netherlands, New Zealand, the United Kingdom of Great Britain and Northern Ireland and the USA. France, Singapore and Trinidad and Tobago joined the High 5s project in 2008, 2009 and 2011, respectively.
The project initially focused on five risk areas (Box 1) whose successful address might have high impact on patient care in five countries over five years (hence the 'High 5s' project name). Three SOPs have been developed and are being tested. These include Managing Concentrated Injectable Medicines, Assuring Medication Accuracy at Transitions of Care and Performance of the Correct Procedure at the Correct Body Site.
Each participating country selected a Lead Technical Agency (LTA) to oversee coordination of High 5s activities among the national institutions and hospitals participating in the High 5s project. In addition, selected LTAs were tasked to lead the development of certain SOPs. Canada, for example, has led development of the SOP for medication reconciliation, the United Kingdom has led development of the concentrated injectables protocol and the USA has led development of the correct site surgery protocol. These three SOPs have been completed, and implementation is in progress. Development of the SOPs for communication during patient handovers and for hand hygiene has been deferred.
The High 5s project has applied established practices and interventions to support the development of standardized processes and tools to ensure that multiple levels of the system—from management to individual health care workers—are included in the improvement processes. This has also permitted development of a consistent system of monitoring that makes possible the production of comparable results locally, nationally and internationally. One of the challenges in developing a SOP is to ensure that it is neither too generic, nor too complex, nor too simplistic to have meaningful applications to a wide range of settings across the globe. At the same time, the SOPs have been designed to acknowledge and accommodate the real-world complexities, interdependencies and variability of health care processes in a variety of hospital settings. This acknowledgement has required their pretesting in selected hospitals prior to broad implementation in the sponsoring countries to ensure the appropriateness and usability of the SOPs.
Each SOP contains a set of instructions for implementing a defined patient care process by multiple users in a consistent and measurable way. It is anticipated that the SOPs will be further improved with user experience and analysis of collected data over time. Each SOP summarizes the problem, proposes a solution, presents the evidence for the solution, identifies potential barriers to adoption and delineates potential unintended consequences of the solution. SOPs are designed to apply quality improvement methods to effect process and systems improvement, as well as health care professional behavioral change needed for successful implementation. Patient and family roles in the implementation process are also described.
A standardized approach to evaluation, the 'Impact Evaluation Strategy', has been designed to assess the feasibility and impact of implementing the SOPs. Both quantitative and qualitative approaches are being used in this process. The use of a triangulated High 5s evaluation strategy allows the project to address the impact evaluation in different ways, thus enhancing confidence in the resulting findings. If the results are positive, this should enhance confidence in the validity of the protocols themselves. The following are the pillars of the High 5s Impact Evaluation Strategy, as described in the Evaluation section of this article:
The pretesting of each SOP was undertaken over a 2-month period in each of the countries implementing the SOP to permit revisions to and adaptations of the SOPs and their related evaluation processes prior to full-scale implementation of the SOPs.
Each participating country has been asked to select one or more SOPs for implementation and identify a minimum of ten hospitals per SOP that will train staff in the SOP and measurement techniques. Each participating hospital may choose to participate in one or more SOPs (of those SOPs selected by the country's LTA). Each hospital site is required to submit data throughout the implementation period. In addition, visits to selected participating hospitals are to be undertaken annually by the LTA to conduct interviews and observe the implementation of the SOP directly. De-identified data are submitted to the WHO Collaborating Centre for Patient Safety (Collaborating Centre) for comparative evaluation and sharing of lessons learned.
The High 5s project aims to answer two main questions: (i) is it feasible to implement standardization in health care within individual hospitals, among multiple hospitals within individual countries and across country boundaries? (ii) What is the impact of standardization on the safety problems that the project is targeting? The High 5s project combines process standardization and intensive evaluation of the feasibility and impact of implementing SOPs on a global scale.
Background
The High 5s project is a World Health Organization (WHO) global patient safety initiative. It was launched in 2007 to facilitate the development, implementation and evaluation of SOPs that were developed to address known patient safety problems. The project has brought together multiple countries and institutions to form a global learning community with the combined aim of producing measurable, significant and sustainable reductions in the incidence of challenging hospital-based patient safety problems. The founding countries were Australia, Canada, Germany, the Netherlands, New Zealand, the United Kingdom of Great Britain and Northern Ireland and the USA. France, Singapore and Trinidad and Tobago joined the High 5s project in 2008, 2009 and 2011, respectively.
The project initially focused on five risk areas (Box 1) whose successful address might have high impact on patient care in five countries over five years (hence the 'High 5s' project name). Three SOPs have been developed and are being tested. These include Managing Concentrated Injectable Medicines, Assuring Medication Accuracy at Transitions of Care and Performance of the Correct Procedure at the Correct Body Site.
Each participating country selected a Lead Technical Agency (LTA) to oversee coordination of High 5s activities among the national institutions and hospitals participating in the High 5s project. In addition, selected LTAs were tasked to lead the development of certain SOPs. Canada, for example, has led development of the SOP for medication reconciliation, the United Kingdom has led development of the concentrated injectables protocol and the USA has led development of the correct site surgery protocol. These three SOPs have been completed, and implementation is in progress. Development of the SOPs for communication during patient handovers and for hand hygiene has been deferred.
The High 5s project has applied established practices and interventions to support the development of standardized processes and tools to ensure that multiple levels of the system—from management to individual health care workers—are included in the improvement processes. This has also permitted development of a consistent system of monitoring that makes possible the production of comparable results locally, nationally and internationally. One of the challenges in developing a SOP is to ensure that it is neither too generic, nor too complex, nor too simplistic to have meaningful applications to a wide range of settings across the globe. At the same time, the SOPs have been designed to acknowledge and accommodate the real-world complexities, interdependencies and variability of health care processes in a variety of hospital settings. This acknowledgement has required their pretesting in selected hospitals prior to broad implementation in the sponsoring countries to ensure the appropriateness and usability of the SOPs.
Each SOP contains a set of instructions for implementing a defined patient care process by multiple users in a consistent and measurable way. It is anticipated that the SOPs will be further improved with user experience and analysis of collected data over time. Each SOP summarizes the problem, proposes a solution, presents the evidence for the solution, identifies potential barriers to adoption and delineates potential unintended consequences of the solution. SOPs are designed to apply quality improvement methods to effect process and systems improvement, as well as health care professional behavioral change needed for successful implementation. Patient and family roles in the implementation process are also described.
A standardized approach to evaluation, the 'Impact Evaluation Strategy', has been designed to assess the feasibility and impact of implementing the SOPs. Both quantitative and qualitative approaches are being used in this process. The use of a triangulated High 5s evaluation strategy allows the project to address the impact evaluation in different ways, thus enhancing confidence in the resulting findings. If the results are positive, this should enhance confidence in the validity of the protocols themselves. The following are the pillars of the High 5s Impact Evaluation Strategy, as described in the Evaluation section of this article:
SOP implementation experience evaluation,
SOP-specific performance measures,
event analysis and
baseline and follow-up patient safety culture survey.
The pretesting of each SOP was undertaken over a 2-month period in each of the countries implementing the SOP to permit revisions to and adaptations of the SOPs and their related evaluation processes prior to full-scale implementation of the SOPs.
Each participating country has been asked to select one or more SOPs for implementation and identify a minimum of ten hospitals per SOP that will train staff in the SOP and measurement techniques. Each participating hospital may choose to participate in one or more SOPs (of those SOPs selected by the country's LTA). Each hospital site is required to submit data throughout the implementation period. In addition, visits to selected participating hospitals are to be undertaken annually by the LTA to conduct interviews and observe the implementation of the SOP directly. De-identified data are submitted to the WHO Collaborating Centre for Patient Safety (Collaborating Centre) for comparative evaluation and sharing of lessons learned.
The High 5s project aims to answer two main questions: (i) is it feasible to implement standardization in health care within individual hospitals, among multiple hospitals within individual countries and across country boundaries? (ii) What is the impact of standardization on the safety problems that the project is targeting? The High 5s project combines process standardization and intensive evaluation of the feasibility and impact of implementing SOPs on a global scale.
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