# Presentation: 766382

## PSO Common Formats for Patient Safety Event Reporting

- AHRQ Annual Conference 2008
- Amy Helwig, MD, MS
- September 7, 2008

## PSO Common Formats

- Agenda
- Overview of Common Formats Version 0.1 Beta
- Definition and Scope
- Components of Version 0.1 Beta and Supporting Materials
- Feedback Process For Common Formats Evolution
- Common Formats Technical Assistance
- Future Steps
- Questions and Answers

## Overview of Common Formats Version 0.1 Beta

- Common Formats Goals:
- Consistent with Common Formats conceptual framework
- Functional
- Flexible
- Facility setting
- Size of facility
- Useable with existing workflows
- Comprehensive in capturing all event types
- Adaptable to work with current systems
- Processes in place to enhance and expand

## What are Common Formats? 

***	******Common Formats describe the definitions, technical requirements, and reporting formats that allow healthcare providers to collect and submit standardized information regarding patient safety events.****** ***
***	***

**Notes:**
The term Common Formats is used to describe the technical requirements and reporting specifications that allow health care providers to collect and submit standardized information regarding patient safety events. 

The use of the Common Formats is voluntary, in recognition of the fact that reporting patient safety work product to a PSO in a standardized manner may not be initially practicable for certain providers or in certain circumstances.

## Common Formats Definition and Scope

- 	Common Formats describe the technical requirements and reporting specifications for the collection and reporting of patient safety data, including all supporting material:
- Paper forms to allow immediate implementation
- A Users Guide
- Descriptions of patient safety events and unsafe conditions to be reported
- Examples of patient safety population reports
- A metadata registry with data element attributes and technical specifications

**Notes:**
Definition
The term Common Formats is employed in this Users Guide to describe the technical requirements pertaining to the collection and reporting of patient safety data, including all supporting material:
Descriptions of patient safety events and unsafe conditions to be reported
Delineation of data to be collected for different types of events
Examples of patient safety population reports
A metadata registry with data element attributes and technical specifications
Paper forms to allow immediate implementation
A Users Guide

## Scope – Settings of Care

Patient Safety Act applies to all settings of care

Common Formats Version 0.1 Beta developed for the hospital setting

Future versions of the Common Formats to include: 
Nursing homes and other bedded facilities
Ambulatory surgery centers
Community health centers
Physician and practitioner offices
Retail establishments, such as pharmacies
Other ambulatory care settings 

- Patient Safety Act applies to all settings of care
- Common Formats Version 0.1 Beta developed for the hospital setting
- Future versions of the Common Formats to include:
- Nursing homes and other bedded facilities
- Ambulatory surgery centers
- Community health centers
- Physician and practitioner offices
- Retail establishments, such as pharmacies
- Other ambulatory care settings

**Common Formats Definition and Scope**

**Notes:**
It should be noted, however, that the Patient Safety Act confers both privilege and confidentiality on all patient safety work product developed under the auspices of a PSO with respect to healthcare in any setting. 
Common Formats Version 0.1 Beta developed for the hospital setting
Event types and details of circumstances most reflective of hospital settings

Future versions of the Common Formats to include: 
Nursing homes and other bedded facilities
Ambulatory surgery centers
Community health centers
Physician and practitioner offices
Retail establishments, such as pharmacies
Other ambulatory care settings 

## Common Formats Definition and Scope

- Common Formats apply to all patient safety concerns:
- Incidents – patient safety events that reached the patient, whether or not there was harm
- Near misses (or close calls) – patient safety events that did not reach the patient
- Unsafe conditions – any circumstance that increases the probability of a patient safety event

**Notes:**
Common Formats apply to all patient safety concerns:
Incidents – patient safety events that reached the patient, whether or not there was harm
	An example of an incident would be administering the wrong medication to a patient

Near misses (or close calls) – patient safety events that did not reach the patient
	An example of a near miss would be the blood bank distributing an incorrect unit of blood to the patient’s bedside, but the nurse catching the unit of wrong blood type before it is actually given to the patient

Unsafe conditions – any circumstance that increases the probability of a patient safety event.
	An example of an unsafe condition is two look alike medications being stored next to each other.

## Common Formats Definition and Scope

- Scope Limits of Version 0.1 Beta
- Limited to issues of patient safety
- Numerator data only
- Voluntary, spontaneous reporting data
- Variability in rate and consistency of reporting
- Goal to reduce risk
- Available as paper forms
- Technical specifications for vendors to follow

**Notes:**
You may note that the Statute and Regulations provide privilege and confidentiality protection for the domains of both quality and safety

A second limit of the common formats is that the information gathered represents numerator data only. 
The Patient Safety Act calls for a  voluntary, spontaneous patient safety reporting system. By its nature, the voluntary, spontaneous reporting will have  variability in the rate and consistency of reporting. The system won’t have standard rates.

The analysis goal of the information gathered is to reduce risk. The value  of a voluntary, spontaneous active reporting is found in the number of reports and the quality of the information.  Success in these two elements will improve the learning for all. 

## Common Formats Definition and Scope

- Scope Limits of Version 0.1 Beta
- Represent the initial reporting and problem identification phase of the 4 phase quality improvement cycle
- Other future phases to be developed
- Root cause analysis – process examination
- Implementation of improvement action
- Evaluation of effectiveness

**Notes:**
When identifying the limits of the common formats, we realize that the quality of the information gathered and anlayzed is only useful if it can be used to reduce risk. Version 0.1 Beta address only the initial reporting phase which is the first step in the 4 phases of the quality improvement cycle.  To truly reduce risk, we also need to know what was done and the effectiveness of the actions taken. 

Our Common Formats are intended to eventually  address all four phases of the improvement cycle, AHRQ will continue to develop Common Formats for the remaining phases of the improvement cycle.
Initial reporting – problem identification
Root cause analysis – process examination
Implementation of improvement action
Evaluation of effectiveness.

## Common Formats Definition and Scope

- Limits of Version 0.1 Beta data elements
*Structured* data elements
- Permit sorting of data for event analysis, pattern analysis and trending at all levels of the healthcare system
- Allow for aggregation of data within and across provider organizations
*Narrative* information
- Provides richness of detail about an individual event or condition needed to understand patient safety concerns at the provider and/or PSO levels
- Not amenable to aggregation

**Notes:**
Version  0. 1 beta is limited to the types of data elements used to gather patient safety information.  

Common Formats will include data elements that are:
Structured
Narrative.
Structured data permit sorting of patient safety incidents and near misses for event analysis, as well as for pattern analysis and trending at all levels of the healthcare system. Structured data can be aggregated within and across provider organizations, as well as for national reports. 

  We realize that Narrative information is particularly beneficial in the field of patient safety., while it cannot be aggregated, provides the richness of detail about an individual event or condition needed to understand patient safety concerns at the provider and/or PSO levels and to act to reduce risk to patients.

## Common Formats Definition and Scope

- Limits of Version 0.1 Beta
- The Common Formats are not an attempt to replace any current mandatory reporting system, collaborative/voluntary reporting system, research-related reporting system, or other reporting/recording system.
- Information that is identifiable to the patient, reporter, provider, and facility:
- May be transmitted to a PSO as patient safety work product
- Confidential and prohibited from disclosure as delineated in the Statute and Regulations
- May not be transmitted to the NPSD

**Notes:**
Finally, two important limits include noting that The Common Formats are not an attempt to replace any current mandatory reporting systems.  As Dr Munier noted, we viewed many of these systems and in our development worked to align whenever possible.

They are intended to facilitate the collection, aggregation, and use of patient safety data regardless of the type of reporting system.

Some data elements comprise information that is identifiable to the patient, reporter, provider, and facility. This information may be transmitted to a PSO as patient safety work product, but it is confidential and prohibited from disclosure as delineated in the Statute and Regulations. It may not be transmitted to the NPSD.

## Using the Common Formats 

- Common Formats are designed to be used at the point of care
- Ideally, initial information should be collected as soon after an event as possible
- Data can be reviewed and analyzed at:
- Healthcare provider organizations (e.g., headquarters of a multi-facility organization)
- PSOs
- NPSD (after de-identification)
- Aggregate, de-identified data on patient safety sent to the NPSD in AHRQ’s annual NHQR

**Notes:**
Common Formats are designed to be used at the point of care, where events occur and where initial information should be collected as soon after an event as possible. Resultant data can be reviewed at healthcare provider organizations (e.g., headquarters of a multi-facility organization), at PSOs, and, after de-identification, by the NPSD. Data on patient safety published in AHRQ’s annual NHQR, and/or released to the public by PSOs, will flow from the Common Formats, although published in aggregate, de-identified form. 

## Components of Version 0.1 Beta and Supporting Materials

- Common Format Components - Version 0.1 Beta
- Paper forms to allow immediate implementation  and collection of event information
- A Users Guide
- Common Format event descriptions
- Examples of patient safety population reports
- A metadata registry with data element attributes and technical specifications

**Notes:**
There are 5 primary components of version 0.1 of the Common Formats.  AHRQ released two of these components- the paper forms and users guide on August 29.  The other three components currently in development are :
Common Format event descriptions 
Examples of patient safety population reports
A metadata registry with data element attributes and technical specifications

## Components of Version 0.1 Beta and Supporting Materials

- Paper forms
- Allow immediate implementation and collection of event information
- Modular construction
- Flexible
- Facility setting
- Size of facility
- Useable with existing workflows
- Comprehensive in capturing all event types

## Components of Version 0.1 Beta and Supporting Materials

- Two categories of paper forms
**Generic Reporting Forms**
- Structured elements pertaining to all types of events
- Narrative section provided
- Three generic forms (HERF, PIF, and FAF)
**Event Specific Forms**
- Forms available for the most commonly-occurring types of events
- Event-specific forms gather more granular structured information to supplement the generic forms.
- Nine event-specific forms available

**Notes:**
Version 0.1 Beta of the Common Formats is being released as three generic and nine event-specific paper forms. These forms allow the collection of information in relevant detail about any patient safety concern reported in an inpatient setting. Structured questions on the generic paper forms provide for capture of basic information along the spectrum of harm, including events resulting in harm, no-harm events that reached the patient, near misses (close calls), and unsafe conditions. Specific information on events is captured via narrative text. For the most commonly-occurring types of events, event-specific forms with more granular structured information supplement that collected on generic forms.

## Complete Patient Safety Report

**Components of Version 0.1 Beta and Supporting Materials**

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**+**

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- Generic Forms

## HERF - Healthcare Event Reporting Form

Designed to be completed by the individual who witnessed, first discovered, or is most familiar with the details of the event

Captures information on incidents, near misses, and unsafe conditions

Structured questions and narrative 

Analogous to incident reports commonly used in hospitals today

Initiates the patient safety event reporting process

- Designed to be completed by the individual who witnessed, first discovered, or is most familiar with the details of the event
- Captures information on incidents, near misses, and unsafe conditions
- Structured questions and narrative
- Analogous to incident reports commonly used in hospitals today
- Initiates the patient safety event reporting process

**Components of Version 0.1 Beta and Supporting Materials**

**Notes:**
The Healthcare Event Reporting Form (HERF) is designed to be completed by the individual who witnessed, first discovered, or is most familiar with the details of the event. The HERF captures information on incidents, near misses, and unsafe conditions. This form is analogous to incident reports commonly used in hospitals today. It contains structured questions and allows for a brief narrative to document the precise details of the event or unsafe condition. The HERF solicits only the most basic information about an event or unsafe condition and is intended to start a reporting process that is completed using other generic and event-specific forms.
The HERF contains information that is, or may be, identifiable to the patient, reporter, provider, and facility. This information may be transmitted to a PSO as patient safety work product, but it is confidential and prohibited from disclosure as delineated in the Statute and Regulations. It may not be transmitted to the NPSD.

## PIF - Patient Information Form 
Supplements the HERF 

Demographic information as well as additional information about the impact of the event on a patient (e.g., level of harm, unplanned interventions)

- Supplements the HERF
- Demographic information as well as additional information about the impact of the event on a patient (e.g., level of harm, unplanned interventions)

**Components of Version 0.1 Beta and Supporting Materials**

**Notes:**
The Patient Information Form (PIF) supplements the HERF in cases where an “incident” occurred (i.e., an event that reached the patient). It provides for collection of demographic information as well as additional information about the impact of the event on a patient (e.g., level of harm, unplanned interventions). When multiple patients are involved in an event, a separate PIF should be completed for each patient. 
The PIF contains information that is, or may be, identifiable to the patient, reporter, provider, and facility. This information may be transmitted to a PSO as patient safety work product, but it is confidential and prohibited from disclosure as delineated in the Statute and Regulations. It may not be transmitted to the NPSD.

## Components of Version 0.1 Beta and Supporting Materials

**Event specific forms:**
- Address the most commonly-occurring types of patient safety events
- Supplement the information collected on the HERF, PIF, and FAF
- Additional structured information
- Outline the use or employment of measures designed to prevent the occurrence of the event

**Notes:**

Event-specific forms address the most commonly-occurring types of patient safety events. They are intended to supplement the information collected on the HERF, PIF, and FAF. Additional structured information is collected about the event itself, as well as information about the use or employment of measures designed to prevent the occurrence of the event. (Specific details about events that occur less frequently and are not addressed by an event-specific form can be captured in the narrative sections of the HERF and FAF.) AHRQ intends to develop additional event-specific Common Formats over time.
Currently-available event-specific forms include:
Anesthesia
Blood, Tissue, Organ Transplantation or Gene Therapy
Device and Medical or Surgical Supply
Fall
Healthcare-Associated Infection
Medication & Other Substances
Perinatal
Pressure Ulcer
Surgical and Other Invasive Procedure (except Perinatal)

## Components of Version 0.1 Beta and Supporting Materials

- Currently-available event-specific forms include:
- Anesthesia
- Blood, Tissue, Organ Transplantation or Gene Therapy
- Device and Medical or Surgical Supply
- Fall
- Healthcare-Associated Infection
- Medication & Other Substances
- Perinatal
- Pressure Ulcer
- Surgical and Other Invasive Procedure (except Perinatal)

*AHRQ intends to develop additional event-specific Common Formats over time*

**Notes:**
Version 0.1 Beta of the Common Formats is being released as three generic and nine event-specific paper forms. These forms allow the collection of information in relevant detail about any patient safety concern reported in an inpatient setting. Structured questions on the generic paper forms provide for capture of basic information along the spectrum of harm, including events resulting in harm, no-harm events that reached the patient, near misses (close calls), and unsafe conditions. Specific information on events is captured via narrative text. For the most commonly-occurring types of events, event-specific forms with more granular structured information supplement that collected on generic forms.

## FAF - Final Assessment Form 
Completed for all incidents, near misses, and unsafe conditions reported on a HERF
Assessment on preventability and recovery actions
Broad coding of location and reporter information obtained from HERF

Opportunity to add any missing information
Structured and narrative

Workflow – likely completed by supervisor or patient safety manager

- Completed for all incidents, near misses, and unsafe conditions reported on a HERF
- Assessment on preventability and recovery actions
- Broad coding of location and reporter information obtained from HERF
- Opportunity to add any missing information
- Structured and narrative
- Workflow – likely completed by supervisor or patient safety manager

**Components of Version 0.1 Beta and Supporting Materials**

**Notes:**
A Final Assessment Form (FAF) should be completed for all incidents, near misses, and unsafe conditions reported on a HERF. It represents everything that is known about the event or unsafe condition at the time when the initial report is completed. It is not a root cause analysis, but instead represents the initial information that could support such an analysis. As with the HERF, it includes structured questions and allows for a final narrative comment.
The FAF contains information that is, or may be, identifiable to the patient, reporter, provider, and facility. This information may be transmitted to a PSO as patient safety work product, but it is confidential and prohibited from disclosure as delineated in the Statute and Regulations. It may not be transmitted to the NPSD.

## Complete Patient Safety Report - Workflow

**Components of Version 0.1 Beta and Supporting Materials**

**+**

**+**

**+**

## Components of Version 0.1 Beta and Supporting Materials

- Common Formats Users Guide
- Common Formats background information and guidance on use of paper forms
- Glossary of terms used with the Common Formats
- Standard value sets
*Facility, location of patient safety event, and provider standard value sets under development*

**Notes:**
Common Formats Users Guide
Common Formats background information and guidance on use of paper forms

Glossary of terms used with the Common Formats

Standard value sets
Facility, location of patient safety event, and provider standard value sets under development

## Components of Version 0.1 Beta and Supporting Materials

- Common Format event descriptions
- Plain language descriptions of the Common Formats objectives
- Define the types of information to be gathered for all events
- Definition of event
- Scope of event
- Preventive actions
- Circumstances of event
*Version 0.1 Beta event descriptions are currently under development *

**Notes:**
These plain language descriptions convey the objectives of each of the Common Formats more easily than review of questions and ‘skip logic’ on paper forms or technical specifications for software programs.    The descriptions define the types of information to be gathered for all events. 
Definition of event
Scope of event
Preventive actions
Circumstances of event

As the  descriptions are developed, the process allows one to articulate the questions to be answered and decide on the information to collect.

## Components of Version 0.1 Beta and Supporting Materials

- Common Format sample population reports
- Can be used by PSOs, providers, and the NPSD
- Allow for reports on identification of occurrence of events and patterns
- Provide the foundation for learning why patient safety events occur
*Version 0.1 Beta event sample reports currently under development** *

**Notes:**
Common Format sample population reports

Can be used by PSOs, providers, and the NPSD
Allow for reports on identification of occurrence of events and patterns
Provide the foundation for learning why patient safety events occur

Version 0.1 Beta event sample reports currently under development

## Components of Version 0.1 Beta and Supporting Materials

- USHIK- United States Health Information Knowledgebase
- Meta data registry
- Supports browsing, comparison, and synchronization of Common Format data elements with standards development organizations (such as HL7) and other healthcare organizations.
- Technical specifications for the Common Formats
- Allows vendors  to write software programs to operationalize the formats
*Currently under development*

**Notes:**
AHRQ will maintain technical specifications for the Common Formats, including all data elements, value sets, logic statements, definitions, etc. that are needed by those writing software programs to operationalize the formats. These specifications, currently under development, will be available when completed at USHIK, which is a health metadata registry funded and directed by AHRQ in partnership with CMS. The USHIK registry supports browsing, comparison, synchronization, and harmonization of Common Format data elements with standards development organizations (such as HL7) and other healthcare organizations.
As AHRQ expands the scope and content of Common Formats in the future, it will also support enhanced capabilities of the PSOPPC and the USHIK metadata registry.

## Common Formats Version 0.1 Beta Goals

- Common Formats Goals
- Consistent with Common Formats conceptual framework
- Functional
- Flexible
- Useable with existing workflows
- Comprehensive in capturing all event types
- Processes for continued refinement and enhanced releases

**Notes:**
Common Formats Goals
Consistent with Common Formats conceptual framework
Functional
Flexible
Facility setting
Size of facility
Useable with existing workflows
Comprehensive in capturing different event types
Processes for continued refinement and enhanced releases

## Feedback Process For Common Formats Evolution 

- AHRQ committed to continued refinement of the Common Formats
- Feedback desired from:
- Private sector organizations
- Non-Federal public organizations
- Individual users of the Common Formats

**Notes:**
AHRQ is committed to continued refinement of the Common Formats.  Version 0. 1 beta was developed within the federal systems. The Agency is specifically interested in obtaining feedback from private sector organizations, non-Federal public organizations, and individuals – particularly those who use the Common Formats. Accordingly, AHRQ has established a process to receive initial feedback that will guide rapid improvement of the formats. 

## Feedback process for Common Formats Evolution 

- The National Quality Forum will:
- Assist with gathering and analyzing comments
- Convene expert panel
- Furnish reports to AHRQ on recommended enhancements to the Common Formats
- This process will be a continuing one, guiding periodic updates of the Common Formats

**Notes:**
AHRQ has established a process to receive initial feedback that will guide rapid improvement of the formats. As part of this process, AHRQ has contracted with the NQF, a non-profit organization focused on healthcare quality, to assist in updating future versions of the formats. NQF will: solicit comments from providers, PSOs, professional organizations, and the general public; triage comments in terms of immediacy of importance; set priorities; convene expert panel(s) to offer advice on suggested improvements and expansions; and furnish reports to AHRQ on recommended enhancements to the Common Formats. NQF reports will be provided by AHRQ to the Federal PSWG, which will work with AHRQ to develop future versions of the formats.
This process will be a continuing one, guiding periodic updates of the Common Formats and, most importantly, reflecting the feedback of those using the formats. Users will be the most sensitive to, and aware of, needed updates and improvements to these formats.

## Common Formats Technical Assistance 

**PSO PPC – Patient Safety Organization Privacy Protection Center**
- Technical Assistance available for using the Common Formats
- Paper forms and user reference documentation are available for download at the PSOPPC Web-site (_[www.psoppc.org](http://www.psoppc.org/)__)_

**Notes:**
AHRQ prepared paper forms for Version 0.1 Beta so that hospitals could use the Common Formats as soon as PSOs are listed. (The forms may be used sooner, but privilege and confidentiality protections afforded under the Patient Safety Act will not be operative until PSOs are listed.) These forms, as well as accompanying user reference documentation, are available for download at the PSOPPC Web site (www.psoppc.org).  AHRQ created the PSOPPC to assist in maintaining the Common Formats and to provide technical assistance to those using them.

## Future Steps

- Develop expanded and enhanced versions based on user feedback
- AHRQ plans to release a second version of the formats in six to nine months
- Annual updates and revisions
- 	(2009 and beyond)

**Notes:**
We really have taken just the first step with the release of version 0.1 beta of a longer process to develop and expand enhanced version based upon the feedback that we receive and use of the common formats by providers and PSOs. AHRQ plans to release a second version of the formats in six to nine months, or perhaps sooner, depending on the nature of initial feedback. 

## Questions and Answers

## Common Formats Pilot Test

- Provided guidance to refine and revise the Common Formats
- AHRQ received feedback on the Common Formats
- Style/ Formatting
- Ease of use
- Length of time to complete
- Navigation
- Wording
- Clarity of instructions
- Overall
- Skip patterns
- Consistency
- Two pilot tests conducted in the Federal health centers
- Department of Defense, Indian Health Services, and Veterans Health Administration

## Thank you!

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