February 4, 2013
Submitted electronically
Farzad Mostashari, M.D.
Office of the National Coordinator for Health Information Technology (ONC)
Department of Health and Human Services
Patriots Plaza II, 355 E Street, SW
Washington, D.C. 20201
RE: Health IT Patient Safety Action & Surveillance Plan for Public Comment
Dear Dr. Mostashari:
Thank you for your leadership in developing the Health IT Patient Safety Action & Surveillance
Plan, which makes several important recommendations to promote the use of health IT to make
care safer, as well as continuously improve the safety of health IT itself. We firmly believe that
electronic health records and other forms of health IT must be safe, and agree that this issue is
most effectively viewed in the broader context of patient safety, as recommended by the Institute
of Medicine (IOM) in its 2011 report Health IT and Patient Safety: Building Safer Systems for
Better Care.1 We strongly support national reporting systems to facilitate data collection
regarding safety issues related to the technical functioning of electronic products on the market,
and support aligning the Action Plan with existing reporting structures whenever appropriate and
feasible. We also support an approach that includes corrective action for serious adverse events.
Meaningful use of health IT to improve the care and safety of all patients must ensure methods
are in place to rapidly report and address any technical issues.
While we are largely supportive of ONC’s recommendations, specific action steps that leverage
the critical role of patients and their families in developing and sustaining a culture of safety are
conspicuously absent. Efforts to learn about the impact of health IT on safety must incorporate
information from the patient and caregiver perspective. Consumers have vital information to
contribute, both in terms of how to use health IT to improve safety, and in the effort to identify
and report safety issues arising from the use of health IT. We encourage you to refine the Action
Plan to recognize patients and families as sources of valuable information and powerful forces
for change in identifying and preventing errors, as recommended by the IOM.
1
Health IT and Patient Safety: Building Safer Systems for Better Care. National Academies Press, 2011. Accessed
at http://www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx,
January 29, 2013.
1875 connecticut avenue, nw ~ suite 650 ~ washington, dc 20009 ~ phone: 202.986.2600 ~ fax: 202.986.2539
email: [email protected] ~ web: www.nationalpartnership.org
Central to the IOM’s recommendation to promote a culture of safety is the idea that safety is a
systems function. The safety of any health IT system is a result of the interaction of the
technology itself, the people who use it, and the organizations who implement it. As patients
gain electronic access to their own health information and begin using health IT to manage and
share their information, their involvement in all of these areas will be critical. For example,
involving consumers in the design of patient-facing technologies would likely enhance safety
from a usability perspective, and could also identify design flaws that may ultimately lead to
safety problems. Given the vantage point of patients and their family caregivers as the only
constants in the care continuum, they are in a unique position to identify breakdowns in care that
may contribute to adverse events.2
Several recent initiatives are encouraging patients, families, and other caregivers to take an
active role in preventing and reporting health care errors. The Joint Commission’s Speak Up™
initiative seeks to empower patients to become active, informed members of the health care team
by encouraging them to pay attention and ask questions regarding the care they are receiving. 3
Similarly, the World Health Organization (WHO) Patients for Patient Safety initiative
emphasizes the central role patients and consumers can play in efforts to improve the quality and
safety of health care around the world.4
Within the Department of Health and Human Services, the Agency for Healthcare Research and
Quality (AHRQ) has funded research to explore how to leverage patients and their families in
patient safety efforts.5 AHRQ has developed common formats for purposes of reporting adverse
events, as referenced in the Action Plan, and are awaiting project clearance for a pilot project to
implement a prototype for collecting and reporting information from patients about safety events.
The results of this pilot will contribute learning on how best to incorporate structured feedback
from patients and their families on safety events.
RECOMMENDATION: ONC should work with AHRQ to develop and add a question(s)
to the Consumer Reporting System for Patient Safety Events regarding errors or harm
caused by malfunctioning health IT products.
RECOMMENDATION: ONC should compile best practices and develop educational
resources to help patients and families to better identify safe and unsafe practices related to
health IT.
2
http://www.ahrq.gov/qual/consrepflyer.htm
http://www.jointcommission.org/speakup.aspx
4
http://www.who.int/patientsafety/patients_for_patient/en/
5
Project Overview: Designing Consumer Reporting Systems for Patient Safety Events. AHRQ Publication No. 110075-EF, July 2011. Agency for Healthcare Research and Quality, Rockville, MD.
http://www.ahrq.gov/qual/consrepflyer.htm
3
RECOMMENDATION: ONC should create a position for patient and family
representation on the ad hoc steering committee that will oversee the ONC Safety Program,
to provide the consumer perspective on how best to identify and address health IT safety
issues.
The notion of a Health IT Patient Safety Action and Surveillance plan with no meaningful role
for patients or their family caregivers does not leverage the role they play as members of their
care team. Acknowledging the critical role of patients and families in fostering a culture of
safety will not only maximize patient safety efforts, it creates the expectation of equal
partnership among providers and their patients and families in the delivery of care and ensuring
its safety.
Sincerely,
Christine Bechtel
Vice President
National Partnership for Women & Families