Health IT Patient Safety and Surveillance and Action Plan

Health IT Patient Safety and Surveillance and Action Plan • David R. Hunt, MD, FACS • Medical Dir., HIT Adoption & Patient Safety ONC, Office of the Chief Medical Officer • ONC Pre-decisional Draft. Do not disclose.

“Doubt is uncomfortable, but certainty is ridiculous… From the depth of our profound ignorance, let us do our best;…” -- Voltaire Letter to Frederick William, Prince of Prussia Ferney, November 28, 1770

Goals: Goals • Use Health IT to Make Care Safer • Improve the Safety and Safe Use of Health IT

Goals Continued • Addresses the role of health IT within HHS’s commitment to patient safety. • Responds to ONC sponsored IOM Report • Builds upon existing authorities • Seeks to strengthen patient safety efforts across government programs and the private sector

Questions: • Meaningful Use and Safety Risk Assessment: • To improve the safety of EHRs, should there be a Meaningful Use requirement for providers to conduct a health IT safety risk assessment? • Are there models or standards that we should look to for guidance? • Meaningful Use and Reporting: • Should ONC require any form of reporting/reporting verification under Meaningful Use?

Questions: • What should be the next steps in terms of EHR technology certification? • Certified EHR technology developers will be required to publicly identify a method of incorporating user - centered design of eight certification criteria that have a high likelihood of helping to prevent medical errors (77 Fed Reg 54186-54189 (September 4, 2012)). • Certified EHR technology developers will also be required to provide transparency regarding their approach to “quality management systems,” (77 Fed Reg 54189-54191 ((September 4, 2012))

Background: 2011 IOM Report • Response to ONC sponsored IOM Report Published Nov. 2011 • 10 Recommendations

Institute of Medicine, 2003 Patient Safety: Achieving a New Standard for Care: November 2003

Fundamentals In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 2: Concepts and Methodology). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb

safe·ty: n. (sāf’tē), [L. salvus ] : the quality or condition of being free from harm, injury, or loss Webster’s New 20th Century Dictionary Unabridged

Claudius Galen(129 – 217) “Primum nonnocere.”

Hippocrates of Kos Hippocrates of Kos (ca. 460 BC – ca. 370 BC) “As to diseases make a habit of two things - to help, or at least, to do no harm.” Epidemics I

Quality = Help Safety = Do no harm Quality - Safety

Goals Goals Health IT to Make Care Safer • Improve the Safe • Use of Health IT

Goals • Health IT can improve patient safety in some areas such as medication safety; however, there are significant gaps in the literature regarding how health IT impacts patient safety overall • Safer implementation and use begins with viewing health IT as part of a larger sociotechnicalsystem • All stakeholders need to work together to improve patient safety

Patient Safety Action & Surveillance Plan • Learning: Increasing the quantity and quality of data and knowledge about health IT safety • Improving: Targeting resources and corrective actions to improve health IT safety and patient safety • Leading: Promoting a culture of safety related to health IT

Learning: Overview Learning: Overview • Clinicians Encourage and facilitate clinicians reporting of health IT – related safety events • Developers Encourage health IT developersto embrace their shared responsibility for patient safety • Safety Programs Incorporate health IT into existing safety programs, e.g. PSOs/AHRQ, CMS, AHRQ • ONC Pre-decisional Draft. Do not disclose.

Learning: Safety Programs Learning: Safety Programs Reporting • AHRQ/PSOs Accrediting • ONC-ACB • CMS • ONC Pre-decisional Draft. Do not disclose.

Improving: Improving • AHRQ/PSO AHRQ will provide technical guidance to help PSOs work with providers to mitigate harm and improve safety through health IT • CMS CMS will provide guidance to surveyors and accreditation organizations to recognize health IT – related adverse events when conducting surveys on CMS’ behalf • ONC-ACBs ONC-ACBs will conduct live testing in clinical environments to determine whether clinician safety complaints are addressed and whether EHR safety features are performing adequately. • ONC Pre-decisional Draft. Do not disclose.

Is Safety Meaningful? “We cannot change the human condition, but we can change the conditions under which humans work.” James Reason Human error: models and management BMJ 2000; 320: 768-70

Thank You Contact Information davidr.hunt@hhs.gov www.healthit.gov Thank you.

Health IT Patient Safety and Surveillance and Action Plan