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

“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,

Goals 3 Use Health IT to Make Care Safer Improve the Safety and Safe Use of Health IT Goals:

Goals Continued 4 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? 5

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 (September 4, 2012)). – Certified EHR technology developers will also be required to provide transparency regarding their approach to “quality management systems,” (77 Fed Reg ((September 4, 2012)) 6

Background: 2011 IOM Report 7 Response to ONC sponsored IOM Report Published Nov Recommendations

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

Fundamentals 9 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 10

Claudius Galen (129 – 217) 11 “Primum non nocere.”

Hippocrates of Kos “As to diseases make a habit of two things - to help, or at least, to do no harm.” Epidemics I Hippocrates of Kos (ca. 460 BC – ca. 370 BC) 12

Quality - Safety 13 Quality = Help Safety = Do no harm

Goals 14 Goals Health IT to Make Care Safer Improve the Safe Use of Health IT

Goals 15 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 sociotechnical system 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 16

Learning: Overview 17 Learning: Overview Clinicians Encourage and facilitate clinicians reporting of health IT – related safety events Developers Encourage health IT developers to 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 18 Learning: Safety Programs Reporting AHRQ/PSOs Accrediting ONC-ACB CMS ONC Pre-decisional Draft. Do not disclose.

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 19

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. 20 Improving: ONC Pre-decisional Draft. Do not disclose.

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 21

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:

THANK YOU. Thank You Contact Information 23