Health Information Technology Patient Safety Action & … · Health Information Technology Patient Safety Action & Surveillance Plan ... government programs and the private sector—including

Health Information TechnologyPatient Safety Action amp Surveillance Plan July 2 2013

Health IT Patient Safety Action amp Surveillance Plan

Table of Contents Introduction 3

Health IT Patient Safety Goal 5

Objectives of the Health IT Patient Safety Plan 7

Health IT Patient Safety Strategies and Actions 10

Summary 29

Appendix A Crosswalk of Health IT Patient Safety Plan amp IOMrsquos 2011 Recommendations from Health IT and Patient Safety Building Safer Systems for Better Care 30

Appendix B Research and Development of Tools Measures and Policies 43

Appendix C Timeline of the Health IT Patient Safety Action and Surveillance Plan 46

Appendix D ONC Patient Safety Program 50

ldquoIt is widely believed that when designed and used appropriately health IT can help create an ecosystem of safer carehelliprdquo

mdashInstitute of Medicine Health IT and Patient Safety Building Safer Systems for Better Care 1

Introduction

Over a decade ago the Institute of Medicine (IOM) report To Err is Human raised an alarm about the failure of health care to recognize and reduce the large number of avoidable medical errors harming patients2 The ability of health information technology (health IT) to reduce medical errors is one of the reasons for the creation of the Office of the National Coordinator for Health Information Technology (ONC) under the Department of Health and Human Services (HHS) through the Health Information Technology for Economic and Clinical Health (HITECH) Act3mdashpassed as part of the American Recovery and Reinvestment Act (Recovery Act) of 20094 In addition to creating ONC the HITECH Act also provided economic incentives for eligible health care providers to adopt and meaningfully use certified EHR technology

A key premise of these initiatives is that health IT when fully integrated into health care delivery organizations facilitates substantial improvements in health care quality and safety as compared to paper records For instance

bull Medication errors can be substantially reduced and clinical decisions can more easily be made based on evidence Electronic health records (EHRs) eliminate prescription and other errors resulting from illegible handwriting while capabilities such as clinical decisions support (CDS) and computerized provider order entry (CPOE) provide clinicians with best practice guidance and information on the allergies and medications of specific patients as part of the clinical decision-making process CDS also supports delivery of care to patients based on clinical guidelines including for preventative care such as immunizations and routine screening tests

bull Patient records can be stored centrally and easily accessed from multiple locations making crucial health information available when and where needed as patients move within and between health care organizations When a patient arrives at an emergency room providers can begin treatment with electronic access to historical patient records

1 Institute of Medicine (IOM) Health IT and Patient Safety Building Safer Systems for Better Care (National Academy Press 2012) (hereinafter ldquoIOM Reportrdquo) 21 available at httpwwwiomeduReports2011Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Careaspx (last accessed May 17 2013)

2 IOM To Err Is Human Building a Safer Health System (National Academy Press 2000) available at httpwwwiomeduReports1999To-Err-is-Human-Building-A-Safer-Health-Systemaspx (last accessed May 17 2013)

3 Pub L 111-5 123 Stat 115 Division A Title XIII amp Division B Title IV The HITECH Act directs the National Coordinator to coordinate the development of a nationwide health IT infrastructure that inter alia ldquoreduces medical errorsrdquo and ldquoimproves health care qualityrdquo 42 USC sect 300jj-11(b)

4 Pub L 111-5

bull Health IT can be used to more efficiently report track and aggregate patient data within and across organizations This allows providers to more efficiently track and manage hospital-acquired illnesses Disease outbreaks can be monitored which allows for improved population health and identification of widespread threats to health such as flu epidemics

While health IT presents many new opportunities to improve patient care and safety it can also create new potential hazards5 For example poor user interface design or unclear information displays can contribute to clinician errors6 Health IT can only fulfill its enormous potential to improve patient safety if the risks associated with its use are identified if there is a coordinated effort to mitigate those risks and if it is used to make care safer Recognizing this ONC commissioned an IOM study to determine how government and the private sector can maximize the safety of health IT-assisted care ldquoThe [IOM] committee interpreted its charge as making health-IT assisted care safer so the nation is in a better position to realize the potential benefits of health ITrdquo7 The IOM Report Health IT and Patient Safety Building Safer Systems for Better Care was published in November 20118

This Health IT Patient Safety Action and Surveillance Plan (the ldquoHealth IT Safety Planrdquo or ldquoPlanrdquo) addresses the role of health IT within HHSrsquos commitment to patient safety Building on the IOM committeersquos recommendations the Plan leverages existing authorities to strengthen patient safety efforts across government programs and the private sectormdashincluding patients health care providers technology companies and health care safety oversight bodies Importantly the Plan outlines specific and tangible actions through which all stakeholders can fulfill their shared obligation to increase knowledge of the impact of health IT on patient safety and maximize the safety of health IT and health IT-assisted care

Successfully implementing this Plan will require a coordinated effort among multiple government agencies private organizations and individuals (eg clinicians software engineers health IT support staff and usability experts) To coordinate this effort ONC has established the Health IT Patient Safety Program (ldquoSafety Programrdquo) within the Office of the Chief Medical Officer with support from the Office of Policy and Planning Through the Safety Program ONC will collaborate with stakeholders to incorporate health IT and patient safety into their organizations and will work closely with all actors to help them fulfill their responsibilities under this Plan ONC will oversee the aggregation and analysis of data from the sources identified in this Plan among others in order to identify trends in patient safety and health IT provide feedback to developers and providers and inform policies and interventions to achieve this Planrsquos objectives

ONC will continuously evaluate the outcomes and effectiveness of this Plan and ensure its efficient implementation Information about this Plan and its implementation will be available at httpwwwhealthitgovpolicy-researchers-implementershealth-it-and-patient-safety

5 IOM Report supra note 1 at 31 (collecting sources) 6 Id 7 IOM Report supra note 1 at 2 (emphasis in original) 8 Supra note 1

Health IT Patient Safety Goal

Inspire Confidence and Trust in Health IT and Health Information Exchange

HHSrsquos goal is that patients and providers have confidence in the safety of the health care system including its health IT infrastructure based on evidence of safety Patient safety and the factors by which it is affected have been studied for decades The IOM the Agency for Healthcare Research and Quality (AHRQ) and other such organizations have contributed to a body of literature focused on patient safety9 Many efforts in the public and private sectors are already in place to improve patient safety and the overall quality of care10

Despite a growing body of research on patient safety the IOM found little published evidence quantifying the magnitude of risks associated with health IT11 In a research appendix to the IOM report a review of seven papers using large databases of reported errors found that health information systems were involved in less than one percent of reported errors12 All the reviewed papers also point to ldquothe need for human diligence when using [health information systems]rdquo13

It is difficult to interpret this initial research which suggests that health IT is a modest cause of medical errors Because health IT is so tightly integrated into care delivery today the extent to which health IT may have caused or contributed to medical errors is often unclear For example determining whether an error was caused by or associated with health IT is problematic where bull The harm to the patient could have been

prevented by more sophisticated or improved implementation of CPOE or CDS or

bull The clinician did not use certain health IT functionality that could have prevented the error

ldquoA traditional perspective on technology draws a sharp distinction between technology

and human users of the technologyhellip [I]n the traditional perspective health ITndash

related adverse events are generally not recognized as systemic problems that is as

problems whose causation or presence is influenced by all parts of the socio-technical

systemrdquo IOM Report (P 64)

Another limitation of this early data is the low rate of EHR utilization prior to passage of the HITECH Act in 2009 As a result the dearth of reported incidents of health IT-related harm may be due less to the inherent safety of health IT and more to its lack of use

As EHR adoption becomes more widespread the incidence of health IT-related harm may increase At the same time the increase in EHR adoption also creates a unique opportunity to improve patient safety For example EHRs can bull Increase cliniciansrsquo awareness of potential medication errors and adverse interactions

9 See eg AHRQ Advancing Patient Safety A Decade of Evidence Design and Implementation AHRQ Pub No 09(10)-0084 (November 2009) available at httpwwwahrqgovlegacyqualadvptsafetyhtm (accessed May 17 2013) (describing progress in patient safety research over the period 1999ndash2009)

10 See eg supra note 9 11 IOM Report supra note 1 at 3 12 IOM Report supra note 1 Appendix C 13 Id

bull Improve the availability and timeliness of information to support treatment decisions care coordination and care planning

bull Make it easier for clinicians to report safety issues and hazards and bull Give patients the opportunity to more efficiently provide input on data accuracy than what paper

records would allow

Objectives of the Health IT Patient Safety Plan

1 Use health IT to make care safer 2 Continuously improve the safety of health IT

This Health IT Safety Plan has two fundamental objectives first to promote the health care industryrsquos use of health IT to make care safer and second to continuously improve the safety of health IT itself The first objective to use health IT to make care safer focuses on the use of health IT as a tool to mitigate or prevent adverse events and hazards14 regardless of their cause (eg CDS systems can warn providers of drug allergies or dangerous drug-drug interactions before the patients receive the drugs) The second objective continuously improving the safety of health IT focuses on preventing adverse events and hazards that are caused by or closely associated with health IT itself (eg medical errors caused by incomplete or poorly designed graphical user interfaces)

Achieving these objectives is a shared responsibility No one entity or group can fully realize the potential of health IT to improve patient safety Therefore this Plan seeks to coordinate the actions of the relevant stakeholders including

ldquoAn environment of safer health IT can be created if

both the public and private sectors acknowledge that

safety is a shared responsibilityrdquo

IOM Report (P 125)

bull Clinicians bull Care Delivery Organizations including

o Administrators o IT staff o Quality improvement staff

bull Patients and their caregivers bull Federal and state governments bull Health IT developers bull Usability experts bull Patient safety organizations bull Accrediting bodies and bull Other organizations and stakeholders including

o Educational organizations o Health insurers o Professional associations o Publishers

14 The term ldquohazardrdquo as used in this Plan refers to any condition that is unsafe for patients (ie a condition that if not corrected could lead to an adverse event) Several other terms are commonly used to refer to hazards including ldquounsafe conditionsrdquo ldquoclose callsrdquo ldquonear missesrdquo and ldquomalfunctions that could lead to death or serious injuryrdquo This Plan treats these terms as interchangeable

1 Use health IT to make care safer

Health IT has enormous potential to improve the quality and safety of health care When properly integrated into health care organizations it enables an infrastructure for identifying patient safety risks deploying interventions and using technology to advance national health and safety aims Indeed the potential for health IT to improve patient safety is one of the reasons for the creation of the Medicare and Medicaid EHR Incentive Programs which provide incentive payments to eligible providers who adopt and meaningfully use health IT to advance national priorities15

The opportunity to use health IT to make care safer also informs broader federal initiatives to improve patient safety including the National Strategy for Quality Improvement in Health Care (ldquoNational Quality Strategyrdquo)16 For example the National Quality Strategy incorporates the goals of the Partnership for Patients17 which aims to reduce preventable hospital-acquired conditions and hospital readmissions Health IT can be used to track and analyze these adverse events which can then become the focus for CDS and other health IT interventions resulting in decreased patient harm Examples of CDS that can be integrated into EHRs include standardized checklists to prevent central venous catheter associated bloodstream infections criteria for verification of the proper position of catheters and notifications to discontinue medications or other interventions For venous thromboembolism (VTE) a risk assessment linked to an order set of preferred VTE prophylaxis methods can potentially diminish the risk of development of hospital-acquired VTE18 In this manner quality measurement efforts and EHR functionality can be leveraged to improve clinical outcomes and avoid patient harm Standardized order sets have also been implemented in labor and delivery setting and demonstrated significant reductions in obstetrical adverse events19 CDS enables electronic integration of protocols to prevent injury from falls or pressure ulcers such as risk assessments or prompts to reevaluate the patientrsquos risk with a change in status or upon transfer 20 CDS also

15 See supra note 3 and accompanying text 16 See AHRQ National Strategy for Quality Improvement in Health Care (2012) (hereinafter ldquoNational Quality Strategyrdquo)

available at httpwwwahrqgovworkingforqualitynqsnqs2012annlrptpdf (accessed May 17 2013) 17 See CMS Partnership for Patients Better Care Lower Costs httppartnershipforpatientscmsgov (accessed May 17 2013)

The Partnership for Patients is a national patient safety and quality improvement initiative that has two goals reducing preventable hospital-acquired conditions by 40 percent and reducing 30-day hospital readmissions by 20 percent by the end of 2014 Through the Partnership the CMS Center for Medicare and Medicaid Innovation (CMMI) is investing in public-private hospital engagement networks that will help hospitals adopt proven strategies to reduce hospital-acquired conditions in their own facilities So far these hospital engagement networks include more than 3700 hospitals nationwide and quality improvement work is well underway As part of the Partnership CMS is also investing in the Community-based Care Transitions Program to fund care transition services to keep high-risk Medicare beneficiaries out of the hospital after discharge

18 Haut ER et al Improved prophylaxis and decreased rates of preventable harm with the use of a mandatory computerized clinical decision support tool for prophylaxis for venous thromboembolism in trauma 147 Arch Surg no 10 Oct 2012 901ndash07 Kucher N et al Electronic alerts to prevent venous thromboembolism among hospitalized patients 352 NEngl JMed no 10 2005 969ndash77 See also AHRQ VTE Safety Toolkit httpvtewashingtonedudefaultasp

19 Mazza F et al Eliminating birth trauma at Ascension Health 33 Jt Comm JQual Patient Saf no 1 Jan 2007 15ndash24 See also Institute for Healthcare Improvement (IHI) How-to Guide Prevent Obstetrical Adverse Events Cambridge (IHI 2012) available at httpwwwihiorgknowledgePagesToolsHowtoGuidePreventObstetricalAdverseEventsaspx (accessed May 17 2013) IHI Perinatal Community Care Bundle Sequencing Elective Induction and Augmentation Bundles (IHI 2012) available at httpwwwihiorgknowledgePagesChangesElectiveInductionandAugmentationBundlesaspx (accessed May 17 2013)

20 Spears GV et al Redesign of an electronic clinical reminder to prevent falls in older adults 51 Med Care no 3 suppl 1 Mar

enhances the safety of e-prescribing by providing drug-drug interaction notifications and drug-allergy warnings which have been shown to decrease adverse drug events21 These adverse events can be further reduced using additional CDS functionalities such as drug-medical condition notifications triggers for lab results indicating risk for adverse drug events and decision support for medication treatments22 Finally two of the most common medication errors are improper dose or quantity CDS can be used to identify these errors early in the prescribing process and can mitigate or prevent harm before it reaches the patient23

Using health IT to improve patient safety is the first objective of the Health IT Safety Plan It will also continue to be a driving force behind HHS programs

2 Continuously improve the safety of health IT

To achieve the first objective of the Health IT Safety Plan using health IT to make care safer physicians and other clinical users of health IT must be able to rely on these systems to perform safely in real clinical environments This requires continuous improvement in the development implementation and use of health IT For instance the developers and users of CPOE and CDS must ensure that these complex interactive functions are designed tested implemented supported and used correctly and safely These technologies must be easy to use in efficient clinical workflows and their content must be accurate up-to-date and clinically relevant Problems and hazards should be identified and promptly mitigated and providers must be trained to use health IT properly and effectively and to report problems to entities that have responsibility for evaluating and improving health IT safety

The second objective of the Health IT Safety Plan addresses these concerns with a focus on continuously improving the safety of health IT so that it enables providers to deliver high quality care

2013 37ndash43 Teigland C et al Clinical Informatics and Its Usefulness for Assessing Risk and Preventing Falls and Pressure Ulcers in Nursing Home Environments in 3 ADVANCES IN PATIENT SAFETY FROM RESEARCH TO IMPLEMENTATION (Henriksen K et al ed 2005) available at httpwwwncbinlmnihgovbooksNBK20539 (accessed May 17 2013)

21 Tham E et al Sustaining and spreading the reduction of adverse drug events in a multicenter collaborative 128 Pediatrics no 2 Aug 2011 438ndash45 Classen DC et al Critical drug-drug interactions for use in electronic health records systems with computerized physician order entry review of leading approaches 7(2) J Patient Saf 61-65 (June 7 2011)

22 Levick DL et al Reducing unnecessary testing in a CPOE system through implementation of a targeted CDS intervention 13 BMC Med Inform Decis Mak no 43 Apr 2013

23 See IOM Preventing Errors in QUALITY CHASM SERIES (Aspden P Wolcott J Bootman JL Cronenwett LR ed 2007) available at httpwwwnapeducatalogphprecord_id=11623description (accessed May 17 2013)

Health IT Patient Safety Strategies and Actions

Increase the quantity and quality of data and knowledge about health IT safety

To achieve the objectives of this Health IT Safety Planmdash(1) using health IT to make care safer while (2) continuously improving the safety of health ITmdasha better understanding is needed regarding the impact of health IT on patient care both as a cause of and means of preventing patient harm across a wide array of care settings The need for more research on the role of health IT in the delivery of safe care was emphasized throughout the IOM Report 24

The following strategies and actions are designed to improve knowledge about the types frequency and severity of health IT-related adverse events and hazards as well as ways to mitigate the risks of health IT while using it to make care safer In particular the following steps are designed to

bull Establish mechanisms that facilitate reporting among users and developers of health IT

bull Enhance the ability of patient safety organizations and other public and private sector entities to identify and address health IT-related safety issues and

bull Aggregate and analyze data on health IT-related adverse events and hazards

ldquoTo fully capitalize on the potential that health IT may have on patient safety a more

comprehensive understanding of how health IT impacts potential harms workflow and safety

is neededrdquo IOM Report (p 49)

24 IOM Report supra note 1 at 13 The report recommends that research inform ldquothe design testing and use of health ITrdquo The report identified as a priority the following areas of research user-centered design and human factors applied to health IT safe implementation and use of health IT by all users socio-technical systems associated with health IT and the impact of policy decisions on health IT use in clinical practice

1 Make it easier for clinicians to report patient safety events and hazards to Patient Safety Organizations (PSOs) using AHRQrsquos Common Formats and health IT

To understand the impact of health IT on patient safety better data is needed about how these technologies function in real clinical environments Inevitably much of the necessary raw data will originate from clinicians and other persons directly involved in the delivery of care to patients To improve the overall quantity and quality of data about health IT these front-line staff must be encouraged to report health IT-related safety events and hazards and empowered with tools that make it easy for them to do so

HHS is developing and implementing policies and programs that encourage safety event reporting and make reporting easier for health IT users The Patient Safety Rule authorizes the creation of Patient Safety Organizations (PSOs) organizations dedicated to improving the quality and safety of health care delivery25 Because PSOs and their members have federal privilege and confidentiality protections for patient safety work product26 PSOs provide a secure environment where clinicians and provider organizations can collect aggregate and analyze data in order to identify and reduce risks associated with patient care including issues related to health IT

To facilitate reporting to PSOs (and other appropriate entities) AHRQ maintains the Common Formats a set of common definitions and reporting formats that allow health care providers to collect and submit standardized information regarding patient safety events and hazards including those involving health IT27 The Common Formats enable one-time data collection and subsequent routing to whoever needs or requests the data28 AHRQ has published Common Formats for the acute hospital setting (Hospital v 11 and 12) and a beta version for skilled nursing facilities or nursing homes AHRQ is currently developing a version of the Common Formats for the ambulatory setting

Patient safety reporting can also be made easier through the use of health IT In particular EHRs can enable providers to easily initiate reports at the time of discovery without interrupting clinical workflow and can reduce reporting burden by pre-populating and transmitting incident reports to multiple entities

25 The Patient Safety and Quality Improvement Final Rule (ldquoPatient Safety Rulerdquo) 42 CFR Part 3 administered by AHRQ and the Office for Civil Rights (OCR) implements select provisions of the Patient Safety and Quality Improvement Act of 2005 Pub L 109-41 (ldquoPatient Safety Actrdquo) The Patient Safety Act authorized the creation of PSOs to improve the quality and safety of US health care delivery by enabling clinicians and health care organizations to voluntarily report and share quality and patient safety information confidentially AHRQ has responsibility for listing and delisting of PSOs as described in Subpart B of the Patient Safety Rule OCR has responsibility for interpreting and implementing the confidentiality protections described in Subpart C and the enforcement provisions described in Subpart D

26 42 USC sect 299bndash22 27 See AHRQ Common Formats httpwwwpsoahrqgovformatscommonfmthtm The most recent version of the

Common Formats includes a ldquoDevice with Health ITrdquo format that allows collection of standardized information about health IT-related adverse events as well as events where health IT may be a contributing factor

28 The Common Formats also provide local facility reporting capabilities for rapidly identifying quality and safety problems facilitating changes to correct identified problems and aggregating and comparing adverse events across care delivery organizations and federal and state programs

including PSOs internal hospital reporting systems and patient safety oversight bodies ONC will propose standards and certification criteria to ensure that where appropriate certified EHR technology can facilitate reporting of patient safety events and hazards using the Common Formats

Work on these standards is already underway With support from AHRQ and the National Library of Medicine (NLM) ONC is pursuing a structured data capture (SDC) initiative through its Standards and Interoperability (SampI) Framework to identify standards that will enable adverse event data to be extracted from EHRs and translated into the Common Formats thereby allowing clinicians to quickly and easily generate incident reports at the time of discovery or occurrence and without disrupting their workflows 29

Use cases for these standards have been developed and work on an initial set of standards has begun ONC expects to receive recommendations from the Health IT Standards Committee (HITSC) in October 2013 concerning the adoption of these and other standards for Stage 3 of Meaningful Use

While this work is being completed ONC has sponsored a Patient Safety Reporting Challenge Award to address the immediate need for development of software tools and interfaces that decrease adverse event reporting burden incorporate the Common Formats to enable aggregation and consistency in reporting and improve workflow efficiency regarding adverse event reporting to healthcare organizations Three winners of this award were announced in November 201230 ONC expects these and similar tools to become much more widely used to help organizations build a culture of safety31 that includes adverse event reporting and follow-up

2 Provide support to PSOs to identify aggregate and analyze health IT safety event and hazard reports

By making it easier for providers to report health IT-related safety events and hazards to PSOs using the Common Formats this Plan seeks to increase the quantity and quality of available data regarding the impact of health IT on patient safety An equally important objective however is to ensure that once reported this data is used to increase knowledge about health IT patient safety and ways through which it can be improved HHS will assist PSOs to improve the range and consistency of health IT safety data that they collect as well as the ability of PSOs to use this data to identify analyze and mitigate health IT-related events and hazards HHS will also assist PSOs to de-identify and share this data in compliance with applicable laws so that it can be aggregated and used to analyze national health IT patient safety risks and trends

29 Earlier pilots of reporting medication adverse event data from EHRs to the FDA Medwatch System resulted in significant increases in reports received at the FDA Linder J et al Secondary use of electronic health record data spontaneous triggered adverse drug event reporting 19 Pharmacoepidem Drug Safe 1211ndash1215 (2010)

30 Challengegov Reporting Patient Safety Events httpchallengegovONC349-reporting-patient-safety-events (accessed May 17 2013)

31 A ldquoculture of safetyrdquo encompasses these key features ldquoacknowledgment of the high-risk nature of an organizations activities and the determination to achieve consistently safe operations a blame-free environment where individuals are able to report errors or near misses without fear of reprimand or punishment encouragement of collaboration across ranks and disciplines to seek solutions to patient safety problems organizational commitment of resources to address safety concernsrdquo AHRQ Safety Culture httppsnetahrqgovprimeraspxprimerID=5 (accessed May 17 2013)

As a first step HHS will support PSOs to leverage the Common Formats in order to efficiently identify aggregate and analyze health IT patient safety data Specifically AHRQ will continue to provide technical assistance to PSOs on using the Common Formats and will continue to encourage PSOs to assist providers in using the Common Formats when reporting adverse events and hazards related to health IT The Centers for Medicare and Medicaid Services (CMS) will support these efforts by encouraging the use of Common Formats in hospital incident reporting programs CMS has already issued guidance in this regard and will educate state survey agencies and surveyors to look for the use of the Common Formats in these programs32

Using the Common Formats will allow PSOs to more effectively collect and analyze data about health IT-related adverse events and hazards Several PSOs have already demonstrated increasing expertise in analyzing these types of issues33 and other PSOs will likely increase their capabilities in this domain in the future HHS does recognize that not all PSOs have expertise in health IT safety Therefore AHRQ plans to issue guidance on how to more effectively involve health IT expertise including from health IT developers in reporting to PSOs and in analysis and correction of problems This guidance will address common concerns among health IT developers who have specialized knowledge about the safety and safe use of their products but who may be reluctant to share this knowledge for legal reasons 34 While health IT developers unlike providers cannot invoke the Patient Safety Rulersquos 35 federal confidentiality and privilege protection for data they submit to a PSO they can nevertheless bring their health IT analytic expertise to working relationships with PSOs by 1) establishing Business Associate Agreements (BAA) with health care provider clients 2) contracting in a consultant role to PSOs and 3) establishing a component PSO ONC will similarly encourage and help to facilitate these working relationships

At this time there are 77 PSOs in 29 states that are listed by AHRQ36 As more data on health IT patient safety becomes available in the Common Formats it will be possible to aggregate this data across PSOs in order to analyze national trends and areas for improvement or further research For this purpose AHRQ has established the Network of Patient Safety Databases (NPSD) which provides a mechanism for aggregating and analyzing data from multiple PSOs37 Using the Common Formats PSOs will submit non-identified and aggregated patient safety event information to the NPSD AHRQ will analyze the data in the NPSD to identify national trends and patterns and will identify specific safety events or hazards that are related in some way to the use of health IT or that can be avoided or mitigated by more effective use of health IT AHRQ will publish its findings as appropriate in reports such as the National Healthcare Quality Report and will share its NPSD analysis and data with ONC ONC will combine this information with analysis from other data sources discussed in this Plan to identify areas in which the

32 See infra Learn section 4 Align CMS patient safety standards and initiatives with the safety of health IT 33 See eg ECRI Institute PSO Deep Dive Health Information Technology (December 2012) 34 See infra Lead section 1 Encourage private sector leadership and shared responsibility for health IT safety 35 The Patient Safety Rule 42 CFR Part 3 administered by AHRQ and the Office for Civil Rights (OCR) implements

select provisions of the Patient Safety Act AHRQ has responsibility for listing and delisting of PSOs as described in Subpart B of the Rule OCR has responsibility for interpreting and implementing the confidentiality protections described in Subpart C and the enforcement provisions described in Subpart D

36 AHRQ Geographic Directory of Listed Patient Safety Organizations httpwwwpsoahrqgovlistinggeolisthtm (accessed May 17 2013) 37 See AHRQ Network of Patient Safety Databases httpwwwpsoahrqgovnpsdnpsdhtm (accessed May 17 2013)

safety or safe use of health IT can be improved and coordinate corresponding policies activities and interventions

To assist PSOs to submit data to the NPSD AHRQ has established the PSO Privacy Protection Center (PSO-PPC)38 which will provide technical assistance to PSOs to assist them in de-identifying their data and submitting it to the NPSD using the Common Formats

3 Incorporate health IT safety in post-market surveillance of certified EHR technology

ONC will use its health IT certification program to monitor how certified EHR technology functions in operational settings This knowledge will provide insight into how specific types of EHR capabilities (eg CPOE) perform in actual clinical environments in which they are used leading to a better understanding of the risks associated with particular capabilities as well as ways to make those capabilities safer

As ONC described in the permanent certification program final rule39 ONC expects that ONC-Authorized Certification Bodies (ONC-ACBs) will conduct surveillance to ensure that the capabilities of certified EHR technology work in operational settings (in the field or in a live environment) to the same extent as when these capabilities were certified ONC will issue guidance to ONC-ACBs to add a specific focus on safety-related capabilitiesmdashsuch as CPOE and drug-drugdrug-allergy interaction checkingmdashto their sur veillance activities This guidance will also prioritize the sur veillance of EHR developersrsquo processes for receiving and responding to user complaints concerning developersrsquo products ONC will work with the ONC-Approved Accreditor (ONC-AA)mdashcurrently the American National Standards Institute (ANSI)mdash to provide direction to ONC-ACBs on the complaint records that developers of certified EHR technology are required to keep and make available to them under the ONC HIT Certification Program 40 ONC will work with ANSI to ensure consistency and reliability in the (1) format and content of complaints (2) process by which records are made available to the ONC-ACBs and (3) documentation of actions taken by EHR technology developers to address complaints Consistent and reliable complaint records will permit ONC-ACBs to sample review and validate complaints reporting concerns about safety-related capabilities of certified EHR technology as part of surveillance 41

38 PSO Privacy Protection Center httpswwwpsoppcorg The PSO-PPC was created by AHRQ to support the implementation of the Patient Safety Act The PSO-PPC works with all PSOs and can check for duplicate reports prior to the non-identification process

39 76 Fed Reg 1283 40 ONC-ACBs are accredited to ISOIEC Guide 65 Section 15 of Guide 65 instructs an ONC-ACB to ensure that the

developers of the health IT that it certifies have a process in place for receiving and addressing complaints related to certified products Section 15 also requires that the developers make complaint records available to the ONC-ACB upon request

41 ONC-ACBs are required to report surveillance results to ONC annually 45 CFR sect 170523(i) In reporting its annual surveillance results to ONC an ONC-ACB will be expected to indicate whether the certified EHR technology was functioning in a manner consistent with its certification and if not the reasons why it was not functioning in this manner (eg implementation error a misapplication by a user or other factors) The ONC surveillance guidance will specify the type and level of information that should be included in surveillance results

4 Align CMS patient safety standards and initiatives with the safety of health IT

CMS is engaged in patient safety and quality improvement initiatives that can be leveraged to support efforts to increase reporting of health IT-related adverse events and hazards and improve knowledge of health IT patient safety

CMS maintains Conditions of Participation (CoPs) that health care organizations must meet in order to begin and continue participating in the Medicare and Medicaid programs42 The CoPs include a requirement for covered health care organizations to have a Quality Assurance and Performance Improvement (QAPI) program that includes internal adverse incident reporting and effective follow-up of a wide range of patient safety events43 CMS recently published interpretive guidance for hospitals and state survey agencies that clarifies the types of adverse events that hospitals should report and strongly encourages the use of AHRQrsquos Common Formats in hospital QAPI programs44 Deploying the Common Formats in QAPI programs will create an additional source of information about the role of health IT across a broad range of patient safety events and will make it easier for hospitals to share this information with PSOs and other oversight entities

CMS will work with ONC to develop training for state survey agencies and surveyors who conduct thou-sands of complaint investigation surveys on CMSrsquos behalf each year When surveys identify deficient practices providers and suppliers must submit to CMS a plan of correction for achieving compliance CMS will educate its surveyors on EHRs and electronic incident reporting as well as safety considerations associated with the use of EHRs by Medicare participating providers45 CMS is also working with ONC to develop educational materials that will assist surveyors as they survey EHR-enabled health care organizations

CMS will continue to use Quality Improvement Organizations (QIOs) to focus on specific patient safety interventions and will leverage health IT and health safety data collected to identify analyze and mitigate health IT-related events and hazards

5 Collect data on health IT safety events through the Quality amp Safety Review System (QSRS)

AHRQ is currently building the Quality amp Safety Review System (QSRS) The QSRS is a software system designed to perform retrospective surveillance for adverse events A replacement for the Medicare Patient Safety Monitoring System (MPSMS) the QSRS incorporates the Common Formats to broaden surveillance to harm from all causes The QSRS will provide national estimates of adverse events and will make it possible to explore the role of health IT in these events QSRS software will initially be deployed

42 See CMS Conditions for Coverage (CfCs) amp Conditions of Participation (CoPs) httpwwwcmsgovRegulations-and-GuidanceLegislationCFCsAndCoPsindexhtml (accessed May 17 2013)

43 42 CFR 48221(a)(2) 44 CMS AHRQ Common Formats-Information for Hospitals and State Survey Agencies (SAs)-Comprehensive Patient Safety Reporting

Using AHRQ Common Formats Ref SampC 13-19-HOSPITALS (March 15 2013) available at httpwwwcmsgovMedicareProvider-Enrollment-and-CertificationSurveyCertificationGenInfoPolicy-and-Memos-to-States-and-Regions-ItemsSurvey-and-Cert-Letter-13-19html (accessed May 17 2013)

at the CMS Clinical Data Abstraction Center and is being designed for use on a voluntary basis by local entities such as states hospital networks or individual hospitals

While work on the QSRS is still underway AHRQ intends to support research in the interim that will provide better estimates of the frequency type and level of harm occurring with adverse events related to health IT Additionally while the QSRS is under development AHRQ has added a new query to the MPSMS For 2012 and 2013 data MPSMS abstractors will identify which patient records in the sample are from EHRs paper records and mixed records This data will provide insight into the extent to which the adverse events measured by MPSMS are correlated with levels of health IT integration

6 Learn from health IT adverse event reports submitted to the Manufacturer and User Facility Device Experience (MAUDE) database

ONC will coordinate with the FDA to identify and evaluate health IT adverse event reports made to the FDA MAUDE database MAUDE is a searchable database of adverse event reports on devices that contains data from several sources including voluntary reports user facility reports and device manufacturersrsquo reports46 This database will provide ONC with an additional source of data from which to analyze potential safety trends and risks associated with health IT

7 Identify opportunities to make care safer through the use of health IT

Health IT has enormous potential to improve the quality and safety of health care Realizing this potential is both the first objective of this Plan as well as an important component of HHSrsquos patient safety and quality improvement initiatives

ONC will work within the apparatus of the National Quality Strategy47 and related public and private sector initiatives to identify opportunities to make care safer through the use of health IT For example through the Partnership for Patients48 over 3700 hospitals collaborated at the regional state national and hospital levels to identify and share knowledge of clinical practices interventions and quality measures for improving patient safety in several critical domains In consultation with its federal advisory committees ONC will exploit lessons learned through the Partnership for Patients and other patient safety and quality improvement initiatives in order to determine specific areas in which health IT has the greatest potential to make care safer This work will also provide a focus for public and private sector research into specific health IT interventions such as CDS that have the greatest potential to improve patient safety

46 MAUDE-Manufacturer and User Facility Device Experience httpwwwaccessdatafdagovscriptscdrhcfdocscfmaudesearchcfm

47 National Quality Strategy supra note 16 see also Lead section 1 infra 48 Partnership for Patients supra note 17

Target resources and corrective actions to improve health IT safety and patient safety

Improve

This Health IT Safety Plan seeks not only to increase knowledge about the impact of health IT on patient safety but also to use that knowledge to improve the safety of health IT and make care safer

As early as 1999 the IOM recognized the enormous potential of health IT to improve patient safety49

Compared with paper based systems health IT provides an efficient mechanism with which to identify problem areas monitor trends measure success and implement improvements As knowledge of health IT safety continues to improve HHS will take the following steps to ensure that such knowledge is used to make health IT safer and to realize its potential to deliver safer care

1 Use Meaningful Use and the National Quality Strategy to establish and advance health IT patient safety priorities

HHS will use knowledge of health IT safety risks and trends to establish priorities for improving patient safety through health IT These priorities will align with national health care quality improvement efforts outlined in the National Quality Strategy and will focus on areas in which improving the safety of health IT will have the greatest potential to advance patient safety In particular the National Quality Strategy seeks to make care safer by reducing patient harm caused in the delivery of care specifically by reducing hospital readmissions and preventable hospital-acquired conditions50 To further these goals CMS launched the Partnership for Patients51 through which it identified ten patient safety domains in which evidence confirms the greatest need for intervention as well as the greatest opportunities for

49 See IOM To Err Is Human Building a Safer Health System supra note 2 see also IOM Crossing the Quality Chasm (National Academy Press 2001) (available at httpwwwiomedureports2001crossing-the-quality-chasm-a-new-health-system-for-the-21st-centuryaspx (last accessed 512013) (calling for ldquothe elimination of most handwritten clinical data by the end of the decaderdquo)

50 National Quality Strategy supra note 16 51 Partnership for Patients supra note 17

improvement (see Table 1) Building on this work ONC is developing electronic clinical quality measures (eCQMs) for specific adverse drug events and will soon expand this work to other patient safety

domains In addition ONC will establish a Table 1 Partnership for Patients Priority Domains public-private mechanism for developing

Adverse Drug Events Pressure Ulcers

Catheter Associated Urinary Tract Infection

Surgical Site Infections

Central Line Associated Blood Stream Infection

Obstetrical Adverse Events

Readmissions Venous Thromboembolism

Ventilator Associated Pneumonia

Injuries from Falls and Immobility

health IT-related patient safety measures and targets in order to align improvement efforts across government programs and the private sector and target and measure success

HHS will provide leadership and incentives to advance health IT patient safety in priority areas ONC will release a health IT focused quality improvement strategy that aims to coordinate evidence-based guidelines CDS tools and eCQMs and that defines specific actions for payers

providers and developers in order to improve patient safety and health care quality using health IT In addition HHS expects to incorporate improvement priorities into the Medicare and Medicaid EHR Incentive Programs (ldquoMeaningful Use Programsrdquo) which offer incentive payments to eligible providers who adopt and meaningfully use certified EHR technology that aims to improve health care quality improve health outcomes and lower costs These incentives have already given considerable momentum to efforts to improve health care quality and safety through the meaningful use of health IT As of April 2013 more than half of eligible providers have qualified for and received incentive payments for adoption of certified EHR technology exceeding HHSrsquos target for the end of 201352 Moreover nearly 80 percent of eligible hospitals have reached this milestone The increase has been rapid adoption of electronic health records doubled among office based physicians from 2008 to 2012 and quadrupled in hospitals53

HHS expects to continue to use the Meaningful Use Programs to advance health IT patient safety priorities Already to receive an incentive payment eligible providers must demonstrate several core objectives that advance patient safety such as using CPOE and maintaining lists of patient medications allergies and problems Stage 2 of Meaningful Use which will begin in 2014 will similarly advance patient safety through core safety-related objectives that include using CDS to improve clinical performance with respect to high-priority health conditions performing electronic medication reconciliation when receiving patients from another setting of care or provider and providing summary of care records when referring patients to another provider or care setting For future regulation ONC plans to work with its federal advisory committees to determine ways to improve clinical documentation

52 See CMS Data and Program Reports httpwwwcmsgovRegulations-and-GuidanceLegislationEHRIncentive ProgramsDataAndReportshtml (accessed May 17 2013) see also The White House Blog More than Half of Doctors Now Use Electronic Health Records Thanks to Administration Policies httpwwwwhitehousegovblog20130524more-half-doctors-now-use-electronic-health-records-thanks-administration-policies (accessed June 27 2013)

thereby reducing the risk that records will be inaccessible or their accuracy or completeness compromised ONC will also explore ways to make existing health IT capabilities safer and maximize their potential for enhancing patient safety

2 Incorporate safety into certification criteria for health IT products

As knowledge of health IT safety grows ONC expects to update its standards and certification criteria to ensure that the capabilities of certified EHR technology support improvement priorities including efforts to improve patient safety through the meaningful use of health IT As necessary ONC would update its standards and certification criteria to improve safety-related capabilities (eg CDS and CPOE) or add capabilities that enhance patient safety

ONC expects to further incorporate safety into its standards and certification criteria by requiring developers of certified EHR technology to integrate safety principles into their software design and development processes The 2014 Edition EHR Standards and Certification Criteria final rule54 adopted two such requirements which were drawn from the IOM committeersquos recommendations identifying usability and quality management principles as key elements of health IT product safety55 First EHR technology developers are required to publicly identify the method used to incorporate user-centered design processes into the development of their EHR technology for the capabilities included in eight medication-related certification criteria56 Second EHR technology developers are required to provide transparency regarding their approach to ldquoquality management systemsrdquo in the development of their products57 ONC intends to build on these certification criteria in future rulemaking as means for enhancing health IT patient safety through continued focus on human factors safety culture and user-centered design in EHR technology development

As part of the ONC HIT Certification Program ONC established the Certified HIT Product List (CHPL)58 The CHPL is a publicly available database of health IT products that have been certified in accordance with ONCrsquos standards and certification criteria Each individual EHR product listed in the database notes the presence or absence of safety features such as drug-drug interaction or drug-allergy checking If there is a need for further registration and listing to promote transparency related to the

54 77 Fed Reg 54163 (September 4 2012) 55 IOM Report supra note 1 at 81 The IOM committee concluded that ldquopoor usability is one of the single greatest

threats to patient safety Id On the other hand once improved it can be an effective promoter of patient safetyrdquo Id The committee explained that usability is a necessary component of effective design the goal of which should be to make ldquothe right thing to do the easy thing to dordquo Id The committee also recommended the use of quality management principles and processes which it described as focusing on ldquodriving performance characteristics at each level to make sure that the product and specifications are in line with the usersrsquo needs and expectationsrdquo and which it concluded ldquocan help health IT vendors take into account characteristics such as interoperability usability and human factors principles as they design and develop safer productsrdquo Id at 143

56 45 CFR sect 170314(g)(3) requires that user-centered design processes be applied to each capability an EHR technology includes that is specified in the following certification criteria sect 170314(a)(1) (CPOE) (a)(2) (drug-drug drug-allergy interaction checks) (a)(6) (medication list) (a)(7) (medication allergy list) (a)(8) (CDS) (a)(16) (eMAR) (b)(3) (e-prescribing) and (b)(4) (clinical information reconciliation)

57 45 CFR sect 170314(g)(4) 58 Certified Health IT Product List httponcchplforcecomehrcertq=chpl

safety of health IT beyond ONCrsquos existing CHPL ONC will consider using its current authorities to broaden the list

3 Support research and development of testing user tools and best practices related to health IT safety

Policies and incentives alone cannot ensure that health IT will be safe nor that it will be used to make care safer Achieving these objectives requires a concerted effort by all stakeholders to understand and address the potential risks of harm associated with health IT in every stage of its design development implementation and use Government can facilitate this process through strategies and actions to improve knowledge of health IT safety such as those described earlier in this Plan Just as important government can play a central role in synthesizing this knowledge and making it available to those who need it in a way that is easy to understand practically relevant and actionable

To this end HHS and its federal partners are currently supporting research and development of evidence-based tools and interventions designed for various stakeholder audiences including health IT developers implementers clinical staff and PSOs Several of these resources are already available and several others are currently under development (see Appendix B)

In 2013 ONC will begin packaging and disseminating a new class of health IT safety tools and interventions designed to improve the ability of health IT implementers and users to assess patient safety within their organizations and benefit from the latest applied knowledge of health IT safety As part of an ONC contract on Anticipating Unintended Consequences 59 health IT safety researchers are developing health IT safety guides Safety Assurance Factors for EHR Resilience (SAFER) Guides comprising self-assessment tools and checklists best practices and more The SAFER Guidesmdashwhich are being developed based on existing research expert opinion stakeholder engagement and field workmdashwill enable everyone who is responsible for safety in health systems and ambulatory settings to implement health IT safety programs in critical areas including bull High Priorities for Health IT Safety bull Organizational Activities and Responsibilities bull System Interfaces bull System Configuration bull Contingency Planning bull Patient Identification bull Order Entry with Decision Support bull Test Reporting and Follow-up bull Clinician Communications

The safety self-assessment recommended in the SAFER Guides while led by EHR users and clinicians often requires input from a team of people dedicated to health IT patient safety including EHR developers laboratory and pharmacy IT personnel and others Under an existing ONC contract the

59 Unintended Consequences of Health IT and HIE Task Order HHSP23337003THHSP23320095655WC

SAFER Guides will be used and evaluated in hospitals and ambulatory practices and in this way provide a foundation from which to develop additional evidence-based tools and interventions as knowledge of health IT safety continues to improve60 ONC will refine and make these resources available to health IT implementers and users so that they can improve the safety of care delivery and develop a culture of safety within their organizations

Health IT developers like their customers must also apply new knowledge of health IT safety to improve the overall safety and efficacy of health IT-assisted care Therefore ONC will coordinate with the National Institute for Standards and Technology (NIST) to develop design and testing tools that developers can use to integrate safety concepts and principlesmdashsuch as usability and quality managementmdashinto their software design and development processes With support from ONC NIST has already developed several tools for usability testing of certified EHR technology Building from this work ONCrsquos Strategic Health IT Advanced Research Projects-C (SHARP-C) Program is researching and conducting usability testing and vendor surveys to provide feedback to ONC on best practices in usability cognitive assistance and decision support ONC and NIST will use this feedback to develop additional tools and resources to enable health IT developers to meet ONCrsquos standards and certification criteria and to develop better and safer products

4 Incorporate health IT safety into education and training for health care professionals

ONC will strengthen health IT-related patient safety improvement efforts by working to integrate knowledge of health IT safety into the education and training of health IT professionals

Through the Workforce Development Program funded by the Recovery Act ONC awarded grants to universities and community colleges to develop health IT-based curricula and expand health IT education and training programs As of May 2013 over 18000 health IT professionals have completed training through these programs61 Most of these programs are self-sustaining and will continue after the Workforce Development Program ends in FY 2013 Similarly curriculum development functions will continue under the leadership of the American Health Information Management Association (AHIMA) ONC will work with these and other organizations to add a focus on health IT patient safety in existing education and training programs

To support these efforts ONC will repurpose cutting-edge knowledge and tools related to health IT safety (eg SAFER Guides) and make these available for use as educational or instructional materials ONC will also encourage the dissemination of these materials by accrediting bodies PSOs liability insurers educational organizations and professional associations and will work with these organizations to integrate health IT patient safety into their programs and practices and foster a culture of safety

60 ONC has awarded a contract Promoting Patient Safety Through Effective Health Information Technology Risk Management contract no HHSP23337003T to identify and evaluate both risk management implementation processes and specific interventions (such as SAFER Guides) and to make recommendations on risk management implementation processes and interventions related to health IT-related risks that contribute to a healthcare system that continually improves the safety and safe use of health IT ONC expects that this contract will be completed in March 2014

61 Health IT Dashboard httpdashboardhealthitgov

5 Investigate and take corrective action to address serious adverse events or hazards involving health IT

Reports of specific adverse events or patterns of serious events must trigger investigations and when appropriate corrective actions The IOM recommended establishing a new federal entity similar to the National Transportation Safety Board62 HHSrsquos approach builds on existing federal authorities as well as private sector safety programs

HHS will work with private sector organizations that have the ability to investigate take corrective actions and publicly report on their analysis of health IT-related events and hazards ONC has awarded a contract to The Joint Commission63 that will enable it to build upon its existing sentinel events program to better identify and address health IT-related events64 The Joint Commission will expand its capacity when appropriate to investigate the role of health IT as a cause of adverse events and will develop educational materials and training opportunities which will be widely available publicly to enable health care providers to better identify investigate and analyze health IT-related adverse events and develop follow-up and corrective action The Joint Commission will also make the results of its investigations available to ONC in summary format (excluding identifiable information and subject to privilege confidentiality and privacy protections) The Joint Commission will also create a de-identified database of sentinel events that will allow it to analyze and report on the role of health IT in such events

CMS will support efforts to investigate and take corrective action to address serious adverse events or hazards involving health IT As previously noted CMS has issued guidance clarifying the requirements for internal adverse event reporting and follow-up of patient safety events in health care organizations subject to the Medicare and Medicaid Conditions of Participation65 CMS is also working with ONC to develop training materials for state survey agencies and surveyors who conduct complaint investigation surveys on CMSrsquos behalf to enhance their ability to identify unsafe conditions associated with health IT When surveys identify deficient practices providers and suppliers must submit to CMS a plan of correction achieving compliance

HHS will continue to evaluate other mechanisms for investigating and taking corrective action to address serious adverse events or hazards involving health IT

62 The National Transportation Safety Board is an independent federal agency charged by Congress with investigating every civil aviation accident the United States

63 The Joint Commission evaluates and accredits more than 20000 health care organizations and programs in the United States An independent not-for-profit organization The Joint Commission is the nationrsquos oldest and largest standards-setting and accrediting body in health care To earn and maintain accreditation by The Joint Commission an organization must undergo an on-site survey by a Joint Commission survey team at least every three years

64 Investigation of Health IT-related Deaths Serious Injuries or Unsafe Conditions Contract No HHSP233201300019C

65 See supra Learn section 4 Align CMS patient safety standards and initiatives with the safety of health IT

Health IT Patient Safety Action amp Surveillance Plan 22

Promote a culture of safety related to health IT

Leadership is essential to building high reliability organizations with strong safety cultures This section describes how HHS will collaborate with the private sector to promote patient safety in a health IT-enabled care delivery system It also lists additional steps that HHS will take to improve federal coordination and integrate health IT patient safety into existing federal programs

1 Encourage private sector leadership and shared responsibility for health IT patient safety

Responsibility for health IT patient safety is shared by all stakeholders including developers and users of health IT and the private organizations that support them66 As the IOM committee explained these actors are part of a complex adaptive socio-technical framework in which health IT software hardware and services are integrated with people processes and ongoing programs67 For health IT to achieve its full potential to make care safer the private sector must work together to develop a culture of safety shared responsibility learning and continuous improvement

ONC will encourage health IT industry groups and trade associations such as the Electronic Health Record Association (EHRA) to educate their members on shared responsibility for patient safety and a culture of safety in a health IT-enabled learning health care system which includes a commitment to bull Engage clients in health IT-related safety efforts

66 IOM Report supra note 1 at 111 (ldquoBuilding health IT for safer use by health professionals is indeed a shared responsibility Vendors care providers provider organizations and their health IT departments and public and private agencies focused on quality of care are all partners in building a safer system in which health IT is usedrdquo)

67 IOM Report supra note 1 at 2 (ldquoHealth IT is not a single product it encompasses a technical system of computers and software that operates in the context of a larger sociotechnical systemmdasha collection of hardware and software working in concert within an organization that includes people processes and technologyrdquo)

bull Promote learning and improvement including by supporting the exchange of information about the safety of health IT products consistent with reasonable intellectual property protections68

bull Cooperate on investigations and follow-up to identify and mitigate health IT-related problems bull Facilitate adverse event reporting using the Common Formats bull Accept shared responsibility for system interface and configuration bull Support continuous availability of electronic records including through terminations and wind

downs and bull Embrace responsibility in areas where developers can control or minimize risks

On June 11 2013 the Electronic Health Records Association (EHRA) announced adoption of a voluntary industry code of conduct which among other important issues includes prominent attention to EHR developer responsibility for patient safety and for interoperability and data portability69 ONC supports this step and other private sector leadership that will promote a culture of safety shared learning and continuous improvement

Like developers users of health IT also have a responsibility for ensuring patient safety Health care providers in the years since 1999 when the IOM report To Err is Human70 galvanized efforts to improve patient safety have built patient safety programs and organizations including in professional associations and the PSOs and accreditation programs previously mentioned Now is the time to fully integrate health IT safety into those programs as both an infrastructure for improving the safety of care and to continuously improve the safety of health IT Providers should pay particular attention to implementation strategies and activities to support patient safety including actions to bull Establish a strong executive and clinical leadership commitment to patient safety as a major

priority bull Engage EHR developers in shared responsibility for the safety and safe use of health IT bull Address with EHR developers shared responsibility for the safety of system interfaces and

configuration bull Select systems that will connect data from clinical and other related health IT and that also

support clinical and administrative workflows bull Create and sustain an approach for managing clinical content and change requests bull Design mechanisms and metrics to promptly identify escalate and remediate health IT-related

patient safety issues and bull Provide user training and periodically assess user competence

68 ONC would also support private sector efforts that aim to make available information comparing user experience with different EHR systems such as efforts by private organizations that report on products and services in health care to develop ways of reporting and publicizing this information especially as it relates to patient safety

69 EHRA EHR Developer Code of Conduct available at httpwwwhimssehraorgASPcodeofconductasp (accessed June 12 2013) Previously in 2012 EHRA issued a Statement of Commitment to Patient Safety and a Learning Healthcare System See EHRA Statement of Commitment to Patient Safety and a Learning Healthcare System (2012) httpwwwhimssehraorgdocs20120221_EHRAPatientSafetyStatementofCommitmentpdf (accessed May 13 2013)

70 To Err is Human supra note 2

A well-informed marketplace for health IT software and services can drive innovations that continuously improve the safety of health IT Yet many EHR developer contracts contain nondisclosure clauses and other provisions that if not clarified could discourage or even prevent users from sharing certain kinds of information (eg screenshots) that may be relevant or even critical to understanding how their products impact patient safety71 To assist EHR users to better understand contractual terms that could impact patient safety ONC has contracted for development of a guide to key contractual terms in EHR developer contracts72 This guide will assist purchasers and users of EHRs to understand and evaluate contract terms they should consider when purchasing EHR systems and services in order to protect their organizations from patient safety risks that may arise when these organizations rely on EHRs for critical aspects of their operations

ONC will continue to evaluate whether private sector efforts to address health IT patient safety are sufficient for achieving the objectives of this Plan ONC will use all of the avenues of communication with stakeholders that are available to it to invite feedback on whether industry self-regulation including an industry code of conduct is effective for building confidence in the safety of health IT

2 Develop a strategy and recommendations for an appropriate risk-based regulatory framework for health IT

Congress enancted the Food and Drug Administration Safety and Innovation Act (FDASIA)73 on July 9 2012 Section 618 of FDASIA instructs the Secretary of HHS acting through the FDA Commissionermdash in collaboration with ONC and the Federal Communications Commission (FCC)mdashto issue a report by January 2014 on a proposed strategy and recommendations on an appropriate risk-based regulatory framework for health IT that promotes innovation protects patient safety and avoids regulatory duplication74

This report will be developed with significant public input FDA ONC and FCC have issued a request for comment seeking broad input from stakeholders on elements they should consider in developing the report75 The report will also be informed by input from the Health IT Policy Committee (which has formed a FDASIA Workgroup) and will incorporate what the agencies learn about risk safety and opportunity for innovative technologies to support improved health outcomes The agencies will consider how to make it easier for innovators to understand the regulatory landscape ways to minimize regulatory burdenmdashsuch as the complexity of navigating numerous agenciesmdashand how to design an oversight approach that supports innovations and patient safety

71 IOM Report at 126ndash127 72 This guide is being developed under the contract Unintended Consequences of Health IT and Health Information

Exchange Task Order HHSP23337003THHSP23320095655WC It should not be viewed as legal advice and does not attempt to address all of the many legal and other issues that may arise in contract negotiations Each healthcare organization presents its own unique circumstances

73 Pub L 112-144 126 Stat 993 74 Id 75 78 Fed Reg 32390

The Health IT Safety Plan is different from the forthcoming FDASIA report in that it lays out immediate and short-term actions HHS and industry stakeholders can take to improve health IT safety In contrast the FDASIA report will focus on responding to the statutory requirement for strategy and recommendations for a regulatory framework ONC expects this work will be complementary to but not a substitute or replacement for the actions included in this Plan

3 Encourage state governments to incorporate health IT into their patient safety oversight programs

State governments play a vital role in patient safety oversight In some cases federal and state patient safety programs are aligned such as the coordination of Medicare and Medicaid on health and safety standards required for participation in those programs States also license health care professionals and facilities In addition 26 states have mandatory adverse event reporting laws requiring in certain circumstances reporting of adverse events to the state

Many states that have enacted patient safety provisions requiring reporting of healthcare associated infections (HAIs) are struggling to implement these initiatives because of the burden associated with this type of reporting using paper-based systems ONC will work with state administrations to focus on using electronic health information exchange (HIE) to facilitate statutorily mandated reporting of HAIs By targeting state-based HAI reporting ONC will bull Support public health policy at the local and federal level with clinically relevant and measureable

targets bull Help individual states meet these relatively new patient safety statutes and bull Further demonstrate the utility of health IT and HIE to providers

Progress in this domain has already been made through the alignment of standards for many HAIs These standards developed across HHS departments have already resulted in the reporting of among others central line-associated blood stream infections (CLABSIs) and catheter-associated urinary tract infections (CAUTIs) Both of these conditions are the focus of national patient safety priority domains incorporated in the Partnership for Patients and the HHS National Action Plan to Prevent Healthcare-Associated Infections76 Currently providers can report patient safety measures for these infections conditions to both the CDC through the National Healthcare Safety Network (NHSN) and to CMS through the inpatient quality reporting program Expansion of these safety measures to include reporting to state-based programs is a practical next goal

76 HHS National Action Plan to Prevent Healthcare-Associated Infections Roadmap to Elimination httpwwwhhsgovashinitiativeshaiactionplan (accessed May 17 2013)

4 Integrate consumer eHealth and patient and family caregiver engagement as an integral part of health IT patient safety

Both federal and private sector quality initiatives call for patient-centered care that engages patients and their families Patient feedback can serve as a valuable ldquosecond pair of eyesrdquo to improve the accuracy and completeness of information in the EHR such as medication history However consumer eHealth is not automatically safer For instance as the IOM observed these new technologies may introduce opportunities for miscommunication and raise the need for ldquorules of engagementrdquo around the use of ldquopatient engagement toolsrdquo

HHS will foster methods with which providers can more effectively engage patients and family caregivers in using health IT especially consumer eHealth to make care safer ONC has already sponsored a report on the unintended consequences of consumer eHealth to better understand challenges to effective and safe use of consumer eHealth and ways to build better and safer consumer eHealth products and programs77 ONC will encourage private sector health care providers and health IT developers to adopt innovative consumer eHealth technologies and programs These technologies can lead to safer care by enabling patients and their family caregivers to participate in their care become more knowledgeable about conditions and treatments improve communication among health care providers and caregivers and facilitate shared decision making

ONC will also lead efforts to identify ways to continuously improve the safety of consumer eHealth ONC will encourage health IT developers to apply user-centered design and quality management system practices to enhance the safety of consumer eHealth technologies ONC will encourage health care providers who integrate consumer eHealth technologies into their systems to take steps to ensure their safety and safe use Consumer eHealth technology like other health IT must be designed implemented and used correctly78

5 Establish an ONC Safety Program to coordinate implementation of the Health IT Safety Plan

ONC has established the Health IT Patient Safety Program (ldquoSafety Programrdquo) led by ONCrsquos Chief Medical Officer in coordination with the Office of Policy and Planning to coordinate and implement this Plan (see figure in Appendix D) The functions of the ONC Safety Program are to bull Coordinate the implementation of the Health IT Safety Plan by

o Assisting all actors in fulfilling their responsibilities under the Plan and o Collaborating with actors to incorporate health IT and patient safety in their organizations

bull Comprehensively analyze data on the safety of health IT from multiple sources to o Identify trends in patient safety and health IT o Provide feedback to developers and providers o Inform policies and other efforts to improve health IT patient safety and

77 Building Better Consumer eHealth Summary Report of Consumer eHealth Unintended Consequences Work Group Activities httpwwwhealthitgovpolicy-researchers-implementersreports (accessed May 17 2013)

78 IOM Report supra note 1 at 122

o Develop policy recommendations and bull Eliminate or significantly reduce inefficiencies across the programs by

o Identifying any unnecessary overlap that occurs when implementing the Plan o Evaluating the outcomes and effectiveness of the Plan as it is implemented and o Determining from the outcomes what actions are beneficial unnecessary or insufficient

(and whether additional actions are required)

Although led and run by ONC the Safety Program will work with and gather input from federal partnersmdashincluding AHRQ CMS FDA and the Office for Civil Rights (OCR)79mdashto accomplish its objectives

To further support the implementation of this Plan ONC will establish an ad hoc HHS multi-agency committee by the end of 2013 The purpose of the ad hoc committee will be to prepare for and when necessary coordinate HHSrsquos response to serious or unforeseen health IT safety concerns or issues The ad hoc committee will comprise all HHS agencies with authority to respond to health IT patient safety issues including CMS FDA OCR and ONC The ad hoc committee will also include other federal partners that have an important stake in health IT patient safety such as AHRQ and the National Institutes of Health (NIH) as well as agencies that administer their own health IT systems such as the Department of Defense (DoD) and the Department of Veterans Affairs (VA)

Information on the ONC Safety Program and the implementation of this Plan will be available at httpwwwhealthitgovpolicy-researchers-implementershealth-it-and-patient-safety

79 OCR administers the HIPAA Security Rule which sets national standards for the confidentiality integrity and availability of electronic protected health information These are key components to addressing health IT patient safety OCR has also been delegated responsibility for enforcing the confidentiality provisions of the Patient Safety and Quality Improvement Act (PSQIA)

Summary

Health IT has enormous potential to improve patient safety In order for physicians and other clinicians to use health IT to make care safer they must be able to rely on these systems to perform safely in real clinical environments The foregoing strategies and action steps constitute HHSrsquos approach to achieving these aims which it has framed in terms of the two objectives (1) using health IT to make care safer and (2) continuously improving the safety of health IT

Learn Increase the quantity and quality of data and knowledge about health IT safety

HHS will continue to devote resources towards building an infrastructure that encourages and facilitates reporting collection and analysis of health IT-related events and hazards HHS will promote the use of the Common Formats to standardize and streamline reporting HHS will also support PSOs to use the Common Formats to identify aggregate and analyze health IT safety event and hazard reports to increase knowledge about health IT patient safety and ways through which it can be improved ONC will propose standards and certification criteria to ensure that where appropriate certified EHR technology can facilitate reporting of patient safety events and unsafe conditions using the Common Formats ONC will also incorporate health IT safety in post-market surveillance of certified EHR technology

Improve Target resources and corrective actions to improve health IT safety and patient safety

HHS will leverage the Meaningful Use and Health IT Certification Programs to align private sector efforts with national patient safety priorities HHS will also disseminate tools and interventions that will improve the ability of health IT implementers and users to assess patient safety within their organizations and enable health IT developers to incorporate the latest applied knowledge of health IT safety in their products The Joint Commission will expand its capacity to identify and investigate the role of health IT as a cause of adverse events and will develop educational materials and training opportunities which will be widely publicly available to enable health care providers to investigate and analyze health IT-related adverse events and develop follow-up and corrective action

Lead Promote a culture of safety related to health IT

For health IT to achieve its full potential to make care safer the private sector must work together to develop a culture of safety shared responsibility learning and continuous improvement HHS will coordinate with health IT developers users PSOs and other stakeholders to work together to advance patient safety through health IT HHS will promote business practices that support a well-informed health IT marketplace that can drive innovations that continuously improve the safety of health IT

Implementation of the Health IT Patient Safety Plan

Through the ONC Health IT Safety Program HHS will monitor progress across all actors towards this Planrsquos objectives HHS will continue to assess policies and other efforts to advance patient safety through health IT and to ensure that patients and providers have confidence in the safety of the health care system including its health IT infrastructure

Appendix A Crosswalk of Health IT Patient Safety Plan amp IOMrsquos 2011 Recommendations from Health IT and Patient Safety Building Safer Systems for Better Care

IOM Recommendation Actions

Recommendation 1

The Secretary of Health and Human Services (HHS) should publish an action and surveillance plan within 12 months that includes a schedule for working with the private sector to assess the impact of health IT on patient safety and minimizing the risk of its implementation and use The plan should specify

This Health IT Patient Safety Plan is the action and surveillance plan prescribed in Recommendation 1 ONC will coordinate the various actors among the public and private sectors to improve the safety of health IT and use health IT to improve patient safety

Recommendation 1a

The Agency for Healthcare Research and Quality (AHRQ) and the National Library of Medicine (NLM) should expand their funding of research training and education of safe practices as appropriate including measures specifically related to the design implementation usability and safe use of health IT by all users including patients

ONC AHRQ and NLM are disseminating and piloting interventions and tools aimed at improving health IT safety and evaluating the effectiveness of those tools in hospitals and provider practices (eg Hazard Manager Promoting Patient Safety through Effective Health IT Risk Management SAFER Guides) AHRQ already has a significant portfolio of useful tools and reports for addressing the potential safety issues that arise when implementing and using EHRs including the following

bull Hazard Manager is a software tool that will alert users to potential health IT-related patient safety events It evaluates near misses and unsafe conditions which allows users to avoid patient harm before it occurs Although not yet available the Hazard Manager will support a wide variety of health industry professionals by helping them discover identify and communicate hazards

bull Promoting Patient Safety through Effective Health IT Risk Management

bull SAFER Guides

Recommendation 1a continued

bull Workflow Assessment for Health IT toolkit available at wwwhealthitahrqgovworkflow is designed to help small and medium-sized outpatient practices better assess their workflows and determine when and how health IT may be used This comprehensive compendium of information describing workflow in the context of health IT includes

o information on how to analyze workflow o tools to analyze workflow o examples of workflow analysis and redesign o othersrsquo experiences with health IT and workflow and o research on health IT and workflow

bull Guide to Reducing Unintended Consequences of Electronic Health Recordsndashan online resource posted on healthITgov that helps organizations and their consultants anticipate avoid and troubleshoot problems and challenges that can emerge when implementing and using an electronic health record (EHR)

bull Implementation Toolsets for E-PrescribingndashThese two toolsets one for physicians in small practices and one for independent pharmacies for supporting e-prescribing implementation are designed to offer a step-by-step guide preparing for and launching an e-prescribing system They include advice on topics ranging from planning the implementation process launching the system troubleshooting common problems and navigating into more advanced practice and pharmacy services Both toolsets and supporting tools are available at httphealthitahrqgoveprescribingtoolsets

ONC will coordinate with liability insurers educational organizations and professional associations to foster a culture of safety and the dissemination of best-in-class tools and strategies to effectively reduce health IT related adverse events and to use health IT to make care safer As part of an ONC contract on Anticipating Unintended Consequences1

health IT safety researchers are developing health IT safety guides Safety Assurance Factors for EHR Resilience (SAFER) Guides

1 Unintended Consequences of Health IT and Health Information Exchange Task Order HHSP23337003THHSP23320095655WC

Recommendation 1b

The Office of the National Coordinator for Health Information Technology should expand its funding of processes that promote safety that should be followed in the development of health IT products including standardized testing procedures to be used by manufacturers and health care organizations to assess the safety of health IT products

The National Institute for Standards and Technology (NIST) with support from ONC has developed tools for usability testing of certified EHR technology NIST and ONC will continue to build upon this work and ONC will use it to strengthen safety-enhanced certification criteria

The Strategic Health IT Advanced Research ProjectsndashC (SHARP-C) Program is developing usability testing tools using NIST protocols

Recommendation 1c

The ONC and AHRQ should work with health IT vendors and health care organizations to promote post deployment safety testing of EHRs for high-prevalence high-impact EHR-related patient safety risks

ONC will collaborate with the ONC-Approved Accreditor on surveillance and provide guidance to ONC-ACBs for the surveillance of EHR technology capabilities that pose the greatest potential for patient harm and greatest opportunity to improve patient safety in future regulatory cycles

Recommendation 1d

Health care accrediting organizations should adopt criteria relating to EHR safety

ONC will work with CMS to align the health and safety standards with the Health IT Safety Plan and train surveyors to improve their ability to identify safe and unsafe practices related to health IT

ONCrsquos regulations establish standards and certification criteria for certified EHR technology and ONC intends to use certification criteria to ensure that where appropriate EHR technology is used to report safety events

Recommendation 1e

AHRQ should fund the development of new methods for measuring the impact of health IT on safety using data from EHRs

AHRQ has developed ldquoCommon Formatsrdquo which would standardize the reporting of adverse events These Formats make it possible to aggregate and compare adverse events across healthcare providers and federal and state programs

The most recent version of the Formats includes a ldquoDevice with Health ITrdquo format that allows collection of standardized information about IT-related adverse events as well as all events where health IT may be a contributing factor

AHRQ is currently building the Quality amp Safety Review System (QSRS) that incorporates the AHRQ Common Formats to broaden the surveillance of harm from all causes This system will provide national estimates of adverse events and can explore the role of health IT in these events

Recommendation 2

The Secretary of HHS should ensure insofar as possible that health IT developers support the free exchange of information about health IT experiences and issues and not prohibit sharing of such information including details (eg screenshots) relating to patient safety

On June 11 2013 the Electronic Health Records Association (EHRA) announced adoption of voluntary industry code of conduct which among other important issues includes prominent attention to EHR developer responsibility for patient safety and for interoperability and data portability ONC supports this step and other private sector leadership that will promote a culture of safety shared learning and continuous improvement

As part of the ONC HIT Certification Program ONC established the Certified HIT Product List (CHPL) The CHPL provides a comprehensive list of Complete EHRs and EHR Modules that have been certified by ONC-ACBs This list is a publicly available database of health IT products that are certified in accordance with the certification criteria adopted by the Secretary and the ONC HIT Certification Program Currently each EHR product listed in the database notes the presenceabsence of safety features such as drug-drug interaction or drug- allergy checking The 2014 Edition EHR certification criteria also require developers to incorporate user-centered design and indicate their approach to quality management and these details will be included in EHR technology test reports If there is a need for further registration and listing to promote transparency related to the safety of health IT beyond ONCrsquos existing CHPL ONC will consider using its current authorities to broaden the list

ONC-ACBs are required to submit a hyperlink of the test results used to issue a certification to an EHR technology Test results hyperlinks are publicly accessible via the CHPL

Recommendation 3

The ONC should work with the private and public sectors to make comparative user experiences across vendors publicly available

ONC will support and collaborate with the private sector to publish information on comparative user experiences

The Plan encourages AHRQ and Patient Safety Organizations (PSOs) to increase data collection and analysis of health IT safety events and hazards PSOs will work with providers to report adverse events involving health IT using the AHRQ Common Formats and to report those events to the Network of Patient Safety Databases (NPSD)

The Plan also calls for EHR developers to facilitate and encourage adverse event reporting using the AHRQ Common Formats and allow for the reporting of comparative user experiences related to the safety and reliability of health IT

Recommendation 4

The Secretary of HHS should fund a new Health IT Safety Council to evaluate criteria for assessing and monitoring the safe use of health IT and the use of health IT to enhance safety This council should operate within an existing voluntary consensus standards organization

The Plan does not call for the creation of a Council but ONC plans to establish an ONC Safety Program to coordinate and implement this Plan The function of this program is to bull Coordinate the implementation of the Health IT Safety Plan by

o Assisting all actors in fulfilling their responsibilities under the Plan and

o Collaborating with actors to incorporate health IT and patient safety in their organizations

bull Comprehensively analyze data on the safety of health IT from multiple sources to o Identify trends in patient safety and health IT o Provide feedback to developers and providers o Inform policies and other efforts to improve health IT patient

safety and o Develop policy recommendations and

bull Eliminate or significantly reduce inefficiencies across the programs by o Identifying any unnecessary overlap that occurs when

implementing the Plan o Evaluating the outcomes and effectiveness of the Plan as it is

implemented and o Determining from the outcomes what actions are beneficial

unnecessary or insufficient (and whether additional actions are required)

The ONC Safety Program will develop policies and procedures to establish an ad hoc HHS multi-agency committee that would address major or systemic health IT patient safety issues through the coordination of policies and programs based on existing authorities

Recommendation 5

All health IT developers should be required to publicly register and list their products with the ONC initially beginning with EHRs certified for the meaningful use program

Registering and listing EHR developer products certified for Meaningful Use is already being performed by ONC via the CHPL The Health IT Safety Plan also highlights additional health IT-related safety criteria for adoption by the Secretary and inclusion in the ONC HIT Certification Program

Recommendation 6

The Secretary of HHS should specify the quality and risk management process requirements that health IT developers must adopt with a particular focus on human factors safety culture and usability

As part of the 2014 Edition Standards and Certification Criteria final rule ONC adopted two safety-enhanced certification criteria This regulation included requirements for the application of user-centered design and quality management systems

ONC will support health IT safety interventions in hospitals and physician practices to evaluate risk management implementation processes and interventions related to the safety of health IT

ONC will support research of approaches that would inform the processes necessary to mitigate risks and improve the quality and accuracy of patient matching

Recommendation 7

The Secretary of HHS should establish a mechanism for both developers and users to report health IT-related deaths seriousinjuries or unsafe conditions

HHS will work to expand reporting in general by promoting the adoption of technology that makes it easier to do reporting by building on the Common Formats and by promoting use of PSOs HHS will develop education and training materials on how to identify and report health IT-related events for use by EHR users and EHR developers

CMS will support efforts to report adverse events or hazards involving health IT using the Common Formats CMS has issued guidance clarifying the requirements for internal adverse event reporting and follow-up of patient safety events in health care organizations subject to the Medicare and Medicaid Conditions of Participation

Recommendation 7a

Reporting of health IT-related adverse events should be mandatory for developers

ONC supports the EHRA Code of Conduct which promotes reporting by EHR developers to PSOs and close collaboration with their customers

ONC-ACBs will conduct surveillance to ensure that the capabilities of certified EHR technology work in operational settings to the same extent as when these capabilities were certified ONC will issue guidance to ONC-ACBs to add a specific focus on safety-related capabilities to their surveillance activities This guidance will also prioritize the surveillance of EHR developersrsquo processes for receiving and responding to user complaints concerning developersrsquo products ONC will also work with the ONC-Approved Accreditor (ANSI) to provide direction to ONC-ACBs on the complaint records that developers of certified EHR technology are required to keep and make available to them under the ONC HIT Certification Program

ONC will monitor health IT adverse event reports using the FDArsquos Manufacturer and User Facility Device Experience (MAUDE) database

Recommendation 7b

Reporting of health IT-related adverse events by users should be voluntary confidential and nonpunitive

AHRQ will encourage PSOs to help providers incorporate AHRQ Common Formats when reporting health IT-related patient safety events to the Network of Patient Safety Databases (NPSD)

AHRQ is already developing the Quality amp Safety Review System (QSRS) to facilitate retrospective surveillance of harm from all causes including health IT safety events AHRQ will also investigate development of a health IT profile for hospitals with QSRS that can detect differences in adverse event rates at hospitals correlated with their level of health IT implementation

AHRQ will also issue guidance on how to more effectively involve health IT expertise including from EHR developers in reporting to PSOs and in analysis and correction of problems

Recommendation 7c

Efforts to encourage reporting should be developed such as removing the perceptual cultural contractual legal and logistical barriers to reporting

The Plan calls for AHRQ to encourage PSOs to help providers use AHRQ Common Formats when reporting patient safety events The most recent version of the Formats includes a ldquoDevice with Health ITrdquo format that allows collection of standardized information about IT-related adverse events as well as all events where health IT may be a contributing factor

To help inform ONCrsquos work with standards and certification criteria related to patient safety AHRQ plans to test extraction of data elements identical and related to AHRQrsquos Common Formats from multiple established EHR implementations and exportation of this data to hospital incident reporting systems

ONC recently funded a challenge to address the need for development of tools and interfaces that decrease reporting burden and improve workflow efficiency that surround adverse event reporting to hospital incident reporting systems and PSOs

ONCrsquos regulations establish standards and certification criteria for certified EHR technology and ONC intends to propose using certification criteria to ensure that where appropriate EHR technology is used to report safety events in AHRQrsquos Common Formats ONC has established a Structured Data Capture Standards and Interoperability Framework initiative that will pilot this technology and standards (httpwikisiframeworkorgStructured+Data+Capture+Initiative)

ONC believes EHR contracts should promote reporting and should not include terms that would discourage reporting ONC has contracted for a guide to key EHR contract terms that will help EHR purchasers understand and evaluate such terms in EHR developer contracts

Recommendation 8

The Secretary of HHS should recommend that Congress establish an independent federal entity for investigating patient safety deaths serious injuries or potentially unsafe conditions associated with health IT This entity should also monitor and analyze data and publicly report results of these activities

Currently the Health IT Safety Plan does not include the establishment of an independent federal entity However the plan incorporates many of the functions described in IOMrsquos recommendation 8 into existing patient safety efforts across government programs and the private sectormdashincluding health care providers technology companies and health care safety oversight bodies

HHS will work with private sector organizations that have the ability to investigate take corrective actions and publicly report on their analysis of health IT-related events and hazards Under a contract with ONC The Joint Commission will expand its capacity to identify and investigate the role of health IT as a cause of adverse events and will develop educational materials and training opportunities which will be widely publicly available to enable health care providers to investigate and analyze health IT-related adverse events and develop follow-up and corrective action

CMS will support efforts to investigate and take corrective action to address serious adverse events or hazards involving health IT CMS has issued guidance clarifying the requirements for internal adverse event reporting and follow-up of patient safety events in health care organizations subject to the Medicare and Medicaid Conditions of Participation CMS is also working with ONC to develop training materials for state survey agencies and surveyors who conduct complaint investigation surveys on CMSrsquos behalf to enhance their ability to identify unsafe conditions associated with health IT When surveys identify deficient practices providers and suppliers must submit to CMS a plan of correction achieving compliance

Recommendation 9a

The Secretary of HHS should monitor and publicly report on the progress of health IT safety annually beginning in 2012 If progress toward safety and reliability is not sufficient as determined by the Secretary the Secretary should direct FDA to exercise all available authorities to regulate EHRs health information exchanges and PHRs

This Health IT Patient Safety Plan serves as the HHS report on the progress of health IT safety for 2012

Recommendation 9b

The Secretary should immediately direct FDA to begin developing the necessary framework for regulation Such a framework should be in place if and when the Secretary decides the state of health IT safety requires FDA regulation as stipulated in Recommendation 9a above

In fulfilling FDASIA requirements the Secretary acting through the FDA Commissioner and in collaboration with ONC and the FCC will issue a report proposing a strategy and recommendations for an appropriate risk-based regulatory framework for health IT that promotes innovation protects patient safety and avoids regulatory duplication This report will be developed with significant public input FDA ONC and FCC have issued a request for comment seeking broad input from stakeholders on elements they should consider in developing the report The report will also be informed by input from the Health IT Policy Committee (which has formed a FDASIA Workgroup) and will incorporate what the agencies learn about risk safety and opportunity for innovative technologies to support improved health outcomes The agencies will consider how to make it easier for innovators to understand the regulatory landscape ways to minimize regulatory burdenmdashsuch as the complexity of navigating numerous agenciesmdashand how to design an oversight approach that supports innovations and patient safety

Recommendation 10

HHS in collaboration with other research groups should support cross-disciplinary research toward the use of health IT as part of a learning health care system Products of this research should be used to inform the design testing and use of health IT Specific areas of research include

a User-centered design and human factors applied to health IT

b Safe implementation and use of health IT by all users

c Socio-technical systems associated with health IT and

d Impact of policy decisions on health IT use in clinical practice

ONC AHRQ and NLM are each supporting development and piloting of different interventions and tools aimed at improving health IT safety and evaluating the effectiveness of those tools in hospitals and provider practices (eg Hazard Manager Promoting Patient Safety through Effective Health IT Risk Management SAFER Guides Workflow Assessment for Health IT Toolkit Guide to Reducing Unintended Consequences of Electronic Health Records Implementation Toolsets for E-Prescribing see also Appendix B) AHRQ already has a portfolio of useful tools and reports for addressing the potential safety issues that arise when implementing and using EHRs

Appendix B Research and Development of Tools Measures and Policies

Date ResearchDevelopment Projects

2011 IOM study (92010-112011)

bull IOM was commissioned by ONC and published the report ldquoHealth IT and Patient Safety Building Safer Systems for Better Carerdquo

2012 Patient Safety Reporting Challenge Award

bull ONC funded a Purple Challenge Award to encourage development of tools and interfaces that decrease reporting burden

bull The first winner of this challenge was KBCoreSM of Houston

Usability Development

bull NIST developed tools for usability testing of certified EHR technology bull Usability Workshop

Hazard Manager

bull AHRQ has developed the Hazard Manager1 a software tool for proactive identification and remediation of health IT-related hazards Hazard Manager can alert users to potential health IT-related hazards and can be used by health care organizations health IT developers PSOs researchers and policy-makers to characterize and communicate information about hazards and their potential causes and adverse effects

Workflow Assessment for Health IT Toolkit

bull AHRQ has developed the Workflow Assessment for Health IT Toolkit2 which helps small and medium-sized outpatient practices better assess their workflows and determine when and how health IT may be used

Guide to Reducing Unintended Consequences of Electronic Health Records

bull AHRQ has developed the Guide to Reducing Unintended Consequences of Electronic Health Records3 which helps health care organizations anticipate avoid and troubleshoot problems that can occur when implementing and using EHRs

Implementation Toolsets for E-Prescribing

bull AHRQ has developed the Implementation Toolsets for E-Prescribing4 a guide for preparing for and launching an e-prescribing system

1 Available at httphealthitahrqgovHealthITHazardManagerFinalReport (accessed May 17 2013) 2 Available at httphealthitahrqgovworkflow (accessed May 17 2013) 3 Available at httpwwwhealthitgovunintended-consequences (accessed May 17 2013) 4 Available at httphealthitahrqgovportalserverptcommunityhealth_it_tools_and_resources919

implementation_toolsets_for_e-prescribing30593 (accessed May 17 2013)

2012 continued

Designing Consumer Health IT A Guide for Developers and Systems Designers

bull AHRQrsquos Health IT Portfolio has published Designing Consumer Health IT A Guide for Developers and Systems Designers5 which presents suggested recommendations for designers and developers of consumer health IT products to incorporate safe design

20136 Professional Forums

bull Workgroups or common interest groups have been or are being established at professional forums such as HIMSS AMIA AMA and other medical professional associations

SAFER Guides

bull ONC has contracted to develop health IT safety guides such as SAFER Guides

bull SHARP- C is developing usability testing tools using NIST protocols bull ONC and NIST will continue to build upon this work and ONC will use it to strengthen

safety-enhanced certification criteria Promoting Patient Safety Through Effective Health IT Risk Management Contract

bull ONC has contracted 7 to identify and evaluate both risk management implementation processes and specific interventions (such as SAFER Guides) and to make recommendations on risk management implementation processes and interventions related to health IT-related risks that contribute to a healthcare system that continually improves the safety and safe use of health IT ONC expects that this contract will be completed in March 2014

Providerrsquos Guide to Key Terms in EHR Developer Contracts bull To assist EHR users to better understand key contractual terms that could impact patient

safety ONC has contracted for development of a guide to key terms in EHR developer contracts8 This guide will assist purchasers and users of EHRs to understand and evaluate contract terms they should consider when purchasing EHR systems and services in order to protect their organizations from patient safety risks that may arise when these organizations rely on EHRs for critical aspects of their operations

Investigation of Health IT-related Deaths Serious Injuries or Unsafe Conditions (The Joint Commission) bull Under a contract with ONC the Joint Commission will build upon existing programs to

better identify understand and investigate health IT-related deaths serious injuries and potentially unsafe conditions (sentinel events) in the private sector It will develop and make widely publicly available educational materials and training opportunities to enable health care providers to investigate and analyze health IT-related adverse events and develop follow-up and corrective action

5 Available at httphealthitahrqgovhealth-it-tools-and-resourcesdesigning-consumer-health-it-guide-developers-and-systems-designers (accessed May 17 2013)

6 2013 action items reflect planned activities 7 Promoting Patient Safety Through Effective Health IT Risk Management Task Order HHSP23337026T 8 This guide is being developed under the contract Unintended Consequences of Health IT and Health Information

20149 Report on appropriate risk-based regulatory framework for health IT

The Secretary acting through the FDA Commissioner and in collaboration with ONC and the FCC will issue a report on strategy and recommendations for an appropriate risk-based regulatory framework for health IT that promotes innovation protects patient safety and avoids regulatory duplication

9 2014 action items reflect planned activities

Appendix C Timeline of the Health IT Patient Safety Action and Surveillance Plan

Date ActionsPrograms

2010 Meaningful Use (Stage 1) and 2011 Edition Standards amp Certification Criteria

bull Stage 1 of the CMS Medicare and Medicaid EHR Incentive Programs (Meaningful Use Programs) requires use of features that can improve patient safety such as o CPOE o CDS and o Maintaining lists of patient medications allergies and problems

2011 Certified Health IT Product List (CHPL) bull Established by ONC the CHPL1 provides a comprehensive list of Complete EHRs and EHR

Modules that have been certified by ONC-ACBs

bull Stage 2 of Meaningful Use specifies two safety-enhanced certification criteria requiring developers to o Publicly identify a method of ensuring user-centered design and o Publicly identify an approach to quality management

bull ONC and CMS will continue to use rulemakings to enhance patient safety bull ONC intends to use certification criteria to ensure that EHR technology can be used to easily

initiate health IT-related adverse event reports using AHRQrsquos Common Formats bull HIT Policy Committee will continue to review patient safety-related comments to inform their

recommendations for future MU recommendations 20132

2013 Q1 Manufacturer and User Facility Device Experience (MAUDE) Database

bull ONC will monitor the MAUDE database for health IT-related adverse event reports

1 Certified Health IT Product List httponcchplforcecomehrcertq=chpl 2 2013 action items reflect planned activities

2013 Q1

2013 Q2

2013 Q1 Align CMS standards and initiatives with the safety of health IT conrsquot

bull CMS will consider options for realignment of its health and safety standards with efforts to increase reporting of health IT-related adverse events and hazards using the Common Formats

bull CMS and ONC will develop training for surveyors that enhances their ability to identify safe and unsafe practices associated with health IT

bull ONC will work with CMS state surveyors and accreditation organizations with CMS-approved programs so that these entities can recognize and investigate health IT-related adverse events

bull CMS can require corrective actions of health IT-related patient safety issues

Medicare Patient Safety Monitoring System (MPSMS)

bull To compare the differences in quality and safety MPSMS abstractors will identify which patient records in the sample are from EHRs paper records and mixed records

2013 Q2 Encourage private sector leadership and shared responsibility for health IT patient safety

bull EHRA has adopted a voluntary industry code of conduct to encourage an increased level of industry self-regulation ONC will continue to support private sector leadership that will promote a culture of safety shared learning and continuous improvement

bull ONC is developing a guide to several important terms commonly included in EHR developer contracts 3 This guide will assist providers to understand common EHR developer contract terms and their implications for providersrsquo patient safety programs It will explain what information users and purchasers should consider when purchasing EHR systems and services in order to protect their organizations from patient safety risks that may arise when these organizations rely on EHRs for critical aspects of their operations

Encourage medical education and training in health IT and patient safety

bull ONC will work with the following types of organizations to foster a culture of safety and the dissemination of tools (eg SAFER Guides) and strategies o Accrediting bodies o Patient safety organizations o Liability insurers o Educational organizations and o Professional associations

3 This guide is being developed under the contract Unintended Consequences of Health IT and Health Information Exchange Task Order HHSP23337003THHSP23320095655WC It should not be viewed as legal advice and does not attempt to address all of the many legal and other issues that may arise in contract negotiations Each healthcare organization presents its own unique circumstances

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

Establish the ONC Safety Program

bull Through the Safety Program ONC will o Coordinate the implementation of the Health IT Safety Plan o Comprehensively analyze data from the data streams and o Ensure that there are no redundancies or inefficiencies across the programs

Enable The Joint Commission to investigate health-IT related deaths serious injuries and potentially unsafe conditions

bull The Joint Commission will investigate health IT-related deaths serious injuries and potentially unsafe conditions in the private sector and provide public safety information based on such investigations The Joint Commission will expand its capacity to investigate the role of health IT as a cause of adverse events and will develop educational materials and training opportunities to enable health care providers to investigate and analyze health IT-related adverse events and develop follow-up and corrective action

Issue ONC-ACB surveillance guidance

bull ONC will incorporate health IT and patient safety into ONC-ACB surveillance and certification of EHRs

bull ONC will provide guidance to ONC-ACBs regarding specific elements of surveillance including o Focusing on certain safety capabilities included in the 2014 Edition EHR certification

criteria and o Reviewing complaints received by EHR technology developers on their certified Complete

EHRs or EHR Modules related to certain safety capabilities

Establish an ad hoc HHS multi-agency committee

bull ONC will establish an ad hoc HHS multi-agency committee to prepare for and when necessary coordinate HHSrsquos response to serious or unforeseen health IT safety concerns or issues

Support PSOs to collect aggregate and analyze safety event and hazard reports

bull AHRQ will issue guidance on how to more effectively involve health IT expertise including from EHR developers in reporting to PSOs and in analysis and correction of problems

bull PSOs supported by AHRQ will incorporate health IT and patient safety when o Facilitating reporting of patient safety events o Investigating patient safety events o Working with providers to mitigate patient safety hazards and o Aggregating and analyzing reports to identify trends in health IT-related patient safety

events

2014 Q1

2014 Q2

2014 Q3

Meaningful Use (Stage 2) and 2014 Edition Standards amp Certification Criteria

bull Stage 2 of Meaningful Use will take effect beginning in 2014 (federal fiscal year 2014 for eligible hospitals and CAHs calendar year 2014 for eligible professionals)

bull Stage 2 specifies two safety-enhanced certification criteria requiring developers to o Publicly identify a method of ensuring user-centered design and o Publicly identify an approach to quality management

bull The HIT Policy Committee will continue to review patient safety-related comments to inform their recommendations for future stages of MU

bull ONC and CMS will continue to use rulemaking to enhance patient safety bull ONC intends to use certification criteria to ensure that EHR technology can be used to easily

initiate health IT-related adverse event reports using AHRQrsquos Common Formats

Incorporation of health IT and patient safety reporting by state governments

bull CMS will work with states to look for health IT-related safety issues when conducting Surveys on CMSrsquos behalf

bull ONC will encourage states to consider health IT when collecting aggregating and analyzing patient safety data produced by statesrsquo existing reporting requirements

Report on appropriate risk-based regulatory framework for health IT

bull HHS will submit to Congress a proposed strategy and recommendations on an appropriate risk-based regulatory framework for health IT that promotes innovation protects patient safety and avoids regulatory duplication

Develop safety priority areas measures and targets

bull ONC will lead a public-private process to identify health IT safety priority areas within the larger context of general patient safety and create related measures and targets for reduction of health IT-related adverse events

AHRQrsquos QSRS

bull To increase surveillance AHRQ will develop the Quality amp Safety Review System (QSRS) that incorporates AHRQrsquos Common Formats (in development during 2013)

Appendix D ONC Patient Safety Program

Health Information TechnologyPatient Safety Action amp Surveillance Plan

Table of Contents

Introduction




















Summary





















IMPROVE -- Target resources and corrective actions to improve health IT safety and patient safety






LEAD -- Promote a culture of safety related to health IT


2 Develop a strategy and recommendations for an appropriate risk-based regulatoryframework for health IT




Summary

Appendix A Crosswalk of Health IT Patient Safety Plan amp IOMrsquos 2011 Recommendations


Appendix C Timeline of the Health IT Patient Safety Action andSurveillance Plan

ltlt13 ASCII85EncodePages false13 AllowTransparency false13 AutoPositionEPSFiles true13 AutoRotatePages All13 Binding Left13 CalGrayProfile (Dot Gain 20)13 CalRGBProfile (sRGB IEC61966-21)13 CalCMYKProfile (US Web Coated 050SWOP051 v2)13 sRGBProfile (sRGB IEC61966-21)13 CannotEmbedFontPolicy Warning13 CompatibilityLevel 1413 CompressObjects Tags13 CompressPages true13 ConvertImagesToIndexed true13 PassThroughJPEGImages true13 CreateJobTicket false13 DefaultRenderingIntent Default13 DetectBlends true13 DetectCurves 0000013 ColorConversionStrategy LeaveColorUnchanged13 DoThumbnails false13 EmbedAllFonts true13 EmbedOpenType false13 ParseICCProfilesInComments true13 EmbedJobOptions true13 DSCReportingLevel 013 EmitDSCWarnings false13 EndPage -113 ImageMemory 104857613 LockDistillerParams false13 MaxSubsetPct 10013 Optimize true13 OPM 113 ParseDSCComments true13 ParseDSCCommentsForDocInfo true13 PreserveCopyPage true13 PreserveDICMYKValues true13 PreserveEPSInfo true13 PreserveFlatness false13 PreserveHalftoneInfo false13 PreserveOPIComments false13 PreserveOverprintSettings true13 StartPage 113 SubsetFonts true13 TransferFunctionInfo Apply13 UCRandBGInfo Preserve13 UsePrologue false13 ColorSettingsFile ()13 AlwaysEmbed [ true13 ]13 NeverEmbed [ true13 ]13 AntiAliasColorImages false13 CropColorImages false13 ColorImageMinResolution 30013 ColorImageMinResolutionPolicy OK13 DownsampleColorImages true13 ColorImageDownsampleType Bicubic13 ColorImageResolution 30013 ColorImageDepth -113 ColorImageMinDownsampleDepth 113 ColorImageDownsampleThreshold 15000013 EncodeColorImages true13 ColorImageFilter DCTEncode13 AutoFilterColorImages true13 ColorImageAutoFilterStrategy JPEG13 ColorACSImageDict ltlt13 QFactor 01513 HSamples [1 1 1 1] VSamples [1 1 1 1]13 gtgt13 ColorImageDict ltlt13 QFactor 01513 HSamples [1 1 1 1] VSamples [1 1 1 1]13 gtgt13 JPEG2000ColorACSImageDict ltlt13 TileWidth 25613 TileHeight 25613 Quality 3013 gtgt13 JPEG2000ColorImageDict ltlt13 TileWidth 25613 TileHeight 25613 Quality 3013 gtgt13 AntiAliasGrayImages false13 CropGrayImages false13 GrayImageMinResolution 30013 GrayImageMinResolutionPolicy OK13 DownsampleGrayImages true13 GrayImageDownsampleType Bicubic13 GrayImageResolution 30013 GrayImageDepth -113 GrayImageMinDownsampleDepth 213 GrayImageDownsampleThreshold 15000013 EncodeGrayImages true13 GrayImageFilter DCTEncode13 AutoFilterGrayImages true13 GrayImageAutoFilterStrategy JPEG13 GrayACSImageDict ltlt13 QFactor 01513 HSamples [1 1 1 1] VSamples [1 1 1 1]13 gtgt13 GrayImageDict ltlt13 QFactor 01513 HSamples [1 1 1 1] VSamples [1 1 1 1]13 gtgt13 JPEG2000GrayACSImageDict ltlt13 TileWidth 25613 TileHeight 25613 Quality 3013 gtgt13 JPEG2000GrayImageDict ltlt13 TileWidth 25613 TileHeight 25613 Quality 3013 gtgt13 AntiAliasMonoImages false13 CropMonoImages false13 MonoImageMinResolution 120013 MonoImageMinResolutionPolicy OK13 DownsampleMonoImages true13 MonoImageDownsampleType Bicubic13 MonoImageResolution 120013 MonoImageDepth -113 MonoImageDownsampleThreshold 15000013 EncodeMonoImages true13 MonoImageFilter CCITTFaxEncode13 MonoImageDict ltlt13 K -113 gtgt13 AllowPSXObjects true13 CheckCompliance [13 None13 ]13 PDFX1aCheck false13 PDFX3Check false13 PDFXCompliantPDFOnly false13 PDFXNoTrimBoxError true13 PDFXTrimBoxToMediaBoxOffset [13 00000013 00000013 00000013 00000013 ]13 PDFXSetBleedBoxToMediaBox true13 PDFXBleedBoxToTrimBoxOffset [13 00000013 00000013 00000013 00000013 ]13 PDFXOutputIntentProfile ()13 PDFXOutputConditionIdentifier ()13 PDFXOutputCondition ()13 PDFXRegistryName ()13 PDFXTrapped False1313 CreateJDFFile false13 Description ltlt13 ARA 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 BGR ltFEFF04180437043f043e043b043704320430043904420435002004420435043704380020043d0430044104420440043e0439043a0438002c00200437043000200434043000200441044a0437043404300432043004420435002000410064006f00620065002000500044004600200434043e043a0443043c0435043d044204380020043704300020043a0430044704350441044204320435043d0020043f04350447043004420020043d04300020043d043004410442043e043b043d04380020043f04400438043d04420435044004380020043800200443044104420440043e043904410442043204300020043704300020043f04350447043004420020043d04300020043f0440043e0431043d04380020044004300437043f0435044704300442043a0438002e002000200421044a04370434043004340435043d043804420435002000500044004600200434043e043a0443043c0435043d044204380020043c043e0433043004420020043404300020044104350020043e0442043204300440044f0442002004410020004100630072006f00620061007400200438002000410064006f00620065002000520065006100640065007200200035002e00300020043800200441043b0435043404320430044904380020043204350440044104380438002egt13 CHS ltFEFF4f7f75288fd94e9b8bbe5b9a521b5efa7684002000500044004600206587686353ef901a8fc7684c976262535370673a548c002000700072006f006f00660065007200208fdb884c9ad88d2891cf62535370300260a853ef4ee54f7f75280020004100630072006f0062006100740020548c002000410064006f00620065002000520065006100640065007200200035002e003000204ee553ca66f49ad87248672c676562535f00521b5efa768400200050004400460020658768633002gt13 CHT ltFEFF4f7f752890194e9b8a2d7f6e5efa7acb7684002000410064006f006200650020005000440046002065874ef653ef5728684c9762537088686a5f548c002000700072006f006f00660065007200204e0a73725f979ad854c18cea7684521753706548679c300260a853ef4ee54f7f75280020004100630072006f0062006100740020548c002000410064006f00620065002000520065006100640065007200200035002e003000204ee553ca66f49ad87248672c4f86958b555f5df25efa7acb76840020005000440046002065874ef63002gt13 CZE 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 DAN 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 DEU ltFEFF00560065007200770065006e00640065006e0020005300690065002000640069006500730065002000450069006e007300740065006c006c0075006e00670065006e0020007a0075006d002000450072007300740065006c006c0065006e00200076006f006e002000410064006f006200650020005000440046002d0044006f006b0075006d0065006e00740065006e002c00200076006f006e002000640065006e0065006e002000530069006500200068006f00630068007700650072007400690067006500200044007200750063006b006500200061007500660020004400650073006b0074006f0070002d0044007200750063006b00650072006e00200075006e0064002000500072006f006f0066002d00470065007200e400740065006e002000650072007a0065007500670065006e0020006d00f60063006800740065006e002e002000450072007300740065006c006c007400650020005000440046002d0044006f006b0075006d0065006e007400650020006b00f6006e006e0065006e0020006d006900740020004100630072006f00620061007400200075006e0064002000410064006f00620065002000520065006100640065007200200035002e00300020006f0064006500720020006800f600680065007200200067006500f600660066006e00650074002000770065007200640065006e002egt13 ESP 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 ETI 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 FRA ltFEFF005500740069006c006900730065007a00200063006500730020006f007000740069006f006e00730020006100660069006e00200064006500200063007200e900650072002000640065007300200064006f00630075006d0065006e00740073002000410064006f00620065002000500044004600200070006f007500720020006400650073002000e90070007200650075007600650073002000650074002000640065007300200069006d007000720065007300730069006f006e00730020006400650020006800610075007400650020007100750061006c0069007400e90020007300750072002000640065007300200069006d007000720069006d0061006e0074006500730020006400650020006200750072006500610075002e0020004c0065007300200064006f00630075006d0065006e00740073002000500044004600200063007200e900e90073002000700065007500760065006e0074002000ea0074007200650020006f007500760065007200740073002000640061006e00730020004100630072006f006200610074002c002000610069006e00730069002000710075002700410064006f00620065002000520065006100640065007200200035002e0030002000650074002000760065007200730069006f006e007300200075006c007400e90072006900650075007200650073002egt13 GRE 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 HEB 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 HRV 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 HUN 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 ITA 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 JPN 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 KOR ltFEFFc7740020c124c815c7440020c0acc6a9d558c5ec0020b370c2a4d06cd0d10020d504b9b0d1300020bc0f0020ad50c815ae30c5d0c11c0020ace0d488c9c8b85c0020c778c1c4d560002000410064006f0062006500200050004400460020bb38c11cb97c0020c791c131d569b2c8b2e4002e0020c774b807ac8c0020c791c131b41c00200050004400460020bb38c11cb2940020004100630072006f0062006100740020bc0f002000410064006f00620065002000520065006100640065007200200035002e00300020c774c0c1c5d0c11c0020c5f40020c2180020c788c2b5b2c8b2e4002egt13 LTH 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 LVI 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 NLD (Gebruik deze instellingen om Adobe PDF-documenten te maken voor kwaliteitsafdrukken op desktopprinters en proofers De gemaakte PDF-documenten kunnen worden geopend met Acrobat en Adobe Reader 50 en hoger)13 NOR 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 POL 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 PTB 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 RUM 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 RUS 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 SKY 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 SLV 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 SUO 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 SVE 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 TUR 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 UKR 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 ENU (Use these settings to create Adobe PDF documents for quality printing on desktop printers and proofers Created PDF documents can be opened with Acrobat and Adobe Reader 50 and later)13 gtgt13 ExportLayers ExportAllLayers13 Namespace [13 (Adobe)13 (Common)13 (10)13 ]13 OtherNamespaces [13 ltlt13 AsReaderSpreads false13 CropImagesToFrames true13 ErrorControl WarnAndContinue13 FlattenerIgnoreSpreadOverrides false13 IncludeGuidesGrids false13 IncludeNonPrinting false13 IncludeSlug false13 Namespace [13 (Adobe)13 (InDesign)13 (40)13 ]13 OmitPlacedBitmaps false13 OmitPlacedEPS false13 OmitPlacedPDF false13 SimulateOverprint Legacy13 gtgt13 ltlt13 AddBleedMarks false13 AddColorBars false13 AddCropMarks false13 AddPageInfo false13 AddRegMarks false13 BleedOffset [13 013 013 013 013 ]13 ConvertColors NoConversion13 DestinationProfileName ()13 DestinationProfileSelector NA13 Downsample16BitImages true13 FlattenerPreset ltlt13 PresetSelector MediumResolution13 gtgt13 FormElements false13 GenerateStructure true13 IncludeBookmarks false13 IncludeHyperlinks false13 IncludeInteractive false13 IncludeLayers false13 IncludeProfiles true13 MarksOffset 613 MarksWeight 025000013 MultimediaHandling UseObjectSettings13 Namespace [13 (Adobe)13 (CreativeSuite)13 (20)13 ]13 PDFXOutputIntentProfileSelector NA13 PageMarksFile RomanDefault13 PreserveEditing true13 UntaggedCMYKHandling LeaveUntagged13 UntaggedRGBHandling LeaveUntagged13 UseDocumentBleed false13 gtgt13 ltlt13 AllowImageBreaks true13 AllowTableBreaks true13 ExpandPage false13 HonorBaseURL true13 HonorRolloverEffect false13 IgnoreHTMLPageBreaks false13 IncludeHeaderFooter false13 MarginOffset [13 013 013 013 013 ]13 MetadataAuthor ()13 MetadataKeywords ()13 MetadataSubject ()13 MetadataTitle ()13 MetricPageSize [13 013 013 ]13 MetricUnit inch13 MobileCompatible 013 Namespace [13 (Adobe)13 (GoLive)13 (80)13 ]13 OpenZoomToHTMLFontSize false13 PageOrientation Portrait13 RemoveBackground false13 ShrinkContent true13 TreatColorsAs MainMonitorColors13 UseEmbeddedProfiles false13 UseHTMLTitleAsMetadata true13 gtgt13 ]13gtgt setdistillerparams13ltlt13 HWResolution [2400 2400]13 PageSize [612000 792000]13gtgt setpagedevice13

Table of Contents Introduction 3

Health IT Patient Safety Goal 5

Objectives of the Health IT Patient Safety Plan 7

Health IT Patient Safety Strategies and Actions 10

Summary 29

Appendix A Crosswalk of Health IT Patient Safety Plan amp IOMrsquos 2011 Recommendations from Health IT and Patient Safety Building Safer Systems for Better Care 30

Appendix B Research and Development of Tools Measures and Policies 43

Appendix C Timeline of the Health IT Patient Safety Action and Surveillance Plan 46

Appendix D ONC Patient Safety Program 50

Introduction

4 Pub L 111-5

records would allow

IOM Report (P 125)

Improve

Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Introduction

4 Pub L 111-5

records would allow

IOM Report (P 125)

Improve

Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





records would allow

IOM Report (P 125)

Improve

Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





records would allow

IOM Report (P 125)

Improve

Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





records would allow

IOM Report (P 125)

Improve

Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





IOM Report (P 125)

Improve

Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Improve

Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Improve

Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Improve

Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Improve

Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Improve

Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Improve

Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Improve

Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Improve

Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Improve

Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Improve

Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Summary

Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Recommendation 1

Recommendation 1a

bull SAFER Guides

Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Recommendation 1b

Recommendation 1c

Recommendation 1d

Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Recommendation 1e

Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Recommendation 2

Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Recommendation 3

Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Recommendation 4

Recommendation 5

Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Recommendation 6

Recommendation 7

Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Recommendation 7a

Recommendation 7b

Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Recommendation 7c

Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Recommendation 8

Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Recommendation 9a

Recommendation 9b

Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Recommendation 10

2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





2011 IOM study (92010-112011)

Hazard Manager

2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





2012 continued

SAFER Guides

2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





2013 Q1

2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





2013 Q2

2013 Q2 conrsquot

2013 Q3

2013 Q4

events

2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





2014 Q1

2014 Q2

2014 Q3

AHRQrsquos QSRS

Table of Contents

Introduction




















Summary

































Summary





Documents

Health Information Technology Patient Safety Action & … · Health Information Technology Patient Safety Action & Surveillance Plan ... government programs and the private sector—including