Monitoring EHRs to Ensure Safe and Effective Use: An Overview of What is Required. Dean F. Sittig, PhD

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1 Monitoring EHRs to Ensure Safe and Effective Use: An Overview of What is Required Dean F. Sittig, PhD

ARRA increases pressure on practitioners to implement EHRs Research and experience on EHR implementation shows: difficult, costly, time-consuming, and fraught with many

2 ARRA increases pressure on practitioners to implement EHRs Research and experience on EHR implementation shows: difficult, costly, time-consuming, and fraught with many unintended consequences EHR evaluation after implementation suggests they do not meet safety standards of safety-critical industries Airline Nuclear Power Space exploration

3 A comprehensive EHR monitoring framework with 5 essential components 1. Reporting actual or potential EHR-related adverse events 2. Enhanced EHR certification program ensures highquality software development practices are used & all reported hazards remediated 3. Self-assessment tools to address the 8 dimensions of safe and effective EHR use 4. Random, unannounced, on-site inspections of EHRs as implemented and used 5. Investigation of serious EHR-related adverse events by a nationally recognized, independent, outside group. Sittig & Classen. JAMA 2010 Feb 3;303(5):

Reporting EHR safety issues Need a method and place for practitioners to report adverse events or safety hazards due to: inadequate design, development, implementation or use of EHRs Many EHR vendors

4 Reporting EHR safety issues Need a method and place for practitioners to report adverse events or safety hazards due to: inadequate design, development, implementation or use of EHRs Many EHR vendors legally limit the ability of their clients to publically report these types of problems Create a national EHR hazard reporting system Patient Safety Organization Statute and associated Agency for Healthcare Research and Quality (AHRQ) common reporting formats.

5 AHRQ Common Format for Reporting Patient-safety Events

6 AHRQ Common Format for Reporting Patient-safety Events

8 c

Enhanced EHR certification Demonstrate good software engineering practices: Performing hazard analyses of their products Designing for safety Documenting these designs Verifying that their

10 Enhanced EHR certification Demonstrate good software engineering practices: Performing hazard analyses of their products Designing for safety Documenting these designs Verifying that their systems work as designed Test all EHRs user interfaces for usability All vendors demonstrate they have addressed all critical software issues identified within the previous year at any time.

11 Enhanced EHR certification EHRs should be load tested Present data describing EHRs: reliability and response time as implemented EHR vendors must demonstrate that their applications have been Designed for safety Developed correctly Work as designed All defects fixed

Self-Assessment of EHR use Vendor-independent, federally-funded EHR oversight group should develop self-assessment guide for EHR users ~ 25 common actions users should be capable of: look up a

12 Self-Assessment of EHR use Vendor-independent, federally-funded EHR oversight group should develop self-assessment guide for EHR users ~ 25 common actions users should be capable of: look up a patient by name or medical record number or review the 3 most recent laboratory test results Organization's EHR downtime and reactivation procedures Any EHR-related adverse events or potential hazards the user has been directly involved in. Self-assessment tool could be developed and implemented similar to the AHRQ/LeapFrog EHR/clinical decision support assessment tool Qual Saf Health Care Apr;15(2):81-4.

Self-Assessment of EHR use Document review of EHRs: 8 dimensions of safe EHR Use framework 1. Hardware and software 2. Clinical content 3. User interfaces 4.

13 Self-Assessment of EHR use Document review of EHRs: 8 dimensions of safe EHR Use framework 1. Hardware and software 2. Clinical content 3. User interfaces 4. User training and authorization procedures 5. Clinical workflow and communication 6. Organizational policies and procedures 7. Compliance with state & federal rules & regulations 8. Periodic measurements of system activity Results of self- and organizational assessments submitted to a central clearinghouse of national EHR safety benchmarks. Qual Saf Health Care 2010;19:i68-i74

14 Example Red Flags: Workflow & Communication % orders by the provider < 50%. Evidence that users are sharing passwords - posted near devices user login records show users logged in > 24 hours continuously or > 2 active logins at one time No online feedback option for clinicians to report bugs or missing items. > 50% of laboratory or radiology tests ordered STAT No computer-based method of notifying RNs of new orders or clinical results

16 Example Red Flags: Workflow & Communication Computer-to-computer interfaces are missing for key ancillary systems resulting in print deliver re-enter data flows Evidence of incomplete EHR use: extensive use of paper or failure to close chart < 72 hrs after discharge or < 24 hrs visits for > 10% of encounters

Example Red Flags: Workflow & Communication Computer-to-computer interfaces are missing for key ancillary systems resulting in print deliver re-enter data flows Evidence of incomplete EHR use:

18 Example Red Flags: Workflow & Communication Computer-to-computer interfaces are missing for key ancillary systems resulting in print deliver re-enter data flows Evidence of incomplete EHR use: extensive use of paper or failure to close chart < 72 hrs after discharge or < 24 hrs visits for > 10% of encounters Median time for STAT lab or rad tests > 4 hrs RNs, PAs, Dos, or MDs routinely spend > 2 hours after their shift completing documentation tasks

Onsite accreditation of EHRs as implemented and used Periodic, unannounced, random, onsite inspections of EHR systems Inspections conducted by The Joint Commission or state

20 Onsite accreditation of EHRs as implemented and used Periodic, unannounced, random, onsite inspections of EHR systems Inspections conducted by The Joint Commission or state departments of health Inspections should address all eight dimensions of Safe EHR use Organizations get 6 months to address all concerns or face significant financial penalties

21 Example Red Flags: Hardware & software Critical hardware components not duplicated Mean response > 3 seconds or any request >10 secs Access to computers is poor: > 2 clinicians waiting during peak usage clinicians must walk > 50 feet to find computer < 1 computer/staffed bed on an acute care unit < 2 computers per staffed bed in an ICU Key hardware over utilized: <40% of disk free, network traffic > 75% bandwidth for > 5 mins or >75% of CPU consumed for > 5 mins Wireless network has dead spots on clinical units No encrypted, offsite, daily backup, periodically tested If BCMA: No barcode scanning capabilities in rooms.

Create a National EHR Adverse Event Investigation Board National Transportation Safety Board or the Commercial Aviation Safety Team Investigate serious EHR adverse events or hazards Findings reported

22 Create a National EHR Adverse Event Investigation Board National Transportation Safety Board or the Commercial Aviation Safety Team Investigate serious EHR adverse events or hazards Findings reported to ONC and Public Board have unlimited access to EHR including: key system backups, change logs, and minutes from the local EHR safety oversight committees Board with authority to investigate all serious EHR-related adverse events or near misses.

hemolytic transfusion reaction involving major blood group incompatibilities surgery on wrong patient or body part unintended

23 Identifying extremely serious EHR-related events Occur in 8 dimensions of socio-technical model of safe EHR use Severity akin to TJC reviewable sentinel events unanticipated death of a full-term infant discharge of an infant to the wrong family hemolytic transfusion reaction involving major blood group incompatibilities surgery on wrong patient or body part unintended retention of a foreign object after surgery Reviewable events where the RCA implicates EHR EHR-related adverse events that affect >100 pts

All unplanned EHR downtimes that adversely impact patient care, or create the potential for an adverse event should be investigated All of the following characteristics: Last for more than 24 hours

24 All unplanned EHR downtimes that adversely impact patient care, or create the potential for an adverse event should be investigated All of the following characteristics: Last for more than 24 hours Affect more than 100 patients Are not the direct result of a natural disaster Simultaneously affect at least two of the following EHR components Admission/Discharge/Transfer (ADT); Clinical Results Review; CPOE, Order Communication, Verification; Barcode Medication Verification; PACS; Clinical Documentation; Alert Notification; access to local HIE

25 ARRA: important step toward improving clinical computing infrastructure Aggressive timeline places pressure on practitioners and their organizations to rapidly implement EHRs.

26 How does your IT department feel?

ARRA: important step toward improving clinical computing infrastructure Aggressive timeline places pressure on practitioners and their organizations to rapidly implement EHRs.

27 ARRA: important step toward improving clinical computing infrastructure Aggressive timeline places pressure on practitioners and their organizations to rapidly implement EHRs. Rapid implementations could lead to significant patient safety events. A comprehensive EHR monitoring and evaluation framework should be considered. Provide tools to help healthcare organizations using EHRs to deliver the highest quality, lowest cost, and safest healthcare possible.

Research and Quality (AHRQ) Contract: # HHSA290200810010; the

contract from the Office of the National Coordinator for Health

28 Thank Supported in part by the Agency for Healthcare Research and Quality (AHRQ) Contract: # HHSA ; the National Library of Medicine (NLM) grant R01- LM and a contract from the Office of the National Coordinator for Health Information Technology SHARP-ONC # Based on: Sittig & Classen. JAMA 2010 Feb 3;303(5):

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