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Lessons Learned in Information Technology IT Patient Safety

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Lessons Learned in Information Technology IT Patient Safety

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    1. 1 Lessons Learned in Information Technology (IT) Patient Safety Class #236 Wednesday August 11, 2010 3:30 PM - 5:00 PM PT

    2. Housekeeping Please silence your cell phones and pagers. If you must answer a call, please leave the room. Thank you. This is a 1.5 hour class. We’ll take a few moments cover to a few housekeeping reminders Please silence your cell phones, smart phones and pagers. If you must answer a call, for the convenience of the other participants we ask that you please leave the roomThis is a 1.5 hour class. We’ll take a few moments cover to a few housekeeping reminders Please silence your cell phones, smart phones and pagers. If you must answer a call, for the convenience of the other participants we ask that you please leave the room

    3. 3 Housekeeping (cont.) Please Hold your questions during the presentation. Questions written on a 3X5 card will be answered at the conclusion of the presentation, time permitting. Any submitted questions not answered during the session will be posted with an answer on the Web. . No questions will be taken during the presentation. If you have any questions please write them on the 3X5 card provided. Answers to your questions will be posted on the VEHU website. So please check the website when you return home.No questions will be taken during the presentation. If you have any questions please write them on the 3X5 card provided. Answers to your questions will be posted on the VEHU website. So please check the website when you return home.

    4. Faculty Toni King, RN, BSN IT Patient Safety Analyst Shirley Lesieur, RPh Pharmacy Consultant Pamela Wright, BS, MA Supervisory Health Systems Specialist

    5. 5 Learning Objectives Identify the impact of IT patient safety in the evolution of the Electronic Health Record (EHR) Discuss how participation in the patch testing process can improve the EHR Discuss approaches to address IT patient safety risks at the local facility Review two case scenarios

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    7. 7 Mission Aligned under the Health Care Information Management Division of VHA’s Office of Health Information (OHI), the IT Patient Safety Office (PSO) was established to provide leadership and direction for safe and effective information technology systems that support the delivery of health care. It actively promotes a culture of safety within health care IT systems by collaborating with Veterans Health Administration (VHA) program offices, Veterans Affairs (VA) medical facilities, and public and private health care organizations

    8. 8 Goals Provide training and education programs to establish an organizational culture of safety within the health care IT community Apply safety principles that are: Based on human factors engineering Reflect best practices such as user-centered design Support standardized IT principles, e.g., testing and release processes, etc. Evolve program focus from reactive issue resolution to systemic and proactive practices

    9. 9 Goals (cont.) Manage a non-punitive issue reporting system emphasizing analysis, understanding and feedback into the information technology engineering process Involve VHA clinical and operational stakeholders in identifying and addressing IT patient safety issues Disseminate information about Office of Health Information’s patient safety program best practices Support program objectives with personnel and budget

    10. 10 Structure Directed by Jeanie Scott Made up of a multidisciplinary staff with expertise in: Management analysis Cognitive engineering Clinical practice Program management Part of the Office of Health Care Information Management, which also includes: Health Data and Information (HDI) VHA Privacy (Office of Information and Privacy) Health Information Management Identity Management/Data Quality National Data Systems VHA Section 508 Compliance Health Information Resources VHA Security (Health Care Security Requirements)

    11. Since 2002, OHI has been collecting and analyzing systematic data to resolve patient safety issues and to identify and eliminate system deficiencies. Greater than 600 patient safety related IT issues have been identified and addressed. The office has grown from only collateral staffing to 14 Full Time Employee Equivalents (FTEE) As the program matures our emphasis is moving towards: Prevention Identification of best practices Incorporation of Human Factors principles within user interfaces (usability testing) Co-operation and collaboration with other VA officesSince 2002, OHI has been collecting and analyzing systematic data to resolve patient safety issues and to identify and eliminate system deficiencies. Greater than 600 patient safety related IT issues have been identified and addressed. The office has grown from only collateral staffing to 14 Full Time Employee Equivalents (FTEE) As the program matures our emphasis is moving towards: Prevention Identification of best practices Incorporation of Human Factors principles within user interfaces (usability testing) Co-operation and collaboration with other VA offices

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    13. 13 And What Do We Do??? Analysis - provide for the review and evaluation of patient safety software issues Provide a systematic and strategic approach to identify and resolve patient safety concerns Maintain a reporting system that includes the collection and analysis of both incidents and close calls Assess risk (through use of defined risk assessment tool) The IT Patient Safety Office is available to work with any area or office concerned about information technology and patient safety. Being proactive vs. reactive is always a big gain. We have a partnership with the National Center for Patient Safety (NCPS). The NCPS is responsible for the overall patent safety program for VHA/VA. It’s not uncommon for facility Patient Safety Officers/Managers to contact NCPS directly with IT patient safety issues. The two offices have a close working relationship with addressing IT patient safety issues using Advisories and Alerts to communicate relevant IT safety information. The IT Patient Safety Office is available to work with any area or office concerned about information technology and patient safety. Being proactive vs. reactive is always a big gain. We have a partnership with the National Center for Patient Safety (NCPS). The NCPS is responsible for the overall patent safety program for VHA/VA. It’s not uncommon for facility Patient Safety Officers/Managers to contact NCPS directly with IT patient safety issues. The two offices have a close working relationship with addressing IT patient safety issues using Advisories and Alerts to communicate relevant IT safety information.

    14. 14 And What Do We Do??? (cont.) Identify patterns, and recommends solutions to address IT patient safety problems Screen New Service Requests to provide an initial patient safety risk screening Review Issue Briefs – assist in identifying risks prior to software release Participate with other offices to provide field notices/alerts/advisories for identified risks Include strategies to mitigate risks We also work with Business owners from Pharmacy Benefit Management (PBM), Nutrition and Food Services (N&FS) and others to distribute notifications. Notifications are generally sent when information is targeted to a specific audience e.g. pharmacist or N&FS staff. We also screen and perform a risk assessment on all New Service Request (NSR) submitted. We also work with Business owners from Pharmacy Benefit Management (PBM), Nutrition and Food Services (N&FS) and others to distribute notifications. Notifications are generally sent when information is targeted to a specific audience e.g. pharmacist or N&FS staff. We also screen and perform a risk assessment on all New Service Request (NSR) submitted.

    15. And What Do We Do??? (cont.) Participate on workgroups Provide external training Remedy™ mining Release Process Testing Our office has active participants on the various clinical projects, ensuring a dynamic flow of information between all participants. We participate in events such as VeHU, the Pharmacy Informatics conference and the PSO/Patient Safety Manager (PSM) conference among others. We have procedures to be on the look out for emerging issues and we are intricately involved in the release process as well as testing phases of major projects. Pam will review this in greater detail later in the presentationOur office has active participants on the various clinical projects, ensuring a dynamic flow of information between all participants. We participate in events such as VeHU, the Pharmacy Informatics conference and the PSO/Patient Safety Manager (PSM) conference among others. We have procedures to be on the look out for emerging issues and we are intricately involved in the release process as well as testing phases of major projects. Pam will review this in greater detail later in the presentation

    16. And What Do We Do??? (cont.) Innovation Requirements Causal Analysis Proactive Risk Analysis Our Human Factors team members are becoming more involved in addressing new technologies through innovation as well as in the software testing phases. Human Factors Engineering principles should always be one of the critical elements of designing new technologies. Our staff routinely participate in the development of requirements for projects providing expertise in risk management and focusing on providing enhancements that meet the needs of the Users with PATIENT SAFETY as our core principle.Our Human Factors team members are becoming more involved in addressing new technologies through innovation as well as in the software testing phases. Human Factors Engineering principles should always be one of the critical elements of designing new technologies. Our staff routinely participate in the development of requirements for projects providing expertise in risk management and focusing on providing enhancements that meet the needs of the Users with PATIENT SAFETY as our core principle.

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    18. 18 Definitions Patient Safety – freedom from accidental harm to individuals receiving healthcare Patient Safety Incident an episode when something goes wrong in healthcare resulting in potential or actual harm to patients

    19. Why IT Patient Safety Technology presents a number of untapped opportunities for patient safety, as well as representing a potential hazardą Payment issues rather than clinical needs have driven most investments in health IT ąhttp://www.who.int/patientsafety/implemenation/technology/en/index.html

    20. 20 The Paper Health Record Inadequate High personalized (used as a reminder) Not designed to be used to support communication among providers of care Can force clinicians to practice in the dark It arose in the 19th century and has become woefully inadequate to meet the needs of 21st century health care.It arose in the 19th century and has become woefully inadequate to meet the needs of 21st century health care.

    21. Computers and information systems can make important fundamental contributions toward creation of safe systems through improving access to information, reducing reliance on memory, increasing vigilance, and contributing to standardization of processes. Kilbridge and Classen Journal of the American Medical Informatics Association April 2008

    22. 22 What ‘s Driving the Evolution? Patient safety Reducing medical errors Efficiency Reducing cost Accessibility So what are some of the drivers? The Institute of Medicine (IOM) recommended computerized orders and decision-support applications as main HIT mechanisms for increasing patient safety in the future. To meet the increase need healthcare must fill the data gaps needs by moving to an electronic platform. This platform has to be accessible, So what are some of the drivers? The Institute of Medicine (IOM) recommended computerized orders and decision-support applications as main HIT mechanisms for increasing patient safety in the future. To meet the increase need healthcare must fill the data gaps needs by moving to an electronic platform. This platform has to be accessible,

    23. 23 What ‘s Driving the Evolution? (cont.) Confidentiality Security Acceptable to clinicians and patients Integration It also has to be confidential, secure, acceptable to patients and clinicians and integrated with other non-patient specific information. Inefficiencies and frustrations associated with the use of paper-based medical records have become increasingly clear. An inefficiencies caused by a lack of integration. It also has to be confidential, secure, acceptable to patients and clinicians and integrated with other non-patient specific information. Inefficiencies and frustrations associated with the use of paper-based medical records have become increasingly clear. An inefficiencies caused by a lack of integration.

    24. 24 Benefits Easier and more accurate record keeping and scheduling Automation of lab orders and integration of lab reports Links to pharmacies (including electronic prescribing) and computerized physician order entry (CPOE) Chronic disease management tools Less paper clutter

    25. 25 Benefits (cont.) Integration of decision support systems (DSS)—alerts and reminders for providers to improve Improve quality of care Reduce medication costs Eliminate redundant tests Reduce errors Epidemiological analysis of data from targeted or broad populations of patients Potentially safer and less expensive care Despite the many benefits EHRs are found in few hospitals or physician offices.Despite the many benefits EHRs are found in few hospitals or physician offices.

    26. 26 Risk Automation can introduce new risk Overall risk has not been widely studied Risk can be mitigated with strong situation awareness and strong solutions that consider the human condition EHR Safety Institute http://www.ehrsafety.com/mission.html As with anything we do-there are risk. You will see that the Benefits of the EHR outweigh the risk. That is why linking with cognitive sciences are important when introducing new technology.As with anything we do-there are risk. You will see that the Benefits of the EHR outweigh the risk. That is why linking with cognitive sciences are important when introducing new technology.

    27. 27 Release Management Process – How did we get here?

    28. 28 Evolution Computerized Patient Record System (CPRS) v.27 release August 2008 Patient Safety Advisory AD09-01 issued October 10, 2008 Upgraded to Alert AL09-04 on November 6, 2008 Patch OR*3*304 developed as a fix Within a week of the full national installation of CPRS v.27, VHA medical facilities began reporting problems of incorrect patient information displays in CPRS. The 1st patient’s information could display in the 2nd patient’s record. Advisory AD09-01 was issued on 10/10/08 and was upgraded to Alert AL09-04 on 11/6/08, and included add’l information and actions for CPRS users to take. Patch OR*3*304 was created to correct the cause and include a safeguard to shut down CPRS upon reoccurence of the issue. Testing of the patch fix was shortened due to the gravity of the issue. Within a week of the full national installation of CPRS v.27, VHA medical facilities began reporting problems of incorrect patient information displays in CPRS. The 1st patient’s information could display in the 2nd patient’s record. Advisory AD09-01 was issued on 10/10/08 and was upgraded to Alert AL09-04 on 11/6/08, and included add’l information and actions for CPRS users to take. Patch OR*3*304 was created to correct the cause and include a safeguard to shut down CPRS upon reoccurence of the issue. Testing of the patch fix was shortened due to the gravity of the issue.

    29. 29 Evolution (cont.) Executive Decision Memo (EDM) November 2008: Switching from one patient to next in CPRS – 1st patient information displayed in 2nd patient record Patient Safety Advisory AD09-04 issued October 31, 2008 Upgraded to Alert AL09-05 on November 6, 2008 Patch OR*3*303 developed as a fix An Executive Decision Memo, approving the release of VistA Patch OR*3*304 and CPRS GUI v. 27.83, was signed on November 18, 2008. VA medical facilities also reported the problem that they were not able to locate “discontinue” orders when reviewing Active Orders view in CPRS. Advisory AD09-04 was issued on 10/31/08 and upgraded to Alert AL09-05 on 11/6/08. Patch OR*3*303 was created to restore the display of discontinued orders based on last activity. An Executive Decision Memo, approving the release of VistA Patch OR*3*304 and CPRS GUI v. 27.83, was signed on November 18, 2008. VA medical facilities also reported the problem that they were not able to locate “discontinue” orders when reviewing Active Orders view in CPRS. Advisory AD09-04 was issued on 10/31/08 and upgraded to Alert AL09-05 on 11/6/08. Patch OR*3*303 was created to restore the display of discontinued orders based on last activity.

    30. 30 Evolution (cont.) EDM December 2008: CPRS displays discontinued orders by original start date instead of date order was discontinued An Executive Decision Memo, approving the release of VistA Patch OR*3*303, was signed on December 4, 2008. An Executive Decision Memo, approving the release of VistA Patch OR*3*303, was signed on December 4, 2008.

    31. 31 Office of Inspector General (OIG) Request (January 2009) from former Secretary of Veterans Affairs to investigate reported software defects in CPRS v.27 Dept. of VA OIG Report No. 09-01033-155 (June 2009) http://www4.va.gov/oig/54/reports/VAOIG-09-01033-155.pdf Results of the report Recommendations In January 2009, the Senate Committee on Veterans Affairs Committee requested that VHA conduct a review “to determine if any adverse drug event reports were related” to a reported error in CPRS v.27. 4 days later, the former Secretary of VA requested that the OIG evaluate testing and deployment of CPRS v.27. Senior VHA leadership was asked who approved the release? It turned out that CPRS Workgroup issued approval (no Under Secretary or Chief Officer) for the release of CPRS v.27 because there was no formal process in place. The Release Approval Process was initiated as a result of the issues related to CPRS > going to the Under Secretary for approval, which resulted in the Chief Officers approving as Business Owners of the IT process. RESULTS: Process for testing and implementing CPRS v.27 did not effectively mitigate risks, associated software functionality defects, and the potential adverse impacts to patient safety. Specifically: 1. limited site participation in Alpha/Beta testing was not sufficient to identify and resolve significant defects 2. field testing teams were missing system end users and programmers to ID & resolve defects 3. Alpha testing did not have full system & integration testing to resolve significant functionality defects, and 4. the rollout of the release did not provide enough time to ID and resolve defects RECOMMENDATIONS: 1. Develop a process to ensure adequate facility representation of sites for Alpha/Beta testing, considering depth and complexity of software changes associated with major releases of CPRS. 2. Establish fully dedicated CPRS testing teams of system end users/programmers to augment Alpha/Beta testing of CPRS and to improve quality and depth of testing. 3. Implement full system functionality and integration testing of CPRS during Alpha testing to reduce risk that defects will affect Patient Safety during Beta testing. 4. Adopt a phased implementation approach for installation of CPRS major releases. 5. Establish criteria for determining how soon safety advisories are issued after CPRS problems are judged to be threats to Patient Safety. In January 2009, the Senate Committee on Veterans Affairs Committee requested that VHA conduct a review “to determine if any adverse drug event reports were related” to a reported error in CPRS v.27. 4 days later, the former Secretary of VA requested that the OIG evaluate testing and deployment of CPRS v.27. Senior VHA leadership was asked who approved the release? It turned out that CPRS Workgroup issued approval (no Under Secretary or Chief Officer) for the release of CPRS v.27 because there was no formal process in place. The Release Approval Process was initiated as a result of the issues related to CPRS > going to the Under Secretary for approval, which resulted in the Chief Officers approving as Business Owners of the IT process. RESULTS: Process for testing and implementing CPRS v.27 did not effectively mitigate risks, associated software functionality defects, and the potential adverse impacts to patient safety. Specifically: 1. limited site participation in Alpha/Beta testing was not sufficient to identify and resolve significant defects 2. field testing teams were missing system end users and programmers to ID & resolve defects 3. Alpha testing did not have full system & integration testing to resolve significant functionality defects, and 4. the rollout of the release did not provide enough time to ID and resolve defects RECOMMENDATIONS: 1. Develop a process to ensure adequate facility representation of sites for Alpha/Beta testing, considering depth and complexity of software changes associated with major releases of CPRS. 2. Establish fully dedicated CPRS testing teams of system end users/programmers to augment Alpha/Beta testing of CPRS and to improve quality and depth of testing. 3. Implement full system functionality and integration testing of CPRS during Alpha testing to reduce risk that defects will affect Patient Safety during Beta testing. 4. Adopt a phased implementation approach for installation of CPRS major releases. 5. Establish criteria for determining how soon safety advisories are issued after CPRS problems are judged to be threats to Patient Safety.

    32. 32 Objective of Release Process To ensure appropriate review and approval by the Business Owners prior to release of the software 12-step VHA Office of Health Information (OHI) Release Process Initially known as EDM – currently Issue Brief Process A meeting was held to create a 12-step release process. The process allows stakeholders in VHA to fully understand the impacts and risks associated with the software prior to signing approval for the release into production accounts. Formal approval was initially known as the EDM and later changed to the Issue Brief.A meeting was held to create a 12-step release process. The process allows stakeholders in VHA to fully understand the impacts and risks associated with the software prior to signing approval for the release into production accounts. Formal approval was initially known as the EDM and later changed to the Issue Brief.

    33. 33 Release Process Membership Enterprise Systems Management (ESM) Office of Enterprise Development (OED) Office of Health Information (OHI) IT Patient Safety Office of Information & Technology (OI&T) Health Data & Informatics (HDI) Office of Nursing Services (ONS)

    34. 34 Patient Safety Contributions 2009 National Deployment release only Revised template to incorporate areas of patient safety concern (no longer EDM but Issue Brief) Developed Standard Operating Procedure for Patient Safety Office Domains within Patient Safety Patient Safety was initially involved in the National Deployment release reviews. The template was revised to incorporate areas of patient safety concerns (summary of facts & background, testing, and implementation issues for example.) Patient Safety Standard Operating Procedure was developed and entire office participated in reviews. Patient Safety restructuring led to Domains of expertise thereby identifying core folks to participate in the various reviews.Patient Safety was initially involved in the National Deployment release reviews. The template was revised to incorporate areas of patient safety concerns (summary of facts & background, testing, and implementation issues for example.) Patient Safety Standard Operating Procedure was developed and entire office participated in reviews. Patient Safety restructuring led to Domains of expertise thereby identifying core folks to participate in the various reviews.

    35. 35 Patient Safety Contributions 2009 (cont.) Face-to-Face (F2F) meeting held with Release Board in September 2009 Outcomes of F2F ESM Issue Brief Decision Tree/Patient Safety Release Request “Global Pass” F2F held to identify areas in the process that could be streamlined, consequently eliminating delays and creating new efficiencies. Constraint? Cannot do away with the system/process. Discussed criteria for an emergency release (<10 TAT required) versus non-emergency release (10 day TAT preferred). OUTCOMES: 1. concurrent review with Patient Safety & Business Owners, 2. Move Patient Safety closer to field testing, 3. Involve Business Owners/users earlier on, 4. Change content of the templates, 5. Formalize signature process for the release. A decision tree was developed for use within Patient Safety to assist staff in determining which briefs may require a PS review. In addition, a “Global Pass” list was created for ESM – applications that generally do NOT have a PS component and therefore would not require our review. This allowed ESM to move those particular reviews to the next desired level.F2F held to identify areas in the process that could be streamlined, consequently eliminating delays and creating new efficiencies. Constraint? Cannot do away with the system/process. Discussed criteria for an emergency release (<10 TAT required) versus non-emergency release (10 day TAT preferred). OUTCOMES: 1. concurrent review with Patient Safety & Business Owners, 2. Move Patient Safety closer to field testing, 3. Involve Business Owners/users earlier on, 4. Change content of the templates, 5. Formalize signature process for the release. A decision tree was developed for use within Patient Safety to assist staff in determining which briefs may require a PS review. In addition, a “Global Pass” list was created for ESM – applications that generally do NOT have a PS component and therefore would not require our review. This allowed ESM to move those particular reviews to the next desired level.

    36. 36 Patient Safety Contributions 2010 Patient Safety review of Initial Operating Capability and National Deployment Issue Briefs Concurrent reviews with Pharmacy Benefits Management (PBM) Software Releases affected (Clinical Observations Clinical Flowsheets (CLiO), Mobile Electronic Documentation (MED), Anticoagulation) Software development, installation, and implementation involve risks not always identified but it is important to identify HOW to mitigate those risks once known and communicated. So in early 2010, after revision of the templates to incorporate Patient Safety concerns, our office started reviewing the Initial Operating Capability briefs – and became involved much earlier in the testing process. A large portion of the software releases involve Pharmacy so our office initiated a concurrent review process with Pharmacy Benefits Management. This is an excellent collaborative effort with objective input offered from both offices. As a result of our increased efforts to mitigate potential patient safety software issues, software application releases have been delayed or halted. CLiO (Clinical Observations Clinical Flowsheets) and MED (Mobile Electronic Documentation) are a couple of examples. OR*3*307 (Anticoagulation software) was in the middle of installation at sites when reports started coming in of issues in which unsigned orders may be inadvertently released by a nurse based on a parameter setting. Alert AL10-09 was issued in April and actions were listed for sites to take until the Patch could be released.Software development, installation, and implementation involve risks not always identified but it is important to identify HOW to mitigate those risks once known and communicated. So in early 2010, after revision of the templates to incorporate Patient Safety concerns, our office started reviewing the Initial Operating Capability briefs – and became involved much earlier in the testing process. A large portion of the software releases involve Pharmacy so our office initiated a concurrent review process with Pharmacy Benefits Management. This is an excellent collaborative effort with objective input offered from both offices. As a result of our increased efforts to mitigate potential patient safety software issues, software application releases have been delayed or halted. CLiO (Clinical Observations Clinical Flowsheets) and MED (Mobile Electronic Documentation) are a couple of examples. OR*3*307 (Anticoagulation software) was in the middle of installation at sites when reports started coming in of issues in which unsigned orders may be inadvertently released by a nurse based on a parameter setting. Alert AL10-09 was issued in April and actions were listed for sites to take until the Patch could be released.

    37. 37 CPRS v.28 Implementation Advisory Group (CIAG) Test site selection and coordination Ensure test sites reflect the healthcare complexity levels to provide a representative sampling of variation in workflow A test site Memorandum of Understanding (MOU), including resource and time commitments A pilot for transferring test site selection to VHA – due by May 31, 2010 The CPRS v.28 Implementation Advisory Group was assembled by VHA on 12/7/09. They meet weekly and consist of reps from VHA offices of OHI, PCS, and ONS. Office of Information & Technology is represented by Field Ops and OED, and VA facility users are included as well. The group is creating a document outlining a risk-based decision making approach to help determine whether a monitored release, phased implementation, or other appropriate implementation plan is required. The group will provide: (read bullets)The CPRS v.28 Implementation Advisory Group was assembled by VHA on 12/7/09. They meet weekly and consist of reps from VHA offices of OHI, PCS, and ONS. Office of Information & Technology is represented by Field Ops and OED, and VA facility users are included as well. The group is creating a document outlining a risk-based decision making approach to help determine whether a monitored release, phased implementation, or other appropriate implementation plan is required. The group will provide: (read bullets)

    38. 38 CPRS v.28 Implementation Advisory Group Criteria and recommendations for dedicated test teams, testing outcomes and potential hiring plans (where necessary) - due by May 31, 2010 Coordination with the CPRS Integrated Project Team to: Conduct advanced project test planning Foster openness and visibility during all phases of test planning and test execution Implement better traceability of requirements to test cases Specific criteria to guide level of phased release involvement and minimize risk to post release issues – due by May 31, 2010 

    39. 39 Release Process – Are We There Yet? F2F scheduled for September 2010 Monthly conference calls with ESM and IT Patient Safety to discuss process issues The Patient Safety Office continues to work closely with ESM to discuss the process, including holding a monthly call to discuss any issues that may pop up. However, our office is just one of the players involved and to that end, another F2F meeting will be held this fall to re-evaluate the process: 1. Better integration of Stakeholders in the early stages of the development of the release  - Release Management too late in the software lifecycle; 2. Streamline the review process for Office of Nursing Services – (looking at only those releases affecting nursing), 3. Standardizing the testing language in the Issue Briefs so that it is all inclusive – (assumes standard testing process for various types of software releases), 4. Template changes – Are there areas that we need focus on (more, less, different information), 5. Terminology and Definitions consistency, 6. Submission Quality – Office of Enterprise Development (OED) Template, Issue Brief Drafts, 7. Integration with other areas – Enterprise Infrastructure Engineering (EIE) Release Management, Field Development, others?, 8. Impact to Healthcare and Business Flow information, 9. Increase Concurrent Stakeholder Reviews. Patient Safety will continue the journey to provide “The Best Care Anywhere” to our nation’s veterans!The Patient Safety Office continues to work closely with ESM to discuss the process, including holding a monthly call to discuss any issues that may pop up. However, our office is just one of the players involved and to that end, another F2F meeting will be held this fall to re-evaluate the process: 1. Better integration of Stakeholders in the early stages of the development of the release  - Release Management too late in the software lifecycle; 2. Streamline the review process for Office of Nursing Services – (looking at only those releases affecting nursing), 3. Standardizing the testing language in the Issue Briefs so that it is all inclusive – (assumes standard testing process for various types of software releases), 4. Template changes – Are there areas that we need focus on (more, less, different information), 5. Terminology and Definitions consistency, 6. Submission Quality – Office of Enterprise Development (OED) Template, Issue Brief Drafts, 7. Integration with other areas – Enterprise Infrastructure Engineering (EIE) Release Management, Field Development, others?, 8. Impact to Healthcare and Business Flow information, 9. Increase Concurrent Stakeholder Reviews. Patient Safety will continue the journey to provide “The Best Care Anywhere” to our nation’s veterans!

    40. 40 Toni King will now discuss the “Culture Shift”.Toni King will now discuss the “Culture Shift”.

    41. 41 Creating a Balanced Safety Culture Learning Open and fair Safe systems design Critical decision making skills A balanced safety culture looks at the whole spectrum from the individual and organization levelA balanced safety culture looks at the whole spectrum from the individual and organization level

    42. Why Report IT Safety Issues? Good for patients and staff Learning opportunity Improves safety through feedback Builds organizational memory of what happened and why Communicates organization’s concerns about IT issues Aids in correcting vulnerabilities Applying High-reliability organizations approach to accident analysis during the reporting phase can be extremely helpful. Personal shame is a disincentive to error reporting. In 1999 Augustine and colleagues did a pretest survey of employee attitudes at 5 facilities prior to the implementation of the National Center for Patient Safety (NCPS) near-miss reporting system 49 percent of the 87 respondents admitted they were ashamed when they made mistakes in front of others. Those that felt ashamed also were more likely to report they did not tell others. A 2005 NCPS culture of safety survey revealed the following for two of the questions. When a mistake is made that results in harm to the patient, of the survey participants 64% of the respondents said they always reported the mistake whereas if a mistake was caught and corrected only 23% of the participants reported the close call. In the 2009 NCPS Culture of Safety survey these 2 questions show small increases-64% increased by 3.1 % to 67.1 % and 23% increased by 5% to 28%. We’ve shown small improvements, but still have some work to do to improve the culture of reporting. Reporting is helpful because: Improves patient and staff safety Learning opportunity- learning organizations that have a fair and just reporting system of near misses and errors helps with analyses and feedback Improves safety through feedback Build organizational memory on what happened and why Communicate organization concerns about IT issues to reinforce the cultural values of safety Aids in correcting vulnerabilities Applying High-reliability organizations approach to accident analysis during the reporting phase can be extremely helpful. Personal shame is a disincentive to error reporting. In 1999 Augustine and colleagues did a pretest survey of employee attitudes at 5 facilities prior to the implementation of the National Center for Patient Safety (NCPS) near-miss reporting system 49 percent of the 87 respondents admitted they were ashamed when they made mistakes in front of others. Those that felt ashamed also were more likely to report they did not tell others. A 2005 NCPS culture of safety survey revealed the following for two of the questions. When a mistake is made that results in harm to the patient, of the survey participants 64% of the respondents said they always reported the mistake whereas if a mistake was caught and corrected only 23% of the participants reported the close call. In the 2009 NCPS Culture of Safety survey these 2 questions show small increases-64% increased by 3.1 % to 67.1 % and 23% increased by 5% to 28%. We’ve shown small improvements, but still have some work to do to improve the culture of reporting. Reporting is helpful because: Improves patient and staff safety Learning opportunity- learning organizations that have a fair and just reporting system of near misses and errors helps with analyses and feedback Improves safety through feedback Build organizational memory on what happened and why Communicate organization concerns about IT issues to reinforce the cultural values of safety Aids in correcting vulnerabilities

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    44. 44

    45. What Actions Can Facilities Take ?? “Data inventory is key….listening to the people in your administration, talking to your administration, talking to focus groups of patients and talking to clinicians. The most extraordinary question we ever asked our staff was, ‘What do you lie awake at night worrying about?’ The list they came up with is massive, full of the things that could fail or go wrong.” James Conway, MS, COO Dana-Farber Cancer Institute In: Reducing Medical Errors, Improving Patient Safety: Taking the Next Step, Health Leaders Roundtable, June 2001. Giving people the space to tell their stories is vital to improving patient safety. The airline industry and other High-Reliability organizations have done this very well. Safety is at the foundation and driver for many of their business processes.Giving people the space to tell their stories is vital to improving patient safety. The airline industry and other High-Reliability organizations have done this very well. Safety is at the foundation and driver for many of their business processes.

    46. 46 Assessments Workarounds are signals: Read them Keep patient safety & clinician needs paramount Vigilance should be unrelenting. Even “perfect” HIT must be fluid Workarounds: In the book Set Phasers on Stun And Other True Tales of Design and, Technology, and Human Error written by Steve Casey. A technician inadvertently entered an X for x-ray mode instead of an E for electron beam mode. She thought she corrected the error by entering “edit” routine and changing the mode to E. This lead to a catastrophic outcome for a patient. This patient was hit not once but 3 times with a deadly and invisible shot to his shoulders and neck or more than 125 times the prescribed dose because the machine was in hybrid proton beam mode. The patient died 4 months later from massive radiation burns and gapping lesions. In spite of his condition in the months leading up to his death he maintained a great attitude and often joked that Captain Kirk forgot to put the machine on stun. Thus the title of the book.Workarounds: In the book Set Phasers on Stun And Other True Tales of Design and, Technology, and Human Error written by Steve Casey. A technician inadvertently entered an X for x-ray mode instead of an E for electron beam mode. She thought she corrected the error by entering “edit” routine and changing the mode to E. This lead to a catastrophic outcome for a patient. This patient was hit not once but 3 times with a deadly and invisible shot to his shoulders and neck or more than 125 times the prescribed dose because the machine was in hybrid proton beam mode. The patient died 4 months later from massive radiation burns and gapping lesions. In spite of his condition in the months leading up to his death he maintained a great attitude and often joked that Captain Kirk forgot to put the machine on stun. Thus the title of the book.

    47. 47 Facility Actions Take IT Patient Safety Serious Address unsafe workarounds Capture as much information as possible Attempt to reproduce the steps in a test account Obtain screen images free of protected health information (PHI) Communicate, communicate, communicate Unsafe workarounds-carrying medications from the medication room to the patients bedside vs. taking the cart, scanner etc. to the bedside.Unsafe workarounds-carrying medications from the medication room to the patients bedside vs. taking the cart, scanner etc. to the bedside.

    48. 48 Facility Reporting Tips and Tricks Tool This tool was developed to assist facility staff with reporting IT patient safety concerns. Input was provided by multidisciplinary staff from various facilities. Capturing the relevant information involves a 3 step process. This tool will be available in a Bookmark or business card format and can be obtained at the IT Patient Safety Office booth located in the Exhibit Hal. It will also be provided on the IT Patient Safety website. The IT Patient Safety web address is included at the end of this presentation. This tool was developed to assist facility staff with reporting IT patient safety concerns. Input was provided by multidisciplinary staff from various facilities. Capturing the relevant information involves a 3 step process. This tool will be available in a Bookmark or business card format and can be obtained at the IT Patient Safety Office booth located in the Exhibit Hal. It will also be provided on the IT Patient Safety website. The IT Patient Safety web address is included at the end of this presentation.

    49. Promoting IT Patient Safety Improve communication Automate tasks that are likely to cause errors Reduce interruptions Intervene when problems are detected Communication is the number one cause of all patient safety errors in hospitals. Knock down any barriers that impede on good communication Automation is a great tool, but it is just that, a tool, you have to be sure that the automation you set up is not automatically committing errors Don’t be afraid to jump in and say wait a minute something is not right here. We have to constantly watch over the safety of our systems, a safe system today can be unsafe tomorrow with the change of one small piece. Communication is the number one cause of all patient safety errors in hospitals. Knock down any barriers that impede on good communication Automation is a great tool, but it is just that, a tool, you have to be sure that the automation you set up is not automatically committing errors Don’t be afraid to jump in and say wait a minute something is not right here. We have to constantly watch over the safety of our systems, a safe system today can be unsafe tomorrow with the change of one small piece.

    50. Focus on IT Patient Safety Report…report…report Engaging senior leadership Involve front end users Use available information technology tools Leaders must be engaged in the process and should not worry alone. Involve front end users who use the technology 24/7 to enhance outcomes for veterans. Transition into “What VA Staff Can Do to Promote a Culture of IT Patient Safety” Leaders must be engaged in the process and should not worry alone. Involve front end users who use the technology 24/7 to enhance outcomes for veterans. Transition into “What VA Staff Can Do to Promote a Culture of IT Patient Safety”

    51. Sustaining a Culture of IT Patient Safety The principles of Patient Safety must be discussed at New employee orientation and annually – It needs to be explained that every single person – regardless of their job, regardless of whether they ever touch a patient, is a key player in patient safety. Leadership must talk the talk and walk the walk. If they say they support a Non-punitive Error Reporting system they have to really support it. Staff only need to see one time that they are not supporting this culture and your reporting system will come to a halt. And of course you must have a means for staff to report errors and feedback to the reporter that there reports are being reviewed. The reporter wants to know that A- someone is reading their concern and B- something is being done. Only once a culture of safety is developed can you really start to create solutions that will make a difference. The principles of Patient Safety must be discussed at New employee orientation and annually – It needs to be explained that every single person – regardless of their job, regardless of whether they ever touch a patient, is a key player in patient safety. Leadership must talk the talk and walk the walk. If they say they support a Non-punitive Error Reporting system they have to really support it. Staff only need to see one time that they are not supporting this culture and your reporting system will come to a halt. And of course you must have a means for staff to report errors and feedback to the reporter that there reports are being reviewed. The reporter wants to know that A- someone is reading their concern and B- something is being done. Only once a culture of safety is developed can you really start to create solutions that will make a difference.

    52. 52 Learning From Disasters Complex set of interactions No single causal factor Combination of Local conditions Human behaviors Social factors Organizational weaknesses

    53. 53

    54. 54 IT Patient Safety Scenarios PSPO #1466: “Inpatient Meds, Comments Truncated When Copying to Special Instructions” PSPO #1483: “Bar Code Medication Administration (BCMA) Program displays incorrect information pop-up display during medication scanning.” I will now review two reported issues and try to cover some of the difficulties that can be experienced along the way as well as provide a short overview of the process. The term PSPO refers to the designation of the patient safety issue number in the OI Patient Safety Office ClearQuest (CQ) tracking software; e.g. PSPO #1466. Today we will discuss PSPO #1466 and PSPO #1483.I will now review two reported issues and try to cover some of the difficulties that can be experienced along the way as well as provide a short overview of the process. The term PSPO refers to the designation of the patient safety issue number in the OI Patient Safety Office ClearQuest (CQ) tracking software; e.g. PSPO #1466. Today we will discuss PSPO #1466 and PSPO #1483.

    55. 55 PSPO #1466 The feature "Copy Provider Comments into Special Instruction" is truncating comments that exceed 180 characters if a particular sequence of events occurs   Normally when a provider enters comments on an order that exceeds 177 characters the Copy feature is not available to the pharmacist. The system prompts the user to transcribe the Special Instructions manually   However, the Copy feature remains available for use if a Quick Order with comments greater than 200 characters is employed. When the copy feature is invoked the comments are truncated to fit the restraints of the Special Instruction Field   Let’s start by reviewing the first issue. This was reported by a site using Remedy™, the assigned support specialist identified that the software was NOT functioning as would be expected and the site had flagged the ticket as a potential patient safety issue. The information was then entered into the Patient Safety database, after confirming all the facts and getting a complete “story” the issue was assessed to be a moderate risk requiring an action plan. Let’s start by reviewing the first issue. This was reported by a site using Remedy™, the assigned support specialist identified that the software was NOT functioning as would be expected and the site had flagged the ticket as a potential patient safety issue. The information was then entered into the Patient Safety database, after confirming all the facts and getting a complete “story” the issue was assessed to be a moderate risk requiring an action plan.

    56. 56 PSPO #1466 (cont.) Provider Comments and Special Instructions fields found in the Pharmacy Patient file (#55) Provider Comments field (#55.06,72) - Word Processing Special Instructions field (#55.06,8) - Free Text up to 180 characters Provider comments is a word processing field with no character limitation. The pharmacist can copy the provider comments to the Special Instructions field but is constrained by a 180 character limit. We’ll now review some screen captures illustrating the problem Provider comments is a word processing field with no character limitation. The pharmacist can copy the provider comments to the Special Instructions field but is constrained by a 180 character limit. We’ll now review some screen captures illustrating the problem

    57. 57 In CPRS the provider enters an order using a Quick order that included extensive instructions which exceeded 177 characters. In CPRS the provider enters an order using a Quick order that included extensive instructions which exceeded 177 characters.

    58. As the pharmacist finishes the order the software accepts a YES response at the Copy Provider Comments prompt. If the pharmacist had been entering the order through back door pharmacy options the pharmacist would not have been allowed to exceed 177 characters.As the pharmacist finishes the order the software accepts a YES response at the Copy Provider Comments prompt. If the pharmacist had been entering the order through back door pharmacy options the pharmacist would not have been allowed to exceed 177 characters.

    59. Instructions as they appear on the BCMA IVP/IVPB tab. Depending on the instructions and where they cut off it could appear to the nurse administering the medication that the order information is complete. Instructions as they appear on the BCMA IVP/IVPB tab. Depending on the instructions and where they cut off it could appear to the nurse administering the medication that the order information is complete.

    60. 60 PSPO #1466 (cont.) IMRSFG increment 3 is currently expected to be released sometime after the Pharmacy Re-engineering v0.5 patch. During discussions on how to best resolve the issue the underlying problem of restricted word processing fields in ancillary packages would continue to cause problems since providers were allowed to use unlimited text within CPRS. The decision was made to address this issue which would also encompass this scenario. This is a complex enhancement to our current software and could not be addressed in a quick fix patch, additionally many of the routines involved are in “lock down” until PRE v0.5 is released – thus delaying the ability to test and release these patches. Since it was recognized that the inherent risk was not readily detectable PBM distributed a notice on August 10th 2009.IMRSFG increment 3 is currently expected to be released sometime after the Pharmacy Re-engineering v0.5 patch. During discussions on how to best resolve the issue the underlying problem of restricted word processing fields in ancillary packages would continue to cause problems since providers were allowed to use unlimited text within CPRS. The decision was made to address this issue which would also encompass this scenario. This is a complex enhancement to our current software and could not be addressed in a quick fix patch, additionally many of the routines involved are in “lock down” until PRE v0.5 is released – thus delaying the ability to test and release these patches. Since it was recognized that the inherent risk was not readily detectable PBM distributed a notice on August 10th 2009.

    61. 61 PSPO #1483 Let’s review the 2nd scenario.Let’s review the 2nd scenario.

    62. 62 PSPO #1483 (cont.) What’s the story? The inappropriate timing of the pop up messages was also witnessed by the BCMA Coordinator. The “Unable to Scan” pop-up should display ONLY when the user intentionally right-clicks on the medication and selects “unable to scan.” This was reported by one nurse during one episode of medication administration occurrence (while accessing 2 patient records) at the reporting site. What’s the story? The inappropriate timing of the pop up messages was also witnessed by the BCMA Coordinator. The “Unable to Scan” pop-up should display ONLY when the user intentionally right-clicks on the medication and selects “unable to scan.” This was reported by one nurse during one episode of medication administration occurrence (while accessing 2 patient records) at the reporting site.

    63. 63 PSPO #1483 (cont.) There have been 5 other Remedy™ tickets submitted by different sites with similar issues. All of the tickets report inappropriate display of the “Unable to Scan” dialog pop-up during the scanning process and all the tickets were submitted after the release of PSB *3*28 Managing Scanning Failures (MSF). There have been 5 other Remedy™ tickets submitted by different sites with similar issues. All of the tickets report inappropriate display of the “Unable to Scan” dialog pop-up during the scanning process and all the tickets were submitted after the release of PSB *3*28 Managing Scanning Failures (MSF).

    64. 64 PSPO#1483 (cont.) What we know – (review bullets) During the assessment of this issue discussions with the Bar Code Medication Administration (BCMA) developers, support specialists and patient safety analysts reviewed the facts as currently known. The groups suggested the following 2 actions: 1-Further analysis by BCMA Development to try to reproduce the issue and investigate possible causes related to the logic in the PSB line of code. 2-The issue be presented on the BCMA workgroup call in order to increase awareness of this problem, and potentially gain more insight into the steps being taken just prior to the erroneous displays on the Virtual Due List (VDL). What we know – (review bullets) During the assessment of this issue discussions with the Bar Code Medication Administration (BCMA) developers, support specialists and patient safety analysts reviewed the facts as currently known. The groups suggested the following 2 actions: 1-Further analysis by BCMA Development to try to reproduce the issue and investigate possible causes related to the logic in the PSB line of code. 2-The issue be presented on the BCMA workgroup call in order to increase awareness of this problem, and potentially gain more insight into the steps being taken just prior to the erroneous displays on the Virtual Due List (VDL).

    65. 65 PSPO #1483 (cont.) Where Do We Go From Here? The problem was presented on a National BCMA call in order to increase awareness and possibly elicit additional information that would assist in duplicating the scenario. To date this problem cannot be reproduced at will – until that critical piece of information is discovered this issue will remain open. These types of problems are FRUSTRATING to all involved – but with everyone’s help and patience they can be resolved!The problem was presented on a National BCMA call in order to increase awareness and possibly elicit additional information that would assist in duplicating the scenario. To date this problem cannot be reproduced at will – until that critical piece of information is discovered this issue will remain open. These types of problems are FRUSTRATING to all involved – but with everyone’s help and patience they can be resolved!

    66. 66 Changing For The Better Communication and detailed information are incredibly important in trying to determine where a problem stems from. User groups are incredibly helpful in the development of requirements to address deficiencies. So thank you for speaking up and reporting problems!Communication and detailed information are incredibly important in trying to determine where a problem stems from. User groups are incredibly helpful in the development of requirements to address deficiencies. So thank you for speaking up and reporting problems!

    67. 67 Summary Discussed: Mission Goals Roles of IT Patient Safety Evolution of the EHR Cultural shift Release Management process Facility actions Scenarios

    68. Closing In closing I’m sharing a quote from a professor of human factors engineering Kim Vicente. Dr. Vicente says “If technology doesn’t work for people, it doesn’t work. As we move forward if you see something you should say something and report incidents and near misses. Keep the focus on the patient and what I have referred to for years as the front end user. Front end users are the staff working on the front lines, everyday, 24x7 doing their part to care for our nations finest men and women who have served and protected our country. In closing I’m sharing a quote from a professor of human factors engineering Kim Vicente. Dr. Vicente says “If technology doesn’t work for people, it doesn’t work. As we move forward if you see something you should say something and report incidents and near misses. Keep the focus on the patient and what I have referred to for years as the front end user. Front end users are the staff working on the front lines, everyday, 24x7 doing their part to care for our nations finest men and women who have served and protected our country.

    69. 69 Questions

    70. Contacts Bookmark the OHI IT Patient Safety Office Website as a favorite: http://vaww.vhaco.va.gov/ohipatientsafety/ Toni King: toni.king1@va.gov Shirley Lesieur: shirley.lesieur@va.gov Pamela Wright: pamela.wright5@va.gov 70

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