VEHU Class 135

1. 1 VEHU Class 135 Quality, Safety, Information Technology and the Computerized Patient Record System August 12, 2010

2. 2 Housekeeping Please turn off or change cell phones to vibrate If you must answer a call or text message, please leave the room Before we get started we need to take care of some Housekeeping issues. This is a XX hour XXXXX session. Please turn off or change your cell phones to vibrate. If you must answer a call, for the convenience of the other participants we ask that you please leave the roomBefore we get started we need to take care of some Housekeeping issues. This is a XX hour XXXXX session. Please turn off or change your cell phones to vibrate. If you must answer a call, for the convenience of the other participants we ask that you please leave the room

3. 3 Housekeeping Please, No questions during the presentation Questions written on a 3X5 card will be answered at the conclusion of the presentation, time permitting All questions and answers will be posted on the Web, including those not answered during class 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. 4 Faculty Donna Kyle, M.S. RPh Chief Pharmacy Service Houston VA Medical Center Shirley Lesieur, B.S. RPh Pharmacist Consultant VHA Office of Health Information IT Patient Safety Nancy R. Smestad, M.S. RPh Pharmacist Consultant VHA Office of Health Information IT Patient Safety

5. 5 Objectives Discuss the role of the electronic medical record in enhancing medication quality and patient safety Describe the purpose of Information Technology (IT) in reducing medication errors Discuss the role of (OHI), IT Patient Safety Office in the responsibilities and reporting structure

6. 6 The Vulnerability of Computerized Provider Order Entry Donna L. Kyle, M.S. RPh

7. 7 Purpose Examine the potential for error in a computerized system Review examples of �near misses� Consider future development needs

8. 8 VA�s Image Transformation Began with the move to Outpatient Care Coupled with the development and implementation of computerized packages Culminated with the Computerized Patient Record System (CPRS)

9. 9 VA Influence Millions of Health Care Dollars are now devoted to development of an integrated system patterned after the VA model Greater automation of information systems is associated with reductions of hospital levels of mortality, complications, and cost

10. 10 Computerized Provider Order Entry (CPOE) Resolves Errors, Right? CPOE and the Electronic Health Record (EHR) should result in safer and more effective patient care Vulnerabilities exist in computerized systems HOW can that be?

11. 11 Effects of Near Misses 2008 VHA Health Services Research and Development (HSR&D) examined pitfalls of computerized order entry VA Medical Center pharmacists were finding potentially harmful errors in order entry Data collected to analyze how this occurred

12. 12 CPRS Ordering Selections Drug Strength Route Frequency Indication Comments

13. 13 Comments Field with Free Text

14. 14 CPRS Display Order View

15. 15 Inpatient Medications View in VistA

16. 16 Inpatient Medications Order View

17. 17 Inpatient Medications Order View

18. 18 CPRS Order Details Display

19. 19 Pending Lidocaine Order

20. 20 CPRS Furosemide Order Details

21. 21 Pending Inpatient Meds Furosemide Order

22. 22 CPRS IV INFUSION

23. 23 IV Infusion Rate

24. 24 Why Does This Occur? Provider cannot find drug strength desired Drug route not found Providers cannot enter complex order or different strengths on different days Lack of computer training by provider Speed of order entry

25. 25 Patient Safety at Risk Pharmacist misses additional directions in comments field Pharmacist cannot reach provider for clarification Medication administration delayed until resolved with provider

26. 26 VA Medical Center Study Findings 0.95% of orders written in study period had inconsistent communication 20% of these errors could have resulted in moderate to severe harm to the patient Certain drug categories were more likely associated with an error

27. 27 Conclusions and Solutions Improve methods for entering the dosage desired Use comments field for clarification Reduce the human errors in communication Continue re-engineering of improved pharmacy order processing

28. 28 Describe the Purpose of Information Technology in Reducing Medication Errors Nancy R. Smestad, M.S. RPh

29. 29 Purpose Address policies and procedures for ensuring patient safety through safe medication practice Provide a environment for end users to share concerns and ideas Allocate resources Address changes in medication use practices and technology. A dedicated team with recognized authority is needed to move initiatives to completion. Development of policies and procedures are crucial to ensure patient safety through safe medication practice. Whether via a medication management team or a medication safety team, the environment should be receptive for end users to present their ideas and concerns. Sites need to ensure the medication safety team encompasses all disciplines and has the time and resources required to investigate all reports.Address changes in medication use practices and technology. A dedicated team with recognized authority is needed to move initiatives to completion. Development of policies and procedures are crucial to ensure patient safety through safe medication practice. Whether via a medication management team or a medication safety team, the environment should be receptive for end users to present their ideas and concerns. Sites need to ensure the medication safety team encompasses all disciplines and has the time and resources required to investigate all reports.

30. 30 Responsibility Focus on system and process solutions Plan for enhancements and future direction Encourage medication error reporting Analyze medication errors in order to improve medication safety 1. Medication Management �Role in medication management will be greatly enhanced in the future. Future: Focus should be on the system and processes involved. Answer questions such as: What software limitations do we live with? What processes can be changed? What are the common errors being made? Analyze work flow before and after implementation/upgrades to improve performance Encourage medication error reporting , self and team monitoring of process. This will allow individuals to identify where improvements are needed and provide a set of procedures to help facilitate change. Encouraging everyone�s participation widens the scope of possible improvements by raising a broad range of issues for consideration. 1. Medication Management �Role in medication management will be greatly enhanced in the future. Future: Focus should be on the system and processes involved. Answer questions such as: What software limitations do we live with? What processes can be changed? What are the common errors being made? Analyze work flow before and after implementation/upgrades to improve performance Encourage medication error reporting , self and team monitoring of process. This will allow individuals to identify where improvements are needed and provide a set of procedures to help facilitate change. Encouraging everyone�s participation widens the scope of possible improvements by raising a broad range of issues for consideration.

31. 31 The problem is never how to get new, innovative thoughts into your mind, It�s how to get the old ones out. Dee Hock, founder of VISA

32. 32 �Just Culture� Behavior Human error At risk behavior Reckless behavior Responses Proactive learning experience Roles The �Just Culture� has been defined as the blameless environment of shared accountability which fosters open and fair reporting, learning from errors, the design of safer systems and management of behavioral choices. It refers to 3 types of behavior: Human error: inadvertent action At risk behavior: A choice that increases risk because it is not recognized or because it is believed to be justified Reckless behavior: A choice to consciously disregard a risk that is substantial and unjustifiable Responses Human error and at risk behavior merits consolation and education �Just culture� creates a proactive learning experience, where ADE�s are viewed not as �something to be fixed� but as opportunities to improve systems and behaviors. To foster a Proactive learning experience it is important to perceive ourselves as having an important role in identifying what needs to be improved, having processes and procedures in place and obtaining positive support and feedback from others in the workplace. Pharmacists considered leaders in the prevention of medication errors and development of a �just culture� due to their responsibility for medication utilization. All disciplines are critically important in the success of the process. The �Just Culture� has been defined as the blameless environment of shared accountability which fosters open and fair reporting, learning from errors, the design of safer systems and management of behavioral choices. It refers to 3 types of behavior: Human error: inadvertent action At risk behavior: A choice that increases risk because it is not recognized or because it is believed to be justified Reckless behavior: A choice to consciously disregard a risk that is substantial and unjustifiable Responses Human error and at risk behavior merits consolation and education �Just culture� creates a proactive learning experience, where ADE�s are viewed not as �something to be fixed� but as opportunities to improve systems and behaviors. To foster a Proactive learning experience it is important to perceive ourselves as having an important role in identifying what needs to be improved, having processes and procedures in place and obtaining positive support and feedback from others in the workplace. Pharmacists considered leaders in the prevention of medication errors and development of a �just culture� due to their responsibility for medication utilization. All disciplines are critically important in the success of the process.

33. 33 Medication Error Reporting Non Punitive environment Do NOT place blame Not WHO but WHAT Look at PROCESS, not PEOPLE: What are the software limitations? What processes can be changed? What are the common errors?

34. 34 Managing Medication Errors Medication errors in Outpatient/Ambulatory Care Medication errors in Inpatient Unit Dose therapy Intravenous therapy Medication errors in Emergency Department

35. 35 Outpatient/Ambulatory Prescription Status Medication Reconciliation �OUTPATIENT MEDICATIONS HOLD STATUS CONFUSING TO PATIENTS AND PROVIDERS� Veterans were discharged from the hospital with a medication list. The list read �HOLD� under the status of outpatient prescriptions for the veterans. Many sites utilize the �HOLD� designation as a workaround to �park� the prescriptions so the prescriptions can be filled and mailed out when the patient requests the prescriptions. � On September 11, 2008 Veteran A was discharged from the hospital with a medication list. The list read �HOLD� under the status for the furosemide prescription and the veteran did not take it. The veteran and his wife interpreted the hold to mean �do not take�. There were two other prescriptions, potassium and trazodone which also appeared on the medication list with a status of �HOLD�. The patient did not take the 3 prescriptions for 6 days. �OUTPATIENT MEDICATIONS HOLD STATUS CONFUSING TO PATIENTS AND PROVIDERS� Veterans were discharged from the hospital with a medication list. The list read �HOLD� under the status of outpatient prescriptions for the veterans. Many sites utilize the �HOLD� designation as a workaround to �park� the prescriptions so the prescriptions can be filled and mailed out when the patient requests the prescriptions. � On September 11, 2008 Veteran A was discharged from the hospital with a medication list. The list read �HOLD� under the status for the furosemide prescription and the veteran did not take it. The veteran and his wife interpreted the hold to mean �do not take�. There were two other prescriptions, potassium and trazodone which also appeared on the medication list with a status of �HOLD�. The patient did not take the 3 prescriptions for 6 days.

36. 36 CPRS ORDER SUMMARY

37. 37 Medication Errors in Inpatient There is a software potential for a pharmacist to edit and finish an inpatient medication order with dispense units = zero. There is a software potential for a pharmacist to edit and finish an inpatient medication order with dispense units = zero.

38. 38 Pharmacy Edit Units/Dose Screen Capture 3: Pharmacy Accepting of Inpatient Medication Order Screen Capture 3: Pharmacy Accepting of Inpatient Medication Order

39. 39 Medication Errors IV IV therapy errors IV delivery IV process Medication errors in IV therapy are 3 times more likely to result in harm to the patient or death. Majority of these errors involve preparation and delivery of IV therapy. The process involves not only the procurement, preparation, and accurate labeling of the medication, but also delivery to the administration site, verification of product and patient identity, accuracy of administration and patient monitoring. Medication errors in IV therapy are 3 times more likely to result in harm to the patient or death. Majority of these errors involve preparation and delivery of IV therapy. The process involves not only the procurement, preparation, and accurate labeling of the medication, but also delivery to the administration site, verification of product and patient identity, accuracy of administration and patient monitoring.

40. 40 Medication Errors Emergency Dept Methodology Medication reconciliation Role of technology in the solution Ensuring pharmacists review orders prior to dispensing and administration. Address the issues and difficulties. If a patient is receiving medication not documented in CPRS, emergency dept. providers would be unaware the patient is receiving the medication and could prescribe medication adverse to the patients condition. Emergency providers assume Medication Reconciliation documentation encompasses all medications and it may not.Ensuring pharmacists review orders prior to dispensing and administration. Address the issues and difficulties. If a patient is receiving medication not documented in CPRS, emergency dept. providers would be unaware the patient is receiving the medication and could prescribe medication adverse to the patients condition. Emergency providers assume Medication Reconciliation documentation encompasses all medications and it may not.

41. 41 Report on an Event Methadone Treatment Clinic and Reported Scenario Overview of the event How did this occur? Why did this occur? Role of Technology in the solution The initial report involved a Methadone clinic patient receiving 70mg of methadone while also undergoing chemotherapy who was subsequently seen in a VA facility emergency dept. The medication reconciliation note did not include the methadone the patient was receiving from the methadone clinic, thus the emergency dept. provider was unaware the patient was receiving methadone. Methadone clinic medications do not appear in the CPRS medication reconciliation note or the pharmacy report for the PCP. The software utilized in methadone treatment clinics is a COTS product which does not interface with CPRS or VisTA. The reporting facility was documenting the methadone treatment clinic medication only in the COTS software and not including any entry for the patient in CPRS. Since CPRS is the VHA�s recognized primary record, providers outside of the Methadone clinic would assume that they have access to all relevant data concerning the patient�s current therapy.The initial report involved a Methadone clinic patient receiving 70mg of methadone while also undergoing chemotherapy who was subsequently seen in a VA facility emergency dept. The medication reconciliation note did not include the methadone the patient was receiving from the methadone clinic, thus the emergency dept. provider was unaware the patient was receiving methadone. Methadone clinic medications do not appear in the CPRS medication reconciliation note or the pharmacy report for the PCP. The software utilized in methadone treatment clinics is a COTS product which does not interface with CPRS or VisTA. The reporting facility was documenting the methadone treatment clinic medication only in the COTS software and not including any entry for the patient in CPRS. Since CPRS is the VHA�s recognized primary record, providers outside of the Methadone clinic would assume that they have access to all relevant data concerning the patient�s current therapy.

42. 42 Medication-Use Quality Safe Effective Patient-centered Efficient Equitable Timely Harm free, preventable errors are avoided Desired outcomes are achieved Patient prioritized over provider or organizational needs Avoids waste Disparities do not exist Influence of wait times on outcomes, safetyHarm free, preventable errors are avoided Desired outcomes are achieved Patient prioritized over provider or organizational needs Avoids waste Disparities do not exist Influence of wait times on outcomes, safety

43. 43 Role in IT Patient Safety Informatics Automated dispensing Software enhancements Medication management Informatics RPH � analyze software for issues and assist in determining software solns. Ensuring software facilitates safety for users without work-arounds and ultimately increases patient safety and reduces medication errors. Automated Dispensing � Informatics RPH is key to automated dispensing, maintaining databases, software interface, set up and ensuring seamless interface between automation and pharmacy software. Medication Management � technician role is expanding beyond dispensing, ward stocking, patient inquiry, to more clinical roles. Role in medication management will be greatly enhanced in the future. Future: What software limitations do we live with? What processes can be changed? What are the common errors being made? Informatics RPH � analyze software for issues and assist in determining software solns. Ensuring software facilitates safety for users without work-arounds and ultimately increases patient safety and reduces medication errors. Automated Dispensing � Informatics RPH is key to automated dispensing, maintaining databases, software interface, set up and ensuring seamless interface between automation and pharmacy software. Medication Management � technician role is expanding beyond dispensing, ward stocking, patient inquiry, to more clinical roles. Role in medication management will be greatly enhanced in the future. Future: What software limitations do we live with? What processes can be changed? What are the common errors being made?

44. 44 Medication Errors and IT Patient Safety Drug error prevention Cost of medication errors Institute of Medicine Institute of Safe Medication Practices National Patient Safety Goals IOM report entitled �To err is Human� suggested between 44,000 and 98,000 people die each year as a result of medical misadventures. Early studies estimated that about 7,000 people die each year because of medication errors. Health care agencies have turned their attention to medication safety activities. The medication-use process is quite complex. National hospital expenses to treat patients who suffer ADE�s during hospitalization are estimated to be between 1.56 and 5.6 billion annually. ISMP provides suggestions relative to reported medication errors and resolution as well as reported software errors. One reported software error discovered by an informatics RPH was an enhancement to the software would help identify by color change on the BCMA important medications that weren�t administered within a certain timeframe. This enhancement resulted in discontinued medications remaining ACTIVE on the BCMA VDL. As an example DC�d enoxaparin order remained active along with the new enoxaparin order. The nurse could have administered both medications to the patient. National Patient Safety Goals � TJC has just developed the revised national patient safety goals for medication reconciliation. Established in 2002 to help accredited organizations address specific areas in regards to patient safety. Several examples include patient identification using 2 Pt. Identifiers, improve safe use of medications such as ensuring medications drawn up in operating rooms are labeled or in the unit of use format, and reduce the likely hood of harm relative to anticoagulation therapyIOM report entitled �To err is Human� suggested between 44,000 and 98,000 people die each year as a result of medical misadventures. Early studies estimated that about 7,000 people die each year because of medication errors. Health care agencies have turned their attention to medication safety activities. The medication-use process is quite complex. National hospital expenses to treat patients who suffer ADE�s during hospitalization are estimated to be between 1.56 and 5.6 billion annually. ISMP provides suggestions relative to reported medication errors and resolution as well as reported software errors. One reported software error discovered by an informatics RPH was an enhancement to the software would help identify by color change on the BCMA important medications that weren�t administered within a certain timeframe. This enhancement resulted in discontinued medications remaining ACTIVE on the BCMA VDL. As an example DC�d enoxaparin order remained active along with the new enoxaparin order. The nurse could have administered both medications to the patient. National Patient Safety Goals � TJC has just developed the revised national patient safety goals for medication reconciliation. Established in 2002 to help accredited organizations address specific areas in regards to patient safety. Several examples include patient identification using 2 Pt. Identifiers, improve safe use of medications such as ensuring medications drawn up in operating rooms are labeled or in the unit of use format, and reduce the likely hood of harm relative to anticoagulation therapy

45. 45 Institute of Medicine Reports on Medical Errors Medication use Adverse drug events Medication harm 4 out of 5 adults use medications, Rx, OTC, dietary and/or herbal 1/3 of adults take 5 or more different medications ADE are common and costly Medications harm 1.5 billion people per year In hospitals there are at least 400,000 preventable ADE per year which approximates 1 medication error per patient per day. 4 out of 5 adults use medications, Rx, OTC, dietary and/or herbal 1/3 of adults take 5 or more different medications ADE are common and costly Medications harm 1.5 billion people per year In hospitals there are at least 400,000 preventable ADE per year which approximates 1 medication error per patient per day.

46. 46 Goals Deliver safe patient care Improve end user confidence in the software and automated dispensing systems Reduce non-compliance at the Point of Care Develop/implement �best practices� and share with others

47. 47  Discuss the IT Patient Safety Office�s Roles, Responsibilities, and Reporting Structure  Shirley Lesieur, B.S. RPh

48. 48 IT PATIENT SAFETY OFFICE Place in the organization Mission History Background information on each of these sub-topicsBackground information on each of these sub-topics

49. 49 IT Patient Safety is a component of the Healthcare Information Office at VACO which also encompasses among other things Library Services, 508 compliance, Bar Code Resource Office. This chart was copied from the OI Leadership Intranet site.IT Patient Safety is a component of the Healthcare Information Office at VACO which also encompasses among other things Library Services, 508 compliance, Bar Code Resource Office. This chart was copied from the OI Leadership Intranet site.

50. 50 IT Patient Safety�s Mission Established to provide leadership and direction for safe and effective IT systems that support the delivery of health care Actively promote a culture of safety within health care IT systems by collaborating with VHA program offices, VA medical facilities, and public and private health care organizations

51. 51 As the program evolved the office Surveyed best practices from VA and external organizations Recognized the importance of Human Factors Engineering principles and the need to incoporate them into software design Provide OI wide trainingAs the program evolved the office Surveyed best practices from VA and external organizations Recognized the importance of Human Factors Engineering principles and the need to incoporate them into software design Provide OI wide training

52. 52 1- Definition: a collection of values and beliefs that are shared/held across the organization 2- VHA has demonstrated its commitment to patient safety by allocating resources with the establishment of the National Center for Patient Safety (NCPS) and OHI IT Patient Safety Office as well as encouraging the development of clinical software incorporating best practices and clinical decision support thus promoting safe patient care. 3- Non-punitive mechanisms to report errors and near misses are available through NCPS and IT issues can be flagged as �Potential Patient Safety� issues within Remedy�. Reporting is encouraged and educational opportunities to �spread the word� are seized at conferences such as VeHU 1- Definition: a collection of values and beliefs that are shared/held across the organization 2- VHA has demonstrated its commitment to patient safety by allocating resources with the establishment of the National Center for Patient Safety (NCPS) and OHI IT Patient Safety Office as well as encouraging the development of clinical software incorporating best practices and clinical decision support thus promoting safe patient care. 3- Non-punitive mechanisms to report errors and near misses are available through NCPS and IT issues can be flagged as �Potential Patient Safety� issues within Remedy�. Reporting is encouraged and educational opportunities to �spread the word� are seized at conferences such as VeHU

53. 53 Dr. James Bagian, VHA Chief Patient Safety Officer co-authored an article describing the journey toward a safe culture within VHA. VHA. DATA SOURCES: VHA documents, congressional testimony, the medical literature, the general press, and personal communications. Dr. James Bagian, VHA Chief Patient Safety Officer co-authored an article describing the journey toward a safe culture within VHA. VHA. DATA SOURCES: VHA documents, congressional testimony, the medical literature, the general press, and personal communications.

54. 54 Role of IT Patient Safety Analysis Collaboration Coordination Communication Moving Forward Our role focuses on the Electronic Health Record, supporting the provision of a safe clinical environment for patient care. How do we do that? Our role focuses on the Electronic Health Record, supporting the provision of a safe clinical environment for patient care. How do we do that?

55. 55 ANALYSIS Remedy� tickets National Center for Patient Safety Pharmacy Benefits Management Veterans Health Administration Management Analysis � we retrospectively review reported software issues which may have a potential patient safety consequence using a formal assessment tool which evaluates the severity, frequency and detectability to determine its potential impact on patient care. We categorize the risk as Low, Moderate or High. Issues are brought to our attention from various sources the principle one being Remedy�. Analysis � we retrospectively review reported software issues which may have a potential patient safety consequence using a formal assessment tool which evaluates the severity, frequency and detectability to determine its potential impact on patient care. We categorize the risk as Low, Moderate or High. Issues are brought to our attention from various sources the principle one being Remedy�.

56. 56 Collaboration/Coordination National Center for Patient Safety Pharmacy Benefits Management software development Clinical support teams Requirements Analysis and Engineering Management Our office actively participates with other offices within VHA as well as with OI&T to provide guidance documents such as NCPS Advisories/Alerts or PBM Notices. We work in partnership with various workgroups during the development of corrective patches and software enhancement projects as well as providing a risk assessment for all submitted NSRs.Our office actively participates with other offices within VHA as well as with OI&T to provide guidance documents such as NCPS Advisories/Alerts or PBM Notices. We work in partnership with various workgroups during the development of corrective patches and software enhancement projects as well as providing a risk assessment for all submitted NSRs.

57. 57 Communication Education Workgroup conference calls We actively participate as presenters at national conferences such as VeHU, Pharmacy Informatics, National PSO/PSM conference etc. Our office has contacts at all levels of the organization and we provide resources such as Human Factors Engineering expertise as needed. We also communicate adverse events up the chain to OHI and VHA leadership as appropriate.We actively participate as presenters at national conferences such as VeHU, Pharmacy Informatics, National PSO/PSM conference etc. Our office has contacts at all levels of the organization and we provide resources such as Human Factors Engineering expertise as needed. We also communicate adverse events up the chain to OHI and VHA leadership as appropriate.

58. 58 Moving Forward Office of Health Information IT Patient Safety Steering Board Human factors principles 1- A steering/oversight board was established in 2010: The Board will recommend policies and provide advice and guidance on system-wide patient safety concerns involving Veterans Health Information Systems and Technology Architecture (VistA) and VHA's next generation electronic health record. The Board will provide strategic direction to address clinical and operational patient safety IT issues. The Board will be an advisory to the Director of OHl's Patient Safety Program and to OHI, and will include membership from: a. Patient Care Services; b. Chief Nursing Office; c. Chief Business Office; d. Deputy Under Secretary for Health for Operations and Management; e. National Center for Patient Safety (NCPS); f. Veterans Integrated Service Network (VISN) Clinical Managers; g. Facility Patient Safety Coordinators; and h. OHI and VA IT staff. 2- Promote best practices by including formal usability testing, user-centered design process and providing expertise in usability engineering as feasible 3- Support the role of end users as a central players in the the development process. Usability needs to be a primary driver of efficient, effective and safe EHRs. 1- A steering/oversight board was established in 2010: The Board will recommend policies and provide advice and guidance on system-wide patient safety concerns involving Veterans Health Information Systems and Technology Architecture (VistA) and VHA's next generation electronic health record. The Board will provide strategic direction to address clinical and operational patient safety IT issues. The Board will be an advisory to the Director of OHl's Patient Safety Program and to OHI, and will include membership from: a. Patient Care Services; b. Chief Nursing Office; c. Chief Business Office; d. Deputy Under Secretary for Health for Operations and Management; e. National Center for Patient Safety (NCPS); f. Veterans Integrated Service Network (VISN) Clinical Managers; g. Facility Patient Safety Coordinators; and h. OHI and VA IT staff. 2- Promote best practices by including formal usability testing, user-centered design process and providing expertise in usability engineering as feasible 3- Support the role of end users as a central players in the the development process. Usability needs to be a primary driver of efficient, effective and safe EHRs.

59. 59 No Allergy Order Checks A Case Scenario Drug ingredient VA drug class VistA patch GMRA*4*17 VistA patch GMRA*4*20 Patient safety advisory AD-06 (11/17/05) In the beginning, a review of identified Allergy Order check issues and some of the �tools� available to reduce the risk. Problems related to the lack of an allergy order check were first reported in NOIS (our old software problem tracking program). All the way back to 1998 problems were starting to be reported that order check were not being triggered appropriately. Important basics: DRUG INGREDIENT: A file (#50.416) which contains generic drugs which are components of various drug products. VA DRUG CLASS: A file (#50.605) which contains the VA Drug Classification codes and their descriptions. Each drug product in the National Drug file is assigned a primary code which is part of the information stored for each drug product in the National Drug file. Some of the early PATCHES released to correct deficiencies: GMRA*4*17 � was designed to identify and correct �free text� entries. Because the free text entries did not necessarily match anything and often had missing information it was not unusual to see reports of missing Allergy/Drug order checks. A subsequent CPRS patch eliminated the ability to enter �free text� allergies. GMRA*4*20 � released September �06. This patch updated the free text utility that was distributed in patch GMRA*4*17 so that it can now be used to identify ingredient file based and drug class file based allergies. AD-06 � NCPS ADVISORY document Alerted the field to the fact that VistA package allergy file (120.8) may have allergy entries that have been accidentally entered without a VA drug class - when a drug class entry was appropriate resulting in the lack of an Allergy/Drug order check. At that time the recommendations were pretty much asking sites to be aware of the problem and to be vigilant. They also reported that a patch was in development to address this issue � subsequently released as GMRA*4*20. In the beginning, a review of identified Allergy Order check issues and some of the �tools� available to reduce the risk. Problems related to the lack of an allergy order check were first reported in NOIS (our old software problem tracking program). All the way back to 1998 problems were starting to be reported that order check were not being triggered appropriately. Important basics: DRUG INGREDIENT: A file (#50.416) which contains generic drugs which are components of various drug products. VA DRUG CLASS: A file (#50.605) which contains the VA Drug Classification codes and their descriptions. Each drug product in the National Drug file is assigned a primary code which is part of the information stored for each drug product in the National Drug file. Some of the early PATCHES released to correct deficiencies: GMRA*4*17 � was designed to identify and correct �free text� entries. Because the free text entries did not necessarily match anything and often had missing information it was not unusual to see reports of missing Allergy/Drug order checks. A subsequent CPRS patch eliminated the ability to enter �free text� allergies. GMRA*4*20 � released September �06. This patch updated the free text utility that was distributed in patch GMRA*4*17 so that it can now be used to identify ingredient file based and drug class file based allergies. AD-06 � NCPS ADVISORY document Alerted the field to the fact that VistA package allergy file (120.8) may have allergy entries that have been accidentally entered without a VA drug class - when a drug class entry was appropriate resulting in the lack of an Allergy/Drug order check. At that time the recommendations were pretty much asking sites to be aware of the problem and to be vigilant. They also reported that a patch was in development to address this issue � subsequently released as GMRA*4*20.

60. 60 CPRS v25 �bug� VistA patch GMRA*4*21 Adverse reaction tracking option �Free Text Utility� An additional issue was identified in July 2007. A patient had a documented allergy to Iodine, the provider ordered a drug with Iodine listed as an ingredient � the expected alert was not triggered. Investigation at that time determined that Allergies entered through the CPRS GUI pulled data from the wrong file for a limited number of items and subsequently the Ingredient field and VA DRUG CLASS were not populated. RESOLVED Patch GMRA*4*21 included an update to all IODINE entries and provided a list of patients so that the data could be reviewed. An additional issue was identified in July 2007. A patient had a documented allergy to Iodine, the provider ordered a drug with Iodine listed as an ingredient � the expected alert was not triggered. Investigation at that time determined that Allergies entered through the CPRS GUI pulled data from the wrong file for a limited number of items and subsequently the Ingredient field and VA DRUG CLASS were not populated. RESOLVED Patch GMRA*4*21 included an update to all IODINE entries and provided a list of patients so that the data could be reviewed.

61. 61 Health Data Repository (HDR) VistA patch GMRA*4*29 Patient safety alert AL08-12 (3/08) With the advent of the HDR it was important to standardize all the data files so that they could be accurately shared across the system. Unfortunately many �free text� allergy entries still existed in individual databases. GMRA*4*29 provided additional functionality and was released in May 2007. If the free text allergy reactant was found in the conversion matrix then the allergy entry was updated to the associated reactant from the matrix. If the free text allergy reactant was not found in the matrix or if updating the reactant would cause a duplicate entry then the free text reactant was updated to include the phrase ( FREE TEXT ) after the reactant. This serves as a visual cue that the allergy is a free text entry and will not be considered during order checking. PATIENT SAFETY ALERT AL08-12 Problems related to free text entries continued to be reported to NCPS and an ALERT was issued reminding facilities that these entries would not trigger ALERTS. The facilities were instructed to run the Allergy Clean UP utility and report the results back to NCPS. Additionally they were instructed to resolve any entries on the list and report back when the task was completed. With the advent of the HDR it was important to standardize all the data files so that they could be accurately shared across the system. Unfortunately many �free text� allergy entries still existed in individual databases. GMRA*4*29 provided additional functionality and was released in May 2007. If the free text allergy reactant was found in the conversion matrix then the allergy entry was updated to the associated reactant from the matrix. If the free text allergy reactant was not found in the matrix or if updating the reactant would cause a duplicate entry then the free text reactant was updated to include the phrase ( FREE TEXT ) after the reactant. This serves as a visual cue that the allergy is a free text entry and will not be considered during order checking. PATIENT SAFETY ALERT AL08-12 Problems related to free text entries continued to be reported to NCPS and an ALERT was issued reminding facilities that these entries would not trigger ALERTS. The facilities were instructed to run the Allergy Clean UP utility and report the results back to NCPS. Additionally they were instructed to resolve any entries on the list and report back when the task was completed.

62. 62 Allergy Order Checks Remain an issue in 2010 Patient safety alert AL10-08 (3/10) New Service Request (NSR) 20080704 Subsequent to additional reports of incidents related to the lack of Allergy/Drug order checks NCPS distributed AL10-08: A review of Safety Reports and Aggregated Review Log events entered into the VHA Patient Safety Information database shows similar situations have occurred. A sampling of records at three VA Medical Centers revealed that thousands of allergies/ADRs (referred to as causative agents in CPRS and reactants in Veteran?s Health Information Systems and Technology Architecture [VistA]) have been documented as ingredients � not drugs � in Veterans? medical records, with penicillin being the most frequently identified reactant. This means these patients would not have Drug-Allergy order checks triggered to warn clinicians about potential serious allergic reactions if a different drug is ordered within the same drug family. Additionally it was found that there is great variation among sites as to which order checks are enabled. On 5/12/2010 CPRS Clinical Workgroup Recommendations: Endorsed recommendation to distribute guidance advising sites to make the following three alerts mandatory and uneditable: Critical Drug Interaction, No Allergy Assessment and Allergy-Drug Interaction. This will be addressed with a POLICY document distributed by ???? LONG TERM � NSR NSR# 20080704 has the following business goal: Incorporate a chemical classification system into the current Adverse Reaction Tracking (ART) or allergy system to provide Veterans an allergy documentation system that can provide alerts for allergies to drugs of a similar chemical structure. This will lead to fewer adverse reactions and will increase usefulness of the documented allergy information. The Adverse Reaction Tracking (ART) or allergy system is also noncompliant with CHI/HITSP standards. Adapting CHI/HITSP standards will make the sharing of information with outside sources more accurate. Our process requires patience as we incrementally improve patient care. As we move forward we are striving to include user-centered design to improve the user interface thus ideally decreasing the opportunity for �misadventures�. Subsequent to additional reports of incidents related to the lack of Allergy/Drug order checks NCPS distributed AL10-08: A review of Safety Reports and Aggregated Review Log events entered into the VHA Patient Safety Information database shows similar situations have occurred. A sampling of records at three VA Medical Centers revealed that thousands of allergies/ADRs (referred to as causative agents in CPRS and reactants in Veteran?s Health Information Systems and Technology Architecture [VistA]) have been documented as ingredients � not drugs � in Veterans? medical records, with penicillin being the most frequently identified reactant. This means these patients would not have Drug-Allergy order checks triggered to warn clinicians about potential serious allergic reactions if a different drug is ordered within the same drug family. Additionally it was found that there is great variation among sites as to which order checks are enabled. On 5/12/2010 CPRS Clinical Workgroup Recommendations: Endorsed recommendation to distribute guidance advising sites to make the following three alerts mandatory and uneditable: Critical Drug Interaction, No Allergy Assessment and Allergy-Drug Interaction. This will be addressed with a POLICY document distributed by ???? LONG TERM � NSR NSR# 20080704 has the following business goal: Incorporate a chemical classification system into the current Adverse Reaction Tracking (ART) or allergy system to provide Veterans an allergy documentation system that can provide alerts for allergies to drugs of a similar chemical structure. This will lead to fewer adverse reactions and will increase usefulness of the documented allergy information. The Adverse Reaction Tracking (ART) or allergy system is also noncompliant with CHI/HITSP standards. Adapting CHI/HITSP standards will make the sharing of information with outside sources more accurate. Our process requires patience as we incrementally improve patient care. As we move forward we are striving to include user-centered design to improve the user interface thus ideally decreasing the opportunity for �misadventures�.

63. 63 Questions