Establishing a Culture of Safety in the Prevention of Medication Errors Margherita Labson, RN, MSHSA, CPHQ Barbara S. Prosser, RPh Jamie Tharp, PharmD Disclosures The speakers declare no conflicts of interest or financial interest in any service or product mentioned in this program. Clinical trials and off label/investigational uses will not be discussed during this presentation. Objectives Discuss three organizational structures required to establish and maintain a culture of safety Describe the process of conducting a medication error root cause analysis within the alternate site infusion setting Describe how LEAN principles were utilized in conducting safety event review and subsequent performance improvement process 2015 NHIA Annual Conference & Exposition 1
At the root of most medical errors: Human Factors Leadership Communication Characteristics of organizations that successfully manage serious hazards well Preoccupation with failure Reluctance to simplify interpretation Sensitivity to operations Commitment to resilience Deference to expertise The 3 Imperatives of A Safety Culture Leadership High Reliability RPI Trust Improve Report Safety Culture 2015 NHIA Annual Conference & Exposition 2
Understanding Culture Artifacts and Practices Norms and Behavior Patterns Values-Beliefs Assumptions Roles and Responsibilities Leadership Management Direct Care Staff Accountability Commitment that safety is a priority Visibility Engagement Regular training Effective Communication Standardization Operationalizing the Culture: Self management: Using credible metrics: Measuring outcomes: 2015 NHIA Annual Conference & Exposition 3
Renewing Your Focus on Medication Safety in Home and Specialty Infusion Barbara S. Prosser, RPh V.P. of Regulatory and Compliance, Soleo Health Creating a Corporate Culture of Improvement Improvement rather than accusation Creativity rather than fear Empowerment rather than exclusion Teamwork rather than isolation Never a punitive process The Root Cause Analysis ( RCA) Element of the RCA Who, What, When Overlay of expected process on the event Contributing factors Analysis Action Plan 2015 NHIA Annual Conference & Exposition 4
Elements of the RCA Who, What, When... Who was involved Include everyone from the branch to the clinician to outside agencies/vendors What happened? Details, Details, Details Time of day, Time of year, Time of month Process Overlay What happened vs what should have happened? Detail the expected process Where variances happened Where breakdowns/barriers Where factors came in to play Contributing Factors What contributed to the series of events Controllable Stress Time management Human (policy adherence, multitasking, fatigue) Uncontrollable Environmental (noise, phones) Equipment failure Systemic (Leadership) 2015 NHIA Annual Conference & Exposition 5
Contributing Factors What contributed to the series of events? Systemic (Leadership) Human Resources Staffing, Competency Training Culture Are employees comfortable bringing issues forward Is there a process Analysis So what do you think really happened? Collaborated effort Get everyone s perspective Explore every detail Leave no stone unturned Action Plan Develop an action plan for each factor identified in your analysis Map out a plan for action Incorporate it in your PI program Evaluate the success of the actions Retool as necessary 2015 NHIA Annual Conference & Exposition 6
Tips for Conducting the RCA Present as a non punitive process Give a copy of the RCA template to everyone that was involved in the event, include staff and leadership Have each person complete the RCA form independently to gain each person s perspective Tips for Conducting the RCA Have a facilitator compile the individual reports Facilitator is generally a risk management staff member or PI Chair Re convene as a group and review the finding Collectively and collaboratively develop the action plan Implement change The RCA Tool 2015 NHIA Annual Conference & Exposition 7
The RCA Tool RCA Experiences Medication error Wrong elastomeric device On call breakdown ET called home, not the service Establishing a Culture of Safety in the Prevention of Medication Errors Applying LEAN Principles to a Patient Safety Program Jamie Tharp, PharmD Operations Pharmacy Manager 2015 NHIA Annual Conference & Exposition 8
What is LEAN Healthcare? LEAN is a process management philosophy developed in manufacturing and translated to the healthcare realm Fundamentals of LEAN include Standardized processes Employee empowerment to stop the work Employee engagement in identifying and solving problems Iterating toward a target/goal (PDCA) Reducing Inefficiencies Maintaining order Visual queues at work station Safety Program Definitions Category System NCC MERP 1 Medication Error Categories 2 A I Product A product includes medication, formula, supply, or equipment Safety Events Encompasses process problems, staff actions, and technology issues that result in inaccuracies in any product or service. Includes both near misses (Cat B) and errors (Cat C I). 1 NCC MERP= National Coordinating Council for Medication Error Reporting and Prevention 2 Categories= A (no error but risk), B (Error, Didn t reach patient), C D (Error, No Harm), E H (Error, Harm), I (Error, Death) History of HomeMed s Safety Program Began in FY 2002 43 Safety Events reported in the entire year 2011 Leadership charge to create a formal safety program Multidisciplinary committee with representatives from every operational area Significant increase in staff engagement in near miss event reporting 2015 NHIA Annual Conference & Exposition 9
New LEAN Evaluation Method is Designed Improves event evaluation and analysis by Managing data avalanche Improve consistency of event categorization (with multiple reviewers) Event review efficiency Tracking, Trending, and PI identification Life of a Prescription became the foundation Uses LEAN thinking to map the processes involved in prescribed (ordered) patient care Life of a Prescription Process Steps Prescribing Transcription Transmission Communication /Coordination Inventory Management Fill Processing Translation/ Transcribing Assessment Order Preparation Order Review Order Delivery Education Monitoring Home Event BEFORE Process Focused Analysis AFTER Medication Error Type Outcome vs. Process Medication Error Type Outcome vs. Process Compliance Error Catch All Administration Process Compounding Error Process Assessment Process Damaged/Unusable/Expired/Etc. Outcome Communication/Coordination Process Discontinued/On-hold Med Given Outcome Delivery Process Dose Given Late Outcome Education Process Dose Not Given Outcome Fill Processing Process Extra Dose/Duplication Outcome Inventory Management Process Improper Storage Condition Process Monitoring Process Incompatible Drugs/Stability Issue Outcome Order Preparation Process Labeling Error Process Prescribing Process Monitoring Error Process Review Process Other Medication Error Catch All Transcription Process Translation/Transcribing (Rx Process Prescriber Error Process Creation/Modification) Pump Program Error Process Transmission Process Unauthorized Drug Error Outcome Wrong Administration Technique Process Wrong Dosage Form Error Outcome Wrong Dose/Volume Outcome Wrong Frequency Outcome Wrong Medication Outcome Wrong Patient Outcome Wrong Rate Outcome Wrong Vehicle Outcome 2015 NHIA Annual Conference & Exposition 10
Putting Our Report to Work Safety events are manually reviewed and categorized by a team of trained clinicians Trends are summarized and reported to the Patient Safety Committee monthly Putting Our Results to Work Program Management & In Process Data Collection Dramatic increase in event reporting required additional resources: Dedicated Pharmacist Champion Med Management Intern (year round) 2 Manager reviewers No fancy dashboards Gathering data from a manual process Focused audits Heijunka Box 2015 NHIA Annual Conference & Exposition 11
Summarize Share Influence Attitudes Get Your Data Working Build a Solid Foundation Phase 1 Build a Solid Foundation Process Standardization Using LEAN tools Staff involvement in developing standards Break down, simplify standardized processes Visual tool to help all staff remember the essential steps to validating a patient order Applicable for: ALL Operational Areas 2015 NHIA Annual Conference & Exposition 12
Phase 3 Who Does What? Double checks aren t LEAN, but humans aren t perfect Focused checks in process steps Hold staff accountable by standardizing documentation Staff Reaction to Standardization Before they buy in I am good at my job, why do I have to standardize? Standardizing slows me down Standardizing may help that slow or new person Getting buy in Share errors, discuss root cause, discuss solutions Standardize together Accountability breaking old habits is hard After they buy in We have standardized, why haven t they? It is easier to understand my tasks and responsibilities Other areas Can we have that same kind of tool? Excellence is an art won by training and habituation. We do not act rightly because we have virtue or excellence, but we rather have those because we have acted rightly. We are what we repeatedly do. Excellence, then, is not an act but a habit. Aristotle Ancient Greek philosopher, scientist and physician, 384 BC 322 BC 2015 NHIA Annual Conference & Exposition 13
Using Data/Staff feedback Fill Processing Transcription/Translation Data entry mistakes lack of template standardization manual data field searching 2012 Order entry templates were standardized into checklist like format 2013 Software enhancement allows staff to tab to key data entry fields < > Using Data/Staff feedback Order Entry/ Mixing Report Standardization Eliminated Narrative Created Checklist Automated dilution instructions 350 Templates updated New Data Monitoring Type Using Data/Staff Feedback Order Preparation Wrong Volume Events Implemented a time out process for the Clean Room 2015 NHIA Annual Conference & Exposition 14
Low Cost Solutions Order Prep Setup Error Intervention Using Data/Staff Feedback Order Delivery Events Forgotten packages from staging chaos Borrowed equipment to try out before $$ Conclusion Employee Engagement can drive dramatic increase in Safety Event Reporting Interventions: Interdisciplinary Safety Committee Event sharing Immediate through e mail to managers, pharmacists, safety group Monthly summary reports shared at area meetings Reports trigger process improvements Challenges: Data avalanche Completing the PDCA cycle Time for proactive interventions 2015 NHIA Annual Conference & Exposition 15
Our Staff are the Safety, LEAN Champions* Clinical Teams Safety Reviewers Inventory & Distribution Patient Safety Committee Members: Jimmy Arnold, Andre Brown, Joan Daniels, Dana Iocoangeli, Lisa Klein, Jenny Kolberg, Jason Moore, Janaki Naickar, Hitesh Patel, Lyman Robertson, Elizabeth Sayler, Mary Schrotenboer, Tricia Sirois, Sean Squires, Adam Stolt, Jamie Tharp, and Jeff Wood Clean Room Training Team In Home Nurses * Unable to photograph all staff members involved in our safety program Acknowledgements Special Thanks to HomeMed Safety Event Reviewers Lisa Klein, PharmD Elizabeth Sayler, PharmD Jenny Kolberg, PharmD Candidate 2017 Co author of the Life of a Prescription Deven Millay, PharmD Candidate 2015 Questions? Please feel free to contact me at jcburke@med.umich.edu 2015 NHIA Annual Conference & Exposition 16