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Dana-Farber Cancer Institute’s Patient Safety Journey: Lessons Learned III Simposio Internacional de Seguridad del Paciente Centro Medico Imbanaco Cali, Colombia Saul N. Weingart, MD, PhD Dana-Farber Cancer Institute & Harvard Medical School Boston, Massachusetts, USA 1 DANA-FARBER ADMITS DRUG OVERDOSE CAUSED DEATH OF GLOBE COLUMNIST, DAMAGE TO SECOND WOMAN 3/23/1995 When 39-year-old Betsy A. Lehman died suddenly last Dec. 3 at Boston's Dana-Farber Cancer Institute, near the end of a grueling three-month treatment for breast cancer, it seemed a tragic reminder of the risks and limits of highstakes cancer care. In fact, it was something very different. The death of Lehman, a Boston Globe health columnist, was due to a horrendous mistake: a massive overdose of a powerful anticancer drug that ravaged her heart, causing it to fail suddenly…. Betsy Lehman Legacy • 1994: 5-fold chemotherapy overdose affecting Betsy Lehman and Maureen Bateman • Discovered on protocol review • Critical media attention and regulatory review 3 Error in oncology: A perfect storm? • • • • • • Aggressive disease Toxic therapies, many novel Vulnerable patients Adverse event vs. clinical end point? Complex regimens and protocols Interdisciplinary and interprofessional care teams • Care distributed over time and place • Production pressure and fiscal constraints 4 DFCI Patient Safety Efforts • Relentless surveillance Including non-punitive reporting and disclosure Hazard Surveillance Event reporting • Staff safety reports • Pharmacy interventions • RCAs, FMEAs Environmental scanning • Literature reviews • Meetings/memberships • Patient safety alerts Executive walk rounds External performance measurement • ISMP • RMF risk assessment • Malpractice claims analysis • Leapfrog survey Research Hazard Surveillance Patient reports • Volunteer rounders • Patient online reporting • Press Ganey surveys • Complaints Internal performance measurement • Department reports • Regulatory readiness • Safety culture survey • Focus groups • IRB/DSMC Clinician-level monitoring • OPPE/FPPE • Credentialing Slide from rL 7 Pharmacy Interventions Intervention Categories Miscellaneous, 25 (11%) Near Miss 43 (19%) Info/Clarification 42 (19%) Clinical Recommendation Protocol Driven 33 (15%) 83 (36%) Total Interventions reported: 226 Safety Culture Survey Results Positively Worded Question Category 2009 % Agree 2010 % Agree Diff 2010 Benchmark When a lot of work needs to be done quickly, we work together as a team to get the work done. Teamwork within units 92 89 -3 85 Supervisor expectations & actions 86 81 -6 76 The actions of hospital management show that patient safety is a top priority. Management support for patient safety 90 88 -2 73 Mistakes have led to positive changes here. Organizational learningimprovement 88 82 -6 63 Overall perceptions 63 64 1 62 Staffing 40 31 -9 54 Teamwork within units 84 80 -4 77 Management support for patient safety 80 83 3 79 We are given feedback about changes put into place based on event reports. Feedback about error 56 53 -3 55 We are informed about errors that happen on this unit or clinic. Feedback about error 49 50 1 62 My supervisor or manager seriously considers staff suggestions for improving patient safety. Patient safety is never sacrificed to get more work done. We have enough staff to handle the workload. In this unit, people treat each other with respect. Hospital management provides a work climate that promotes patient safety. DFCI Patient Safety Efforts • Relentless surveillance • Ongoing information technology (IT) investments Chemotherapy order-entry Electronic medical record Bar coding Smart pumps Oral Chemotherapy Risks • Adherence problematic in high-risk populations Partridge et al., JNCI 2002 • Administration errors common among ALL families Taylor et al., Cancer 2006 • Routine safety precautions not used at 1/3 of US cancer centers; serious AE in past year at 1/4. Weingart et al., BMJ 2007 14 15 Calculator for dose reduction Users have option of choosing calculated doses based on Weight or BSA, or a fixed dose option. Height and Weight pulled from vital signs flowsheet 1) Diagnosis from LMR or pick list 2) Indication is pick list 3) Both can be suppressed by nononcology users 16 16 DFCI Patient Safety Efforts • Relentless surveillance • Ongoing IT investments • Patient/family involvement Incident reporting Medication reconciliation Teamwork training Medication Reconciliation 19 Medication Reconciliation Protocol Collect & Evaluate Providers or Pharmacists Update EMR Patients Update Med Lists CAs Prep Charts CAs Provide Med Lists Medication Reconciliation Monthly Totals 2500 2000 1500 1000 500 Implement Sustain Develop '07 M ar M ay Ju ly '0 7 Se pt No v Ja n '08 M ar ch Ja n No v Ju l '0 6 Se pt ay M ar M '06 Ja n '0 5 0 No v Medication sheets reconciled November 2005 - March 2008 Sheets reconciled 95% CI Teamwork Training for Patients High-Performance Teamwork Training • Promising application in ICU, OR, ER, L&D, other? • Key principles: Appropriate assertiveness Briefing Close-loop communication Situational awareness 25 Revised approach • Campaign rather than education or research • Focus on hazards rather than skills Wrong chemotherapy, last-minute change, hand hygiene • Bringing messages to the patient • Empowerment without obligation “You CAN… check, ask, notify” In 2012, we proudly celebrate Adult Council for 14 years Pediatric Council for 11 years DFCI Patient Safety Efforts • • • • Relentless surveillance Ongoing IT investments Patient/family involvement Research and development Research and Development 34 Amb. oncology medication errors • Prospective cohort study of outpatient infusion units at one cancer center in 2000. • 10,112 medication orders for 1,380 adults and 226 children were reviewed. • The medication order error rate was 3%. 2/3 had the potential to cause harm (none did, most intercepted by pharmacist or nurse). 1/3 related to chemotherapy. Gandhi et al., Cancer 2005 35 Chemotherapy order errors 25% 20% 15% 10% 5% 0% Missed dose Failure to Missing d/c order for parameters held tmt Gandhi et al., Cancer 2005 Failure to use etemplate Teamwork Training for Staff “Change Order” Guidelines Telephone/Page When… •Change in treatment plan Hold chemotherapy- orders must be promptly d/c’d in COE New chemotherapy regimen is started New chemotherapy drug is added Does not include reduction in dose if COE contains specific reason(s) for reduction •New chemotherapy patients •Disease progression •Restart of therapy after significant break •Additional non chemo orders have been entered that day ( i.e. blood transfusions, electrolyte replacement) Guidelines: •Telephone callback is not required once orders are entered Email When… •Use DFCI D10 Charge Nurse for non-urgent needs (greater than 24 hour response time) Charge nurse will deliver message to treating nurse Case Patient arrives for chemotherapy. MD writes to give chemotherapy regardless of counts. ANC returns at 300, well below standard parameters. Pharmacist is uncomfortable and concerned for patient safety so calls MD. MD angrily says to pharmacist, “I said to treat regardless of counts.” 39 Conflict Video Conflict Video 40 DFCI Patient Safety Efforts • • • • • Relentless surveillance Ongoing IT investments Patient/family involvement Research and development Trustee engagement Vulnerabilities Annual • Production pressure • Oral/IV chemotherapy • Complex protocols • Team communication re: patient status & handoffs efenses Risk DAssessment • Offload & redistribute clinical volume • IT improvements (LMR, COE, bar coding, eMAR, Gateway) • Lack of process improvement infrastructure • Safety culture and oversight • Satellite sites • QI/PI skill development Hazards Defenses • Teamwork training 43 Dana-Farber Cancer Institute Patient Safety Timeline Leapfrog Group survey results Conditional Joint Commission posted IHI Mentor hospital accreditation Joint Commission accreditation with commendation 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Next Chemo ADEs Remediation plan Board level quality committee revitalized Hospital and community partnerships Adult PFAC Sentinel Event Policy Medical Error Disclosure Policy Disclosure Pedi PFAC Medical Executive Committee engagement Patient Safety Committee Center for Patient Safety Fair and Just Culture policy Adopt JCAHO Patient Safety Goals MHA Patients First Baldrige assessment Root cause analysis FMEA Pharmacy interventions reported Patient/family volunteer rounding RR FMEaPatient safety rounds Hand hygiene monitoring Electronic safety reporting Extra checks and approvals for high-dose chemo Separate look-alike, sound-alike drugs in pharmacy Specialized training for nurses in new chemo procedures Increased supervision of trainees Patient intervention program in pharmacy records and reports errors and trends COE startup (Standardize protocols; Drug/allergy initiative; Chemo flow sheets) COE major expansion Pediatric templates Pediatric daily and course dosage checking LMR Falls task force PEAR Percipio Bar code wristband pilot Bar code system-wide Inpatient eMAR Key Pediatric Powerchart Culture and infractructure Medication reconciliation Analysis of risk Teamwork training for Surveillance for hazards Patient gateway Improvement initiatives Anticoagulation Oral chemotherapy improvement Outpatient eMAR 44 Outpatient medication errors reaching the patient and requiring monitoring or causing harm, 1997 to 2004. Dosage data captured from pharmacy system. Harm data captured from DFCI incident reporting systems (USP Error Outcome Category D-I). Source: Conway et al., ASCO Education Book 2006. 45 Current priorities • Reduce infection risk for patients and staff • Enhance safety of high-risk therapies (medications and radiation) across the network • Improve teamwork and communication • Enhance quality measurement and reporting • Improve operational efficiencies through the dissemination of performance improvement techniques • Enhance clinician engagement in performance improvement and peer review activities Thank you “Say…What’s a mountain goat doing way up here in a cloud bank?”