Laura M. Lee, R.N. Clinical Center, NIH The Epidemiology of Clinical Errors in a Research Hospital: Mining Occurrence Reporting Data for Mining Occurrence.

Slides:



Advertisements
Similar presentations
NABH AND NURSES CONTRIBUTION TO QUALITY
Advertisements

National Reporting & Learning System (NRLS) Reporting systems are vital in providing a core of sound, representative information on which to base analysis.
Patient Safety What is it? Why is it important? What are we doing? What is my part to play?
Conducting Patient Safety Rounds with Staff. First Steps Set the stage –Unit and Hospital Leadership Support –Identify a “champion(s)” for each unit where.
What IMPACT Means to Physicians November 2014 Physician Champion: William Bradshaw, MD, FACS.
Continuity of Medication Management Medication Reconciliation: Beyond Admission Hospital Presenter Month YYYY.
Update on Therapies: Clinical Trials Timothy PM Whelan Assistant Professor of Medicine Medical Director, Interstitial Lung Disease Program University of.
Protecting patients- now and in the future Linda Matthew Senior Pharmacist National Patient Safety Agency.
Topic 1 What is patient safety?. Understand the discipline of patient safety and its role in minimizing the incidence and impact of adverse events, and.
Capturing and Reporting Adverse Events in Clinical Research
Clinical Information Systems HINF Medical Methodologies Session 5.
The Nature of Errors Richard M. Satava, MD FACS Professor of Surgery University of Washington School of Medicine and Program Manager, Advanced Biomedical.
The New Patient Safety Net How to enter a report.
Laboratory Management - 1
Implementing and Evaluating a Program of Patient Safety Katherine Jones, PhD, PT Anne Skinner, RHIA Gary Cochran, PharmD Keith Mueller, PhD Supported by.
2014 Summit Co-Convener:Founder: Patient Safety Science & Technology Summit 2014.
Unit 6b: Clinical Decision Support Systems that Help Improve Quality Decision Support for Quality Improvement This material was developed by Johns Hopkins.
Unit 6.2: Clinical Decision Support Systems that Help Improve Quality Decision Support for Quality Improvement Component 12/Unit 6.21Health IT Workforce.
Safety data collected during clinical trials is incorporated into the product’s approved label. Regulatory reviewers monitor products’ safety profiles.
By Ruth Kavita Senior Pharmaceutical Technologist, KNH.
Risk Management - the process of identifying and controlling hazards to protect the force.  It’s five steps represent a logical thought process from.
EMERGENCY ROOM OF THE FUTURE LEVERAGING IT AT WELLSTAR HEALTH SYSTEM: KENNESTONE EMERGENCY DEPARTMENT Jon Morris, MD, FACEP, MBA WellStar Health Systems.
Smart Device Integration
Coming Full Circle: AMI and Med Rec Across the Continuum Medication Reconciliation in Home Care Date: April 23 rd, 2007 Time: 10 – 11 am MDT Dial-in:
Examples of ADE Surveillance Systems MedDRA ® Processing of Adverse Event Reports in ADE Surveillance Systems Amarilys Vega, M.D, M.P.H., Sonja Brajovic,
Preventing Surgical Complications Prevent Harm from High Alert Medication- Anticoagulants in Primary Care Insert Date here Presenter:
FOCUSFOCUS. CPOE at Cedars-Sinai What Worked, What Didn’t Cedars-Sinai Medical Center Los Angeles, California C S Paul Hackmeyer, M.D. Chief of Staff.
Occurrence Reports. An occurrence report is a document used to record an event when it occurs Occurrences are reported each time an occurrence occurs.
Role of the Oncology Research Team Carmen B. Jacobs, BS, RN,OCN, CCRP U.T.M.D. Anderson Cancer Center Houston, Texas U.S.A.
Learning From Mistakes: Error Reporting and Analysis and HIT Unit12a: The Role of HIT in Error Detection & Reporting This material was developed by Johns.
Standard 4: Medication Safety Advice Centre Network Meeting Margaret Duguid Pharmaceutical Advisor February 2013.
CHP400: Community Health Program - lI Research Methodology STUDY DESIGNS Observational / Analytical Studies Present: Disease Past: Exposure Cross - section.
Ruth Carrico PhD RN FSHEA CIC Associate Professor Division of Infectious Diseases.
Copyright © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins Chapter 10Safety Concerns in Healthcare.
Us Case 5 ICU Event with Pharmacy and Pt Monitoring and Follow-up Care by PCP Care Theme: Transitions of Care, Medical Device Integration Use Case 15 Interoperability.
The Quality Colloquium at Harvard University August 27, 2003 Patient Safety Organizational Readiness Assessment Tool Louis H. Diamond, MDBeverly A. Collins,
Health Management Information Systems
METHODS TO STUDY DRUG SAFETY PROBLEMS animal experiments clinical trials epidemiological methods –spontaneous reporting case reports case series –Post-Marketing.
Learning From Mistakes: Error Reporting and Analysis and HIT Unit12.1: HIT and Error Detection & Reporting Component 12/Unit 121 Health IT Workforce Curriculum.
Managing Hospital Safety: Common Safety Concerns Part 1 of 4.
Occurrence Reports. An occurrence report is a document used to record an event when it occurs Occurrences are reported each time an occurrence occurs.
On the CUSP: STOP BSI Improving Situational Awareness by Conducting a Morning Briefing.
Barcode Technology in healthcare Nowadays, published reports illustrate high rates of medical error (adverse events) and the increasing costs of healthcare.
On the CUSP: STOP BSI Improving Situational Awareness by Conducting a Morning Briefing.
Department of Patient RelationsMeasuring to Achieve Patient Safety Safety Observer’s Orientation.
Preventing Errors in Medicine
ULTIMA*DCF for children and adolescents clinics and hospitals.
Managing Hospital Safety: Common Safety Concerns Part 4 of 4.
Medication Safety Lizabeth Martin, MD Faculty Fellowship: Safety and Quality Mentors: Lynn Martin and Sally Rampersad.
National Patient Safety Goals 2008 T he University of Toledo Medical Center Toledo, Ohio.
European Patients’ Academy on Therapeutic Innovation Introduction to pharmacovigilance Monitoring the safety of medicines.
Methodological Issues in Implantable Medical Device(IMDs) Studies Abdallah ABOUIHIA Senior Statistician, Medtronic.
Patient Safety and Quality: Where Does Health Care in Schools Fit In? Howard Bauchner, M.D. Professor of Pediatrics & Public Health Director, Division.
ICPs for HIV care in NHS Tayside Morgan Evans Clinical lead.
ADVERSE DRUG EVENT (ADE) Driver Diagram OHA HEN 2.0.
The Regulation on Cell Therapy Products in Japan
CLINICAL TRIALS.
Is a Clinical Trial Right for Me?
Critical Care Services Pharmacist Royal Manchester Children’s Hospital
Research Questions Does integration of behavioral health and primary care services, compared to simple co-location, improve patient-centered outcomes in.
Community Hospital Pharmacy Practice January 29, 2004
Mary Alexander, MA, RN, CRNI®, CAE, FAAN Chief Executive Officer
Remote Monitoring of Adverse Events
Impact of Technology on Quality & Safety Initiatives
Remote Monitoring of Adverse Events
Comparing Options for Management:PAtient-centered REsults for Uterine Fibroids Evan R. Myers, MD, MPH Department of Obstetrics & Gynecology and Duke Clinical.
Patient Safety and Quality care Movement
Cindy Murray NP Princess Margaret Cancer Centre
CPOE Medication errors resulting in preventable ADEs most commonly occur at the prescribing stage. Bobb A, et al. The epidemiology of prescribing errors:
Adverse Event Analysis
Presentation transcript:

Laura M. Lee, R.N. Clinical Center, NIH The Epidemiology of Clinical Errors in a Research Hospital: Mining Occurrence Reporting Data for Mining Occurrence Reporting Data for “Low Hanging Fruit”

Bona BenjaminSteve Bergstrom Ginnie DaineCharles Daniels Clare HastingsDavid Henderson Mary Sparks 250 bed hospital at NIH250 bed hospital at NIH Mission is clinical research; primary product is scienceMission is clinical research; primary product is science All patients are volunteersAll patients are volunteers Over 1100 protocols (Phase I or II clinical trials, natural history)Over 1100 protocols (Phase I or II clinical trials, natural history) “High risk; high reward”“High risk; high reward” The Clinical Center The Team

First implemented in 1980 First implemented in 1980 Part of Medical Information System Part of Medical Information System Exceeded regulatory requirements Exceeded regulatory requirements User feedback – uniformly negative User feedback – uniformly negative  Inflexible architecture  Limited data entry options  “Black hole” - no feedback  Limited use as an improvement tool Electronic Occurrence Reporting:

In 1998 reengineered entire system based on stakeholder requirements In 1998 reengineered entire system based on stakeholder requirements  Non-punitive environment  Web-based  Logical, user-friendly data entry  Automatic notification of “content experts”  Users ability to view occurrence reports and follow-up information  Flexible architecture that allows for customizable data collection  Customization of reports (e.g., unit, Institute, protocol) Occurrence Reporting: Present

Occurrence Reporting System

Number of Occurrences System redesign Education and increase attention to patient safety Regular feedback provided to users Occurrence Reporting Trends

Treatment Related Code Blue Code Blue Protocol/Consent Protocol/Consent Clinical Care Clinical Care Allergy Allergy Contact difficulty Contact difficulty Transfers Transfers Specimen collection Specimen collection Restraints Restraints Vascular Access Device Vascular Access Device Types of Occurrences

Medication Events Number of Occurrences Other issues Wrong dose Omission Not documented Wrong time Wrong drug Wrong rate Pyxis issues Expired drug Wrong form Wrong patient Delay in admin Allergy Wrong quant

Treatment-Related Occurrences Clinical Care Specimen collection Other events Vascular access Difficulty with transfer Blood and blood products Code Blue Restraints Delay in service Transfer to ICU Difficult contacting MD Allergy Wrong pt info Consent Number of Occurrences

Total reports classified as errors38% Did not reach patient24% Reached patient but no change in patient status36% Resulted in increased monitoring37% Temporary change in status2% Prolonged LOS or harm<1% Near-death event<1% Death---- Errors adversely affecting patient outcomes3% Errors adversely affecting clinical research<1% Impact on Patient Care and Clinical Research

So we know that bad things happen… We now have lots of data about “untoward events” that occur in our clinical research environment We now have lots of data about “untoward events” that occur in our clinical research environment Needed a process / methodology for: Needed a process / methodology for:  Managing the data  Identifying clusters of events  Driving process improvement  Continuously monitoring the events

Medication Clusters Fent/Mida mix- ups      9  Look alike meds      45 Ongoing Delay in starting PCA       20  Cyclosporine levels      8  Peds dosing errors     7  Rituximab rates    4  Meds at bedside       12  Omitted resp therapy rx      6  Omissions r/t roller clamps     5 Ongoing Sterile product labels      65 Ongoing ORS Data Staff education Communication Patient Education Information Systems DocumentationDevice ChangePolicy ChangePractice Change Process Redesign Continuous Monitoring Cluster

Care Delivery and Device Clusters Device Related  Butterfly needle failure     28 ORS Data Staff education Communication Patient Education Information Systems DocumentationDevice ChangePolicy ChangePractice Change Process Redesign Continuous Monitoring Cluster Care Delivery      Management of tracheotomy patients Ongoing   17

Implementation of a non-punitive, interactive Occurrence Reporting System dramatically increased reporting of clinical care events in a clinical research institution; Implementation of a non-punitive, interactive Occurrence Reporting System dramatically increased reporting of clinical care events in a clinical research institution; The ORS database facilitates epidemiological identification of clusters of adverse events; The ORS database facilitates epidemiological identification of clusters of adverse events; Data from the ORS can be used to drive clinical performance improvement activities and increase patient safety in our environment; Data from the ORS can be used to drive clinical performance improvement activities and increase patient safety in our environment; U The ORS is a reliable mechanism for monitoring the efficacy of improvement interventions. Conclusions