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Rapid Response Teams	Pressure Ulcers
Acute Myocardial Infarction	High-Alert Medications
Medication Reconciliation (ADE)	Congestive Heart Failure
Central Line Infections	MRSA
Surgical Site Infections	Surgical Complications
Ventilator-Associated Pneumonia	Boards on Board

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Duke University Hospital – Durham, NC
Availability Status: Available to answer requests
Licensed Beds: 924
Teaching / Non-Teaching Status: Teaching
Setting: Urban
Start Date of Intervention Work: January 2004
Mentor Contact Name: Lynn Eschenbacher, PharmD
Mentor Contact Email: lynn.eschenbacher@duke.edu
Mentor Contact Phone: 919-668-5398

Additional Information:

Duke University Hospital (DUH) has strong senior leadership support for improvements and patient safety.  DUH uses data to drive improvements and uses the Six Sigma Methodology for Peformance Improvement efforts.  In addition, there is oversight by the Six Sigma Oversight Committee, Medication Safety Council and P&T for medication safety related efforts.  In addition, we have a multidisciplinary team (Patient Safety and Clinical Quality) that reviews all transfusion and clinical engineering related events as well as medication safety related events to determine common causes and system failures.  The Patient Safety and Clinical Quality team also reviews the Root Cause Analyses performed in order to translate findings and ensure the best actions are taken.  Finally, DUH has Medication Safety Leaders embedded in the organization to empower the front line staff to improve medication safety and outcomes for patients. The Medication Safety Leaders also work with the Clinical Service Line Core Safety Teams to improve safety in their service line and also work as a united team for all of DUH to improve safety across DUH.

Reduction of Opiate Related Adverse Drug Events at Duke University Hospital

The Pain Management Oversight Committee (PMOC) and Six Sigma Oversight Committee (SSOC) collaborate to improve the safety of patients receiving pain management interventions.  At their direction, a dynamic multi-disciplinary team that included advanced practice nurses (APNs), pharmacists, physicians and staff nurses was established to identify the focus of a Six Sigma medication safety project.  Analysis of the voluntarily reported ADE reports revealed that the initial focus should be on opiate-related ADEs and, more specifically, on patient controlled analgesia (PCA) in the post-operative period.  The team’s goal was to reduce the occurrence of ADEs resulting in harm to patients using PCA.  Of particular concern were instances of respiratory depression.  Further drill down on the data led to a focus on orthopedic patients.   The group assessed issues related to prescribing, administering, and monitoring of opiate medications when analgesia is controlled and administered by the patient.  The ultimate goal was to error proof the process, to ensure that whoever is involved, no adverse events occur.  In order to properly evaluate the process, a global look from pre-op screening to the OR to the PACU, to the patient stay on the unit was needed. 

A number of “just do it’s” were identified and implemented.  These included eliminating extension tubing on all PCA lines, placing patient & family caution labels regarding use of the PCA activation button on the PCA machine, and the addition of a label to the PCA pendant with a stoplight that states “Caution: Only the patient can press the PCA button.”  The team also focused on setting realistic expectations for the patients and family members.  The previous pain management slogan was “Healing Doesn’t Have to Hurt,” and, as a result, patients expected to not experience any pain.  The pain program and PMOC designed a new slogan: “Managing your Pain.  Caring for your Safety.” The team developed informational flyers that are distributed in the pre-op screening clinic, during the pre-op class, and on the patient care floor.  In addition, lapel pins were made displaying the slogan with a scale graphic and are worn by pain management providers.

Nursing knowledge of opiates and their management was also an area for improvement.  The pain management APNs provided intense staff nurse education.  In addition to didactic education, they provided individual coaching and competency checks.  The APNs’ focus was on critical thinking on the individual patient’s pain management history and the medication to be administered.  They also prepared the nurses to educate patients about safe pain management and reasonable pain expectations.  A patient education sheet was developed to re-enforce these concepts.  This was produced in English and Spanish as Duke has a substantial Hispanic patient population.

After the “just do its” the Six Sigma team worked to develop a plan of action to error proof the system.   A prospective Healthcare Failure Mode and Effects Analysis (HFMEA) was conducted to analyze the process and identify potential failure points.    To simplify the effort, the team split in to two working groups: one focused on prescribing and another focused on administration/monitoring.  The Veterans Affairs HFMEA model was followed and resulted in the identification of 134 failure modes for prescribing and 219 failure modes for administration and monitoring.  The next step was to identify solutions for each of these failure modes.

Error proofing is the ultimate goal and generation of solutions that eliminate, replace, facilitate, detect or mitigate have been proven to demonstrate the best return on investment.  To reduce the overwhelming number of solution recommendations, a systematic approach to prioritizing the order for implementation was developed with the help of error proofing experts from the North Carolina State University.  This methodology narrowed the number of critical solutions to be implemented from 278 to 30.  Examples of recommendations are: communication of critical risk factors through the continuum of care, standardization of opiate concentrations, post-anesthesia care unit (PACU) summary sheet of opiates given in pre-op holding, the OR and PACU, and revision of the current PCA form to include lean body weight, contraindications for morphine PCA including end stage renal disease, and critical risk factors.

The critical risk factors are those characteristics or diagnoses known to increase the risk of respiratory depression in patients using PCA.  Assessment of the past adverse drug events revealed that the first twenty-four hours post-operatively was the critical time period for respiratory depression.  As a result, nursing assessment of the patient’s respiratory status was increased to every two hours during the first 24 hours of PCA use from every 4 hours.  This assessment also increases following an increase in the PCA dose.

Prior to this project there were a number of serious PCA-related errors on the orthopedic surgical unit.  Since June 2004, on this unit, there has been a 50% decrease in reported events resulting in harm to a patient related to a PCA.  As a result of team efforts, in each of these instances, the staff nurses recognized the concerns early and intervened to reduce harm.  In addition, prior to the standardization of the adult PCA concentrations, 25% of the PCA events were related to concentration errors.  After the standardization to one concentration per drug, the events associated with a PCA concentration have been reduced to 6.8%.  Morphine PCA use with end stage renal disease patients has also decreased housewide since the implementation of the new PCA order form on March 1, 2005.   As of May 2007, these improvements have been sustained.  The opiate oversight implementation team will continue to meet until all recommendations have been implemented in all areas of Duke University Hospital and opiate ADEs resulting in harm to patients have been reduced by 50% from baseline.  The lessons learned from this Six Sigma project have been and are being translated to areas throughout the hospital where PCAs are used. 

This project and its positive impact on patient safety is a single example of error proofing efforts at Duke University Hospital.  The hospital maintains several patient safety indicators on its balanced scorecard with performance targets that are well defined.  The goal is to eliminate preventable adverse drug events that reach the patient.  This project is one step in that direction. 

Reduction of Insulin Related Adverse Drug Events at Duke University Hospital

Mission Statement
Reduce the number of insulin ADEs on 3100, 3200 and 3300 with severity score > 2 by 20% per quarter in 6 months to increase patient safety.

Findings:	Additional Findings:
47% - Insulin guidelines not followed	22% - Patients on Tube feedings
17% - 6 Rights of medication use errors	11% - Patients were NPO
14% - Prescribing errors
11% - Transcription errors

Actions:

• Standardize to one Cardiac Insulin Protocol and standardize insulin sliding scale parameters.
• Change to Lien-Spratt Insulin Nomogram for IV insulin titration.
• Revise pre-printed Insulin order form. In CPOE, add insulin advisor to instruct prescriber.
• Provide insulin education for preceptors and nurses.
• Provide insulin and glucose management education for Housestaff.
• Prepare standardized communication tools for nursing reports.
• Reeducate nurses for required chart checks and MAR reconciliation to catch transcription errors and missed orders.
• Place hypoglycemia treatment protocol in bedside notebook.
• Teach critical thinking with case examples for early detection of insulin adverse patient effects.
• Emphasize the need to report insulin ADEs.
• Emphasize the need for immediate intervention and appropriate patient care for insulin adverse patient effects to reduce complications and possible patient injury.
• Emphasize communication steps to alert appropriate personnel when ADEs with SI > 2 occur.

Lessons Learned:

• Simplify insulin therapy and BG management protocols.
• Good communication in nurse reports and patient transfer improves patient care.
• Communication between caregivers and prescribers about food intake, tube feeds, NPO and IV glucose is extremely important to BG management.
• Teamwork between all members of the clinical team is needed to decrease insulin ADEs.
• Knowledge and educational programs improve insulin therapy and BG management.
• Process maps facilitate understanding the breakdowns and system failures.

[6/5/07]

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Fairview Health Services – Minneapolis, MN
Availability Status: Available to answer requests
Licensed Beds: Depending on the site, from 41 beds to 1,700
Teaching / Non-Teaching Status: one teaching, the rest non-teaching
Setting: Some rural and some urban
Start Date of Intervention Work: 2000
Mentor Contact Name: Steven Meisel
Mentor Contact Email: smeisel1@fairview.org
Mentor Contact Phone: 612-672-7061

Additional Information:

Using the principles of a high reliability organization, an interdisciplinary team has identified and implemented over 2 dozen changes designed to close every hole in the “Swiss cheese.”  Interventions have included some relating to order sets, monitoring tools, pharmacy preparation of drug, extensive education and training, and the establishment of a pain consultation service. Changes were identified and implemented in the operating rooms, the recovery rooms, as well as the general care units.

• Reduced serious narcotic oversedation from an order of magnitude of 10 to the -3 to 10 to the -4.
• Number of days between serious events increased from 1 every 56 days in 2000 to 1,700 days in 2006 on one surgical unit and from 111 days to 650 days on a second surgical unit.

Changes later spread to other sites in the integrated health system
[3/13/07]

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Missouri Baptist Medical Center – St. Louis, MO
Availability Status: Available to answer requests
Licensed Beds:  419
Teaching/ Non-Teaching Status:  Non-Teaching
Setting:  Urban
Start Date of Intervention Work: January 2001
Mentor Contact Name: Nancy Kimmel
Mentor Contact Email: nlk5885@bjc.org
Mentor Contact Phone: 314-996-5066

Additional Information:

• Missouri Baptist Medical Center (MBMC) has been using the IHI ADE trigger tool since January 2001 to identify harm associated with medications and using this information for process review, evaluation, and action.
• MBMC has automated portions of the ADE trigger tool to alert clinical pharmacy staff to evaluate the need for an intervention.
• Performance data is shared with the Pain Management Team, Diabetes Management Team, and Medication Safety Team for actions.
• Known, tested, change recommendations or packages from IHI and ISMP were used to proactively evaluate current processes associated with anticoagulation, insulin, and opiates/narcotics.
• Standardized Pain order set, PCA order set, Epidural Order set, Heparin Order set, Insulin Order set (prandial, basal and correction)

16 fold decrease in patient harm from January 2001 to December 2006
           - 2001 avg: 2.2 ADEs per 1000 pt days to 2006 avg: 0.14 ADEs per 1000 pt days
50% reduction in the use of reversals associated with Narcotic PCAs
            - 2005 avg: 1.4%  to 2006 avg: 0.6%
30% Reduction in overall Narcotic reversal use
            - 2005 avg: 0.7%  to 2006 avg: 0.4%
2006 : 93.4% of ALL patients received VTE prophylaxis
2006: 76% of the patients in Critical Care have a blood glucose in 70 to 150 range
Medication Reconciliation : 2006 avg: 98%  medications reconciled on admission
                                                       98%  medications reconciled at transfer
                                                       96%  medications reconciled at discharge

[3/13/07]

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OSF Saint James- John W. Albrecht Medical Center—Pontiac, IL
Availability Status: Available to answer requests
Licensed Beds:  50
Teaching/ Non-Teaching Status:  Non-Teaching
Setting:  Rural
Start Date of Intervention Work: 2002
Mentor Contact Name: Bill Wightkin, Pharm.D.
Mentor Contact Email: bill.t.wightkin@osfhealthcare.org
Mentor Contact Phone: 815-842-4926

Additional Information:

Opioid Analgesics

1. Limited stocking of hydromorphone
2. Meperidine: PCA not allowed; renal dose substitution plan
3. PCA: Safety Check on order form; continous mode not allowed; continuous pulse oximetry required

Insulin

1. Continous insulin infusion protocol using Glucommander technique
2. Subcutaneous order set using basal, nutritional and correction doses of insulin
3. Protocol for management of patient using own insulin pump from home
4. Diabetes educators review therapy on all diabetic patients

Anticoagulants 

1. Requirement for pretherapy INR and PTT
2. Requirement for daily INR while on warfarin
3. Autosubstitution of subcutaneous enoxaparin for IV heparin infusions
4. Auto-renal dose adjustment for enoxaparin
5. Default pharmacy management protocol of inpatient warfarin doses
6. Pharmacy education of new warfarin patients
7. Pharmacist involvement in ambulatory anticoagulation clinic (12 hrs per week)

We utilized the Global Trigger Tool and our Medication Incident Reporting system to identify medication management issues and patient harm.

Our approach is to have medication protocols managed by a high-reliability controller. We have found that a highly-trained hospital pharmacist is best suited to fill this role in our institution.    
[3/13/07]

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St. Luke’s Hospital – Cedar Rapids, IA
Availability Status: Available to answer requests
Licensed Beds: 560
Teaching / Non-Teaching Status: Non-Teaching
Setting: Urban
Start Date of Intervention Work: May 2005
Mentor Contact Name: Pat Thies
Mentor Contact Email: thiespw@crstlukes.com
Mentor Contact Phone: 319-368-5861

Additional Information:

Narcotics:

• Anesthesiologist led an in-service, “Opiate Management from the Perspective of the Anesthesiologist” to PACU and to the receiving patient care areas.  Areas reviewed included topics of spinal and epidural analgesia for surgical patients, types of drugs, therapeutic effects, duration of effect, side effects, monitoring of patients and treatment interventions for complications.
• The Pharmacy and Therapeutics Committee, along with the Pain Clinic, has monitored opiate management use concurrently.  Standardized PCA order sets for standardized concentrations of morphine and hydromorphone have been developed and implemented. Meperidine PCA has been removed.
• Nursing double check of PCA settings has been implemented.
• The medical director of pre-operative care reviews all inpatient cases in which Narcan is administered.  Oversedation is evaluated as to being related to the administration of Duramorph, Depodur, an Epidural, or a PCA.  Case review was expanded to include ED in which Narcan was used for overdoses or other indications.  Each case is rated based on "Care Appropriate" or "Aspect of Care could be improved".  Follow up includes:  1) No further action needed; 2) Request a review by the medical department chair; or 3) Request for review by nursing or other department.  Results of the audit are presented to related oversight committees.
• Emergency Guidelines include protocols for respiratory depression due to narcotic administration, and sedation/analgesic protocol for flumazenil administration.

Sedatives:

• Anesthesiologist presented an in-service to the medical-surgical nursing units on the topic of sedation, discussing types of medications, therapeutic effects, duration of effect, side effects, monitoring parameters and treatment of complications.
• Sedation guidelines are under the direction of our anesthesia department and the Operative and Other Procedures Committee.  The medical director of pre-operative care oversees the creation, approval and education of sedation protocols at our hospital.  Sedation audits are done monthly in all areas that provide sedation.  The medical director performs chart review on a regular basis and as requested for special cases.  Sedation case reviews are presented at the Operative and Other Procedures Committee.
• Sedation education/competency evaluation is completed annually by all associates involved in administering or caring for the sedated patient.  Sedation education is now available in 6 modules on the Intranet NetLearning.  Further staff education is provided through simulation modules associated with sedation education.

Anticoagulants:

• Anticoagulation management has been approached through a number of different processes.  The use of anticoagulation flow sheets, a single weight-based heparin protocol, a IIbIIIa inhibitor protocol, a bivalrudin protocol, DVT assessment and prophylaxis protocol and a Lovenox dosing protocol are all in effect.
• For warfarin management, the organization participates in an AHRQ grant for a community anticoagulation therapy clinic and produces a Warfarin therapy management booklet for prescriber use based on the most recent CHEST guidelines.
• For heparin I. V. administration, standardized concentrations for therapeutic heparin and procedural heparin are utilized with an extra High-Alert label for both the bag and the administration line.  Recently, a standardized, pharmacy prepared NICU heparin procedure has been implemented.

Insulin:

• A physician developed intravenous insulin protocol has been trialed, modified, approved, implemented, and spread housewide.  The protocol drives the dosing of insulin infusions based on the patient's blood sugars.  The protocol defines the patient's basal insulin dose and adds/substracts units of insulin per hour dependent on the patient's basal, nutritional, and correctional insulin needs.  The determination of insulin rate changes is based on hourly blood sugars.  The nurse is allowed to increase or decrease the dose based on the protocol without contacting the physician for orders.
• A corresponding insuling protocol has been written and implemented that provides direction to the physician when converting the patient from an intravenous insuling infusion to subcutaneous insulin administration.
• Separate insulin protocols have been developed for a patient in DKA.
• Concerning opioid serious and life-threatening adverse events, we have seen a decline from an average of 8.25 events per 100 admissions per quarter for 2005 to 3 events per 100 admissions per quarter for 2006.
• Concerning anticoagulant serious and life-threatening adverse events, we have seen a decline from an average of 7 events per 100 admissions per quarter for 2005 to zero events per 100 admissions per quarter for 2006.
• Electronic downloads of Accucheck (bedside blood glucose monitoring) data is completed every two weeks. The data is aggregated by unit and house-wide.  Stacked bar graphs are created and disseminated that depicts the number/percent of blood sugars below, within, and above normal limits.  Control charts are created and disseminated for the percent of blood sugars within normal limits.  Success is based on an increase in the percent of blood sugars within normal limits.  Recently, our medical neuro/oncology unit graph depicted a positive special cause variation indicating that significant improvement has been made in the percent of patients who's blood sugars are within normal limits.  Best practice identification is underway with that unit.
• Incidents in the use of narcan have decreased.
• Our Romazicon use for treatment of a sedation ADE is reported at a very low incidence (1Q06 = 3, 2Q06 = 2, 3Q06 = 2, 4Q06 = 1, 1Q07 = 1)

[4/30/07]