Conference Report Published by CareFusion Center for Safety and Clinical Excellence
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- Content
- The Joint Commission’s Anticoagulant-related
- Heparin Medication Safety
- Pooled Data from Smart IV Pumps
- Using Smart Infusion Continuous Quality
- Heparin Safety and the Coagulation Laboratory
- Issues in Heparin Management
- The Epidemiology and Outcomes of Patients Treated
- A Systematic Approach to Improving
- A Coordinated Inpatient Anticoagulation
- Reducing Heparin Errors
- Heparin Safety in Children
- Improving Heparin Safety
- Nursing Perspective on Heparin Safety
- Heparin-induced Thrombocytopenia
- USP MEDMARX® data findings
- Table 1. Severity of heparin errors Error Category a % b Potential error
- Selected heparin error reports Case 1
- Table 2. Most frequently reported types of error involving heparin a Type of Error a n %
- Table 3. Most frequently reported causes of error involving heparin a Cause of Error a n
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Conference Report Published by CareFusion Center for Safety and Clinical Excellence carefusion.com Improving Heparin Safety
Proceedings from The Ninth Conference CareFusion Center for Safety and Clinical Excellence March 13-14, 2008, San Diego, CA Philip J. Schneider, MS, FASHP, Editor
National Conference on Heparin Safety
The ninth invitational conference at the CareFusion Center for Safety and Clinical Excellence in San Diego, held on March 13 through 14, 2008, brought together more than 40 anticoagulation experts and practitioners to share information, offer perspectives and address issues on the topic of improving heparin safety. The day and a half of presentations and round-table discussions included individuals representing The Joint Commission, United States Pharmacopoeia, the Institute for Safe Medical Practices, academic institutions, large health care systems and small hospitals. This conference report summarizes 21 presentations by nationally recognized experts on the types and frequency of heparin errors, National Patient Safety Goals, impact of smart infusion technology, laboratory and nursing issues and identified opportunities to improve heparin safety. The proceedings were edited by Philip J. Schneider, MS, FASHP; at time of conference: Clinical Professor and Director, Latiolais Leadership Program, College of Pharmacy, The Ohio State University, Columbus, OH; at time of publication: Clinical Professor and Associate Dean, University of Arizona College of Pharmacy, Phoenix Biomedical Campus, Phoenix, AZ. Executive Summary Conference Report
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Content
P3 Medication Errors Involving Heparin: John P. Santell, MS, RPh, FASHP Findings from a National Reporting Program Director, Practitioner Programs and Services
Pharmacopeial Education
Rockville, MD P6 The Joint Commission’s Anticoagulant-related Darryl S. Rich, PharmD, MBA, FASHP National Patient Safety Goals Surveyor, Joint Commission P9
Michael R. Cohen, RPh, MS, ScD Failure Modes Associated with Administration Institute for Safe Medication Practices
P13 Heparin Medication Safety: John Fanikos, RPh, MBA Impact of Smart Infusion Technology Assistant Director of Pharmacy,
Boston, MA P16 Pooled Data from Smart IV Pumps: Tim Vanderveen, PharmD, MS Review of Heparin Averted Errors and Variability Vice President, Center for Safety and Clinical
P20 Using Smart Infusion Continuous Quality Ray R. Maddox, PharmD Improvement (CQI) Data to Improve Director, Clinical Pharmacy Anticoagulation Management Research and Pulmonary Medicine
Savannah, GA P22 Heparin Safety and the Coagulation Laboratory Robert Gosselin, CLS
University of California
Davis Medical Center, Sacramento, CA P28 Issues in Heparin Management William Dager, PharmD, FCHSP
Medical Center, Sacramento, CA P31 Venous Thromboembolism: Robert Raschke, MD, MS Improving Safety and Outcomes of Heparin Therapy Director, Critical Care Services, Banner Good
P34 The Epidemiology and Outcomes of Patients Treated Vikas Gupta, PharmD, BCPS With Heparin During Hospitalization CareFusion, MedMined Services
Birmingham, AL P37 A Systematic Approach to Improving Steven Meisel, PharmD Anticoagulation Safety Director of Medication Safety, Fairview Health
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Executive Summary Conference Report 9th Invited Conference: Improving Heparin Safety P41 A Coordinated Inpatient Anticoagulation Michael P. Gulseth, PharmD, BCPS
Assistant Professor/Clinical Specialist
Duluth, MN P43 Reducing Heparin Errors: Jim Fuller, PharmD The Indianapolis Coalition for Patient Safety Director of Pharmacy, Vice President
Clinical Support Services
P46 Heparin Safety in Children Charles Homer, MD, MPH
Chief Executive Officer, National Initiative for
Children’s Healthcare Quality
Cambridge, MA P49 Improving Heparin Safety: Patricia C. Kienle, RPh, MPA, FASHP A Pharmacy Perspective Director, Accreditation and Medication Safety
Clinical Excellence
San Diego, CA P51 Nursing Perspective on Heparin Safety Vicki S. Good, MSN, RN, CCNS CENP
P54 Using Heparin Safely: Ian Jenkins, MD A Hospitalist Perspective Hospitalist, University of California San Diego
P58 Heparin-induced Thrombocytopenia William Dager, PharmD, FCHSP
Pharmacist Specialist, University of California
Davis Medical Center
Sacramento, CA 3
Executive Summary Conference Report 9th Invited Conference: Improving Heparin Safety Key points • Heparin has been one of the most commonly reported products involved in errors and one of the leading medications involved in harmful errors. • The majority of heparin errors originate during administration and nursing staff were most frequently involved. • Compared to the general error data set, there are fewer problems with prescribing heparin therapy but more problems with preparing/dispensing or administering the correct dose. • Frequently occurring problems included: – Incorrect infusion rates as a result of incorrectly programming an intravenous (IV) infusion pump – Infusion rate switches with another large-volume infusion – Order incorrectly entered by pharmacy – Staff unfamiliar with heparin protocols – Incomplete documentation on medication administration record – General IV pump programming errors • Any discussion of implementing new policies, procedures or protocols for heparin use should evaluate their potential for increasing the opportunities for error events. PROCEEDINGS Medication Errors Involving Heparin: Findings from a National Reporting Program John P. Santell, MS, RPh, FASHP, Director, Practitioner Programs and Services, Pharmacopeial Education, United States Pharmacopeia, Rockville, MD Medication errors involving antico- agulants, especially heparin, are common 1-3
. Heparin has been one of the most com- monly reported products involved in errors overall and one of the leading medications involved in harmful errors, according to pre- vious MEDMARX® reports published by the United States Pharmacopeia (USP) 4-6
. USP MEDMARX® data findings More than 17,000 heparin medication errors were reported to the USP’s MEDMARX® program during a five-year period from 2003 to 2007. Of these, 556 errors (3.1%) resulted in harm to patients, including seven deaths (Table 1). The average percentage of harm for error reports submitted to MEDMARX® has been approximately 1.5%, indicating that when heparin is involved, it may be twice as likely to result in harm. Analysis of the reported heparin errors pro- vided information about where in the medica- tion use process they originated and the most frequent types and causes associated with these events. The majority (47.6%) of heparin errors originate in administering the medica- tion, followed by 18.8% in transcribing the order, 14.1% in prescribing the product, 13.9% in dispensing functions and 5.4% in patient/ laboratory monitoring activities. Nursing staff were most frequently involved with hepa- rin errors (60%), followed by pharmacy staff (14%) and prescribers (13%). The three most frequently reported types of error were wrong dose, omission and pre- scribing error, comprising nearly 70% of all
Category A (n=628) 3.5
Category B (n=5,130) 28.5 Categories C-D (n=11,661) 64.9 Error, harm Categories E-I (n=556) (7 fatalities) 3.1 a. For complete definitions of the NCC MERP Error Category Index, see www.nccmerp.org b. Based on 17,975 records for the period of Jan. 2003 – Dec. 2007. Executive Summary Conference Report
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error type selections (Table 2). These error types are also frequently among the lead- ing types of error in the general MEDMARX® data set. There were, however, differences between the general error data set and the sub-set of heparin errors for several types including wrong dose (21.7% vs. 36.5% for heparin errors) prescribing error (18.4% vs. 12.7% for heparin errors) and wrong admin- istration technique (1.4% vs. 3.5% for heparin errors). This suggests there are fewer prob- lems with prescribing heparin therapy, but more problems either in the pharmacy or by nursing staff with preparing/dispensing or administering the correct dose. Many of the wrong administration technique errors involved problems with programming and using an intravenous (IV) infusion pump. Most patient safety experts agree that error events are the result of multiple causes. Among the nearly 70 different causes of errors tracked in the MEDMARX® program, the leading causes associated with heparin errors were performance deficit, procedure/ protocol not followed and communication (Table 3). Performance deficit is often cited in combination with procedure/ protocol not followed, indicating a logical inter-connec- tion between them. Contributing factors such as distractions, inexperienced staff and work- load increase are often cited in reports when performance deficit or procedure/protocol not followed are listed as error causes. This may explain their high ranking among the numerous possible causes that a reporter may select. Other causes frequently reported with heparin errors were knowledge deficit, docu- mentation and transcription inaccurate/omit- ted. These findings point to areas where safe- ty improvements are needed. Discussions of implementing new procedures/protocols on heparin use should examine errors associated with failing to follow current procedures/ protocols and communications between pre- scribers, nurses and pharmacists, to avoid introducing new error opportunities. Selected heparin error reports Case #1: A patient being administered a heparin infusion at 1,000 units/hr via an IV pump was transported to radiology for an MRI. The nurse in radiology discontinued use of the pump and regulated the heparin infusion with a manual flow device but inadvertently altered the heparin infusion rate so that the patient received 20,000 units (8,000 units/hr). A stat-activated partial thromboplastin time was performed and the heparin infusion held.
Wrong dose/quantity 6,482 36.5
21.7 Omission error 4,203 23.7
20.7 Prescribing error 2,259 12.7
18.4 Unauthorized/wrong drug 1,926 10.8
12.2 Extra dose 1,018 5.7
5.3 Wrong time 992 5.6
6.3 Wrong administration technique 627 3.5
1.4 Wrong patient 575 3.2
4.7 Drug prepared incorrectly 423 2.4
2.8 Wrong route 355 2.0
1.4 Wrong dosage form 233 1.3
2.5 a. USP’s MEDMARX® program tracks 14 different types of error.
Only the 10 most frequently reported involving heparin are shown. b. Based on 17,756 records for the period of Jan. 2003 – Dec. 2007 c. Based on 1,108,803 records for the period of Jan. 2003 – Dec. 2007 Table 3. Most frequently reported causes of error involving heparin a Cause of Error a n % b Performance Deficit 7,845 43.1
Procedure / Protocol not followed 5,175
28.4 Communication 2,578 14.2
Knowledge deficit 2,078
11.4 Documentation 1,900 10.4
Transcription inaccurate/omitted 1,776
9.8 Computer entry 1,681 9.2
Calculation error 1,301
7.1 Monitoring inadequate/lacking 1,191 6.5
Pump, improper use 980
5.4 a. USP’s MEDMARX® program tracks nearly 70 different types of error. Only the 10 most
frequently reported involving heparin are shown. b. Based on 17,572 records submitted to MEDMARX® during the period Jan. 2003 – Dec. 2007 5
Executive Summary Conference Report 9th Invited Conference: Improving Heparin Safety Fortunately, the patient did not experience any significant sequelae.
A patient returned from a procedure in the cardiac catheterization laboratory arrived on the nursing unit with an infusion of tissue plasminogen activator and heparin. Heparin (50 units/mL) was ordered at a rate of 16 mL/ hr but was found to be infusing at a rate of 166 mL/hr (8,300 units/hr). The physician was contacted and the heparin infusion held for one hour and then resumed at the ordered rate. Partial thromboplastin time three hours later was 182. The error led to temporary harm and the primary cause was improper use of the IV pump. Case #3: A patient presented in the emergency room, was given a heparin bolus and started on a heparin infusion. The patient was trans- ferred to the coronary care unit where a physician, unaware that the patient was on a heparin infusion, ordered enoxaparin. Later an on-call physician, unaware that the patient was receiving the enoxaparin, ordered anoth- er dose of the heparin infusion. The nurse who received the physician’s call did not inform him of the patient’s other medica- tions. The patient received both heparin and enoxaparin for 15 hours, leading to a drop in the patient’s hemoglobin and hematocrit, shortness of breath and rales. The patient was given a blood transfusion and placed on a ventilator. The causes of error were reported as failures in communication and not follow- ing procedures and protocols. Common error scenarios
Based on a review of several hundred reported error events, frequently occurring problems included: • Incorrect infusion rates (generally by a fac- tor of 10) as a result of incorrectly program- ming an IV pump (e.g., 60 units/hr vs 6 units/hr) • Infusion rate switches with another large- volume infusion (e.g., heparin rate and a standard hydration infusion), especially during patient transfers from their primary unit to other areas such as radiology or the cardiac catheterization laboratory • Order incorrectly entered by pharmacy, leading to an incorrect concentration being prepared and infused • Staff unfamiliar with heparin protocols, leading to inadequate monitoring • Incomplete documentation on medication administration record (MAR), leading to unclear or omitted information on rate, when infusion started, among others • General IV pump programming errors Conclusion Heparin therapy is commonly associated with safety problems and the potential for medication errors. Data submitted to the USP’s MEDMARX® program can help iden- tify where safety risks exist and how current practices contribute to error events. Any dis- cussion of implementing new policies, pro- cedures or protocols for heparin use should evaluate their potential for increasing the opportunities for error events.
1. Fanikos J, et. al. Medication errors associated with anti- coagulant therapy in the hospital. Am J Cardiol Aug 15 2004;94(4):532-5. 2. Winterstein AG, et. al. Identifying clinically significant preventable adverse drug events through a hospital's database of adverse drug reaction reports. Am J Health Syst Pharm Sep 15 2002;59(18):1742-9. 3. Errors Involving Drug Products Used to Treat Cardiovascular Diseases: Part III. USP CAPSLink Newsletter. May 2005. Retrieved on June 30, 2008 from http://www.usp.org/pdf/EN/patientSafety/ capsLink2005-05-01.pdf. 4. Hicks RW, Becker SC, Cousins DD. MEDMARX® data report. A report on the relationship of drug names and medication errors in response to the Institute of Medicine’s call for action. Rockville, MD: Center for the Advancement of Patient Safety, US Pharmacopeia; 2008.
5. Hicks RW, Becker SC, Cousins DD. MEDMARX® data report: A Chartbook of Medication Error Findings from the Perioperative Settings from 1998-2005. Rockville, MD: Center for the Advancement of Patient Safety, US Pharmacopeia; 2006. 6. Santell JP, Hicks RW, Cousins DD. MEDMARX® data report: A Chartbook of 2000-2004 Findings from Intensive Care Units and Radiological Services. Rockville, MD: Center for the Advancement of Patient Safety, US Pharmacopeia; 2005. Executive Summary Conference Report
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PROCEEDINGS
• In 2008, the Joint Commission added a requirement to the National Patient Safety Goals (NPSG 3E, renamed NPSG 03.05.01) that organizations implement a defined anticoagulation management program to individualize care provided to each patient receiving anticoagula- tion therapy. • NPSG 03.05.01 is currently limited to warfarin, heparin and the low-molecular-weight heparins and does not address anti-platelets, heparinoids or other anticoagulants. • Implementation of NPSG 03.05.01 is effective as of January 1, 2009 and organizations will be scored on 9 elements of performance related to this goal. • NPSG 03.05.01 will be evaluated and scored by Joint Commission surveyors and results will be publicly disclosed on the Joint Commission’s website. The Joint Commission’s Anticoagulant-related National Patient Safety Goals Darryl S. Rich, PharmD, MBA, FASHP, Surveyor, Joint Commission In 2008 the Joint Commission added a requirement to the National Patient Safety Goals (NSPG 3) that organizations implement a defined anticoagulation management pro- gram to individualize care provided to each patient receiving anticoagulation therapy (Table 1). There are nine elements of per- formance (EPs) associated with this require- ment that will be evaluated and scored by Joint Commission surveyors. To meet NPSG 03.05.01, an organization must be in compli- ance with all nine EPs as of January 1, 2009. Detailed interpretations of the EPs can be found in the FAQs on the Joint Commission website
1 . This article includes a discussion of Joint Commission goals and standards and a brief review of the EPs for NPSG 03.05.01 for anti- coagulation therapy, particularly unfraction- ated heparin and low-molecular-weight hep- arin (LMWH).
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