Conference Report Published by CareFusion Center for Safety and Clinical Excellence
Figure 2. Dosing Errors and their Magnitude
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- Table 1. Names used for heparin: examples 2 Figure 1. Smart pump CQI data reports 2
- Bolus (loading) dosing from continuous infusion bag
- Additional heparin safety issues Programming rates and doses interchangeably
- Lack of a single standard concentration
- 40unit/1mL
- 200unit/1mL
- 80unit/1mL
- Figure 2. 52 hospital aggregated smart pump data – Top 10 drugs 2
- Smart pump limits that may be too tight
- Delayed restarting of infusions on hold
- Figure 3. Heparin averted errors 2
- Figure 4. Smart pump alerts for programming ≥ 2X “hard” limits 2
- Table 3. Heparin CQI analysis– 54 hospital sample 2 Dosing Units Ave Averted Errors Total Alerts
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Figure 2. Dosing Errors and their Magnitude Figure 3. Alerts by Time of Day 0 5 10 15
20 25
30 35
40 45
10X Underdose 100X Underdose >100X Overdose 100X Overdose 10X Overdose
UFH
ARG Lep
Bival UFH
ARG Lep
Bival 12-2AM 12-2PM 2-4AM 2-4PM 4-6AM 4-6PM 6-8AM 6-8PM 8-10AM 8-10PM 10A-12P 10P-12P 100 80 60 40 20 0 Executive Summary Conference Report
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PROCEEDINGS
• Smart pumps help avert high-risk intravenous (IV) medication errors and provide previously unavailable data on IV medication use. • Wireless networking increases the usefulness of smart pump technology. • Analysis of pooled smart-pump data from many hospitals has identified patterns of errors and unnecessary variability in IV medication practices. • Heparin safety concerns include: – Mixing dosing units – Switching from weight-based load/continuous dosing to non-weight based protocols – Interchanging rates and doses – Allowing the use of many different heparin concentrations – Not complying with smart pump use policies – Bolus dosing from continuous infusion bag (without bolus feature on smart pump) – Setting smart pump limits that are too narrow – Delayed restarting of infusions after an order is placed on hold. • Hospitals need to allocate sufficient resources to educate and train staff, maintain system software and identify opportunities to improve IV-medication safety. PROCEEDINGS Pooled Data from Smart IV Pumps: Review of Heparin Averted Errors and Variability Tim Vanderveen, PharmD, MS, Vice President, Center for Safety and Clinical Excellence, San Diego, CA The introduction of smart pumps (comput- erized intravenous [IV] infusion systems) has helped clinicians avert errors with high-risk IV infusion medications and collect previously unavailable data about IV medication use. Analysis of pooled data from many hospitals makes it possible to identify problems and trends that might not be apparent at individ- ual institutions. These include unnecessary or undesirable variability with IV medication use that increases complexity and opportunities for error. This article presents a brief overview of averted errors, variability and other safety issues associated with the use of IV heparin. Smart pumps Traditional infusion pumps can be pro- grammed to deliver any dose at any rate. Smart pumps with dose-error-reduction- software (DERS) allow hospitals to create customized drug libraries with standardized concentrations and pre-established dosage limits based on best practices for infusion of IV medications. If infusion programming is outside drug-library limits, the software gen- erates an alert that must be addressed before infusion can begin. The software also logs when a clini- cian reprograms or cancels an infusion in response to an alert (averted error). Analysis of these data for continuous quality improve- ment (CQI) efforts identifies opportunities to improve drug library datasets, best practices and quality of care. In 2007, it was estimated that 44% of US hospitals had implemented smart pump technology 1 . Implementation of wireless networking further increases the clinical usefulness of this technology. CQI data can be downloaded in close to real time and reported in a variety of formats (Figure 1) to help clinicians more easily identify problem areas and opportu- nities for improvement. Changes to drug library parameters can quickly be uploaded wirelessly to all devices throughout a hos- pital. Although no survey has reported the adoption rate of wireless connectivity, it is estimated from marketing data that approxi- mately 400 hospitals have implemented wire- less connectivity 2 .
Averted errors
Aggregated smart pump data from 52 hos- pitals show that heparin was second only to propofol in the number of alerts for infusion programming outside hospital-established limits and was associated with the great- est number of "low dose" alerts (Figure 2) 2 . Figure 3 shows two typical examples of “good catches” in which the initial heparin dos- age was multiple times the reprogrammed dose. In the first example 800 units/Kg/hr was reprogrammed to 8 units/Kg/hr, which sug- gests that initially the number for the total units/Kg the patient was supposed to receive
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Executive Summary Conference Report 9th Invited Conference: Improving Heparin Safety (assuming a 100 unit/mL concentration) was inadvertently entered as the dose. The sec- ond example in Figure 3 shows that 240 units/ Kg/hr was reprogrammed to 9.2 units/Kg/hr, which suggests that the volume of the con- tainer was initially entered as the dose. Figure 4 shows a typical distribution of how many “times the limit” heparin doses were initially programmed. In some cases, the incorrectly programmed dose was 50 times the hospital’s limit for a continuous heparin infusion 4 . Data
such as these can greatly increase staff aware- ness of IV medication errors and provide compelling evidence of the need to improve IV medication practice. Variability After the introduction of smart pumps, a sample drug library was developed based on evidence and consensus reports to help hos- pitals more quickly develop their customized data sets. Hospital pharmacists reported they could not simply adapt the sample library to their institutions because of the high degree of variability among institutions. This experience prompted Bates et al. 3 to
compare the smart pump drug libraries of 100 hospitals to assess the number of drug names used and the variation in concentra- tions, dose units, dose limits and admin- istration practices. Investigators concluded that “…[s]ubstantial unnecessary variation in IV medication practices is likely associated with increased risk of harm. Standardization has the potential to substantially improve IV medication safety.” 3 This is particularly true with heparin. Drug names For drugs such as heparin, hospitals had been encouraged to incorporate descriptors into the drug library that would reflect the way of using a particular drug. Pooled data from 207 hospitals showed that a total of 191 different names were used for heparin (examples, Table 1) 2 .
Although heparin is available from IV solu- tion manufacturers in standard concentra- tions, analysis of data from 207 hospitals with smart pump drug libraries identified a surpris- ing and troubling lack of standardiza- tion
2 . Fifteen unique heparin concentra- tions were included, with eight in pedi- atric care units and seven in adult care units (Table 2) 2 . Recent media reports have highlighted tragic errors result- ing from confusion between 1 unit/mL heparin concentrations used to flush IV catheters and 1000 units/mL used to anticoagulate patients.
Analysis of data from 54 hospi- tals showed that while most hospitals used only units/Kg/hr or units/hr, 29% allowed the use of both weight-based and non-weight-based dosing 2 . In hos- pitals where drug libraries had both dosing units, smart pump alerts result- ing in reprogrammed doses were two to four times more frequent (Table 3) 2 . This
suggests that standardizing on one method of ordering and programming doses could dramatically reduce the potential for heparin programming errors. Heparin Heparin
heparin (DBL) heparin (protocolWt) heparin–units/hr heparin (dilute) heparin (standard) heparin–wt based heparin (DOUBLE STR) heparin (STD) Heparin Drip heparin (DOUBLE) Heparin (STROKE) Heparin Drip TRAIN Heparin (Drip) heparin (unit/h) 1/4NS heparin 1:1 heparin (DS) heparin (units/hr) A –heparin–units/hr Heparin (DVT/PE) heparin (universal) A –heparin–wt based heparin (Flush) heparin (WB) Art Line w Heparin Heparin (IV drip) heparin (weight) D10 1/8NS w/heparin Heparin (Lines) heparin (wgt based) hepaBAR -u/hr heparin (MAX) Heparin + 1/2 NS IV HEParin 2.5-4.9 kg Heparin (NICU) heparin NEO UV heparin (>40 kg) heparin (NURSERY) Heparin NICU FLUSH Heparin (2x) Heparin (Ped ArtLine heparin NON PROTOCOL heparin (Art Line) Heparin (pedi) Heparin NON WEIGHT Heparin (CARDIO) Heparin (Peds) heparin PEDS heparin (CARDIOLOGY) heparin (premix) heparin PROTOCOL heparin (DBL conc) heparin (Protocol) heparin sodium
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for standardizing and limiting the number of drug concentrations available, many orga- nizations still use many different concen- trations. Over time, the Joint Commission’s requirement will help move organizations to select a single concentration as the standard, thereby decreasing opportunities for error. Bolus (loading) dosing from continuous infusion bag When bolus dose programming is not available or a clinician does not use the bolus feature, administration of loading or bolus doses from the continuous infusion bags is not a safe practice. Since the continuous infu- sion containers typically contain many hours of heparin, a calculation or programming error can lead to a very large overdose. To improve safety, many hospitals have changed drug library limits on high-risk drugs to hard limits that cannot be overridden, so that clini- cians are forced to use the bolus feature with its safety limits. Other opportunities for error arise when patients are started on a weight-based bolus and weight-based continuous infusion (units/ Kg/hr) and subsequent orders are written to decrease heparin by 100 units/hr based on laboratory results. Making this switch requires complicated, error-prone computation. This is particularly likely in hospitals that use both types of dosing unit.
Smart pumps allow clinicians to enter either a rate or a dose. CQI data show many mismatches between rates and doses, which can lead to 100-fold under-or overdose with a 100 units/mL concentration. It would be possible to eliminate rate-setting from pump programming; however, nurses report that often they want to enter the rate or to be able to know what the rate is while administering a dose.
Despite the Joint Commission requirement Table 2. Heparin concentrations on smart pump libraries: 207 hospital analysis 2 Heparin 0.5 unit/1mL 25unit/1mL 100unit/1mL 0.5unit/1mL 2500unit/100mL 100unit/1mL 25unit/50mL 6250unit/250mL 2000unit/20mL 50unit/100mL 40unit/1mL 2500unit/25mL 250unit/500mL 20000unit/500mL 5000unit/50mL 500unit/1000mL 50unit/1mL 10000unit/100mL 1unit/1mL 50unit/1mL 25000unit/250mL 1unit/1mL 1500unit/30mL 30000unit/300mL 50unit/50mL 2500unit/50mL 50000unit/500mL 250unit/250mL 12500unit/250mL
500unit/500mL 25000unit/500mL 4000unit/20mL 2unit/1mL 60unit/1mL 5000unit/25mL 2unit/1mL 15000unit/250mL 10000unit/50mL 1000unit/500mL 80unit/1mL 20000unit/100mL 6unit/1mL 80unit/1mL 50000unit/250mL 3000unit/500mL 20000unit/250mL
40000unit/500mL 400unit/1mL 10unit/1mL 500unit/1mL 5000unit/500mL 1000unit/20mL
52 Hospital Aggregate - Top 10 Drugs Alert Count Total Alerts Dose Above Max Dose Below Min insulin Drug
0 30000
40000 60000
80000 nitr
ogly cer
in ox ytocin phen ylephr
ine dopamine
nor epinephr
ine fen
tan yl hepar in pr opof ol midaz
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Executive Summary Conference Report 9th Invited Conference: Improving Heparin Safety Smart pump limits that may be too tight Drug library limits that are too tight can result in inconsequential, nuisance alerts that lead to “alert fatigue” whereby clinicians begin to disregard all alerts. The introduction of wireless networking makes it much easier for an institution to recognize this situation and quickly change the drug library in all smart pumps across an institution. To facilitate the fine-tuning of dose limits, it is essential that the CQI data from smart pump use be ana- lyzed frequently to identify current practices. Delayed restarting of infusions on hold Smart pumps cannot now alert a clinician that an infusion is still on hold, even after sev- eral hours. Compliance with smart pump use Experience has shown that after smart pump implementation, there is a need to ensure continuing education, training and monitoring with regard to smart pump use to realize the full benefits of this technology. Summary Smart pumps originally were designed to help avert medication errors associated with the highest risk of harm (i.e., IV medication administration errors at the point of care). After their introduction, it rapidly became apparent that the previously unavailable data provided by smart pumps could play an equally important role in improving IV medication safety. To obtain full benefit of the safety improvements possible with this technology, it is critically important that suf- ficient resources be allocated to maintain staff education and training, maintain and update system software and identify and act on opportunities for IV medication best practice improvements.
1. Pederson CA, Gumpper KF: ASHP National survey on informatics: Assessment of the adoption and use of pharmacy informatics in US hospitals. Am J Health Syst Pharm, 2008; 65:2244-64. 2. Data on file, CareFusion, San Diego, CA. 3. Bates DW, Vanderveen T, Seger DL, et al. Variability in intravenous medication practices: implica- tions for medication safety. Jt Comm J Pt Safety Qual 2005;31(4):203-10. 4. Data on file, CareFusion Performance Analytics Service.
Figure 3. Heparin averted errors 2 Units/Kg/hour Log scale
Good Catches Limit 28 800
240 9.2
8 Initial Dose Final Dose 1 10 100 1000
Figure 4. Smart pump alerts for programming ≥ 2X “hard” limits 2 Heparin Alerts — Jan to June 2007 "Hard" Alerts for Settings Two Times or Greater the Limit 50 40 30 20 10 0 Table 3. Heparin CQI analysis– 54 hospital sample 2 Dosing Units Ave # Averted Errors Total Alerts Units/hr 48% 64 (2x) 26%
Units/kg/hr 23% 32 (x)
12% Both 29% 123 (4x) 62%
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PROCEEDINGS
• In 2001 St. Joseph’s/Candler Health System, Inc. (SJCHS) determined that intravenous (IV) medication errors were associated with the greatest risk of patient harm and began imple- mentation of a smart infusion system with dose-error-reduction software (DERS) 2,3
. • Wireless networking of the infusion devices improved the efficiency and timeliness of process interventions based on continuous quality improvement (CQI) data collected by the devices. • Failure mode and effects analyses (FMEA) before and after smart system implementation showed a reduction in IV heparin administration risk score from 210 to 56, primarily achieved by improved detection of infusion programming errors 2 .
highest potential for patient harm, the great majority of which occurred in non-critical care settings
4 . • Heparin CQI data analyses in 2004 and 2006 resulted in: − Standardization of IV heparin concentrations to 50 units/mL − Elimination of three time-consuming dose-calculation steps − Elimination of infusion-rate calculations by nurses and pharmacists by using dose-based pump programming in units/Kg/hr − Addition of bolus parameters to infusion-system drug library − Extensive computer-based re-education of nurses and pharmacists Using Smart Infusion Continuous Quality Improvement (CQI) Data to Improve Anticoagulation Management Ray R. Maddox, PharmD, Director, Clinical Pharmacy, Research and Pulmonary Medicine, St. Joseph’s/Candler Health System, Savannah, GA St. Joseph’s/Candler Health System, Inc (SJCHS) is a multi-hospital, community-based, tertiary care referral health system located in Savannah, GA. It consists of two acute care and one rural hospital; the two Savannah hos- pitals are St. Joseph’s and Candler Hospitals, together equaling 644 beds. These facilities provide primarily adult care, including all medical and surgical specialties except solid organ transplantation. There are about 500 physicians and surgeons on staff. SJCHS is a teaching site for students in all health disci- plines except post-graduate medicine and is affiliated with several public and private universities throughout Georgia. After an extensive internal analysis of vari- ous issues related to medication safety, in 2001 SJCHS elected to implement technol- ogy that reduced the likelihood of intrave- nous (IV) medication errors, since these errors are ones most often associated with patient harm 1
began a process of implementing a smart infusion system with dose-error-reduction software (DERS) that extended over several years
2,3 . The computerized system generates an alert whenever infusion programming exceeds pre-established drug library limits. Data from this system have been used for continuous quality improvement (CQI) of our medication use processes 2 . CQI has been tre- mendously aided by the implementation of wireless networking of the infusion devices, which allows more rapid downloading of smart-system data and uploading of drug library revisions.
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