IV Integration and a Culture of Safety: Reducing Complexity and Its Consequences
A Continuing Education Monograph for Pharmacists
A ProCE-publication
Contributors
Amanda E. Prusch, PharmD, BCPS Ronald H. Small, RPh, MBA, ScD, FASHP, FAPhA
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IV INTEGRATION AND A CULTURE OF SAFETY: REDUCING COMPLEXITY AND ITS CONSEQUENCES
CONTENTS
CE INFORMATION .................................................................................................................3
FACULTY ................................................................................................................................4
IV INTEGRATION AND A CULTURE OF SAFETY TO ADDRESS MEDICATION ERRORS: A MULTIBILLION-DOLLAR OPPORTUNITY ..........................................................................6 – Ronald H. Small, RPH, MBA, ScD, FASHP, FAPhA
INTEGRATED INFUSION MANAGEMENT ................................................................................16 – Amanda E. Prusch, PharmD, BCPS
POST-TEST .............................................................................................................................25
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IV INTEGRATION AND A CULTURE OF SAFETY: REDUCING COMPLEXITY AND ITS CONSEQUENCES
ACTIVITY DESCRIPTION
A culture of safety is an essential component of preventing medication errors and improving overall healthcare quality. Integration of smart IV infusion pumps and the electronic health record creates a closed-loop process that transforms infusion preparation and delivery workflow. Data derived from smart pump safety software can be used to enhance the delivery of quality patient care. This monograph reviews the scope and causes of adverse drug events, especially those associated with IV medications. The components and benefits of a closed-loop IV medication administration process are discussed, as well as the use of device-generated data to evaluate practice patterns, reduce alarm fatigue, and contribute to a patient-centered culture of safety.
LEARNING OBJECTIVES The target audience for this activity is pharmacists. Upon completion of this activity, the reader will be able to: Summarize the scope and cost of adverse drug events in hospital settings, including medication
errors associated with intravenous medications Explain how medication-related adverse incidents can result from alarm fatigue and manipulation of
devices that have alarm systems Discuss the rationale and elements of performance in the National Patient Safety Goal on Alarm
Management Describe the components and benefits of integrated infusion management in terms of patient safety,
workflow efficiency, and institutional cost savings
Describe how smart pump data can be used to evaluate practice patterns and contribute to a patient-centered culture of safety
Describe the current biotherapeutics landscape, including the off-patent status of many biologics and the emergence of biosimilars in the U.S.
ACCREDITATION ProCE, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number 0221-0000-15-046-H05-P has been assigned to this knowledge-based, home-study activity (initial release date 02-16-15). This activity is approved for 1.0 contact hour (0.10 CEU) in states that recognize
ACPE providers. This CE activity is provided at no cost to participants. Statements of credit will be issued online at www.ProCE.com upon completion of the evaluation and post-test with a score of 70% or higher. Proof of completion will be posted in NABP CPE Monitor profiles. No partial credit will be given.
Release Date: February 16, 2015 Expiration Date: February 16, 2017
FUNDING This activity is supported by an educational grant from Hospira, Inc.
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FACULTY AMANDA E. PRUSCH, PHARMD, BCPS
Dr. Prusch is currently the Medication Safety Specialist at Lancaster General Health. She is involved in coordinating medication safety and quality improvement initiatives to augment the organization’s medication safety culture. She actively participates in many organizational and departmental patient-safety initiatives and oversees the management of the intelligent infusion device drug libraries and data analysis. The team’s efforts related to IV interoperability earned them the ASHP Best Practice in Health-System Pharmacy Award in 2009, an ASHP Foundation Award Finalist for Excellence in Medication Use Safety in 2010, and the Institute for Safe Medication Practices Cheers Award in 2010.
Amanda began her career at Lancaster General Health in 2005 as a Clinical Pharmacist contributing to the medication management for patients of the Family Health Medical Residency team. Amanda has been involved in various leadership roles, including current Program Director for Lancaster General’s PGY-1 residency program, and in the past has served as President for the South East Chapter of the Pennsylvania Society of Health-System Pharmacists. She received her PharmD from Philadelphia College of Pharmacy, University of the Sciences in Philadelphia. Following graduation, she completed a pharmacy practice residency program with York Hospital in York, Pa. Amanda is also Lean Six-Sigma trained and has achieved board certified pharmacotherapy specialist (BCPS) status.
RONALD H. SMALL, RPH, MBA, SCD, FASHP, FAPHA
Dr. Small is a Consultant with Joint Commission International and Joint Commission Resources, focusing on the medication use process, safe health system design, and the safe adoption of technologies. Ronald is also the President and CEO of Eagle Strategic Alliances, a healthcare consulting company, which enables him to pursue his passion for leadership development by creating and utilizing centers of knowledge and excellence in healthcare processes. Dr. Small retired in 2011 as Vice-President of Quality, Safety and Service Excellence and Chief Pharmacy Officer at Wake Forest University Health. His experience across the continuum of care included responsibility for the Heart
Center, Diagnostic Cardiology, Infection Control, Service Excellence, Materials Management, Respiratory Therapy, Quality Resource Center and included responsibility for Pharmacy practices in retail, long term care, home care, Infusion Centers, Antimicrobial Stewardship, physician practices and community health centers. Additionally, Dr. Small served for 18 months as the Interim CIO for the Medical Center’s Informatics Center and 24 months as the Chief Procurement Officer. Ronald is among a small number of practitioners who have been recognized as a Fellow in both the American Pharmaceutical Association and the American Society of Health System Pharmacists. In 2013, Dr. Small was elected to the APhA Board of Trustees for a 3- year term and will serve the APhA in a leadership role for the Strategic Directions Committee. He is a member of the Faculty of the ASHP Foundation’s Leadership Academy.
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Dr. Small has also contributed to the professional body of knowledge and has served as an invited international speaker on such topics as quality leadership and quality improvement, antimicrobial utilization stewardship, drug cost reduction strategies, the safe adoption of technologies in the medication use process and quality of care improvement strategies. Dr. Small earned his degree in pharmacy and an MBA from the University of North Carolina and was honored with a doctor of science degree from Campbell University. He was certified as a Quality Improvement Trainer by The Juran Institute, and additionally certified by the Intermountain Institute for Healthcare Delivery Research. Dr. Small is a Certified Executive Coach with the International Coaching Federation and a Yellow Belt in Six Sigma.
FACULTY DISCLOSURE
It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants any significant financial interest or affiliation with companies that manufacture or market products discussed during their presentation. Dr. Prusch has no relevant commercial or financial relationships to disclose. Dr. Small has no relevant commercial or financial relationships to disclose. A portion of grant funds received by ProCE from Hospira, Inc. will be used to compensate the faculty for preparation of this monograph. Peer review of the material in this CE activity was conducted to assess and resolve potential conflict of interest. Content of this activity was found to be fair balanced and lacking commercial bias. The opinions expressed in this activity should not be construed as those of the CE provider or Hospira, Inc. The information and views are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include the use of drugs for unlabeled indications. Use of drugs outside of labeling should be considered experimental and participants are advised to consult prescribing information and professional literature
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IV INTEGRATION AND A CULTURE OF SAFETY TO ADDRESS
MEDICATION ERRORS: A MULTI-BILLION DOLLAR OPPORTUNITY By Ronald H. Small, RPH, MBA, ScD, FASHP, FAPhA
Whether you're in an environment that is adding new technologies or one that is improving current processes, it has to be an environment in which leaders accept responsibility and accountability for change and have a commitment to excellence. In health care, there is an additional need for an environment with a culture of safety. Incorporating technology into processes is not the solution to the problem, but it is part of the strategy. In a culture of safety, there is heightened awareness of medication errors. There is a need to establish a baseline of data to help identify opportunities for improvement. And, there needs to be a total understanding throughout the organization of the impacts of medication errors and a plan for educating patients and staff members alike on medication safety.
DON’T FEAR CHANGE
It has been attributed to Albert Einstein that the definition of insanity is “doing the same thing over and over again and expecting different results.” Healthcare workers in the United States and the world seem to think that if you just do what you have been doing, but try to do it a little bit better, then things will change. That is the definition of insanity. Don’t be afraid of change. Change the changeable, accept the unchangeable, and remove yourself from that which is unacceptable.
WHAT DOES EXCELLENCE LOOK LIKE?
Operational and leadership excellence involves having outcomes in mind. That is, “What does excellence look like?” Excellence is achieved when:
Staff are well trained in their job roles
The medication system is analyzed from a point of risk, efficiency, and effectiveness
Technology has been safely integrated
Key performance measures are identified, collected, and analyzed to assess medication system performance
Performance is audited to ensure achievement of three objectives of a safe medication use system: – No harm to patients – No harm to the healthcare workers – No wastage in the system that may harm the community
HIGH RELIABILITY ORGANIZATIONS
There is significant interest from The Joint Commission and others in creating organizations that are highly reliable. One definition of high reliability is: all people always experience the safest, highest-quality, best-value health care across all settings (Figure 1).1 Very few organizations can be considered highly reliable in health care. Although significant improvements in quality of care are being made, and miracles are happening in organizations every day, there still is patient harm – avoidable harm – that should be prevented.
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FIGURE 1. Building blocks to achieving high reliability1
High reliability can be achieved with leadership’s commitment to excellence, a systematic approach to process improvement (e.g., Lean Six Sigma or a plan-do-study-act model), and most important, a culture of safety.
FACTS ABOUT HUMAN ERROR
The science of human factor studies is based on how people interact with their environment. It examines workplace factors that influence decisions and actions of workers. One of the key insights of James Reason, a recognized expert on causes of human error, is that human error is inevitable, especially in systems as complex as health care.2 Simply striving for perfection – or punishing individuals who make mistakes – will not appreciably improve safety. Furthermore, expecting flawless performance from human beings working in complex, high-stress environments is unrealistic. The systems approach holds that efforts to catch human errors before they occur, or block them from causing harm, will ultimately be more fruitful than efforts that seek to somehow create flawless providers. With an emphasis on high reliability and an acceptance that errors are inevitable, The Joint Commission has created a new chapter for the Comprehensive Accreditation Manual for Hospitals, effective as of January 2015, titled “Patient Safety Systems.”3 This chapter has no new standards or elements of performance, but it includes all of the standards and elements of performance related to improving processes for patient safety. Medication management is a significant part of this, and requires looking at how systems can be monitored to identify opportunities for improvement. Many situations put healthcare workers at risk to make errors. Some errors occur because people are not well informed or educated. They may lack experience. People rush to do things because of perceptions of being “so busy.” Many people believe that they are able to multitask; but doing more than one thing at a time optimally is a significant challenge. (Multitasking may be okay as long as you realize that you can’t
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optimally perform any particular task if you're distracted with another.) Interruptions, fatigue, poor teamwork, and poor communication are other significant concerns. Additionally, there is a reluctance in healthcare to rely on checklists, protocols, and other memory aids; yet reliance on memory sets us up for failure. Thus, both individual and organizational factors contribute to the occurrence of medication errors. Humans are fallible and errors inevitable. Even the best people are error prone, and errors fall into concurrent patterns. Making errors is part of human nature, but so is finding ways to face and limit medication errors.
EXERCISING FREE SPEECH AMONG HEALTHCARE WORKERS
Results of an AHRQ survey on the perceptions of a culture of safety, at first glance, do not look so bad (Table 1).4 Survey results show that staff will speak up 76% of the time if they see something that may affect patient care. However, staff will question decisions or actions of persons in authority less than 50% of the time. This is a significant issue of concern that’s causing some of the problems with patient harm. Healthcare workers have a responsibility to speak up to prevent patient harm, and should be encouraged to do so (Table 2).
Table 2. Six Actions Leaders Should Take to Encourage Healthcare Workers to Speak Up
• Provide inter-disciplinary training to ensure a “Just Culture” environment • Ensure that teams train as teams • Adopt and publish a zero-tolerance policy for "payback“ • Embed assertiveness training in new-hire training • Revise P&P Manuals with clear and unambiguous directives requiring the use of stop-the-line
language • Celebrate loudly and often those who speak up and stop the line to protect a patient's safety
JUST CULTURE: CATEGORIES OF HUMAN BEHAVIOR
The “just culture” concept, created by David Marx,5 teaches us to shift attention from retrospective judgment of others, which is focused on the severity of outcomes, to real-time evaluation of behavioral choices in a rational and organized manner. Just Culture organizations recognize 3 major categories of human behavior and the importance of responding appropriately to each: human error, at-risk behavior, and reckless behavior.6
Human error is inadvertently doing other than what should have been done – a slip, lapse, or mistake. Human error may be managed through changes in processes, procedures, or training design, and the response may be to console the person.
At-risk behavior involves choices that increase risk, when risk is not recognized or is mistakenly believed to be justified. It may be managed through creating incentives for healthy behaviors and
Table 1. Healthcare Workers’ Communication Openness4
Staff will speak freely if they see something that may affect patient care
76%
Staff feel free to question decisions or actions of person in authority
47%
Staff are afraid to ask questions when something does not seem right
63%
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increasing situational awareness. Coaching is a strategy for addressing at-risk behavior at the individual level.
Reckless behavior implies the choice to disregard a substantial and unjustifiable risk. It may be managed through remedial action, although punitive action may be considered in some cases.
COMMON AT-RISK BEHAVIORS
It is human nature to look for quicker and easier ways to accomplish tasks, but these actions may lead to or be a result of at-risk behaviors. At-risk behaviors are actions may compromise patient safety and may include:
Engaging in "grab and go"
Intimidation or reluctance to ask for help or clarification
Failure to educate patients
Using medications without complete knowledge
Failure to double check high-alert medications
Not communicating important information
Failure to respond to alerts and alarms
Bypassing “smart pump” drug libraries Practitioners may use at-risk behaviors because the rewards are immediate and the risk of patient harm seems remote. However, this makes it difficult to motivate people to always choose the safest way to work. We lose the perception of risk when we become comfortable and competent with the task at hand. At-risk behaviors often result in convenience, comfort, and saved time. The perceived benefits of taking shortcuts rapidly lead to continued at-risk behaviors, despite the knowledge, on some level, that patient safety could be compromised. In addition, as one or more practitioners have what appears to be success with an at-risk behavior, they will likely influence fellow practitioners until that behavior becomes a standard practice. These behaviors often emerge because of system-based problems and complexities in healthcare organizations.
DRIVERS FOR CHANGE
Drivers for change in behaviors and outcomes are significantly different and present challenges for organizations. Overall reduction of medication errors requires a multipronged approach, ranging from financial incentives to organizational and care-delivery improvements that address the root causes of errors. Action steps include providing incentive payments to assist health professionals and hospitals in adopting clinical IT tools (e.g., electronic health records, e-prescribing, CPOE, use of bar-codes at the beside, and use of smart pumps). CMS is imposing penalties on organizations that exceed set readmission rates and/or have hospital-acquired conditions that will no longer be reimbursed. Drivers of change are making some significant inroads. A report released by HHS in 2014 indicates a 17% drop in healthcare-acquired infections from 2010 to 2013, or approximately 1.3 million fewer infections.7 Such a decline also translates to approximately 50,000 fewer patient deaths in hospitals and a $12 billion reduction in healthcare costs.
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THE OPPORTUNITY
In 2010, the National Quality Forum convened a National Priorities Partnership and published “A Roadmap for Increasing Value in Health Care.” Conservative estimates of harm from medication errors were documented, placing costs at over $21 billion annually.8 Nationally, serious preventable medication errors occur in 3.8 million inpatient admissions and 3.3 million outpatient visits each year. In its report To Err Is Human, the Institute of Medicine estimated 7,000 deaths in the U.S. each year due to preventable medication errors.9 Other data from the publication include:
Inpatient preventable medication errors cost approximately $16.4 billion annually.
Outpatient preventable medication errors cost approximately $4.2 billion annually.
Regarding preventable medication errors: ― 37% result from dosing errors. ― 11% result from drug allergies or harmful drug interactions. ― 22% of reconciliation errors occur during admissions, 66% during transitions in care, and
12% during discharge. In addition, unnecessary surgery and other services are provided about 11% of the time.10 Only about 50% of recommended care is being received by our patients.10 According to another IOM report, medication errors injure 1.5 million people each year and result in $3.5 billion in costs.11 According to an AHRQ report, a significant concern is that 90% of patients receive IV therapy, and there is a 61% probability of error in the administration stage of IV medications.12 Approximately 55% of all medication errors are associated with IV medication, and overall probability of at least one error in IV is 73%. IV errors increase the length of hospital stay and add significant additional costs. Errors can potentially occur at any of the stages in the medication use process (Figure 2).13 The potential for errors is slightly higher at the prescribing stage (39%) than at the administration stage (38%). But the key issue is the interception of errors. Only about 2% of potential errors during administration are caught. In contrast, in the prescribing stage various backup systems – nursing, pharmacists, and others – prevent potential errors from happening. This identifies where we should be focusing our attention.13
FIGURE 2. Potential for errors in the medication use process.13
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THE SOLUTIONS
Care coordination strategies, interdisciplinary teamwork, and computer technologies can significantly reduce preventable medication errors.8 These interventions increase the availability of data, provide clinical decision support, engage patients, and improve the accuracy of prescriptions. Patient care improvements include improving coordination of care related to: Communication: Improved communication among physicians, pharmacists, and nurses has been documented to prevent 85% of serious medication errors. Care Teams: Including a pharmacist on routine medical rounds has led to a 78% reduction in medication errors. Patients who received pharmacist follow-up calls were 88% less likely to have a preventable medication error resulting in an ED visit or hospitalization. Patient-Informed Decision Making: Active engagement of patients and family caregivers with the care team, use of patient safety checklists, and increased awareness of publicly reported hospital safety records can help reduce medication errors. Enhancing Technology Interventions: Electronic prescribing systems have reduced medication errors by approximately 85%. Verifying the correct drug dosage with eMAR technology led to a 51% reduction in medication errors. Within a large academic hospital, the use of pharmacy barcodes led to annual savings of $2.2 million. Computerized physician order entry with clinical support reduced serious medication errors by 81%. Additionally, smart pump utilization is an essential element in strategies to reduce errors and improve process related to IV utilization.
SAFE USE OF TECHNOLOGY
At least two Joint Commission Sentinel Event Alerts deserve additional study and follow-up: #42 on Safely Implementing Health Information and Converging Technologies and #50 regarding Medical Device Alarm Safety in Hospitals.14,15 A systematic approach should be developed to respond to these alerts. The overall safety and effectiveness of technology in health care ultimately depends on its human users, ideally working in close concert with properly designed and installed electronic systems.
A ROADMAP FOR TECHNOLOGY CONVERGENCE
Based on Sentinel Event Alert #42, we can create a roadmap for technology convergence (Table 3).14 The information can be useful in developing an assessment document to ensure that technology is adopted safely into medication processes. It is often assumed that adding technology solves a problem, yet patients may actually be more quickly subjected to harm.
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Table 3. Roadmap for Technology Convergence14
Ensure That You Have a Strategic Vision
Implement a strategic vision that aligns with the business and safety values of the hospital; sustain that vision and adapt to changing circumstances as needed.
Make Clinical Work Processes a Priority
Involve clinicians in decision related to converging technologies, and carefully consider their needs at all stages of convergence activities.
Establish Strong Leadership Ensure that hospital management supports and is involved in the convergence of technologies, including redirection of priorities and allocation of resources.
Understand the Life-Critical Nature of the Medical Data
Being Exchanged
Establish requirements for the quality and reliability of medical data communications; prioritize these requirements based on the criticality and clinical impact of the information involved.
Foster Relationships Help the many departments involved in convergence efforts to recognize one another’s needs and to understand how technology decision can affect a wide variety of hospital areas.
Approach Projects with a System-Based Methodology
Adopt a systems-based approach to convergence activities-that is, one that encompasses all the interrelated elements of the process rather than just focusing on each element in isolation.
Ensure That Decisions Are Patient-Centric
Focus first on convergence projects that will have a tangible impact on patient care-especially patient safety- and monitor them closely.
Purchase Wisely When selecting devices for purchase, keep in mind convergence requirements and the impact of new technologies on increasingly interrelated systems. Involve stakeholders in the decision process.
Protect the Security of Medical Information
Make the security of medical information a key priority for converging technologies, at both the device and the network level.
Perform Risk Management Analyses on Converging
Technologies
As part of managing converging technologies, make one of these technologies the subject of a formal risk analysis.
Carefully Plan Your Wireless Enterprise
When implementing or upgrading wireless systems, make sure you consider all the interrelated issues, including infrastructure needs, clinical priorities, and frequency coordination.
Develop a Plan for the Future Construct a three-to five-year strategy that outlines your convergence needs, including costs, staffing requirements, technology life spans, and data storage necessities.
Understand Software Issues Recognize the complexities of intermingling medical software with nonmedical software and implement all necessary planning and precautions.
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NPSG ON ALARM MANAGEMENT
The first phase of the National Patient Safety Goal on Alarm Management was to have been initiated by January 2014.16 In the first phase, hospitals are required to:
Establish alarms as an organization priority
Identify the most important alarms to manage based on: ― Their own internal situations ― Input from medical staff and clinical departments ― Risk to patients due to lack of response, malfunction ― Whether specific alarms are needed or contributing to noise/fatigue ― Potential for patient harm based on internal incident history ― Published best practices/guidelines
The next phase, which is to begin in January 2016, is a more challenging, and it is essential that pharmacists become extensively involved to ensure compliance with the NPSG. Smart pumps should be included to avoid alarm fatigue. In the second phase of the NPSG, hospitals will be expected to:
Develop and implement specific components of policies and procedures that address at minimum: ― Clinically appropriate settings ― When they can be disabled ― When parameters can be changed ― Who can set and who can change parameters, and who can set to “off” ― Monitoring and response expectations ― Checking individual alarm signals for accurate settings, proper operation, and detectability
Educate those in the organization about alarm system management for which they are responsible Based on reports of Sentinel Event Alerts and an analysis of 98 reports in the database, The Joint Commission determined that between 2009 and 2012, 80 of alarm-related events resulted in patient deaths. In addition, 13 of the events resulted in permanent loss of function and five resulted in unexpected additional care or additional length of stay. It was also determined that of the thousands of alarms in organizations each day, 85% to 99% do not require clinical intervention.
BENEFITS AND LIMITATIONS OF SMART INFUSION PUMPS
Many IV medications are also classified as high-alert medications and thus are more likely to cause harm if an error occurs during administration. Benefits of smart pumps. One of the benefits of smart pump technology is that it can reduce administration errors associated with miscalculated doses. Smart pumps can provide a check of manual calculations and ensure that the dosing formula selected is appropriate for the medication and the patient (e.g., mcg/kg/hr vs. mcg/kg/min). Alerts and stops provided by the infusion pump allow clinicians to recognize programming errors and miscalculated doses that could otherwise result in patient harm. Another benefit of using these devices is the availability of data captured when practitioners program the pumps. Analysis of this information can guide practice change and performance improvement efforts.
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Limitations of smart pumps. These very same benefits can also be limitations of the system if not used appropriately. Smart pump technology is also not without limitations. If the smart pump drug library is bypassed, and the infusion rate and volume are entered manually, the dose error-reduction software will not be in place to prevent a potential error. This example of at-risk behavior reduces the likelihood that an error will be identified since no alerts will be triggered. The smart pump software also cannot replace independent double checks. The accuracy of information entered into the smart pump (patient identity, selection of medication, patient weight, etc.) is dependent on correct data entry. Errors in data entry can be exacerbated if medication concentrations have not been standardized within an organization. An independent double check is warranted for certain identified high-alert medications. Too many concentration options for each drug increase the potential for the wrong concentration to be selected. User alerts have limitations as well. Soft-stop alerts can be easily overridden, often with one key stroke. Hard stops that aren’t set appropriately can create a barrier to care delivery and may result in nurses using work-arounds, such as programming the infusion device using the rate/volume mode rather than using the drug library. Failure of users to understand or critically evaluate the information provided by the alert can also result in an error.
USE OF MEDICATION SYSTEM DATA
To systematically use data:
Develop a process for evaluation of the data
Analyze the information from medication errors to identify needed improvements
Share information about errors throughout the organization Remember that data are essential to process-improvement efforts. The new Patient Safety Chapter in the Manual for Hospitals requires that hospitals take a systematic approach to error analysis and not just identify the need for an RCA or FMEA.3 Patient harm is a common concern among healthcare practitioner and patient-safety advocates, yet most don't have a lot of confidence in their current technology to track harm. This insight comes from the results of a survey on patient safety, which was conducted at the National Patient Safety Foundation's 2014 congress.17 The survey results included:
90% of respondents agreed that patient harm is commonly discussed in their organization
47% disagreed or strongly disagreed that their technology showed detailed harm patterns
An overwhelming majority (98%) agreed or strongly agreed that technology that provided real-time patient harm patterns would be valuable
In closing, I encourage you to take a look at how you're using the data that are generated from these devices. I have always professed to be a learner from the noted statistician W. Edwards Deming, and I’ve always felt that if it’s really important you can measure it. Although a definitive source is elusive, a statement frequently attributed to Deming reads: “In God we trust, all others must bring data.”18
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REFERENCES
1. Chassin MR, Loeb JM. High-reliability health care: getting there from here. Milbank Quarterly. 2013;91(3):459-490.
2. Reason J. Human error: models and management. BMJ. 2000;320:768-770.
3. The Joint Commission. 2015 Comprehensive Accreditation Manual for Hospitals: The Patient Safety Systems Chapter. January 2015. Available at: http://www.jointcommission.org/assets/1/6/PSC_for_Web.pdf.
4. Sorra J, Famolaro T, Dyer N, et al. Hospital Survey on Patient Safety Culture 2010 user comparative database report, appendixes, parts II and III. AHRQ Publication No. 10-0026. Rockville, MD: Agency for Healthcare Research and Quality; March 2010.
5. Marx D. Patients Safety and the “Just Culture”: A Primer for Health Care Executives. April 17, 2001. Available at: http://www.safer.healthcare.ucla.edu/safer/archive/ahrq/FinalPrimerDoc.pdf.
6. The Joint Commission. Perspectives on Patient Safety. June 2010;10.
7. U.S. Department of Health and Human Services. Interim update on 2013 annual hospital-acquired condition rate and estimates of cost savings and deaths averted from 2010 to 2013. Available at: http://www.ahrq.gov/professionals/quality-patient-safety/pfp/interimhacrate2013.pdf.
8. National Quality Forum / National Priorities Partnership. Compact Action Brief: A Roadmap for Increasing Value in Health Care. Available at: http://www.pointofcareforum.com/wp-content/uploads/2011/02/NPP_Medication_Error.pdf.
9. Institute of Medicine. To Err Is Human: Building a Safer Health System. November 1999. Available at: https://www.iom.edu/Reports/1999/To-Err-is-Human-Building-A-Safer-Health-System.aspx.
10. Goldman DP, McGlynn EA. U.S. Health Care: Facts about Cost, Quality, and Access. The RAND Corporation. 2005. Available at http://www.rand.org/pubs/corporate_pubs/2005/RAND_CP484.1.pdf.
11. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. March 2001. Available at: https://www.iom.edu/~/media/Files/Report%20Files/2001/Crossing-the-Quality-Chasm/Quality%20Chasm%202001%20%20report%20brief.pdf.
12. Agency for Healthcare Research and Quality. Reducing and Preventing Adverse Drug Events to Decrease Hospital Costs. Research in Action, Issue 1. AHRQ Publication Number 01-0020, March 2001. Rockville, MD.
13. California Healthcare Foundation. Addressing Medication Errors in Hospitals: A Framework for Developing a Plan. Protocare Sciences; July 2001. Available at: http://www.chcf.org/~/media/MEDIA%20LIBRARY%20Files/PDF/A/PDF%20addressingmederrorsframework.pdf.
14. The Joint Commission. Safely implementing health information and converging technologies. Sentinel Event Alert. Issue 42; December 11, 2008. Available at: http://www.jointcommission.org/assets/1/18/SEA_42.pdf.
15. The Joint Commission. Medical device alarm safety in hospitals. Sentinel Event Alert. Issue 50; April 8, 2013. Available at: http://www.jointcommission.org/assets/1/18/sea_50_alarms_4_5_13_final1.pdf.
16. The Joint Commission. The Joint Commission announces 2014 National Patient Safety Goal. Joint Commission Perspectives. July 2013;33. Available at: http://www.jointcommission.org/assets/1/18/jcp0713_announce_new_nspg.pdf.
17. Pascal Metrics. Patients at risk: survey finds few healthcare facilities have access to reliable patient harm data. [Press release] July 21, 2014. Available at: http://www.pascalmetrics.com/patients-at-risk-survey-finds-few-healthcare-facilities-have-access-to-reliable-patient-harm-data.
18. W. Edwards Deming. In: Wikipedia. Available at: http://en.wikipedia.org/wiki/W._Edwards_Deming#cite_note-learning-30.
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INTEGRATED INFUSION MANAGEMENT By Amanda E. Prusch, PharmD, BCPS
BACKGROUND The incorrect administration of an intravenous (IV) medication can lead to significant or life-threatening patient harm. This can be attributed to most high-alert medications that are predominantly administered intravenously.1 IV medications are associated with 54% of potential adverse drug events, 56% of medication errors, and 61% of serious or life-threatening errors. Each node throughout the medication use process is fraught with opportunities for human and system error; hence, the incorporation of medication safety technology throughout the continuum should be an essential component of an organization’s risk-mitigation strategy. The ADE Prevention Study Group found that medication errors were most common in the prescribing and administration nodes, 39% and 38%, respectively.2 Of the prescribing errors, 48% were intercepted prior to reaching the patient. In contrast, only 2% of administration errors were intercepted, rendering this step in the medication use process the most vulnerable to errors that reach the patient. Unfortunately, these errors often go unreported unless patient harm ensues or the clinician reports that an error occurred. This demonstrates the clinical need for error prevention at the bedside. Bar-coded medication administration (BCMA) and intelligent infusion devices (“smart pumps”) independently provide substantial safeguards at the point of care. However, despite these prevention strategies, incorrect programming of intelligent infusion devices remains prevalent. Infusion pump medication errors, along with alarm hazards, ranked highest on the ECRI Institute’s Top 10 Health Technology Hazards for 3 consecutive years (2012 to 2014).3-5
The ECRI Institute, a federally recognized patient safety organization, randomly analyzed 100 of their 468 database infusion pump–related events.6 While 28% of these errors could have been averted with smart pump libraries alone, nearly 75% would have been prevented with successful pump integration. Pump-related medication administration errors that cannot be prevented by the intelligent software on the device (i.e., the drug library) include selection of the wrong medication within the drug library, a misprogrammed dose or rate that does not trigger a soft or hard library limit, a medication not in the drug library (perhaps a wildcard entry), or failing to start the infusion.
TERMINOLOGY
6 Auto-Programming: IV medication order sent from the electronic medication administration record
(+/- within an electronic health record [EHR]) that auto-populates the required parameters (medication, concentration, dose/rate, volume-to-be-infused, weight) on a specific pump channel.
Auto-Documentation (also referred to as Data Validate): pump communicates to the electronic medication administration record (+/- within an EHR) that documents pump programming (e.g., dose/rate changes, volume infused).
Auto-Verification: pump settings are communicated to the electronic medication administration record and the nurse is alerted if the pump settings do not match the medication order.
Bi-directional Communication: contains all three components: auto-programming, auto-verification, and auto-documentation.
Upper and Lower Soft Limits: drug library dosing safeguards that can be overridden.
Upper and Lower Hard Limits: drug library dosing safeguards that are not able to be overridden.
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EARLY ADOPTERS In this article, I will highlight the successful implementation and experience of an IV-integrated solution at Lancaster General Health located in Lancaster, Pa. Lancaster General’s IV integration journey began in 2008 as one of the industry’s auto-programming pioneers by passing five elements of the medication order – medication, concentration, dose/rate, volume to be infused, and patient weight, when applicable – from our electronic medication administration record to the pump. In 2011, we transitioned to an integrated EHR with a modified (or limited) integration platform that allowed us to continue to communicate the medication, concentration, and patient weight (when applicable). By 2013, full 5-element auto-programming was restored in addition to introducing a two-way (bi-directional) communication (Figure 1).
FIGURE 1. Bi-Directional Communication
IV integration closes the gap on IV administration errors, thereby improving patient safety. On top of leveraging the safety impact, Lancaster General found that additional meaningful benefits to the patient, clinician, and organization could be realized (Table 1), particularly streamlined workflows that offer efficiencies as well as quality data to support process improvement (Figure 2).
FIGURE 2. IV Integration Benefits
Safety
EfficiencyQuality
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Table 1. Benefits of IV Integration
Safety Eliminate (reduce) IV medication administration errors
Efficiency Standardized, consistent workflow for nursing Reduction in nursing time (both programming device and
documenting in EHR
Quality
Patient-specific data Pump-specific data Nurse-specific data Clinically meaningful data
Additional
Accurate documentation Additional data sources for troubleshooting (pump/EHR interface) Organizational learning: ask the “why” Comprehensive event report investigation Auto-program medications not present in the drug library Easily identify drug library entries needed for future update Pharmacy workflow management
IV INTEGRATION BENEFITS IV integration standardizes a consistent nursing workflow requiring the nurse to focus on a single medication at a time. In many ways, the safety benefits are a direct result of the more efficient process. Utilization of the auto-programming workflow eliminates 10 manual programming steps that are most prone to contributing to a pump programming error (Figure 3).7
FIGURE 3. Manual vs. Auto-programming Steps
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A time and motion study in 2008 demonstrated a 24.8% reduction in nursing time with auto-programming compared with the nurse manually programming the pump.7
In areas where the IV integrated technology was deployed, overall monthly compliance rates exceeded our organizational goal of 90%. For example: the compliance snapshot rate in December 2014 was 94%, excluding the emergency department. With the bi-directional integration in most of our clinical areas, including outpatient oncology services and the emergency department, our drug library compliance is approximately 80% or above, and drug library limit edits due to manual misprogramming continue to trend downward (Figure 4).
FIGURE 4. Compliance and Edits
The data–validate feature automatically documents how the pump infused the medication, eliminating the need for a nurse to manually document. It also captures the truth of how the medication was infused (vs. how it was supposed to be programmed). With data validation, there is increased visibility and transparency within the medical record to correlate with the patient’s condition, and can potentially guide future therapy. Finally, an integrated platform improves the quality and depth of data. This meaningful data is now easily traced to the patient, the nurse, and the infusion device for in-depth data analysis.
ADDITIONAL BENEFITS OF IV INTEGRATION
Standardized workflow ― Nurse performs the same steps for all intermittent or continuous infusions (eliminates variation) ― Focus on one medication at a time versus setting up multiple infusions at the same time, which
has the potential to contribute to errors with various root causes
Accurate documentation: actual infusion record versus how the infusion was supposed to occur based on the provider’s order
Event investigation: comprehensive evaluation can occur as the integration connects the patient, nurse, and pump to the medication order
Auto-program medications not presently in drug library ― Useful for new medications, limited/rare formulary items, and/or limited drug library space
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― Four medication order elements are communicated to the wildcard entry in the drug library (concentration, dose/rate, VTBI, patient weight)
Reports easily identify medications to be added to drug library
Pharmacy workflow management ― Close the loop further by providing pharmacy the opportunity to have access to real-time
electronic dashboards to transition certain IV medications to on-demand preparation
Organizational learning about the administration practices of intermittent and continuous IV medications
Drug shortages. Another advantage of IV integration pertains to drug shortages. Drug shortages can be problematic for utilizing drug libraries safely. The problem arises when a medication within the drug library has a defined total drug and total volume concentration that cannot be altered by the end-user. For medications that cannot be compounded or purchased in the same total drug/total volume concentration as defined in the drug library, there are inherent risks:
First, that the nurse would misprogram the new concentration utilizing the previous drug library settings, leading to wrong (over/under) dose.
Second, that the misprogramming that would occur when the nurse must manually program a medication that is not in the drug library. Since the medication at that concentration would not be in the drug library, basic safeguards of the pump – upper, lower, soft, and hard limits – would be absent. Updating drug libraries is a possibility, but with the abundance and abrupt presence of a drug shortage this is not always feasible.
Other considerations include the estimated time period for the shortage as well as the education and resources necessary for a drug library update. However, IV integration provides a solution by auto-programming medications that are not in the drug library. We do not allow the new concentration to match/find the established concentration in the pumps – therefore, it auto-programs the wild card (No Drug Selected) option, eliminating manual programming of the concentration, dose/rate, VTBI, and patient weight.
WORKFLOW The auto-programming component of bi-directional IV integration casts the largest safety net to mitigate misprogrammed infusions from reaching a patient. Key steps in the workflow process are intended to achieve safety benefits (Figure 5). These steps include:
1. Medication order originates with computerized provider order management 2. Pharmacist verifies the order ensuring the order is complete and clinically appropriate 3. Medication order is available in the electronic medication administration record (eMAR) 4. Nurse initiates the bar-coded workflow (5 Right checking) 5. Organization determines the parameters and defines which medications prompt the IV integration
workflow for the nurse ― Inclusion: most intermittent and continuous intravenous medications ― Exclude: IV push medications, epidural and patient-controlled anesthesia infusions [different
devices that currently lack IV integration capabilities] 6. Nurse scans the specific channel on the device 7. Infusion parameters (as ordered by the provider) will automatically populate the device 8. Prior to initiating the infusion, the nurse must always perform a visual validation that the pump
settings match the electronic medication record medication order
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― Nurse starts the infusion 9. Auto-verification occurs prior to documentation being complete in the eMAR
― Auto-verification is the comparison of pump infusion parameters between the pump and the eMAR Match: no warning for the nurse and documentation is complete Mis-match: nurse encounters a warning that must be addressed prior to documentation
being complete ― Auto-verification provides an additional safety check
FIGURE 5. Auto-programming Workflow
To complete the process, the data-validate (or auto-documentation) component of bi-directional IV integration, which automatically documents how the pump was programmed to infuse, enhances overall efficiencies and guarantees accurate documentation.
ORGANIZATIONAL LEARNING AND DATA ANALYSIS A bi-directional IV integration technology platform provides a plethora of data to the organization. The key is to identify and focus on meaningful reports that build upon mainstay smart pump reports. This evidence-based approach can compel improvement within the IV medication administration process – improving safety while gaining efficiencies. Indispensable data can be ascertained from similar reports as detailed below.
Smart Pump Reports:
Infusion summary: adherence to the drug library
Edits: detect near misses or critical catches ― Misprogrammed events corrected due to a soft/hard limit in the drug library ― Beneficial for guiding when to institute hard limits in future drug library updates
Overrides: ― Detect alert fatigue ― Identify nursing practice patterns
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Electronic Health Record:
Adherence to the IV integration workflow
Side-by-side mismatch: details the discrepancies during auto-verification (Figure 6)
Near miss / critical catches Additional Data Sources:
Interface messages between the EHR and the smart pump: ― Identify why the integration failed ― Messages can be investigated and fixes implemented either in the drug library or EHR
medication record to prevent future communication failures
Medication event reports
FIGURE 6. Side-by-side mismatch (dopamine as an example).
LEARNING OPPORTUNITIES The incorporation of any new technology or process often presents new challenges or expose underlying challenges; bi-directional IV integration is no exception. As we continue to learn from our IV integration data, we have identified opportunities for system enhancements. One opportunity is for duration-based orders, as currently these do not communicate the defined duration.
For example: an oxytocin bolus that is to infuse at 15 units/hour for 15 minutes using the standard concentration of 30 units/500 mL. ― The VTBI is auto-populated at 500 mL versus the desired 250 mL based on the desired duration
and established concentration. ― To prevent the wrong volume from infusing, the nurse must first remember and then manually
edit the pump parameters prior to starting the infusion.
ALARM FATIGUE AND INFUSION DEVICES Together with The Joint Commission’s National Patient Safety Goal on Alarm Management, the ECRI Institute has identified alarm hazards as a leading medical technology hazard for the last few years and ranked alarm hazards as #1 in their 2015 report.8 Alarms related to infusion pumps are no exception. Alarms serve a dual purpose to enhance patient safety: prevent clinical deterioration and identify device malfunction/functioning.9 As we put more safeguards in place with IV integration, we introduce more alerts at the point of care. The challenge is to determine which alarms and alerts are the most meaningful in mitigating patient harm. Which have clinical significance? Which of them signal a patient safety concern? Which of them add to alarm fatigue?
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We performed a 1-month snapshot to gauge the contribution of pump alarms within our health system. During 1 month, we determined that approximately 99,000 alarms were generated by the infusion devices alone – not accounting for additional safety alerts provided by drug library limits or IV integration alerts (i.e., auto-verification and other warnings). The goal with alarm and alert management is to incorporate intelligent, standardized, integrated alarm systems centered on the patient with response protocols.10 Ideally, we need to strive for alarms/alerts that are 100% specific and 100% sensitive.9 By 100% specific, we mean never alarm when there is no clinically important event; by 100% sensitive, our intent is to never miss a critically important event. Examples of fatigue due to pump alerts and alarms can be found in Table 2.
Table 2. IV integration Fatigue Due to Alarms and Alerts
Pump Alarm Fatigue10 Integration Alert Fatigue
Alarm meaning False alarms Too soft/too loud Distinguishable among devices Does the pump alarm Inappropriate turning off/down of alarms Indication of severity/urgency (how to
prioritize) Responsibility
Pump safety limits ― Overrides >>> edits
Integrated Health Exchange alerts ― Standard interface alerts
eMAR / EHR alerts ― Mismatch ― Near miss
SUMMARY IV integration offers a much needed, additional layer of safety at the point of IV medication administration that smart pumps alone cannot provide. Successful implementation can be achieved by considering the following when instituting this integrated technology:
Clearly defined scope (patient population, nursing units, medications)
Understanding of current workflows, streamline accordingly
Standardized processes (medication concentrations, dosing units, workflow)
EHR aligned with pump settings
Solid bar-coding medication administration scanning and culture
Robust wireless infrastructure
Reliable pump channel bar-coding
Key stakeholder identification and engagement
Engaged governance structure
Communication/Collaboration: organization – pump vendor – EHR vendor
Internal expert identified to navigate clinical, device, and integration needs
Commitment to evolving technology: ongoing testing required
Data analysis (routine/ongoing)
Alert management: meaningful alerts/alarms that provide clear directive to the end-user
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REFERENCES
1. Vanderveen T. Averting highest-risk errors is first priority. Patient Safety and Quality Health Care. May/June 2005. Accessed October 27, 2014.
2. Leape LL, Bates DW, Cullen DJ, et al. System analysis of adverse drug events. ADE Prevention Study Group. JAMA 1995;274:35-43.
3. ECRI. Top 10 Health Technology Hazards for 2012. Health Devices. 2011;40(11).
4. ECRI. Top 10 Health Technology Hazards for 2013. Health Devices. 2012;41(11).
5. ECRI. Top 10 Health Technology Hazards for 2014. Health Devices. 2013;42(11): 1-12.
6. ECRI. Infusion Pump Integration. Guidance Article. Health Devices. 2013;42(7): 210-221.
7. Prusch AE, Suess TM, Paoletti RD, et al. Integrating Technology to Improve Medication Administration. Am J Health-Syst Pharm. 2011,68:835-42.
8. ECRI. Top 10 Health Technology Hazards for 2015. Health Devices. 2014:1-33.
9. Cvach M. An Alarming Situation: Managing Clinical Alarms Using a Systems Management Approach. VHA Webinar. Viewed 10/27/14.
10. Association for the Advancement of Medical Instrumentation (AAMI). http://www.aami.org/publications/summits/AAMI_FDA_Summit_Report.pdf Accessed 10/27/2014
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IV INTEGRATION AND A CULTURE OF SAFETY:
REDUCING COMPLEXITY AND ITS CONSEQUENCES
POST-TEST 1. Objectives of a safe medication use system are
intended to avoid:
a. Harm to the patient b. Harm to the healthcare worker c. Wastage that may harm the community d. All of the above
2. The building blocks for high-reliability
organizations include:
a. Leadership commitment b. Systematic approach to process
improvement c. Culture of safety d. All of the above e. Only A and C
3. Dr. James Reason's insights related to human
error is:
a. People are human b. Processes that depend on perfect human
performance are flawed c. People need to be disciplined to drive
process improvements d. Technology will eliminate human errors
4. In a Culture of Safety, categories of human
behaviors include all of the following, except:
a. Coerced behavior b. Human error c. At-risk behavior d. Reckless behavior
5. According to an AHRQ survey, how often will
healthcare workers question decisions or actions of someone in authority in order to prevent patient harm?
a. 76% of the time b. 63% of the time c. 57% of the time d. < 50% of the time
6. Which of the following is a benefit of an integrated infusion management system?
a. Prevention of manual misprogramming of an IV infusion device
b. Streamlined workflow that focuses on a single IV medication
c. Pharmacy workflow management for IV medications
d. Patient, pump, and infusion specific data e. All of the above
7. With integrated infusion management, pump
settings are communicated to the eMAR, and the nurse is alerted if the settings do not match the medication order. This is known as:
a. Auto-programming b. Auto-documentation c. Auto-verification d. Bi-directional communication
8. One of the goals of alarm management is to
have alarms that are:
a. 100% specific b. 100% sensitive c. Distinguishable d. All of the above
9. According to the ECRI Institute, what
percentage of medication errors related to infusion pumps can be averted with successful smart pump integration?
a. 100% b. 75% c. 50% d. 25%
10. How many manual programming steps can be
eliminated with auto-programming workflow?
a. 3 b. 5 c. 10 d. 12
Complete the Post-Test and Evaluation online at:
www.ProCE.com/IVinteg
Continuing Education for this activity is processed through the ProCE online CE Center. To receive CE credit: Go to www.ProCE.com/IVinteg to enroll and complete the Post-Test and Evaluation. With a passing score of 70% or better, you will be able to print your CE Statement of Completion online.
