Conference Report Published by CareFusion Center for Safety and Clinical Excellence
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- Need for improved anticoagulation medication safety
- Incorporating heparin into the program
- Table 2. If a hospital did not have a heparin service 1 Table 1. Heparin errors Example 1.
- Indianapolis Patient Safety Coalition
- Assessing safe practices
- Anticoagulation library
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Conclusion It is commonly believed that because of the complex nature of anticoagulation it is simply not possible to eliminate all errors or adverse events. Such fatalistic perspective will defeat excellence. By understanding the complexity of heparin therapy, managing every step and taking actions to identify and eliminate every source of error, significant progress can be made towards achieving the goal of “do no harm.”
Nolan TW. System changes to improve patient safety Brit Med J 200 Mar 18; 320(7237):771-3. PROCEEDINGS 9th Invited Conference: Improving Heparin Safety 41
Key points • Comparison of data from 955 hospitals shows that those with heparin services have lower death rates, length of stay, Medicare charges and bleeding complication rates, compared with hospitals that do not have this service. • The Fairview Southdale model for heparin dosing specifies that all patients receiving hepa- rin are managed by pharmacy and all dosing and titrations are weight-based and custom- ized to the disease state being managed. • St. Mary’s Medical Center (SMMC) experienced four serious warfarin-related events with a few months, which underscored the need to improve anticoagulation therapy. • A hospital-wide anticoagulation program eliminated sentinel events for warfarin, low molecular weight heparin (LMWH) and direct thrombin inhibitors (DTI) and showed that 80% to 90% of heparin errors could also be prevented. • Anticoagulation program data helped convince senior leadership of the need for smart infusion pumps; work on incorporating heparin into the anticoagulation program continues. This article includes a brief review of the successful anticoagulation program at St. Mary’s Medical Center (SMMC) in Duluth, MN that improved medication safety of warfarin, low molecular weight heparin (LMWH) and direct thrombin inhibitor (DTI) therapies and a discussion of continuing efforts to incorpo- rate heparin management into the program. Need for improved anticoagulation medication safety Anticoagulation therapy involves the use of high-risk medications and complex proto- cols that increase the likelihood of error. The demands of increasingly complex environ- ments and staff shortages can overwhelm even the most professional nurse’s capac- ity to follow a complex protocol correctly. Pharmacists are able to assist in managing complex heparin dosing more efficiently and accurately. The Fairview Southdale model in use at many hospitals reflects the type of system change that is needed. With this model, all patients on heparin are managed by pharmacy and all dosing and titrations are weight-based and customized to the disease state being managed. The impact of pharmacist management of heparin and warfarin was evaluated by Bond and Raehl in 2004 1 . Using 1995 Medicare and the National Clinical Pharmacy Services Databases from 955 hospitals, they compared data from hospitals that do and do not have anticoagulation services. Results showed that, when compared with hospitals that have heparin services, hospitals without such services had higher death rates, length of stay, Medicare charges and bleeding compli- cation rates (Table 1) 1 . St. Mary’s Medical Center St. Mary’s Medical Center (SMMC) is a 380- bed, tertiary care hospital, the flagship of the SMDC Health System with 20 clinics, hospitals and specialty care facilities located in north- ern Minnesota, Wisconsin and Michigan. In 2003 SMMC faced the emergency situation of four serious warfarin-related events with a few months, which focused attention on the need to manage anticoagulant therapy in the hospital and outpatient setting. An inter- professional team was formed to deal with this. Chaired by the Vice President of Medical Affairs, the team included primary and spe- cialty physicians, outpatient clinic adminis- trators, information technology personnel, nurses and a pharmacist clinical coordinator. A hospital-wide anticoagulation program, focusing its efforts on improving the safe and effective use of warfarin, was implemented and no sentinel events involving warfarin occurred in program patients. The program went on to create one of the first computer programs specifically designed for use by an inpatient anticoagulation service. LMWH and DTI were added to the program and no sentinel events occurred with these agents 2 .
A Coordinated Inpatient Anticoagulation Program: Part of the Heparin Solution? Michael P. Gulseth, PharmD, BCPS, Assistant Professor/Clinical Specialist, University of Minnesota College of Pharmacy, Duluth, MN
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Incorporating heparin into the program The anticoagulation program was then focused on heparin errors. The existing proto- col had called for a floor nurse to adjust infu- sion dosing and led to errors such as those shown in Table 1. The pharmacist anticoagu- lation program chair worked with pharmacy students who were on acute care rotations to evaluate heparin medication usage and iden- tify opportunities to improve heparin use at SMMC. Results showed that partial thromboplas- tin time (PTT) values were not obtained as scheduled to ensure accurate use of the pro- tocol, the protocol was not always interpreted correctly and platelets were not consistently monitored as intended in the protocol to watch for heparin-induced thrombocytope- nia (HIT). Even though a system was in place, heparin therapy was not being delivered as specified. Analysis of data over a two-year time period by the anticoagulation team showed that between 80% and 90% of heparin errors could be prevented by the adoption of two strategies: 1) have pharmacists actively man- age the dosing of heparin infusions and 2) implement smart (computerized) infusion pump technology. The anticoagulation team successfully used data about heparin errors to obtain administrative approval to pur- chase smart infusion pumps, which will be implemented for heparin this year.
Important questions still need to be answered at SMMC. Should pharmacists begin to actively manage all patients on heparin therapy? Should the anticoagula- tion program be modeled after the Fairview Southdale service? As was done for other anticoagulants, computerizing the monitor- ing system for heparin is needed but raises issues of resource allocation and staff accep- tance. If the primarily nursing-driven model con- tinues, how can compliance with the anti- coagulation program be assured? The Joint Commission National Patient Safety Goal (NPSG) 3E requires hospital to improve the safety of anticoagulation therapy. To meet this mandate, clinicians need to function as a multidisciplinary team. Does the current SMMC model meet this standard? Addressing large issues of heparin man- agement remains difficult. However, NPSG 3E has prompted more focus on this issue. The two-year data analysis of heparin errors can be used to raise concern about this issue with administration. Shared learning with clini- cians from other hospitals dealing with these issues can help advance heparin medication safety efforts.
Implementation of an inpatient antico- agulation program virtually eliminated warfa- rin, LMWH and DTI sentinel events; however, eliminating heparin errors continues to be a challenge. Anticoagulation program data helped convince senior leadership of the need for smart infusion pumps. Work contin- ues on defining how to incorporate heparin into the anticoagulation program. References 1. Bond CA, Raehl CL. Pharmacist-provided anticoagula- tion management in United States hospitals: death rates, length of stay, Medicare charges, bleeding com- plications, and transfusions. Pharmacother 2004; 24(8): 953-63. 2. Schneider BL, Gulseth MP, Cusick M. et. al. A com- puter program for a pharmacy managed inpatient warfarin dosing service. Am J Health-Syst Pharm 2005; 62:2393-6.
• Death rates were 11.41% higher – 6.37% vs. 7.19% • Length of stay was 10.05% higher – 7.79 days vs 8.66 days • Medicare charges were 6.6% higher – $1145 more per patient • Bleeding complications were 3.1% higher – 8.84% vs 9.12% Table 2. If a hospital did not have a heparin service 1 Table 1. Heparin errors Example 1. Heparin gtt (drop) was increased at 0600 to 1800 units/hr. A new bag was hung at 0815 because the previous bag was empty. The previous pump settings were not changed when the new bag was hung. At 0930 the pump was alarming for air because the bag was dry. At 0930, a nurses inspected the pump and settings and discovered that the rate was set at 18,000 units/hr rather than 1800 units/hr.
heparin by100 units/hr. Heparin was accidently increased by100 units/hr. Example 3: Patient returned from dialysis with the infusion pump shut off. His heparin gtt bag was dry and he had blood backed up about 12 inches in his intravenous (IV) tube, which was difficult to flush. Patient had left the floor around 0700. Dialysis was called to ask why they had not called for a heparin drip bag. They replied that the bag had gone dry right before transport so they shut it off and sent the patient back to the nursing unit. At 0600, the PTT for this patient was 70 and the drip rate was 1500 units/hr. At 1405, blood was drawn for a stat PTT, which was 33. The heparin drip rate needed to be increased by 200 units/hr and a bolus of 40 units/Kg was administered per heparin protocol, instead of restarting the heparin dose the patient was already stabilized on.
PROCEEDINGS 9th Invited Conference: Improving Heparin Safety 43
Reducing Heparin Errors: The Indianapolis Coalition for Patient Safety Jim Fuller, PharmD, Director of Pharmacy, Vice President, Clinical Support Services, Wishard Health Services
• The Indianapolis Coalition for Patient Safety (ICPS) was established to improve patient safety among the six major health systems in Indianapolis. • ICPS has standardized procedures for surgical-site verification, established a standardized list of unsafe abbreviations and collaborated on the Institute for Healthcare Improvement (IHI) 100,000 Lives campaign. • The ICPS anticoagulant workgroup, working with the Institute for Safe Medication Practices (ISMP), completed a safe-practices self-assessment of all organizations, developed a univer- sal anticoagulant metric, created a library of documents related to anticoagulant use and assessed how well hospital computer systems alerted clinicians to anticoagulant safety con- cerns. • Institutions reported the percent of partial thromboplastin time (PTT) values that were therapeutic, sub-therapeutic, high or super-therapeutic. • Analysis of computerized prescriber order entry (CPOE) and pharmacy computer systems revealed variations in alerts with regard to providing anticoagulant safety alerts. • The ICPS workgroup educated coalition members about systems and processes so that more educated questions could be asked and further work done to improve anticoagulant safety city-wide. Identifying outliers within the group enabled members to answer the question: How do I compare? coalition is presented to the CEOs at a semi- annual meeting. Several task forces and work groups have been developed, including one focused on anticoagulant safety.
Several successes illustrate the coalition’s effectiveness. For example, ICPS first worked to standardize surgical-site verification for all coalition hospitals. Many of these are teach- ing hospitals and residents circulate from hospital to hospital. Establishing uniform procedures for surgical site verification and other processes can greatly increase compli- ance by the medical group. ICPS established one list of unsafe abbreviations for hospitals throughout the city. A letter outlining the rationale for the list was signed by the CEO of every hospital and sent to the medical staff at all hospitals sending a very powerful message. ICPS hospitals participated in a col- laborative project aimed at reducing rates of methicillin-resistant Staphylococcus aureus (MRSA) infections in Indianapolis hospitals. The project helped improve preventive prac- tice adherence and resulted in a significant reduction in MRSA infection rates on study units. Staff recognition has also been an impor- tant aspect of the coalition’s work. Every year, each hospital awards a patient safety hero award to an individual or team in the hospi- tal that has done the best work to promote patient safety. ICPS also collaborated with the Institute for Healthcare Improvement (IHI) 100,000 Lives campaign. Each of the health
The Indianapolis Coalition for Patient Safety (ICPS) is one of a handful of citywide coalitions in the United States focusing on patient safety. The coalition was formed in 2003 to provide a forum for Indianapolis-area hospitals to share information about best practices and to work together in a non-puni- tive setting to solve the patient safety issues of most concern in Indianapolis hospitals. ICPS membership includes Wishard Health Services, which has a level-one trauma cen- ter, burn unit and 10 community healthcare centers; the Richard L. Roudebush Veterans Administration Medical Center; St. Francis Hospitals and Health Centers and St. Vincent Health, both faith-based organizations; Clarian Health; Community Health Network and Suburban Health Organization hospitals. An executive director was hired in 2006. Primary membership includes all chief executive officers (CEOs), chief nursing officers (CNOs), chief medical officers (CMOs), safety officers and pharmacy leaders. Meetings are held every two months, and the work of the
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systems took ownership for one part of the IHI campaign and formed work groups among all the hospitals to work on that issue. Anticoagulant workgroup The goal of the anticoagulant workgroup is to improve anticoagulant medication safe- ty in Indianapolis health systems. The work- group included 12 pharmacists and one reg- istered nurse. Each organization completed the Institute for Safe Medication Practices (ISMP) failure mode and effects analysis (FMEA) to identify areas of vulnerability. After that, members completed best-practice self- assessments and agreed to share and com- pare data. The group began work in February 2007, met every two or three weeks through the summer, and identified four major tasks to complete. The first task was a self-assess- ment of all organizations using a list of safe practices provided by ISMP. Other tasks were to develop a universal anticoagulant metric among participating hospitals, create a library of documents related to anticoagulant use for hospitals to share and assess how well hospital computer systems were alerting phy- sicians, pharmacists and others about antico- agulant safety concerns.
The ISMP list of safe practices includes 14 universal practices that all hospitals should have in place, including having “U” on the list of “Do not use” unsafe abbreviations, having a standardized heparin concentration and using a manufacturer-prepared solution whenever possible. Other core practices included ensuring that computerized prescriber order entry (CPOE) and pharmacy systems provided drug interaction warnings and that medication rec- onciliation was done. There were also four “stretch” goals resulting in a total of 18 core practices. Grids were developed with cells represent- ing each of the core and target safe practices for each of the six hospitals. Medication rec- onciliation was assessed at admission, transfer and discharge, which required more cells for each of the stages. Cells were color-coded to show assessment results: green meant that a hospital was completely compliant with that core practice; yellow meant there was still work to do; red meant that work had not begun.
The majority of core practices were green, some were yellow and very few were red. Core safe practice that needed improvement included having functional drug interaction warnings for CPOE and pharmacy systems and compliance with medication reconciliation for anticoagulants. Compliance with target safe practices indicated more challenges, includ- ing dispensing of all anticoagulant doses from pharmacy, independent double checks and monitoring service for all anticoagulants by pharmacists. Universal metric A universal metric was developed to mea- sure the impact of safety strategies that were implemented. The goal was to avoid laborious chart reviews and automate measurement as much as possible, have results be meaningful from a safety standpoint and be able to com- pare results across systems. Discussions with ISMP and IHI led to the use of partial thromboplastin time (PTT) as the universal metric. Because institutions used different therapeutic ranges, each orga- nization did not report PTT values, but the percent of PTTs that were therapeutic (within the target range), sub-therapeutic, high or super-therapeutic (two or more times the upper therapeutic limit). The first question was whether an institu- tion had a weight-based protocol in place. Electronic data already available from hospital laboratories were used to separate PTT results into the four categories. Results for all were compared.
The coalition created a library compris- ing studies, protocols, nomograms and other information related to anticoagulant safety. The documents were scanned and compiled in a CD library that was distributed to every member organization to allow everyone to learn from existing practices. Computer systems test The last task was to evaluate how well the CPOE and pharmacy computer systems were alerting clinicians to therapeutic duplication, disease-drug and drug-drug interactions. Two pharmacists who specialized in the use of anticoagulants and had run an anticoagu- lant outpatient clinic created an assessment tool that tested 19 different scenarios for both CPOE and pharmacy alerts. While it later became apparent that the tool could be more complete, the first version provided a starting point. All coalition hospitals used the assessment tool to evaluate their CPOE and pharmacy systems to see what alerts were provided. Every time an alert occurred the screen was printed so that alerts could be measured and compared. Alert fatigue and the need for meaningful alerts were also discussed. A grid comparing all systems showed that one CPOE system provided no alerts. Further investigation revealed that the hospital had just installed their CPOE system and did not want a too many alerts so that physicians might be deterred from using it. Physicians knew that the pharmacy system screened for the same potential problems and they were relying on the pharmacist to correct these problems. Two hospitals used the same system, but each provided different alerts because the alerts had been customized for each institution.
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Executive Summary Conference Report 9th Invited Conference: Improving Heparin Safety In addition to data, the printed screens were also shown to CEOs, CNOs and CMOs in the coalition so they could see the actual screens that practitioners see to recognize and understand alerts. Screens were often overloaded with information and difficult to read. Senior leadership might have thought that the existing systems would catch all problems, but when they examined what users saw, they realized that the value of providing alerts was not as straightforward as one might think. Results of this study underscored the need for standardization. CEOs and CMOs discussed that a physician could enter an order at one hospital and get an alert and then go to another hospital, enter the exact same order for the exact same patient and not get an alert.
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