Institution A

Anticoagulation Management

Stewardship Program

<Date>

Table of Contents

I. Executive Summary – Page 3

II. Environmental Analysis and Background – Page 4

·  Patient Safety

·  Regulatory Compliance

·  Financial Implications

·  Institution A Compliance versus National Best Practice Recommendations

·  Current Institution A Anticoagulation Management Performance Data

·  Literature Evaluation and Institution B Survey on Anticoagulation Management Teams

III. Proposal – Page 10

IV. Benefits to Institution A – Page 12

V. Organizational Fit and Linkages – Page 13

VI. Business Case Analysis – Page 14

·  Resource Requirements

·  Financial Analysis (Return on Investment)

VII. Implementation Plan – Page 16

·  Key Deliverable Actions and Timetable

·  Exit Strategy

VIII. Acknowledgements – Page 18

IX. References – Page 19

X. Appendix I – Institution A Anticoagulation Management Regulatory Compliance Analysis

XI. Appendix II – Anticoagulation Management Team Literature Review Summary

Executive Summary

Background

Anticoagulation management has moved to the forefront of many health care system performance improvement projects for three main reasons:

·  Patient safety concerns

·  Regulatory compliance (i.e. 2008 Joint Commission National Patient Safety Goal 3E, National Quality Forum (NQF) Safe Practice 28, 29)

·  Financial implications

Preventable medical/surgical complications from the inappropriate use of anticoagulants can be categorized into two primary categories; thromboembolic (e.g. pulmonary embolism (PE), deep vein thrombosis (DVT)) and hemorrhagic (e.g. retroperitoneal bleed). The sequelae of these complications include increased length of stay (LOS), avoidable treatment costs, and increased morbidity and mortality. Targeted interventions by pharmacist-led teams provide annual cost-savings of $825,000 to $9,500,000 in the literature depending on the scope of the team and intervention methods.

Patient Safety Net (PSN) and Patient Safety Indicator (PSI) data from the Agency for Healthcare Research and Quality (AHRQ) that are collected by the Institution A quality department indicate that many preventable high cost medical and surgical complications (postoperative DVT/PE thromboembolic and hemmorhagic events) occur annually at Institution A from the inappropriate use of anticoagulants.

A recent gap analysis documents substantial noncompliance at Institution A with the current Joint Commission Anticoagulation Management National Patient Safety Goal (3E) and with NQF Safe Practice standards for anticoagulation management. Heparin protocol non-compliance is high, and VTE prophylaxis assessment is not documented appropriately for Institution A inpatients today.

Proposal

Implement a pharmacist-led interdisciplinary anticoagulation management stewardship program (0.8 pharmacist, 0.2 nurse, 0.2 physician) to lead and coordinate implementation of evidence-based anticoagulation management related care throughout all areas of Institution A, achieve regulatory compliance, and monitor all aspects of improvement.

Benefits

  1. Improved patient care and outcomes via maximizing the use of standardized practices by all providers
  2. Improved patient safety secondary to reduced anticoagulant therapy complications
  3. Improved regulatory compliance (e.g.; Joint Commission NPSG 3E)
  4. Improved performance on externally reported quality scores (e.g.; NQF)
  5. Increased reimbursed through pay for performance
  6. Reduced cost (extremely positive ROI, see below) as a result of fewer inpatient hemorrhagic and thromboembolic event complications and reduced inpatient length of stay
  7. Time savings for providers via improved continuity of patient care

Return on Investment

Year-1 additional operating expense (salary) will be $150,000. However, conservative estimated year-1 savings to Institution A as a result of fewer inpatient thromboembolic and hemmorhagic adverse events will be $1.7 million, generating a net savings of $1.55 million to Institution A in year-1 with a cumulative 5-year net savings of $7.9 million.

Conclusion

It is recommended that Institution A approve additional personnel costs associated with implementing a new interdisciplinary anticoagulation management stewardship program as this investment will result in a substantial positive ROI in year-1 as well as dramatic improvement in patient safety, regulatory compliance and publicly reported quality scores.

Environmental Analysis and Background

PATIENT SAFETY

Anticoagulants have the ability to prevent devastating medical complications. In fact, venous thromboembolism (VTE) is considered the most preventable cause of hospital death in the United States.1 Without prophylaxis, the incidence of hospital-acquired deep vein thrombosis (DVT) in general medical and surgical patients ranges from 10 to 40%. The incidence increases to roughly 50% in patients with no prophylaxis prior to major orthopedic surgery. 1 Prophylactic anticoagulants have been shown to significantly reduce this risk. Therapeutic anticoagulation is the cornerstone of treatment for thromboembolic disease. However, titrating anticoagulants within narrow therapeutic indices at times proves difficult, even for the most experienced practitioners. Individual patient response to a standard dose is not always predictable. Variation in patient-specific factors such as rate of drug elimination further complicates the picture. Over-anticoagulation exposes patients to increased risk of hemorrhage, one of the most feared hospital complications. Under-anticoagulation leaves patients vulnerable to recurrent VTE.

Consequently, heparin, warfarin, and enoxaparin are ranked in the United States Pharmacopoeia (USP) Top 50 Drug Products Associated with Medication Errors as numbers 5, 7, and 12, respectively.2 The Institute for Safe Medication Practices (ISMP) has designated all anticoagulants as High-Alert Medications, a category which includes those medications at increased risk of causing significant patient harm when used improperly.

Throughout Calendar Year 2007, a total of 62,934 doses of anticoagulant medications (warfarin, heparin, dalteparin, and enoxaparin) were administered to inpatients at Institution A. Institution A received documented Patient Safety Net (PSN) reports of 83 events related to anticoagulant use within this time period. Thirty-one of these errors (37%) were Harm Score D or above, which implies that at minimum, the event reached the individual and required additional monitoring or treatment to prevent harm. The five most common type of events reported were: medication omitted, error in monitoring, extra dose given, wrong dose/overdose, and wrong administration rate. Related PSN data from the last 3 years is presented below. Given the episodic and volitional nature of PSN reporting, it is likely these numbers underestimate the true incidence of anticoagulation errors. It is important to note that number of errors has remained relatively consistent over the past three years, despite targeted efforts to improve the anticoagulation process.

Calendar Year 20XX / Anticoagulation PSN Reports
Total # of PSNs related to anticoagulant use / 83
# related to heparin use / 47 (57%)
# related to warfarin use / 21 (25%)
# related to dalteparin/enoxaparin use / 15 (18%)
# of errors that were Harm Score D or above / 31 (37%)
Calendar Year 20XX / Anticoagulation PSN Reports
Total # of PSNs related to anticoagulant use / 74
# related to heparin use / 42 (57%)
# related to warfarin use / 22 (30%)
# related to dalteparin/enoxaparin use / 10 (13%)
# of errors that were Harm Score D or above / 28 (38%)
Calendar Year 20XX / Anticoagulation PSN Reports
Total # of PSNs related to anticoagulant use / 76
# related to heparin use / 40 (52%)
# related to warfarin use / 21 (28%)
# related to dalteparin/enoxaparin use / 15 (20%)
# of errors that were Harm Score D or above / 35 (46%)

REGULATORY COMPLIANCE

Increased awareness of patient safety implications surrounding anticoagulant use has motivated hospital quality and regulatory organizations to develop various anticoagulation-specific requirements and recommendations. Specific examples include the following:

National Patient Safety Goal 3E

As part of the 2008 National Patient Safety Goals, the Joint Commission™ (JC) mandated a requirement to reduce patient harm associated with anticoagulant use. 3 The JC provided eleven specific implementation expectations and a timeline for implementation by January 1, 2009.

Specific Implementation Expectations by January 1, 2009 (TJC NPSG 3E A1-A11)

1. The organization implements a defined anticoagulation management program to individualize the care provided to each patient receiving anticoagulant therapy
2. To reduce compounding and labeling errors, the organization uses ONLY oral unit dose products and pre-mixed infusions, when these products are available
3. When pharmacy services are provided by the organization, warfarin is dispensed for each patient in accordance with established monitoring procedures
4. The organization uses approved protocols for the initiation and maintenance of anticoagulation therapy appropriate to the medication used, to the condition being treated, and to the potential for drug interactions
5. For patients being started on warfarin, a baseline INR is available, and for all patients receiving warfarin therapy, a current INR is available and is used to monitor and adjust therapy
6. When dietary services are provided by the organization, the service is notified of all patients receiving warfarin and responds according to its established food/drug interaction program
7. When heparin is administered intravenously and continuously, the organization uses programmable infusion pumps
8. The organization has a policy that addresses baseline and ongoing laboratory tests that are required for heparin and low molecular weight heparin therapies
9. The organization provides education regarding anticoagulation therapy to prescribers, staff, patients, and families
10. Patient/family education includes the importance of follow-up monitoring, compliance issues, dietary restrictions, and potential for adverse drug reactions and interactions
11. The organization evaluates anticoagulation safety practices

National Quality Forum Safe Practice Recommendations 28 and 29

The National Quality Forum (NQF) is an organization concerned with creating an avenue for national healthcare quality measurement and reporting. The safe practices are a set of 30 consensus standards that serve as a guide for healthcare consumers and providers to identify those practices that will reduce errors and improve care. Two of the safe practices are specifically related to anticoagulation. 4

Safe Practice 28

Evaluate each patient upon admission, and regularly thereafter, for the risk of developing venous thromboembolism/deep vein thrombosis (VTE/DVT). Utilize clinically appropriate, evidence-based methods of thromboprophylaxis.

Additional Specifications
Document the VTE risk assessment and prevention plan in the patient’s record
Explicit organizational policies and procedures should be in place for the prevention of VTE

Safe Practice 29

Every patient on long-term oral anticoagulants should be monitored by a qualified health professional using a careful strategy to ensure the appropriate intensity of supervision.

Additional Specifications
Explicit organizational policies and procedures should be in place regarding anti-thrombotic services that include, at a minimum, documentation of the following:
·  Indication for long-term anticoagulation
·  Target INR range
·  Duration of long-term anticoagulation and/or a review date
·  A longitudinal record of INR values and warfarin doses
·  Timing of the next INR appointment

As part of the 2007 Leapfrog Hospital Quality and Safety Survey, Institution A scored itself against each of the 30 NQF Safe Practices. Institution A compliance with Safe Practice 28, was scored 23.4/35 (67%). Compliance with Safe Practice 29 was scored 11.76/25 (47%). These results indicate opportunities for improved compliance with the safe practices specified above.

Hospital Quality Measure SCIP-VTE-1 and SCIP-VTE-2

The Surgical Care Improvement Project (SCIP) is a partnership of national organizations aimed at reducing the incidence of surgical complications in the United Sates by 25% by 2010. While some surgical complications are unavoidable, patient outcomes can be improved by adhering to standardized evidence-based care processes. Four SCIP hospital quality measures focus on collecting data regarding frequency of appropriate VTE prevention and outcomes. 5

Hospital Quality Measure SCIP-VTE-1:

Surgery patients with recommended VTE prophylaxis ordered

Hospital Quality Measure SCIP-VTE-2:

Surgery patients who received appropriate VTE prophylaxis within 24 hours prior to surgery to 24 hours after surgery

Hospital Quality Measure SCIP-VTE-3:

Intra- or postoperative PE diagnosed during index hospitalization and within 30 days of surgery

Hospital Quality Measure SCIP-VTE-4:

Intra- or postoperative DVT diagnosed during index hospitalization and within 30 days of surgery

Summary of Institution A Regulatory Compliance (See Appendix I for details)

Regulatory Standard / Total # of Criteria / Fully Compliant
# (%) / Partially Compliant
# (%) / Not Compliant
# (%)
NPSG3E / 11 / 3 (28%) / 4 (36%) / 4 (36%)
NQF Safe Practices / 2 / 0 / 2 (100%) / 0

Select Examples of Institution A Compliance with NPSG 3E/NQF Safe Practices

·  Institution A uses programmable infusion pumps for the administration of heparin infusions

·  The dietary service is notified of all patients receiving warfarin

·  Documentation of VTE risk/prophylaxis within 24 hours of ICU transfer is audited quarterly

·  Institution A uses only unit dose oral anticoagulants

Select Examples of Institution A Noncompliance with NPSG 3E/NQF Safe Practices

§  Lack of written guidelines/policies (i.e. standardized warfarin dosing nomogram)

§  Lack of standardized chart documentation (i.e. indication for anticoagulation; goal INR, expected duration of anticoagulation)

§  Lack of defined monitoring standards (i.e. required baseline and ongoing laboratories)

§  Lack of documented anticoagulant education (i.e. standardized patient counseling; physician/pharmacist/nurse competencies)

FINANCIAL IMPLICATIONS

CMS Pay for Performance

Increased patient safety is only one of the reasons anticoagulation management is at the forefront of hospital quality improvement projects across the nation. The Centers for Medicare and Medicaid Services (CMS) has advocated for pay-for-performance legislation, which aims to increase healthcare quality and safety by providing financial incentives for adherence to practices known to decrease patient morbidity and mortality. As CMS is one of the main constituents in the SCIP initiative, it may potentially use SCIP measures, in addition to other above-mentioned nationally recognized goals and practices, as a way of evaluating and reimbursing hospital performance.

Similarly, it has been proposed that hospitals may not be reimbursed for re-admissions related to avoidable medical and surgical complications. Thus, it is increasingly important to avoid admissions due to bleeding and VTE caused by over- and under-anticoagulation, respectively.

Capitated Reimbursement

In an era of capitated reimbursement, it is essential to explore avenues that allow for timely patient discharge while continuing to maximize optimal patient care. As an example, patients initiated on wafarin often require several days and multiple dose adjustments before attaining stable INR values within their goal range. It is not uncommon for a patient to remain hospitalized solely for the purpose of INR stabilization. It is financially wise to adopt practices that will lead to more rapid INR stabilization or that help identify appropriate candidates for outpatient “bridging” therapy with subcutaneous LMWH injections until the INR value is within goal.