D.1 ANTICOAGULATION MANAGEMENT PROGRAM2.pdf

D.1 ANTICOAGULATION MANAGEMENT PROGRAM

36C25922R0102

ANTICOAGULATION MANAGEMENT PROGRAM

MCP 11-111

Oklahoma City VA Healthcare System OKlahomoa City, OK 73099

Signatory Authority:

Oklahoma City VA Healthcare System Director

Responsible Owner:

Anticoagulation Management Program Committee

1. POLICY

Rescinded Document:

CM 11-111, Anticoagulation

Management Program, dated February 23, 2016

Effective Date:

November 3, 2020

Recertification Date:

November 30, 2025

This medical center policy (MCP) rescinds and updates Center Memorandum 11-111, dated February 23, 2016 to provide procedures for the management of patients receiving therapeutic anticoagulation therapy and to describe the interdisciplinary, multi-service Anticoagulation Management Program (AMP) for the Oklahoma City VA Health Care System.

The medical facility will manage anticoagulation therapy in compliance with VHA Directive for Anticoagulation Therapy Management. The Anticoagulation Management Program incorporates associates from multiple clinical services and disciplines in order to provide optimal delivery of effective and safe care to patients receiving anticoagulation therapy. The AMP consists of the following:

a. Anticoagulation Management Program Committee to facilitate medical facility anticoagulation-related protocol maintenance/updates, quality assurance monitoring, and quality improvement activities;

b. Anticoagulation Management Program Provider Toolkit that includes the protocols, algorithms, and other resources to manage patients on anticoagulation therapy;

c. Educational outreach efforts for clinical services to enhance compliance with practice guidelines;

d. Anticoagulation clinic(s) that will accept criteria-based referrals for the management of patients receiving treatment with anticoagulation therapy and currently under the care of a primary care provider; and

e. Compliance with the safe use of anticoagulation therapy by all clinical staff involved in anticoagulation management (e.g., nurses, clinical pharmacists, pharmacy technicians, registered dietitians/nutritionists, Advanced Practice Registered Nurses (APRN), physician assistants, and physicians), consistent with the required components of an anticoagulation management program as outlined in Appendix A of VHA Directive

November 3, 2020 MCP 11-111

1033 including: the maintenance of a well-organized program, sufficient time allotted for the anticoagulation program manager to perform leadership and administrative functions, appropriate staff-to-patient ratios to provide safe care, and readily available telephone access to anticoagulation prescribers at any time for patients and staff.

Additional requirements include:

(1) Development and implementation of approved protocols/algorithms for the initiation and maintenance of appropriate anticoagulation therapy. Documents can be found on the Anticoagulation Management Program Provider Toolkit SharePoint site (currently located at https://dvagov.sharepoint.com/sites/okl/Clinical/SitePages/Anticoagulation.aspx)

(a) Initiation of Warfarin.

1 See VHA Pharmacy Benefits Management (PBM) Warfarin Management Algorithm (Initiation Phase)

2 All patients initiated on warfarin must have an INR measurement within 7 days of initiation, although INR measurement within 4 days is recommended. Patients currently stabilized on warfarin outside VA are exempt from this requirement.

(b) Maintenance of Warfarin. See VHA PBM Warfarin Management Algorithm (Maintenance Phase of Therapy)

(c) Peri-Procedural Management of Anticoagulants

(d) Weight-based, Unfractionated Heparin Algorithms

(2) All patients receiving warfarin or long-term parenteral anticoagulants on an ongoing basis must be managed by VA staff properly educated on anticoagulant therapy.

(3) All services involved in managing patients on anticoagulation therapy must provide coordinated processes to ensure that patients are treated appropriately and receive appropriate follow-up. Processes must also ensure smooth transitions between inpatient and outpatient status, and address continuity and safety of anticoagulation care. Processes must be in place to minimize patient loss to follow-up and to address patient no-shows and noncompliance with the treatment plan.

(4) All laboratory tests for anticoagulation management should be performed at a VA laboratory to ensure accuracy of results and retrievability of information.

Baseline and ongoing laboratory tests should be utilized as recommended by nationally published guidelines and in the product labeling as appropriate for the individual medication and patient. At minimum, this should include:

(a) Required baseline laboratory tests for patients on anticoagulation therapy:

1 Heparin: complete blood count (CBC), activated partial thromboplastin time (aPTT) or heparin assay.

2 LMWHs and anti-Xa inhibitors (fondaparinux): CBC, serum creatinine.

3 Warfarin: CBC, PT, and INR.

4 Direct Oral Anticoagulants (DOAC, formerly TSOAC): CBC, serum creatinine.

(b) Ongoing labs:

1 Heparin: CBC and aPTT or heparin assay as specified in the heparin dosing protocols

2 LMWHs and anti-Xa inhibitors (fondaparinux): CBC and serum creatinine

3 Warfarin: CBC , PT, and INR.

4 DOAC: CBC, serum creatinine.

(5) A defined process that ensures appropriate patient follow-up when a new drug that critically interacts with anticoagulants is added to the medication regimen of patients on anticoagulant therapy. This process should address responsibility for assessment of the interaction, adjustment of the anticoagulant dose if needed, order and follow-up of any needed lab tests and how communication occurs between the applicable providers.

(6) A defined process to minimize the risk associated with incorrect tablet strength dosing errors with warfarin. Whenever possible, patients should only be prescribed one tablet strength of warfarin to minimize risk for confusion.

(7) Clinical staff involved in managing anticoagulation must add the appropriate International Classification of Diseases (ICD) Diagnosis Codes to the problem list of patients on long-term anticoagulation therapy. In addition, appropriate Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT) codes may be used as applicable. In the current ICD Tenth Revision (ICD-10) the diagnosis code is Z79.01, “Long-term current use of anticoagulants”.

(8) All INR results must be evaluated in a timely manner by the close of the next business day (or within 48 hours) and in accordance with VHA Directive 2009-019 Ordering and Reporting Test Results, or subsequent policy issue, and facility policy.

(9) Outpatient prescriptions for warfarin should be labeled appropriately to avoid patient confusion with changes to the instructions for use.

(10) Clinical staff involved in managing anticoagulation should perform appropriate and periodic risk-benefit assessments for all patients receiving anticoagulant therapy and managed in the anticoagulation management program.

(11) An educational plan for clinical staff directly involved in caring for patients receiving anticoagulation therapy. Education may include the following, as appropriate:

results of anticoagulation quality assurance program and quality improvement activities, education based on locally identified learning needs, and VA educational programs or forums. Newly hired prescribers and staff involved in caring for patients receiving anticoagulation therapy will be required to complete an initial online anticoagulation training course as appropriate.

(12) At a minimum, ongoing patient and family education provided by anticoagulation providers should address the following issues:

(a) Indication for therapy;

(b) Interactions (drug, diet, and disease);

(c) Daily dosage;

(d) The importance of medication adherence;

(e) The management of missed doses;

(f) Signs and symptoms of bleeding and thromboembolic events, and what to do if such an event occurs;

(g) The need to inform other health care providers about long-term anticoagulation therapy;

(h) The need to inform the anticoagulation provider when changes in medications occur or upcoming procedures are expected;

(i) Risks associated with falling;

(j) Proper tablet identification (for warfarin);

(k) Need to inform the anticoagulation provider about acute illness, major changes in diet, or upcoming travel (for warfarin);

(l) The dangers of using medication from different sources (especially for warfarin);

(m) Monitoring requirements (specifically for warfarin); and

(n) Proper medication storage (specifically for dabigatran).

f. An ongoing quality assurance plan to evaluate the anticoagulation management program. This provides the opportunity to identify practice improvements, ensures appropriate action is taken to improve the practice, and measures the effectiveness of those actions on a regular basis. The plan includes:

(1) Reports for tracking and trending INR values at the National, Veterans Integrated Service Network (VISN), and facility levels

(2) Proportion of patients with pathologic bleeding events;

(3) Proportion of patients with thromboembolic events; and

(4) Patient incidents, close calls, and near misses associated with an anticoagulant. Adverse drug events (ADEs) involving anticoagulants should be assessed and analyzed in accordance with the facility Pharmacy and Therapeutics (P&T) Committee and VHA Directive 1070, Adverse Drug Event Reporting and Monitoring, or subsequent policy issue.

(5) Any identified issues found in the quality assurance program should be tracked and trended by the facility Anticoagulation Program Manager and reported through the Anticoagulation Management Program Committee, Health Care Delivery Committee, or other committees as appropriate.

2. JUSTIFICATION

This policy develops a defined anticoagulation management program, in accordance with the National VA Directive for Anticoagulation Management, to individualize care provided to patients treated with anticoagulant therapy and improve patient safety by reducing the likelihood of patient harm associated with anticoagulant therapy.

3. RESPONSIBILITIES

a. Medical Facility Director. The Medical Facility Director is responsible for ensuring:

(1) A written policy, using an interdisciplinary process, for the safe management of anticoagulation therapy is in place and meets all standards in VHA Directive for Anticoagulation Therapy Management, or subsequent policy issue.

(2) The medical facility has an established anticoagulation management program for management of inpatients and outpatients on anticoagulants.

(3) An Anticoagulation Program Manager has been designated to lead the medical center’s anticoagulation management program and has been provided with appropriate time to fulfill these duties.

(4) Adequate staff and resources are allotted for the anticoagulation management program to include anticoagulation providers, nurses, pharmacy technicians, registered dieticians/nutritionists, program administration, and information technology support, as appropriate. This includes ensuring anticoagulation providers have adequate anticoagulation support staff to work at the top of their license and maximize operation efficiency.

(5) The anticoagulation management program has an appropriate staff-to-patient ratio to provide safe and appropriate care.

(6) Competencies specific to anticoagulation management are established for anticoagulation providers and clinical staff directly involved in caring for patients receiving anticoagulation therapy. Minimum competencies are defined in the VHA Directive for Anticoagulation Management.

(7) The medical facility ensures care is coordinated for traveling patients on anticoagulants in accordance with VHA Handbook 1101.11, Coordinated Care Policy for Traveling Veterans, or subsequent policy issue.

(8) The medical facility uses programmable infusion pumps for inpatients receiving parenteral anticoagulants, including, but not limited to unfractionated heparin, argatroban, and bivalirudin.

(9) The medical facility employs standardized, evidence-based, algorithms for the management of patients on anticoagulants.

(10) Anticoagulants are included on the medical facility’s list of high-alert medications.

b. Chief of Staff and Associate Director for Patient Care Services. The facility Chief of Staff and Associate Director for Patient Care Services (PCS) is responsible for:

(1) Ensuring that a physician is identified as anticoagulation management champion, to be actively involved in defined components of the anticoagulation management program. This champion will serve collaboratively with the pharmacy anticoagulation management champion to advocate for, provide consultation on anticoagulation issues, and support anticoagulation initiatives at the facility level.

(2) Ensuring that all medical facility policies governing the provision of anticoagulation management are approved by the Health Care Delivery Committee (HCDC). Anticoagulation providers will collaborate in the development of medical facility guidelines/algorithms for anticoagulants through the Anticoagulation Management Program Committee.

(3) Ensuring that clinical staff directly involved in caring for patients receiving anticoagulation therapy are educated on the importance of anticoagulation safety and its associated risks, as well as the principles of anticoagulation management, as appropriate.

(4) Reviewing quality assurance (QA) information for the facility anticoagulation management program at appropriate and regular intervals through the HCDC, Pharmacy and Therapeutics (P&T) Committee, or other appropriate facility governing body, as appropriate.

(5) Ensuring the competency of non-pharmacist anticoagulation providers and clinical staff directly involved in caring for patients receiving anticoagulation therapy to include minimum components outlined in the VHA Directive for Anticoagulation Therapy Management, or subsequent policy issue.

(6) Ensuring that anticoagulation providers have adequate anticoagulation support staff (e.g., pharmacy technicians or other anticoagulation staff) to maximize operational efficiency.

c. Associate Chief of Staff, Ambulatory Care, and Clinical Services Chiefs. The Associate Chief of Staff, Ambulatory Care, and Clinical Services Chiefs (within their service and for their providers and patients) are responsible for ensuring:

(1) A defined process exists for the coordinated transition of patients who will be maintained on anticoagulant therapy from inpatient to outpatient status, and is aimed at assuring appropriate continuity of care and that patients are not lost to follow-up.

(2) A defined process exists to describe how patients initiated on anticoagulant therapy by specialty services will be transitioned back to Primary Care for routine management services.

(3) Outpatients receiving anticoagulant therapy are followed up appropriately and the frequency of INR testing is performed according to the established protocol.

(4) A process exists to address no-shows for laboratory testing and clinic appointments, and patient non-compliance with the treatment plan for anticoagulation therapy.

(5) A consistent approach to anticoagulation therapy is maintained according to established medical center guidelines and protocols for anticoagulation therapy use.

(6) Staff performing ancillary testing (e.g. point-of-care INR testing) undergoes competency assessment as defined in national and local Pathology and Laboratory Medicine Service Procedures, if applicable.

(7) A method is established to train and assess competency for all staff involved in coordination of anticoagulation therapy.

(8) Staff completing anticoagulation-related progress notes complete and document delivery of patient education for anticoagulant therapy.

(9) Ongoing, anticoagulation-specific training and education required for appropriate clinical staff and prescribers is completed in accordance with medical center policies and procedures and VHA directives.

(10) Anticoagulation management activities are conducted in compliance with the Oklahoma City VA Anticoagulation Management Program, as well as related VHA directives and the Joint Commission.

d. Associate Chief of Staff, Education. The Associate Chief of Staff, Education is responsible for ensuring:

(1) Appropriate educational materials and training programs specific to anticoagulation therapy are developed, coordinated, and available for appropriate medical center staff.

(2) Ongoing, anticoagulation-specific training and education required for appropriate clinical staff and prescribers is completed in accordance with medical center policies and procedures and VHA directives. [Insert responsibilities here.]

e. Office of Performance and Quality. The Office of Performance and Quality is

(1) Assistance is provided to the Anticoagulation Program Manager for implementing policies and procedures to maintain medical center compliance with VHA directives, Joint Commission standards and National Patient Safety Goals.

(2) Assistance is provided to the Anticoagulation Program Manager for implementing quality assurance (QA) and performance improvement plans or initiatives.

(3) The quarterly QA measure for patient incidences, close calls, and near misses related to anticoagulant therapy is reported to the Anticoagulation Program Manager in a timely manner.

f. Chief, Pharmacy Service. The Chief, Pharmacy Serice is responsible for:

(1) Ensuring that a clinical pharmacist anticoagulation provider is identified as the pharmacy anticoagulation management champion to be actively involved in defined components of the anticoagulation program at the facility level. This champion may be the anticoagulation program manager and serves to advocate for and support anticoagulation initiatives at the facility.

(2) Assessing the competency of clinical pharmacist anticoagulation providers and pharmacy technicians who serve in the anticoagulation management program to include the minimum components outlined in VHA Directive 1033, Anticoagulation Therapy Management, or subsequent policy issue.

(3) Ensuring clinical pharmacists that serve as anticoagulation providers have adequate anticoagulation support staff to work at the top of their license and maximize operational efficiency. Tasks that support the duties of the clinical pharmacist may be performed by pharmacy technicians or other anticoagulation support staff to maximize time for clinical pharmacists to perform direct patient care.

(4) Ensuring that only oral unit dose products, pre-filled syringes, or pre-mixed infusion bags for anticoagulants are dispensed for inpatients when these types of products are available.

(5) Ensuring that the number of concentrations and quantities of heparin dosage forms stocked in patient care and procedural areas are limited to the minimum needed to meet patient care needs, and no multi-dose heparin product more concentrated than 5,000 Units/ml is stocked without the prior approval of the Chief of Pharmacy.

(6) Ensuring the safe storage of anticoagulants in automated dispensing devices if the medical center uses automated dispensing devices to store anticoagulants. If multiple strengths or concentrations of the same anticoagulant are stored in the same automated dispensing device they need to be stored in separate drawers (or single access cubie) and clearly labeled as high alert medications.

g. Chief, Nutrition and Food Service. The Chief, Nutrition and Food Service is

(1) Warfarin is included in Nutrition and Food Service’s established food/medication interaction program.

(2) A process is established to notify Nutrition and Food Service of patients receiving meal services that are also receiving warfarin.

(3) Nutrition and Food Service responds according to its established food and medication interaction program to patients receiving meal services and warfarin therapy.

Meal planning and educational efforts are focused on steady vitamin K intake, individualized to meet the overall health needs, and supporting an adequate dietary reference intake for Vitamin K.

h. Chief or Director, Pathology and Laboratory Medicine Service. The Chief or Director, Pathology and Laboratory Medicine Service is responsible for:

(1) Ensuring a critical INR value is established and listed in the Laboratory Veterans Health Information System and Technology Architecture (VistA) software package.

(2) Establishing a Standard Operating Procedure, in conjunction with the anticoagulation program manager, for the communication of critical INR results from the laboratory to the ordering provider (or designee).

(3) Ensuring the correct International Sensitivity Index (ISI) value for the lot number of thromboplastin, currently in use, is entered into the coagulation testing instrumentation.

(4) Ensuring there is documentation of periodic monitoring to ensure the entered value remains accurate.

(5) Ensuring the correct Geometric Mean Prothrombin Time (PT) is calculated for the current lot number of thromboplastin and is entered into the coagulation testing instrumentation as required for calculation of the INR. The Geometric Mean PT needs to be recalculated with each change of lot number of thromboplastin reagent.

(6) Ensuring the availability of reliable testing of heparin levels (factor Xa levels), heparin associated antibodies and a serotonin release assay for the evaluation of heparin induced thrombocytopenia.

(7) Ensure the availability of appropriate laboratory tests for Direct Oral Anticoagulants (DOAC) [previously Target Specific Oral Anticoagulants (TSOAC)] in special situations (e.g., suspected overdose, bleeding, urgent procedure, etc.).

(8) Education of staff providing clinical services in an outpatient anticoagulation clinic and staff involved in home anticoagulation therapy management on national and local laboratory policies related to point-of-care testing and patient self-testing, if applicable.

(9) In the event that a non-VA laboratory INR result is received, a standardized process for documenting that result ensures it is readily retrievable.

(10) Evaluation of the process used to document INRs done at non-VA labs in the electronic medical record and collaboration with anticoagulation therapy providers to identify and maintain the safest and most effective method.

i. Facility Ancillary Testing Coordinator. The Facility Ancillary Testing Coordinator is responsible for:

(1) Assessing the competency of staff involved in ancillary testing; and

(2) Documenting training, authorization, and annual competence evaluation for all staff that perform ancillary testing.

j. Anticoagulation Program Manager. The Anticoagulation Program Manager, in conjunction with the Anticoagulation Management Program Committee, is responsiblefor the following functions related to the Anticoagulation Program at the facility level:

(1) Serving as a leader or co-leader and subject matter expert in the oversight, design, implementation, and function of the anticoagulation management program.

(2) Developing medical facility policy related to use of anticoagulants. This encompasses policies to govern practice within the anticoagulation management program, but may also include policies relating to the use of anticoagulants in other areas (e.g., surgical or specialty areas), as directed by the HCDC. A multidisciplinary approach to policy development should be employed to include meeting with all disciplines involved in caring for patients receiving anticoagulants to assist with unified practice and education to patients as in the Anticoagulation Management Program Committee.

(3) Promoting learning and unified practice for the anticoagulation management program through activities such as educational initiatives, regular staff meetings, and journal clubs.

(4) Coordinating and reporting quality assurance activities and results for the anticoagulation management program through the HCDC (or P&T Committee), as appropriate.

(5) Coordinating the facility educational program for clinical staff directly involved in caring for patients receiving anticoagulation therapy.

(6) Ensuring availability of appropriate patient education materials and classes, as applicable.

k. Clinical Staff Involved in Managing Anticoagulaed Patients. The clinical staff involved in managing anticoagulated patietns are responsible for:

(1) Managing anticoagulation patients in accordance with facility and VHA policy including, but not limited to, coordination of anticoagulation management for patients transitioning between care settings (e.g., inpatient to outpatient), peri-procedural anticoagulation, and traveling Veterans.

(2) Serving as subject matter experts on anticoagulation management to patients and health care professionals throughout the facility.

(3) Delivering initial and ongoing patient and family education that includes the importance of follow-up monitoring, compliance issues, dietary restrictions, and potential for adverse drug reactions and interactions.

(4) Conducting appropriate and periodic risk-benefit assessments for all patients receiving anticoagulant therapy and communicating recommendations to the original referring provider and/or Patient Aligned Care Team (PACT) provider as appropriate.

(5) Performing and/or facilitating the day-to-day operations of the anticoagulation management program.

(6) Reporting, as per local policy, adverse drug events (ADE), close calls, and any unsafe conditions of which they are aware, even though the conditions have not yet resulted in an adverse event or close call to the facility Patient Safety Manager (PSM) in accordance with VHA Directive 1070, Adverse Drug Event Reporting and Monitoring, or subsequent policy issue.

4. OTHER PARAGRAPHS

None

5. DEFINITIONS

None

6. REFERENCES

a. VHA Directive 1033, Anticoagulation Therapy Management, dated July 29, 2015, http://www.va.gov/vhapublications/viewpublication.asp?pub_id=3129&usg=afqjcnfyt0qib i1sy_svhxrs3ei9vv4vdq

b. Antithrombotic Therapy and Prevention of Thrombosis, 9th edition: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. CHEST.

2012; 141(2): February Supplement.

c. The Joint Commission, 2020 National Patient Safety Goals; NPSG 03.05.01.

https://www.jointcommission.org/assets/1/6/NPSG_Chapter_HAP_Jan2020.pdf

d. VHA Handbook 1106.01, Pathology and Laboratory Medicine Service (P&LS) Procedures, dated January 29, 2016, https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169

e. VHA Directive 1070, Adverse Drug Event Reporting and Monitoring, dated May 15, 2020, https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8831

f. VHA Directive 1088, Communicating Test Results to Providers and Patients, dated October 7, 2015, https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3148

g. VHA Handbook 1101.11(3), Coordinated Care For Traveling Veterans, dated April 22, 2015, https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3099

7. RESCISSION

CM 11-111, Anticoagulation Management Program, dated February 23, 2016, is rescinded.

8. REVIEW

To be reviewed and updated every five years or as required according to the directive.

9. RECERTIFICATION

This MCP is scheduled for recertification on or before the last working day of November 2025 – 5 years. This MCP will continue to serve as local policy until it is recertified or rescinded. In the event of contradiction with national policy, the national policy supersedes and controls.

http://www.va.gov/vhapublications/viewpublication.asp?pub_id=3129&usg=afqjcnfyt0qibi1sy_svhxrs3ei9vv4vdq http://www.va.gov/vhapublications/viewpublication.asp?pub_id=3129&usg=afqjcnfyt0qibi1sy_svhxrs3ei9vv4vdq https://www.jointcommission.org/assets/1/6/NPSG_Chapter_HAP_Jan2020.pdf https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8831 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3148 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3099

10. SIGNATORY AUTHORITY

Wade Vlosich Health Care System Director Date Approved: November 3, 2020

NOTE: The signature remains valid until rescinded by an appropriate administrative action.

DISTRIBUTION: MCPs are available at:

https://dvagov.sharepoint.com/sites/OKL/Memos/Lists/Center%20Memorandums/ByServi ce.aspx https://dvagov.sharepoint.com/sites/OKL/Memos/Lists/Center%20Memorandums/ByService.aspx https://dvagov.sharepoint.com/sites/OKL/Memos/Lists/Center%20Memorandums/ByService.aspx