D.33- ANTICOAGULATION CLINIC POLICIES AND PROCEDURES.pdf

ANTICOAGULATION (AC) CLINIC POLICIES AND PROCEDURES

MCP 11-06

Syracuse VA Medical Center Syracuse, NY 13210

Signatory Authority:

Medical Center Director

Responsible Owner:

Anticoagulation Clinic Physician

Rescinded Document:

MCPM 11-006 Anticoagulation (AC)

Clinic Policies and Procedures, dated February 2017

Effective Date:

February 2021

Recertification Date:

February 2026

1. POLICY

This medical center policy (MCP) establishes policies and procedures for the Anticoagulation (AC) Clinic at the Syracuse VA Medical Center.

2. JUSTIFICATION

VHA Directive 1033 Anticoagulation Therapy Management, dated July 29, 2015 requires that each VA Facility have a local policy in place to ensure safe management of anticoagulation therapy.

3. RESPONSIBILITIES

a. Anticoagulation (AC) Service Manager/Physician(MD): Anticoagulation (AC) Service Manager/MD is responsible for;

(1) Providing expert oversight of the program, including program and policy development,

(2) Supervising inpatient and outpatient multidisciplinary team of pharmacists/Doctors of Pharmacy (PharmD) and Registered Pharmacists (RPh), Nurse Practitioner (NP), Physician Assistant (PA), nurse and support staff with an organized approach and emphasis on patient education and safety

(3) Promoting learning and educational opportunities related to anticoagulation for AC staff and hospital staff, and coordinates and report quality assurance measures to the Pharmacy and Therapeutics (P+T) Committee.

b. Anticoagulation Inpatient PharmD : Anticoagulation Inpatient PharmD is responsible for;

(1) Supervising inpatient pharmacists on AC related issues, Attachment D.33 36C24224R0049

January 2021 MCP 11-06

(2) Facilitating inpatient to outpatient transition for patients on AC including consultations and assists AC Service Manager with AC policies and program initiatives.

c. Anticoagulation Providers : Anticoagulation Providers are responsible for;

(1) Running the day to day operations of the outpatient AC Clinic,

(2) Providing optimal dosing and monitoring of patients on anticoagulants with risk/benefit analysis and drug-drug interaction assessments,

(3) Providing patient/caregiver education, in order to minimize complications and maximize patient care. Pharmacists also manage the clinical dashboard for direct oral anticoagulants and provide AC management for inpatients on AC therapy.

d. Anticoagulation Nurse : AC Nurse is responsible for;

(1) Screening clinic patients, entering vitals in the medical electronic record, triaging phone calls

(2) Completing electronic clinic contract with patients

(3) Assisting clinic providers with patient /caregiver education and evaluation

(4) Assisting support staff with tracking labs, and recording, maintaining and stocking clinic supplies.

e. Support staff (medical support assistant/MSA): Support staff is responsible for;

(1) Calling, scheduling and sending letters to patients for new, follow up and no-show appointments for clinic,

(2) Faxing documentation, answering phone/clinic voicemail and secure messages,

(3) Maintaining close communication with clinic nurse and providers,

(4) Maintaining Consult Tracking Manager

4. OTHER PARAGRAPHS

a. Evaluation of patients:

(1) Initial evaluation of patients will occur after an electronic consult is sent to the “Anticoagulation Clinic” by a physician (attending or house staff member) or primary care provider of the Syracuse VA Medical Center or affiliated Community Based Outpatient Clinics (CBOC) or from a VA approved Community Care Provider.

(2) The patient must have a documented need for anticoagulation therapy and be an outpatient while attending the AC Clinic.

(3) The inpatient anticoagulation provider(s) will work together with the AC Clinic to ensure continuity of care and smooth transitions between inpatient and outpatient status.

(4) The following information will be obtained as available for the clinic database:

(a) past medical/surgical history

(b) hospital course

(c) medications/allergies

(d) anticoagulant therapy received, date of initiation and proposed length of treatment

(e) primary care provider

(f) patient telephone number, address and emergency contact/phone number

(g) alcohol history

(h) indication for warfarin, or another anticoagulant

(i) thrombotic diagnosis (es)

(5) Patient will be seen by a member of the clinic (NP, PA, PharmD, RPh, MD) who will review the following:

(a) Clinic policy and procedure.

(b) Comprehensive patient education to include risks of anticoagulation, signs and symptoms to report, diet, alcohol and medication interactions with anticoagulant.

(c) Medication, risks, benefits and goals of AC therapy with the patient.

(6) Patients will sign anticoagulation program contract, which will outline their responsibilities as participants in the program. A copy of this contract will be provided to the patient.

(7) All new patient encounters to the Anticoagulation clinic will be reviewed by the AC Clinic Manager/MD.

b. Target Prothrombin Time/International Normalized Ratio (PT/INR) Range

(1) Target Prothrombin Time/International Normalized Ratio (PT/INR) ranges will be determined by the clinic physician according to individual patient indication and clinical guidelines. Changes in these therapeutic ranges will be made as clinically indicated by the primary physician, clinic physician, hematologist and/or cardiologist. Any changes in these ranges by a physician other than the clinic physician need to be discussed with the AC clinic physician. These changes will be documented in an electronic progress note in the patient's medical electronic record and documented in the Anticoagulation Management Tool (AMT).

c. Expected Duration of Therapy

(1) Expected length of anticoagulant therapy will be determined by the primary care provider or clinic provider and will be made on an individual basis, depending upon indication. When therapy has reached the expected discontinuation date, the primary care provider/specialty provider, and/or the AC Clinic provider will evaluate the need for continuation of anticoagulant therapy and the decision will be discussed with the patient and will be documented in the electronic progress note.

d. Use of Weight-Based Unfractionated Heparin: See Facility SOP 119-01 Heparin Dosing VIA Weight Based Heparin Nomogram.

e. Initiation of Warfarin*

(1) Day 1: Obtain baseline PT/INR, Complete Blood Count (CBC) and begin with 5mg daily. Use a lower dose (2-2.5mg) if patient has liver disease or congestive heart failure, is elderly or chronically malnourished, or is on medications that can significantly potentiate warfarin.

(2) Day 3-4: If INR <1.5, increase weekly dose by 5-25%. If INR is 1.5-1.9, no dose adjustment is required. If INR is 2.0-2.5, decrease weekly dose by 25-50%. If INR >2.5, decrease weekly dose by 50% +/- hold dose.

(3) Day 5-7: If INR <1.5, increase weekly dose by 10-25%. If INR is 1.5-1.9, increase weekly dose by 0-20%. If INR is 2.0-3.0, no dose adjustment is required. If INR >3.0, decrease weekly dose by 10-25% +/- hold dose.

(4) Day 8-10: If INR <1.5, increase weekly dose by 15-35%. If INR is 1.5-1.9, increase weekly dose by 5-20%. If INR is 2.0-3.0, no dose adjustment is required. If INR >3.0, decrease weekly dose by 10-25% +/- hold dose.

(5) Day 11-14: If INR <1.6, increase weekly dose by 15-35%. If INR is 1.6-1.9, increase weekly dose by 5-20%. If INR is 2.0-3.0, no dose adjustment is required. If INR >3.0, decrease weekly dose by 5-20% +/- hold dose.

f. Maintenance of Patients on Warfarin*

(1) For patients with a goal INR of 2.0-3.0:

(a) If INR ≤1.5, increase weekly dose by 10-15% and repeat INR within 7 days.

(b) If INR is 1.51-1.79 and falling or low on two or more occasions, increase weekly dose by 5-10% and repeat INR in 7-14 days.

(c) If INR is 1.80-1.99, consider not changing the dose unless a consistent pattern has been observed. Repeat INR in 7-14 days.

(d) If INR is 2.00-3.00, no change in dose is recommended. Obtain follow-up INR within 28 days, or as determined by clinical judgement. If INR is 3.01-3.20, consider not changing the dose unless a consistent pattern has been observed. Repeat INR in 7-14 days.

(e) If INR is 3.21-3.69, hold or decrease one dose of warfarin. If rising or high on two or more occasions, decrease weekly dose by 5-10% and repeat INR in 7-14 days.

(f) If INR is 3.70-4.99, hold 1-2 days and decrease weekly dose by 5-15%. Repeat INR within 7 days.

(g) If INR is 5.00-9.99, hold warfarin and check INR within 5 days. When INR is therapeutic, restart at lower dose (decrease weekly dose by 10-20%). Check INR at least weekly or as clinically indicated until stable.

(h) If INR is ≥10.0 without bleeding, hold warfarin and give oral vitamin K 2.5mg.

Check INR at least weekly or as clinically indicated until stable.

(i) If serious bleeding (regardless of INR), hold warfarin and refer patient to emergency department immediately.

(2) For patients with a goal INR of 2.5-3.5:

(a) If INR ≤1.5, increase weekly dose by 10-15% and repeat INR within 7 days.

(b) If INR is 1.51-1.99 and falling or low on two or more occasions, increase weekly dose by 10-15% and repeat INR in 7-14 days.

(c) If INR is 2.00-2.29 and falling or low on two or more occasions, increase weekly dose by 5-10%. Repeat INR in 7-14 days.

(d) If INR is 2.30-2.49, consider not changing the dose unless a consistent pattern has been observed. Repeat INR in 7-14 days.

(e) If INR is 2.50-3.50, no change in dose is recommended. Obtain follow-up INR within 28 days.

(f) If INR is 3.51-3.70, consider not changing the dose unless a consistent pattern has been observed. Repeat INR in 7-14 days.

(g) If INR is 3.71-4.19, consider holding or decreasing one dose of warfarin. If rising or high on two or more occasions, decrease weekly dose by 5-10% and repeat INR in 7- 14 days.

(h) If INR is 4.20-4.99, hold for one day and decrease weekly dose by 5-15%.

Repeat INR within 7 days.

(i) If INR is 5.00-9.99, hold warfarin and check INR within 5 days. When INR is therapeutic, restart at lower dose (decrease weekly dose by 10-20%). Check INR at least weekly until stable.

(j) If INR is ≥10.0 without bleeding, hold warfarin and give oral vitamin K 2.5mg.

Check INR within 24-48 hours, and at least weekly until stable, or as clinically indicated.

May need to repeat/ increase vitamin K dose. Consider evaluation in Emergency Department for observation/evaluation.

(k) If serious bleeding (regardless of INR), hold warfarin and refer patient to emergency department immediately.

g. Frequency of PT/INR Testing for patients taking warfarin*

(1) When anticoagulation therapy has been initiated, all patients must have an INR measurement within 7 days prior to initiation. The PT/INR will be checked one to three times weekly until therapeutic or more frequently if needed.

(2) When the PT/INR remains therapeutic and the dose of warfarin remains stable for two consecutive tests, the PT/INR will be checked approximately every 2 weeks.

(3) When the PT/INR and dose of warfarin remain stable for two weeks, the PT/INR will be checked approximately every 4 weeks.

(4) Most patients will have their PT/INR checked at least every 4weeks or as determined by clinical judgment. However, patients with consistently stable INRs within their target ranges may have the frequency of PT/INR testing extended from 28 days to up to 42 days if both Anticoagulation clinic provider and patient are in agreement.

(5) After a change in dose is made, all patients will be scheduled to have their PT/INR in a timely manner

h. The following laboratory tests will be utilized to monitor patients on anticoagulants*:

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

(a) Heparin: CBC, activated Partial Thromboplastin time (aPTT), INR

(b) Low Molecular Weight Heparin (LMWH) and fondaparinux: CBC, creatinine, anti-activated factor X (antiXa) as clinically indicated

(c) Warfarin: CBC, INR, PT *NOTE: Initial INR should not be performed using point of care testing devices.

(d) Direct Oral Anticoagulants (DOAC): CBC, creatinine, Liver Function Tests (LFTs)

(2) Required ongoing laboratory tests for patients on anticoagulation therapy:

(a) Heparin: CBC, aPTT or anti-Xa

(b) LMWH and fondaparinux: CBC, creatinine, antiXa as clinically indicated

(c) Warfarin: CBC, INR, PT

(d) DOAC: CBC, creatinine, +/- LFTs. New starts to be seen in clinic. Follow up monitoring after initial visit within 1 month, then laboratory assessment every 6-12 months minimum with creatinine, CBC or as clinically indicated. *Note: These are only general monitoring guidelines for patients. Frequency of PT/INR, DOAC monitoring or LMWH/fondaparinux monitoring will depend on individual patient condition and overall treatment plan.

i. Eligibility Criteria

(1) Patients must be willing to attend clinic, virtual appointments or telehealth appointments at least once every 12 months or more often depending on individual needs based on clinical assessment.

(2) All patients must have a primary care provider in Ambulatory Care within the VA Health Care Network Upstate New York at Syracuse or a VA approved Community Care Provider and agree to come in for appropriate comprehensive follow-up visits with this VA provider. Traveling Veterans who need laboratory testing or follow up for anticoagulation related issues while traveling will be consulted to the Traveling Veteran Coordinator to assist in the management of these AC clinic patient as needed. Refer to the Traveling Veteran Policy (MCPM 11-191)

(3) The patients or family members should have the capacity to understand the patient’s condition and implications of anticoagulant therapy and be able to self-administer the medication or have a caretaker who can supervise the anticoagulation medication.

(4) Patients must be willing to be active participants in their health care.

(5) Patients must be able to travel to and from clinic appointments.

(6) Patients must be accessible by telephone and patients need to update this information if changes occur.

(7) Patients who do not have a telephone must wait at the clinic for test results.

(8) Patients must have a documented need for anticoagulant therapy.

(9) Patients must be compliant and NOT abusing drugs or alcohol.

(10) Patients who are stable on a direct oral anticoagulant (DOAC), with a creatinine clearance of > or = to 50ml/min, and who are not significantly anemic nor thrombocytopenic, will be discharged back to their primary care providers in Syracuse, Rome and Binghamton for DOAC renewal and management. PCP providers will be assisted by anticoagulation clinical pharmacists utilizing the DOAC Dashboard.

j. Procedures

(1) For all new patient referrals to the clinic, the primary physician or referring provider is responsible for all anticoagulant dosing and follow-up until the patient is seen in the clinic for the first visit. If the patient’s primary physician does not initiate the anticoagulation therapy, the initiating physician, if not from the AC clinic, must notify the primary physician regarding follow-up. When the patient is seen in the AC clinic for the first time, the primary physician will receive a copy of the initial Anticoagulation Clinic consult.

(2) The Anticoagulation Clinic staff will only be responsible for labs ordered by the clinic staff. If any lab is ordered by another physician or primary care provider, that provider will be responsible for evaluating these lab results and for the appropriate arrangements with the clinic staff prior to the next AC clinic visit.

(3) If a physician or primary care provider who is not on the AC clinic staff makes any changes to a clinic patient’s dose or regimen or orders a new medication or changes medications that can affect/interact with a patient’s anticoagulant, that provider should call the AC clinic at 315-425-2615 and speak to an AC Clinic provider. A message can be left on the AC clinic phone off hours for a provider to address these drug changes or potential interactions on the next business day. The AC Clinic staff should also be alerted to these changes via an alerted electronic medical note.

(4) Clinic hours: Monday through Friday 7:30 am – 4:00 pm with expanded hours in the early evening on most Tuesdays, Wednesdays and Thursdays for telephone follow-ups. An AC clinic nurse practitioner (NP), physician assistant (PA) or clinic pharmacist (PharmD/RPh) will be available daily from 7:30 am to 4 pm and may be reached through the Syracuse VA Medical Center operator or by pager (315) 241-1035. For emergencies, if the clinic staff or clinic MD is not available, the Chief of Medicine may be called or the Emergency attending physician called as a back-up provider.

(5) Clinic visits are by appointment only. If patients are unable to keep an appointment, they are to notify the clinic office and reschedule. Patients will have PT/INRs drawn by the hospital laboratory for all AC clinic visits and by the hospital laboratory, home based primary care staff, or by the patient's respective CBOC laboratory for “lab only” appointments. Testing for PT/INR may be also done by staff trained in Point of Care (POC) testing in specific situations (HBPC or CBOC). These INR test results will be entered into CPRS and the AMT.

(6) If a patient has a lab drawn outside the VA, or if the patient is eligible for and has requested patient self-testing (PST) with point of care (POC) device adhering to the

Anticoagulation POC PST policy (MCPM 11-175), (see PST of International Normalized Ratio Policy), the AC Clinic providers will make the clinical decision if this is a feasible alternative for laboratory testing. It will be the patient’s responsibility to follow-up on this appointment for the lab testing and financial arrangements. These PT/INR results must be faxed the day it was drawn to the appropriate AC Clinic fax number 315-425-2616.

The patient is responsible for calling the clinic within 24 hours to make sure that the clinic staff has received the result if he/she does not hear from our clinic within that time period.

(7) The frequency of clinic visits versus “lab only” appointments will be made by the clinic staff on an individual basis as needed.

(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. Patients who have a “lab only” INR drawn will be notified by phone within 24 hours of the lab result if an adjustment in therapy is necessary. If a patient cannot be reached by phone within 24 hours and the INR result is within the patient's therapeutic range, a letter will be sent to the patient noting this therapeutic lab result. A progress note will be entered in the electronic record when the patient is contacted by a phone call and/or a letter.

(9) For lab test results with INRs above or below the patient's therapeutic range, repeated attempts will be made within 24 hours to contact the patient by his/her phone until reached. The patient's emergency contact number(s) will be used if needed. The ability of our clinic staff to leave messages on home machines, voice mails or with emergency contacts will be documented in patient's electronic record and clinic contract. If critically high INRs are returned outside of normal business hours, the lab will contact the Emergency attending physician on call. An AC Clinic provider will address the elevated INR the following business day.

(10) For critical drug-drug interactions with anticoagulant medications, the ordering provider will notify the anticoagulation provider by calling the AC Clinic at 315-425-2616 upon ordering the new medication. The anticoagulation provider will assess the interaction, adjust the anticoagulant dose as appropriate, and order any subsequent laboratory tests.

(11) Patients will be seen by the clinic staff for clinic appointments and will be assessed for the following:

(a) Compliance with anticoagulant therapy and missed doses

(b) Degree of control with warfarin, measured by Time in Therapeutic Range (TTR) or proportion of values in therapeutic range (if TTR is not available).

(c) Signs/symptoms of bleeding episodes (gingival bleeding, epistaxis, ecchymosis, hematuria, melena, blood per rectum, etc.).

(d) Signs/symptoms of a thrombotic or thromboembolic event (shortness of breath, pleuritic chest pain, pain swelling of an extremity, numbness, tingling, headache, change in vision, etc.).

(e) Changes in patient parameters such as kidney and/or liver function.

(f) Changes in general health, frailty, fall risk, and other relevant considerations.

(g) Significant changes in diet or alcohol intake.

(h) Any changes in medications (includes prescriptions, herbal or vitamin preparations or over-the-counter medications).

(i) Signs/symptoms of intolerance of drug (nausea/vomiting/diarrhea, rash, skin necrosis, etc.).

(j) Knowledge deficits regarding anticoagulation therapy.

(k) Provide medication organizers and/or tablet splitters as needed to assist in compliance.

(12) Based on these assessments and the PT/INR, dosage adjustment in anticoagulant therapy will be made if necessary and patients counseled on these changes.

(13) A calendar of warfarin dosage changes will be given to patients during face to face visits and telehealth visits.

(14) All clinic visits and patient phone calls will be documented in the electronic medical record.

(15) Anticoagulation providers will add the appropriate International Classification of Diseases (ICD) Diagnosis Codes to the problem list of patients on long-term anticoagulants. In addition, appropriate Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT) codes may be used if applicable. The current ICD-10 diagnosis code is Z79.01 for “Long-term use of anticoagulants.”

(16) Patients and their families will receive ongoing education that will include but is not limited to the following information:

(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; consider Physical Therapy evaluation/referral for ambulatory assessment to decrease fall risks or Occupational Therapy evaluation/referral for bathroom safety evaluations if clinically indicated.

(j) Proper tablet identification for warfarin and DOACs.

(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.

(n) Proper medication storage, including discussion on the handling and storage of dabigatran (i.e. keeping capsules in bottles or blister packs and not placing into pill boxes).

(17) Patients will be instructed on when to return for clinic and lab appointments.

(18) Patients will be referred to his/her primary care provider or to the Emergency Department, or directly admitted to the hospital depending upon the severity of the following:

(a) Signs/symptoms of thrombosis.

(b) Signs/symptoms of bleeding.

(c) Significant adverse drug reactions.

(d) Significantly elevated or subtherapeutic PT/INR.

(e) Any other acute problem related or unrelated to anticoagulant therapy.

(f) Prescriptions for anticoagulant therapy may be written or renewed by clinic staff members with hospital approved clinical privileges allowing them to do so.

(g) Whenever possible, patients will only be prescribed one tablet strength of warfarin to minimize confusion. Patients will be provided written education during clinic visits with instructions regarding their anticoagulation dosage and frequency, along with laboratory and clinic follow up appointments.

(h) Outpatient prescriptions for warfarin will be labeled appropriately to avoid patient confusion with changes to the instructions for use. The following statements may be used:

1. “Refer to the latest anticoagulation clinic dosing sheet.”

2. “Use as directed by the anticoagulation clinic.”

3. “Call anticoagulation clinic at 315-425-2615 with any questions or concerns.”

(19) Patients taking anticoagulants other than warfarin will have periodic monitoring as clinically indicated

(20) Patients and/or providers will notify the AC Clinic prior to any surgical procedures requiring temporary/permanent cessation of anticoagulation. The anticoagulation provider will suspend anticoagulation therapy with input from the surgeon/proceduralist and/or the primary care provider as needed. Each patient’s risk and benefit for bleeding vs. thromboembolism will be assessed prior to procedure. The risks will depend on the type of procedure and the clinical indication for AC therapy as well as individual variables. The decision of when to restart therapy will be made by the provider performing the procedure/surgery with communication to the anticoagulation provider as appropriate. Follow up laboratory testing after temporary cessation of anticoagulation will be scheduled by the AC Clinic providers as clinically indicated.

k. Documentation

(1) Anticoagulant therapy will be documented in the electronic progress notes.

(2) Assessments of patients during the clinic visits will also be documented in the electronic progress notes.

(3) Future clinic visits and scheduled laboratory visits will be ordered by the clinic providers and scheduled by the clinic clerical staff

l. Management of NonCompliance, No Shows and Patients Lost to Follow-Up

(1) Scheduled Clinic Visits:

(a) First time – patient phone call, re-schedule for next available appointment.

(b) Second time – patient phone call, re-schedule for next available appointment.

(c) Third time – patient phone call, electronic progress note to primary caregiver, reschedule for next available appointment, patient warning letter.

(d) Fourth time or if patient fails to respond to repeated phone calls and or letter(s)– patient phone call to discharge (D/C) patient from clinic, send electronic progress note to primary caregiver stating D/C from clinic, letter to patient if not already sent.

(2) Scheduled Lab Only’s (INR’s) or DOAC labs

(a) First time – patient will be called or sent a letter after a missed lab visit, to reschedule lab.

(b) Second time – patient will be called or sent a letter after a missed lab visit, to reschedule lab.

(c) Third time – patient will be assigned to Anticoagulation Clinic appointments for all lab work until compliance can be established. Patient will then be followed according to above Scheduled Clinic Visit No-Shows.

(3) In order to assess for noncompliance, no-shows, and patients lost to follow-up, the Anticoagulation Management Tool (AMT) will be used for warfarin patients to periodically generate lists of patients who have not had a PT/INR drawn in 42 days or more.

m. Clinic Staffing

(1) The Anticoagulation Clinic is a specialty clinic directed by a physician (MD) and staffed by midlevel providers (NP/PA), and registered pharmacists (PharmD/RPh) with specific knowledge and training in anticoagulation therapy, and with a licensed practical nurse(LPN) providing nursing care per scope of practice, and clerk (MSA) providing clerical and administrative assistance.

n. Educational Plan

(1) All current AC Clinic providers have received ~40 Continuing Education hours after completing the “Anticoagulation Therapy Management Program” from the University of Southern Indiana or will complete this course or similar training.

(2) Upon hire into the AC Clinic, all providers will complete the mandatory Talent Management System (TMS) training entitled “Advanced Anticoagulation Webcourse.”

(3) AC Clinic staff will participate in monthly AC Clinic meetings to discuss pertinent journal articles and any issues or developments that would affect the management of anticoagulants.

(4) Providers will continue to attend training per their individual disciplines with a focus on thrombosis and antithrombotic therapy and provide education to AC Clinic staff upon return from these educational training courses.

(5) Providers in the AC Clinic will complete at least biannual peer chart reviews in order to assess for competency specific to anticoagulation management.

Competencies, at a minimum, will include knowledge of standard terminology, pharmacology of anticoagulants, monitoring requirements, dose calculations, common side effects, nutrient interactions, and drug-drug interactions associated with anticoagulant therapy.

o. Quality Assurance

(1) An ongoing quality assurance plan will evaluate the anticoagulation management program to identify practice improvements, ensure appropriate action is taken to improve the practice, and measure the effectiveness of those actions. The AMT will be used to track and review the following data on a quarterly basis:

(a) Patients with pathologic bleeding events.

(b) Patients with thromboembolic events.

(2) Patient incidents, close calls, and near misses associated with an anticoagulant will 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.

(3) Any identified issues found in the quality assurance program will be tracked and trended by the Anticoagulation Program Manager and reported quarterly through the P&T Committee to the Medical Staff Executive Committee (MSEC) as appropriate.

5. DEFINITIONS

None

6. REFERENCES

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

2012;141(2): February Supplement.

b. VHA Directive 1033, Anticoagulation Therapy Management, July 29, 2015 .

c. VHA Directive 1070, Adverse Drug Event Reporting and Monitoring, dated May 15, 2020.

d. VHA Directive 1088, Communicating Test Results to Providers and Patients, October 7, 2015.

e. VHA Handbook 1108.05(2), Outpatient Pharmacy Services, dated June 16, 2016 .

f. VHA Directive 1108.06, Inpatient Pharmacy Services, dated February 8, 2017 .

g. VHA Handbook 1108.11(1), Clinical Pharmacy Services, dated July 1, 2015, Amended June 29, 2017.

h. VA PBM services, MAP, and VISN pharmacy executives, Direct Oral anticoagulants (DOACs) criteria for use for venothromboembolism.

Attachment D.33 36C24224R0049 https://dvagov.sharepoint.com/sites/VHAPBM/Formulary/Clinical%20Guidance/Forms/AllItems.aspx?viewid=197a14fe-98b3-4137-a6f5-cd2118dd0b69&id=%2Fsites%2FVHAPBM%2FFormulary%2FClinical%20Guidance%2FCriteria%20For%20Use https://dvagov.sharepoint.com/sites/VHAPBM/Formulary/Clinical%20Guidance/Forms/AllItems.aspx?viewid=197a14fe-98b3-4137-a6f5-cd2118dd0b69&id=%2Fsites%2FVHAPBM%2FFormulary%2FClinical%20Guidance%2FCriteria%20For%20Use https://vaww.va.gov/vhapublications/publications.cfm?Pub=1 https://vaww.va.gov/vhapublications/publications.cfm?Pub=1 https://vaww.va.gov/vhapublications/publications.cfm?Pub=1 https://vaww.va.gov/vhapublications/publications.cfm?Pub=1 https://vaww.va.gov/vhapublications/publications.cfm?Pub=1 https://vaww.va.gov/vhapublications/publications.cfm?Pub=1 https://vaww.va.gov/vhapublications/publications.cfm?Pub=1 https://vaww.va.gov/vhapublications/publications.cfm?Pub=1 https://vaww.va.gov/vhapublications/publications.cfm?Pub=1 https://journal.chestnet.org/article/S0012-3692(12)60114-7/pdf https://journal.chestnet.org/article/S0012-3692(12)60114-7/pdf https://journal.chestnet.org/article/S0012-3692(12)60114-7/pdf

i. VA PBM services, MAP, and VISN pharmacy executives, Direct Oral anticoagulants (DOACs) criteria for use for Nonvalvular Atrial Fibrillation

j. SOP 119-01 Heparin Dosing Via Weight Based Heparin Nomogram

k. MCPM 11-175, Patient Self-testing of International Normalization Ratio Policy

l. American Society of Hematology 2018 VTE GUIDELINES: ANTICOAGULATION MANAGEMENT, Blood Adv 27 Nov 2018, Vol 2, No. 22 3257-3291.

7. RESCISSION

MCPM 11-06 Anticoagulation (AC) Clinic Policies and Procedures, dated February 2017, is rescinded.

8. REVIEW

At minimum at recertification and including when there are changes to the governing document (for example, national policy or a health care accreditation body mandate).

9. RECERTIFICATION

This MCP is scheduled for recertification on or before the last working day of February 2026. 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.

10. SIGNATORY AUTHORITY

Frank P. Pearson, DPT, PA-C CAPT, USN (Ret) U.S. Department of Veterans Affairs Director, Syracuse VA Medical Center Date Approved: February 26, 2021

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

DISTRIBUTION: MCPs are available at: Syracuse Medical Center Document Control SharePoint (DCS) .

Attachment D.33 36C24224R0049 https://dvagov.sharepoint.com/sites/VHASYR/svdc/ https://dvagov.sharepoint.com/sites/VHASYR/svdc/ https://ashpublications.org/bloodadvances/article/2/22/3257/16107/American-Society-of-Hematology-2018-guidelines-for https://ashpublications.org/bloodadvances/article/2/22/3257/16107/American-Society-of-Hematology-2018-guidelines-for https://dvagov.sharepoint.com/sites/VHASYR/svdc/ https://dvagov.sharepoint.com/sites/VHASYR/svdc/ https://dvagov.sharepoint.com/sites/VHAPBM/Formulary/Clinical%20Guidance/Forms/AllItems.aspx?viewid=197a14fe-98b3-4137-a6f5-cd2118dd0b69&id=%2Fsites%2FVHAPBM%2FFormulary%2FClinical%20Guidance%2FCriteria%20For%20Use https://dvagov.sharepoint.com/sites/VHAPBM/Formulary/Clinical%20Guidance/Forms/AllItems.aspx?viewid=197a14fe-98b3-4137-a6f5-cd2118dd0b69&id=%2Fsites%2FVHAPBM%2FFormulary%2FClinical%20Guidance%2FCriteria%20For%20Use