D.34- ANTICOAGULATION CLINIC PROCESSES SOP- APRIL 2022.pdf
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- Solicitation number
- 36C24224R0049
About this file
This document is a Standard Operating Procedure (SOP) for the Anticoagulation Clinic (ACC) at the Syracuse VA Medical Center. The SOP establishes procedures for addressing patient calls and staff questions regarding anticoagulation outside of normal business hours, managing critical drug-drug interactions, minimizing dosing errors with warfarin, and coordinating peri-procedural anticoagulation management.
The SOP references VHA Directive 1108.16 on Anticoagulation Therapy Management and VHA Handbook 1106.01 on Pathology and Laboratory Medicine Service Procedures. It outlines the clinic's operating hours, responsibilities for lab ordering and results, and requirements for notifying the clinic of medication changes or procedures involving anticoagulant patients. The SOP also provides guidance on bridge therapy decisions and avoiding unnecessary bridging, especially for direct-acting oral anticoagulants.
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ANTICOAGULATION CLINIC PROCESSES
SOP 119AC-001
Syracuse VA Medical Center Syracuse, NY 13210
Signatory Authority:
Anticoagulation Clinic Champion
Responsible Owner:
Anticoagulation Clinic Director
Service Line(s):
Anticoagulation (AC) Clinic
Effective Date:
June 2022
Recertification Date:
June 2027
1. PURPOSE AND JUSTIFICATION
a. The purpose of this standard operating procedure (SOP) is to establish procedures for Anticoagulation Clinic (ACC) at the Syracuse VA Medical Center.
Specifically, to addressing patient calls and facility staff questions regarding anticoagulation outside of normal business hours, appropriate follow up for Veterans identified with a critical drug-drug interaction with anticoagulation medications, how to minimize the risk associated with incorrect tablet strength dosing errors with warfarin and how the Anticoagulation (AC) Clinic is informed of veterans on anticoagulation undergoing procedures. This SOP must be followed by all Syracuse VAMC personnel.
b. This SOP sets forth mandatory procedures and processes to ensure compliance with VHA Directive 1108.16(1), Anticoagulation Therapy Management, dated January 29, 2021, amended April 23, 2021, and VHA Handbook 1106.01, Pathology and Laboratory Medicine Service (P&LMS) Procedures, dated January 29, 2016.
2. PROCEDURES
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.
b. Use of Weight-Based Unfractionated Heparin. See Facility SOP 119-01, Heparin Dosing VIA Weight Based Heparin Nomogram, dated August 31, 2021.
c. Use of Warfarin. Algorithms and practice guidelines based on current evidence-based published guidelines, as determined by the facility P&T committee for initiation and maintenance, frequency of testing for warfarin.
(1) Current guidelines: 1266-2019-01-09-110040.pdf (acforum-excellence.org).
NOTE: This is an internal VA website that is not available to the public.
Attachment D.34 RFP 36C24224R0049 https://acforum-excellence.org/Resource-Center/resource_files/1266-2019-01-09-110040.pdf
June 2022 SOP 119AC-001
d. Addressing labs.
(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.
(a) If the patient’s primary physician does not initiate the anticoagulation (AC) therapy, the initiating physician, if not from the AC clinic, must notify the primary physician regarding follow-up.
(b) 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.
(a) 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) 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.
(b) The AC Clinic staff should also be alerted to these changes via an alerted electronic medical note.
(4) Clinic hours:
(a) 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.
(b) An AC clinic nurse practitioner (NP), physician assistant (PA) or clinic pharmacist (PharmD/RPh) will be available daily from 7:30 am to 4:00 pm and may be reached through the Syracuse VA Medical Center operator or by pager (315) 241-1035.
(c) 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.
e. Anticoagulation Clinic Outside of Normal Business Hours.
(1) If outside of normal AC clinic hours, patients can call the VA Health Connect number at 1-800-877-6976, formerly they were told to call the VA Telecare.
(a) This phone number is given to patients on the Anticoagulation clinic appointment sheet at their annual follow up appointment.
(b) VA Health Connect number is staffed by nursing, physicians and pharmacists 24 hours a day, 7 days a week.
(2) Directing Facility Staff Questions:
(a) Facility staff questions regarding anticoagulation outside of normal business hours, can go through the Syracuse VA Inpatient Pharmacy.
(b) Critical Lab Levels Outside of Normal Business Hours:
1. The Lab will contact an Emergency Department (ED) Physician with any critical lab value ordered by AC clinic staff.
2. The ED Physician will contact the Veteran regarding the critical lab value.
3. The ED Physician will document in the Electronic Medical Record (EMR).
f. For critical drug-drug interactions.
(1) The ordering provider will notify the anticoagulation provider by calling the AC Clinic at 315-425-2616 upon ordering the new medication that interacts with warfarin.
(a) The pharmacy can also notify the AC clinic of any critical drug interactions.
(2) The anticoagulation provider will assess the interaction, adjust the anticoagulant dose as appropriate, and order any subsequent laboratory tests.
(3) The AC clinic also tracks interacting medication with direct oral anticoagulants through the Direct Oral Anticoagulant Monitoring Report, in Pharmacy Benefits Management (PBM) Med Safety Reports.
g. Minimize Dosing Errors.
(1) Patients enrolled in the AC clinic can only be given one strength of warfarin tablets to minimize the risk associated with incorrect tablet strength dosing errors.
(2) After each dosage change a letter will be given or mailed to the Veteran with the new dose and tablet strength.
(3) Prescriptions for anticoagulant therapy may be written or renewed by clinic staff members with hospital approved clinical privileges allowing them to do so.
(4) 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:
(a) “Refer to the latest anticoagulation clinic dosing sheet.”
(b) “Use as directed by the anticoagulation clinic.”
(c) “Call anticoagulation clinic at 315-425-2615 with any questions or concerns.”
h. Peri-Procedural AC Management.
(1) Primary care or specialty clinics are required to enter the anticoagulation pre-op clearance request consult to alert AC clinic of any Veterans on anticoagulants undergoing a procedure requiring temporary/permanent cessation of anticoagulation.
(2) Clinical Providers are required to alert AC clinic of the following:
(a) Date of procedure
(b) Type of surgical procedure
(3) A risk assessment by the AC provider should be done for all patients prior to a scheduled procedure.
(a) The risks will depend on the type of procedure and the clinical indication for AC therapy as well as individual variables.
(b) The bleeding risk of procedure along with thromboembolic risk of patient will need to be determined using the latest guidelines. See -2018-05-01-172900.pdf (acforum-excellence.org). NOTE: This is an internal VA website that is not available to the public.
(c) Since the release of The American College of Chest Physicians 2012 Perioperative Management of Antithrombotic Therapy guidelines, several studies have been published that provide evidence to guide bridge therapy decisions. Previously, the practice of bridging was based solely on expert opinion. It is now realized that the use of bridge therapy produces net harm for the majority of patients. In all studies to date, bridging was associated with a 2.5- to 5-fold increase in major bleeding. Furthermore, no study has yet to demonstrate a reduction in thromboembolism from use of bridge therapy. Given the above, bridging may be considered for high-risk patients, but the risks and benefits must be considered carefully. The AC provider has the choice of full or prophylactic dose.
(d) In General, Peri-procedural bridging is NOT indicated in Direct-Acting Oral Anticoagulants (DOACs).
(e) Contraindications to enoxaparin therapy include prior diagnosis of heparin-induced thrombocytopenia (HIT), severe thrombocytopenia (platelets <100,000), those patients receiving hemodialysis, or those patients at a significant bleed risk where risks outweigh any benefit that would be received.
Attachment D.34 RFP 36C24224R0049 https://acforum-excellence.org/Resource-Center/resource_files/-2018-05-01-172900.pdf
1. Spinal or epidural hematomas may occur in patients who are anticoagulated with enoxaparin and receiving neuraxial anesthesia or spinal anesthesia. These risks must be discussed with the proceduralist prior to using in this situation. NOTE: The optimal timing between administration of enoxaparin and these procedures is not known.
(4) The decision of when to restart therapy will be made by the provider performing the procedure/surgery with communication to the patient/caregiver as appropriate.
(5) Follow up laboratory testing after temporary cessation of anticoagulation will be scheduled by the AC Clinic providers as clinically indicated.
3. ASSIGNMENT OF RESPONSIBILITIES
None
4. DEFINITIONS
None
5. REFERENCES
a. VHA Directive 1108.16(1), Anticoagulation Therapy Management, dated January 29, 2021, amended April 23, 2021. NOTE: This is an internal VA website that is not available to the public.
b. MCP 11-006, Anticoagulation (AC) Clinic Policies and Procedures, dated February 2021. NOTE: This is an internal VA website that is not available to the public.
c. VHA Handbook 1106.01, Pathology and Laboratory Medicine Service (P&LMS) Procedures, dated January 29, 2016. NOTE: This is an internal VA website that is not available to the public.
d. Pharmacy Benefits Management (PBM) Med Safety Report: Scorecard - Power BI Report Server (va.gov). NOTE: This is an internal VA website that is not available to the public.
e. Anticoagulation Forum, Centers of Excellence: VHA CPPO Pharmacy Benefits Management (PBM) Strong Practice Recommended Warfarin Management Algorithm (Maintenance Phase of Therapy) 1266-2019-01-09-110040.pdf (acforum-excellence.org). NOTE: This is an internal VA website that is not available to the public.
f. Anticoagulation Forum, Centers of Excellence: Protocol for Peri-Procedural Management of antithrombotic therapy: -2018-05-01-172900.pdf (acforum-excellence.org). NOTE: This is an internal VA website that is not available to the public.
6. REVIEW
Attachment D.34 RFP 36C24224R0049 https://vaww.va.gov/vhapublications/index.cfm https://vaww.va.gov/vhapublications/index.cfm https://dvagov.sharepoint.com/sites/VHASYR/svdc/ https://dvagov.sharepoint.com/sites/VHASYR/svdc/ https://vaww.va.gov/vhapublications/index.cfm https://vaww.va.gov/vhapublications/index.cfm https://vaww.pbi.cdw.va.gov/PBI_RS/report/GPE/PBM_MedSafeRpts/SSRS/Reports/DOAC/Scorecard https://vaww.pbi.cdw.va.gov/PBI_RS/report/GPE/PBM_MedSafeRpts/SSRS/Reports/DOAC/Scorecard https://acforum-excellence.org/Resource-Center/ https://acforum-excellence.org/Resource-Center/resource_files/1266-2019-01-09-110040.pdf https://acforum-excellence.org/Resource-Center/resource_files/1266-2019-01-09-110040.pdf https://acforum-excellence.org/Resource-Center/
At minimum at recertification, when there are changes to the governing document (for example, national policy or a health care accreditation body mandate).
7. RECERTIFICATION
This SOP is scheduled for recertification on or before the last working day of June 2027.
In the event of contradiction with national policy, the national policy supersedes and controls.
8. SIGNATORY AUTHORITY
TAMMY ANTHONY, MD
Anticoagulation Clinic Champion Date Approved: June 14, 2022
NOTE: The signature remains valid until rescinded by an appropriate administrative action.
DISTRIBUTION: SOPs are available at: Syracuse Medical Center Document Control SharePoint (DCS). https://dvagov.sharepoint.com/sites/VHASYR/svdc.
https://dvagov.sharepoint.com/sites/VHASYR/svdc/ https://dvagov.sharepoint.com/sites/VHASYR/svdc/
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