Warfarin Management Policy and Procedure Audit Tool Facility: _______________________________________Date:_________________________________ Data Collector’s name: ___________________________Email/phone:__________________________ Purpose: To perform a comprehensive review of your facility policies and procedures relating to the management of warfarin. Instructions:  Prepare for the review by compiling or locating all facility policies, procedures, order sets, and other documents that relate directly or indirectly to: a. New patient, admissions/re-admissions physical assessment and documentation b. Warfarin dosing, administration, monitoring, and documentation (e.g. tracking forms, etc) c. Nurse response to abnormal findings (e.g. patient bleeding, abnormal laboratory values, etc.) d. Documentation of staff education and competency (e.g. training on anticoagulant use) e. Any other document that relate to anticoagulant use in your facility f. Quality improvement processes and reports  Rank each section using scale provided below. Indicate rank for each item by circling the most appropriate level.  For questions contact: Vicky Agramonte, [email protected] or Anne Myrka, [email protected]  Please FAX this completed form to 518-426-3418 to Vicky or Anne (main phone:518-426-3300) Ranking Scale Rank A: Policies and procedures exist and include ALL elements described as best practices. (It is anticipated that only a small number of sections will qualify for this level.) Rank B: Policies and procedures exist, but do not reflect all aspects of the identified best practices. Rank C: Policies and procedures do not exist that address this identified best practice.

Initiation of warfarin therapy 1. The facility has policies and procedures that  Proactively identify all patients eligible for oral anticoagulation and  Specifically mention the identification of transfers, re-admissions, and new admissions that already use or have indications for oral anticoagulation. Rank:

A

B

C

________________________________________________________________________________ Rank A: Policies and procedures exist and include ALL elements described as best practices. (It is anticipated that only a small number of sections will qualify for this level.) Rank B: Policies and procedures exist, but do not reflect all aspects of the identified best practices. Rank C: Policies and procedures do not exist that address this identified best practice

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2. The facility has policies and procedures that  Specifically guide initial warfarin dosages and frequency of INR monitoring in a manner compatible with current therapy guidelines. “For patients sufficiently healthy to be treated as outpatients, we suggest initiating VKA therapy with warfarin 10 mg daily for the first 2 days followed by dosing based on international normalized ratio (INR) measurements rather than starting with the estimated maintenance dose (Grade 2C).” CHEST / 141 / 2 / FEBRUARY, 2012 SUPPLEMENT

Rank:

A

B

C

_________________________________________________________________________________________

Maintenance of warfarin therapy 3. The facility has policies and procedures that  Specifically describe the physical assessment and documentation processes to be employed by nurses and clinical staff evaluating anticoagulated patients and  The procedures include routine evaluation of patients for signs/symptoms of bleeding and thromboembolism. Rank:

A

B

C

________________________________________________________________________________ 4. The facility has policies and procedures that  Specifically describe the minimum frequency of laboratory INR monitoring for stable patients in a manner that is compatible with current therapy guidelines and regulations.  Monitoring of INR is performed at least monthly in most cases. Patients monitored less frequently have documented longstanding INR stability. Use must be monitored by Prothrombin Time (PT)/International Normalization Ratio (INR), with frequency determined by clinical circumstances, duration of use, and stability of monitoring results. CMS Appendix PP- Interpretive Guidelines for LTC Facilities. For patients taking VKA therapy with consistently stable INRs, we suggest an INR testing frequency of up to 12 weeks rather than every 4 weeks (Grade 2B). CHEST / 141 / 2 / FEBRUARY, 2012 SUPPLEMENT

Rank:

A

B

C

____________________________________________________________________________________

Rank A: Policies and procedures exist and include ALL elements described as best practices. (It is anticipated that only a small number of sections will qualify for this level.) Rank B: Policies and procedures exist, but do not reflect all aspects of the identified best practices. Rank C: Policies and procedures do not exist that address this identified best practice

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5. The facility has policies and procedures that  Explicitly state the INR goal for patients based on indication for therapy in a manner compatible with current therapy guidelines. For patients treated with VKAs, we recommend a therapeutic INR range of 2.0 to 3.0 (target INR of 2.5) rather than a lower (INR < 2) or higher (INR 3.0-5.0) range (Grade 1B). CHEST / 141 / 2 / FEBRUARY, 2012 SUPPLEMENT

Rank:

A

B

C

________________________________________________________________________________

Responsiveness 6. The facility has explicit policies and procedures to  Assure increased frequency of INR monitoring when patients are at identified risk of bleeding or INR instability, including: a. INR out of range (i.e. unstable) b. Interacting drugs started c. Interacting drugs stopped d. Patient condition changes (e.g. fever, infection, or acute event) e. Anticoagulation interrupted (e.g. patient NPO, undergoing procedures, etc.) Rank:

A

B

C

________________________________________________________________________________ 7. The facility has explicit policies and procedures that  Assure the timely and effective communication of out of range INR values to prescribers. Rank:

A

B

C

________________________________________________________________________________ 8. The facility has policies and procedures in place that  Provide prescribers of warfarin with evidence-based guidance for the effective and appropriate titration of warfarin doses in response to an observed INR value.  The guidance addresses both subtherapeutic and marginally supratherapeutic INR values.  The original source of the dosing guidance is cited (commercially available dosing algorithms or warfarin management software is also acceptable). Rank:

A

B

C

________________________________________________________________________________

Rank A: Policies and procedures exist and include ALL elements described as best practices. (It is anticipated that only a small number of sections will qualify for this level.) Rank B: Policies and procedures exist, but do not reflect all aspects of the identified best practices. Rank C: Policies and procedures do not exist that address this identified best practice

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9. The facility has  Explicit policies and procedures for responding to critically elevated INR values and/or bleeding events in a manner consistent with current therapy guidelines.

TABLE 1: Management of Non-Therapeutic INR (Adapted from AT91) Bleeding Severity No evidence of bleeding in a patient with previously stable INR No evidence of bleeding in a patient with unstable/unknown INR

INR 0.5 above or below target

3.6 - 4.4 No evidence of bleeding in any VKA-treated patient

Bleeding management

Continue current dose and repeat INR within 1–2 weeks (Grade 2C)

No intervention necessary

Provider discretion

NA

Provider discretion

NA

Hold dose, repeat INR within 24 hours, then decrease maintenance dose Hold dose, repeat INR within 24 hours, then decrease maintenance dose

4.5 - 10 ≥10

Major bleeding in any VKA-treated patient

Warfarin Changes

Hold dose, repeat INR frequently, then decrease maintenance dose

Any value

Do not use vitamin K (Grade 2B) Give vitamin K 2.5 - 5mg by mouth (Grade 2C) Give vitamin K 5-10 mg via slow IV infusion (Grade 2C) Give PCC as needed (Grade 2C) [rVIIa or FFP may be considered when PCC is unavailable]

PCC= prothrombin complex concentrate; rVIIa=recombinant factor VIIa; INR=international normalized ratio; VKA=vitamin K antagonist; FFP=fresh frozen plasma; Vitamin K is available as 5 mg tab (response in 12-24hours) and IV solution (response in 6-24 hours); SC administration is not recommended1

http://journal.publications.chestnet.org/ss/guidelines.aspx

Rank:

A

B

C

________________________________________________________________________________

Quality Assurance/Continuous Quality Improvement 10. The facility has policies and procedures in place  For visually tracking and trending individual patient INR results for all warfarin users (automated reports within an electronic data system that display these data graphically and/or in tables are acceptable). Rank:

A

B

C

________________________________________________________________________________

Rank A: Policies and procedures exist and include ALL elements described as best practices. (It is anticipated that only a small number of sections will qualify for this level.) Rank B: Policies and procedures exist, but do not reflect all aspects of the identified best practices. Rank C: Policies and procedures do not exist that address this identified best practice

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11. The facility employs processes  For the routine review (at least quarterly) of performance relating to warfarin utilization.  The process includes review of facility-level measures, for example, time in therapeutic range (TTR), INR excursions above and below target range, and clinical events such as relevant bleeding, use of rescue agents, thromboembolism, hospitalization, and mortality related to anticoagulant use. Rank:

A

B

C

_________________________________________________________________________________ 12. The facility has policies and procedures in place  To assure comprehensive staff education relating to anticoagulant use.  Routinely, and objectively demonstrate staff competency  To assure, all clinical staff complete the training, and training is renewed periodically (at least annually). Rank:

A

B

C

________________________________________________________________________________

Please FAX this completed form to 518-426-3418 to Vicky or Anne (main phone: 518-426-3300)

Rank A: Policies and procedures exist and include ALL elements described as best practices. (It is anticipated that only a small number of sections will qualify for this level.) Rank B: Policies and procedures exist, but do not reflect all aspects of the identified best practices. Rank C: Policies and procedures do not exist that address this identified best practice

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