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C.1. VTE Prophylaxis Audit Form Designed To Evaluate a Sample of Inpatients

Reviewer_______________ Patient ID_______________ Date of review_________
Hospital Day #___________ Service______________ Ward/location_________

1. Is patient eligible for survey? (not on therapeutic anticoagulation or comfort care only)
    Yes ______   No _____   If No, stop here and go to next patient.

2. Assign venous thromboembolism risk (see reverse side and circle category)
    LOW    MODERATE    HIGH

3. Document current prophylaxis ordered
    NONPHARMACOLOGIC
    __ Sequential compression device: Are these in place and on? ______
    __ Elastic stockings

    PHARMACOLOGIC
    __ Heparin 5,000 units subcutaneous q 12 hours
    __ Heparin 5,000 units subcutaneous q 8 hours
    __ Enoxaparin (Lovenox) 40 mg subcutaneous q day
    __ Enoxaparin (Lovenox) 30 mg subcutaneous q day
    __ Enoxaparin (Lovenox) 30 mg subcutaneous q 12 hours
    __ Fondaparinux (Arixtra) 2.5 mg subcutaneous daily
    __ Coumadin ______mg daily
    __ Other___________________________________

4. If patient is at moderate or high risk and is not receiving anticoagulant prophylaxis: Does patient have contraindications to pharmacologic prophylaxis? (see reverse, circle appropriate category if present)
   Yes    No    N/A

5. If patient has an indication for SCDs but does not have them ordered: Does patient have a contraindication for mechanical prophylaxis, such as edema, wound infection of legs, vascular compromise, or bilateral lower extremity amputation?
   Yes _____ No _____ N/A _____

6. Is the patient receiving prophylaxis that matches the level of risk per protocol (see table on reverse)? Final judgment, was prophylaxis order for patient at the time of the survey appropriate? Remember that SCDs alone are appropriate for moderate- to high-risk VTE patients with contraindications to anticoagulant prophylaxis.
   Yes    No, patient is under-prophylaxed     No, patient is over-prophylaxed

7. If prophylaxis was inappropriate per protocol, notify physician within 24 hours.
    Physician notified ____________   Date/Time ____________

8. Did physician change order to align with protocol as a result of your intervention?
    Yes _____ No _____ If no, list reason given.

(Reverse/Reference Side of the Data Collection Form)

DVT/PE Risk Level & Acceptable Choices Per Protocol

Low Risk Observation patients; expected LOS <48 hrs. Minor/ambulatory surgery unless multiple strong risk factors. Patients no longer/never ill, awaiting disposition. Ambulatory cancer patients admitted for short chemotherapy infusion. Medical patient able to ambulate outside room and not meeting criteria for moderate or high risk.	Early ambulation, education.
Moderate Risk Moderate to major surgery with impaired mobility. Moderate to major surgery with any VTE risk factor. Active malignancy with acute medical illness, reduced mobility, or other VTE risk factors. Medical patient, reduced mobility, AND acute illness. Medical patient, prior VTE or known thrombophilia.	Enoxaparin 40 mg SC q 24 hrs or Enoxaparin 30 mg SC q 24 hrs or (if renal insufficiency) Heparin 5,000 units SC q 8 hrs or Heparin 5,000 units SC q 12hrs (preferred over q 8 hrs age >75)
High Risk Hip/knee replacement or hip/femur fracture. Acute spinal cord injury with paresis. Multiple major trauma. Abdominal or pelvic surgery for cancer. Craniotomy. or (after bleeding risk subsides) Spine surgery, if anterior approach, fusion, or cancer.	Enoxaparin 40 mg SC q day or Enoxaparin 30 mg SC q 24 hrs or (if renal insufficiency) Heparin 5,000 units SC q 8 hrs or (ESRD only) Enoxaparin 30 mg SC q 12 hrs or` (knee replacement) Fondaparinux 2.5 mg SC q day or Warfarin, target INR 2–3
	AND Sequential compression device.

Note: For patients at moderate or high risk for VTE with bleeding contraindications, sequential compression devices are the preferred mode of prophylaxis.

Bleeding Risk Factors and Contraindications to Anticoagulant Prophylaxis

Active bleeding. Active gastroduodenal ulcer. Platelet count <50,000 or <100,000 and downtrending. Therapeutic levels of anticoagulation. Advanced liver disease with INR >1.5. Heparin-induced thrombocytopenia (no heparinoids, consider consultation).

Intracranial bleeding within last year. Intraocular surgery within 2 weeks. Untreated inherited bleeding disorders. Hypertensive urgency/emergency. Postoperative bleeding concerns.* Epidural/spinal anesthesia within previous 4 hours or expected within next 12 hours.

* Leeway times: 24 hours maximum for most general surgery and orthopedic surgery patients.
s/p Transplant or multiple major trauma to clear bleeding risk: 48 hours.
s/p spinal cord open surgery: 5 days leeway.

Description

• The audit form is designed for use on sampled active inpatients.
• The level of VTE risk as scored by the reviewer is recorded. The audit tool is used to determine if the current prophylaxis is consistent with the VTE risk level.
• Contraindications for prophylaxis are determined.
• Over-prophylaxis, as well as under-prophylaxis, can be determined.

Variations and Other Comments

• The VTE risk level, choices for prophylaxis, contraindications for prophylaxis, and surgical leeway times should all be aligned with order sets and protocols being used by the ordering provider.
• This audit form is merely an example and should be revised to reflect each individual institutional protocol.
• The case scenarios in Appendix B, along with real patient cases, should be used to pilot the audit tool (comparing results from different observers).
• The importance of clear operational definitions for terms such as “reduced mobility” becomes clear, and audit results should be reviewed by the improvement team for adjudication until definitions are clear.

C.2. Sample Completed Red/Yellow/Green or “Stoplight” Algorithm and Sample Data Collection Form

Data Collection Algorithm

Algorithm courtesy of Dignity Health, Tamra O’Bryan.

VTE Prophylaxis Audit Data Collection Form

Site: UCSD
Unit: 6U
Unit Description: Medical floor
Primary Unit: Yes
Month/Year of Audit: 01/2011

We recommend NOT using actual Patient ID numbers. Please review explanations and definitions on reverse of form.

			Please answer 1 and 2 if no Mechanical prophylaxis; Please answer 1-3 if no Pharmacologic or Mechanical prophylaxis
Patient ID	Pharmacologic Prophylaxis?	Mechanical Prophylaxis?	1. Low Risk?	2. Pharmacologic Contraindication?	3. Mechanical Contraindication?	Category	Adequate Prophylaxis?
1	Yes	No				Green	Yes
2	No	Yes	No	No		Yellow	No
3	No	No	No	No	Yes	Red	No
4	Yes	Yes				Green	Yes
5	Yes	No				Green	Yes
6	Yes	No				Green	Yes
7	No	No	Yes			Red	Yes
8	No	No	No	No	No	Red	No
9	No	Yes	No	Yes		Yellow	Yes
10	Yes	Yes				Green	Yes
11	Yes	No				Green	Yes
12	Yes	No				Green	Yes
13	No	Yes	Yes			Yellow	Yes
14	No	Yes	No	No		Yellow	No
15	No	Yes	No	Yes		Yellow	Yes

Definitions and Explanations

Categories

Green = on pharmacologic alone or with mechanical

Yellow = on mechanical only

Red = on nothing

Low Risk:

Is the patient low risk?

• Ambulating Independently with 0-1 risk factors.
• Expected LOS <48 hours.
• Minor surgery with NO risk factors.

Pharmacologic Contraindicated

Does patient have any obvious contraindication to pharmacologic prophylaxis?

• Active hemorrhage now or within last 3 days.
• Postoperative bleeding concerns (within 24 hours for most surgeries; within 48 hours of transplant surgery or major trauma).
• Platelet count under 50,000; INR >1.8; known bleeding disorder; Hgb <8.0.
• Concern over CNS bleeding (brain or spinal cord surgery in last week, recent intracranial hemorrhage, proximity in time to epidural insertion or removal, for example).
• Hypertensive urgency/emergency.
• Comfort care only patient.

Mechanical Contraindicated

Does patient have any obvious contraindication to mechanical prophylaxis?

• Documented refusal.
• Peripheral arterial disease/ischemia of the lower extremities.
• Open wounds/ulcerations of both lower extremities.
• Other

Adequate Prophylaxis

A patient has "adequate VTE prophylaxis" if he or she is:

• Green.
• OR Yellow AND Question 1 response is "yes" OR if Question 1 reply is "no" AND Question 2 is "yes".
• OR Red AND Question 1 response is "yes" OR if Question 1 reply is "no" AND BOTH Questions 2 and 3 are "yes".

Description

• This type of report begins with simply recording what prophylaxis the patient is on.
• Yellow (mechanical prophylaxis) and Red (no prophylaxis) patients are rapidly identified for closer scrutiny.
• The algorithm is used to further classify each patient as having adequate versus not adequate prophylaxis.
• The color code remains indicative of the prophylaxis the patient is receiving, whether adequate or inadequate for the patient. Adequate prophylaxis can be quickly calculated by adding up all the adequate prophylaxis categories in the algorithm.
• This particular example depicts a paper version that could be used on a sampling basis—or used on every unit, everyday.
• This kind of measurement lays the foundation for concurrent intervention to address inappropriate prophylaxis in real time (aka measure-vention).

Variations and Other Comments

• This example is based on the classic 3 bucket model of VTE risk.
• The model can be modified to accommodate a wide range of other VTE risk assessment models.
• Variations can address detection of over-prophylaxis as well as under-prophylaxis.
• Automation and bringing in other discrete data elements can make this process more efficient.
• More sophisticated variants are depicted in Appendixes C.3 and C.4.

C.3. Automated/Electronic Stoplight Report of VTE Prophylaxis—UC San Diego

Description

• This is a more sophisticated version of the stoplight report shown in C.2.
• Patient identifiers are captured but not depicted here.
• Service and provider are captured.
• VTE risk level chosen by provider in order set is captured. "No Risk Category" response in this field implies the standardized admission/transfer order set was bypassed, allowing rapid identification and remediation of the situation.
• Anticoagulant (if present), absence/presence of sequential compression devices (SCDs), and several lab contraindications (low platelet count, low hemoglobin, or elevated INR) are all captured and available for the reviewer.
• Color coding is added to enhance ease of use. Green represents the presence of an anticoagulant, yellow represents SCDs, and red represents patients with no VTE prophylaxis. The orange represents patients with a lab contraindication within the last 2 days who are on mechanical prophylaxis only.
• Automation allows monitoring of virtually every inpatient on a daily basis, rather than focusing only on the first hospital day or a relatively small subset of patients captured by sampling techniques.
• Attention can quickly be focused on those who are at highest risk of under-prophylaxis, namely those in the red and yellow categories.

Variations and Other Comments

• In some settings, this kind of report can display real-time reporting; in others, the report can only be generated once or twice per day. Interventions triggered by the report, in that case, would need to be initiated as soon as possible.
• This report captures what is ordered for prophylaxis. Variants or additions to this report could also display what is actually being administered.
• The degree of activity/ambulation can sometimes be captured as discrete data from the Braden decubitus score or other sources.

C.4. Stoplight Report—Banner Good Samaritan Regional Medical Center Example

Courtesy of Lori Porter, D.O.

Description

• In this variant, all the individual unit reports can be rolled up to depict the prophylaxis patterns in place on any given unit and across the entire medical center.
• Blue represents patients on combination mechanical and anticoagulant prophylaxis, while gray represents patients without prophylaxis but with an elevated INR.
• The pie chart for each unit can be converted into a patient roster listing the prophylaxis in place for each, allowing targeting of patients for remediation of under-prophylaxis.

Variations and Other Comments

• This site aggressively addressed adherence to ordered mechanical prophylaxis using these reports.
• More information on strategies used by this very successful site are available in Chapter 5.

C.5. Suggested Method for Tracking Key Metric #2: Incidence of Hospital-Associated VTE

Administrative data are imperfect for tracking outcomes, but coding changes in October 2009 improved administrative coding to reflect acute versus chronic deep vein thrombosis, superficial versus deep vein thrombosis, and other refinements. For most medical centers, this is the most practical method of tracking hospital-associated VTE (HA-VTE).

The term "hospital-associated VTE" is used in favor of the term "hospital-acquired VTE" for two reasons:

• VTE is often due to underlying illnesses or injuries, rather than specific events during the hospital stay.
• VTE associated with hospitalization may not present until after the index admission, often causing a readmission.

This strategy will capture patients who develop VTE during an admission as well as patients who were discharged from an index admission without VTE diagnosis but return to the hospital to be readmitted with a newly diagnosed VTE.

Since October 2007, medical centers must report one of these indicators on diagnostic codes:

• Y = yes (present at the time of inpatient admission).
• W = clinically undetermined (provider is unable to clinically determine if condition was present on admission).
• N = no (not present at the time of inpatient admission).
• U = unknown (documentation insufficient to determine if condition was present on admission).

For most conditions, Y and W codes define hospital-associated conditions, while N and U codes are considered community-acquired conditions. Here, this categorization is refined to capture all VTEs that are associated with hospitalization as follows:

• The denominator is all adult inpatients discharged from the services tracked in a given timeframe, while the numerator will contain all cases with HA-VTE.
• The numerator is patients from the denominator population with a VTE diagnostic code (detailed below) who did not have VTE signs or symptoms on admission (POA indicator N or U)

  PLUS

  Patients readmitted within 30 days for new diagnosis of VTE on readmission with a POA indicator of Yes (Y) or clinically undetermined (W). The word “new” is emphasized to avoid double counting of patients who are readmitted with a VTE that was already detected in the prior index admission. Capturing these patients who are readmitted with newly diagnosed VTE is very important, as a very substantial portion of HA-VTE patients present as readmissions, particularly in the medical population.

The incidence of HA-VTE should generally be reported as the number of patients in the numerator per 1,000 discharged cases in the denominator.

VTE Diagnostic Codes To Include

Improvement teams should at a minimum track lower extremity deep vein thrombosis (DVT) and pulmonary embolism (PE). Also tracking upper extremity DVT is advisable as this is a significant source of morbidity. However, upper extremity events are predominantly catheter related, and the evidence for efficacy of chemical prophylaxis is unconvincing for upper extremity DVT. Thus, hospitals may want to track these separately, as efforts to improve upper extremity DVT might focus on reducing inappropriate central venous catheter use as much as on increasing pharmacologic prophylaxis.

Administrative Coding Data Validation

When feasible, hospitals may want to validate the coding with manual chart reviews on a sampling of patients, excluding cases diagnosed by screening ultrasound.

Potentially Preventable Hospital-Associated VTE

Situations arise in which recommended thromboprophylaxis was not in place prior to VTE diagnosis. This is in contrast to the definition for The Joint Commission Measure VTE-6, which states that an HA-VTE is not preventable if the patient was ever on ANY prophylaxis prior to diagnostic study used to detect VTE. For this measure, VTE prophylaxis consistent with a medical center’s protocol should be in place in the days preceding VTE diagnosis.

ICD-9ⁱ Codes for Lower-Extremity DVT and PE

415.1	PE and infarction
415.11	Iatrogenic PE and infarction
415.13	Saddle embolus of pulmonary artery (effective 10/1/2011)
415.19	Other PE and infarction
451.11	Phlebitis and thrombophlebitis of deep vessels of lower extremities,femoral vein
451.19	Phlebitis and thrombophlebitis of deep vessel of lower extremities, other
451.2	Phlebitis and thrombophlebitis of lower extremities, unspecified*
451.81	Phlebitis and thrombophlebitis of other sites, Iliac vein*
451.9	Phlebitis and thrombophlebitis of unspecified site*
453.2	Other venous embolism and thrombosis of inferior vena cava
453.40	Acute venous embolism and thrombosis of unspecified deep vessels of lower extremity
453.41	Acute venous embolism and thrombosis of deep vessels of proximal lower extremity
453.42	Acute venous embolism and thrombosis of deep vessels of distal lower extremity
453.89	Acute venous embolism and thrombosis of other specified veins*
453.9	Other venous embolism and thrombosis of unspecified site*
997.2	Phlebitis or thrombophlebitis during or resulting from a procedure*
997.3	Respiratory complications*

ⁱ International Classification of Diseases, 9th Revision.

ICD-9 Codes for Upper-Extremity DVT

451.83	Phlebitis and thrombophlebitis of deep veins of upper extremities
451.84	Phlebitis and thrombophlebitis of upper extremities, unspecified*
451.89	Phlebitis and thrombophlebitis of other sites
453.82	Acute venous embolism and thrombosis of deep veins of upper extremity
453.83	Acute venous embolism and thrombosis of upper extremity, unspecified
453.84	Acute venous embolism and thrombosis of axillary veins
453.85	Acute venous embolism and thrombosis of subclavian veins
453.86	Acute venous embolism and thrombosis of internal jugular veins
453.87	Acute venous embolism and thrombosis of other thoracic veins

*Some of these events may represent superficial VTE or, in the case of 997.3, complications other than VTE. Further chart review is desirable for these codes.

Codes for obstetrics-related VTE are included in this appendix. Tracking these events is optional and can be pursued if your medical center has high volumes of obstetric patients.

ICD-9 Codes for Obstetrics VTE

634.60	Spontaneous abortion complicated by embolism, unspecified
634.61	Spontaneous abortion complicated by embolism, incomplete
634.62	Spontaneous abortion complicated by embolism, complete
635.60	Legally induced abortion complicated by embolism, unspecified
635.61	Legally induced abortion complicated by embolism, incomplete
635.62	Legally induced abortion complicated by embolism, complete
637.60	Unspecified abortion complicated by embolism, unspecified
637.61	Unspecified abortion complicated by embolism, incomplete
637.62	Unspecified abortion complicated by embolism, complete
638.6	Failed attempted abortion complicated by embolism
639.6	Complications following abortion and ectopic and molar pregnancies, embolism
671.30	Deep phlebothrombosis, antepartum, unspecified
671.31	Deep phlebothrombosis antepartum, delivered
671.33	Deep phlebothrombosis, antepartum
671.40	Deep phlebothrombosis, postpartum, unspecified
671.42	Deep phlebothrombosis, postpartum, delivered
671.44	Deep phlebothrombosis, postpartum
671.50	Venous complications in pregnancy and the puerperium, Other phlebitis and thrombosis, unspecified
671.51	Venous complications in pregnancy and the puerperium, Other phlebitis and thrombosis, delivered
671.52	Venous complications in pregnancy and the puerperium, Other phlebitis and thrombosis, delivered with mention of postpartum complication
671.53	Venous complications in pregnancy and the puerperium, Other phlebitis and thrombosis, antepartum
671.54	Venous complications in pregnancy and the puerperium, Other phlebitis and thrombosis, postpartum
671.90	Unspecified venous complication of pregnancy and the puerperium, unspecified
671.91	Unspecified venous complication of pregnancy and the puerperium, delivered
671.92	Unspecified venous complication of pregnancy and the puerperium, delivered with mention of postpartum complication
671.93	Unspecified venous complication and the puerperium, antepartum
671.94	Unspecified venous complication and the puerperium, postpartum
673.20	Obstetrical pulmonary embolism, unspecified
673.21	Obstetrical pulmonary embolism, delivered
673.22	Obstetrical pulmonary embolism, delivered with mention of postpartum complication
673.23	Obstetrical pulmonary embolism, antepartum
673.24	Obstetrical pulmonary embolism, postpartum

C.6. Strategy To Monitor for Bleeding Complications With Administrative Codes

• Exclude those <18 years of age, length of stay <2 days.
• Include only diagnoses with a present on admission (POA) indicator of N (No) or U (Undetermined).

AND

• Patients readmitted within 30 days with POA = Y (Yes) (May want to exclude these readmitted patients if looking exclusively at prophylactic anticoagulant adverse drug events [ADEs].)

PLUS

• Patients who were exposed to anticoagulant of interest—unfractionated heparin, low molecular weight heparin (enoxaparin, tinzaparin, dalteparin), warfarin, fondaparinux, rivaroxaban, dabigatran, argatroban, bivalrudin, and lepirudin. Customize the list of anticoagulants and doses as required, based on your formulary, and whether you want to capture ADEs from prophylactic anticoagulation, therapeutic anticoagulant, or both.

ICD-9 Codes Associated With Inpatient Hemorrhage (Principal and Secondary Codes)

430	Subarachnoid hemorrhage
431	Intracerebral Hemorrhage
432.X	Other and unspecified intracranial hemorrhage
459.0	Hemorrhage, unspecified
530.82	Esophageal hemorrhage
568.81	Hemoperitoneum (nontraumatic)
569.3	Hemorrhage of rectum and anus
578.0	Hematemesis
578.1	Blood in stool
578.9	Hemorrhage of gastrointestinal tract, unspecified
599.70	Hematuria, unspecified
599.71	Gross hematuria
784.7	Epistaxis
786.30	Hemoptysis, unspecified
964.2	Poisoning by anticoagulants
E858.2	Accidental poisoning by agents primarily affecting blood constituents
E934.2	Anticoagulants causing adverse effects in therapeutic use

Description

• Adult discharges with ICD-9 codes indicative of significant hemorrhage are limited to those patients who were also exposed to pertinent anticoagulant medications during their stay.
• The same limitations of accuracy of ICD-9 coding seen with HA-VTE apply to this measure.
• Monthly chart review is recommended for those using this strategy.
• Chart review should focus on validating that a hemorrhage occurred and, if so, determining whether the anticoagulant could have conceivably contributed to the hemorrhage. Note that it is difficult to determine if the anticoagulant exposure preceded the diagnosis of hemorrhage by electronic means alone (i.e., without manual review). Finally, if harm did occur in the presence of an anticoagulant, undertake a review to determine if the anticoagulant was being used appropriately—and a search for potentially remedial causes.

Variations and Other Comments

• Bleeding events can be categorized as being associated with therapeutic versus prophylactic doses of anticoagulation.
• Since bleeding events can occur in the absence of anticoagulation, attributing the bleeding event to prophylactic doses of anticoagulation with any accuracy is difficult. However, conducting case review and tracking the overall rate of anticoagulant-related hemorrhage over the course of a VTE prevention effort can be useful.
• Which anticoagulants to include may vary by protocol and the underlying focus of the improvement team.
• Different methods for monitoring bleeding may be complementary.

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