Hospital Harm - Anticoagulant-Related Major Bleeding

The proportion of inpatient hospitalizations for patients age 18 and older who were administered at least one anticoagulant medication within the first 24 hours of admission and had a subsequent bleeding event.
 
Bleeding events must occur during the encounter.

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Medication-related bleeding is a serious health problem in the inpatient setting and has been found to result in increased morbidity and mortality (Nikolsky et al., 2009; Tsai et al., 2009; Spencer et al., 2007; Cannon et al., 2000; Michaels et al., 2010; Abraham et al., 2018). Hemorrhage has been identified as one of the more common medication-related adverse drug events (ADEs) (US Department of Health, 2014; Menzin et al., 2012; Partnership for Patients, 2017; Kanjanarat et al., 2003). Hospitalized patients are at risk of harm from medication-related bleeding due to factors including complex dosing based on weight and renal function, the required frequency of monitoring, and transitions from intravenously administered medications to those taken orally (Cannon et al., 200; Michaels et al., 2010; US Department of Health 2014). 

While many medication classes can increase a patient’s risk of bleeding, anticoagulant and thrombolytic bleeding events in particular are the most common, preventable, and measurable adverse drug events (ADEs) (Michaels et al., 2010; US Department of Health, 2014). Unfractionated heparin and warfarin have been found to be the most commonly implicated medications in anticoagulant-associated adverse drug events (ADEs) (Piazza et al., 2011). However, newer anticoagulants (i.e. direct acting oral anticoagulants (DOACs) such as apixaban and rivaroxaban) are now routinely in use, and risks of adverse bleeding events and other negative outcomes from these newer anticoagulants have been identified (McConeghy et al., 2014; Abraham et al, 2016; Vinogradova et al., 2018). Thrombolytics are also high alert medications that have a narrow therapeutic window, may not be used routinely and are therefore less familiar to staff, and yet must be used rapidly for the patient to benefit (e.g. thrombolysis for acute stroke) leading to time pressure and increased risk of error (Cannon et al., 2000; Fagan, 2005; Paparella, 2004).

Investigators have deemed many anticoagulant- and thrombolytic-associated ADEs to be potentially preventable and prevention of these harms has been prioritized by several patient safety organizations (US Department of Health, 2014; Piazza et al., 2011; US Department of Veterans Affairs, 2015; Hoffman et al., 2015). The National Quality Forum (NQF) endorsed the following patient-safety goal for reducing anticoagulant-associated harms, Safe Practice #29 (Anticoagulation Therapy): “Organizations should implement practices to prevent patient harm due to anticoagulant therapy” (US Department of Health, 2014; Healthcare Facilities Accreditation Program, 2013). Likewise, The Joint Commission has identified the National Patient Safety Goal 03.05.01 to “Reduce the likelihood of patient harm associated with the use of anticoagulant therapy” (US Department of Health, 2014; Healthcare Facilities Accreditation Program, 2013). Other professional organizations such as the Veteran’s Administration and the American Heart Association recommend hospital practices for medication safety including standardized order forms and protocols for anticoagulation and staff education on high-alert medications such as anticoagulants.

Although there are multiple definitions of anticoagulant-related major bleeding, the most widely used was developed by the Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis (ISTH): 

Major Bleeding in Non-Surgical Patients (Schulman & Kearon, 2005):

1. Fatal bleeding, and/or 
2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or
3. Bleeding causing a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.

Major Bleeding in Surgical Patients (Schulman et al., 2010)

1. Fatal bleeding, and/or
2. Bleeding that is symptomatic and occurs in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, pericardial, in a non‐operated joint, or intramuscular with compartment syndrome, assessed in consultation with the surgeon, and/or
3. Extrasurgical site bleeding causing a fall in hemoglobin level of 20 g L−1 (1.24 mmol L−1) or more, or leading to transfusion of two or more units of whole blood or red cells, with temporal association within 24–48 h to the bleeding, and/or
4. Surgical site bleeding that requires a second intervention– open, arthroscopic, endovascular – or a hemarthrosis of sufficient size as to interfere with rehabilitation by delaying mobilization or delayed wound healing, resulting in prolonged hospitalization or a deep wound infection, and/or
5. Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability, as assessed by the surgeon. There should be an associate fall in hemoglobin level of at least 20 g L−1 (1.24 mmol L−1), or transfusion, indicated by the bleeding, of at least two units of whole blood or red cells, with temporal association within 24 h to the bleeding.
6. The period for collection of these data is from start of surgery until five half‐lives after the last dose of the drug with the longest half‐life and with the longest treatment period (in case of unequal active treatment durations).
7. The population is those who have received at least one dose of the study drug.

These definitions were clarified and compared with alternative definitions by Piran and Schulman (2019), and validated by Seto et al. (2012) and Franco et al. (2020). The ISTH definition is similar to the BARC (Bleeding Academic Research Consortium) standardized bleeding definitions for cardiovascular clinical trials (Mehran et al., 2011), except that BARC requires a 30 g/L drop in hemoglobin if the bleeding is nonfatal, not into a critical site, and not requiring surgery.

A lower proportion indicates better quality

Reference Type: CITATION

Reference Text: 'Abraham P, Arroyo DA, Giraud R, et al. Understanding haemorrhagic risk following thrombolytic therapy in patients with intermediate-risk and high-risk pulmonary embolism: a hypothesis paper. Open Heart. 2018;5:e000735.'

Reference Type: CITATION

Reference Text: 'Abraham, NS. Prevention of gastrointestinal bleeding in patients receiving direct oral anticoagulants. American Journal of Gastroenterology Supplements. 2016;32-12.'

Reference Type: CITATION

Reference Text: 'Fagan, SC. 2005. Hold the tPA. 2005. AHRQ PSNet.'

Reference Type: CITATION

Reference Text: 'Healthcare Facilities Accreditation Program. National Quality Forum's 30 safe practices and the HFAP related standards. Chicago, IL.2013.  '

Reference Type: CITATION

Reference Text: 'Hoffman JL, Aneese NJ, Schmidt KJ, et al. Optimizing anticoagulation management through the use of a hospital engagement network metric for inpatient anticoagulant-associated hemorrhage. Ann Pharmacother. 2015;49(12):1305-1310.'

Reference Type: CITATION

Reference Text: 'Kanjanarat P, Winterstein A, Johns T, et al. Nature of preventable adverse drug events in hospitals: a literature review. American Journal of Health-System Pharmacy. 2003;60(17), 1750-1759.'

Reference Type: CITATION

Reference Text: 'McConeghy KW, Bress A, Qato DM, et al. Evaluation of dabigatran bleeding adverse reaction reports in the FDA adverse event reporting system during the first year of approval. Pharmacotherapy. 2014;34(6):561-569.  '

Reference Type: CITATION

Reference Text: 'Menzin J, Hoesche J, Friedman M, et al. Failure to correct International Normalized Ratio and mortality among patients with warfarin-related major bleeding: an analysis of electronic health records. J Thromb Haemost. 2012;10(4):596-605.  '

Reference Type: CITATION

Reference Text: 'Michaels, AD, Spinler, SA, Leeper, B, et al. Medication errors in acute cardiovascular and stroke patients. A scientific statement from the American Heart Association. 2010;121(14), 1664-1682. '

Reference Type: CITATION

Reference Text: 'Nikolsky E, Stone GW, Kirtane AJ, et al. Gastrointestinal bleeding in patients with acute coronary syndromes: incidence, predictors, and clinical implications: analysis from the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial. J Am Coll Cardiol. 2009;54(14):1293-1302.'

Reference Type: CITATION

Reference Text: 'Partnership for Patients; Alaska State Hospital & Nursing Home Association; Washington State Hospital Association. Medication Safety Action Bundle - Adverse Drug Events (ADE). Anticoagulants. 2017.	'

Reference Type: CITATION

Reference Text: 'Piazza G, Nguyen TN, Cios D, et al. Anticoagulation-associated adverse drug events. Am J Med. 2011;124(12):1136-1142.  '

Reference Type: CITATION

Reference Text: 'Tsai TT, Maddox TM, Roe MT, et al. Contraindicated medication use in dialysis patients undergoing percutaneous coronary intervention. JAMA. 2009;302(22):2458-2464'

Reference Type: CITATION

Reference Text: 'Spencer FA, Moscucci M, Granger CB, et al. Does comorbidity account for the excess mortality in patients with major bleeding in acute myocardial infarction? Circulation. 2007;116(24):2793-2801.  '

Reference Type: CITATION

Reference Text: 'U.S. Department of Health and Human Services: Office of Disease Prevention and Health Promotion. National Action Plan for Adverse Drug Event Prevention. Washington, D.C. 2014.'

Reference Type: CITATION

Reference Text: 'US Department of Veterans Affairs. VA National Center for Patient Safety: Anticoagulation Vulnerability. https://www.patientsafety.va.gov/professionals/hazards/anticoag.asp. Published June 2015. Accessed July 13, 2018'

Reference Type: CITATION

Reference Text: 'Vinogradova, Y., Coupland, C., Hill T. et al., Risks and benefits of direction oral anticoagulants versus warfarin in a real world setting: cohort study in primary care. BMS. 2018;362:k2505.'

Reference Type: CITATION

Reference Text: 'Schulman, S., Kearon, C., & Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis (2005). Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. Journal of thrombosis and haemostasis : JTH, 3(4), 692–694. https://doi.org/10.1111/j.1538-7836.2005.01204.x'

Reference Type: CITATION

Reference Text: 'Schulman, S., Angerås, U., Bergqvist, D., Eriksson, B., Lassen, M. R., Fisher, W., & Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis (2010). Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. Journal of thrombosis and haemostasis : JTH, 8(1), 202–204. https://doi.org/10.1111/j.1538-7836.2009.03678.x'

Reference Type: CITATION

Reference Text: 'Seto AC, Kenyon K, Wittkowsky AK. Discrepancies in identification of major bleeding events in patients taking warfarin. Pharmacotherapy. 2008;28(9):1098–103.'

Reference Type: CITATION

Reference Text: 'Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. 2011; 123:2736–2747.'

Reference Type: CITATION

Reference Text: 'Piran, S., & Schulman, S. (2019). Treatment of bleeding complications in patients on anticoagulant therapy. Blood, The Journal of the American Society of Hematology, 133(5), 425-435.'

Reference Type: CITATION

Reference Text: 'Franco L, Becattini C, Beyer-Westendorf J. et al. Definition of major bleeding: prognostic classification. J Thromb Haemost 2020; 18 (11) 2852-2860.'

Inpatient hospitalizations: Includes time in the emergency department and observation when the transition between these encounters (if they exist) and the inpatient encounter are within an hour or less of each other. 

Present on admission (POA) is defined as the conditions present at the time the order for inpatient admission occurs. The POA Indicator is intended to differentiate conditions present at the time of admission from those conditions that develop during the inpatient admission. 

A POA Indicator of Y = yes (Diagnosis was present at time of inpatient admission).
A POA Indicator of N = no (Diagnosis was not present at time of inpatient admission.)
A POA Indicator of W = clinically undetermined
A POA Indicator of U = documentation insufficient to determine if the condition was present at the time of inpatient admission

Per CMS and the Agency for Healthcare Research and Quality (AHRQ) convention, POA indicators of Y and W are accepted indicators of a diagnosis present on admission. POA indicators of N and U are accepted indicators of a diagnosis that is not present on admission.

The measure uses g/dL as the unit of measurement for hemoglobin results.

To calculate the hospital-level measure result, divide the total numerator encounter events by the total number of eligible inpatient hospitalizations (denominator). 

This eCQM is an episode-based measure. An episode is defined as each inpatient hospitalization or encounter that ends during the measurement period.

This version of the eCQM uses QDM version 5.6. Please refer to the eCQI resource center (https://ecqi.healthit.gov/qdm) for more information on the QDM.

TBD

Inpatient hospitalizations for patients age 18 and older with a length of stay of 48 hours or longer, without a diagnosis of obstetrics, and at least one anticoagulant medication was administered within the first 24 hours of the hospitalization.

Equals Initial Population

Inpatient hospitalizations for:

     - Patients who had a critical or non-critical site bleeding diagnosis present on admission

     - Patients who received dialysis during the hospitalization

     - Patients who had a diagnosis of a coagulation disorder during the encounter

     - Patients who had extracorporeal membrane oxygenation (ECMO) during the hospitalization

Inpatient hospitalizations that include bleeding events during the encounter following an anticoagulation medication administration during the same encounter. 

A bleeding event is defined as the presence of one of the following: 

Criterion A: A diagnosis of acute bleeding at/into a critical anatomic site, with the bleeding diagnosis not present on admission, i.e., a bleeding diagnosis Present on Admission indicator = N (Diagnosis was not present at time of inpatient admission) or U (Documentation insufficient to determine if the condition was present at the time of inpatient admission) 

OR

Criterion B: One evidence factor of a bleeding event and a diagnosis of acute bleeding at/into a non-critical anatomic site, with the bleeding diagnosis not present on admission, i.e., a bleeding diagnosis Present on Admission indicator = N (Diagnosis was not present at time of inpatient admission) or U (Documentation insufficient to determine if the condition was present at the time of inpatient admission)  

Evidence of Criterion B bleeding event is determined by EITHER:
- An absolute decrease in hemoglobin results of 2 g/dL within a 48-hour period,  excluding the first 24 hours of arrival,  and within 5 days of the anticoagulation administration. An absolute decrease is determined when a confirmatory decrease is identified using the highest hemoglobin within 24 hours of the initial hemoglobin drop

   OR

-Transfusion of whole or red blood cells, excluding the first 48 hours of arrival in the hospital (including the emergency department and observation) and within 5 days of the anticoagulation administration

Not Applicable

None

For every patient evaluated by this measure also identify payer, race, ethnicity and sex