[Federal Register Volume 85, Number 224 (Thursday, November 19, 2020)]
[Notices]
[Pages 73716-73718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25574]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-21AT; Docket No. CDC-2020-0114]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Evaluation of Venous 
Thromboembolism Prevention Practices in U.S. Hospitals. This proposed 
study is designed to support a framework for improving hospital venous 
thromboembolism (VTE) prevention practices through the evaluation of 
current VTE prevention practices in U.S. adult general medical and 
surgical hospitals.

DATES: CDC must receive written comments on or before January 19, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0114 by any of the following methods:
    [ballot] Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
    [ballot] Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7118; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information,

[[Page 73717]]

including the validity of the methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Evaluation of Venous Thromboembolism Prevention Practices in U.S. 
Hospitals--New--National Center on Birth Defects and Developmental 
Disabilities (NCBDDD), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    Venous thromboembolism (VTE), which includes deep vein thrombosis 
(DVT) and pulmonary embolism (PE), is an important and growing public 
health problem. Each year in the U.S., it is estimated that VTE affects 
as many as 900,000 people, is responsible for up to 100,000 deaths, and 
is associated with healthcare costs of approximately $10 billion. 
Recurrence after a VTE is common, and complications include post-
thrombotic syndrome and chronic thromboembolic pulmonary hypertension. 
Over half of VTE events are associated with recent hospitalization or 
surgery and most occur after discharge. An analysis of the National 
Hospital Discharge Survey from 2007 to 2009 estimated that almost 
550,000 U.S. adult hospitalizations had a discharge diagnosis of VTE 
each year. Hospital-associated VTE (HA-VTE) is often preventable but 
VTE prevention strategies are not applied uniformly or systematically 
across U.S. hospitals and healthcare systems.
    The Agency for Healthcare Research and Quality (AHRQ) published a 
guide for preventing HA-VTE in 2016. The framework for improving VTE 
prevention in hospitalized patients includes a hospital VTE prevention 
policy, an interdisciplinary VTE team, standardization of VTE 
prevention processes, monitoring of processes and outcomes, and VTE 
prevention education for providers and patients. A VTE prevention 
protocol includes VTE risk assessment, bleeding risk assessment (risk 
of bleeding with anticoagulant prophylaxis) and clinical decision 
support for appropriate prophylaxis (i.e., ambulation, anticoagulant 
prophylaxis, and/or mechanical prophylaxis) based on both VTE and 
bleeding risk assessments.
    Despite evidence-based guidelines for VTE prophylaxis in at-risk 
hospitalized patients, there is systemic underuse of appropriate VTE 
prophylaxis. As many as 70% of HA-VTE events are potentially 
preventable but less than half of hospitalized patients receive 
appropriate VTE prophylaxis. An implementation gap exists between 
evidence-based guidelines for VTE prophylaxis in hospitalized adult 
patients and implementation of those guidelines in real-world hospital 
settings. The 2008 Surgeon General's Call to Action to Prevent DVT and 
PE included instituting formal systems related to risk assessment and 
the provision of prophylaxis to high-risk hospitalized patients. For 
World Thrombosis Day in 2016, the International Society on Thrombosis 
and Haemostasis (ISTH) issued a call to clinical leaders, hospitals, 
and payers to work together to make VTE risk assessment for all 
hospitalized patients a priority.
    In England, The National Venous Thromboembolism Prevention 
Programme was launched in 2010 with the goal of reducing preventable 
HA-VTE morbidity and mortality (Roberts, 2017). VTE risk assessment was 
mandated for all adult patients on admission to an acute hospital 
utilizing a previously developed national VTE risk assessment tool/
model. Hospitals were required to report VTE risk assessment rates, 
with a financial incentive applied to achieve a target of 90%. This 
resulted in an impressive, sustained increase in VTE risk assessment 
rates with a corresponding increase in anticoagulant prophylaxis. There 
was evidence of significant reductions in HA-VTE and associated 
mortality following implementation of this program.
    Unlike England, the U.S. has no national VTE prevention program 
with hospital risk assessment rates tied to financial incentives and no 
national VTE risk assessment tool/model. Various VTE risk assessment 
models (RAMs) have been developed and published to identify 
hospitalized patients whose risk for VTE is high enough to offset the 
risk of bleeding with anticoagulant prophylaxis. However, there is no 
standardized RAM currently in use across U.S. hospitals and healthcare 
systems. Implementation of risk assessment varies in terms of the 
patient population (e.g., medical vs. surgical), time frames (e.g., on 
admission, on transfer to another unit), method of administration 
(i.e., electronic vs. paper), person/s performing the risk assessment 
(e.g., physician, nurse, pharmacist), type of RAM (e.g., quantitative 
vs. qualitative), and linkage to a clinical decision support tool for 
appropriate VTE prophylaxis.
    An evaluation of the extent to which U.S. hospitals utilize VTE 
risk assessment is needed to better understand the landscape around VTE 
prevention practices in real-world hospital settings in order to guide 
efforts and inform interventions to reduce the burden of HA-VTE. CDC is 
funding The Joint Commission to evaluate VTE prevention practices in 
U.S. hospitals. The Joint Commission has had a role in patient safety 
through standards and performance measurement. It is the measure 
steward for two electronic clinical quality measures (eCQMs) on VTE 
prevention available for Center for Medicare and Medicaid Services 
Inpatient Quality Reporting and Joint Commission hospital accreditation 
since 2016. However, these two VTE prevention eCQMs only address the 
initiation of VTE prophylaxis within a specified timeframe; they do not 
assess the patient's level of VTE risk or the appropriateness of 
prophylaxis.
    For this project, The Joint Commission, in collaboration with CDC, 
developed a survey on hospital VTE prevention practices. The survey was 
piloted in nine hospitals and their feedback was used to improve the 
survey. After OMB approval, the survey will be implemented by The Joint 
Commission as a one-time data collection in a nationally representative 
sample of U.S. adult general medical and surgical hospitals. No 
individual-level data will be collected. CDC will not receive any 
individual or hospital identifiable information.
    The overall purpose of this project is to evaluate current VTE 
prevention practices in a nationally representative sample of U.S. 
hospitals (American Hospital Association adult general medical and 
surgical hospital service category) in order to support a framework for 
HA-VTE prevention. The information collected in this hospital survey 
will be used to improve understanding of hospital VTE prevention 
practices, which will guide efforts and inform interventions to reduce 
the burden of HA-VTE. Specifically, the information collected on 
hospital VTE prevention policy and protocol, VTE prevention team, VTE 
data collection and reporting, VTE risk assessment, VTE prophylaxis 
safety considerations (i.e., bleeding risk assessment), ambulation 
protocol, VTE prevention education for providers and

[[Page 73718]]

patients, and VTE prophylaxis monitoring and support will be used to 
assess the extent to which hospitals apply these components of the 
framework for HA-VTE prevention. The responses to specific VTE 
prevention practices can be used to assess VTE prevention practices by 
hospital characteristics (e.g., bed size, urban vs. rural location, 
teaching vs. non-teaching status) to better target efforts or 
interventions to improve HA-VTE prevention. Information collected on 
the barriers to establishing a hospital-wide VTE prevention policy will 
be helpful in addressing these challenges. Information will be 
collected on both adult general medical and surgical units since VTE 
prevention practices differ by specialty. Information on VTE risk 
assessment (e.g., who conducts the assessment, when is it performed, 
mandatory or optional, format, type of RAM) will improve understanding 
of real-world hospital VTE risk assessment practices. Information on 
the capacity of hospitals to collect data on VTE risk assessment will 
be helpful in determining the feasibility of VTE risk assessment as a 
VTE prevention performance measure. The data collected can also serve 
as a baseline for evaluation of future HA-VTE prevention initiatives.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of        Number        burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response (in        hours
                                                                    respondent        hours)
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The Director of Patient Safety  Recruitment                  384               1           15/60              96
 and Quality, the Chairperson    material:
 of the Patient Safety           Implementation
 Committee, other quality        email and
 improvement professional.       project
                                 information
                                 sheet.
The Director of Patient Safety  Evaluation of                384               1               1             384
 and Quality, the Chairperson    Venous
 of the Patient Safety           Thromboembolism
 Committee, other quality        Prevention
 improvement professional.       Practices in
                                 U.S. Hospitals
                                 Questionnaire.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             480
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-25574 Filed 11-18-20; 8:45 am]
BILLING CODE 4163-18-P