[Federal Register Volume 80, Number 183 (Tuesday, September 22, 2015)]
[Notices]
[Pages 57187-57189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23990]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Announcement of Requirements and Registration for Healthcare
Associated Venous Thromboembolism Prevention Challenge
Authority: 15 U.S.C. 3719
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
Award Approving Official: Thomas R. Frieden, MD, MPH, Director,
Centers for Disease Control and Prevention, and Administrator, Agency
for Toxic Substances and Disease Registry.
ACTION: Notice.
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SUMMARY: The Centers for Disease Control and Prevention (CDC) located
within the Department of Health and Human Services (HHS) announces the
launch of the Healthcare Associated Venous Thromboembolism (HA-VTE)
Prevention Challenge on November 2, 2015. The challenge will be open
until January 10, 2016.
Venous thromboembolism (VTE), blood clots occurring as deep vein
thrombosis (DVT), pulmonary embolism (PE), or both, is an important and
growing public health issue. Prevention of healthcare associated VTE
(HA-VTE) is a national hospital safety priority. Many HA-VTEs can be
prevented, but VTE prevention strategies and are still not being
applied regularly or effectively across the United States.
To support and promote HA-VTE prevention, HHS/CDC is announcing the
2015 HA-VTE Prevention Challenge. The challenge will bring prestige to
organizations that invest in VTE prevention, improve understanding of
successful implementation strategies at the health system level, and
motivate health systems to strengthen their VTE prevention efforts. The
top-judged organizations found to have implemented innovative and
effective VTE prevention strategies will be recognized as HA-VTE
Prevention Champions. HHS/CDC will document these successful strategies
and highlight the systems, processes, and staffing that contributed to
exceptional VTE prevention outcomes achieved by Champions. Champions
will receive a cash prize (if eligible) and other forms of recognition.
DATES: Contest begins on November 2, 2015 and ends on January 10, 2016.
FOR FURTHER INFORMATION CONTACT: Michele Beckman, Division of Blood
Disorders, National Center on Birth Defects and Developmental
Disabilities, Centers for Disease Control and Prevention, 1600 Clifton
Road NE., Mailstop E-64, Atlanta, GA 30329, Telephone: 404-498-6474,
Fax: 404-498-6799, Attention: HA-VTE Prevention Challenge, Email:
[email protected].
SUPPLEMENTARY INFORMATION: The challenge is authorized by Public Law
111-358, the America Creating Opportunities to Meaningfully Promote
Excellence in Technology, Education and Science Reauthorization Act of
2010 (COMPETES Act).
Subject of Challenge Competition
Entrants of the HA-VTE Prevention Challenge will be asked to
describe the VTE prevention strategy and reasons that support the
strategy choice developed by their organization. In addition, entrants
will be asked to describe the specific intervention(s) (e.g.
implementation of VTE protocols and order sets, risk assessment,
electronic alerts, clinical decision support tools, performance
monitoring systems and dashboards, patient and/or provider education
and awareness, post-discharge follow-up, etc.), methods, and systems
used to implement, support and evaluate the strategy. Entrants will be
asked to submit at least one quantitative measure showing an increase
of VTE prevention (e.g. number of patients assessed for VTE risk,
number of at risk patients receiving appropriate VTE prevention, number
of patients and/or providers receiving education on VTE prevention,
etc.) and/or decrease in HA-VTE rates for the organization's population
of interest. Each measure submitted must include two data points: One
for the control or pre-intervention period and a second for the post-
intervention period. Control/pre-intervention and post-intervention
measures must cover a period of at least six months. This information
collection is approved by the Office of Management and Budget under OMB
Control Number 0990-0390, expiration April 30, 2018.
Eligibility Rules for Participating in the Competition
To be eligible to win a monetary prize under this challenge, an
individual or entity--
(1) Shall have completed and submitted the nomination form in its
entirety to participate in the competition under the rules promulgated
by HHS/CDC;
(2) Must be a hospital, multi-hospital system, hospital network or
managed care organization, incorporated in and maintaining a primary
place of business in the United States that provides inpatient medical
care for patients.
(3) May not be a Federal entity or Federal employee acting within
the scope of their employment (Federal entities or employees are
eligible to participate in the challenge; however, they are not
eligible to receive a monetary prize. Federal entities are eligible for
non-monetary recognition only.);
(4) Shall not be an HHS employee working on their applications or
submissions during assigned duty hours;
(5) Shall not be an employee or contractor at HHS/CDC;
(6) Federal grantees may not use Federal funds to develop COMPETES
Act challenge applications unless consistent with the purpose of their
grant award.
(7) Federal contractors may not use Federal funds from a contract
to develop COMPETES Act challenge applications or to fund efforts in
support of a COMPETES Act challenge submission;
(8) Must agree to participate in a data validation process to be
conducted by an HHS/CDC-selected contractor. To the extent applicable
law allows, data will be kept confidential by the contractor and will
be shared with the CDC in aggregate form only; i.e., the VTE prevention
coverage rate for the practice not individual data;
(9) Must have a data management system (electronic or paper) that
allows HHS/CDC or their contractor to check data submitted;
(10) Individual nominees and individuals in a group practice must
be free from convictions or pending investigations of criminal and
health care fraud offenses such as felony health care fraud, patient
abuse or neglect; felony convictions for other healthcare-related
fraud, theft, or other financial misconduct; and felony convictions
relating to unlawful manufacture, distribution, prescription, or
dispensing of controlled substances as verified through the Office of
the Inspector General List of Excluded Individuals
[[Page 57188]]
and Entities. http://oig.hhs.gov/exclusions/background.asp
Individual nominees must be free from serious sanctions, such as
those for misuse or mis-prescribing of prescription medications. Such
serious sanctions will be determined at the discretion of the agency
consistent with CDC's public health mission. HHS/CDC's contractor may
perform background checks on individual clinicians or medical
practices.
(11) Health systems must have a written policy in place that
conducts periodic background checks as described in (10) on all
providers and takes appropriate action accordingly. In addition, a
health system background check may be conducted, as deemed necessary,
by HHS/CDC or an HHS/CDC contractor that includes a search for The
Joint Commission sanctions and current investigations for serious
institutional misconduct (e.g., attorney general investigation). HHS/
CDC's contractor may also request the policy and any supporting
information deemed necessary.
(12) Must agree to accept the monetary prize and be recognized if
selected, and agree to participate in an interview to develop a success
story that describes the systems and processes that support VTE
prevention. Champions will be recognized on HHS/CDC Web sites.
Strategies used by Champions that support VTE prevention may be written
into a success story, placed on HHS/CDC Web sites, and attributed to
Champions.
An individual or entity shall not be deemed ineligible because the
individual or entity used Federal facilities or consulted with Federal
employees during a competition if the facilities and employees are made
available to all individuals and entities participating in the
competition on an equal basis.
By participating in this challenge, an individual or organization
agrees to assume any and all risks related to participating in the
challenge. Individuals or organizations also agree to waive claims
against the Federal Government and its related entities, except in the
case of willful misconduct, when participating in the challenge,
including claims for injury; death; damage; or loss of property, money,
or profits, and including those risks caused by negligence or other
causes.
By participating in this challenge, individuals or organizations
agree to protect the Federal Government against third party claims for
damages arising from or related to challenge activities.
Entrants who are a U.S. federal hospital, multi-hospital system,
hospital network or managed care organization that provides inpatient
medical care for patients may apply for non-monetary recognition. No
monetary prize will be awarded.
Entrants who are an international hospital, multi-hospital system,
hospital network or managed care organization that provides inpatient
medical care for patients may apply for non-monetary recognition. No
monetary prize will be awarded.
Registration Process for Participants
To participate, interested parties will navigate to
www.challenge.gov. On this site, nominees will have access to the
nomination form. Information required of the nominees on the nomination
form includes:
The organization name, address, and contact information of
the nominee.
The size, scope, and general demographic characteristics
of the nominees' patient population.
Details regarding the nominee's VTE prevention strategy
and implementation including the population(s) observed, intervention,
and methods of implementation. Examples of strategies include
implementation of sustainable systems or processes that support VTE
prevention. These may include but are not limited to implementation of
VTE protocols and order sets, risk assessment, electronic alerts,
clinical decision support tools, performance monitoring systems and
dashboards, patient and/or provider education and post-discharge
follow-up.
A description of the observed results of the VTE
prevention strategy including the pre-implementation and post-
implementation measures for the observed VTE prevention activity.
Examples of outcome measures include but are not limited to the number
of patients assessed for VTE risk, the number of at risk patients
receiving appropriate VTE prevention, and the number of patients and/or
providers receiving education on VTE prevention.
A brief summary of the barriers and successes to
implementation.
The VTE prevention rates achieved should be for the organizations
entire patient population observed as outlined in their strategy and
intervention methods, not limited to a sample. Data on subpopulations
is allowed, but must be inclusive of all patients seen during the
stated time period of study. Examples of ineligible data submissions
include VTE prevention interventions limited to treatment cohorts from
clinical trials of novel anticoagulant drugs.
The estimated burden for completing the nomination form is 30
minutes to 1 hour.
Amount of the Monetary Prize
An estimated 7 of highest scoring U.S. hospitals, multi-hospital
systems, hospital networks and managed care organizations will be
recognized as HA-VTE Prevention Champions and will receive a cash award
of $10,000. A maximum of $70,000 will be awarded in this challenge.
Additional honorable mention awards, pending availability of funds, may
be made if the judges identify more than 7 deserving entries. Federal
and international winners will receive non-monetary recognition but no
prize.
Payment of the Monetary Prize
Monetary prizes awarded under this challenge will be paid by
electronic funds transfer and may be subject to Federal income taxes.
HHS will comply with the Internal Revenue Service withholding and
reporting requirements, where applicable.
Basis Upon Which Winner Will Be Selected
Challenge submissions will be evaluated by a panel of three to five
judges (CDC, HHS agencies such as the Agency for Healthcare Research
and Quality and the Centers for Medicare and Medicaid Services, and
external industry experts) using the information provided on, and in
accordance with, the nomination form. The judges will score the
nomination form using a rubric based on the following evaluation
criteria: methods (30% of score); results (50% of score); and
feasibility/utility (20% of score) of the strategy and interventions
associated with the intended outcome of interest. Nominees with the
highest score will be required to participate in a process to verify
their data. Final selection will take into account all the information
form the nomination form, the background check, and data verification.
Geographic location and population treated may be used to break any
ties in the event of tie scores at any point in the selection process.
An estimated 7 organizations will be recognized as prize winners.
Some Champions will participate in a post-challenge telephone
interview. The interview will include questions about the strategies
employed by the organization to achieve high rates of VTE prevention,
including barriers and facilitators for those strategies. The interview
will focus on systems and processes and should not require preparation
time by the Champion. The estimated time for the interview is one
[[Page 57189]]
hour, which includes time to review the interview protocol with the
interviewer, respond to the interview questions, and review a summary
report about the Champion's practices. The summary will be written as a
success story and will be posted on the CDC Web site.
Additional Information
Information received from nominees will be stored in a password
protected file on a secure server. The challenge Web site may post the
number of nominations received but will not include information about
individual nominees. The database of information submitted by nominees
will not be posted on the Web site. Personal information collected and
stored from nominees will only include general details, such as the
organization name, address, and contact information of the nominee.
This type of information is generally publically available. The
nomination form and submission will collect and store only aggregate
clinical data through the nomination process; no individual
identifiable patient data will be collected or stored. Confidential or
propriety data, clearly marked as such, will be secured to the full
extent allowable by law.
Information for selected Champions, such as the hospital or health
system's name, location, VTE prevention outcomes, and practices that
support HA-VTE prevention will be shared through press releases, the
challenge Web site, social media, and other HHS/CDC resources. Summary
data on the types of systems and processes used to increase VTE
prevention will be shared in documents or other communication products
that describe generally used practices for successful VTE prevention.
HHS/CDC will use the summary data only as described.
Compliance With Rules and Contacting Contest Winners
Finalists must comply with all terms and conditions of these
official rules, and winning is contingent upon fulfilling all
requirements herein. The finalists will be notified by email,
telephone, or mail after the date of judging.
Privacy
Personal information provided by entrants on the nomination form
through the challenge Web site will be used to contact selected
finalists. Information is not collected for commercial marketing.
Winners are permitted to cite that they won this challenge.
The names, cities, and states of selected Champions will be made
available in HHS/CDC's educational materials on VTE prevention and at
recognition events.
General Conditions
HHS/CDC reserves the right to cancel suspend, and/or modify the
challenge, or any part of it, for any reason, as HHS/CDC's sole
discretion.
Dated: September 15, 2015.
Sandra Cashman,
Acting Director, Division of the Executive Secretariat, Office of the
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2015-23990 Filed 9-21-15; 8:45 am]
BILLING CODE 4163-18-P