[Federal Register Volume 89, Number 132 (Wednesday, July 10, 2024)]
[Notices]
[Pages 56815-56818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15110]
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DEPARTMENT OF VETERANS AFFAIRS
Notice of Request for Information on the Department of Veterans
Affairs
Clinical Perfusionists Standard of Practice
AGENCY: Department of Veterans Affairs.
ACTION: Request for information.
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SUMMARY: The Department of Veterans Affairs (VA) is requesting
information to assist in developing a national standard of practice for
VA Clinical Perfusionists. VA seeks comments on various topics to help
inform VA's development of this national standard of practice.
DATES: Comments must be received on or before September 9, 2024.
ADDRESSES: Comments must be submitted through http://www.regulations.gov. Except as provided below, comments received before
the close of the comment period will be available at http://www.regulations.gov for public viewing, inspection, copying, including
any personally identifiable or confidential business information that
is included in a comment. We post the comments received before the
close of the comment period on the following website as soon as
possible after they have been received: http://www.regulations.gov. VA
will not post on http://www.regulations.gov public comments that make
threats to individuals or institutions or suggest that the commenter
will take actions to harm the individual. VA encourages individuals not
to submit duplicative comments. We will post acceptable comments from
multiple unique commenters even if the content is identical or nearly
identical to other comments. Any public comment received after the
comment period's closing date will not be accepted.
FOR FURTHER INFORMATION CONTACT: Ethan Kalett, Office of Governance,
Regulations, Appeals and Policy (10B-GRAP), Veterans Health
Administration, Department of Veterans Affairs, 810 Vermont Avenue NW,
Washington, DC 20420, 202-461-0500. This is not a toll-free number.
SUPPLEMENTARY INFORMATION:
Authority
Chapters 73 and 74 of 38 U.S.C. and 38 U.S.C. 303 authorize the
Secretary to regulate VA health care professions to make certain that
VA's health care system provides safe and effective health care by
qualified health care professionals to ensure the well-being of those
veterans who have borne the battle.
On November 12, 2020, VA published an interim final rule confirming
that VA health care professionals may practice their health care
profession consistent with the scope and requirements of their VA
employment, notwithstanding any state license, registration,
certification, or other state requirements that unduly interfere with
their practice (38 CFR 17.419; 85 FR 71838). Specifically, this
rulemaking confirmed VA's current practice of allowing VA health care
professionals to deliver health care services in a state other than the
health care professional's state of licensure, registration,
certification, or other state requirement, thereby enhancing
beneficiaries' access to critical VA health care services. The
rulemaking also confirmed VA's authority to establish national
standards of practice for its health care professionals which would
standardize a health care professional's practice in all VA medical
facilities, regardless of conflicting state laws, rules, regulations,
or other state requirements.
The rulemaking explained that a national standard of practice
describes the tasks and duties that a VA health care professional
practicing in the health care profession may perform and may be
permitted to undertake. Having a national standard of practice means
that individuals from the same VA health care profession may provide
the same type of tasks and duties regardless of the state where they
are located or the state license, registration, certification, or other
state requirement they hold. We emphasized in the rulemaking and
reiterate here that VA will determine, on an individual basis, that a
health care professional has the proper education, training, and skills
to perform the tasks and duties detailed in the national standard of
practice, and that they will only be able to perform such tasks and
duties after they have been incorporated into the individual's
privileges, scope of practice, or functional statement. The rulemaking
explicitly did not create any such national standards and directed that
all national standards of practice would be subsequently created via
policy.
Preemption of State Requirements
The national standard of practice will preempt any state laws,
rules, regulations, or requirements that both are and are not listed in
the national standard as conflicting, but that do in fact conflict with
the tasks and duties as authorized in VA's national standard of
practice. In the event that a state changes their requirements and
places new limitations on the tasks and duties it allows in a manner
that would be inconsistent with what is authorized under the national
standard of practice, the national standard of practice will preempt
such limitations and authorize the VA health care professional to
continue to practice consistent with the tasks and duties outlined in
the national standard of practice.
In cases where a VA health care professional's license,
registration, certification, or other state requirement allows a
practice that is not included in a national standard of practice, the
individual may continue that practice so long as it is permissible by
Federal law and VA policy, is not explicitly prohibited by the national
standard of practice and is approved by the VA medical facility.
[[Page 56816]]
Need for National Standards of Practice
It is critical that VA, the Nation's largest integrated health care
system, develops national standards of practice to ensure, first, that
beneficiaries receive the same high-quality care regardless of where
they enter the system and, second, that VA health care professionals
can efficiently meet the needs of beneficiaries when practicing within
the scope of their VA employment. National standards are designed to
increase beneficiaries' access to safe and effective health care,
thereby improving health outcomes. The importance of this initiative
has been underscored by the coronavirus disease 2019 (COVID-19)
pandemic. The increased need for mobility in VA's workforce, including
through VA's Disaster Emergency Medical Personnel System, highlighted
the importance of creating uniform national standards of practice to
better support VA health care professionals who practice across state
lines. Creating national standards of practice also promotes
interoperability of medical data between VA and the Department of
Defense (DoD), providing a complete picture of a Veteran's health
information and improving VA's delivery of health care to the Nation's
Veterans. DoD has historically standardized practice for certain health
care professionals, and VA has closely partnered with DoD to learn from
their experience.
Process to Develop National Standards of Practice
As authorized by 38 CFR 17.419, VA is developing national standards
of practice via policy. There is one overarching directive to describe
the Veterans Health Administration (VHA) policy on national standard of
practice. The directive is accessible on the VHA Publications website
at https://vaww.va.gov/vhapublications/ (internal) and https://www.va.gov/vhapublications/ (external). As each individual national
standard of practice is finalized, it is published as an appendix to
the directive and accessible at the same websites.
To develop these national standards, VA is using a robust,
interactive process that adheres to the requirements of Executive Order
(E.O.) 13132 to preempt conflicting state laws, rules, regulations, or
other requirements. The process includes consultation with internal and
external stakeholders, including state licensing boards, VA employees,
professional associations, Veterans Service Organizations, labor
partners, and others. For each VA occupation, a workgroup comprised of
VA health care professionals in the identified occupation conducts
research to identify internal best practices that may not be authorized
under every state license, certification, or registration, but would
enhance the practice and efficiency of the profession throughout VA. If
a best practice is identified that is not currently authorized by every
state, the workgroup determines what education, training, and skills
are required to perform such tasks and duties. The workgroup then
drafts a proposed VA national standard of practice using the data
gathered during the research and incorporates internal stakeholder
feedback into the standard. The workgroup may consult with internal or
external stakeholders at any point throughout the process.
The proposed national standard of practice is then internally
reviewed, to include by an interdisciplinary VA workgroup consisting of
representatives from Quality Management, VA medical facility Chief of
Staff, Academic Affiliates, Veterans Integrated Services Network (VISN)
Chief Nursing Officer, Ethics, Workforce Management and Consulting,
Surgery, Credentialing and Privileging, VISN Chief Medical Officer, and
Electronic Health Record Modernization.
Externally, VA hosts listening sessions for members of the public,
professional associations, and VA employees to provide comments on the
variance between state practice acts for specific occupations and what
should be included in the national standard of practice for that
occupation. The listening session for Clinical Perfusionists was held
on August 31, 2023. No professional associations presented comments on
the Clinical Perfusionist scope of practice.
VA has developed a robust process to engage with partners, members
of the public, states, and employees on the proposed national standard
of practice. VA provides the proposed national standard of practice to
our DoD partners as an opportunity to flag inconsistencies with DoD
standards. VA also engages with labor partners informally as part of a
pre-decisional collaboration. Consistent with E.O. 13132, VA sends a
letter to each state board and certifying organization or registration
organization, as appropriate, which includes the proposed national
standard and offers the recipient an opportunity to discuss the
national standard with VA. After the state boards, certifying
organizations, or registration organizations have received
notification, the proposed national standard of practice is posted in
the Federal Register for 60 days to obtain feedback from the public,
professional associations, and any other interested parties. At the
same time, the proposed national standard is posted to an internal VA
site to obtain feedback from VA employees. Responses received through
all vehicles--from state boards, professional associations, unions, VA
employees, and any other individual or organization who provides
comments via the Federal Register--will be reviewed. VA will make
appropriate revisions in light of the comments, including those that
present evidence-based practice and alternatives that help VA meet our
mission and goals. VA will publish a collective response to all
comments at https://www.va.gov/standardsofpractice/.
After the national standard of practice is finalized, approved, and
published in VHA policy, VA will implement the tasks and duties
authorized by that national standard of practice. Any tasks or duties
included in the national standard will be properly incorporated into an
individual health care professional's privileges, scope of practice, or
functional statement once it has been determined by their VA medical
facility that the individual has the proper education, training, and
skills to perform the task or duty. Implementation of the national
standard of practice may be phased in across all VA medical facilities,
with limited exemptions for health care professionals as needed.
Format for National Standard for Clinical Perfusionists
The proposed format for national standards of practice when there
is a national certification body and there are state licenses is as
follows. The first paragraph provides general information about the
profession and what the health care professionals can do. For this
national standard, Clinical Perfusionists are medical professionals
qualified by academic education, clinical education, and professional
credentialing to provide extracorporeal patient care services. We
reiterate that the proposed standard of practice does not contain an
exhaustive list of every task and duty that each VA health care
professional can perform. Rather, it is designed to highlight generally
what tasks and duties the health care professionals perform and how
they will be able to practice within VA notwithstanding their state
license, certification, registration, or other state requirements.
The second paragraph references the education and certification
needed to practice this profession at VA. Qualification standards for
employment
[[Page 56817]]
of health care professionals by VA are outlined in VA Handbook 5005,
Staffing, dated June 21, 2024. VA follows the requirements outlined in
the VA qualification standards even if the requirements conflict with
or differ from a state requirement. National standards of practice do
not affect those requirements. This includes, but is not limited to,
when a state requires a license to practice a specific occupation, but
VA does not require a state license as part of the qualification
standards. For Clinical Perfusionists, VA qualification standards
require an active, current, full, and unrestricted certification from
the American Board of Cardiovascular Perfusion (ABCP).
The second paragraph also notes whether the national standard of
practice explicitly excludes individuals who practice under
``grandfathering'' provisions. Qualification standards may include
provisions to permit employees who met all requirements prior to
revisions to the qualification standards to maintain employment at VA
even if they no longer meet the new qualification standards. This
practice is referred to as grandfathering. Clinical Perfusionists have
grandfathering provisions included within their qualification
standards, and VA proposes to have those individuals be authorized to
follow the Clinical Perfusionist national standard of practice.
Therefore, there would be no notation regarding grandfathered employees
in the national standard of practice as they would be required to
adhere to the same standard as any other VA Clinical Perfusionist who
meets the current qualification standards.
The third paragraph confirms that this profession follows the
Standards and Guidelines for Perfusion Practice from the American
Society of ExtraCorporeal Technology (AmSECT). The standard of practice
for Clinical Perfusionists can be found at: https://www.amsect.org/Portals/0/AmSECT_Perfusion_S%26G_2023%20Ratified%20021023.pdf/. For
Clinical Perfusionists, VA confirmed that all individuals follow the
standards from AmSECT.
The fourth paragraph notes that VA reviewed if there are any
required alternative registrations, certifications, licenses, or other
state requirements for Clinical Perfusionists. VA found that 17 states
also require a state license for Clinical Perfusionists.
The fourth paragraph also includes information on which states
offer an exemption for Federal employees and whether VA is preempting
any conflicting state laws, rules, regulations, or requirements. Of
those 17 states that require a license, 13 states exempt Federal
employees from their state license requirements. Furthermore, the tasks
and duties set forth in the state license requirements for all 17
states are consistent with what is permitted under the national
certification. Therefore, there is no variance in how Clinical
Perfusionists practice in any state. VA thus proposes to adopt a
standard of practice consistent with the Standards and Guidelines for
Perfusion Practice from AmSECT. VA Clinical Perfusionists will continue
to follow this standard.
This national standard of practice does not address training
because it will not authorize VA Clinical Perfusionists to perform any
tasks or duties not already authorized under their national
certification and state license.
Following public and VA employee comments and revisions, each
national standard of practice that is published into policy will also
include the date for recertification of the standard of practice and a
point of contact for questions or concerns.
Proposed National Standard of Practice for Clinical Perfusionists
Note: All references herein to VA and VHA documents incorporate
by reference subsequent VA and VHA documents on the same or similar
subject matter.
1. Clinical Perfusionists are medical professionals qualified by
academic education, clinical education, and professional credentialing
to provide extracorporeal patient care services. Patient care services
include, but are not limited to, cardiopulmonary bypass,
autotransfusion, intra-aortic counter pulsation, ventricular
assistance, extracorporeal membrane oxygenation, and point of care
testing. Clinical Perfusionists are responsible for the selection of
appropriate equipment and techniques necessary for the support,
treatment, measurement, and supplementation of the cardiopulmonary
system of a patient. They use a comprehensive understanding of anatomy,
physiology, physics, pharmaceutical administration, and mechanics of
extracorporeal circulation to provide monitoring, analysis, and
treatment of patient physiologic conditions to maintain blood pressure,
anticoagulation, myocardial electromechanical silence and preservation
(with unique administration of cardioplegia), thermal regulation, fluid
balance, electrolyte/acid-base balance, and blood gas composition
according to established guidelines and protocols.
2. Clinical Perfusionists in the Department of Veteran Affairs (VA)
possess the education and certification required by VA qualification
standards. See VA Handbook 5005, Staffing, Part II, Appendix G63, dated
July 2, 2020.
3. VA Clinical Perfusionists practice in accordance with the
American Society of ExtraCorporeal Technology (AmSECT) Standards and
Guidelines for Perfusion Practice, available at: https://amsect.org/.
The American Board of Cardiovascular Perfusion (ABCP) is the national
certifying body for Clinical Perfusionists. VA reviewed certification
requirements from ABCP for this occupation in January 2024 and
confirmed that all Clinical Perfusionists in VA followed the AmSECT
Standards and Guidelines for Perfusion Practice.
4. Although VA only requires a certification, 17 states require a
state license in order to practice as Clinical Perfusionists in that
state: Arkansas, Connecticut, Georgia, Illinois, Maryland,
Massachusetts, Missouri, Nebraska, Nevada, New Jersey, New York, North
Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, and Wisconsin.
Of those, 13 states exempt Federal employees from their state
license requirements: Arkansas, Georgia, Illinois, Massachusetts,
Missouri, Nebraska, New Jersey, New York, North Carolina, Oklahoma,
Pennsylvania, Tennessee, and Texas.
VA reviewed state laws and practice acts for Clinical Perfusionists
in January 2024 and did not identify any conflicts that impact practice
of this profession in VA.
Request for Information
1. Is VA's assessment of what states allow and do not allow
accurate?
2. Are there any other areas of variance between state licenses,
certifications, or registrations that VA should preempt that are not
listed?
3. Is there anything else you would like to share with us about
this VA national standard of practice?
Signing Authority
Denis McDonough, Secretary of Veterans Affairs, approved and signed
this document on June 7, 2024, and authorized the undersigned to sign
and submit the document to the Office of the Federal Register for
publication
[[Page 56818]]
electronically as an official document of the Department of Veterans
Affairs.
Luvenia Potts,
Regulation Development Coordinator, Office of Regulation Policy and
Management, Office of General Counsel, Department of Veterans Affairs.
[FR Doc. 2024-15110 Filed 7-9-24; 8:45 am]
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