[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]
BILLING CODE 8320-01-P