AN ACT relating to organ donation safety.

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AN ACT relating to organ donation safety. 1
WHEREAS, an organ donation is a remarkable and life -saving gift that allows 2
thousands of individuals each year to receive life -sustaining transplants and offers hope 3
to patients and families awaiting organs; and 4
WHEREAS, the success of the organ donation and transplant system depends upon 5
public trust, transparency, and strict adherence to ethical and clinical standards that 6
prioritize patient safety and human dignity; and 7
WHEREAS, the United States Department of Health and Human Services through 8
the Health Resources and Services Administration has announced major reforms to 9
strengthen oversight of the national organ procurement system; and 10
WHEREAS, donation after circulatory death, which occurs following the 11
withdrawal of life-sustaining treatment and declaration of death based on circulatory and 12
respiratory criteria, presents unique clinical risks requiring procedural safeguards; and 13
WHEREAS, existing Kentucky law defines the determination of death but does not 14
expressly require a mandatory pause in organ procurement when new neurological 15
information or indications of life arise; and 16
WHEREAS, it is in the inter est of the Commonwealth to ensure that patients, 17
families, and health care professionals have clear, enforceable protocols for organ 18
procurement; 19
NOW, THEREFORE, 20
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 21
SECTION 1. A NEW SECTION OF KRS CHAPTER 311 IS CREATED TO 22
READ AS FOLLOWS: 23
(1) As used in this section: 24
(a) "Death declaration" means the formal determination of death made by a 25
hospital physician, in accordance with accepted medical standards and 26
applicable state and federal law, based on either the irreversible cessation 27
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of: 1
1. Circulatory and respiratory functions; or 2
2. Functions of the entire brain, including the brain stem; 3
(b) "Donation after brain death" or "DBD" means the organ recovery process 4
that may occur following death by irreversible cessation of cerebral and 5
brain stem function that is characteri zed by an absence of electrical activity 6
in the brain, blood flow to the brain, and brain function, as determined by 7
clinical assessment of responses; 8
(c) "Donation after circulatory death" or "DCD" means the organ recovery 9
process that may occur following death by irreversible cessation of 10
circulatory and respiratory functions; 11
(d) "Indication of life" includes but is not limited to: 12
1. Spontaneous movement; 13
2. Vocalization or attempts to vocalize; 14
3. Purposeful or reflexive responses to stimuli; 15
4. Observed respiratory effort by a patient-initiated attempt at breath; 16
5. Changes in heart rate or blood pressure inconsistent with a death 17
declaration; and 18
6. Any neurological or physiological sign suggesting pain perception or 19
neurological activity; 20
(e) "Neurological status" means the clinical assessment of brain and nervous 21
system function, including level of consciousness, reflexes, responsiveness, 22
and indicators of pain perception; 23
(f) "Organ donation" has the same meaning as anatomical gift in KRS 24
311.1911; and 25
(g) "Pause in procedure" means the immediate suspension of any organ 26
donation recovery, preservation, or procurement activity. 27
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(2) (a) During any organ donation recovery, preservation, or procurement activity 1
for a DCD or DBD, a pause in procedure shal l be initiated if any individual 2
included in paragraph (b) of this subsection reports on any of the following: 3
1. Observed or suspected change in neurological status; 4
2. Observed or suspected indication of life; or 5
3. Uncertainty regarding the accuracy or completeness of neurological 6
status or death declaration assessments. 7
(b) A pause in procedure may be requested or initiated by any individual 8
involved or present, including but not limited to: 9
1. Hospital physicians, nurses, or clinical staff; 10
2. Organ procurement organization personnel; 11
3. Transplant center personnel; 12
4. Members of the surgical or anesthesiology team; and 13
5. The patient’s spouse or legal representative. 14
(c) An individual shall not be penalized, disciplined, or retaliated against for 15
requesting or initiating a pause in procedure. 16
(3) If a pause in procedure is initiated during any organ donation recovery, 17
preservation, or procurement activity for a DCD or DBD: 18
(a) All organ donation recovery, preservation, or procurement activities shall 19
cease; 20
(b) A comprehensive reassessment of the patient's neurological and 21
physiological status shall be conducted by the hospital’s clinical team; 22
(c) Organ donation recovery, preservation, or procurement activity shall not be 23
resumed until the patient's neurological function is reassessed and a DCD 24
or DBD is determined and deemed appropriate by a hospital physician; 25
(d) All determinations regarding patient status shall remain unde r the sole and 26
exclusive authority of the treating hospital and physicians; and 27
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(e) A patient shall not be denied appropriate comfort care, nutrition, hydration, 1
or life -sustaining treatment solely for the purpose of facilitating organ 2
donation. 3
(4) Any pause in procedure shall be documented in the patient's medical record by 4
the treating hospital and physician. The documentation shall include but not be 5
limited to: 6
(a) The reason for the pause in procedure; 7
(b) Observations triggering the pause in procedure; 8
(c) Reassessment findings; and 9
(d) Final determinations. 10
(5) (a) All pauses in procedure as described in this section shall be reported to: 11
1. All applicable federal oversight entities in accordance with federal 12
law; or 13
2. Any entity directed by the Uni ted States Department of Health and 14
Human Services, Health Resources and Services Administration 15
(HRSA) to receive the pause in procedure report and any oversight 16
and corrective guidelines. 17
(b) A copy of reports required under paragraph (a) of this subsect ion and any 18
follow-up reporting shall be forwarded to the Cabinet for Health and 19
Family Services. 20
(6) The Cabinet for Health and Family Services shall, by October 1, 2026, and by 21
October 1 of each year thereafter, submit a report to the Legislative Researc h 22
Commission for referral to the Interim Joint Committee on Health Services that 23
provides an overview of: 24
(a) Pause in procedure cases and outcomes; and 25
(b) Any corrective actions related to pause and procedure cases issued by 26
HRSA. 27
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(7) (a) Failure of a pe rson or entity to comply with this section may result in 1
administrative actions, including but not limited to: 2
1. Reports to appropriate licensing or certification authorities; 3
2. Suspension of organ donation recovery, preservation, or procurement 4
activities in the Commonwealth; and 5
3. Assessment of civil penalties. 6
(b) The Cabinet for Health and Family Services shall promulgate 7
administrative regulations in accordance with KRS Chapter 13A to 8
implement and enforce this section. 9
(c) A health care professional or any employee of a hospital who has 10
knowledge of a failure to comply with the requirements of subsection (2) of 11
this section shall immediately report the failure to the Cabinet for Health 12
and Family Services. 13
(8) This section shall not be construed to: 14
(a) Conflict with the determination death under KRS 446.400; 15
(b) Discourage ethical organ donation; 16
(c) Interfere with independent end-of-life decision making; 17
(d) Conflict with the Revised Uniform Anatomical Gift Act; or 18
(e) Authorize the Commonwealth to suspend, revoke, or otherwise affect the 19
federal certification, d esignation, or service area of an organ procurement 20
organization, which shall remain under the exclusive authority of the 21
United States Department of Health and Human Services. 22
(9) If any provision of this section or the application thereof to any person o r 23
circumstance is held invalid, the invalidity shall not affect other provisions or 24
applications of the section that can be given effect without the invalid provisions 25
or application, and to this end the provisions of this section are severable. 26