Bill Text: TX SB2517 | 2023-2024 | 88th Legislature | Introduced

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Bill Title: Relating to the regulation of human body acquisition services and authorized recipients.

Spectrum: Partisan Bill (Republican 1-0)

Status: (Introduced - Dead) 2023-03-23 - Referred to Business & Commerce [SB2517 Detail]

Download: Texas-2023-SB2517-Introduced.html

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By: Parker S.B. No. 2517

A BILL TO BE ENTITLED
AN ACT
relating to the regulation of human body acquisition services and
authorized recipients.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle B, Title 8, Health and Safety Code, is
amended by adding Chapter 692B to read as follows:
CHAPTER 692B. HUMAN BODY ACQUISITION SERVICES AND AUTHORIZED
RECIPIENTS
Sec. 692B.001. DEFINITIONS. In this chapter:
(1) "Authorized recipient" means a person or facility
located in this state that in accordance with state law obtains a
whole body, body segment, or nontransplant anatomical part from a
human body acquisition service.
(2) "Commission" means the Funeral Service Commission
of the State of Texas.
(3) "Body" means the intact corporeal remains of a
human.
(4) "Body segment" means a portion of a whole body
detached for purposes of study, evaluation, education, or research
and composed of contiguous mixed tissues with relationships altered
only at the segment boundaries.
(5) "Human body acquisition service" means a person or
facility that solicits, retrieves, performs donor selection on,
preserves, transports, allocates, distributes, acquires,
processes, stores, or arranges storage for whole bodies, body
segments, or nontransplant anatomical parts, solely for education
or research purposes.
(6) "Nontransplant anatomical part" means a part
donated for a purpose other than transplantation.
(7) "Part" has the meaning assigned by Section
692A.002.
Sec. 692B.002. RULES. To protect the public health,
safety, and welfare, the commission may adopt the rules necessary
to implement and enforce this chapter.
Sec. 692B.003. INFORMED CONSENT REQUIRED. (a) A human body
acquisition service may accept a donation of a whole body, body
segment, or nontransplant anatomical part only if the service
obtains documented informed consent to the donation from a person
authorized to consent to the donation in accordance with Chapter
692A.
(b) The informed consent document for a donation governed by
this chapter must:
(1) identify the authorized recipient of the donation;
(2) indicate whether the gift is of the whole body or
is limited to specified identifiable body segments or nontransplant
anatomical parts; and
(3) clearly specify the authorized uses of the donated
body, segments, or parts.
(c) The human body acquisition service shall electronically
record or document in writing any consent obtained by telephone.
The service shall transcribe an electronically recorded telephone
consent into a written consent document before using a whole body,
body segment, or nontransplant anatomical part for education or
research.
(d) Except as provided by Section 692B.004, a human body
acquisition service may only use or transfer a whole body, body
segment, or nontransplant anatomical part for a purpose specified
in the informed consent document.
Sec. 692B.004. PRESUMPTION FOR RECIPIENT OF UNSPECIFIED
DONATION. (a) Unless specific direction is provided in an informed
consent document for a donation of a whole body, body segment, or
nontransplant anatomical part, the donated body, segment, or part
is presumed to be donated to the commission or another person
authorized to receive the body of a deceased person under Chapter
691 or 692A.
(b) The commission or person may transfer or authorize the
transfer of the whole body, body segment, or nontransplant
anatomical part to another person authorized to receive an
anatomical gift under Chapter 691 or 692A for purposes of:
(1) medical or dental education;
(2) medical or dental research; or
(3) the advancement of medical or dental science,
therapy, or transplantation.
Sec. 692B.005. RETRIEVAL AND ACQUISITION OF NONTRANSPLANT
ANATOMICAL PARTS. (a) A nontransplant anatomical part may be
retrieved only on the premises of:
(1) a hospital licensed under Chapter 241; or
(2) a human body acquisition service in accordance
with this section.
(b) A whole body, body segment, or nontransplant anatomical
part may be retrieved, acquired, distributed, transported, or used
only for a purpose authorized by Chapter 691 or 692A. For the
purposes of this section, the term "research" as used in Section
692A.011 is limited to research conducted in accordance with
accepted research protocols designed to improve the public health,
safety, and welfare.
Sec. 692B.006. HUMAN BODY ACQUISITION SERVICE: PERSONNEL,
SPACE, AND RECORD REQUIREMENTS. (a) A human body acquisition
service shall employ:
(1) a director who holds a graduate degree in anatomy
or the health sciences;
(2) a technician, morgue attendant, diener, or
licensed funeral director who is responsible for the preparation,
care, and maintenance of whole bodies, body segments, and
nontransplant anatomical parts; and
(3) at least one support staff member other than the
director, but who may be an individual described by Subdivision
(2), who is responsible for recordkeeping.
(b) A human body acquisition service must have a dedicated,
secure, and restricted space to prepare whole bodies and body
segments for research or education purposes. The service shall
limit access to the space to only individuals directly associated
with receipt and preparation of whole bodies or body segments. The
space must include:
(1) a working sink and adequate counter space for
preparation of whole bodies or body segments;
(2) suitable space to store chemicals and materials
used in preparation of whole bodies or body segments;
(3) counters, tables, and cabinetry built of material
easily disinfected and cleaned;
(4) a refrigerated storage room, walk-in cooler, or
cadaver drawer cooler, dedicated solely to storage of whole bodies
or body segments and with lockable access doors and alarms to signal
intrusion or unacceptable temperature deviation;
(5) a device approved by the Occupational Safety and
Health Administration for handling, lifting, and internal
transportation of whole bodies or body segments;
(6) eye wash stations approved by the Occupational
Safety and Health Administration;
(7) if embalming is performed, a morgue compliant with
federal and state standards; and
(8) if cremation is performed, a crematory compliant
with federal and state standards.
(c) A human body acquisition service shall maintain
complete and accurate records of each donation made to the service.
The records must include:
(1) for:
(A) a whole body, identification of the deceased
individual; or
(B) a body segment, a description and source of
the body segment;
(2) documentation of unclaimed acquisitions, death
certificates, and burial transit permits associated with receipt
and use of a whole body or body segment;
(3) documentation of the facilities and institutions
to which the whole bodies or body segments are transferred or of any
other disposition;
(4) a copy of any contract or letter of agreement
between the service and an authorized recipient; and
(5) documentation of the intended method of final
disposition of the whole body or body segment.
Sec. 692B.007. TRANSFER OF WHOLE BODIES, BODY SEGMENTS, AND
NONTRANSPLANT ANATOMICAL PARTS. (a) A transfer of a whole body,
body segment, or nontransplant anatomical part shall be conducted
in compliance with existing state laws and standards. The
burial-transit permit issued under Section 193.008, or written
documentation of the source and a description of the body segment
or nontransplant anatomical part, shall accompany each whole body,
body segment, or nontransplant anatomical part.
(b) A human body acquisition service shall maintain a copy
of the properly executed burial transit permit for each whole body
transferred to or by the service.
Sec. 692B.008. AUTHORIZED RECIPIENT: PERSONNEL, SPACE, AND
RECORD REQUIREMENTS. (a) An authorized recipient shall store and
use whole bodies and body segments solely for education or research
purposes. Unless another lawful donee is specified in the donor
informed consent document, the authorized recipient of a whole
body donated for education purposes shall be a person authorized to
receive the bodies of deceased persons under Chapter 691.
(b) An authorized recipient may not transfer a whole body or
body segment to any other entity, except as authorized in writing by
the commission or the human body acquisition service from which the
body or segment was obtained.
(c) An authorized recipient shall employ at least one staff
member who holds a graduate degree in the health sciences and has
successfully completed training specific to human dissection or the
activity to be performed.
(d) The dissection or other authorized use of a whole body
or body segment may occur only in dedicated rooms on the premises
listed on the certificate of formation of the authorized recipient
or at an off-site location approved by the commission or the
director of the human body acquisition service from which a whole
body or body segment was obtained. The rooms must:
(1) be equipped with lockable doors and acces
restricted to only individuals directly associated with the
dissection or other authorized use;
(2) be isolated from public view;
(3) be of sufficient size and construction with
equipment suitable to ensure safe and respectful handling of whole
bodies and body segments;
(4) be equipped with tables designed for
dissection of whole bodies or other work spaces appropriate for the
specific authorized activity to be performed;
(5) contain a working sink and adequate counter
space to ensure the safety of individuals involved in using whole
bodies and body segments in dissection or another authorized use;
(6) contain surfaces constructed of nonporous
materials;
(7) include eye wash stations approved by the
Occupational Safety and Health Administration; and
(8) include facilities to store any necessary
chemicals in accordance with Occupational Safety and Health
Administration guidelines.
(e) An authorized recipient shall maintain complete and
accurate records of receipt, use, and disposition of whole bodies,
body segments, and nontransplant anatomical parts. The records must
include:
(1) for:
(A) a whole body, an identification of the
deceased individual; or
(B) a body segment or nontransplant anatomical
part, a description and source of the segment or part;
(2) a copy of any contract or letter of agreement
between the human body acquisition service and authorized
recipient;
(3) documentation of the final disposition method for
a whole body or body segment; and
(4) for a whole body transfer, a copy of a properly
executed burial-transit permit.
Sec. 692B.009. DISPOSITION OF WHOLE BODIES, BODY SEGMENTS,
AND NONTRANSPLANT ANATOMICAL PARTS. (a) An authorized recipient
shall dispose of whole body remains, body segments, and
nontransplant anatomical parts in accordance with existing state
laws and standards for disposition of regulated medical waste.
(b) An authorized recipient may return a whole body or
body segment to the human body acquisition service from which the
recipient originally obtained the body or segment.
(c) Disposition of a whole body or body segment shall
be consistent with instructions provided in the informed consent
document.
Sec. 692B.010. SAFETY AND INFECTION CONTROL POLICIES AND
PROCEDURES. (a) A human body acquisition service or authorized
recipient shall implement written safety and infection control
policies and procedures to ensure protection from unnecessary
physical, chemical, and biological hazards.
(b) A human body acquisition service or authorized
recipient shall implement decontamination and disposal techniques
for regulated medical waste and ensure hazardous and regulated
waste materials are handled, stored, and discarded in accordance
with Section 361.0905 and any other applicable state law.
(c) A human body acquisition service or authorized
recipient shall record and maintain the pressure, temperature, and
duration of each autoclave sterilization cycle until at least the
first anniversary of the sterilization date. The service or
recipient shall:
(1) ensure the pressure, temperature, and duration for
each cycle is within the manufacturer's recommended operating
procedures and if any parameter falls outside the manufacturer's
standards, rerun the cycle for all material included in the cycle;
and
(2) use chemical, biological, and physical detection
systems in conjunction with the other autoclave performance
measurements listed in Subdivision (1).
(d) A staff member may not eat, drink, smoke, apply
cosmetics, or apply contact lenses in a work area subject to this
section of a human body acquisition service or authorized
recipient.
(e) A human body acquisition service or authorized
recipient may not use for any other purpose a refrigerator or
freezer used to store nontransplant anatomical parts or reagents.
(f) Each staff member who handles a nontransplant
anatomical part:
(1) shall wear gloves and laboratory coats,
gowns, or other protective clothing sufficient to protect against
the transmission of disease and exposure to toxic substances;
(2) may not wear protective clothing outside the
work area; and
(3) shall dispose of protective clothing in an
appropriate receptacle.
Sec. 692B.011. REPORT TO COMMISSION. On request, a human
body acquisition service or authorized recipient shall submit to
the commission reports on the service's or user's activities as may
be required by this chapter or commission rule. The director of the
human body acquisition service or authorized recipient shall sign
each report.
Sec. 692B.012. ENFORCEMENT AND PENALTIES. (a) Each human
body acquisition service and authorized recipient is subject to
regulation, including commission investigations and enforcement,
under Chapter 691.
(b) A person who violates this chapter is subject to the
enforcement and penalties authorized under Chapter 691 as if the
person violated or failed to perform a duty imposed under that
chapter.
SECTION 2. Chapter 692B, Health and Safety Code, as added by
this Act, applies only to conduct that is subject to regulation,
enforcement, and penalties under that chapter that occurs on or
after the effective date of this Act. Conduct that occurs before
that date is governed by the law in effect on the date the conduct
occurred, and the former law is continued in effect for that
purpose.
SECTION 3. This Act takes effect September 1, 2023.