|
|
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. |