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.