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.