TITLE 22. EXAMINING BOARDS

(5) "Anatomical activity" means an activity, whether or not authorized, involving activity involving the physical presence, use, dissection, operation, examination, experimentation, education, training, research, demonstration, or temporary storage of a body or anatomical specimen at a site. Transportation alone is not an anatomical activity.

(12) "Burial" means the permanent disposition of human remains in the ground in a grave or other lawful burial space. The term is a form of interment under Health and Safety Code Chapter 711.

(13) "Commission-designated electronic system" means the electronic system or systems designated by the commission for regulatory administration under this chapter, including entity registration, identification, chain-of-custody tracking, transfers, imports and exports, inspections, reconciliation, reporting, and related records.

(14) "Commission-issued identifier" means an official identifier created and assigned by the commission for regulatory identification, custody, tracking, inspection, transfer, reconciliation, or disposition under this chapter. Commission-issued identifiers include, as applicable:

(A) "Commission Entity Identifier" means the unique entity-level identifier assigned by the commission to each anatomical entity registered or authorized in Texas. The Commission Entity Identifier may be used to identify the entity in the Commission-designated electronic system and on Commission-issued identification media.

(B) "Commission Whole Body Identifier" means the unique identifier assigned by the commission to each whole body received through the Texas willed body program pathway. The Commission Whole Body Identifier identifies the donor within the commission's regulatory identification system and remains associated with the donor through tracking, transfer, reconciliation, and final disposition.

(C) "Commission Specimen Identifier" means the unique identifier assigned by the commission to each separately tracked anatomical specimen when separate identification is required under this chapter. When the specimen is derived from a Commission-identified whole body, the Commission Specimen Identifier must remain linked to the applicable Commission Whole Body Identifier and Commission Entity Identifier.

(15) "Commission-issued tag" means a physical tag, label, device, or other identification medium created, issued, or distributed by the commission that bears, encodes, or corresponds to an applicable Commission-issued identifier and is required by commission rule or procedure to remain associated with the donor, body, anatomical specimen, or primary specimen container to which the identifier is assigned.

(19) "Final disposition" means the lawful permanent disposition of a body or human remains after authorized anatomical use has concluded, including burial, flame cremation, entombment, inurnment, incineration and disposal of residual soft tissue as permitted by §206.14(c) of this title, or another method expressly authorized by Texas law. The term does not include temporary storage, transportation, transfer, anatomical use, or movement out of this state for continued custody or use.

(20) "Flame cremation" means cremation as defined by Health and Safety Code §716.001(5) and Occupations Code §651.651(1): the irreversible process of reducing human remains to bone fragments through direct flame, extreme heat, and evaporation. The term may include pulverization as provided by those statutes and does not include a process that does not satisfy the statutory definition of cremation.

(23) "Host venue" means the hotel, resort, convention or conference center, meeting or event facility, hospital, ambulatory surgical center, educational facility, physician office, clinical or commercial training site, or other property at which temporary anatomical use is proposed or authorized. A host venue does not become an Authorized Person or Authorized Entity solely by hosting an authorized temporary anatomical use.

(25) "Mobile anatomical laboratory" means a mobile unit designed, equipped, and used for anatomical activity in which a body or anatomical specimen may be dissected, manipulated, stored, used for training, or otherwise subjected to an authorized activity. A vehicle used solely for transportation is not a mobile anatomical laboratory.

(27) "Organ procurement organization" has the meaning assigned in Health and Safety Code §692A.002(19).

(30) "Purpose-built anatomical facility" means a fixed or mobile anatomical facility designed and equipped principally for anatomical activity and registered, inspected, or approved by the commission under §691.034, Health and Safety Code, for the activity being conducted.

(31) "Qualified Instructor" means an individual who satisfies at least one of the following qualifications:

(A) a physician or dentist who holds a current, unrestricted license issued by the appropriate licensing authority and, when Texas law requires a license, permit, or other authorization for the activity being conducted, holds that Texas authorization;

(B) a person holding an earned doctoral, master's, or professional degree from an accredited institution in anatomy or a related health science. For purposes of this paragraph, a related health science is a health or biomedical discipline in which the completed degree program includes formal education in human anatomy relevant to the anatomical activity, including medicine, dentistry, nursing, physician assistant studies, physical therapy, occupational therapy, biomedical science, biomedical engineering, anatomy, or physiology;

(C) a licensed or certified anatomist holding a current credential issued by a governmental licensing authority or nationally recognized professional certifying organization;

(D) a state-licensed educator whose current credential authorizes instruction in anatomy, biology, health science, medical science, or another subject directly related to the anatomical activity;

(E) a state-licensed embalmer providing instruction related to embalming, preservation, dissection, anatomical preparation, or another subject within the person's professional education or lawful scope of practice;

(F) a medical, doctoral, or master's student currently enrolled in an accredited educational program whose course of study is related to the anatomical activity and who acts under the direct supervision of a Qualified Instructor described by subparagraphs (A) through (E) of this paragraph. Employment, job title, years of experience, industry reputation, or self-designation alone does not establish that a person is a Qualified Instructor. The commission may require documentation sufficient to verify the qualification relied upon under this paragraph.

(33) "Temporary anatomical use" means an anatomical activity conducted for a limited duration at a location that is not otherwise operating as a currently registered and inspected anatomical facility for the activity being conducted and that requires commission authorization under §206.13 of this title.

(34) "Temporary anatomical use site" means the specific room, laboratory, mobile unit, suite, controlled area, or other portion of a host venue authorized by the commission under §206.13 of this title for temporary anatomical use.

§206.10. Enforcement, Administrative Penalties, and Sanctions.

(a) Purpose, scope, and jurisdiction.

(1) This section establishes administrative penalty classifications and enforcement guidelines for violations of Health and Safety Code Chapters 691 and 692A and this chapter only to the extent the conduct is within the jurisdiction of the commission.

(2) This section applies to a willed body program, non-transplant anatomical donation organization, anatomical facility, Authorized Person as defined by §206.1 of this title (relating to Scope and Definitions), and a person designated by the commission under §206.2(b)(5) of this title (relating to Authorized Activities), to the extent each person is subject to the commission's anatomical jurisdiction.

(3) A reference in this section to an Authorized Person has the meaning assigned by §206.1 of this title and includes only a person authorized to receive or use a body or anatomical specimen under Health and Safety Code §691.033(a) and designated, registered, inspected, or otherwise authorized by the commission as provided by Chapter 206 of this title.

(4) A person or entity not otherwise listed in §206.2(b)(1) of this title may be treated as an authorized person for purposes of this section only after designation by the commission under §206.2(b)(5) of this title. Nothing in this section independently creates a new category of authorized recipient.

(5) This section does not establish an anatomical violation based solely on conduct governed by the commission's funeral-service, embalming, crematory, or other non-anatomical jurisdiction. Such conduct remains subject to the statutes and rules otherwise applicable to that regulated activity.

(6) This section does not establish a violation based solely on a duty imposed by Chapter 692A on an organ procurement organization, hospital, transplant hospital, Donate Life-Texas Registry administrator, physician, technician, or other person outside the commission's anatomical jurisdiction, unless that person separately acts as a TFSC-regulated or TFSC-authorized person with respect to a body or anatomical specimen governed by Chapter 691, Health and Safety Code, or Chapter 206 of this title.

(b) Available enforcement actions.

(1) The commission may issue a reprimand, assess an administrative penalty, impose other penalties, or revoke, suspend, or probate a registration or other authorization for a violation of Health and Safety Code, Chapter 691, or any commission rule in Chapter 206, including a violation related to an inspection conducted under Health and Safety Code, Section 691.034, in the manner provided by Chapter 651, Occupations Code.

(2) The commission may require corrective action; impose probation or conditions; suspend or revoke a registration or authorization when authorized by law; or refer conduct to a prosecuting attorney, law-enforcement agency, regulatory agency, or other governmental entity having jurisdiction.

(3) Administrative action by the commission and referral to another governmental entity are separate remedies and may proceed concurrently to the extent permitted by law.

(c) Authorized-activity safe harbor.

(1) A violation may not be based solely on the physical nature of an activity if the activity is an authorized activity under §206.2(c) of this title, is performed by an Authorized Person, is within the scope of the consent for donation, and otherwise complies with applicable law and commission rule.

(2) When authorization or consent is disputed, the commission shall determine whether the person and activity were authorized and within the scope of the consent for donation before applying a violation classification under this section.

(3) This subsection does not limit the independent authority or prosecutorial discretion of another governmental entity.

(d) Non-transplant anatomical donation organization carve-out and downstream responsibility.

(1) Consistent with Health and Safety Code §§691.022(a) and 691.030(e), and applicable provisions of §206.4(d)(3) of this title (relating to Transport, Importation and Exportation of Bodies) and §206.5(c)(2) of this title (relating to Transfer of Bodies or Anatomical Specimens), the commission will not classify as a transfer-approval, export-approval, or commission-tagging violation the qualifying distribution or export by a registered non-transplant anatomical donation organization of a body or anatomical specimen donated directly to that organization when the statutory or rule carve-out applies.

(2) A registered non-transplant anatomical donation organization shall receive a Commission Entity Identifier for entity-level identification upon registration. A NADO is not required to use the Commission-issued whole-body and specimen identifier and tag system for a body or anatomical specimen donated directly to the NADO, unless a future statute or commission rule expressly requires otherwise.

(3) A NADO may maintain its own internal donor or specimen identifier for material donated directly to the NADO. An internal identifier may not be represented as a commission-issued identifier or tag. It may not be used to create, duplicate, counterfeit, or substitute for an official commission identifier or tag where a commission identifier or tag is required, however, a NADO internal identifier entered in the commission-designated electronic system satisfies the requirements of §206.3 of this title (relating to Chain of Custody).

(4) The carve-out in this subsection does not exempt a NADO from requirements that otherwise apply, including chain of custody, transport, applicable import or export notice, registration, inspection, annual reporting, recordkeeping, donor-consent requirements, and final disposition.

(5) A willed body program, anatomical facility, or other TFSC-authorized recipient that receives a body or anatomical specimen from a NADO remains independently responsible, to the extent that the registrant is subject to the Commission's jurisdiction, for every requirement applicable to that recipient, including recipient authorization, chain of custody, transport, required transfer documentation, possession of documentation sufficient to establish lawful donation and consent, inspection, recordkeeping, reporting, identification, tagging when applicable, and disposition.

(e) Commission-issued identifiers and tags.

(1) Each anatomical entity registered or authorized by the commission shall be assigned a Commission Entity Identifier for entity-level regulatory identification.

(2) For each whole body received by, or distributed by or through, the Commission, including through a willed body program, the commission shall assign a unique Commission Whole Body Identifier. The Commission-issued whole-body tag shall bear or encode the Commission Entity Identifier of the receiving willed body program and the Commission Whole Body Identifier assigned to the donor. The Commission-issued tag is required for each Texas donor entering a Texas willed body program and is the official regulatory tag for commission custody, tracking, inspection, transfer, reconciliation, and final disposition.

(3) If a whole body is divided into one or more separately tracked anatomical specimens, or natural desiccation results in material that must be separately tracked, the commission shall assign a unique Commission Specimen Identifier to each separately tracked specimen. Each Commission-issued specimen tag shall bear or encode the Commission Entity Identifier, Commission Whole Body Identifier, and Commission Specimen Identifier so that the specimen remains traceable to the originating whole body and willed body program.

(4) Only the commission may create, assign, issue, or distribute an official Commission Entity Identifier, Commission Whole Body Identifier, Commission Specimen Identifier, or Commission-issued tag. A willed body program shall obtain, affix, maintain, and use the applicable Commission-issued tags in the manner prescribed by the commission.

(5) A willed body program may maintain an internal record number, inventory number, or internal tracking identifier in addition to the Commission-issued identifiers. An internal identifier may not replace, obscure, alter, duplicate, or be represented as a Commission Entity Identifier, Commission Whole Body Identifier, Commission Specimen Identifier, or Commission-issued tag and must remain mapped to the applicable Commission-issued identifiers.

(6) An anatomical facility or other TFSC-authorized recipient is not required to obtain a commission-issued tag unless required elsewhere by law or commission rule, but shall preserve, use, and reconcile each Commission-issued identifier and tag accompanying material for which the identifier or tag is required. The recipient may maintain an internal tracking identifier if it remains mapped to the Commission-issued identifiers.

(7) A regulated entity may not manufacture, print, encode, emboss, engrave, assign, reproduce, or otherwise create a tag or identifier represented as an official Commission Entity Identifier, Commission Whole Body Identifier, Commission Specimen Identifier, or Commission-issued tag, or operate equipment for that purpose, unless expressly authorized by the commission.

(8) A regulated entity shall not remove, destroy, conceal, alter, exchange, reuse, or transfer a Commission-issued identifier or tag in a manner that breaks traceability or causes the identifier or tag to correspond to a different entity, donor, body, or anatomical specimen.

(9) Discovery of non-commission tagging or labeling equipment at a regulated location is not, standing alone, a violation if the equipment is used solely for lawful internal inventory or tracking. Use of such equipment to create or assign a substitute or purported Commission-issued identifier or tag is subject to enforcement under subsection (k) of this section.

(f) Unclaimed bodies entering the non-transplant anatomical pathway.

(1) Sections 691.023 through 691.027, Health and Safety Code, impose duties on the person or entity having custody of an unclaimed body. This section does not transfer funeral-side, governmental, or custodial duties imposed by those statutes to a willed body program, non-transplant anatomical donation organization, or anatomical facility that did not otherwise owe the duty.

(2) A TFSC-regulated or TFSC-authorized anatomical entity may not accept, use, transfer, or distribute an unclaimed body unless its records are sufficient to establish lawful authority for the body to enter the anatomical donation pathway.

(3) For an unclaimed body received from another person or entity, the receiving anatomical entity shall retain documentation sufficient to identify the source of the body, establish the legal basis for release or donation, and demonstrate, when applicable, that the notice, next-of-kin search, identification, claim-period, and other prerequisites required by §§691.023 through 691.027 were completed by the person legally responsible for those duties.

(4) Knowingly accepting or using an unclaimed body when the entity knows or reasonably should know that the body was not lawfully released, required identification or next-of-kin efforts were not performed, or a valid claim or refusal was disregarded may constitute a Class C or Class D violation depending on whether consent, lawful custody, traceability, or the dignity and integrity of the remains was impaired.

(g) Final disposition.

(1) A willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person shall use only a method of final disposition authorized by applicable Texas law and commission rule in effect on the date of the conduct.

(2) Donor instructions or consent may not authorize a method of final disposition that is not authorized by applicable Texas law.

(3) Actual use of a method of final disposition that is not authorized by applicable Texas law is subject to Class D enforcement under subsection (k) of this section.

(4) Installation, possession, maintenance in operational condition, or use-readiness of equipment designed or configured to perform a method of final disposition not authorized by applicable Texas law may be considered evidence of a violation when competent evidence establishes that the equipment is intended for use on human bodies or anatomical specimens subject to this chapter.

(5) Evidence relevant to final-disposition enforcement may include disposition records, chain-of-custody records, equipment cycle or operating records, photographs or video, physical evidence, residue or effluent records, utility records, vendor or maintenance records, employee or contractor statements, or other competent evidence.

(h) Willed body programs and non-transplant anatomical donation organization utilizing crematory establishments and licensed professionals.

(1) A crematory located at, within this state owned by, operated within this state by, or used within this state by a willed body program or non-transplant anatomical donation organization must hold the license required by Subchapter N, Chapter 651, Occupations Code, if that subchapter applies, and any authorization required under §106.494 of Title 30 or other applicable law. A crematory on willed body program or non-transplant anatomical donation organizations premises is inspected with the program under §691.034(a-2) and §206.31 of this title (relating to Inspections) regardless of if it is separately licensed as a crematory establishment. If a willed body program or non-transplant anatomical donation organization does not sell goods or services within this state related to burial or final disposition, it is not required to be licensed under Occupations Code §651.652 as a crematory establishment. Registration or authorization of the willed body program or non-transplant anatomical donation organization does not authorize the operation of a crematory establishment.

(2) A willed body program or non-transplant anatomical donation organization remains independently responsible for compliance with this chapter before and through lawful release or transfer for final disposition, including donor identification, commission-issued identifiers and tags, chain of custody, lawful transport, authorized use, authorization for final disposition, and records sufficient to reconcile the donor through final disposition.

(3) A willed body program or non-transplant anatomical donation organization that directly accepts whole body donations shall comply with §206.13(b) of this title (relating to Standards for Anatomical Facilities and Other Anatomical Use Locations).

(4) A willed body program or non-transplant anatomical donation organization shall not contract with a crematory establishment for final disposition unless the crematory establishment holds the license and other authorization required by applicable Texas law. The willed body program or non-transplant anatomical donation organization shall maintain documentation sufficient to verify the crematory establishment was authorized at the time the donor was released for final disposition.

(5) The existence of a separately licensed crematory establishment, funeral establishment, licensed funeral director, or licensed embalmer does not relieve the willed body program or non-transplant anatomical donation organization of a duty imposed by Chapter 691 or this chapter. The existence of a willed body program or non-transplant anatomical donation organization registration likewise does not relieve a crematory establishment or individual licensee of duties imposed by Occupations Code Chapter 651, Health and Safety Code Chapter 716, or other applicable commission rules.

(6) Conduct attributable solely to a crematory establishment, funeral establishment, funeral director, or embalmer in that separately regulated capacity shall be enforced under the statutes and rules governing that license or establishment rather than classified as an anatomical violation under this section, unless the same respondent separately engages in conduct subject to Chapter 691 or this chapter.

(7) Separate enforcement actions may arise from the same occurrence when the evidence establishes separate violations by the willed body program, crematory establishment, funeral establishment, or individual licensee.

(8) For purposes of this section, a reference to the licensed funeral director required by §206.13(b) of this title includes a funeral director serving in a Funeral Director in Charge role when applicable, but the title or role does not alter the duties imposed on the willed body program by §206.13(b) of this title.

(i) Texas priority before out-of-state export.

(1) A willed body program shall give priority to the documented needs of authorized persons and anatomical facilities in this state, consistent with §691.030(b) and (c), Health and Safety Code, before requesting, arranging, or causing the export of a body or anatomical specimen to an out-of-state recipient.

(2) A willed body program may not export a body or anatomical specimen subject to §206.4(d) of this title unless the commission has granted written permission and determined that the supply of bodies or anatomical specimens in this state exceeds the need for bodies or anatomical specimens in this state and the applicable donor authorization permits out-of-state shipment.

(3) Before requesting export approval, a willed body program shall make a reasonable, documented determination of current Texas need. The program shall maintain records sufficient for the commission to evaluate that determination, including:

(A) pending requests from Texas authorized persons;

(B) the requesting entity, date of request, type and quantity of material requested, and intended authorized use;

(C) requests fulfilled, partially fulfilled, declined, or pending;

(D) the reason a request was not fulfilled, including donor-consent limitations, suitability, timing, specimen characteristics, or other documented incompatibility;

(E) bodies and anatomical specimens reasonably available for distribution; and

(F) the body or anatomical specimen proposed for export and the basis for treating that material as excess to Texas need.

(4) A willed body program may not represent a body or anatomical specimen as excess to Texas need when a pending bona fide request from an authorized person in this state could reasonably be satisfied by that material within the scope of donor consent, applicable suitability requirements, and the authorized use, unless the commission determines otherwise based on documented circumstances.

(5) For purposes of this subsection, Texas need includes lawful education, training, research, medical or forensic science, and research or development activities conducted in this state by an authorized person under §206.2 of this title, including eligible medical device, biotechnology, pharmaceutical, and other authorized research or training entities.

(6) A willed body program shall provide records concerning Texas demand, allocation, availability, and proposed export to the commission on request. It shall not conceal, omit, or materially misrepresent information relevant to the commission's determination under §206.4(d)(1)(B) of this title.

(7) This subsection does not impose the commission's distribution or export-approval requirements on a body or anatomical specimen donated directly to a registered non-transplant anatomical donation organization (NADO) to the extent Health and Safety Code §691.030(e) or another applicable statutory carve-out provides otherwise.

(j) Classification criteria. The commission shall classify a violation according to the protected interest affected, the seriousness of the conduct, and the circumstances of the case. The commission shall consider:

(1) impairment of the dignity or physical integrity of a body or anatomical specimen;

(2) impairment, disregard, or exceedance of consent for donation;

(3) impairment of the ability to identify, locate, reconcile, or establish the chain of custody of a body or anatomical specimen;

(4) impairment of the commission's ability to administer or oversee the anatomical donation system;

(5) whether the violation was remediable and whether corrective action was timely taken;

(6) whether the violation concealed, altered, or destroyed information necessary to identify, investigate, or evaluate the violation;

(7) whether the body or anatomical specimen remained identifiable, accounted for, and recoverable;

(8) the number of donors, bodies, anatomical specimens, transfers, or transactions affected;

(9) whether the conduct was isolated or constituted a pattern or practice;

(10) whether the conduct was intentional, knowing, reckless, negligent, or inadvertent; and

(11) prior warnings, corrective action plans, disciplinary actions, or commission orders addressing substantially similar conduct.

(k) Violation classes and penalty ranges. Violations are classified as follows. The entity or person identified in each item is the respondent to whom that violation applies.

(1) Class A--$100 to $750. Class A violations are primarily administrative and remediable and do not materially impair donor dignity, consent, or traceability. Class A violations include:

(A) Willed body program or non-transplant anatomical donation organization -- failure to timely file the yearly cadaver procurement and use report required by §206.4(f) of this title, when the entity received, directly or by transfer, and/or used a body during the reporting period.

(B) Anatomical facility -- failure to timely file the annual need or use report required by §206.4(f) of this title.

(C) Forensic science program described by Health and Safety Code §692A.011(a)(5) -- failure to submit the separate quarterly report required by §692A.011(c). The quarterly statutory report is distinct from any annual report that applies to the same program in another regulated capacity.

(D) Registered non-transplant anatomical donation organization -- failure to provide written notice of a qualifying export exempt from case-by-case approval under §206.4(d)(3) of this title before or at the time of shipment.

(E) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person -- failure to provide a required importation notice under §206.4(c) of this title, when the failure does not materially impair traceability and the material remains identified and accounted for.

(F) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person -- another substantially similar administrative failure that is timely correctable and does not materially impair consent, dignity, or traceability.

(2) Class B--$751 to $2,000. Class B violations materially impair documentation, recordkeeping, transport controls, or traceability, but the affected body or anatomical specimen remains identifiable and accounted for, and consent remains intact. Class B violations include:

(A) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person with custody -- failure to initiate, complete, sign, transfer, or retain the chain-of-custody form as required by §206.3 of this title, including failure to create a derived-specimen form when required.

(B) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person with custody -- failure to provide the original or a complete copy of the chain-of-custody form to the receiving party at the time custody changes, or failure to retain the required copy.

(C) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other person subject to §206.3 of this title -- failure to produce a chain-of-custody record not later than two business days after a written request by the commission or a district or county attorney.

(D) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person that causes or controls transportation -- failure to ensure the transport container is labeled as containing material derived from human tissue, securely closed, packaged to prevent leakage, and maintained at an appropriate interior temperature as required by §206.4(a) of this title.

(E) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person that causes or controls transportation -- use of a transport arrangement that materially increases the risk of loss of identification, custody documentation, leakage, decomposition, or unauthorized access, when the body or specimen remains identifiable and accounted for.

(F) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person -- failure to maintain required permanent identification or intake-to-disposition records when the body or specimen remains identifiable, and the deficiency can be reconciled.

(G) Anatomical entity with a Designated Responsible Individual requirement -- failure to ensure the Designated Responsible Individual is present when and where required by §206.1 and §206.2 of this title.

(H) Authorized Person receiving a transferred body or anatomical specimen -- failure to return the material for final disposition within the period required by §206.14(a)(1) of this title (relating to Disposition of the Body and Disposition of Remains), or within any period stated in the Commission's transfer approval under §206.5 of this title, absent an approved extension, when the material remains identified and accounted for.

(I) Willed body program -- failure to obtain, affix, maintain, or use a required Commission-issued whole-body or specimen tag, or failure to maintain the required Commission Entity Identifier, Commission Whole Body Identifier, or Commission Specimen Identifier, when the donor, body, or specimen remains reliably identifiable and the deficiency is fully reconcilable.

(J) Anatomical facility or other TFSC-authorized recipient -- failure to preserve or reconcile a required commission-issued identifier or tag received with a body or anatomical specimen, when the material remains reliably identifiable, and the deficiency is fully reconcilable.

(K) Willed body program or non-transplant anatomical donation organization that directly accepts donations within the state -- failure to employ or maintain a current valid contract with the Texas-licensed funeral director or Texas-licensed embalmer required by §206.13(b) of this title, when no acceptance or transportation of whole bodies or embalming procedure occurred during the period of noncompliance.

(L) Willed body program -- failure to maintain documentation sufficient to verify that a crematory establishment used for final disposition held the required license or authorization, when the crematory was in fact duly licensed, and no unauthorized disposition occurred.

(M) Willed body program -- failure to maintain complete and reasonably current records of Texas requests, allocations, availability, and the basis for an excess-supply determination as required by subsection (i) of this section, when no out-of-state export occurred, and the deficiency is remediable.

(3) Class C--$2,001 to $3,500. Class C violations materially impair consent, lawful custody, transfer authorization, or traceability, or constitute a significant dignity violation that does not rise to Class D. Class C violations include:

(A) Willed body program, anatomical facility, or other Authorized Person for whom commission transfer approval is required -- transfer of a body or anatomical specimen without approval under §206.5 of this title, or transfer to a recipient that is not an approved willed body program, registered non-transplant anatomical donation organization, or Authorized Person for use at an approved anatomical facility.

(B) Willed body program, anatomical facility, or other Authorized Person -- export of a body or anatomical specimen without written commission approval when approval is required by §206.4(d) of this title. This paragraph does not apply to a qualifying NADO export governed by §206.4(d)(3) of this title.

(C) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person -- removal or relocation of a body or anatomical specimen from designated premises without written permission when required by §206.4(e) of this title.

(D) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person -- acceptance of a body or anatomical specimen without documentation sufficient to establish lawful donation, consent, source, and custody, when the deficiency materially impairs the ability to establish lawful authority but no knowing use outside consent has occurred.

(E) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person -- use or activity at a location not approved by the commission for that activity.

(F) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person that causes or controls transport -- transport in a manner that unnecessarily exposes a body or anatomical specimen to public view. For purposes of this paragraph, unnecessary public display includes exposing uncovered or visibly identifiable human remains to persons not involved in the authorized transport or activity, except for the minimum exposure reasonably necessary for secure loading, unloading, emergency response, or another lawful operational need.

(G) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person that causes or controls transport -- transport resulting in leakage, decomposition, offensive odor, unsecured access, or other preventable condition that materially compromises dignified handling but does not result in direct physical injury, loss, or unreconciled custody.

(H) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person -- failure to maintain traceability to the extent the body or anatomical specimen cannot be reliably reconciled, but there is no evidence of knowing diversion or use outside consent.

(I) TFSC-regulated or TFSC-authorized anatomical entity -- acceptance or use of an unclaimed body without records sufficient to establish lawful release and completion, when applicable, of the statutory identification, notice, next-of-kin, and claim prerequisites described in subsection (f) of this section.

(J) Willed body program or non-transplant anatomical donation organization -- failure to timely notify the commission of loss of accreditation when notice is required by Health and Safety Code §691.034(e).

(K) Willed body program -- use of a non-commission tagging machine, printer, encoder, or other system to create or assign a Commission Entity Identifier, Commission Whole Body Identifier, Commission Specimen Identifier, or tag in place of, as a substitute for, or represented as an official Commission-issued identifier or tag.

(L) Anatomical facility or other TFSC-authorized recipient -- creation or assignment of a substitute or purported commission identifier or tag for material required to retain a commission-issued identifier. This paragraph does not prohibit a separate internal tracking identifier that remains mapped to the commission-issued identifier.

(M) Willed body program or non-transplant anatomical donation organization that directly accepts whole body donations -- permitting acceptance or transport of a cadaver or anatomical specimen within this state without supervision by the Texas-licensed funeral director required by §206.13(b) of this title, or permitting embalming to be performed without the Texas-licensed embalmer required by §206.13(b) of this title.

(N) Willed body program -- releasing or delivering a donor to a crematory establishment for final disposition when the program knew or reasonably should have known that the crematory establishment was not separately licensed or otherwise authorized as required by applicable Texas law, but the evidence does not establish knowing participation in an unauthorized method of final disposition.

(O) Willed body program -- requesting or arranging an out-of-state export without first making and documenting the Texas-need assessment required by subsection (i) of this section.

(P) Willed body program -- seeking or obtaining export approval for a body or anatomical specimen while a pending bona fide request from a Texas authorized person could reasonably be satisfied by that material within donor-consent, suitability, timing, and authorized-use requirements, unless the commission approves the export based on documented circumstances.

(4) Class D--$3,501 to $5,000. Class D violations directly or substantially impair donor dignity, bodily integrity, consent, lawful custody, or the integrity of the anatomical donation system. Class D violations include:

(A) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person -- knowing use of a body or anatomical specimen outside the scope of the consent for donation.

(B) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person -- improper use of a body or anatomical specimen within the meaning of Health and Safety Code §691.034(c).

(C) Person or entity subject to TFSC anatomical jurisdiction -- operation of a willed body program or non-transplant anatomical donation organization without the registration required by Health and Safety Code §691.034(a).

(D) TFSC-regulated or TFSC-authorized anatomical entity -- knowing acceptance, use, transfer, or retention of a body or anatomical specimen after a valid revocation or refusal, or with knowledge that the donation or release was not legally authorized.

(E) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person -- knowing distribution or transfer to a person not authorized to receive or use the body or anatomical specimen under Health and Safety Code Chapter 691 and §206.2 of this title.

(F) TFSC-regulated or TFSC-authorized anatomical entity -- falsification, forgery, concealment, defacement, destruction, or knowing material alteration of a document of gift, consent record, revocation, refusal, chain-of-custody record, transfer record, identifier record, tag record, disposition record, or other material compliance record in connection with anatomical activity.

(G) Willed body program, anatomical facility, or other TFSC-authorized person -- counterfeiting, duplicating, knowingly altering, reassigning, exchanging, reusing, or affixing a Commission Entity Identifier, Commission Whole Body Identifier, Commission Specimen Identifier, or Commission-issued or purported Commission-issued tag to an entity, donor, body, or anatomical specimen other than the entity, donor, body, or specimen to which the identifier was assigned.

(H) Willed body program, anatomical facility, or other TFSC-authorized person -- removing, destroying, concealing, or replacing a required commission-issued identifier or tag with intent to conceal identity, custody, origin, use, transfer, or disposition.

(I) TFSC-regulated or TFSC-authorized anatomical entity -- sale or purchase of a body or part in violation of §206.2(f)(2) of this title. Conduct by a person outside TFSC anatomical jurisdiction is addressed through referral under subsection (o) of this section rather than classified as an administrative violation under this schedule.

(J) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person that causes or controls transport -- transport or handling that results in preventable direct physical damage to remains, loss or unreconciled custody of a body or specimen, or exposure of remains in a manner that substantially compromises dignity or physical integrity.

(K) TFSC-regulated or TFSC-authorized anatomical entity -- knowing acceptance or use of an unclaimed body when the entity knows that required legal authority, identification efforts, next-of-kin efforts, claim rights, or a valid refusal were disregarded.

(L) Willed body program, non-transplant anatomical donation organization, anatomical facility, or other Authorized Person -- actual disposition, or knowingly causing or permitting disposition, of a body or anatomical specimen by a method not authorized as a method of final disposition under applicable Texas law and commission rule in effect on the date of the conduct.

(M) Willed body program -- knowingly directing, releasing, or delivering a donor to an unlicensed or unauthorized crematory establishment for final disposition.

(N) Willed body program -- knowingly directing, authorizing, participating in, or permitting a crematory establishment or other disposition provider to use a method of final disposition that is not authorized by applicable Texas law or commission rule.

(O) Willed body program -- knowingly exporting, causing the export of, or releasing for export a body or anatomical specimen after the commission has denied export approval or determined that the material is needed to meet Texas demand.

(P) Willed body program -- knowingly concealing, falsifying, omitting, or materially misrepresenting a pending Texas request, available inventory, allocation decision, or other material fact for the purpose of obtaining or facilitating out-of-state export approval.

(l) Aggravating and mitigating factors. In determining the amount of an administrative penalty or the appropriate sanction within the applicable class, the commission may consider:

(1) the seriousness and duration of the violation;

(2) the threat the violation poses to health and safety;

(3) the respondent's history of previous violations;

(4) the amount necessary to deter a future violation;

(5) whether the conduct was intentional, knowing, reckless, negligent, or inadvertent;

(6) efforts to correct, stop, mitigate, or voluntarily disclose the violation;

(7) the number of donors, bodies, or anatomical specimens affected;

(8) whether chain-of-custody, identification, tagging, disposition, Texas-demand, allocation, availability, or export records or information were impaired, altered, concealed, falsified, materially omitted, or destroyed;

(9) whether the affected body or anatomical specimen was ultimately identified, located, reconciled, and lawfully disposed of;

(10) whether the conduct occurred after a prior warning, corrective action plan, disciplinary action, or commission order involving substantially similar conduct;

(11) whether the respondent failed to verify or knowingly disregarded the license or authorization status of a crematory establishment or other disposition provider; and

(12) any other factor relevant to the seriousness of the violation and the protection of donors, regulated entities, and the public.

(m) Multiple and continuing violations.

(1) Separate violations may be assessed for separate donors, bodies, anatomical specimens, identifiers or tags, transfers, uses, dispositions, or other distinct acts or omissions when supported by the facts and applicable law.

(2) A continuing violation accrues as provided by §206.1 of this title. In determining an appropriate penalty for a continuing violation, the commission may consider whether assessment for each day would be proportionate to the seriousness and duration of the underlying conduct.

(n) Corrective action, suspension, and revocation.

(1) The commission may require a corrective action plan in addition to or in place of another sanction when authorized by law.

(2) A corrective action plan may require record correction or supplementation, chain-of-custody or inventory reconciliation, identifier or tag reconciliation, enhanced tracking procedures, verification of disposition-provider licensure, documentation of compliance with §206.13(b) of this title, staff training, revision of policies or procedures, additional reporting, increased inspection or monitoring, restriction of particular activities, surrender or discontinuation of unauthorized tagging equipment or systems, cessation of an unauthorized disposition method, or other measures reasonably necessary to restore compliance and prevent recurrence.

(3) Nothing in this section limits the commission's authority under Health and Safety Code §691.034 to suspend or revoke an authorization when the commission determines that a body or anatomical specimen has been improperly used.

(4) A person or institution entitled to a hearing under Health and Safety Code §691.034(d) retains that right regardless of the violation classification assigned under this section.

(o) Referral outside the commission.

(1) Conduct by an organ procurement organization, hospital, registry administrator, or other person outside the commission's anatomical jurisdiction is not converted into an administrative violation by this section. When information indicates a possible violation of law by such a person, the commission may refer the matter to the governmental entity having jurisdiction.

(2) The commission may refer evidence of intentional falsification or destruction of records, unlawful financial gain, prohibited sale or purchase, physical treatment of remains outside lawful authority, knowing unregistered operation, unlicensed crematory operation, counterfeit or fraudulent commission identifiers or tags, unauthorized methods of final disposition, or other potentially criminal conduct to an appropriate prosecuting attorney or law-enforcement agency.

(3) Referral does not prohibit the commission from proceeding with an administrative investigation or enforcement action against a TFSC-regulated respondent to the extent authorized by law.

(p) Procedure and implementation.

(1) An enforcement action under this section is subject to applicable commission rules governing investigation, notice, settlement, hearings, and disciplinary proceedings and to Government Code Chapter 2001. The State Office of Administrative Hearings is designated by the commission as its hearings examiner under Health and Safety Code §691.034(d).

(2) A respondent must receive notice of the alleged conduct, the statute, rule, or order alleged to have been violated, and the proposed penalty or sanction.

(3) The classifications and ranges in this section are guidelines intended to promote consistent enforcement and do not eliminate individualized consideration of the facts and circumstances of a case.

(4) Violations based on duties created by §206.3 of this title may be charged only for conduct occurring on or after October 6, 2026.

§206.11. Coordination with Organ Procurement Organizations, Eye Banks, and Tissue Banks.

(a) Purpose and definitions.

(1) This section governs the receipt, identification, transfer, use, and final disposition of a whole body or anatomical specimen derived therefrom that an organ procurement organization, eye bank, or tissue bank accepts and transfers into the commission's jurisdiction, pursuant to Health and Safety Code §692A.011(a)(4), for research, education, or another purpose authorized under Health and Safety Code Chapter 691, as described by §206.1(b)(5) of this title (relating to Scope and Definitions). This section imposes obligations only on authorized persons. Nothing in this section regulates an organ procurement organization, eye bank, or tissue bank or requires an organ procurement organization, eye bank, or tissue bank to register with or obtain an authorization from the commission.

(2) In this section, "organ procurement organization," "eye bank," and "tissue bank" have the meanings assigned in Health and Safety Code §692A.002.

(3) In this section, "receiving entity" means the registered willed body program or registered non-transplant anatomical donation organization that accepts custody of a body or anatomical specimen from an organ procurement organization, eye bank, or tissue bank under subsection (c) of this section.

(b) Application.

(1) This section applies to a body or anatomical specimen from the time a receiving entity accepts custody of it from an organ procurement organization, eye bank, or tissue bank.

(2) Consistent with §206.1(b)(5) of this title, this section does not apply to the recovery, screening, testing, storage, or allocation of an organ, an eye, or tissue for transplantation into a living individual. A body or anatomical specimen that was recovered or evaluated for transplantation and is later transferred to a receiving entity for a purpose authorized under Health and Safety Code Chapter 691 is subject to this section from the time the receiving entity accepts custody.

(3) If an organ procurement organization, eye bank, or tissue bank is registered with the commission under Health and Safety Code §691.034 as a non-transplant anatomical donation organization, a body or anatomical specimen enters the commission's jurisdiction when the organization receives it in that capacity, and §206.3 of this title (relating to Chain of Custody), not this section, governs its identification. This section applies only to a transfer from an organ procurement organization, eye bank, or tissue bank that is not so registered.

(c) Points of entry.

(1) Only a registered willed body program or a registered non-transplant anatomical donation organization may accept custody of a body or anatomical specimen directly from an organ procurement organization, eye bank, or tissue bank.

(2) An anatomical facility or other authorized person may not accept custody of a whole body or anatomical specimens derived from whole bodies directly from an organ procurement organization, eye bank, or tissue bank. An anatomical facility or other authorized person may receive a body or anatomical specimen that originated with an organ procurement organization, eye bank, or tissue bank only by transfer from a receiving entity under §206.5 of this title (relating to Transfer of Bodies or Anatomical Specimens), documented under §206.3 of this title. This section does not restrict an organ procurement organization, eye bank, or tissue bank's own research or educational use under Health and Safety Code §692A.011(a)(1).

(3) Acceptance of custody in violation of paragraph (2) of this subsection is a violation of this chapter, is not an authorized activity under §206.2 of this title (relating to Authorized Activities), and is not within the safe harbor of §206.2(e) of this title.

(d) Authorization to receive; relationship to §206.5 of this title.

(1) Acceptance of custody by a receiving entity is a transfer, as defined in §206.1(c) of this title, and is subject to §206.5 of this title except as provided by this subsection.

(2) A registered non-transplant anatomical donation organization is a donee of the body or anatomical specimen under Health and Safety Code §692A.011(a)(8) and (b). Consistent with §206.5(c)(2) of this title, the approval requirement of §206.5(b) of this title does not apply to its acceptance of custody from an organ procurement organization, eye bank, or tissue bank. The organization shall document the receipt as provided by §206.3 of this title and this section.

(3) Acceptance of custody by a registered willed body program is subject to approval under §206.5(b) of this title. The executive director or the executive director's designee may grant a willed body program a standing approval to receive bodies or anatomical specimens from one or more named organ procurement organizations, eye banks, or tissue banks for the purposes stated in the approval, conditioned on compliance with this section. A standing approval may be conditional, limited in duration, or revoked. A request for a standing approval shall be made or approved in writing by a Designated Responsible Individual of the willed body program.

(4) The commission's approval under paragraph (3) of this subsection and its assignment of identifiers under subsection (f) of this section constitute the commission's receipt and distribution of the body or anatomical specimen to the willed body program under Health and Safety Code §§691.029 and 691.030(a)(1). A body or anatomical specimen received in compliance with this section is a body or anatomical specimen distributed under Health and Safety Code Chapter 691 for purposes of Health and Safety Code §691.033(a).

(e) Acceptance; documentation required.

(1) A Designated Responsible Individual of the receiving entity shall approve acceptance of each body or anatomical specimen in writing. That approval satisfies §206.2(g) of this title as to the receiving entity.

(2) Before accepting custody, the receiving entity shall obtain documentation sufficient to establish:

(A) the identity of the donor;

(B) the consent for donation under which the body or anatomical specimen was donated, by a copy of the document of gift or of the record of authorization made under Health and Safety Code §§692A.009 and 692A.010, or by a written attestation of the organ procurement organization, eye bank, or tissue bank identifying that document or record;

(C) that the consent for donation permits use of the body or anatomical specimen for research or education under Health and Safety Code §692A.011, and any restriction on that use;

(D) the name of the transferring organ procurement organization, eye bank, or tissue bank and the donor identification number or other unique reference it assigned to the donor;

(E) a description of the body or anatomical specimen transferred;

(F) a description of any organ, eye, or tissue previously recovered from the donor, to the extent reasonably necessary to identify the material received and maintain an accurate chain of custody. This subparagraph does not require disclosure of information identifying a transplant recipient;

(G) the date and time custody is transferred; and

(H) any instruction of the donor or the donor's agent regarding use or final disposition of the body or anatomical specimen.

(3) The receiving entity shall retain the documentation required by this subsection with the chain-of-custody form for the period required by §206.3(h) of this title and shall make it available for inspection as provided by §206.3(j) of this title.

(f) Identification and chain of custody.

(1) For purposes of §206.3(d)(1) of this title, the receiving entity is the entity that first acquires the body or anatomical specimen under Health and Safety Code Chapter 691 and shall initiate the chain-of-custody form by completing Section A (Header) at the time custody is accepted, identifying the organ procurement organization, eye bank, or tissue bank as the transferring party and recording any donor identification number or other unique reference assigned to a donor by an organ procurement organization, eye bank, or tissue bank.

(2) Not later than the second business day after the date custody is accepted, the receiving entity shall enter the body or anatomical specimen into the Commission-designated electronic system.

(3) A whole body or anatomical specimen received under this section shall be tagged or labeled using Commission-issued identifiers and tags as defined in new §206.1(14) - (15). If the entity is a non-transplant anatomical donation organization, any internal identifier entered in the commission-designated electronic system satisfies the requirements of §206.3 of this title.

(g) Importation. A transfer from an organ procurement organization, eye bank, or tissue bank located outside this state to a receiving entity is an importation subject to §206.4(c) of this title (relating to Transport, Importation and Exportation of Bodies). The submission required by subsection (f)(2) of this section satisfies the notification requirement of §206.4(c) of this title if made within the time that subsection requires. The return of a body or anatomical specimen to the same out-of-state organ procurement organization, eye bank, or tissue bank from which it was received, on completion of the authorized activity, is governed by §206.4(d)(4) of this title.

(h) Records and reporting.

(1) The receiving entity shall keep a permanent record of each body or anatomical specimen received under this section that is sufficient to identify the body or anatomical specimen, tracks it from intake to final disposition, and is available for inspection by the commission or the commission's representative. The policies and procedures required by §206.12(c)(4)(D) of this title (relating to Registration Application and Inspection Required) must address bodies and anatomical specimens received under this section.

(2) The receiving entity shall include bodies and anatomical specimens received under this section in the report required by §206.4(f) of this title.

(i) Final disposition.

(1) Final disposition of a body or anatomical specimen received under this section is subject to §206.14 of this title (relating to Disposition of the Body and Disposition of Remains) and to any instruction documented under subsection (e)(2)(H) of this section.

(2) The receiving entity is an authorized entity described by §206.14(a)(2) of this title with respect to a body or anatomical specimen received under this section. In lieu of disposition under §206.14(a)(2) of this title, the receiving entity may return the body or anatomical specimen to the organ procurement organization, eye bank, or tissue bank if the organization or bank has agreed in writing to accept its return and to provide for final disposition consistent with the consent for donation.

(3) An authorized entity that receives a body or anatomical specimen originating with an organ procurement organization, eye bank, or tissue bank by transfer from a receiving entity shall, on completion of use, return it to the receiving entity as provided by §206.14(a)(1) of this title.

(j) Responsibility not transferred. This section does not exempt any person from any requirement of this chapter on account of the source of a body or anatomical specimen. A person that receives a body or anatomical specimen that originated with an organ procurement organization, eye bank, or tissue bank remains subject to every requirement of this chapter applicable to that person, including registration or authorization under §206.12 of this title, chain of custody under §206.3 of this title, transport and importation under §206.4 of this title, recordkeeping and reporting, inspection as authorized by Health and Safety Code §691.034, and disposition under §206.14 of this title.

(k) Forms; electronic submission. Information required by this section shall be submitted through the Commission-designated electronic system. The commission may prescribe forms and an alternative method of submission for use when the system is unavailable.

(l) Implementation. The commission will not enforce subsection (f) of this section before the later of the 30th day after the effective date of this section or the date the commission publishes the identifier nomenclature under §206.3(m) of this title.

§206.13. Standards for Anatomical Facilities and Other Anatomical Use Locations.

(a) Applicability and general standards.

(1) Applicability. The standards in this section apply to any location in Texas in which a donated human body or anatomical specimen subject to Chapter 691, Health and Safety Code, is received, prepared, stored, held, dissected, manipulated, used for education, training, research, or demonstration, or otherwise present in connection with an activity regulated under this chapter. The applicable standards follow the donated human body or anatomical specimen regardless of whether the location is a permanent anatomical facility, temporary anatomical use location, mobile anatomical laboratory, hotel, convention center, conference facility, clinical or educational setting, or other location.

(2) Applicability of individual requirements. A person or entity subject to this section shall comply with the standards applicable to the nature of the anatomical material, the activity conducted, the preservation method, the duration of use, and the physical setting. A requirement that by its terms applies only to a particular activity, including preparation, embalming, storage, dissection, use of hazardous chemicals, or use of radiation, applies only when that activity occurs.

(3) Equivalent protection. A temporary anatomical use location may satisfy an applicable requirement through temporary equipment, controls, procedures, or other measures when the Commission determines that the measures provide protection substantially equivalent to that required for the same activity at a permanent purpose-built anatomical facility.

(4) Anatomical use areas. Dissection areas must be clean, well ventilated, and well lighted. Floors, tables, tanks, work surfaces, and other surfaces exposed to anatomical material must be maintained in a condition that permits effective cleaning and decontamination and, when appropriate to the activity, must be nonskid and resistant to leakage or absorption. The area must provide sufficient space for the activity to be conducted without compromising specimen integrity, participant safety, sanitation, or donor dignity.

(5) Storage facilities. Storage facilities must be conducive to long-term storage of bodies and conducive to the health of personnel who must work in the area. Storage facilities must be of sufficient size and capacity to safely accommodate the anatomical material reasonably anticipated for the location without undue crowding and must maintain preservation-appropriate temperature and environmental conditions.

(6) Preparation area. The preparation area must be clean, well ventilated, and well lighted. When preparation or embalming is performed, the area must contain the equipment, work surfaces, drainage or containment, ventilation, and sanitation controls appropriate to the procedure being performed. Construction and temporary protective measures must permit effective cleaning, containment, and decontamination.

(7) Embalming. The embalming formula shall be appropriate to the long-term preservation of cadavers and will not present a health hazard to persons dissecting. When embalming or other chemical preservation is performed or chemically preserved material is used, the person or entity responsible for the activity shall provide storage, ventilation, exposure controls, spill response, and other safeguards appropriate to the chemicals involved.

(8) Sanitation and personal protective equipment. Anatomical use areas must provide access to handwashing or an alternative sanitation method appropriate to the activity, appropriate personal protective equipment, and procedures and materials for spill containment, decontamination, and cleanup.

(9) Notice for Complaints. All anatomical facilities and other anatomical use locations shall post at the entrance to the facility a notice of the name, mailing address, and telephone number of the commission for the purpose of directing complaints to the commission. If the anatomical use location is a temporary facility located in a hotel, convention center, conference facility, or other location open to the public, the applicant must provide a copy of the notice to the front desk, information desk or other location where members of the public might make inquiry as to the anatomical use event.

(10) Sharps and regulated waste. The location must provide for the safe containment of sharps and for the segregation, containment, storage, transportation, and lawful disposition of biological, medical, chemical, and other regulated waste.

(11) Preservation. Fresh or fresh-frozen material must be maintained under temperature and storage conditions sufficient to preserve the material, control decomposition and odor, and protect health and safety. Refrigeration, freezers, insulated containers, validated cooling systems, or other appropriate equipment may be used when capable of maintaining required conditions for the period of use.

(12) Emergency preparedness. The location must maintain clear and usable emergency exits and evacuation routes and have procedures appropriate to the activity for loss of electrical service, failure of refrigeration or temperature-control equipment, ventilation failure, spill or container failure, fire or evacuation, inability to continue the activity, and secure relocation or return of anatomical material.

(13) Receipt and removal. The location must provide a secure method for receiving and removing anatomical material that minimizes public exposure and maintains required packaging, labeling, identity, and chain of custody.

(14) Other law. A person or entity subject to this section shall comply with other applicable federal, state, and local health, safety, fire, building, occupational, environmental, radiation, and waste requirements.

(b) Professional Oversight of Donor Care and Embalming.

(1) A willed body program or non-transplant anatomical donation organization that directly accepts donated human bodies within this state must employ or maintain a current valid contract with a funeral director licensed in Texas for professional oversight of donor dignity, preservation, transportation and handling. The oversight role is not the practice of funeral directing under Occupations Code, §651.001(7). The contractual relationship may not convey an ownership interest, as prohibited by Health and Safety Code, §691.034(f).

(2) Embalming of a body by arterial, cavity or hypodermic injection or direct application of chemical preservatives subject to Chapter 651, Occupations Code, by a willed body program or a non-transplant anatomical donation organization operating within the state, must be performed by a licensed embalmer, consistent with Occupations Code §651.251(b). Preservation solely by refrigeration and freezing does not require the employment or contracting with a licensed embalmer.

(c) Safety and environmental standards.

(1) Ventilation. Anatomical use, preparation, and storage areas must provide ventilation and environmental controls appropriate to the preservation method, chemicals present, number and type of bodies or anatomical specimens, size and configuration of the work area, duration of the activity, and procedure being performed. Ventilation and environmental controls must prevent unsafe accumulation or migration of odors, vapors, aerosols, fumes, or other contaminants into areas accessible to the public or unauthorized persons.

(2) Storage of hazardous chemicals. All hazardous chemicals shall be stored in a separate and approved facility or area. Explosive or flammable chemicals must be properly stored. Chemical storage must also comply with applicable labeling, compatibility, access-control, and fire-safety requirements.

(3) Hazardous exposures. Chemicals, fumes, vapors, aerosols, fluids, and other hazards associated with anatomical activity must be controlled through ventilation, containment, appropriate storage, work practices, personal protective equipment, and other measures necessary to protect participants, workers, and the public.

(4) Radiation. If sources of radiation are utilized, the person or entity responsible for the activity shall comply with all applicable requirements of the Department of State Health Services under Chapter 401, Health and Safety Code.

(5) Power and equipment. Equipment necessary to maintain preservation, environmental control, security, or safe operation must be maintained in operable condition. When failure of equipment could compromise specimen integrity, safety, or security, an appropriate backup or contingency capability must be available.

(d) Public welfare, security, privacy, and dignity.

(1) Visibility. All areas where human bodies are handled must not be visible from the outside of the building or so located that the public has ready visibility of transport, preparation, or dissection in progress. Anatomical activity and the receipt, transport, preparation, storage, or removal of anatomical material must be arranged to prevent public sightlines and unnecessary public display.

(2) Accessibility. All areas used for receipt and preparation, storage, or dissection of human bodies must be inaccessible and inadmissible to the general public and all unauthorized personnel. All areas must have appropriate locks. Only personnel concerned with the preparation of cadavers should have access to storage and preparation areas. Storage areas should be securely locked at all times when bodies are not being placed in or removed from storage. Access to any anatomical use area, including a field location, must be restricted to individuals whose presence is reasonably necessary for the authorized activity while anatomical material is present.

(3) Security. Anatomical material must be secured whenever it is not under direct supervision and may not be left unattended in an unsecured room, hallway, loading area, vehicle, or other location accessible to unauthorized persons.

(4) Dignity. Anatomical material must be handled at all times with dignity and respect and with the least possible public display.

(5) Prohibited display. A donated human body or anatomical specimen may not be displayed as entertainment, spectacle, decoration, advertising, or for a purpose inconsistent with the donor's authorization and this chapter.

(6) Photography and recording. Photography, video recording, livestreaming, or other image capture involving anatomical material is restricted to non-identifiable subject matter and may occur only when authorized by the donor documentation applicable to the anatomical material, reasonably related to the authorized educational, training, scientific, or documentation purpose, and controlled to prevent unauthorized dissemination. This subsection does not prohibit recording by a fixed security system for facility security purposes; a security recording is not required to obscure identifying features, may not be used, sold, or distributed for any other purpose, and is subject to the treatment-with-respect standard adopted under §691.022(b), Health and Safety Code.

(e) Temporary anatomical use.

(1) Applicability. Temporary anatomical use, as defined in §206.1(33) of this chapter (relating to Scope and Definitions), may occur at a hotel or resort; convention or conference center; meeting or event facility; hospital or ambulatory surgical center; university, college, or other educational facility; physician office or clinical training site; corporate or commercial training facility; temporary surgical or bioskills laboratory; mobile anatomical laboratory; or another location approved by the Commission.

(2) This subsection does not apply when the anatomical activity occurs entirely within a currently registered and inspected anatomical facility at its approved location; the activity occurs entirely within a currently registered and inspected purpose-built mobile anatomical laboratory and no anatomical material is removed from that laboratory for use elsewhere at the host property; or no donated human body or anatomical specimen is physically present, including training conducted solely through synthetic models, computer-generated simulation, augmented reality, virtual reality, or other digital representation.

(3) Prior Commission authorization required.

(A) A person may not conduct temporary anatomical use unless the Commission has issued written authorization for the activity.

(B) Authorization applies only to the authorized person, event, dates, location, activity, and conditions identified in the Commission's approval; does not constitute registration of the host venue as a permanent anatomical facility; does not independently authorize the host venue to acquire, possess, transfer, distribute, use, dissect, or dispose of anatomical material; and may not be transferred to another person, host venue, or event.

(C) A hotel, convention center, conference facility, property owner, or other host venue does not become a regulated anatomical entity solely because it rents, licenses, or otherwise makes space available for an authorized anatomical activity, provided that the venue does not independently receive, possess, use, dissect, manipulate, transfer, or otherwise exercise custody or control over the anatomical material.

(D) A material change in the authorized person, location, dates, anatomical source, specimen type or quantity, preservation method, activity, storage arrangement, custody arrangement, responsible individual, or other condition material to approval must be reported to and approved by the Commission before implementation.

(4) Application and advance notice.

(A) An application for temporary anatomical use must be submitted to the Commission on a form prescribed by the Commission not later than 30 calendar days before the first date on which a donated human body or anatomical specimen will be present at the temporary location.

(B) The Commission may accept and approve an application submitted fewer than 30 calendar days before the proposed activity when the Commission determines that expedited review can be completed without compromising donor protection or regulatory oversight, the applicant demonstrates good cause for the late request, and sufficient information is available to determine compliance with this section.

(C) Expedited review is discretionary and does not create an entitlement to expedited approval.

(5) Application information. The applicant shall provide information sufficient for the Commission to evaluate the proposed activity, including:

(A) the name and contact information of the applicant or operator;

(B) the name, address, and contact information of the host venue;

(C) written acknowledgment and consent from an authorized representative of the host venue;

(D) the date and hours of the activity, including setup, receipt of anatomical material, overnight storage, and removal;

(E) a description of the education, training, research, demonstration, or other proposed activity;

(F) the identity of each willed body program or non-transplant anatomical donation organization supplying anatomical material;

(G) the number and general type of bodies or anatomical specimens anticipated;

(H) the preservation method applicable to the anatomical material;

(I) identification of the individual responsible on site for compliance with this chapter for the activity;

(J) identification of the individual or entity retaining custody of the anatomical material after the activity;

(K) a floor plan or site diagram identifying, as applicable, the anatomical work area, specimen receipt and loading location, storage areas, entrances and exits, access-controlled boundaries, handwashing or sanitation locations, waste and sharps collection areas, and any area in which anatomical material will be held overnight;

(L) the proposed method for maintaining appropriate temperature and preservation;

(M) security and access-control procedures;

(N) ventilation, environmental control, and chemical-exposure controls appropriate to the preservation method and procedure being performed;

(O) sanitation, decontamination, spill response, personal protective equipment, and bloodborne-pathogen procedures;

(P) procedures for sharps, biological waste, medical waste, and other regulated waste;

(Q) transportation and chain-of-custody arrangements;

(R) an emergency and contingency plan addressing, as applicable, loss of electrical service, failure of refrigeration or temperature-control equipment, ventilation failure, spill or container failure, fire or evacuation, inability to continue the scheduled activity, and secure relocation or return of anatomical material;

(S) the intended return, transfer, or final disposition of each donated human body or anatomical specimen after the activity; and

(T) other information reasonably required by the Commission to determine compliance with this chapter.

(6) Responsibility and custody.

(A) Each temporary anatomical use event must have an identified responsible individual present and available during anatomical activity.

(B) The applicant or operator is responsible for ensuring that the anatomical activity is conducted in accordance with the Commission's authorization and this chapter.

(C) A host venue does not become authorized to acquire or independently exercise custody over anatomical material solely by hosting the activity.

(D) Custody must remain with, or be transferred only among, persons or entities authorized to possess the donated human body or anatomical specimen under applicable law and this chapter.

(E) The supplying willed body program or non-transplant anatomical donation organization and any receiving authorized entity remain responsible for duties imposed upon them by this chapter notwithstanding the use of a third-party venue, event organizer, contractor, or other service provider.

(F) Contracting with another person does not relieve a regulated person or entity of a duty imposed by this chapter.

(7) Temporary-site compliance. Before anatomical material is received and throughout the period anatomical material remains on site, a temporary anatomical use location must comply with the applicable requirements of subsections (a) through (d) of this section. The Commission may approve temporary equipment, procedures, controls, or other measures that provide substantially equivalent protection to permanent infrastructure appropriate to the same activity.

(8) Storage and overnight custody.

(A) Anatomical material stored between sessions or overnight must be secured against unauthorized access, maintained under preservation-appropriate temperature and environmental conditions, protected from public view, and continuously accounted for through required chain-of-custody records.

(B) A guest room, ordinary hotel storage room, unmonitored loading dock, unlocked meeting room, or similar space may not be used for storage unless specifically included in the approved application and demonstrated to satisfy this section.

(9) Transportation and receipt.

(A) Transportation to and from a temporary anatomical use location must comply with §§206.3, 206.4, and 206.5 of this chapter (relating to Transport, Importation and Exportation of Bodies, relating to Transfer of Bodies or Anatomical Specimens, and relating to Fees) and other applicable provisions of this chapter.

(B) Anatomical material must be received through a controlled process that minimizes public exposure, maintains required packaging and labeling, documents transfer of custody, and verifies the identity and quantity of material received.

(C) Packaging must remain secured and leak-resistant during receipt, staging, and removal.

(10) Mobile anatomical laboratories.

(A) A mobile unit in which a donated human body or anatomical specimen is dissected, manipulated, stored, used for training, or otherwise subjected to anatomical activity is an anatomical-use space and is not merely a transportation vehicle.

(B) A mobile anatomical laboratory must provide safeguards substantially equivalent to those required under this section, including appropriate security, sanitation, ventilation, temperature control, power supply and backup or contingency capability, sharps and waste management, spill response, and access control.

(C) A registered and inspected purpose-built mobile anatomical laboratory may operate at a hotel, convention center, or other property without subjecting the adjoining host building to temporary anatomical use requirements if all anatomical activity remains within the approved mobile laboratory, anatomical material is not stored, staged, dissected, or otherwise used inside or adjacent to the host building and outside of the mobile anatomical laboratory, and any location notice required by the Commission is submitted.

(11) Inspection and Commission access.

(A) A temporary anatomical use location is subject to inspection by the Commission.

(B) The Commission may conduct pre-event document review; inspect the site after setup and before receipt or use of anatomical material; inspect while anatomical activity is underway; conduct an unannounced inspection at a reasonable time; require photographs, measurements, records, certifications, or other evidence of compliance; or require correction of a deficiency before anatomical activity begins or continues.

(C) Approval of an application based on submitted documents does not prevent the Commission from determining through inspection that the actual site fails to comply with this section. An application is not authorized by the Commission until the on-site inspection is completed and approved by the Executive Director or designee.

(D) The Commission may deny, condition, suspend, or withdraw an event authorization when required information is materially false or incomplete; the actual setup materially differs from the approved application; anatomical material cannot be maintained safely or securely; custody or specimen identity cannot be reliably established; the activity is inconsistent with donor authorization; continued activity presents a threat to health, safety, specimen integrity, donor dignity, or lawful disposition; or the applicant fails to comply with this chapter.

(E) The holder of a temporary anatomical use authorization is entitled to a hearing prior to revocation of such authorization pursuant to Health and Safety Code §691.034(d).

(12) End-of-event reconciliation.

(A) At the end of each event and before the temporary anatomical use authorization is considered complete, the responsible individual shall reconcile all anatomical material associated with the event.

(B) Reconciliation must establish for each donated human body or anatomical specimen the unique identifier; quantity and identity received; any division, alteration, consumption, or creation of derived specimens occurring during the authorized activity; quantity and identity remaining at the conclusion of the activity; and the person or entity to whom the body or specimen was returned or transferred, or the authorized manner of final disposition.

(C) Every donated human body and anatomical specimen received for the event must be accounted for at the conclusion of the event.

(D) Discrepancies must be reported to the Commission as required by this chapter.

(13) Venue acknowledgment. Before authorization is issued, the host venue shall acknowledge in writing that:

(A) it is aware that donated human bodies or anatomical specimens will be present;

(B) it consents to the proposed activity and identified areas of the property being used;

(C) it will permit Commission inspection of the areas associated with the authorized activity;

(D) it will permit implementation of the access-control, security, environmental, loading, sanitation, and emergency measures identified in the approved application; and

(E) it understands that Commission authorization applies to the specific temporary activity and does not constitute registration of the venue as a permanent anatomical facility.

(14) Records. The applicant and each regulated entity required to maintain records under this chapter shall retain the application, Commission authorization, venue acknowledgment, applicable chain-of-custody records, inspection documentation, disposition records, and end-of-event reconciliation for the period required by this chapter and shall produce them to the Commission upon request.