SF 1567

as introduced - 86th Legislature (2009 - 2010) Posted on 02/09/2010 02:22am

A bill for an act
relating to anatomical gifts; establishing requirements for nontransplant
anatomical recovery organizations and anatomical user organizations; amending
Minnesota Statutes 2008, sections 144.99, subdivision 1; 525A.11; proposing
coding for new law as Minnesota Statutes, chapter 525B.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2008, section 144.99, subdivision 1, is amended to read:

Subdivision 1.

Remedies available.

The provisions of chapters 103I deleted text begin and deleted text end new text begin , new text end 157 new text begin ,
and 525B new text end and sections 115.71 to 115.77; 144.12, subdivision 1, paragraphs (1), (2),
(5), (6), (10), (12), (13), (14), and (15); 144.1201 to 144.1204; 144.121; 144.1222;
144.35; 144.381 to 144.385; 144.411 to 144.417; 144.495; 144.71 to 144.74; 144.9501
to 144.9512; 144.992; 326.70 to 326.785; 327.10 to 327.131; and 327.14 to 327.28 and
all rules, orders, stipulation agreements, settlements, compliance agreements, licenses,
registrations, certificates, and permits adopted or issued by the department or under any
other law now in force or later enacted for the preservation of public health may, in
addition to provisions in other statutes, be enforced under this section.

Sec. 2.

Minnesota Statutes 2008, section 525A.11, is amended to read:

525A.11 PERSONS THAT MAY RECEIVE ANATOMICAL GIFT; PURPOSE
OF ANATOMICAL GIFT.

(a) An anatomical gift may be made to the following persons named in the document
of gift:

(1) a hospital; accredited medical school, dental school, college, or university; organ
procurement organization; or deleted text begin nonprofit organization in medical education or research, deleted text end
for research or education new text begin , a nontransplant anatomical user organization or a registered
nontransplant anatomical recovery organization that meets the requirements of chapter
525B new text end ;

(2) subject to paragraph (b), an individual designated by the person making the
anatomical gift if the individual is the recipient of the part; and

(3) an eye bank or tissue bank.

(b) If an anatomical gift to an individual under paragraph (a), clause (2), cannot be
transplanted into the individual, the part passes in accordance with paragraph (g) in the
absence of an express, contrary indication by the person making the anatomical gift.

(c) If an anatomical gift of one or more specific parts or of all parts is made in a
document of gift that does not name a person described in paragraph (a) but identifies the
purpose for which an anatomical gift may be used, the following rules apply:

(1) if the part is an eye and the gift is for the purpose of transplantation or therapy,
the gift passes to the appropriate eye bank;

(2) if the part is tissue and the gift is for the purpose of transplantation or therapy, the
gift passes to the appropriate tissue bank;

(3) if the part is an organ and the gift is for the purpose of transplantation or therapy,
the gift passes to the appropriate organ procurement organization as custodian of the
organ; and

(4) if the part is an organ, an eye, or tissue and the gift is for the purpose of research
or education, the gift passes to the appropriate new text begin organ new text end procurement organization new text begin or
nonprofit eye or tissue bank whose primary mission is transplantation and is overseen by
the Food and Drug Administration; or to a nontransplant anatomical user organization or a
registered nontransplant anatomical recovery organization that meets the requirements of
chapter 525B new text end .

(d) For the purpose of paragraph (c), if there is more than one purpose of an
anatomical gift set forth in the document of gift but the purposes are not set forth in any
priority, the gift must be used for transplantation or therapy, if suitable. If the gift cannot
be used for transplantation or therapy, the gift may be used for research or education.

(e) If an anatomical gift of one or more specific parts is made in a document of gift
that does not name a person described in paragraph (a) and does not identify the purpose
of the gift, the gift may be used only for transplantation or therapy, and the gift passes in
accordance with paragraph (g).

(f) If a document of gift specifies only a general intent to make an anatomical gift
by words such as "donor," "organ donor," or "body donor," or by a symbol or statement
of similar import, the gift may be used only for transplantation or therapy, and the gift
passes in accordance with paragraph (g).

(g) For purposes of paragraphs (b), (e), and (f), the following rules apply:

(1) if the part is an eye, the gift passes to the appropriate eye bank;

(2) if the part is tissue, the gift passes to the appropriate tissue bank; and

(3) if the part is an organ, the gift passes to the appropriate organ procurement
organization as custodian of the organ.

(h) An anatomical gift of an organ for transplantation or therapy, other than
an anatomical gift under paragraph (a), clause (2), passes to the organ procurement
organization as custodian of the organ.

(i) If an anatomical gift does not pass pursuant to paragraphs (a) to (h) or the
decedent's body or part is not used for transplantation, therapy, research, or education,
custody of the body or part passes to the person under obligation to dispose of the body or
part.

(j) A person may not accept an anatomical gift if the person knows that the gift was
not effectively made under section 525A.05 or 525A.10 or if the person knows that the
decedent made a refusal under section 525A.07 that was not revoked. For purposes of
this paragraph, if a person knows that an anatomical gift was made on a document of gift,
the person is deemed to know of any amendment or revocation of the gift or any refusal
to make an anatomical gift on the same document of gift.

(k) Except as otherwise provided in paragraph (a), clause (2), nothing in this chapter
affects the allocation of organs for transplantation or therapy.

Sec. 3.

new text begin [525B.01] DEFINITIONS.
new text end

new text begin Subdivision 1. new text end

new text begin Scope. new text end

new text begin The definitions in this section apply to this chapter.
new text end

new text begin Subd. 2. new text end

new text begin Anatomical gift. new text end

new text begin "Anatomical gift" has the meaning given in section
525A.02, subdivision 4.
new text end

new text begin Subd. 3. new text end

new text begin Commissioner. new text end

new text begin "Commissioner" means the commissioner of health.
new text end

new text begin Subd. 4. new text end

new text begin Distribution. new text end

new text begin "Distribution" means the removal of a human body or part
from a storage location to any other location for educational or research use.
new text end

new text begin Subd. 5. new text end

new text begin Education. new text end

new text begin "Education" means the use of a human body or part for the
purpose of teaching or training individuals, including, but not limited to, medical or
dental professionals and students, with regard to the anatomy and characteristics of the
human body.
new text end

new text begin Subd. 6. new text end

new text begin Nontransplant anatomical recovery organization. new text end

new text begin "Nontransplant
anatomical recovery organization" means a corporation or an entity that is a state, a
political subdivision of a state, or an agency or public educational organization of a state
or political subdivision that is engaged in the recovery or distribution of a human body
or part donation for education or research. This definition does not include an organ
procurement organization as defined in section 525A.02, subdivision 18, or a nonprofit
eye or tissue bank whose primary mission is transplantation and is overseen by the United
States Food and Drug Administration.
new text end

new text begin Subd. 7. new text end

new text begin Nontransplant anatomical user organization. new text end

new text begin "Nontransplant anatomical
user organization" means an organization that uses or facilitates the use of a human body
or part donation for education or research. This definition does not include an organ
procurement organization as defined in section 525A.02, subdivision 18, or a nonprofit
eye or tissue bank whose primary mission is transplantation and is overseen by the United
States Food and Drug Administration.
new text end

new text begin Subd. 8. new text end

new text begin Organ procurement organization. new text end

new text begin "Organ procurement organization"
has the meaning given in section 525A.02, subdivision 18.
new text end

new text begin Subd. 9. new text end

new text begin Part. new text end

new text begin "Part" means an organ, an eye, or tissue of a human being.
new text end

new text begin Subd. 10. new text end

new text begin Recovery. new text end

new text begin "Recovery" means obtaining the consent of an anatomical gift
and the obtaining, processing, storing, and distributing of a human body or part, including,
but not limited to, performing surgical or other technical procedures necessary for
recovering the body or part. Recovery does not include actions taken by a nontransplant
anatomical user organization or by a medical examiner or coroner as part of their
professional duties.
new text end

new text begin Subd. 11. new text end

new text begin Research. new text end

new text begin "Research" means the performance of scientific testing and
observation designed to result in the acquisition of generalizable knowledge. Research
does not include an autopsy or other investigation conducted for the purpose of obtaining
information related to the decedent, and does not include, at the discretion of the
commissioner, clinical studies, cellular-level research, brain autopsies for specific disease
research, and biomedical device explants.
new text end

Sec. 4.

new text begin [525B.02] REGISTRATION STANDARDS FOR NONTRANSPLANT
ANATOMICAL RECOVERY ORGANIZATIONS.
new text end

new text begin Subdivision 1. new text end

new text begin Prohibition. new text end

new text begin Any nontransplant anatomical recovery organization
that engages in the recovery or distribution of a human body or part donation for education
or research where all or part of the recovery or distribution takes place in Minnesota
must be registered with the commissioner of health in accordance with this chapter. The
registration required under this chapter is in addition to any license or permit required by a
local board of health, other local health agency, or any state or federal agency.
new text end

new text begin Subd. 2. new text end

new text begin Registration. new text end

new text begin (a) To become registered, a nontransplant anatomical
recovery organization must submit to the commissioner an application for registration on
a form prescribed by the commissioner and any applicable fees required under subdivision
5. The application must contain, at a minimum:
new text end

new text begin (1) the name of the applicant;
new text end

new text begin (2) the type of organization to be registered;
new text end

new text begin (3) the location of the organization;
new text end

new text begin (4) the name of the organization's medical director and the state in which the director
is licensed; and
new text end

new text begin (5) any other information deemed applicable by the commissioner.
new text end

new text begin (b) The registration is valid for a one-year period and may be renewed subject to
compliance with the requirements of this section.
new text end

new text begin (c) The commissioner may enter and inspect the premises and records of
any nontransplant anatomical recovery organization as is deemed necessary by the
commissioner to enforce the provisions of this section.
new text end

new text begin Subd. 3. new text end

new text begin Requirements for operating as a nontransplant anatomical recovery
organization. new text end

new text begin A nontransplant anatomical recovery organization registered under this
section must comply with the following requirements:
new text end

new text begin (a) The organization's medical director must be a physician licensed in Minnesota or
the state in which the organization is incorporated. The medical director is responsible
for ensuring compliance with the provisions of this section and the maintenance of any
records required under this section.
new text end

new text begin (b) The organization shall create, compile, and maintain a complete record on each
donor from which it recovers a human body or part for educational or research purposes.
The record must include, at a minimum:
new text end

new text begin (1) documentation that the donor or other person authorized to make an anatomical
gift under chapter 525A designated the anatomical gift for educational or research
purposes, as required under chapter 525A;
new text end

new text begin (2) documentation of the identity and address of each person that has been in
possession of the human body or part prior to the organization, including, but not limited
to, a funeral home, coroner, medical examiner, hospital, or procurement organization;
new text end

new text begin (3) documentation of the use and disposition of each human body or part, including
the name and address of each person that receives a human body or part directly from the
organization;
new text end

new text begin (4) documentation that each anatomical gift has been screened for communicable
diseases reportable under Minnesota Rules, chapter 4605, or other applicable law; and
new text end

new text begin (5) documentation that the donor's death has been registered under section 144.221
or other applicable law if the death did not occur in Minnesota.
new text end

new text begin (c) The organization shall not solicit for donations as prohibited under section
149A.70, subdivision 5a, clause (1).
new text end

new text begin (d) The organization shall not provide reimbursement as prohibited under section
149A.70, subdivision 5.
new text end

new text begin (e) The organization shall clearly disclose the organization's incorporation status on
all marketing or informational materials distributed to the public.
new text end

new text begin (f) The organization shall clearly disclose the incorporation status on the informed
consent document signed by the donor or donor's next of kin.
new text end

new text begin (g) The organization may reimburse a donor's next of kin for any reasonable
expenses directly related to the donation, including the transportation, filing of mandatory
paperwork, serology testing, storage, handling, preservation, distribution, cremation, and
returning cremated remains to next of kin.
new text end

new text begin (h) The organization shall disclose the source of a donation in the event that the
nontransplant anatomical recovery organization did not directly receive the anatomical
gift from the donor or donor's next of kin. All sources of anatomical donations being
distributed in Minnesota must be registered as a nontransplant anatomical recovery
organization with the commissioner.
new text end

new text begin Subd. 4. new text end

new text begin Transfers. new text end

new text begin A nontransplant anatomical recovery organization shall not
transfer a whole human body or part to any other entity unless authorized in writing by
the nontransplant anatomical recovery organization from which the whole body or part
was obtained.
new text end

new text begin Subd. 5. new text end

new text begin Registration fees. new text end

new text begin (a) Each application for an initial registration or
registration renewal to operate a nontransplant anatomical recovery organization shall be
accompanied by a fee of $........
new text end

new text begin (b) All fees are nonrefundable and must be deposited in the state government special
revenue fund and appropriated to the commissioner of health to implement this section.
new text end

Sec. 5.

new text begin [525B.03] NONTRANSPLANT ANATOMICAL USER ORGANIZATION.
new text end

new text begin Subdivision 1. new text end

new text begin Standards. new text end

new text begin (a) Any nontransplant anatomical user organization
that uses a human body or part donation for education or research when the education
or research takes place in Minnesota must comply with the requirements described in
subdivision 2. The requirements under this section are in addition to any license or permit
required by a local board of health, other local health agency, or any state or federal agency.
new text end

new text begin (b) The commissioner may enter and inspect the premises and records of any
nontransplant anatomical user organization as is deemed necessary by the commissioner
to enforce the provisions of this section.
new text end

new text begin Subd. 2. new text end

new text begin Requirements for operating as a nontransplant anatomical user
organization. new text end

new text begin (a) A nontransplant anatomical user organization must create, compile, and
maintain a complete record on each donor from which it uses a human body or part for
educational or research purposes. The record must include, at a minimum:
new text end

new text begin (1) the chain of custody for the anatomical gift from acquisition by the organization
through final disposition;
new text end

new text begin (2) documentation that the donor or other person authorized to make an anatomical
gift under this chapter designated the anatomical gift for educational or research purposes;
new text end

new text begin (3) compliance with section 149A.93 if the whole body is being transported and
compliance with all federal laws and regulations if parts of the body are being transported;
new text end

new text begin (4) that each human body or part used for anatomical education or research was
received from a nontransplant anatomical recovery organization registered under section
525B.02; and
new text end

new text begin (5) documented compliance with section 149A.95 upon the cremation of each
human body or part.
new text end

new text begin (b) Unless otherwise authorized by the commissioner of health, the use of an
anatomical gift by a nontransplant anatomical user organization must occur in a laboratory
setting that, at a minimum, meets the following requirements:
new text end

new text begin (1) walls and floors must be nonporous and doors, ceilings, and windows must be
constructed to prevent odors from entering any other part of the building;
new text end

new text begin (2) working sinks and adequate drainage throughout the laboratory space;
new text end

new text begin (3) nonporous tables for specimen dissection;
new text end

new text begin (4) adequate space for storage of chemicals and materials used in the preparation
of specimens;
new text end

new text begin (5) counters, tables, and cabinetry must be built of materials that can be easily
disinfected and cleaned;
new text end

new text begin (6) designated refrigerated or freezer storage for unpreserved specimens that is
lockable and equipped with an alarm that signals unacceptable temperature deviation;
new text end

new text begin (7) independent ventilation with an exhaust fan that provides at least 12 air changes
per hour;
new text end

new text begin (8) lockable doors with restricted private access. The laboratory setting must be
secure at all times and entry to the room must be limited to authorized persons;
new text end

new text begin (9) each door allowing ingress or egress must carry a hazard warning sign
incorporating the universal symbol for each applicable biohazard;
new text end

new text begin (10) decontamination and disposal procedures for regulated medical waste shall
be utilized. All hazardous and regulated waste materials shall be handled, stored, and
discarded as appropriate and in compliance with state law;
new text end

new text begin (11) eating, drinking, smoking, and the application of cosmetics or contact lenses
must not be permitted in work areas; and
new text end

new text begin (12) gloves, laboratory coats, gowns, or other protective clothing must be worn
while handling anatomic material. This protective clothing must not be worn outside the
work area and must be disposed of in an appropriate biohazardous waste receptacle.
new text end

Sec. 6.

new text begin [525B.04] ENFORCEMENT.
new text end

new text begin The commissioner shall enforce this chapter in accordance with sections 144.989 to
144.993.
new text end