Current through Register Vol. 30, No. 38, September 20, 2024
A. A
non-accredited procurement organization shall maintain a legible, reproducible
record for each donor from whom it obtains NAM for at least 10 years beyond the
date of final disposition according to A.R.S. §
36-851.03(A)(7).
B. To ensure traceability of NTAD and NAM, a
non-accredited procurement organization shall:
1. Document each procedure performed on a
NTAD and NAM related to processing and storing NAM;
2. For each document created in subsection
(1), include:
a. The date and time for each
procedure completed; and
b. The
name of the technician who performed the procedure; and
3. Submit information required to register
the death of a NTAD within seven calendar days after receiving the NTAD
according to A.R.S. §
36-325.
C. A non-accredited procurement organization
shall ensure a donor record is:
1.
Confidential and kept in a location with controlled access,
2. Stored in a manner to prevent unauthorized
access, and
3. Maintained in a
manner to preserve the donor record's completeness and accuracy.
D. A non-accredited procurement
organization shall ensure a donor record shall include the following donor
information:
1. The donor's name;
2. The donor's unique identifying number
specified in A.R.S. §
36-851.03(A)(6);
3. The donor's date of birth and date of
death; and
4. The name and contact
information of the person responsible for a donor's anatomical gift; if
applicable.
E. A
non-accredited procurement organization shall include the following donor
records, as applicable:
1. Donor consent form
or documentation of authorization for an anatomical gift includes:
a. The intended use of the NAM;
b. How the NAM may be used;
c. A statement that the NAM will be treated
with dignity at all times; and
d. A
statement that the NAM may require international export to an
end-user;
2. Document of
authorization "" a legal record of the gift, to take place postmortem,
permitting and defining the scope of the postmortem acquisition and use of NAM
for education and research, signed or otherwise recorded by the authorizing
person, pursuant to law;
3.
Documentation of gift "" the donor's legal record of the gift of NAM permitting
and defining the scope of the postmortem acquisition and use of NAM for
education and research. It must be signed or otherwise recorded by the donor or
individual authorized under law to make a gift during the donor's
lifetime;
4. Donor's death record
specified in A.A.C.
R9-19-303;
5. Human remains release form specified in
A.A.C.
R9-19-301;
6. Information for a death record specified
in A.A.C.
R9-19-302
for transporting human remains into the state;
7. Disposition-transit permit specified in
A.A.C.
R9-19-308;
8. Medical examiner's release of information
specified in A.R.S. §
36-861;
9. All documents and permits that establish
the chain of custody and identifies the individuals and organizations that had
physical custody of the NAM;
10.
Medical records, including:
a. Donor's
physical assessment;
b. Risk
assessment questionnaire;
c.
Pathology and laboratory testing and reports;
d. Physician summaries;
e. Transfusion or infusion information;
and
f. Plasma dilution
calculations;
11.
Information from the donor referral source;
12. Donor eligibility;
13. Donor acceptability assessment;
14. Physical assessment
questionnaire;
15. Documentation
related to distribution;
16.
Serological results, when applicable;
17. Cremation authorization
document;
18. Documentation related
to NAM recovery, storage, and distribution activities;
19. Final disposition documentation,
including all records demonstrating chain of custody; and
20. Documentation of the report in
R9-9-201(F) and (G).
F. A
donor's consent form shall be accessible to the donor's known
consenter.
G. Upon demonstration of
a legal right to acquire a donor's record, a non-accredited procurement
organization shall provide access to:
1. An
agent legally authorized or other individual designated at the time a donor
gives consent;
2. An individual
appointed by a court or authorized by state laws;
3. An individual of a procurement
organization as identified by SOPs;
4. An individual from an approving
accrediting body, if applicable; and
5. An individual from the Department or other
regulatory agency authorized by state and federal laws or
regulations.
H. Except
for a donor record specified in subsection (A), a non-accredited procurement
organization shall maintain documentation required by this Chapter for at least
three years after the date of the documentation and provide copies of the
documentation to the Department for review upon request.
