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Stat. Auth.:ORS438.710 & 438.720 Stats. Implemented:ORS438.705-438.720 & 438.994 Hist.: Ph 6-2014, F. 1-30-14, Cert. Ef. 2-1-14


Published: 2015

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The Oregon Administrative Rules contain OARs filed through November 15, 2015

 

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OREGON HEALTH AUTHORITY,

PUBLIC HEALTH DIVISION

 

DIVISION 81
NONTRANSPLANT ANATOMICAL RESEARCH
RECOVERY ORGANIZATIONS
333-081-0000
Purpose
The purpose of these rules is to establish
standards for licensure of Nontransplant Anatomical Research Recovery Organizations.
Stat. Auth.: ORS 438.705-438.720 & 438.994
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0005
Definitions
As used in OAR 333-081-0000 through
333-081-0090 the following definitions apply:
(1) “Accrediting body”
means an entity that is approved by the Public Health Division and meets the requirements
of ORS 438.720(2).
(2) “Anatomical material”
has the meaning given that term in ORS 438.705(1).
(3) “Division”
means the Public Health Division of the Oregon Health Authority.
(4) “Donor” has
the meaning given that term in ORS 97.953.
(5) “Human Remains”
has the meaning given that term in ORS 97.010.
(6) “Nontransplant
anatomical research recovery organization” or “NARRO” has the
meaning given that term in ORS 438.705(3) and is defined
as follows:
(a) A NARRO means a person
that engages in the recovery or distribution of anatomical material from a donor
for research or education purposes other than transplanting the anatomical material
or therapy.
(b) A NARRO does not include:
(A) A hospital or other health
care facility as those terms are defined in ORS 442.015;
(B) A public corporation
as defined in ORS 353.010;
(C) A public or private institution
of higher education; or
(D) A clinical laboratory,
as defined in ORS 438.010, that is:
(i) Licensed under ORS 438.010
to 438.510; and
(ii) Owned or controlled
by, or under common ownership with, a hospital described in paragraph (A) of this
subsection.
(7) “Survey”
means an inspection of the premises or records of either an applicant for licensure
as a NARRO or of a licensed NARRO in order to determine the extent to which that
entity is in compliance with ORS 438.710 & 438.715 and
these rules.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0010
Application for Licensure
(1) Persons meeting the definition of
a NARRO as set out in ORS 438.705(3) and OAR 333-081-0005(5)
may not act as a NARRO or hold themselves out as a NARRO unless licensed as such
by the Division.
(2) An applicant wishing
to apply for a license to operate a NARRO shall submit an application on the most
current form prescribed by the Division and pay the application fee specified in
OAR 333-081-0035.
(3) An applicant that has
obtained accreditation from an accrediting body approved by the Division shall provide
proof of accreditation to the Division with its license application and shall include:
(a) All of the approved accrediting
body survey and inspection reports; and
(b) Written evidence of all
corrective actions underway or completed in response to the approved accrediting
body recommendations including progress reports.
(4) If any of the information
delineated in a NARRO’s most recent application changes at a time other than
the annual renewal date, it must submit a revised application to the Division within
30 calendar days of the change.
(5) Notwithstanding section
(4) of this rule, a NARRO must submit a revised application to the Division 30 calendar
days prior to any of the following changes:
(a) Change in ownership or
management, acquisition by or of, or merger with another NARRO;
(b) Change in facilities
because of expansion, relocation, renovations or structural changes that affect
NARRO operations; and
(c) Change in the scope of
operations of the NARRO.
(6) In order to allow the
Division to determine whether any of the changes reported in accordance with section
(4) or (5) of this rule may affect NARRO compliance with NARRO licensing laws and
rules, the Division may request NARRO documents, records or other materials for
review or it may conduct an on-site inspection.
(7) If a NARRO loses accreditation,
it shall immediately notify the Division and surrender its license in accordance
with OAR 333-081-0045.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0015
Review of License Application
(1) Following receipt of a completed
application and the required fee, the Division must conduct a survey in accordance
with OAR 333-081-0050 to determine whether the NARRO is in compliance with ORS 438.710 & 438.715 and these rules.
(2) In lieu of conducting
a survey, the Division may accept proof of accreditation by an accrediting body
approved by the Division.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0020
Approval of License Application
(1) The Division must notify an applicant
in writing if a license application is approved and must include a copy of the license.
(2) The Division will issue
a license only for the premises and person(s) named in the application and it may
not be transferred or assigned.
(3) A licensed NARRO must
post the license in a conspicuous location where it is viewable by the public.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0025
Denial of License Application
If the Division intends to deny a license
application, it shall issue a Notice of Proposed Denial of License Application in
accordance with ORS 183.411 through 183.470.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0030
Expiration and Renewal of License
(1) An initial or renewed license expires
two years after the date of issuance or renewal.
(2) If the ownership of a
NARRO changes, a new license is required.
(3) If renewal or a new license
is sought because of a change of ownership, the licensee shall make application
at least 45 days prior to the change of ownership using a form prescribed by the
Division.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0035
Fees
(1) The fee for an initial or renewed
NARRO license is $1,750.
(2) All application fees
are non-refundable.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0040
Denial, Suspension or Revocation
of License
(1) A license for a NARRO may be denied,
suspended or revoked by the Division if a licensed NARRO has failed to comply with
Oregon Laws 2013, chapter 356, sections 2 and 3, OAR 333-081-0080 or for violations
of laws, regulations or administrative rules that governs how it obtains, processes
and distributes donor material.
(2) If the Division intends
to suspend or revoke a NARRO license, it shall do so in accordance with ORS 183.411
through 183.470.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0045
Return of License
Each license certificate in the licensee's
possession shall be returned to the Division immediately upon the suspension or
revocation of the license, failure to renew the license by the date of expiration,
loss of accreditation or if operation is discontinued by the voluntary action of
the licensee.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0050
Surveys
(1) The Division must, in addition to
any investigations conducted pursuant to OAR 333-081-0065, conduct at least one
survey of each NARRO prior to licensure and once every two years thereafter as a
requirement of licensing and at such other times as the Division deems necessary.
(2) In lieu of an on-site
inspection required by section (1) of this rule, the Division may accept proof of
accreditation by an accrediting body approved by the Division if the NARRO:
(a) Gives the Division sufficient
advance notice to allow the Division to participate in any exit interviews conducted
by the accrediting body; and
(b) Provides the Division
with copies of all documentation concerning the accreditation that it requests.
(3) A NARRO must permit Division
staff access to its premises during a survey.
(4) A survey may include,
but is not limited to:
(a) Interviews of NARRO management
and staff;
(b) On-site observations
of the NARRO premises, staff performance and activities; and
(c) Review of documents,
records and other materials required to be kept by OAR 333-081-0070.
(5) A NARRO shall make all
requested documents and records available to the surveyor for review and copying.
(6) Following a survey, Division
staff may conduct an exit conference with a NARRO agency owner, administrator, or
designee. During an exit conference, Division staff must:
(a) Inform the NARRO owner,
administrator or designee of the preliminary findings of the inspection; and
(b) Give the owner, administrator
or designee a reasonable opportunity to submit additional facts or other information
to the surveyor in response to those findings.
(7) Following a survey, Division
staff must prepare and provide the NARRO owner or administrator specific and timely
written notice of the findings.
(8) If no deficiencies are
found during a survey, the Division must issue written findings to the NARRO owner
or administrator indicating that fact.
(9) Upon conclusion of a
survey the Division must, upon request, publicly release the written documents described
in sections (7) and (8) of this rule in accordance with the Oregon Public Records
Act.
(10) If deficiencies are
found, the Division must take informal or formal enforcement action in accordance
with OAR 333-081-0085 and 333-081-0090.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0055
Approval of Accrediting Bodies
(1) If the Division finds that an accrediting
body has the necessary qualifications to certify that state licensing standards
have been met, the Division will accept accreditation from the accrediting body
in accordance with the requirements of OAR 333-081-0050(2).
(2) In order to allow the
Division to make the finding set forth in section (1) of this rule, the accrediting
body must request approval in writing using the most recent approval form provided
by the Division and shall provide, at a minimum:
(a) Documentation of program
policies and procedures that show that its accreditation process at least meets
the requirements set out in ORS 438.720(2) and these
rules;
(b) Documentation evidencing
that the accrediting body has the resources and expertise to successfully carry
out the accreditation process; and
(c) An attestation that it,
or any of its owners or employees, does not have a direct or indirect financial
interest in any of the NARROs that it seeks to accredit.
Stat. Auth.: ORS 438.720
Stats. Implemented: ORS 438.720
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0060

Complaints
(1) Any person may make a complaint
to the Division regarding an allegation as to violations of ORS438.710 & 438.715 or these rules.
(2) Upon conclusion of an
investigation, the Division shall, upon request, publicly release a report of its
findings in accordance with the Oregon Public Records Act. The Division may use
any information obtained during an investigation in an administrative or judicial
proceeding concerning the licensing of a NARRO.
(3) If a complaint involves
an allegation of criminal conduct or an allegation that is within the jurisdiction
of another local, state, or federal agency, the Division shall refer the matter
to that agency.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0065
Investigations
(1) As soon as practicable after receiving
a complaint, taking into consideration the nature of the complaint, Division staff
must begin an investigation.
(2) An investigation may
include but is not limited to:
(a) Interviews of the complainant,
persons identified by the complainant as having knowledge of the facts alleged in
the complaint, NARRO management and staff, and other persons having knowledge of
the practices of the NARRO; and
(b) On-site observations
of staff performance and of the physical environment of the NARRO facility; and
(c) Review of documents,
records and other materials.
(3) A NARRO must permit Division
staff access to its premises during an investigation.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0070
Records
(1) A NARRO must keep and maintain a
legible, reproducible record of each donor from whom it obtains anatomical material.
This record must include at least the following:
(a) Documentation showing
that the donor donated the anatomical material for the purpose of research or education.
However, if the decision to donate is made after the donor’s death, documentation
that the donation was made by a person authorized to make an anatomical gift under
the process set out in ORS 97.965 and that this person donated the anatomical material
for the purpose of research or education is required;
(b) The name, address and
phone number of each person that had possession of the donor’s anatomical
material before the organization took possession of the anatomical material;
(c) Documentation of the
disposition of the donor’s anatomical material by the NARRO, including the
name, address and phone number of each person to whom it provides anatomical material
from the donor; and
(d) A copy of the disclosure
given to a relative or personal representative of the donor if any anatomical material
is returned to them as required by OAR 333-081-0075(2).
(2) The NARRO must keep and
maintain a legible, reproducible record of the notice required by ORS 438.715(4) and OAR 333-081-0075 and provided to each individual from
whom the NARRO agrees to accept an offer of the donation of anatomical material.
If an offer of anatomical material is not subsequently rescinded or rejected, this
record must be included in the donor record for each individual.
(3) The records required
by sections (1) and (2) of this rule must be kept and maintained by the NARRO for
a minimum of 10 years from the date that the NARRO takes possession of the donor’s
anatomical material and shall be kept and maintained in the following manner:
(a) It must be kept in a
manner that renders it easily and completely retrievable;
(b) Reasonable precautions
must be taken to protect the record from unauthorized access and from destruction
including, but not limited to, fire, water, and theft;
(c) Authorized employees
of the Division must be permitted to review the records upon request;
(d) If a NARRO changes ownership,
all records must remain with the successor NARRO and it shall be the responsibility
of the new owner to protect and maintain these records; and
(e) Before a NARRO terminates
its business, it must notify the Division where the records will be stored and,
if the location changes, those responsible must notify the Division of each successive
location.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0075
Notice
(1) As required by ORS 438.715(4), when a NARRO accepts an offer from an individual to donate
anatomical material it must provide that individual notice that clearly explains:
(a) How the NARRO intends
to dispose of the anatomical material if donated, and whether and how any anatomical
material may be returned;
(b) Whether or not the NARRO
guarantees the coverage of costs related to transporting and disposing of the anatomical
material and, if all costs will not be covered, what costs will be the responsibility
of the individual making the donation; and
(c) What costs will be covered
by the NARRO and what costs will be the responsibility of the individual making
the donation if the individual or relative or personal representative subsequently
rescinds, or the NARRO later rejects, the offer of anatomical material.
(2) If a NARRO returns any
anatomical material to a relative or personal representative of a donor, the NARRO
must provide that person with a notice that discloses whether all or part of the
donor’s body is being returned.
(3) The notice required by
sections (1) and (2) of this rule must be in writing and be printed in at least
14-point type.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0080
NARRO Duties
In addition to the requirements set
out in these rules, a NARRO shall dispose of any anatomical material not returned
to a relative or personal representative of the donor in accordance with all laws
pertaining to the disposition of human remains. This requirement does not apply
to anatomical material that the NARRO has recovered or distributed for research
or educational purposes.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0085
Informal Enforcement
(1) If during an investigation or survey
Division staff document violations of NARRO licensing rules or laws, the Division
may issue a statement of deficiencies that cites the law or rule alleged to have
been violated and the facts supporting the allegation.
(2) Upon receipt of a statement
of deficiencies, a NARRO shall be provided an opportunity to dispute the Division’s
survey findings but must still comply with sections (3) and (4) of this rule. The
following conditions apply:
(a) If a NARRO desires an
informal conference to dispute the Division’s survey findings, the NARRO must
submit a request in writing to the Division within 10 business days after receipt
of the statement of deficiencies. The written request must include a detailed explanation
of why the NARRO believes the statement of deficiencies is incorrect;
(b) A NARRO may not seek
a delay of any enforcement action against it on the grounds the informal dispute
resolution has not been completed; and
(c) If a NARRO is successful
in demonstrating some or all of the deficiencies should not have been cited, the
Division must withdraw or reissue the statement of deficiencies, removing such deficiencies
and rescinding or modifying any remedies issued for such deficiencies. A reissued
statement of deficiencies must include a statement that it supersedes the previous
statement of deficiencies and shall clearly identify the date of the superseded
statement of deficiencies.
(3) A signed plan of correction
from a NARRO must be mailed to the Division within 10 business days from the date
the statement of deficiencies was received by the NARRO. A signed plan of correction
will not be used by the Division as an admission of the violations alleged in the
statement of deficiencies.
(4) A NARRO must correct
all deficiencies within 60 days from the date of the receipt of the statement of
deficiencies, unless an extension of time is granted by the Division. A request
for such an extension must be submitted in writing and must accompany the plan of
correction.
(5) The Division must determine
if a written plan of correction is acceptable. If the plan of correction is not
acceptable to the Division, the Division must notify the NARRO owner or administrator
in writing:
(a) Identifying which provisions
in the plan the Division finds unacceptable;
(b) Citing the reasons the
Division finds the provisions unacceptable; and
(c) Requesting that the plan
of correction be modified, resubmitted and received by the Division no later than
10 business days from the date notification of non-compliance was received by the
NARRO owner or administrator.
(6) If the NARRO does not
come into compliance by either the date of correction reflected in the plan of correction
or a Division approved extension as provided for in section (4) of this rule, or
60 days from the date of receipt of the statement of deficiencies, whichever is
sooner, the Division may propose to deny, suspend or revoke the agency license or
impose civil penalties.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14
333-081-0090
Formal Enforcement
(1) If during an investigation or survey
Division staff document ongoing or substantial failure to comply with NARRO laws
or rules, or if a NARRO fails to pay a civil penalty imposed under ORS 438.994(1) and these rules, the Division may issue a Notice of Proposed
Suspension or Notice of Proposed Revocation in accordance with ORS 183.411 through
183.470.
(2) The Division may impose
civil penalties for violations of ORS 438.710 or 438.715
or these rules, in accordance with ORS 183.745. Civil penalties imposed under this
rule shall not exceed $1000 per violation.
(3) At any time the Division
may issue a Notice of Emergency License Suspension under ORS 183.430.
(4) If the Division revokes
a NARRO license, the order shall specify when, if ever, the NARRO may reapply for
a license.
Stat. Auth.: ORS 438.710 & 438.720
Stats. Implemented: ORS 438.705-438.720 & 438.994
Hist.: PH 6-2014, f. 1-30-14,
cert. ef. 2-1-14


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