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The Oregon Administrative Rules contain OARs filed through September 15, 2014
 
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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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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 Oregon Laws 2013, chapter 356, section 4(2).

(2) “Anatomical material” has the meaning given that term in Oregon Laws 2013, chapter 356, section 1(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 Oregon Laws 2013, chapter 356, section 1(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 Oregon Laws 2013, chapter 356, sections 2 and 3 and these rules.

Stat. Auth.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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 Oregon Laws 2013, chapter 356, section 1(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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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 Oregon Laws 2013, chapter 356, sections 2 and 3 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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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 Oregon Laws 2013, chapter 356, section 4(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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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 Oregon Laws 2013, chapter 356, sections 2 and 3 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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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 Oregon Laws 2013, chapter 356, section 3(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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
Hist.: PH 6-2014, f. 1-30-14, cert. ef. 2-1-14

333-081-0075

Notice

(1) As required by Oregon Laws 2013, chapter 356, section 3(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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
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 Oregon Laws 2013, chapter 356, section 5(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 Oregon Laws 2013, chapter 356, Sections 2 or 3 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.: OL 2013, Ch. 356
Stats. Implemented: OL 2013, Ch. 356
Hist.: PH 6-2014, f. 1-30-14, cert. ef. 2-1-14

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