Or. Admin. Code § 333-081-0070

Current through Register Vol. 63, No. 12, December 1, 2024

Section 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 If an offer of anatomical material is not subsequently rescinded or rejected, this record must be included in the donor record for each individual.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.

Or. Admin. Code § 333-081-0070

PH 6-2014, f. 1-30-14, cert. ef. 2-1-14

Stat. Auth.: OL 2013, Ch. 356

Stats. Implemented: OL 2013, Ch. 356