333-047-0010
Definitions Used in the Vaccine Accountability Rules

(1) All definitions of ORS 433.090 and 433.235 apply to OAR chapter 333,, division 47.

(2) In addition to the definitions of ORS 433.090 and 433.235, the following definitions apply:

(a) "Authority" means the Oregon Health Authority.

(b) "Authority’s Immunization Registry" means the immunization information system (IIS) established by the Authority under ORS 433.094 and OAR chapter 333, division 49.

(c) "Certify" means to attest, in writing, on a form prescribed by the Oregon Health Authority that at least two employees, owners or partners have completed required vaccine-related trainings as provided or approved by the Oregon Health Authority.

(d) "Entity" means a health clinic or provider, pharmacy or pharmacist who receives state-supplied vaccine.

(e) "Oregon Immunization Program" means the Oregon Health Authority, Public Health Division, Immunization Program.

(f) "Public Health Division" means the Oregon Health Authority, Public Health Division.

(g) "Receives vaccines" means an entity is supplied with vaccines by the Oregon Immunization Program, including vaccines acquired with federal and state funds, including the Vaccines for Children (VFC) program, the Vaccine Access Program (VAP), state Special Project vaccine, and state Billable Project vaccine.

(h) "State supplied vaccine" means vaccine provided by the federal government or the Oregon Immunization Program.

Statutory/Other Authority: ORS 433.103
Statutes/Other Implemented: ORS 433.103
History:
PH 1-2025, amend filed 01/22/2025, effective 01/22/2025
PH 76-2021, amend filed 10/11/2021, effective 10/11/2021
PH 30-2021, amend filed 07/12/2021, effective 07/12/2021
PH 5-2021, temporary amend filed 01/22/2021, effective 01/22/2021 through 07/20/2021
PH 14-2011, f. 12-28-11, cert. ef. 1-1-12

333-047-0030
Training

(1) Any entity receiving state supplied vaccine shall require that at least two currently employed staff persons, owners or partners complete immunization related training at least once every two years as follows:

(a) Clinical administration of vaccines; and

(b) Storage, handling and inventory management of vaccines.

(2) An entity shall provide Authority staff with written documentation that it has met the requirements of section (1) of this rule or that it is exempt from training upon request or at every official Vaccines for Children site visit.

(3) An entity receiving state-supplied vaccine is responsible for retaining documentation that at least two currently employed staff persons, owners, or partners have completed the required clinical administration and vaccine management training course at least once every two years.

(4) The Authority will make available to entities no-cost internet based training available in on-demand format.

(5) Web-based training will include an official certification receipt for staff meeting competence standards.

(6) The Authority will exempt an entity from the training requirement in section (1) of this rule if an entity demonstrates to the satisfaction of the Authority that it, or that a licensing board with jurisdiction over some employees of the entity, requires training that is substantially similar to the training available from the Authority. An entity may submit a request for an exemption on a form prescribed by the Authority.

(7) The training requirements required by section (1) of this rule are effective January 1, 2013.

Statutory/Other Authority: ORS 433.103
Statutes/Other Implemented: ORS 433.103
History:
PH 14-2011, f. 12-28-11, cert. ef. 1-1-12

333-047-0040
Accounting for Vaccine

(1) Any entity receiving state supplied vaccine shall account for all vaccines the clinic administers (state-supplied and privately purchased) through data submission and inventory management via the Authority’s Immunization Registry, as outlined in OAR 333-049-0010 through 333-049-0040 and for COVID-19 vaccine, as outlined in OAR 333-047-1000.

(2) An entity receiving state supplied vaccine may only transfer or redistribute vaccine to another Authority enrolled provider.

Statutory/Other Authority: ORS 433.103
Statutes/Other Implemented: ORS 433.103
History:
PH 76-2021, amend filed 10/11/2021, effective 10/11/2021
PH 30-2021, amend filed 07/12/2021, effective 07/12/2021
PH 5-2021, temporary amend filed 01/22/2021, effective 01/22/2021 through 07/20/2021
PH 14-2011, f. 12-28-11, cert. ef. 1-1-12

333-047-1000
COVID-19 Vaccine Requirements

(1) A person or entity receiving, storing, administering, or transferring COVID-19 vaccine must report:

(a) All COVID-19 vaccine dose administration and adjuvant (if applicable) within 24 hours of administration.

(b) All on-hand inventory of COVID-19 vaccine on a weekly basis, no later than 5 p.m. Pacific Time on Sunday.

(c) All spoiled, expired, or wasted COVID-19 vaccine to the Authority’s Immunization Registry or through a survey managed by the Authority within 24 hours of knowledge or discovery of the spoilage, expiration or wasting.

(d) All transfers of COVID-19 vaccine within 24 hours of the transfer.

(2) A person or entity must report the information required under this rule in the Registry in accordance with OAR chapter 333, division 49.

(3) A person or entity receiving state-supplied COVID-19 vaccine must promptly (within 24 hours) respond to requests for information from the Authority or a Local Public Health Authority about its COVID-19 vaccine storage, handling, use, administration plans, transfers, or inventory, including temperature logs.

(4) If the Authority determines that a person or entity with COVID-19 vaccine cannot make immediate use of the vaccine and that the vaccine is needed more urgently elsewhere, the Authority may request the vaccine be transferred to another enrolled provider and the vaccine must be transferred within 24 hours of the Authority’s request.

(5) If the Authority determines that a person or entity with COVID-19 vaccine is not appropriately storing or handling COVID-19 vaccine, the Authority may demand return of the vaccine or appear on-site to collect and remove the vaccine.

(6) A person or entity receiving state-supplied COVID-19 vaccine must, in addition to any requirements in OAR 333-047-0030, complete trainings identified on the Authority’s COVID-19 Training for Vaccine Provider’s webpage: https://www.oregon.gov/oha/ph/PreventionWellness/VaccinesImmunization/RulesLaws/Pages/index.aspx.

(7) A person or entity who violates any provision of this rule is subject to a civil penalty of $500 per day per violation.

Statutory/Other Authority: ORS 433.103 & 431A.010
Statutes/Other Implemented: ORS 433.103 & 431A.010
History:
PH 30-2021, adopt filed 07/12/2021, effective 07/12/2021
PH 5-2021, temporary adopt filed 01/22/2021, effective 01/22/2021 through 07/20/2021

333-047-2000
COVID-19 Vaccine Guidance and Consent Requirements

(1) For purposes of this rule "COVID-19 vaccine administration site" means any location where COVID-19 vaccines are administered.

(2) A person or entity receiving state-supplied COVID-19 vaccine must comply with OAR 333-003-5000 regarding minor consent to vaccination.

(3) A COVID-19 vaccine administration site must:

(a) Have a designated site coordinator.

(b) Post signs, in conspicuous locations with contact information for the designated site coordinator, so people know who to contact if there are concerns about the site or services provided.

(c) Provide people who received their first dose of a vaccine at the site, with the date and time to return for their second dose of a vaccine, if applicable.

(d) Provide a person who is vaccinated with a vaccine card that shows at a minimum the date of the COVID-19 vaccination, the location of the vaccine administration site, which vaccine was administered, and the due date of the second dose, if applicable.

(4) A COVID-19 vaccine administration site and staff and volunteers at the site are prohibited from:

(a) Asking a person seeking to be vaccinated to provide their social security number. The site may choose to ask for a social security number for purposes of billing insurance, but it must be made clear that providing a social security number is optional and will only be used for purposes of insurance billing and is not a condition to receive the vaccine.

(b) Denying a COVID-19 vaccine to someone who is otherwise eligible on the basis that a person:

(A) Is uninsured;

(B) Is a citizen of another country;

(C) Is a resident of another state; or

(D) Is a resident of another county.

(c) Charging a person seeking to be vaccinated for the vaccine or the vaccine administration fee. A provider may bill insurance for the administration fee but cannot charge the person seeking to be vaccinated.

(d) Requiring a person to provide:

(A) Proof of health insurance information. This information may be requested but it cannot be required and it must be made clear that providing the information is optional.

(B) Government issued identification.

(5) A person or entity who violates any provision of this rule is subject to a civil penalty of $500 per day per violation.

Statutory/Other Authority: ORS 433.103 & ORS 431A.010
Statutes/Other Implemented: ORS 433.103 & ORS 431A.010
History:
PH 82-2021, adopt filed 11/22/2021, effective 11/22/2021
PH 28-2021, temporary adopt filed 07/09/2021, effective 07/09/2021 through 11/22/2021
PH 21-2021, temporary adopt filed 05/27/2021, effective 05/27/2021 through 11/22/2021