Hold CLIA certificate; complete and sign application

Owners and laboratory directors must hold an appropriate federal CLIA certificate; operating a clinical laboratory without a federal CLIA certificate, a valid certificate, or a temporary permit is unlawful. Applications must be executed by the owner or authorized official and include owner, director, location, specialties requested, and other information the Division requires; not-for-profit or government labs with same owner/director may file a single application under specified limits.

• Operation without a CLIA certificate or temporary permit is prohibited except for specified federal or pure research/teaching labs.
• Application must be executed by owner or authorized officer and list owner, director, location, and specialties requested.
• Not-for-profit or state/local government labs with same owner and director may file a single application and may perform a combined total of fifteen test methods in waived/PPM/moderate categories.

Obtain 45‑day temporary permit and comply with required plans/reports

The Division may issue a temporary permit valid for 45 days and may require submission of compliance plans, periodic progress reports, and temporary provisions to protect public health; the Division may cancel the permit if the laboratory no longer protects public health and may grant one renewal if in the public interest.

• Temporary permits are valid for 45 days from issuance.
• Division may require plans for compliance and periodic reports while the permit is in effect.
• Division may cancel the temporary permit if public health/safety is threatened and may grant one renewal with fee.

Risk of refusal, suspension, or revocation for violations

The Division may refuse to issue, refuse to renew, suspend, or revoke a certificate or permit for cause, including intentionally false statements, demonstrated incompetence, falsified reports, referring specimens to unlicensed or non‑CLIA labs, misrepresenting scope of services, failing to permit inspections, or failing to meet rule requirements.

• Sanctions include refusal to facilitate issuance or renewal, suspension, or revocation of certificate/permit.
• Grounds include false statements on applications, incompetence per OAR 333-024-0055, falsified reports, improper referrals, misrepresentation of services, and failure to permit inspections or continue to meet requirements.
• Owners/directors must notify Division within 30 days of change of laboratory name or technical supervisor as required.

Director must meet qualifications, be accessible, and limit oversight to ≤5 labs

A laboratory director is responsible for overall operation and administration, including hiring competent staff, QA, proficiency testing and test reporting; a director may direct no more than five laboratories and must be accessible for on-site, telephone, or electronic consultation and may delegate responsibilities in writing.

• Director duties include equipment maintenance review, monthly QC review, review of proficiency testing within 30 days, validation of new procedures, assuring qualified personnel and annual competency assessments.
• A director may serve as director of no more than five laboratories.
• Director may delegate responsibilities in writing to other qualified individuals.

Ensure pathologist/qualified physician supervision for transfusion services

Facilities providing transfusion services must be under adequate control and technical supervision of a pathologist or other qualified MD/DO; they must provide procurement, safekeeping and transfusion capacity, prompt ABO/D typing and compatibility testing, and retain samples of transfused units per facility procedures.

• Transfusion services require supervision by a pathologist or other qualified doctor of medicine or osteopathy.
• Blood and blood products must be stored under appropriate conditions with a 24‑hour audible temperature alarm system and documented inspections.
• Facilities must ensure prompt ABO/D typing, unexpected antibody detection, compatibility testing, and investigation of transfusion reactions either in-house or via approved arrangement.

Follow written histocompatibility procedures and maintain crossmatch availability

Histocompatibility testing must be governed by written criteria and policies covering selection of patient serum samples, crossmatch techniques, preparation and labeling/storage of donor lymphocytes and reagents, reporting crossmatch results, and availability of final crossmatches prior to transplantation when required; monthly verification of personnel reproducibility and documented specimen storage/temperature alarm procedures are required.

• Maintain criteria for selecting patient serum samples for crossmatching and the crossmatch technique.
• Prepare and properly label/store donor lymphocytes, reagents, complement, buffers and dyes; use temperature alarms and emergency storage plans.
• Have final crossmatch results available before organ/tissue transplantation when presensitization is shown and document emergency circumstances.
• Perform monthly unknown specimen verification for each individual to verify reproducibility and maintain records.

Implement written critical‑result reporting and retain test authorization records ≥2 years

Laboratories must develop and follow written procedures for reporting imminent life‑threatening or panic values and must maintain written test authorization or documentation of efforts to obtain written authorization for at least two years; specimens may be examined only at the request of an authorized person, and oral requests must be followed by written authorization within 30 days.

• Written procedures required for reporting life‑threatening/panic values.
• Maintain written test authorization or documentation of attempts to obtain it for a minimum of two years.
• Specimens may only be examined at request of an authorized person; oral requests require written authorization within 30 days.

Prepare for Division investigations, surveys, and potential disciplinary action

The Division may investigate complaints, conduct on‑site validation or random surveys, and take disciplinary action including refusing, suspending, or revoking permits/certificates for specified violations; accredited organizations and labs must provide access and information to enable investigations and surveys.

• Division may investigate complaints, perform complaint or random on‑site validation surveys, and take disciplinary action.
• Accreditation organizations must provide lists, survey schedules, findings, and allow Division access to support investigations.
• Failure to permit inspections or to continue meeting rule requirements are grounds for sanction.

Authorize PT submission to Division and maintain proficiency participation/reapplication

Accredited laboratories must authorize proficiency testing providers to submit PT results to the Division and must reapply for permit/licensure within specified timeframes after loss or withdrawal of accreditation; laboratories must participate in required PT programs and accept consequences for unsuccessful performance.

• Authorize PT providers to submit proficiency testing results to the Division when required.
• Participate in CMS‑approved proficiency testing for applicable analytes at the laboratory's expense.
• Failure in proficiency testing (e.g., two out of three events) can lead to suspension, revocation, or withdrawal of permit until satisfactory performance is demonstrated; reapplication deadlines apply after loss of accreditation.

Submit same specimen for confirmatory testing with a different method before adverse actions

When a positive on‑site SOA screening result will be used to deny or deprive employment or benefits, the exact same specimen must be submitted to a licensed or CLIA‑certified clinical laboratory (or equivalent out‑of‑state lab) for confirmatory testing using a different analytical method before releasing the screening result; approved confirmatory methods include chromatography, immunoassay, spectroscopy, and mass spectroscopy, and out‑of‑state testing must meet or exceed Oregon standards.

• Submit the same specimen for confirmatory testing to a licensed or CLIA‑certified clinical laboratory prior to releasing an on‑site SOA result that may deprive or deny employment/benefits.
• Confirmatory testing must use a different analytical method than the initial screen; approved methods include chromatography, immunoassay, spectroscopy, and mass spectroscopy.
• Out‑of‑state laboratories used for confirmatory testing must meet or exceed Oregon standards/equivalency.

Timely notify Authority of test or ownership/director/location changes and allow inspections

Notify the Authority within six months if analysis of a test is discontinued or added; notify within 30 days of any change of director, owner, laboratory name, or permanent location address; be prepared for on‑site inspections without advance notice during normal business hours and for additional inspections to verify corrections.

• Notify the Authority within six months if a test analysis is discontinued or added.
• Notify the Authority within 30 days of change of director, owner, name, or permanent location address.
• On‑site inspections may be conducted by the Authority at reasonable times without advance notice; additional inspections may be performed to verify corrective actions.