(a) Provide the Division with;

(A) Documentation of current deemed status from the Health Care Financing Administration;

(B) A list of all laboratories and accreditation expiration dates;

(C) A list of scheduled surveys and proposed survey dates;

(D) Copies of routine survey findings, upon request;

(E) Copies of all complaint investigations performed.

(b) Allow the Division to investigate complaints, conduct complaint or random on-site validation surveys and take disciplinary action.

(c) Provide a detailed description of the organization's survey process, including:

(A) Frequency of surveys performed;

(B) Copies of survey forms and guidelines;

(C) Accreditation survey review process;

(D) Deficiency writing and monitoring process;

(E) Policy on facility notification prior to survey;

(F) Surveyor qualifications;

(G) Policy for the investigation of complaints on accredited laboratories;

(H) Description of all types and categories of accreditation offered; and

(I) Procedure for proficiency testing monitoring including;

(i) Frequency of monitoring;

(ii) Correlation of proficiency testing with subspecialties, specialties, and analytes performed by the laboratory;

(iii) Definition of unsuccessful performance; and

(iv) Action to be taken regarding unsuccessful performance.

(d) Notify all of their accredited laboratories within 10 days of the loss of accreditation authority in Oregon.

(e) Notify the Division:

(A) Within 30 days of any changes in accreditation requirements;

(B) Verbally, within 5 days of identifying any deficiency posing an immediate and serious risk to patient or staff safety or health in an accredited laboratory, to be followed by a written notification within 14 days of the verbal notification;

(C) Of actions taken due to unsuccessful proficiency testing performance;

(D) Within 30 days of enforcement or sanction actions taken against their accredited laboratories;

(E) Within 30 days if a laboratory terminates it's accreditation; and

(F) Within 30 days if the organization revokes a laboratory's accreditation.

(a) Notify the Division of accreditation or changes in accreditation status within 30 days of occurrence;

(b) Authorize proficiency testing providers to submit copies of all proficiency testing results to the Division;

(c) Allow the Division to investigate complaints, conduct complaint or random on-site validation surveys, and take disciplinary action;

(d) Have a valid State License;

(e) Reapply for licensure within 60 days after the accrediting organization's deeming authority has been withdrawn;

(A) Pay applicable fees;

(B) Submit to survey by the Division; and

(C) Meet all applicable requirements for non-accredited laboratories in the appropriate licensure categorization.

(f) Reapply for licensure within 30 days after the withdrawal or revocation of the laboratory's accreditation by the accrediting organization;

(A) Pay applicable fees;

(B) Submit to survey by the Division; and

(C) Meet all applicable requirements for non-accredited laboratories in the appropriate licensure categorization.

(3) The Division may deny or terminate the license of a laboratory if the owner fails to authorize the accrediting organization to notify the Division of the laboratory's compliance with the accrediting organization requirements.