OAR 333-024-0053
Accreditation Organizations and Accredited Laboratories

(1)

Accreditation organizations shall:

(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 its accreditation; and

(F)

Within 30 days if the organization revokes a laboratory’s accreditation.

(2)

Accredited laboratories shall:

(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)