Or. Admin. R. 333-024-0053 - Accreditation Organizations and Accredited Laboratories

Current through Register Vol. 61, No. 4, April 1, 2022

(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 it's 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) 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.

Notes

Or. Admin. R. 333-024-0053
HD 6-1995, f. & cert. ef. 9-13-95

Stat. Auth.: ORS 438.310

Stats. Implemented: ORS 438.310

The following state regulations pages link to this page.



State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.