Or. Admin. Code § 333-024-0053

Current through Register Vol. 63, No. 10, October 1, 2024

Section 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 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.

Or. Admin. Code § 333-024-0053

HD 6-1995, f. & cert. ef. 9-13-95

Stat. Auth.: ORS 438.310

Stats. Implemented: ORS 438.310