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: (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: (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. 9-13-95Stat. Auth.: ORS 438.310
Stats. Implemented: ORS 438.310