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) 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. Statutory/Other Authority: ORS 438.310 Statutes/Other Implemented: ORS 438.310 History: HD 6-1995, f. & cert. ef. 9-13-95