1. (1) Accreditation organizations shall:

   1. (a) Provide the Public Health Division (Division) with;

      1. (A) Documentation of current deemed status from the U.S. Centers for Medicare and Medicaid Service (CMS);
      2. (B) A list of all laboratories and accreditation expiration dates;
      3. (C) A list of scheduled surveys and proposed survey dates;
      4. (D) Copies of routine survey findings, upon request; and
      5. (E) Copies of all complaint investigations performed.
   2. (b) Allow the Division to investigate complaints, conduct complaint or random on-site validation surveys and take disciplinary action;

   3. (c) Provide a detailed description of the organization’s survey process, including:

      1. (A) Frequency of surveys performed;
      2. (B) Copies of survey forms and guidelines;
      3. (C) Accreditation survey review process;
      4. (D) Deficiency writing and monitoring process;
      5. (E) Policy on facility notification prior to survey;
      6. (F) Surveyor qualifications;
      7. (G) Policy for the investigation of complaints on accredited laboratories;
      8. (H) Description of all types and categories of accreditation offered; and

      9. (I) Procedure for proficiency testing monitoring including;

         1. (i) Frequency of monitoring;
         2. (ii) Correlation of proficiency testing with subspecialties, specialties, and analytes performed by the laboratory;
         3. (iii) Definition of unsuccessful performance; and
         4. (iv) Action to be taken regarding unsuccessful performance.
         5. (d) Notify all of their accredited laboratories within 10 days of the loss of accreditation authority in Oregon;

   4. (e) Notify the Division:

      1. (A) Within 30 days of any changes in accreditation requirements;
      2. (B) Verbally, within five 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;
      3. (C) Of actions taken due to unsuccessful proficiency testing performance;
      4. (D) Within 30 days of enforcement or sanction actions taken against their accredited laboratories;
      5. (E) Within 30 days if a laboratory terminates its accreditation; and
      6. (F) Within 30 days if the organization revokes a laboratory’s accreditation.

2. (2) Accredited laboratories shall:

   1. (a) Notify the Division of accreditation or changes in accreditation status within 30 days of occurrence;
   2. (b) Authorize proficiency testing providers to submit copies of all proficiency testing results to the Division; and
   3. (c) Allow the Division to investigate complaints, conduct complaint or random on-site validation surveys, and take disciplinary action.
3. (3) The Division may facilitate the denial or facilitate the termination of the certificate 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 & ORS 438.160

Statutes/Other Implemented

ORS 438.310 & ORS 438.160

History

PH 21-2026, amend filed 05/20/2026, effective 05/21/2026
HD 6-1995, f. & cert. ef. 9-13-95