OAR 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.

Source: Rule 333-024-0053 — Accreditation Organizations and Accredited Laboratories, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-024-0053.

333–024–0005
Purpose
333–024–0010
Definitions
333–024–0012
Licensure
333–024–0016
Licensure Categories
333–024–0020
Licensure for Performance of Laboratory Specialties
333–024–0021
Qualifications and Responsibilities of Directors for High Complexity Laboratories
333–024–0022
Qualifications and Responsibilities for Director of Moderate Complexity Laboratories
333–024–0023
Qualifications and Responsibilities of Consultants, Supervisors and Testing Personnel for Moderate and High Complexity Laboratories
333–024–0026
Equipment and Facilities
333–024–0035
Internal Quality Control for Moderate and High Complexity Laboratories
333–024–0037
Specialty and Subspecialty Quality Control
333–024–0040
External Quality Control (Proficiency Testing Programs and On-Site Inspections)
333–024–0043
Quality Assurance
333–024–0045
Venereal Disease Testing
333–024–0050
Records and Reports
333–024–0053
Accreditation Organizations and Accredited Laboratories
333–024–0055
Incompetence
333–024–0260
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Purpose
333–024–0265
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Procedure
333–024–0305
Testing for Substances of Abuse: Purpose and Scope
333–024–0310
Testing for Substances of Abuse: Definitions
333–024–0315
Testing for Substances of Abuse: Licensure
333–024–0320
Testing for Substances of Abuse: Qualifications and Responsibilities of Directors
333–024–0325
Testing for Substances of Abuse: Incompetence
333–024–0330
Testing for Substances of Abuse: Specimen Collection, Chain of Custody, Records, and Reports
333–024–0335
Testing for Substances of Abuse: Internal Quality Assurance
333–024–0340
Testing for Substances of Abuse: External Quality Control (Proficiency Testing Program and On-Site Inspections)
333–024–0345
Testing for Substances of Abuse: Confirmatory Testing
333–024–0350
Testing for Substances of Abuse: Equipment and Facilities
333–024–0360
Testing for Substances of Abuse: Special Category Laboratories
333–024–0365
Testing for Substances of Abuse: Substance of Abuse Registration
333–024–0370
Health Screen Testing: Purpose
333–024–0375
Health Screen Testing: Definitions
333–024–0380
Health Screen Testing: Permits
333–024–0385
Health Screen Testing: Testing Site Schedule
333–024–0390
Health Screen Testing: Personnel Qualifications and Responsibilities
333–024–0395
Health Screen Testing: Tests Performed
333–024–0400
Health Screen Testing: Quality Assurance
333–024–1000
Newborn Screening: Purpose
333–024–1010
Newborn Screening: Definitions
333–024–1020
Newborn Screening: Persons Responsible for Ensuring that First Specimens are Collected and Submitted
333–024–1025
Newborn Screening: Persons Responsible for Ensuring that Second, Third and Repeat Specimens are Collected and Submitted
333–024–1030
Newborn Screening: Timing for Collecting Specimens
333–024–1040
Newborn Screening: Manner of Submitting Specimens
333–024–1050
Newborn Screening: Religious Exemption from Newborn Testing
333–024–1060
Newborn Screening: Improperly Collected Specimens
333–024–1070
Newborn Screening: The Newborn Screening Panel and Methods of Testing
333–024–1080
Newborn Screening: Result Reporting and Follow-up
333–024–1090
Newborn Screening: Use, Release and Retention of Residual Specimens
333–024–1100
Newborn Screening: Ordering Specimen Collection Kits and Fees
333–024–1110
Newborn Screening: Failure to Comply
333–024–2000
Fees for Communicable Disease Tests Performed in the State Laboratory
Last Updated

Jun. 8, 2021

Rule 333-024-0053’s source at or​.us