333-024-0040 External Quality Control (Proficiency Testing Programs and On-Site Inspections) (1) Physician performed microscopy, moderate and high complexity laboratories shall: (a) At the laboratory’s own expense, be required to participate successfully in a proficiency testing program approved by the Health Care Financing Administration. Lists of currently approved programs are available from the Division. Continued or consistent failure, two out of three testing events, may result in the laboratory’s license for that specialty, subspecialty or test being suspended or revoked by the Division; (b) Authorize release of proficiency test results and provide documentation of corrective action to the Division; (c) Assure proficiency testing is performed on each physician performed microscopy, moderate and high complexity regulated analyte listed in the Clinical Laboratory Improvement Amendments of 1988, 42 CFR, Part 493, subpart I, available on request from the Division; (d) Meet the proficiency testing requirements as described in the Clinical Laboratory Improvement Amendments of 1988, 42 CFR, Part 493, subpart H, available on request from the Division; (e) Notify the Division within six months if the analysis of a specialty, subspecialty or test has been discontinued or added to patient testing; (f) Assure that individuals performing gynecologic cytology participate successfully in a proficiency testing program approved by the Health Care Financing Administration; (g) Be required to participate successfully in the proficiency testing programs conducted by the Division involving the laboratory specialty, subspecialty or tests in which the laboratory performs tests; (h) Analyze test samples submitted by the Division prior to, during, or subsequent to inspection. (2) A laboratory shall have their license suspended or revoked for one year, pursuant to ORS 438.160, if it submits a proficiency testing sample to another laboratory for analysis prior to reporting to the proficiency testing program. (3) Any laboratory that knowingly receives proficiency testing samples from another laboratory prior to the reporting deadline must notify the Division. (4) On-site inspections and testing may be conducted by representatives of the Division or Federal Government at reasonable times during the laboratory’s normal business hours without advance notice. The representative shall inspect the facilities, personnel policies, procedures, materials, staff qualifications, equipment, and records: (a) Routine inspections of moderate and high complexity laboratories shall occur at a minimum of every two years. (b) Laboratories accredited by a Health Care Financing Administration approved accreditation organization are exempt from routine, on site inspection provided the laboratory submits a copy of their accreditation certificate and authorizes its accreditation organization to release inspection data to the Division. The accreditation organization shall make available, upon request, a copy of the laboratory’s statement of deficiencies, plan of correction and proof of accreditation to the Division. (5) The Owner or Director may be required to submit reports on the operations and procedures of the laboratory to the Division or the Federal Government. (6) Additional inspections may be performed without notice to verify correction of deficiencies, investigate complaints, validation of accrediting organizations’ inspections, review unsatisfactory proficiency testing and verify personnel qualifications or other monitoring of compliance with OAR 333-024-0005 through 333-024-0050 and 333-024-0260 and 333-024-0265. (7) Inspection of waived and physician performed microscopic procedures laboratories: (a) The Division shall conduct inspections of any laboratory during routine hours of operation only to assess validation, complaint, and compliance with the applicable requirements of these rules; (b) The laboratory is required to: (A) Allow the Division or Federal Government to interview all employees of the laboratory concerning compliance with these rules; (B) Allow the Division or Federal Government access to all areas of the facility including specimen procurement and processing areas, storage facilities for specimens, reagents, supplies, records and reports, testing and reporting areas; (C) Permit employees to be observed performing tests, data analysis and reporting; (D) Allow the Division to review all information and data necessary to evaluate complaints, determine immediate and serious risk to public health, and confirm that the laboratory is only performing tests within the scope of their license; (E) Provide copies of all records and data that the Division or Federal Government requires under these rules; and (F) Provide all information and data needed by the Division or Federal Government to make a determination of compliance with these rules. (8) Failure to permit an inspection under these rules will result in the suspension of the laboratory’s license. (9) A waived laboratory conducting moderate and/or high complexity tests shall be considered a moderate or high complexity laboratory and the Division shall: (a) Conduct an on-site survey; (A) Examine the records of the laboratory; (B) Give written notice of any deficiencies; (C) Require the laboratory to return a written plan of correction, and verify that the corrections have occurred; and (D) The time frames for the plan of correction and verification are the same as a moderate or high complexity laboratory. (b) Require compliance with Division directives when there is an immediate threat to life, health, or safety. (c) Charge the laboratory the appropriate fee. (10) A physician performed microscopy procedure laboratory conducting additional moderate complexity or high complexity tests shall be considered a moderate or high complexity laboratory and the Division shall: (a) Conduct an on-site survey: (A) Examine the records of the laboratory; (B) Give written notice of any deficiencies; (C) Require the laboratory to return a written plan of correction, and verify that the corrections have occurred; and (D) The time frames for the plan of correction and verification are the same as a moderate or high complexity laboratory. (b) Require compliance with Division directives when there is an immediate threat to life, health, or safety. (11) Inspection of non-accredited, moderate and high complexity laboratories: (a) The Division will conduct inspections on at least a biennial basis of any laboratory at any time during routine hours of operation; (b) The Division will conduct an on-site inspection prior to the issuance of a license; (c) The laboratory may be required to: (A) Test samples or perform procedures as the Division or Federal Government requires; (B) Allow the Division or Federal Government to interview all employees of the laboratory concerning the laboratory’s compliance with these rules; (C) Permit employees to be observed performing tests, data analysis and reporting; (D) Allow the Division or Federal Government access to all areas of the facility including: specimen procurement and processing areas, storage facilities for specimens, reagents, supplies, records and reports, testing and reporting areas; (E) Provide copies to the Division or Federal Government of all records and data it requires. (d) The laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection; (e) The laboratory must provide, upon request, all information and data needed by the Division or Federal Government to make a determination of the laboratory’s compliance with these rules; (f) The Division or Federal Government may reinspect a laboratory at any time necessary to evaluate the ability of the laboratory to provide accurate and reliable test results; (g) The laboratory must retain records as specified in OAR 333-024-0050. (12) Inspection of accredited laboratories: (a) The Division and the Federal government may conduct random validation inspections of any accredited laboratory at any time during its hours of operation; (b) The Division and the Federal government may conduct complaint inspections of an accredited laboratory at any time during its hours of operation upon receiving a complaint about that laboratory; (c) The laboratory may be required to comply with OAR 333-024-0040(11)(c)–(f). [Publications: Publications referenced are available from the agency.] Statutory/Other Authority: ORS 438.320 Statutes/Other Implemented: ORS 438.320 History: HD 6-1995, f. & cert. ef. 9-13-95 HD 20-1994, f. & cert. ef. 7-20-94 HD 28-1988, f. & cert. ef. 12-7-88 HB 248, f. 6-30-70, ef. 7-25-70