333-024-0012 Licensure (1) It shall be unlawful: (a) For any Owner or Director of a clinical laboratory to operate or maintain a clinical laboratory without a license or without a temporary permit issued under this rule or to perform or permit the performance of any laboratory specialty for which the laboratory is not licensed, unless the laboratory has been issued a valid certificate from the federal government under the Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, 42.U.S.C. 201 and 263a, except as specified herein; (b) For any person to serve in the capacity of Director of a high complexity clinical laboratory without being qualified as a Clinical Laboratory Director under OAR 333-024-0021; (c) For any person to serve in the capacity of Director of a moderate complexity clinical laboratory without being qualified as a Clinical Laboratory Director under OAR 333-024-0022; and (d) For any person other than a physician or clinician to direct or perform microscopic procedures listed in OAR 333-024-0016(1)(b) in a Physician Performed Microscopy Laboratory. (2) OAR 333-024-0005 through 333-024-0055 and 333-024-0260 and 333-024-0265 apply to all clinical laboratories and laboratory personnel within the State of Oregon, except: (a) Clinical laboratories operated by the United States Government; (b) Clinical laboratories operated and maintained purely for research or teaching purposes, and that involve no patient or public health services. (3) It shall be unlawful for an out-of-state laboratory to perform health screen testing in Oregon without a permit issued as provided in OAR 333-024-0380. (4) The Division shall issue and renew waived, physician performed microscopy, moderate and high complexity licenses for any or all clinical laboratory specialties to the Owners of clinical laboratories who demonstrate to the satisfaction of the Division that: (a) The clinical laboratory is in compliance with OAR 333-024-0005 through 333-024-0055, 333-024-0260, 333-024-0265, 333-024-0305 through 333-024-0360 and 333-024-0370 through 333-024-0400; (b) The laboratory is equipped to perform within the scope of its license; (c) The clinical laboratory retains complete laboratory records as stated in OAR 333-024-0050; (d) The clinical laboratory meets the standards of the Division for safety, disposal of hazardous and infectious waste, ventilation, handling of specimens, and maintenance of equipment to ensure protection of the public health. (5) Requirements for license application, fees, exemptions, expiration, and renewal are as follows: (a) The application for a license for a clinical laboratory shall be made on forms provided by the Division and shall be executed by the Owner or one of the Owners or by an officer of the firm or corporation owning the clinical laboratory, or in the case of a county or municipality, by the public official responsible for operation of the laboratory, or in the case of an institution, by the administrator of the institution. The application shall contain the names of the Owner, the Director or Directors of the clinical laboratory, the location and physical description of the clinical laboratory, the laboratory specialties for which a license is requested, and such other information as the Division may require: (A) Not-for-profit, or state, or local government laboratories that engage in limited public health testing may file a single application, provided they have the same owner and director. They may perform a combined total of fifteen test methods listed in the waived, physician performed microscopy and moderate complexity category. (B) Laboratories that are located at the same site and are under the same director may file a single application. (b) Laboratories must pay an annual or biennial, non-refundable license fee prior to issuance of a license or permit. Numbers in the fee category indicate the number of tests performed annually; count tests on patient/client specimens only. Count the number of tests in each profile. Do not count waived tests, physician-performed microscopy by physicians and clinicians, standards, controls, calculated tests, or proficiency testing samples. Effective July 1, 1999, the annual fees are: (A) Waived — Accredited and Non-Accredited — $71; (B) Physician Performed Microscopy (PPM) — Accredited and Non-Accredited — $95; (C) Non-Accredited Moderate and High Complexity: (i) Low Volume A (LVA) 1–2,000 tests — $261; (ii) A — 2,001 to 10,000 tests; ≤ 3 specialties — $517; (iii) B — 2,001 to 10,000 tests; ≥ 4 specialties — $650; (iv) C — 10,001 to 25,000 tests; ≤ 3 specialties — $916; (v) D — 10,001 to 25,000 tests; ≥ 4 specialties — $1,037; (vi) E — 25,001 to 50,000 tests — $1,254; (vii) F — 50,001 to 75,000 tests — $1,584; (viii) G — 75,001 to 100,000 tests — $1,914; (ix) H — 100,001 to 500,000 tests — $2,263; (x) I — 500,001 to 1,000,000 tests — $4,365; (xi) J — > 1,000,000 tests — $5,298. (D) Accredited Moderate and High Complexity: (i) Low Volume A (LVA) 1–2,000 tests — $118; (ii) A — 2,001 to 10,000 tests; ≤ 3 specialties — $138; (iii) B — 2,001 to 10,000 tests; ≥ 4 specialties — $145; (iv) C — 10,001 to 25,000 tests; ≤ 3 specialties — $285; (v) D — 10,001 to 25,000 tests; ≥ 4 specialties — $295; (vi) E — 25,001 to 50,000 tests — $401; (vii) F — 50,001 to 75,000 tests — $620; (viii) G — 75,001 to 100,000 tests — $840; (ix) H — 100,001 to 500,000 tests — $1,078; (x) I — 500,001 to 1,000,000 tests — $3,070; (xi) J — > 1,000,000 tests — $3,893. (c) Laboratories must pay an annual or biennial, non-refundable license fee prior to issuance of a license or permit. Numbers in the fee category indicate the number of tests performed annually; count tests on patient/client specimens only. Count the number of tests in each profile. Do not count waived tests, physician-performed microscopy by physicians and clinicians, standards, controls, calculated tests, or proficiency testing samples. Effective July 1, 2000, the annual fees are: (A) Waived — Accredited and Non-Accredited — $75; (B) Physician Performed Microscopy (PPM) — Accredited and Non-Accredited — $100; (C) Non-Accredited Moderate and High Complexity: (i) Low Volume A (LVA) 1–2,000 tests — $275; (ii) A — 2,001 to 10,000 tests; ≤ 3 specialties — $545; (iii) B — 2,001 to 10,000 tests; ≥ 4 specialties — $685; (iv) C — 10,001 to 25,000 tests; ≤ 3 specialties — $965; (v) D — 10,001 to 25,000 tests; ≥ 4 specialties — $1,092; (vi) E — 25,001 to 50,000 tests — $1,320; (vii) F — 50,001 to 75,000 tests — $1,667; (viii) G — 75,001 to 100,000 tests — $2,015; (ix) H — 100,001 to 500,000 tests — $2,382; (x) I — 500,001 to 1,000,000 tests — $4,595; (xi) J — > 1,000,000 tests — $5,577. (D) Accredited Moderate and High Complexity: (i) Low Volume A (LVA) 1–2,000 tests — $125; (ii) A — 2,001 to 10,000 tests; ≤ 3 specialties — $146; (iii) B — 2,001 to 10,000 tests; ≥ 4 specialties — $153; (iv) C — 10,001 to 25,000 tests; ≤ 3 specialties — $300; (v) D — 10,001 to 25,000 tests; ≥ 4 specialties — $311; (vi) E — 25,001 to 50,000 tests — $422; (vii) F — 50,001 to 75,000 tests — $653; (viii) G — 75,001 to 100,000 tests — $884; (ix) H — 100,001 to 500,000 tests — $1,136; (x) I — 500,001 to 1,000,000 tests — $3,232; (xi) J — > 1,000,000 tests — $4,098. (d) A prorated fee may be assessed for a license that will be in effect for a year or less; (e) Unless sooner voided, suspended or revoked, all licenses issued under this section expire on June 30 of the one or two year cycle following the date of issuance and shall be renewable in the manner prescribed by the Division; (f) All monies received by the Division for the licensure of clinical laboratories shall be credited to the Division account and shall be used for payment of the expenses of the Division in administering OAR 333-024-0005 through 333-024-0055 and 333-024-0260 and 333-024-0265. (6) A license issued to the Owner of a clinical laboratory shall show on its face the names of the Owners and Directors, the location of the laboratory and the clinical laboratory specialties authorized under the license. The license shall be displayed at all times in a prominent place in the laboratory. (7) A license issued to the Owner of a clinical laboratory is not transferable. The license of the laboratory is voided 30 days after a change of its Director if it has only one Director or if all Directors change or a change in the ownership or in the location of the laboratory. Upon the death of a laboratory’s Director and the immediate notification to the Division, the Division shall be empowered to issue, after the payment of the proper fee, a special temporary permit. This permit shall be of 30 days’ duration and issued to an approved substitute Director. If a license is voided or a special temporary permit is issued under this rule, a new license application, accompanied by the non-refundable license fee prescribed in subsection (4)(b) of this rule shall be filed with the Division. (8) Temporary permit requirements are as follow: (a) In addition to the license of a clinical laboratory required by this rule, the Division may issue a temporary permit, valid for 45 days from the date of issuance, in any or all clinical laboratory specialties upon payment of the respective required fees as prescribed in subsection (5)(b) or (5)(c) of this rule; (b) In issuing the temporary permit, the Division may require that: (A) Plans for compliance with applicable laws and rules be submitted with the application for temporary permit; (B) During the period in which the temporary permit is in effect, periodic reports be submitted on the progress of the plans for compliance; and (C) Temporary provisions specified by the Division upon application of the temporary permit be maintained for the protection of the public. (c) If at any time the Division determines that the clinical laboratory can no longer operate in a manner which protects the public health and safety or that the requirements imposed under paragraphs (7)(b)(A), (B) and (C) of this rule are not being maintained, the Division shall cancel the temporary permit; (d) One renewal of the temporary permit may be granted if deemed to be in the best interest of public health by the Division. The fee for renewal is the respective required fee as prescribed in subsection (4)(b) of this rule. (9) Subject to ORS 183.310 to 183.550, the Division may refuse to issue or renew the license or may suspend or revoke the license of any clinical laboratory, if it finds that the Owner or Director has: (a) Intentionally made false statements on an application for a clinical laboratory license or any other documents required by the Division, or made any misrepresentation in seeking to obtain or retain a license; (b) Demonstrated incompetence as defined in OAR 333-024-0055; (c) Intentionally falsified any report; (d) Referred a specimen for examination to an unlicensed clinical laboratory in this State unless the laboratory is exempt from the application of this rule, or a clinical laboratory not certified or accredited under the provisions of CLIA 88, or other authorized CLIA exempt state laboratory certification program; (e) Misrepresented the scope of laboratory service offered by the clinical laboratory or the clinical laboratory specialties authorized by the license; (f) Rendered a report on clinical laboratory work actually performed in another clinical laboratory without designating the name and address of the clinical laboratory in which the test was performed; (g) Knowingly had professional connection with or permitted the use of the name of the licensed clinical laboratory or its Director by a clinical laboratory that is required to but has not obtained a license; (h) Failed to perform or cause to be performed within the time specified analysis of test samples as stated in OAR 333-024-0040(1) or failed to report on the results of such analysis within the specified time; (i) Failed to permit within a reasonable time the entry or inspection as stated in OAR 333-024-0040(4), (6), (7), (9), (10), (11) and (12); (j) Failed to continue to meet requirements of this rule, inclusive; (k) Violated any provision of OAR 333-024-0005 through 333-024-0055 and 333-024-0260 and 333-024-0265. (10) The owner or director must notify the Division within 30 days of a change of laboratory name and technical supervisor. [Publications: Publications referenced are available from the agency.] Statutory/Other Authority: ORS 433.017, 438.010, 438.040 & 438.055 Statutes/Other Implemented: ORS 438.040 - 438.055 & 438.110 - 438.160 History: OHD 5-1999, f. & cert. ef. 7-30-99 HD 6-1995, f. & cert. ef. 9-13-95 HD 20-1994, f. & cert. ef. 7-20-94 HD 7-1990, f. & cert. ef. 3-21-90 HD 28-1988, f. & cert. ef. 12-7-88