Chapter 341 Oregon Laws 1999

Session Law

AN ACT

HB 2175

Relating to clinical laboratories; creating new provisions; amending ORS 438.040, 438.055, 438.110, 438.120, 438.130 and 438.160; and declaring an emergency.

Be It Enacted by the People of the State of Oregon:

SECTION 1. ORS 438.040 is amended to read:

438.040. On and after July 1, 1970, it shall be unlawful:

(1) For any owner or director of a clinical laboratory to operate or maintain a clinical laboratory without a license issued under ORS 438.110 or without a temporary permit issued under ORS 438.150 or to perform or permit the performance of any laboratory specialty for which the laboratory is not licensed except as specified under ORS 438.050, unless the laboratory has been issued a valid certificate from the federal government under the Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578, 42 U.S.C. 201 and 263a).

(2) For an out-of-state laboratory to perform health screen testing in Oregon without a permit issued under ORS 438.150 (5).

[(2)] (3) For any person to serve in the capacity of director of a clinical laboratory without being qualified as a clinical laboratory director under ORS 438.210.

SECTION 2. ORS 438.055 is amended to read:

438.055. Clinical laboratories operated by [fewer than five] physicians or clinicians [and] that conduct only waived tests and physician performed microscopy procedures used exclusively for the diagnosis and treatment of their patients shall not be subject to regulation that is more strict than regulation imposed under the Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578; 42 U.S.C. 201 and 263a).

SECTION 3. ORS 438.110 is amended to read:

438.110. (1) The Health Division shall establish four levels of laboratory licenses as follows:

(a) A high complexity laboratory license;

(b) A moderate complexity laboratory license;

(d) A waived laboratory license.

(2) The division shall issue and renew [biennial] licenses required under ORS 438.040 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 this chapter and the rules of the division adopted under ORS 438.450;

(b) The laboratory is adequately equipped to perform proficiently within the scope of its license;

(c) The clinical laboratory has facilities for retaining and does retain complete laboratory records for an appropriate length of time as the division by rule may require; and

(d) The clinical laboratory meets the standards of the division for safety, sanitary conditions, plumbing, ventilation, handling of specimens, maintenance of equipment and requirements of general hygiene to insure protection of the public health.

SECTION 4. ORS 438.120 is amended to read:

438.120. (1) In determining the specialties that are authorized to be performed in a clinical laboratory, the Health Division shall consider laboratory personnel, with particular emphasis on the qualifications of the director, laboratory equipment and any other relevant factors affecting the ability of the laboratory to perform different laboratory specialties.

(2) No laboratory shall be licensed to perform examinations in the fields of surgical pathology, autopsy pathology, exfoliative cytology, or immunohematology, except as the Health Division may establish exemptions from the requirements of this subsection in the field of immunohematology, unless its director is a physician or dentist specifically qualified in these fields.

(3) The list of waived tests, physician performed microscopy procedures and moderate and high complexity tests shall be established by the division.

[(4) A moderate complexity laboratory may perform up to three high complexity tests from a list established by the division.]

SECTION 5. ORS 438.130 is amended to read:

438.130. (1) The application for a license for a clinical laboratory shall be made on forms provided by the Health 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 Health Division may require.

(2)(a) [The application shall be accompanied by a biennial license fee to be established by the division. The fee shall be based on test volume, and for each level of laboratory testing shall be not more than 90 percent of the corresponding fees charged by federal laboratory licensing agencies and shall not exceed $300 for a waived laboratory license, $400 for a physician-performed microscopy procedure, $4,000 for a moderate complexity laboratory license or $6,000 for a high complexity laboratory license. The Health Division shall establish a fee for a license issued pursuant to an inspection performed by a private laboratory accrediting organization recognized under ORS 438.310 (3), not to exceed $1,200.] The application shall be accompanied by an annual or biennial license fee to be established by the division. The fee shall be based on test volume, test complexity, the number of specialties performed and private laboratory accreditation. For each level of laboratory testing, the fee shall be not more than 95 percent of the corresponding fee charged by the federal laboratory certification program known as the Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578, 42 U.S.C. 201 and 263a) in effect on the effective date of this 1999 Act. The fee for substance of abuse screening laboratories not certified under the Clinical Laboratory Improvement Amendments of 1988 shall be comparable to the clinical laboratory fee established under this section.

(b) The division may establish prorated fees for licenses issued for a year or less and when there is a change in the laboratory's owner, director or address. A prorated license fee shall be issued to a laboratory accredited by an organization recognized by the division.

(3) Unless sooner voided, suspended or revoked, all licenses issued under this section expire on June 30 of the [next odd-numbered year] one- or two-year cycle following the date of issuance and shall be renewable in the manner prescribed by the division.

(4) Subject to prior approval of the Oregon Department of Administrative Services and a report to the Emergency Board prior to adopting the fees and charges, the fees and charges established under this section shall not exceed the cost of administering the regulatory program of the division pertaining to the purpose for which the fee or charge is established, as authorized by the Legislative Assembly within the division's budget, as the budget may be modified by the Emergency Board.

SECTION 6. ORS 438.130, as amended by section 5 of this 1999 Act, is amended to read:

(2)(a) The application shall be accompanied by an annual or biennial license fee to be established by the division. The fee shall be based on test volume, test complexity, the number of specialties performed and private laboratory accreditation. For each level of laboratory testing, the fee shall be not more than [95] 100 percent of the corresponding fee charged by the federal laboratory certification program known as the Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578, 42 U.S.C. 201 and 263a) in effect on the effective date of this 1999 Act. The fee for substance of abuse screening laboratories not certified under the Clinical Laboratory Improvement Amendments of 1988 shall be comparable to the clinical laboratory fee established under this section.

(3) 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.

SECTION 7. The amendments to ORS 438.130 by section 6 of this 1999 Act become operative on July 1, 2000.

SECTION 8. ORS 438.160 is amended to read:

438.160. Subject to ORS 183.310 to 183.550, the Health Division may refuse to issue or renew the license, or may suspend or revoke the license or health screen testing permit, of [any] a clinical laboratory[,] if it finds that the owner or director has:

(1) Intentionally made false statements on an application for a clinical laboratory license or any other documents required by the Health Division, or made any misrepresentation in seeking to obtain or retain a license.

(2) Demonstrated incompetence as defined pursuant to regulations promulgated after public hearing.

(3) Intentionally falsified any report.

(4) Referred a specimen for examination to a nonlicensed or an unlicensed clinical laboratory in this state unless the laboratory is exempt from the application of this chapter.

(5) Misrepresented the scope of laboratory service offered by the clinical laboratory or the clinical laboratory specialties authorized by the license.

(6) 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.

(7) 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.

(8) Failed to perform or cause to be performed within the time specified analysis of test samples as authorized by ORS 438.320, or failed to report on the results of such analysis within the specified time.

(9) Failed to permit within a reasonable time the entry or inspection authorized by ORS 438.310.

(10) Failed to continue to meet requirements of ORS 438.110 and 438.120.

(11) Violated any provision of this chapter.

SECTION 9. This 1999 Act being necessary for the immediate preservation of the public peace, health and safety, an emergency is declared to exist and this 1999 Act takes effect on July 1, 1999.

Approved by the Governor June 24, 1999

Filed in the office of Secretary of State June 24, 1999

Effective date July 1, 1999

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