reglab/housing_qa huggingface dataset:
OR Rev Stat § 438.120 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.120 - Standards for licensing specialties; exceptions.

(1) In determining the specialties that are authorized to be performed in a clinical laboratory, the Oregon Health Authority 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, unless its director is a physician or dentist specifically qualified in these fields. The authority may establish exemptions from the requirements of this subsection for the field of immunohematology. (3) The list of waived tests, physician performed microscopy procedures and moderate and high complexity tests shall be established by the authority. [1969 c.685 §6; 1993 c.109 §6; 1999 c.341 §4; 2009 c.595 §702]
OR Rev Stat § 438.130 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.130 - License application; fees; expiration and renewal.

(1) The application for a license for a clinical laboratory shall be made on forms provided by the Oregon Health Authority 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 authority may require. (2)(a) The application shall be accompanied by an annual or biennial license fee to be established by the authority. 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 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 July 1, 1999. 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 authority 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 authority. (3) Unless sooner voided, suspended or revoked, all licenses issued under this section expire on June 30 of the one-year or two-year cycle following the date of issuance or on such date as may be specified by authority rule. Licenses issued under this section shall be renewable in the manner prescribed by the authority. (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 authority pertaining to the purpose for which the fee or charge is established, as authorized by the Legislative Assembly within the authority’s budget, as the budget may be modified by the Emergency Board. [1969 c.685 §7; 1977 c.284 §3; 1979 c.696 §2; 1989 c.776 §5; 1991 c.703 §6; 1993 c.109 §7; 1999 c.341 §§5,6; 2007 c.768 §4; 2009 c.595 §703]
OR Rev Stat § 438.140 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.140 - License content; display; nontransferability; voidability; special permit when director changes.

(1) 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. (2) 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 in 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. In case of death of a director, immediate notification to the Director of the Oregon Health Authority or a designee who shall be empowered to issue a special temporary permit of 30 days’ duration issued to a designated substitute director is required. If a license is voided or a special temporary permit is issued under this section, a new license application, accompanied by the nonrefundable license fee prescribed in ORS 438.130, shall be filed with the authority. [1969 c.685 §8; 2009 c.595 §704]
OR Rev Stat § 438.150 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.150 - Temporary permit; fees; health screen testing permit; conditions and limitations; rules.

(1) In addition to the license of a clinical laboratory required by ORS 438.040, the Oregon Health Authority may issue a temporary permit valid for a period, to be determined by the authority, from the date of issuance in any or all clinical laboratory specialties upon payment of the respective required fees as described in ORS 438.130 (2). (2) In issuing the temporary permit, the authority may require that: (a) Plans for compliance with applicable laws and rules be submitted with the application for the 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) Special temporary provisions specified by the authority upon application of the temporary permit be maintained for the protection of the public. (3) If at any time the authority determines that the clinical laboratory can no longer operate in a manner that protects the public health and safety or that the requirements imposed under subsection (2) of this section are not being maintained, the authority shall cancel the temporary permit. (4) One renewal of the temporary permit may be granted if deemed to be in the best interest of public health by the authority. The fee for renewal is the respective required fee as described in ORS 438.130 (2). (5) The authority may issue permits for health screen testing. (6) The authority by rule shall specify: (a) Appropriate quality assurance procedures; (b) Personnel qualifications; (c) Standards for counseling and referral of persons being tested; (d) Tests a health testing service may conduct; (e) The procedure for applying for a permit; and (f) The procedure for reporting to the authority the location of all health screening facilities. (7) The authority by rule may specify the maximum length of time a health screen testing service may remain in one location. [1969 c.685 §9; 1989 c.776 §2; 2007 c.71 §122; 2009 c.595 §705]
OR Rev Stat § 438.160 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.160 - Refusal to issue or renew license; suspension or revocation of license or permit.

Subject to ORS chapter 183, the Oregon Health Authority may refuse to issue or renew the license, or may suspend or revoke the license or health screen testing permit, of 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 authority, 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 ORS 438.010 to 438.510. (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 ORS 438.010 to 438.510. [1969 c.685 §10; 1993 c.109 §13; 1999 c.341 §8; 2001 c.104 §172; 2009 c.595 §706]
OR Rev Stat § 438.210 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.210 - Qualifications of laboratory director.

A person is qualified to act as a laboratory director of a clinical laboratory if: (1) The person is a pathologist certified in clinical or anatomical pathology by a national organization or organizations recognized by the Oregon Health Authority, or is a physician who possesses qualifications equivalent to those required for such certification; (2) The person is a physician who possesses special qualifications that enable the person to perform as a laboratory director, or is directing a laboratory on January 1, 1970; (3) The person has an earned degree of Doctor of Science or Doctor of Philosophy, or an acceptable degree as determined by the authority, from an accredited college or university, with a major in the chemical, physical, or biological sciences and possesses special qualifications as described in the administrative rules of the authority that enable the person to perform as a laboratory director; (4) The person is a member of a group of five or more physicians who operate on November 4, 1993, a laboratory performing work only on their patients and is the member designated by the group to be the director; or (5) The person was responsible for the direction of a clinical laboratory for at least 12 months within the five years preceding January 1, 1970, and has had at least two years of pertinent clinical laboratory experience, as determined by the authority. [1969 c.685 §12; 1993 c.109 §8; 2007 c.71 §123; 2009 c.595 §707]
OR Rev Stat § 438.220 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.220 - Special qualifications for laboratory director at chiropractic college.

Notwithstanding ORS 438.210, a person is qualified to act as the laboratory director of the clinical laboratory at any accredited chiropractic college in this state for the benefit of chiropractic patients if that person is a chiropractic physician licensed by the State Board of Chiropractic Examiners, and possesses special qualifications, as determined by the State Board of Chiropractic Examiners, that enable that person to perform as a laboratory director. [1979 c.303 §2]
OR Rev Stat § 438.310 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.310 - Inspection of laboratory premises; owner to submit reports and findings on communicable disease; information confidential.

(1) The Oregon Health Authority or its authorized representative may: (a) At reasonable times enter the premises of a clinical laboratory licensed or subject to being licensed under ORS 438.010 to 438.510 to inspect the facilities, methods, procedures, materials, staff, equipment, laboratory results and records of the clinical laboratory. (b) Require the owner or director to submit reports on the operations and procedures of the laboratory. (c) Require the owner or director to submit initial laboratory findings indicative of communicable disease as defined by law or by rule. Each report shall include the name of the person from whom the specimen was obtained, if the name was reported to the laboratory, and the name and address of the physician for whom such examination or test was made. Such reports shall not be construed as constituting a diagnosis nor shall any laboratory making such report be held liable under the laws of this state for having violated a trust or confidential relationship. (2) The Director of the Oregon Health Authority or a designee, the authority, or any employee thereof, shall not disclose information contained in reports on communicable diseases submitted to the authority under subsection (1) of this section except as such information is made available to employees of the authority and to local health officers for purposes of administering the public health laws of this state. However, information contained in such reports may be used in compiling statistical and other data in which persons are not identified by name or otherwise. (3) The authority shall by rule set standards for the recognition of private laboratory accrediting organizations whose standards meet or exceed federal standards. A laboratory that is accredited by a private laboratory accrediting organization recognized by the authority under this section may submit proof of such accreditation to the authority. Upon receipt of such proof, the authority shall issue a license pursuant to ORS 438.130. [1969 c.685 §13; 1993 c.109 §9; 2001 c.104 §173; 2009 c.595 §708]
OR Rev Stat § 438.320 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.320 - Laboratory evaluation system; rules; quality control systems.

(1) The Oregon Health Authority shall institute a laboratory evaluation system, as defined in ORS 438.010, and shall make such rules as are necessary to insure quality control of laboratory work. (2) As part of this system, the authority may require each laboratory to: (a) Participate in on-site inspection and testing; (b) Analyze test samples submitted by the authority prior to, during or subsequent to the inspection; and (c) Contract with, at the laboratory’s own expense, an authority-approved source of test samples for such test samples to be submitted periodically to the laboratory and to be returned to that source for grading after testing. The test results shall be made available to the authority. (3) The procedures under subsection (2) of this section shall be referred to as external quality control. The samples are to be tested by regularly assigned personnel using routine methods. The test samples shall be confined to the specialty of the laboratory as indicated on the license. A specified time shall be allowed for such testing and reporting of the results and shall be the time required under conditions of normal operation. (4) In addition to external quality control, each clinical laboratory shall establish an internal laboratory quality control system pursuant to rules of the authority including but not necessarily limited to the testing of reference or control sera and other biological samples, verifying concurrent calibration standards and control charts recordings, and reporting on its control system as required by the authority. [1969 c.685 §14; 1983 c.740 §154; 1993 c.109 §10; 2009 c.595 §709]
OR Rev Stat § 438.420 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.420 - Communicable disease reports to be from licensed laboratory.

When the control or release of a case contact or carrier of a communicable disease is dependent on laboratory findings, the health officer may require such findings to be obtained by a clinical laboratory licensed by the Oregon Health Authority. [Formerly 433.325; 2009 c.595 §710]
OR Rev Stat § 438.430 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.430 - Examination of specimens; reports and results.

(1) Except as otherwise provided in ORS 438.010 to 438.510, a clinical laboratory shall examine specimens only at the request of a physician, dentist, or other person authorized by law to use the findings of laboratory examinations. (2) A person may not report the result of any test, examination, or analysis of a specimen submitted for evidence of human disease except to: (a) The patient or the patient’s authorized representative, unless the physician, dentist or other person requesting the laboratory test, examination or analysis under subsection (1) of this section notifies the clinical laboratory of a reasonable belief that an exception applies to the prohibition on information blocking under 42 U.S.C. 300jj-52; and (b) A physician, dentist, their agents, or other person authorized by law to employ the results in the conduct of a practice or in the fulfillment of official duties. (3) Except as provided in subsection (2) of this section, a clinical laboratory or the designee of the laboratory, after verifying the identity of the requester and after determining the results are ready for release, shall without unreasonable delay provide the results of a test, examination or analysis of a specimen submitted by a patient in writing to the patient or the patient’s authorized representative. [1969 c.685 §21; 2001 c.104 §174; 2003 c.376 §1; 2009 c.583 §1; 2021 c.285 §1]
OR Rev Stat § 438.440 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.440 - Disposition of fees.

All moneys received by the Oregon Health Authority under ORS 438.010 to 438.510 and 438.990 shall be credited to the Public Health Account and shall be used for payment of the expenses of the authority in administering the provisions of ORS 438.010 to 438.510 and 438.990. [1969 c.685 §16; 2009 c.595 §712]
OR Rev Stat § 438.450 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.450 - Rules.

The Oregon Health Authority shall make such rules as are necessary for carrying out ORS 438.010 to 438.510 in accordance with ORS 183.330. [Formerly 433.335; 2001 c.104 §176; 2009 c.595 §713]
OR Rev Stat § 438.510 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.510 - Prohibited acts.

It is unlawful for the owner of a clinical laboratory or the director of a clinical laboratory to: (1) Operate or maintain a clinical laboratory unless the laboratory is under personal supervision of a director who is qualified to supervise the laboratory. (2) Violate any provision of ORS 438.010 to 438.510. [1969 c.685 §11; 1987 c.669 §3; 2001 c.104 §177]
OR Rev Stat § 438.605 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.605 - Definitions for ORS 438.605 to 438.620, 448.280 and 448.285.

As used in ORS 438.605 to 438.620, 448.280 and 448.285: (1) "Accrediting authority" means the official accrediting authority for the Oregon environmental laboratory accreditation program comprised of the Director of the Oregon Health Authority or designee, the Director of the Department of Environmental Quality or designee and the Director of Agriculture or designee. (2) "Authority" means the Oregon Health Authority. (3) "Environmental laboratory" means a fixed location or mobile facility that performs chemical, physical, radiological, microbiological or biological testing of environmental samples or the collection of environmental samples. (4) "Environmental testing" means laboratory analysis of any matter, pollutant, contaminant or hazardous substance subject to regulation pursuant to: (a) Rules adopted or enforced by the Oregon Health Authority, the Department of Environmental Quality or the State Department of Agriculture; or (b) A federal environmental statute or regulation administered or enforced by the United States Environmental Protection Agency. [1999 c.1063 §1; 2009 c.595 §714]
OR Rev Stat § 438.610 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.610 - Standards for accreditation; rules.

(1) The Oregon Health Authority, in concurrence with the accrediting authority, may adopt by rule standards for any laboratory seeking accreditation and performing environmental testing for a fee or for determining compliance with environmental statutes, rules or regulations. (2) In developing standards under subsection (1) of this section, the authority shall cooperate with and may seek advice from the United States Environmental Protection Agency and any other state or federal agency that may have adopted rules or regulations for environmental monitoring. (3) The standards adopted under this section may address testing and sampling procedures or methods, record keeping, disposal or retention of testing materials or samples, or any other practice related to work performed by an environmental laboratory. [1999 c.1063 §2; 2009 c.595 §715]
OR Rev Stat § 438.615 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.615 - Environmental laboratory accreditation program; rules.

The Oregon Health Authority, in concurrence with the accrediting authority, shall establish by rule and implement an environmental laboratory accreditation program. The standards for accreditation may be equivalent to, but may not exceed, standards adopted by national accreditation programs. [1999 c.1063 §3; 2009 c.595 §716]
OR Rev Stat § 438.620 (2021)
2021 Oregon Revised Statutes|Volume : 12 - Public Health|Chapter 438 - Laboratories; Anatomical Material|Section 438.620 - Accreditation fees; disposition of fees.

(1) In conjunction with the environmental laboratory accreditation program established under ORS 438.615, the Oregon Health Authority may establish and collect a fee for laboratory accreditation under the program. A fee imposed under this section shall not exceed the cost of administering the program. (2) Prior to imposing the fee under subsection (1) of this section, the authority shall obtain the approval of the Oregon Department of Administrative Services and report to the appropriate legislative committee. (3) All moneys collected by the Oregon Health Authority under this section shall be deposited in a dedicated account of the authority. Such moneys are continuously appropriated to the Oregon Health Authority to pay the costs of the authority, the State Department of Agriculture and the Department of Environmental Quality in administering the environmental laboratory accreditation program established under ORS 438.615. [1999 c.1063 §4; 2009 c.595 §717]