ORS Chapter 438
Chapter 438 — Clinicaland Environmental Laboratories
2009 EDITION
CLINICALAND ENVIRONMENTAL LABORATORIES
PUBLICHEALTH AND SAFETY
CLINICALLABORATORIES
(Generally)
438.010 Definitionsfor ORS 438.010 to 438.510
438.030 Policy
438.040 Laboratorylicense; out-of-state laboratory permit; qualifications of director
438.050 Application;exceptions
438.055 Exemption
438.060 Permitfor health screen testing; exception
438.070 Personnel;rules
(ClinicalLaboratory License)
438.110 Standardsfor issuance and renewal of laboratory license
438.120 Standardsfor licensing specialties; exceptions
438.130 Licenseapplication; fees; expiration and renewal
438.140 Licensecontent; display; nontransferability; voidability; special permit when directorchanges
438.150 Temporarypermit; fees; health screen testing permit; conditions and limitations; rules
438.160 Refusalto issue or renew license; suspension or revocation of license or permit
(ClinicalLaboratory Director)
438.210 Qualificationsof laboratory director
438.220 Specialqualifications for laboratory director at chiropractic college
(Inspectionand Evaluation)
438.310 Inspectionof laboratory premises; owner to submit reports and findings on communicabledisease; information confidential
438.320 Laboratoryevaluation system; rules; quality control systems
(Miscellaneous)
438.420 Communicabledisease reports to be from licensed laboratory
438.430 Examination,specimens; reports and results
438.435 Testingfor substance of abuse; rules; fees
438.440 Dispositionof fees
438.450 Rules
438.510 Prohibitedacts
ENVIRONMENTALLABORATORIES
438.605 Definitionsfor ORS 438.605 to 438.620, 448.280 and 448.285
438.610 Standardsfor accreditation; rules
438.615 Environmentallaboratory accreditation program; rules
438.620 Accreditationfees; disposition of fees
PENALTIES
438.990 Penalties
CLINICALLABORATORIES
(Generally)
438.010Definitions for ORS 438.010 to 438.510. As used in ORS 438.010 to 438.510,unless the context requires otherwise:
(1)“Authority” means the Oregon Health Authority.
(2)“Clinical laboratory” or “laboratory” means a facility where themicrobiological, serological, chemical, hematological, immunohematological,immunological, toxicological, cytogenetical, exfoliative cytological,histological, pathological or other examinations are performed on materialsderived from the human body, for the purpose of diagnosis, prevention ofdisease or treatment of patients by physicians, dentists and other persons whoare authorized by license to diagnose or treat humans.
(3)“Clinical laboratory specialty” or “laboratory specialty” means the examinationof materials derived from the human body for the purpose of diagnosis andtreatment of patients or assessment of health, employing one of the followingsciences: Serology, microbiology, chemistry, hematology, immunohematology,immunology, toxicology, cytogenetics, exfoliative cytology, histology orpathology.
(4)“Clinician” means a nurse practitioner licensed and certified by the OregonState Board of Nursing, or a physician assistant licensed by the Oregon MedicalBoard.
(5)“Custody chain” means the handling of specimens in a way that supports legaltestimony to prove that the sample integrity and identification of the sample havenot been violated, as well as the documentation describing those proceduresfrom specimen collection to the final report.
(6)“Dentist” means a person licensed to practice dentistry by the Oregon Board ofDentistry.
(7)“Director of clinical laboratory” or “director” means the person who plans,organizes, directs and participates in any or all of the technical operationsof a clinical laboratory, including but not limited to reviewing laboratoryprocedures and their results, training and supervising laboratory personnel,and evaluating the technical competency of such personnel.
(8)“Health screen testing” means tests performed for the purpose of identifyinghealth risks, providing health information and referring the person beingtested to medical care.
(9)“High complexity laboratory” means a facility that performs testing classifiedas highly complex in the specialties of microbiology, chemistry, hematology,diagnostic immunology, immunohematology, clinical cytogenetics, cytology,histopathology, oral pathology, pathology, radiobioassay and histocompatibilityand that may also perform moderate complexity tests and waived tests.
(10)“High complexity test” means a procedure performed on materials derived fromthe human body that meet the criteria for this category of testing in thespecialties of microbiology, chemistry, hematology, immunohematology,diagnostic immunology, clinical cytogenetics, cytology, histopathology, oralpathology, pathology, radiobioassay and histocompatibility as established bythe authority.
(11)“Laboratory evaluation system” means a system of testing clinical laboratorymethods, procedures and proficiency by periodic performance and reporting ontest specimens submitted for examination.
(12)“Moderate complexity laboratory” means a facility that performs testingclassified as moderately complex in the specialties of microbiology,hematology, chemistry, immunohematology or diagnostic immunology and may alsoperform any waived test.
(13)“Moderate complexity test” means a procedure performed on materials derivedfrom the human body that meet the criteria for this category of testing in thespecialties of microbiology, hematology, chemistry, immunohematology ordiagnostic immunology as established by the authority.
(14)“Operator of a substances of abuse on-site screening facility” or “operator”means the person who plans, organizes, directs and participates in any or allof the technical and administrative operations of a substances of abuse on-sitescreening facility.
(15)“Owner of a clinical laboratory” means the person who owns the clinicallaboratory, or a county or municipality operating a clinical laboratory or theowner of any institution operating a clinical laboratory.
(16)“Physician” means a person licensed to practice medicine by the Oregon MedicalBoard.
(17)“Physician performed microscopy procedure” means a test personally performed bya physician or other clinician during a patient’s visit on a specimen obtainedduring the examination of the patient.
(18)“Physician performed microscopy procedures” means a limited group of tests thatare performed only by a physician or clinician.
(19)“Specimen” means materials derived from a human being or body.
(20)“Substances of abuse” means ethanol and controlled substances, except thoseused as allowed by law and as defined in ORS chapter 475 or as used in ORS689.005.
(21)“Substances of abuse on-site screening facility” or “on-site facility” means alocation where on-site tests are performed on specimens for the purpose ofscreening for the detection of substances of abuse.
(22)“Substances of abuse on-site screening test” or “on-site test” means asubstances of abuse test that is easily portable and can meet the requirementsof the federal Food and Drug Administration for commercial distribution or analcohol screening test that meets the requirements of the conforming productslist found in the United States Department of Transportation National HighwayTraffic Safety Administration Docket No. 94-004 and meets the standards of theUnited States Department of Transportation Alcohol Testing Procedure, 49 C.F.R.part 40, in effect on October 23, 1999.
(23)“Waived test” means a procedure performed on materials derived from the humanbody that meet the criteria for this category of testing as established by theauthority. [1969 c.685 §2; 1989 c.776 §1; 1993 c.109 §3; 1997 c.355 §1; 1999c.739 §1; 2001 c.104 §168; 2001 c.900 §255; 2009 c.595 §698]
438.030Policy.It shall be the declarative purpose of ORS 438.010 to 438.510 to ensure thequality of medical laboratory work in order to protect the health and welfareof the people of the State of Oregon by establishing a regulatory program forclinical laboratories. [1969 c.685 §1; 2001 c.104 §169]
438.040Laboratory license; out-of-state laboratory permit; qualifications of director. It is unlawful:
(1)For any owner or director of a clinical laboratory to operate or maintain aclinical laboratory without a license issued under ORS 438.110 or without atemporary permit issued under ORS 438.150 or to perform or permit theperformance of any laboratory specialty for which the laboratory is notlicensed except as specified under ORS 438.050, unless the laboratory has beenissued a valid certificate from the federal government under the ClinicalLaboratory Improvement Amendments of 1988 (P.L. 100-578, 42 U.S.C. 201 and263a).
(2)For an out-of-state laboratory to perform health screen testing in Oregonwithout a permit issued under ORS 438.150 (5).
(3)For any person to serve in the capacity of director of a clinical laboratorywithout being qualified as a clinical laboratory director under ORS 438.210. [1969c.685 §3; 1999 c.341 §1; 2005 c.22 §298]
438.050Application; exceptions. (1) ORS 438.010 to 438.510 apply to all clinicallaboratories 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 teachingpurposes, and that involve no patient or public health services.
(2)Nothing in ORS 438.010 to 438.510 is intended to confer on any licensedpractitioner of the healing arts any authority the practitioner would nototherwise possess under the license. [1969 c.685 §§4,20; 1973 c.829 §54; 1979c.193 §1; 1993 c.109 §4; 2001 c.104 §170]
438.055Exemption.Clinical laboratories operated by physicians or clinicians that conduct onlywaived tests and physician performed microscopy procedures used exclusively forthe diagnosis and treatment of their patients shall not be subject toregulation that is more strict than regulation imposed under the ClinicalLaboratory Improvement Amendments of 1988 (P.L. 100-578; 42 U.S.C. 201 and263a). [1993 c.109 §12; 1999 c.341 §2]
438.060Permit for health screen testing; exception. Notwithstanding ORS 438.050, anyperson performing health screen testing must obtain a permit under ORS 438.150(5). However, an employer providing health screen testing to employees of theemployer is exempt from the applications of ORS 438.010, 438.130, 438.150 andthis section if such employer contracts for the testing through a licensedphysician, a clinical laboratory or a hospital, which is a permittee of theOregon Health Authority as provided in this section. [1989 c.776 §3; 2009 c.595§699]
438.070Personnel; rules.The Oregon Health Authority shall establish by rule the qualifications andresponsibilities of technical and clinical consultants, general and technicalsupervisors and testing personnel. A person is qualified to act as a technicalor clinical consultant, a general or technical supervisor, or a testing personin a clinical laboratory if the person meets the requirements established bythe authority. Rules adopted under this section shall not be more stringentthan comparable rules adopted under the Clinical Laboratory ImprovementAmendments of 1988 (P.L. 100-578; 42 U.S.C. 201 and 263a). [1993 c.109 §2; 2009c.595 §700]
(ClinicalLaboratory License)
438.110Standards for issuance and renewal of laboratory license. (1) The OregonHealth Authority shall establish four levels of laboratory licenses as follows:
(a)A high complexity laboratory license;
(b)A moderate complexity laboratory license;
(c)A physician performed microscopy laboratory license; and
(d)A waived laboratory license.
(2)The authority shall issue and renew licenses required under ORS 438.040 for anyor all clinical laboratory specialties to the owners of clinical laboratorieswho demonstrate to the satisfaction of the authority that:
(a)The clinical laboratory is in compliance with ORS 438.010 to 438.510 and therules of the authority adopted under ORS 438.450;
(b)The laboratory is adequately equipped to perform proficiently within the scopeof its license;
(c)The clinical laboratory has facilities for retaining and does retain completelaboratory records for an appropriate length of time as the authority by rulemay require; and
(d)The clinical laboratory meets the standards of the authority for safety,sanitary conditions, plumbing, ventilation, handling of specimens, maintenanceof equipment and requirements of general hygiene to insure protection of thepublic health. [1969 c.685 §5; 1971 c.650 §18; 1993 c.109 §5; 1999 c.341 §3;2001 c.104 §171; 2009 c.595 §701]
438.120Standards for licensing specialties; exceptions. (1) Indetermining the specialties that are authorized to be performed in a clinicallaboratory, the Oregon Health Authority shall consider laboratory personnel,with particular emphasis on the qualifications of the director, laboratoryequipment and any other relevant factors affecting the ability of thelaboratory to perform different laboratory specialties.
(2)No laboratory shall be licensed to perform examinations in the fields ofsurgical pathology, autopsy pathology, exfoliative cytology, orimmunohematology, unless its director is a physician or dentist specificallyqualified in these fields. The authority may establish exemptions from therequirements of this subsection for the field of immunohematology.
(3)The list of waived tests, physician performed microscopy procedures andmoderate and high complexity tests shall be established by the authority. [1969c.685 §6; 1993 c.109 §6; 1999 c.341 §4; 2009 c.595 §702]
438.130License application; fees; expiration and renewal. (1) Theapplication for a license for a clinical laboratory shall be made on formsprovided by the Oregon Health Authority and shall be executed by the owner orone of the owners or by an officer of the firm or corporation owning theclinical laboratory, or in the case of a county or municipality, by the publicofficial responsible for operation of the laboratory, or in the case of aninstitution, by the administrator of the institution. The application shallcontain the names of the owner, the director or directors of the clinicallaboratory, the location and physical description of the clinical laboratory,the laboratory specialties for which a license is requested and such otherinformation as the authority may require.
(2)(a)The application shall be accompanied by an annual or biennial license fee to beestablished by the authority. The fee shall be based on test volume, testcomplexity, the number of specialties performed and private laboratoryaccreditation. For each level of laboratory testing, the fee shall be not morethan 100 percent of the corresponding fee charged by the federal laboratorycertification program known as the Clinical Laboratory Improvement Amendmentsof 1988 (P.L. 100-578, 42 U.S.C. 201 and 263a) in effect on July 1, 1999. Thefee for substance of abuse screening laboratories not certified under theClinical Laboratory Improvement Amendments of 1988 shall be comparable to theclinical laboratory fee established under this section.
(b)The authority may establish prorated fees for licenses issued for a year orless 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 anorganization recognized by the authority.
(3)Unless sooner voided, suspended or revoked, all licenses issued under thissection expire on June 30 of the one-year or two-year cycle following the dateof issuance or on such date as may be specified by authority rule. Licensesissued under this section shall be renewable in the manner prescribed by theauthority.
(4)Subject to prior approval of the Oregon Department of Administrative Servicesand a report to the Emergency Board prior to adopting the fees and charges, thefees and charges established under this section shall not exceed the cost ofadministering the regulatory program of the authority pertaining to the purposefor which the fee or charge is established, as authorized by the LegislativeAssembly within the authority’s budget, as the budget may be modified by theEmergency 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]
438.140License content; display; nontransferability; voidability; special permit whendirector changes.(1) A license issued to the owner of a clinical laboratory shall show on itsface the names of the owners and directors, the location of the laboratory andthe clinical laboratory specialties authorized under the license. The licenseshall 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. Thelicense of the laboratory is voided 30 days after a change in its director ifit has only one director or if all directors change or a change in theownership 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 adesignee who shall be empowered to issue a special temporary permit of 30 days’duration issued to a designated substitute director is required. If a licenseis voided or a special temporary permit is issued under this section, a newlicense application, accompanied by the nonrefundable license fee prescribed inORS 438.130, shall be filed with the authority. [1969 c.685 §8; 2009 c.595 §704]
438.150Temporary permit; fees; health screen testing permit; conditions andlimitations; rules.(1) In addition to the license of a clinical laboratory required by ORS438.040, the Oregon Health Authority may issue a temporary permit valid for aperiod, to be determined by the authority, from the date of issuance in any orall clinical laboratory specialties upon payment of the respective required feesas 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 theapplication for the temporary permit;
(b)During the period in which the temporary permit is in effect periodic reportsbe submitted on the progress of the plans for compliance; and
(c)Special temporary provisions specified by the authority upon application of thetemporary permit be maintained for the protection of the public.
(3)If at any time the authority determines that the clinical laboratory can nolonger operate in a manner that protects the public health and safety or thatthe requirements imposed under subsection (2) of this section are not beingmaintained, the authority shall cancel the temporary permit.
(4)One renewal of the temporary permit may be granted if deemed to be in the bestinterest of public health by the authority. The fee for renewal is therespective 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 healthscreening facilities.
(7)The authority by rule may specify the maximum length of time a health screentesting service may remain in one location. [1969 c.685 §9; 1989 c.776 §2; 2007c.71 §122; 2009 c.595 §705]
438.160Refusal to issue or renew license; suspension or revocation of license orpermit.Subject to ORS chapter 183, the Oregon Health Authority may refuse to issue orrenew the license, or may suspend or revoke the license or health screentesting permit, of a clinical laboratory if it finds that the owner or directorhas:
(1)Intentionally made false statements on an appl