reglab/statecodes huggingface dataset:
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0230 - Testing for Metabolic Diseases: Methods of Testing

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Infants shall be tested for congenital
			 disorders on the newborn screening test panel by methods approved by rule of
			 the Oregon Health Authority. The following laboratory procedures are approved.
			 No other method shall be approved unless it meets or exceeds these methods in
			 respect to specificity, sensitivity, and precision of the assay. Persons
			 wanting amendment of this rule to include another method must provide technical
			 data to the state public health laboratory showing to the satisfaction of the
			 state public health laboratory that the proposed method meets or exceeds the
			 approved methods in these respects.
(2) Laboratory methods for detecting
			 congenital disorders shall be performed upon dried blood specimens and be as
			 follows:
(a) Amino acid and urea cycle
			 disorders: Quantitative measurement of amino acids by tandem mass
			 spectrometry.
(b) Biotinidase
			 deficiency: Colorimetric assay for biotinidase activity.
(c) Congenital adrenal hyperplasia:
			 Fluorescent immunoassay of 17-alpha hydroxyprogesterone (17-OHP).
(d) Congenital hypothyroidism: Fluorescent
			 immunoassay of thyroxine (T4) with secondary assay of thyroid stimulating
			 hormone (thyrotropin or TSH).
(e)
			 Cystic fibrosis: Fluorescent immunoassay for the presence or absence of
			 immunoreactive trypsinogen (IRT).
(f) Fatty acid oxidation disorders:
			 Quantitative measurement of acylcarnitines by tandem mass
			 spectrometry.
(g) Galactosemia:
			 Fluorescent immunoassay for the presence or absence of detectable galactose
			 uridyl transferase in erythrocytes and galactose.
(h) Hemoglobinopathies: Primary screening by
			 isoelectric focusing and confirmation by high performance liquid chromatography
			 to detect hemoglobin variants.
(i)
			 Severe combined immunodeficiencies: DNA polymerase chain reaction (PCR) to
			 detect the absence or presence of T-cell receptor excision circles (TREC
			 assay).
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0231 - Testing for Metabolic Diseases: Procedures for Follow-Up of Specimens Administered Too Early, Improperly Collected, and Those That Show Abnormal Results

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Improperly
			 collected specimens. Where specimens contain insufficient blood, are
			 contaminated or are found to be otherwise unsuitable for testing (refer to
			 Newborn Screening Specimen Collection in the state public health laboratory's
			 Practitioner's Manual or website), a repeat specimen will be requested. A
			 letter will be mailed or faxed by the state public health laboratory to the
			 practitioner who submitted the original specimen within two to four working
			 days after receiving the sample. If there is no response after 10 working days,
			 the state public health laboratory will send a follow-up letter. If there is no
			 response within 21 working days after the second letter, a certified letter
			 will be sent indicating that the state public health laboratory will no longer
			 be tracking that infant and that the responsibility for further screening rests
			 with the practitioner and the parents.
(2) Specimens that show anomalous results.
			 The state public health laboratory will refer anomalous results to the
			 screening program's medical consultants. Reports of anomalous findings will be
			 made by the medical consultants to individual practitioners. Requests for
			 repeat or diagnostic specimens will be made through the medical consultants by
			 letter or telephone call, depending upon the urgency of the situation. The
			 practitioner will inform the state public health laboratory of the final
			 resolution or confirmation of each case to ensure timely and complete
			 follow-up.
Publications: Publications referenced are available from the
				  agency.
Statutory/Other Authority: ORS
				  433.285
Statutes/Other Implemented: ORS
				  433.285
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0232 - Demographic Data

Current through Register Vol. 63, No. 7, July 1, 2024
The state public health laboratory will maintain demographic
				data records on infants to be used for the purposes of monitoring statistical
				trends and screening practices in hospitals, birthing facilities, and
				individual practices. This monitoring will enable the state public health
				laboratory to:
(1) Identify
			 facilities and health care providers that submit inadequate specimens;
(2) Evaluate the overall
			 effectiveness of the screening program;
(3) Monitor and ensure timely and complete
			 follow-up; and
(4) Ensure that the
			 most effective newborn screening program for the State of Oregon will be
			 maintained.
Stat. Auth.: ORS 433.285 & 433.290
Stats. Implemented: ORS 433.285 &
				  433.290
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0235 - Religious Exemption from Newborn Screening Testing

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A religious exemption from testing for
			 congenital disorders may be claimed if the infant is being reared as an
			 adherent to a religion the teachings of which are opposed to such testing.
(2)
(a) In the event a religious exemption is
			 claimed from the requirements for testing for congenital disorders, the person
			 otherwise responsible for submitting the specimen for testing shall be
			 responsible for submitting a completed statement to the state public health
			 laboratory signed by the infant's parent or legal guardian using the following
			 language:
STATEMENT OF RELIGIOUS EXEMPTION
The undersigned parent or legal guardian of___________, born
				on_________, states that this child is exempt from newborn screening testing
				for detection of congenital disorders in that the child is being reared as an
				adherent to a religion the teachings of which are opposed to such testing.
				________________________________________________
(Signature of parent or legal guardian)
_____________________
(Date)
(b)
			 The completed statement in subsection (a) of this section may be made on the
			 reverse side of the original specimen identification form which otherwise
			 accompanies the dried blood specimen used to test the infant for congenital
			 disorders.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0240 - Renumbered

Current through Register Vol. 63, No. 7, July 1, 2024
To view attachments referenced in rule text, click here to
				  view rule.
Statutory/Other Authority: 433.285 & ORS
				  431A.750
Statutes/Other Implemented: 433.285 & ORS
				  431A.750
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0260 - Purpose

Current through Register Vol. 63, No. 7, July 1, 2024
(1) OAR
			 333-024-0260  through
			 333-024-0265  shall
			 apply to the assay of Maternal Serum Alpha-Fetoprotein (MSAFP), Amniotic Fluid
			 Alpha-Fetoprotein (AFAFP), Serum Human Chorionic Gonadotropin, Unconjugated
			 Estriol, Amniotic Fluid Acetylcholinesterase or other related markers for the
			 purposes of congenital/genetic screening.
(2) All sections of Clinical Laboratory OAR
			 333-024-0005  through
			 333-024-0055  shall
			 apply.
Stat. Auth.: ORS 438.320
Stats. Implemented: ORS
				  438.320
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0265 - Procedure

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Prior to
			 performing patient screening, the laboratory shall have available documentation
			 of its expertise with the assays of MSAFP, AFAFP, Serum Human Chorionic
			 Gonadotropin, Unconjugated Estriol, Amniotic Fluid Acetylcholinesterase or
			 other related markers for the purposes of congenital/genetic
			 screening.
(2) Each laboratory
			 shall establish reference data based on the laboratory's own test results for
			 normal MSAFP, AFAFP, Serum Human Chorionic Gonadotropin, Unconjugated Estriol,
			 Amniotic Fluid Acetylcholinesterase or other related markers for medically
			 applicable times throughout the pregnancy.
(3) When required for calculation or
			 interpretation of results, protocols shall be developed and implemented for
			 adjusting test values for variables such as: gestational age, maternal weight,
			 diabetic status, race or other factors.
(4) At least annually, the laboratory shall:
(a) Review the most recent patient test
			 results;
(b) Compare current
			 patient test data to previous results to ascertain changes in the median and
			 dispersion of values;
(c)
			 Investigate the causes of variation;
(d) Make corrections as needed; and
(e) Calculate and review percentages of
			 abnormal results.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0305 - Purpose and Scope

Current through Register Vol. 63, No. 7, July 1, 2024
OAR
				333-024-0305 through
				333-024-0365 are for the purpose of carrying out ORS 438.435 regarding substance of abuse
				testing in order to protect the people of the State of Oregon. OAR
				333-024-0315  through
				333-024-0350 establishes a regulatory program for laboratories performing medical testing or
				non-medical testing by automated methods to ensure the quality of testing. OAR
				333-024-0360 sets standards for substance of abuse testing in correctional institutions or
				programs. OAR
				333-024-0365 establishes a registry for entities performing non-medical substance of abuse
				screening using easily portable screening tests.
Stat. Auth.: ORS 438.050, 438.130, 438.435(2), 438.435(4),
				  438.435(5) & 438.435(6)
Stats. Implemented: ORS 438.050, 438.130 &
				  438.435
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0315 - Licensure

Current through Register Vol. 63, No. 7, July 1, 2024
(1) It shall be
			 unlawful:
(a) For any owner or director of a
			 SOA or a clinical laboratory to perform medical or automated non-medical SOA
			 screening tests without a license issued under this rule unless they have been
			 certified for that testing under the Clinical Laboratory Improvement Amendments
			 of 1988, Public Law
			 100-578, 42.U.S.C. 201 and 263a;
(b) For any person to serve in the capacity
			 of director of an SOA screening laboratory without being qualified as a
			 laboratory director under OAR
			 333-024-0320(1).
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0320 - Qualifications and Responsibilities of Directors

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The director of a substances of abuse
			 screening laboratory shall meet one of the following qualifications:
(a) Is a pathologist certified in clinical
			 pathology by the American Board of Pathology, the American Osteopathic Board of
			 Pathology, or is eligible for such certification;
(b) Is a physician with two or more years of
			 clinical chemistry experience, with one year in toxicology;
(c) Has an earned degree of Doctor of Science
			 (ScD), Doctor of Public Health (DrPH) or Doctor of Philosophy (PhD) in
			 chemistry or biochemistry and has two or more years of clinical chemistry
			 training or experience with one year in toxicology;
(d) Is certified or is eligible for
			 certification by the American Board of Clinical Chemistry or by the American
			 Board of Forensic Toxicology;
(e)
			 Has an earned master of science degree in medical technology, chemistry, or
			 biochemistry and has three or more years of clinical chemistry training or
			 experience, with one year of pertinent experience in toxicology;
(f) Has a bachelor of science, bachelor of
			 technology or bachelor of arts degree in medical technology, chemistry or
			 biochemistry, and has four or more years of clinical chemistry training or
			 experience, with one year experience in toxicology;
(g) Has directed substance of abuse screening
			 for at least 12 months within the four years preceding January 1, 1987, and has
			 at least two years of pertinent experience in toxicology.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0325 - Incompetence

Current through Register Vol. 63, No. 7, July 1, 2024
An SOA laboratory owner or director has "demonstrated
				incompetence" if there is:
(1)
			 Repeated error demonstrated in the performance of laboratory tests or
			 procedures or the results thereof;
(2) Failure to comply with the requirements
			 of OAR
			 333-024-0335  and
			 333-024-0340  relating to internal and external quality control;
(3) Failure to comply with ORS 438.435 or any
			 regulations pertaining to the laboratory;
(4) Work assigned to personnel not qualified
			 to perform in that specialty;
(5)
			 Repeated erroneous reporting of test results.
Stat. Auth.: ORS 438.050, 438.130, 438.435(4), 438.435(5)
				  & 438.435(6)
Stats. Implemented: ORS 438.160 &
				  438.435
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0330 - Testing for Substances of Abuse: Specimen Collection, Chain of Custody, Records, and Reports

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The specimen
			 container shall be clean, tightly sealed and free of any interfering substance.
			 It shall be transported and stored in such a manner as to preserve the
			 integrity and security of the specimen.
(2) The specimen container shall be
			 permanently labeled with time and date of collection and at least one of the
			 following:
(a) The name of the person from
			 whom the specimen was taken, if available;
(b) Social security number;
(c) Employee number;
(d) Unique identifying number.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0335 - Internal Quality Assurance

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 Laboratory procedure manuals and relevant texts of appropriate current
			 laboratory methods shall be available for the use of the personnel in the
			 laboratory.
(2) Each instrument
			 system shall be calibrated according to the manufacturer's specifications and
			 the calibrations shall be checked and recorded at intervals compatible with the
			 proper operation of that instrument.
(3) Quality control requirements:
(a) Automated: At least one positive and one
			 negative standard or control shall be included with the frequency recommended
			 by the manufacturer; or at a frequency documented to assure the stability of
			 the analytical method; but no less than once per day of testing.
(b) Manual:
(A) Test kits without positive and negative
			 procedural controls, the laboratory must run at least one positive and one
			 negative standard or control each day of testing for each analyte;
(B) Test kits with positive and negative
			 procedural controls, the laboratory must run at least one positive and one
			 negative standard or control with each lot/shipment and at least once per month
			 for each analyte tested. Results of internal procedural controls must be
			 documented with each sample tested.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0340 - External Quality Control (Proficiency Testing Program and On-Site Inspections)

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Licensed
			 SOA laboratories shall:
(a) At the
			 laboratory's own expense, be required to participate satisfactorily in the
			 proficiency testing programs of the College of American Pathologists, or the
			 American Association of Bioanalysts, or such other substantially equivalent
			 testing program as may be approved by the Division involving substances of
			 abuse testing and make available to the Division all test results;
(b) Be required to participate satisfactorily
			 if required in the proficiency testing programs conducted by the Division
			 involving substances of abuse testing;
(c) Analyze test samples submitted by the
			 Division prior to, during, or subsequent to inspection if requested to the
			 Division;
(d) Achieve satisfactory
			 results on test samples in agreement with reference laboratories or within
			 stated acceptable limits and which results shall be reviewed by the Division.
			 Continued or consistent failure two out of three periods may result in the
			 laboratory's license being withdrawn by the Division until satisfactory
			 performance is demonstrated; and
(e) Ensure that proficiency samples are
			 tested by regularly assigned personnel using routine methods. A specified time
			 shall be allowed for such testing and reporting of results.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0345 - Confirmatory Testing

Current through Register Vol. 63, No. 7, July 1, 2024
(1) When the
			 substances of abuse screening laboratory obtains a positive test result and the
			 submitter indicates the result is to be used to deprive or deny any person any
			 employment or any benefit, that same specimen must be submitted and confirmed
			 prior to the release of the screening results. When performed within the State
			 of Oregon, the confirmatory testing shall be by a clinical laboratory licensed
			 under ORS 438.110 and 438.150 or certified under the
Clinical Laboratory
			 Improvement Amendments of 1988
,
Public Law
			 100-578
,
42 U.S.C. 201 and 263  a
for that testing. The confirmatory testing shall be as described in
			 section (4) of this rule.
(2) The
			 administrator of the Division shall appoint a substances of abuse methods panel
			 to recommend approval of methods used to confirm the presence of substances of
			 abuse. The panel shall be composed of individuals from laboratories performing
			 substances of abuse testing and shall include, but not be limited to,
			 representatives from the Oregon State Police Crime Laboratory, laboratories
			 licensed under ORS Chapter 438, and the Oregon Health Sciences
			 University.
(3) Any scientifically
			 tested method for substances of abuse analysis may be submitted to the
			 Division, for approval, by written request from a manufacturer, laboratory, or
			 other party. Each candidate method shall be evaluated as to its capacity for
			 accuracy by the panel, with recommendation based thereon, by one or more of the
			 following means:
(a) Government or
			 independent studies of the method's accuracy;
(b) Comparative data on proficiency test
			 performance of various methods;
(c)
			 Application of the method by panel members in performance of analysis;
			 or
(d) Other means as determined by
			 the Division.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0350 - Equipment and Facilities

Current through Register Vol. 63, No. 7, July 1, 2024
(1) All
			 equipment shall be maintained in good working order, checked routinely, and
			 precisely calibrated.
(2) Work
			 bench space shall be ample, clean, well-organized, well-lighted, and convenient
			 to sink, water and electrical outlets.
(3) The SOA laboratory shall be ventilated to
			 protect the health of the personnel and patients against accidental release of
			 hazardous vapors or aerosols.
(4)
			 The premises shall be free from unnecessary physical, chemical, and biological
			 hazards.
(5) Electrical equipment
			 shall be maintained in a safe condition with regards to shock and fire hazards.
			 All electrical equipment, except battery operated, shall be grounded.
			 Protective fuses shall not be bypassed.
(6) Caustic, explosive and flammable
			 materials shall carry labels to indicate their nature and shall be placed in
			 containers and stored in locations which are suitable to ensure stability,
			 purity, and safety as is necessary regarding the material involved.
Stat. Auth.: ORS 438.110 & 438.320 & 438.435
Stats. Implemented: ORS 438.110, 438.320 &
				  438.435
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0360 - Special Category Laboratories

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The rules in this section set standards
			 for special category screening laboratories, as authorized in ORS 438.435(4),
			 (6) and (7). These rules apply to the testing of inmates within state and local
			 correctional facilities and to the testing of offenders on parole, probation,
			 or under post-prison supervision.
(2) Special category laboratories as defined
			 in this rule must use only manual or automated substance of abuse screening
			 methods approved by the U.S. Food and Drug Administration. Any alcohol
			 screening test must meet the requirements of the conforming products list found
			 in the
United States Department of Transportation National Highway
			 Traffic Safety Administration Docket No. 94-004
and meets the standards
			 of the
United States Department of Transportation Alcohol Testing
			 Procedure
,
49 C.F.R. part 40
, in effect on October
			 23,1999.
(3) Individuals who
			 perform screening tests for substances of abuse must complete a training course
			 offered by the manufacturer or provider of the test, an educational facility,
			 or training provided by the Department of Corrections Drug Control Unit with
			 curriculum acceptable to the Public Health Division. No testing is to be
			 performed prior to the completion of this training. A certificate of
			 satisfactory completion, including the dates and hours of training completed,
			 shall be kept by the SOA testing program manager at each facility and parole
			 office. A copy shall also be on file with the Drug Control Manager at the
			 Department of Corrections.
(4)
			 Protocols, procedures, and records of all testing shall be maintained as
			 described in this section and shall be followed:
(a) Each local and state correctional
			 facility or parole office shall have a designated substance of abuse program
			 manager who shall assure that:
(A) Written
			 policies established by the Department of Corrections are followed regarding
			 specimen collection, specimen identification, and chain of custody, as defined
			 in OAR
			 333-024-0310(2);
(B) Written procedure manuals are available
			 to testing individuals, and that the written procedures require following the
			 manufacturer's testing protocol. The written procedures must describe the test
			 limitations and the use of approved standards and quality control, as defined
			 in OAR
			 333-024-0310(4) and
			 (21).
(C) There is a written record of the:
(i) Date and time the specimen was
			 obtained;
(ii) Date and time the
			 test was performed;
(iii) Lot
			 number of the test kit used, test results, including the results of
			 controls;
(iv) Signature or
			 initials of the analyst.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0365 - Testing for Substances of Abuse: Substance of Abuse Registration

Current through Register Vol. 63, No. 7, July 1, 2024
(1) It shall be
			 unlawful for any entity to perform any on-site test for non-medical substance
			 of abuse screening tests prior to filing a registration form with the Division
			 and payment of the registration fee, except laboratories:
(a) Owned and operated by the U.S.
			 Government;
(b) Performing pure
			 research;
(c) Performing substance
			 of abuse tests for forensic purposes only;
(d) Performing substance of abuse tests from
			 autopsy specimens;
(e) Identified
			 as teaching facilities only training students in test performance;
(f) Owned and operated by the Oregon State
			 Police performing substance of abuse screens for forensic purposes.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0370 - Purpose

Current through Register Vol. 63, No. 7, July 1, 2024
OAR
				333-024-0370  through
				333-024-0400 are for the purpose of carrying out ORS 438.010(8); 438.060; 438.130(2);
				438.150(5), (6) and (7). The purpose of the rules is to regulate the quality of
				health screen testing and to govern the issuance of permits to perform this
				type of testing.
Stat. Auth.: ORS 438.010(10), 438.060, 438.130(2),
				  438.150(5), 438.150(6) & 438.150(7)
Stats. Implemented: ORS 438.060, 438.130, 438.150 &
				  438.310
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0375 - Health Screen Testing: Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
Except as provided in this section, definitions in OAR
				333-024-0010  are applicable to OAR 333-024-0370  through 333-024-0400.
				Additionally:
(1) "Clinician" means a
			 nurse practitioner licensed and certified by the Oregon State Board of Nursing,
			 or a physician associate licensed by the Board of Medical Examiners for the
			 State of Oregon.
(2) "Health Screen
			 Testing" means tests performed without a physician's or clinicians's order for
			 the purpose of identifying health risks, providing health information, and
			 referring the person being tested to medical care.
(3) "Health Screen Testing Service" means a
			 service providing health screen testing.
(4) "Health Screen Testing Site" means the
			 permanent location, temporary site or mobile vehicle where health screen
			 testing is performed.
(5) "Human
			 Chorionic Gonadotropin (HCG)" means a hormone produced by the placenta which
			 appears in serum and urine and may be an indication of pregnancy.
(6) "Operator" means the person (e.g.,
			 individual, corporation, political subdivision, etc.) which operates the health
			 screen testing service.
(7)
			 "Person" includes individuals, corporations, associations, firms, partnerships
			 and joint stock companies.
(8)
			 "Pertinent Laboratory Experience" means the activity of performing laboratory
			 testing or directing the performance of testing in human clinical
			 chemistry.
(9) "Site Day" means the
			 24-hour period during which, either all or part of the time, testing is
			 performed at a specific location.
Statutory/Other Authority: ORS 438.010(10), 438.060,
				  438.130(2), 438.150(5), (6) & (7)
Statutes/Other Implemented: ORS 438.010, 438.060, 438.130  & 438.150
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0380 - Permits

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Any person who
			 operates a health screen testing service must obtain a permit from the
			 Division.
(2) OAR
			 333-024-0370  through
			 333-024-0400  apply to all health screen testing services and their personnel within the
			 State of Oregon except:
(a) Health screen
			 testing services operated by the United States Government;
(b) Health screen testing performed in a
			 physician's, or clinician's office for the purpose of diagnosis and treatment
			 of their own patients;
(c) Health
			 screen testing provided by an employer to employees if such employer contracts
			 for the testingthrough a licensed physician, a clinical laboratory or a
			 hospital, which is a health screen testing permittee of the Division;
(d) Screening provided by blood banks solely
			 for assuring blood donor suitability;
(e) Health screen testing provided by local
			 health departments; and
(f) Testing
			 by grantee agencies for the purpose of establishing eligibility for programs
			 administered by the Public Health Division of the Oregon Health
			 Authority.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0385 - Testing Site Schedule

Current through Register Vol. 63, No. 7, July 1, 2024
The health screen testing service shall, in writing, notify the
				Oregon Health Authority, Oregon State Public Health Labratory (OSPHL) of the
				proposed testing site schedule. The schedule must be received at the OSPHL,
				3150 NW 229th Ave., Hillsboro, OR 97124 or faxed to 503-693-5602 at least 15
				days prior to testing at each site. All changes and cancellations regarding
				this schedule must be reported to the OSPHL prior to testing
				date.
Stat. Auth.: ORS 438.010(10), 438.060, 438.130(2),
				  438.150(5), 438.150(6) & 438.150(7)
Stats. Implemented: ORS
				  438.150
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0390 - Personnel Qualifications and Responsibilities

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Each health screen testing service shall
			 have a director who shall meet at least one of the following qualifications:
(a) Is a Medical Doctor (MD) or a Doctor of
			 Osteopathy (DO) licensed to practice in Oregon and has one or more years of
			 pertinent clinical laboratory experience;
(b) Has an earned Doctor of Science (ScD) or
			 Doctor of Public Health (DrPH) or Doctor of Philosophy (PhD) degree in
			 chemistry, biochemistry, or other closely related science from an accredited
			 institution, and has one or more years of pertinent clinical laboratory
			 experience;
(c) Has an earned
			 Master of Science degree in medical technology, chemistry, biochemistry, or
			 other closely related science from an accredited institution, and has two or
			 more years of pertinent clinical laboratory experience;
(d) Has a Bachelor of Science, Bachelor of
			 Technology, or Bachelor of Arts degree in Medical Technology, Chemistry, or
			 Biochemistry, from an accredited institution, or is a licensed pharmacist, and
			 has four or more years of pertinent clinical laboratory experience;
			 or
(e) Has performed the duties of
			 Director of a health screen testing service for at least six site days during
			 the 12 months prior to January 1, 1990.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0395 - Tests Performed

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The health
			 screening testing service may perform only test procedures of waived or
			 moderate complexity, as defined in OAR 333-024-0102(4) and (16), from the
			 following list of allowed tests.
(a) Blood
			 hemoglobin;
(b) Packed red cell
			 volume;
(c) Total
			 cholesterol;
(d) Blood
			 glucose;
(e) Blood in
			 feces;
(f) Human chorionic
			 gonadotropin;
(g) High density
			 lipoprotein cholesterol. If the test is performed outside of a licensed
			 clinical laboratory, only procedures not requiring a pre-precipitation step may
			 be used;
(h) Triglyceride, only
			 after an individual has fasted for 12 to 16 hours;
(i) Low density lipoprotein cholesterol by
			 automated calculation using the Friedenwald equation.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-1000 - Newborn Screening: Purpose

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 Newborn screening identifies conditions and diseases that may not be clinically
			 evident in the first few days or weeks of an infant's life but that can affect
			 an infant's long-term health or survival. If these conditions are detected
			 early they can be diagnosed, and appropriate intervention can prevent death or
			 lessen or prevent disability. In Oregon, all infants are required to be
			 screened, except for those whose parents opt out because of their religious
			 beliefs. The Oregon State Public Health Laboratory performs this newborn
			 screening testing and provides the results to those designated on the testing
			 form as responsible for the health and medical care of the infant so that they
			 can undertake the necessary confirmatory diagnostic testing and medical
			 follow-up. To obtain more information about Newborn Bloodspot Screening go to
www.healthoregon.org/nbs
.
(2) These rules do not apply to newborn
			 hearing screening, congenital heart defect screening, or other "point of care"
			 newborn screening tests.
Statutory/Other Authority: ORS
				  413.014,
				  433.285  & 431A.750
Statutes/Other Implemented: ORS
				  433.285,
				  433.290  & 433.295
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-1010 - Newborn Screening: Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
As used in OAR 333-024-1000  to 333-024-1110:
(1) "Abnormal result" means a laboratory
			 examination result that meets the screening criteria for a newborn screening
			 panel condition requiring additional diagnostic testing and medical follow-up.
(2) "Clinical Laboratory
			 Improvement Amendments (CLIA)" means the rules that apply to clinical
			 laboratories in OAR 333-024-0005  to 333-024-0055.
(3) "Facility" means:
(a) Hospitals and freestanding birthing
			 centers; and
(b) Health care
			 clinics and offices where practitioners and other health care professionals
			 provide direct medical care to newborns or infants six months or
			 younger.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-1020 - Newborn Screening: Persons Responsible for Ensuring that First Specimens are Collected and Submitted

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The
			 following, in order of priority, are responsible for ensuring that first
			 specimens are collected and submitted in accordance with this rule:
(a) Hospitals and freestanding birthing
			 centers, if the infant is born at the hospital or freestanding birthing
			 center.
(b) A facility or
			 practitioner responsible for the infant's medical care soon after
			 birth.
(c) Parents or legal
			 guardians of the infant when the birth is unattended by a
			 practitioner.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-1025 - Newborn Screening: Persons Responsible for Ensuring that Second, Third and Repeat Specimens are Collected and Submitted

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The following, in order of priority, are
			 responsible for ensuring that the second specimens, and when applicable, third
			 or repeat specimens, are collected and submitted in accordance with this rule:
(a) A facility or practitioner responsible
			 for the care of an infant at any time during the first six months of
			 life.
(b) A parent or legal
			 guardian.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-1030 - Newborn Screening: Timing for Collecting Specimens

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The facility or individual responsible
			 for collecting specimens for newborn screening under OAR 333-024-1020  and OAR
			 333-024-1025  must collect newborn screening specimens from every infant born in
			 Oregon, and surviving more than two days, unless exempt according to OAR
			 333-024-1050, as follows:
(a) The first
			 specimen shall be collected as soon as possible after 24 hours of age but
			 before 48 hours of age.
(b) The
			 second specimen shall be collected between 10 and 14 days of age.
(c) Repeat specimens shall be collected if
			 requested by the Oregon State Public Health Laboratory.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-1040 - Newborn Screening: Manner of Submitting Specimens

Current through Register Vol. 63, No. 7, July 1, 2024
A person responsible for submitting specimens to the Oregon
				State Public Health Laboratory under OAR 333-024-1020  and OAR 333-024-1025 must:
(1) Collect the specimens:
(a) Using kits available from the Oregon
			 State Public Health Laboratory; and
(b) According to instructions provided by the
			 Oregon State Public Health Laboratory, which can be viewed in the Oregon
			 Newborn Bloodspot Screening Practitioner's Manual (Practitioner's Manual), 12th
			 Edition; 2022 found at
www.healthoregon.org/nbs
.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-1050 - Newborn Screening: Religious Exemption from Newborn Testing

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A parent may
			 opt not to have their infant tested in accordance with these rules because of
			 religious beliefs opposed to such testing. In order to claim such an exemption,
			 the parent must complete a Statement of Religious Exemption on behalf of the
			 infant on a form prescribed by the Oregon State Public Health
			 Laboratory.
(2) The form must be
			 completed and submitted to the Oregon State Public Health Laboratory within 30
			 calendar days from the day the infant was born.
Statutory/Other Authority: ORS
				  413.014,
				  433.285  & 431A.750
Statutes/Other Implemented: ORS
				  433.285,
				  433.290  & 433.295
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-1060 - Newborn Screening: Improperly Collected Specimens

Current through Register Vol. 63, No. 7, July 1, 2024
(1) If a specimen contains insufficient
			 blood, is contaminated or is found to be otherwise unsuitable for testing, the
			 Oregon State Public Health Laboratory will notify the individual or individuals
			 identified as responsible for collecting and submitting the specimen in OAR
			 333-024-1020  and OAR 333-024-1025  that the specimen submitted is unsuitable for
			 testing and that a repeat specimen must be collected and submitted to the
			 Oregon State Public Health Laboratory in accordance with OAR 333-024-1030  and
			 OAR 333-024-1040, no later than 10 calendar days from receiving
			 notice.
(2) If the Oregon State
			 Public Health Laboratory does not receive the repeat specimen as specified in
			 section (1) of this rule, the Oregon State Public Health Laboratory will send a
			 second notice to the individual or individuals identified as responsible for
			 patient care in OAR 333-024-1020  and 333-024-1025.
Statutory/Other Authority: ORS
				  413.014,
				  431A.750  &
				  433.285
Statutes/Other Implemented: ORS 433.285,
				  433.290  & 433.295
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-1070 - Newborn Screening: The Newborn Screening Panel and Methods of Testing

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Every properly
			 collected specimen submitted for newborn screening will be tested by the Oregon
			 State Public Health Laboratory or, at the discretion of the Oregon State Public
			 Health Laboratory, another CLIA certified laboratory.
(2) Newborn Screening specimens will be
			 tested for the medical conditions listed in subsections (3) through (11), using
			 the methods listed below. At its discretion, and consistent with CLIA
			 standards, the Oregon State Public Health Laboratory may use an equivalent or
			 better alternative method.
(3)
			 Metabolic Disorders:
(a) Organic Acid
			 Disorders. Method: Quantitative measurement of amino acids by tandem mass
			 spectrometry.
(A) Propionic acidemia
			 (PA);
(B) Methylmalonic acidemia
			 (MMA);
(C) Isovaleric acidemia
			 (IVA);
(D) 3-methylcrotonyl CoA
			 carboxylase deficiency (3MCC);
(E)
			 3-Hydroxy-3-Methyglutaric Aciduria (HMG);
(F) Holocarboxylase Synthase
			 Deficiency;
(G) Beta-ketothiolase
			 deficiency (BKT);
(H) Glutaric
			 acidemia, Type I (GA-I);
(I)
			 Malonic acidemia (MAL);
(J)
			 Isobutyrylglycinuria;
(K)
			 2-Methylbutyrylglycinuria;
(L)
			 3-Methylglutaconic aciduria; and
(M) 2-methyl-3-hydroxybutyric
			 aciduria.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-1080 - Newborn Screening: Result Reporting and Follow-up

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Newborn screening results will be
			 reported by the Oregon State Public Health Laboratory to the following persons
			 responsible for the medical care and treatment of the infant, in order of
			 priority:
(a) The individual or individuals
			 identified as responsible on the kit as required in OAR 333-024-1040(2);
			 or
(b) The entity or individual
			 that collected and submitted the specimen if no individual is identified on the
			 kit as required in OAR 333-024-1040(2);
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-1090 - Newborn Screening: Use, Release and Retention of Residual Specimens

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Residual
			 specimens may be used by the Oregon State Public Health Laboratory for:
(a) Quality assurance and method development
			 activities as required to maintain CLIA compliance.
(b) Program evaluation and quality
			 improvement.
(c) Educational
			 activities as required in ORS
			 433.290.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-1100 - Newborn Screening: Ordering Specimen Collection Kits and Fees

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Kits for
			 collecting specimens for newborn screening must be ordered from the Oregon
			 State Public Health Laboratory.
(2)
			 Orders must be accompanied by payment for the full amount of the order, based
			 on the fees in section (3) of this rule, or fee exemption request based on
			 section (4) of this rule. Refunds will not be issued for specimens that cannot
			 be used for testing due to an error in the collection of the specimen or
			 incomplete patient information.
(3)
			 The fees for newborn screening specimen collection kits include the cost of
			 newborn screening services provided by the Oregon State Public Health
			 Laboratory and are as follows:
(a) $100 per
			 one-specimen kit.
(b) $175 per
			 two-specimen kit.
(c) $175 per
			 three-specimen kit.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-1110 - Newborn Screening: Failure to Comply

Current through Register Vol. 63, No. 7, July 1, 2024
The Oregon State Public Health Laboratory may refer a hospital,
				freestanding birthing center or a practitioner to the appropriate licensing
				entity for failure to comply with these rules.
Statutory/Other Authority: ORS
				  413.014,
				  431A.750  &
				  433.285
Statutes/Other Implemented: ORS 433.285,
				  433.290  & 433.295
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-2000 - Fees for Tests Performed in the State Laboratory

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
(a) The
			 person responsible for submitting communicable disease specimens for those
			 tests performed on specimens received in the state public health laboratory on
			 or after March 1, 2014, shall pay a test fee upon billing by the Authority, in
			 accordance with the August 2013 Division of Medical Assistance Programs Fee for
			 Service Fee Schedule.
(b) Public
			 and private non-profit agencies may apply for a reduction or waiver of the test
			 fees stated in subsection (1)(a) of this rule. Reduction or waiver requests
			 must be sent to the director of the state public health laboratory and be
			 accompanied by proof of non-profit status. Requests should include the
			 estimated number and type of tests anticipated per year. The decision to reduce
			 or waive fees is discretionary with the state public health
			 laboratory.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 25 - GENETIC INFORMATION AND PRIVACY › Section 333-025-0100 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
As used in these rules:
(1) "Anonymous research" means scientific or
			 medical genetic research conducted in such a manner that any DNA sample or
			 genetic information used in the research is unidentified. "Anonymous research"
			 does not include research conducted in such a manner that the identity of such
			 an individual, or the identity of the individual's blood relatives, can be
			 determined by use of a code, encryption key or other means of linking the
			 information to a specific individual.
(2) "Biological sample" means any human
			 biological specimen that may be used as a DNA sample.
(3) "Blanket informed consent" means that the
			 individual has consented to the use of that individual's DNA sample or health
			 information for any future research, but has not been provided with a
			 description of or consented to the use of the sample in genetic research or any
			 specific genetic research project.
(4) "Blood relative" means a person who is:
(a) Related by blood to an individual;
			 and
(b) A parent, sibling, son,
			 daughter, grandparent, grandchild, aunt, uncle, first cousin, niece or nephew
			 of the individual.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 25 - GENETIC INFORMATION AND PRIVACY › Section 333-025-0105 - Scope

Current through Register Vol. 63, No. 7, July 1, 2024
(1) OAR
			 333-025-0100  to 0165
			 apply to all genetic research subject to the law of the State of
			 Oregon.
(2) All genetic research
			 must comply with the applicable standards set forth in the Federal Common Rule.
			 Additional protections for subjects of research are authorized by ORS 192.531 et seq. and these rules. These rules set state standards that are in addition
			 to, and not intended to alter, any requirements under the Federal Common Rule
			 or the Federal Privacy Rule.
Stat. Auth.: ORS 192.531-192.549
Stats. Implemented: ORS
				  192.531-192.549