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Oregon Bulletin

May 1, 2014

Oregon Health Authority, Public Health Division, Chapter 333

Rule Caption: Moratorium by local governments on medical marijuana facilities and defining products dispensed.

Adm. Order No.: PH 9-2014(Temp)

Filed with Sec. of State: 4-1-2014

Certified to be Effective: 4-1-14 thru 9-27-14

Notice Publication Date:

Rules Adopted: 333-008-1225, 333-008-1245, 333-008-1275, 333-008-1400

Rules Suspended: 333-008-1240(T), 333-008-1270(T)

Subject: The Oregon Health Authority, Public Health Division is temporarily adopting rules in chapter 333, division 8 pertaining to medical marijuana facilities.

   The rules will implement the provisions of SB 1531, Oregon Laws 2014, Chapter 79.

   The rules define the process for local governments to submit moratoriums by local government jurisdictions on medical marijuana facilities to the Oregon Health Authority; define child resistant packaging for the dispensing of medical marijuana; and define the manufacturing and packaging of marijuana in a manor that is attractive to minors.

   Two temporary rules (333-008-1240, Transfers to a Patient or Designated Primary Caregiver; and 333-008-1270, Enforcement) are being suspended and readopted under new rule numbers (333-008-1245 and 333-008-1275 respectively) so they can be updated with added language pertaining to Oregon Laws 2014, Chapter 79 (SB 1531) while maintaining the same effective dates of the newly adopted rules (333-008-1225 and 333-008-1400) pertaining to the same legislation.

Rules Coordinator: Alayna Nest—(971) 673-1291

333-008-1225

Packaging

(1) For purposes of this rule:

(a) “Child-resistant safety packaging” means:

(A) Tamper-proof, child-proof containers designed and constructed to be significantly difficult for children under five years of age to open and not difficult for adults to use properly;

(B) Opaque so that the product cannot be seen from outside the packaging;

(C) Closable for any product intended for more than a single use or containing multiple servings; and

(D) Labeled in accordance with OAR 333-008-1220.

(b) “Container” means a sealed, hard or soft-bodied receptacle in which a tetrahydrocannabinol-infused product is placed prior to being transferred to a patient or caregiver.

(c) “Packaged in a manner not attractive to minors” means the tetrahydrocannabinol-infused product is not in a container that is brightly colored, depicts cartoons or images other than the logo of the facility, unless the logo of the facility depicts cartoons, in which case only the name of the facility is permitted.

(2) A registered facility may not transfer any tetrahydrocannabinol-infused product that is meant to be swallowed or inhaled, unless the product is:

(a) Packaged in child-resistant safety packaging; and

(b) Packaged in a manner that is not attractive to minors.

Stat. Auth.: ORS 475.314

Stats. Implemented: ORS 475.314

Hist.: PH 9-2014(Temp), f. & cert. ef. 4-1-14 thru 9-27-14

333-008-1245

Transfers to a Patient or Designated Primary Caregiver

(1) A registered facility may not transfer a tetrahydrocannabinol-infused product that is manufactured in a manner that is attractive to minors. For purposes of this section a product is considered to be manufactured in a manner that is attractive to minors if it is:

(a) Brightly colored; or

(b) In the shape of an animal or any other commercially recognizable toy or candy.

(2) Prior to a registered facility transferring usable marijuana or an immature plant to a patient or a designated primary caregiver the PRF must ensure that:

(a) The usable marijuana or an immature plant has not tested positive for mold, mildew or pesticides as specified in OAR 333-008-1190; and

(b) The identity and cardholder status of the person requesting usable marijuana or an immature plant is verified by viewing the person’s OMMP card and picture identification and making sure the two match.

(3) The PRF must ensure that for each transfer of usable marijuana or an immature plant to a patient or a designated primary caregiver the following information is documented:

(a) The name, OMMP card number and expiration date of the card of each person to whom the registered facility transfers usable marijuana or an immature plant;

(b) A copy of the person’s picture identification;

(c) The amount of usable marijuana transferred in metric units, if applicable;

(d) The number of immature plants transferred, if applicable;

(e) The amount of a finished product transferred in metric units, or units of the finished product, if applicable;

(f) A description of what was transferred;

(g) The date of the transfer; and

(h) The amount of money paid by a patient or a designated primary caregiver to a registered facility for the transfer of usable marijuana or an immature plant.

(4) The PRF must ensure that a registered facility does not transfer at any one time more usable marijuana or immature plants than a patient or designated primary caregiver is permitted to possess under ORS 475.320(1)(a). A PRF is not responsible for determining whether a patient or designated primary caregiver is limited in the amount of usable marijuana he or she can possess under 475.320(1)(b).

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 9-2014(Temp), f. & cert. ef. 4-1-14 thru 9-27-14

333-008-1275

Enforcement

(1)(a) Informal Enforcement. If, during an inspection the Authority documents violations of ORS 475.314 or any of these rules, the Authority may issue a written Notice of Violation to the PRF that cites the laws alleged to have been violated and the facts supporting the allegations.

(b) The PRF must submit to the Authority a signed plan of correction within 10 business days from the date the Notice of Violation was mailed to the person. A signed plan of correction will not be used by the Authority as an admission of the violations alleged in the Notice.

(c) A PRF must correct all deficiencies within 10 days from the date of the Notice, unless an extension of time is requested from the Authority. A request for such an extension shall be submitted in writing and must accompany the plan of correction.

(d) The Authority must determine if a written plan of correction is acceptable. If the plan of correction is not acceptable to the Authority it must notify the PRF in writing and request that the plan of correction be modified and resubmitted no later than 10 working days from the date the letter of non-acceptance was mailed.

(e) If the registered facility does not come into compliance by the date of correction reflected on the plan of correction, the Authority may propose to revoke the registration of the facility or impose civil penalties.

(f) The Authority may conduct an inspection at any time to determine whether a registered facility has corrected the deficiencies in a Notice of Violation.

(2) Formal Enforcement. If, during an inspection or based on other information the Authority determines that a registered facility or PRF is in violation of ORS 475.314 or these rules the Authority may issue:

(a) A Notice of Proposed Revocation in accordance with ORS 183.411 through 183.470; or

(b) A Notice of Imposition of Civil Penalties in accordance with ORS 183.745. Civil penalties may be issued for any violation of ORS 475.314 and these rules, not to exceed $500 per violation per day.

(3) The Authority must determine whether to use the informal or formal enforcement process based on the nature of the alleged violations, whether there are mitigating or aggravating factors, and whether the PRF or the registered facility has a history of violations.

(4) The Authority must issue a Notice of Proposed Revocation if the:

(a) Facility no longer meets the criteria in ORS 475.314(3)(a) to (d); or

(b) PRF is not a resident of Oregon, has disqualifying criminal convictions as described in OAR 333-008-1120, or a court has issued an order that prohibits the PRF from participating in the OMMP under ORS 475.300 through 475.346 unless a new PRF is approved by the Authority.

(5) The Authority may maintain a civil action against a facility that is operating but not registered in accordance with ORS 475.314 and these rules.

(6) The Authority may revoke the registration of a facility for failure to comply with an ordinance adopted by a city or county pursuant to Oregon Laws 2014, chapter 79, section 2, if the city or county:

(a) Has provided the facility with due process substantially similar to the due process provided to a registration or license holder under the Administrative Procedures Act, ORS 183.413 to 183.470; and

(b) Provides the Authority with a final order that is substantially similar to the requirements for a final order under ORS 183.470 that establishes the facility is in violation of the local ordinance.

(7) The Authority must post a final order revoking the registration of a facility on the Authority’s website and provide a copy of the final order to the OMMP.

(8) To the extent permitted by law, if the Authority discovers violations that may constitute criminal conduct or conduct that is in violation of laws within the jurisdiction of other state or local governmental entities, the Authority may refer the matter to the applicable agency.

(9) If the registration of a facility is revoked the PRF must make arrangements to return the usable marijuana and immature plants in amounts still possessed by the facility, to the person who transferred the usable marijuana or immature plants and must document the same.

Stat. Auth.: ORS 431.262, 475.314 & 475.338

Stats. Implemented: ORS 431.262 & 475.314

Hist.: PH 9-2014(Temp), f. & cert. ef. 4-1-14 thru 9-27-14

333-008-1400

Moratoriums

(1) For purposes of this rule, “moratorium” means an ordinance, adopted by the governing body of a city or county by May 1, 2014, that specifically suspends the operation of registered medical marijuana facilities within the area subject to the jurisdiction of the city or county, for a period of time that does not extend past May 1, 2015.

(2) If a city or county adopts a moratorium it must notify the Authority and provide a copy of the ordinance.

(3) An applicant applying for registration of a facility proposing to operate in an area subject to a moratorium may submit a request, in writing, to withdraw the application and may request a refund of the fees.

(4) A PRF of a registered facility located in an area subject to a moratorium may submit a request, in writing, to surrender its registration and request a refund of the fees.

(5) Upon receipt of a request to withdraw an application or surrender a registration under sections (3) or (4) of this rule the Authority shall determine whether the ordinance falls within the definition of moratorium and inform the applicant or PRF in writing whether:

(a) The application is considered withdrawn and the fees refunded; or

(b) The registration has been surrendered and the fees refunded.

(6) The Authority may refund all fees, including the non-refundable registration fee.

(7) Notifications or requests described in sections (2) to (4) of this rule may be submitted to the Authority:

(a) By mail at P.O. Box 14116, Portland, OR 97293; or

(b) By electronic mail to medmj.dispensaries@state.or.us.

Stat. Auth.: 2014 OL, Ch. 79, Sec. 3

Stats. Implemented: 2014 OL, Ch. 79, Sec. 3

Hist.: PH 9-2014(Temp), f. & cert. ef. 4-1-14 thru 9-27-14


Rule Caption: Criteria for eligibility of school-based health center funding and grant awards

Adm. Order No.: PH 10-2014

Filed with Sec. of State: 4-1-2014

Certified to be Effective: 4-1-14

Notice Publication Date: 2-1-2014

Rules Adopted: 333-028-0260, 333-028-0270, 333-028-0280

Subject: The Oregon Health Authority, Public Health Division is adopting permanent rules pertaining to the criteria for continuation funding for certified school-based health centers (SBHCs), awarding grants to communities planning for certified SBHCs, and incentive funding to: (1) increase the number of SBHCs as patient-centered primary care homes; (2) improve the coordination of care of patients served by coordinated care organizations and school-based health centers; and (3) improve the effectiveness of the delivery of health services through school-based health centers to children who qualify for medical assistance as mandated by the passage of House Bill 2445 by the 2013 Legislature. The rules are intended to fulfill the mandates by prescribing the criteria for eligibility of funding and grant awards.

Rules Coordinator: Alayna Nest—(971) 673-1291

333-028-0260

Funding Criteria for Certified SBHCs

(1) The program is required, under ORS 413.225 to provide funds for the expansion and continuation of certified school-based health centers.

(2) A SBHC that is certified by the program is eligible for funding by the program.

(3) Funding for a certified SBHC may be provided, but is not limited to being provided, to:

(a) A local public health authority, as that is defined in ORS 431.260;

(b) A sponsoring agency; or

(c) A coordinated care organization, or governmental entity or person that can demonstrate a significant interest and involvement in assisting and coordinating with SBHCs.

(4) Funding award amounts will be primarily based on the number of certified SBHCs in the county and legislatively approved budget. The program may take into consideration other factors such as the quality of the health care services, clients served, and population needs.

(5) Funding for certified SBHCs shall be awarded for up to two years. Fund awards are renewable based on the certification renewal process per OAR 333-028-0220.

(6) Funding for a certified SBHC may be suspended or discontinued at the program’s discretion if a certified SBHC is out of compliance with certification requirements and the program has issued a suspension notice under OAR 333-028-0250(4).

(7) The program must discontinue funding of an SBHC that has been decertified.

Stat. Auth.: ORS 413.225

Stats. Implemented: 2013 OL Ch. 683, ORS 413.225

Hist.: PH 10-2014, f. & cert. ef. 4-1-14

333-028-0270

Funding Criteria for SBHC Planning Communities

(1) The program is required to direct funds to communities planning for certified school-based health centers and will do so through a competitive grant proposal process for one or two year planning grants.

(2) Any of the following entities may be eligible to apply for planning grant funds on behalf of their community:

(a) A local public health authority;

(b) A school or school district;

(c) A coordinated care organization as that is defined in ORS 414.025;

(d) Medical, dental or mental health organizations; or

(e) A governmental entity or person that can demonstrate a significant interest and involvement in establishing, assisting or coordinating with SBHCs.

(3) The program will specify in its published request for proposals which entities within a community are eligible for that specific grant award.

(4) Planning grant applicants will be evaluated on elements outlined in the request for proposal, which must include but is not limited to an evaluation of community need and readiness for a SBHC.

(5) The grant amount awarded shall be determined based on number of awarded applicants and legislatively approved budget.

(6) Funding for planning communities shall be awarded for up to two years.

Stat. Auth.: ORS 413.225

Stats. Implemented: 2013 OL Ch. 683, ORS 413.225

Hist.: PH 10-2014, f. & cert. ef. 4-1-14

333-028-0280

Funding Criteria for Incentive Funds

(1) The program shall award grant funding to communities with certified SBHCs through a competitive grant proposal process in order to incentivize:

(a) Increasing the number of SBHCs as state-recognized patient-centered primary care homes as that is defined in ORS 414.025;

(b) Improve coordination of care of patients served by coordinated care organizations and SBHCs; and

(c) Improve the effectiveness of the delivery of health services through SBHCs to children who qualify for medical assistance.

(2) Any entity or person described in OAR 333-028-0270(2) may apply for funding and the program will specify in its published request for proposals which entities within a community are eligible for that specific grant award.

(3) The program will evaluate applicants based on elements outlined in the request for proposals, which must include but is not limited to an evaluation of whether the person or entity has the qualifications to accomplish one or more of the activities described in subsections (1)(a) through (c) of this rule.

(4) Funding awards shall be determined based on number of awarded applicants and legislatively approved budget.

(5) Funding for the incentive grants shall be awarded for up to two years.

Stat. Auth.: ORS 413.225

Stats. Implemented: 2013 OL Ch. 683, ORS 413.225

Hist.: PH 10-2014, f. & cert. ef. 4-1-14


Rule Caption: Update newborn screening program rules and fees including addition of severe combined immunodeficiencies (SCID).

Adm. Order No.: PH 11-2014

Filed with Sec. of State: 4-15-2014

Certified to be Effective: 5-1-14

Notice Publication Date: 2-1-2014

Rules Amended: 333-024-0205, 333-024-0210, 333-024-0215, 333-024-0220, 333-024-0225, 333-024-0230, 333-024-0231, 333-024-0232, 333-024-0235, 333-024-0240

Subject: The Oregon Health Authority, Public Health Division, Oregon State Public Health Laboratory is permanently amending administrative rules in chapter 333, division 24. The amendments will: update newborn screening program rules regarding definitions, congenital disorders tested for and methods of testing, timing of specimen collection and requirements for fee exemption; add severe combined immunodeficiencies (SCID) to the screening panel no later than May 1, 2014; and increase the newborn screening kit fee effective May 1, 2014.

Rules Coordinator: Alayna Nest—(971) 673-1291

333-024-0205

Definitions

As used in these rules:

(1) “Colorimetric assay” means a qualitative laboratory procedure to detect the presence of the enzyme biotinidase which, when present, produces a color change.

(2) “Congenital disorder” means a condition that is present at birth. This includes but is not limited to cystic fibrosis, endocrine, hemoglobinopathy, metabolic, and immunodeficiency disorders.

(3) “County health department” means those county and district health departments formed under ORS 431.416.

(4) “Cystic fibrosis” means a disorder, usually due to a single enzyme deficiency of genetic origin, in which the individual is completely or partially unable to produce a functioning transmembrane conductance regulator protein that results in progressive multi-organ dysfunction and the accumulation of trypsinogen in the blood during the newborn period.

(5) “Diagnostic laboratory” means a laboratory approved to perform testing for the congenital disorders listed herein to rule out a specific disorder suspected by newborn screening or for screening infants older than six months of age.

(6) “Division” means the Public Health Division of the Oregon Health Authority.

(7) “Dried blood specimen” means a blood specimen obtained from an infant by means of capillary-puncture or skin-puncture (heel stick), not by means of venipuncture or any other method, which is placed on special filter paper kits and allowed to air dry.

(8) “Endocrine disorders” means disorders related to hormone production or utilization resulting in abnormal growth and development, fluid and electrolyte imbalance or other disturbance, including hypothyroidism and congenital adrenal hyperplasia.

(9) “Fluorescent immunoassay” means a competitive binding or direct assay creating specific antibody-antigen reactions to detect thyroxin, thyroid stimulating hormone, 17-alpha-hydroxyprogesterone and immunoreactive trypsinogen.

(10) “Fluorescent spot test” means a biochemical laboratory test procedure utilizing certain naturally occurring enzymes in erythrocytes and added chemicals used to detect galactose in blood specimens as a screening test for galactosemia. It is described occasionally in the scientific literature as a “Hill test.”

(11) “Hemoglobinopathy” means one of a group of disorders which results in abnormal structure and function of hemoglobin that leads to variable degrees of anemia, hemolysis and other complications. These include sickle cell disease and other clinically significant hemoglobinopathies.

(12) “High performance liquid chromatography” means the utilization of a separation column to detect various hemoglobin proteins based on their retention time.

(13) “Immunodeficiency disorders” means a group of disorders in which the immune system is not functioning properly. This includes severe combined immunodeficiency (SCID), a primary immune disorder characterized by a defect in T-cell production and function. SCID is also described as the “bubble boy disease”.

(14) “Isoelectric focusing” means a laboratory procedure in which protein, hemoglobin in blood, is subjected to an electric field in a gel medium with a gradient pH causing it to migrate to its pH and isoelectric point, revealing specific patterns for each type of hemoglobin.

(15) “Kit” means any or all parts of the combined materials, laboratory slips, tubes, mailing containers, or other components provided by the state public health laboratory for the purposes of collection or submission of specimens for laboratory tests.

(16) “Metabolic disorders” means those disorders of intermediary metabolism and hormone production, regulation, or utilization in which the individual is completely or partially incapable of normal metabolism of biotin, single amino acids, galactose, or fatty acids resulting in the abnormal accumulation of those and other metabolites in the blood. These include phenylketonuria and medium-chain acyl-CoA dehydrogenase deficiency.

(17) “Newborn screening panel” means those disorders identified by the Oregon Health Authority in these rules for which all infants shall be tested, except if the infant is being reared as an adherent to a religion the teachings of which are opposed to such testing.

(18) “Practitioner” means a person duly and regularly licensed by the proper authority to practice medicine, naturopathy or chiropractic or to be a nurse practitioner. For purposes of OAR 333-024-0215(1) only, this definition is extended to include the licensed or unlicensed person who takes responsibility for delivery or the health care of the baby; or being none, the person responsible for the health care of the mother prior to birth of the baby.

(19) “Precision” of an assay means a quantitative measure of reproducibility of a laboratory procedure in assaying a particular chemical under defined conditions. Examples include, but are not limited to, statistically determined values of standard deviations from the mean and coefficients of variation.

(20) “Sensitivity” of an assay means the lowest concentration or quantity of a particular chemical that can be reliably detected or measured by a laboratory assay procedure under defined conditions.

(21) “Specificity” of an assay means the accuracy with which a laboratory assay procedure can reliably identify or measure the quantity of a particular chemical to distinguish it from other related or unrelated chemicals under defined conditions.

(22) “Specimen for newborn screening” means a dried blood specimen from an infant submitted to the state public health laboratory to detect congenital disorders included on the newborn screening test panel.

(23) “State public health laboratory” means the Oregon State Public Health Laboratory of the Public Health Division, 3150 NW 229th Avenue, Hillsboro, Oregon 97124.

(24) “Tandem mass spectrometry” means a laboratory procedure in which amino acids and acylcarnitines are detected and quantified in a sample taken from a dried blood spot.

(25) “These rules” means OAR 333-024-0205 through 333-024-0240.

(26) “TREC assay” means a DNA polymerase chain reaction method to detect T-cell receptor excision circles. An absence or reduction in TRECs can be used as an indicator for severe combined immunodeficiency or other primary immune deficiencies.

Stat. Auth.: ORS 431.310

Stats. Implemented: ORS 433.285, 433.290 & 433.295

Hist.: HD 18-1981(Temp), f. & ef. 9-11-81; HD 3-1982, f. & ef. 2-25-82; HD 10-1986, f. & ef. 6-11-86; PH 11-2014, f. 4-15-14, cert. ef. 5-1-14

333-024-0210

Infants Tested for Metabolic Diseases

Every infant born in Oregon on or after May 1, 2014, shall be tested for at least the following congenital disorders by the state public health laboratory:

(1) Cystic fibrosis (CF).

(2) Endocrine disorders:

(a) Congenital hypothyroidism (CH); and

(b) Congenital adrenal hyperplasia (CAH).

(3) Galactosemia (GALT).

(4) Hemoglobin disorders:

(a) Sickle cell disease (Hb S/S);

(b) Sickle cell/beta thalassemia (Hb S/A); and

(c) Sickle cell/hemoglobin C disease (Hb S/C).

(5) Metabolic disorders:

(a) Amino acid disorders:

(A) Homocystinuria (HCY);

(B) Phenylketonuria (PKU); and

(C) Tyrosinemia (TYR).

(b) Biotinidase deficiency;

(c) Fatty acid oxidation disorders:

(A) Carnitine uptake defect (CUD);

(B) Carnitine/acylcarnitine translocase deficiency (CT);

(C) Carnitine palmitoyl transferase deficiency (CPT), Types I and II;

(D) Glutaric acidemia, Type II (GA-II);

(E) Long-chain L-3 hydroxyacyl-CoA dehydrogenase deficiency (LCHAD);

(F) Medium-chain acyl-CoA dehydrogenase deficiency (MCAD);

(G) Short-chain acyl-CoA dehydrogenase deficiency (SCAD);

(H) Trifunctional protein deficiency (TFP); and

(I) Very long-chain acyl-CoA dehydrogenase deficiency (VLCAD).

(d) Organic acid disorders:

(A) Beta-ketothiolase deficiency (BKT);

(B) Glutaric acidemia, Type I (GA-I);

(C) Isobutryl-CoA dehydrogenase deficiency (IBG);

(D) Isovaleric acidemia (IVA);

(E) Malonic aciduria (MAL);

(F) Maple syrup urine disease (MSUD);

(G) Methylmalonic acidemia (MMA);

(H) Propionic acidemia (PA);

(I) 2-Methyl-3-hydroxybutyryl CoA dehydrogenase deficiency (2M3HBA);

(J) 2-Methylbutyryl CoA dehydrogenase deficiency (2MBG);

(K) 3-hydroxy-3-methylglutaryl-CoA lyase deficiency (HMG);

(L) 3-methylcrotonyl-CoA carboxylase deficiency (3-MCC);

(M) 3-methylglutaconyl-CoA hydratase deficiency (3MGA); and

(N) Multiple carboxylase deficiency (MCD).

(e) Urea Cycle Disorders:

(A) Arginase deficiency (ARG);

(B) Argininosuccinate lyase deficiency (ASA); and

(C) Citrullinemia, Type I (CIT I).

(6) Other disorders as defined by Oregon Health Authority.

(7) Severe combined immunodeficiencies (SCID).

Stat. Auth.: ORS 433.285

Stats. Implemented: ORS 433.285

Hist.: HD 18-1981(Temp), f. & ef. 9-11-81; HD 3-1982, f. & ef. 2-25-82; HD 17-1983, f. & ef. 10-12-83; HD 10-1986, f. & ef. 6-11-86; HD 28-1994, f. 10-28-1994, cert. ef. 11-1-94; OHD 15-2002, f. & cert. ef. 10-4-02; PH 30-2004(Temp), f. & cert. ef. 9-17-04 thru 3-13-05; PH 37-2004, f. & cert. ef. 12-7-04; PH 11-2014, f. 4-15-14, cert. ef. 5-1-14

333-024-0215

Person Responsible for Submitting Specimens for Newborn Screening Testing

(1)(a) The person responsible for assuring that specimens are submitted for testing the infant for congenital disorders shall be in order of responsibility:

(A) The hospital, freestanding birthing center, or other health care facility licensed under ORS Chapter 441, or if the infant is not in such a facility;

(B) The practitioner, or if no practitioner is in attendance;

(C) The parent or legal guardian.

(b) For purposes of this section and OAR 333-024-0225, in the case of infants entering a health care facility before 48 hours of age as a result of transfer from another health care facility or from out-of-hospital birth, the receiving health care facility shall be responsible for the timely collection of specimens.

(2) The state public health laboratory may perform tests for certain congenital disorders for patients from outside Oregon.

Stat. Auth.: ORS 433.285

Stats. Implemented: ORS 433.285

Hist.: HD 18-1981(Temp), f. & ef. 9-11-81; HD 3-1982, f. & ef. 2-25-82; HD 17-1983, f. & ef. 10-12-83; HD 10-1986, f. & ef. 6-11-86; OHD 15-2002, f. & cert. ef. 10-4-02; PH 30-2004(Temp), f. & cert. ef. 9-17-04 thru 3-13-05; PH 37-2004, f. & cert. ef. 12-7-04; PH 11-2014, f. 4-15-14, cert. ef. 5-1-14

333-024-0220

Manner of Submitting Specimens

(1) All specimens submitted to the state public health laboratory for testing for congenital disorders shall be collected using kits available from the state public health laboratory according to procedures, protocols, and shipping instructions specified in the Newborn Screening Practitioner’s Manual or on the website maintained by the state public health laboratory.

(2) Specimens collected for newborn screening testing shall be sent to the state public health laboratory within 24 hours of collection.

(3) Specimens shall be transmitted to the state public health laboratory in such a manner that they are received by the laboratory no later than five days after collection, preferably within 24 to 48 hours.

[Publications: Publications referenced are available from the agency.]

Stat. Auth.: ORS 433.285

Stats. Implemented: ORS 433.285

Hist.: HD 18-1981(Temp), f. & ef. 9-11-81; HD 3-1982, f. & ef. 2-25-82; HD 17-1983, f. & ef. 10-12-83; HD 10-1986, f. & ef. 6-11-86; OHD 15-2002, f. & cert. ef. 10-4-02; PH 30-2004(Temp), f. & cert. ef. 9-17-04 thru 3-13-05; PH 37-2004, f. & cert. ef. 12-7-04; PH 11-2014, f. 4-15-14, cert. ef. 5-1-14

333-024-0225

Time of Collecting Specimens for Testing Infants

A specimen for newborn screening testing shall be collected within five days after birth from every infant surviving more than two days, as follows:

(1) In the case of infants born outside a hospital or other health care facility and of infants who will remain in the hospital or health care facility for 24 hours or more, a specimen shall be collected after 24 hours but before five days after birth, preferably between 24 and 48 hours after birth. A second specimen shall be collected between 10 and 14 days but before one month of age.

(2) In the case of infants discharged from a hospital or other health care facility before 24 hours of age, a specimen shall be collected just prior to discharge from the facility, and a second specimen shall be collected from such infants 10 to 14 days after birth.

(3) In the case of infants who are preterm, low birth weight or ill and are admitted to a special care baby unit or neonatal intensive care unit, a specimen shall be collected at admission, a second specimen collected between 48 and 72 hours of age and a third specimen collected at discharge or 28 days of life, whichever comes first.

(4) In the case of infants up to six months of age entering the care of a practitioner and for whom the screening status is unknown or cannot be determined, a specimen shall be collected within two weeks of the first visit to the practitioner and sent to the state public health laboratory for screening.

(5) In the case of infants over six months of age entering the care of a practitioner and for whom the screening status is unknown or cannot be determined, a specimen shall be collected within two weeks of the first visit and sent to a diagnostic laboratory providing screening services for older infants.

Stat. Auth.: ORS 433.285

Stats. Implemented: ORS 433.285

Hist.: HD 18-1981(Temp), f. & ef. 9-11-81; HD 3-1982, f. & ef. 2-25-82; HD 17-1983, f. & ef. 10-12-83; HD 10-1986, f. & ef. 6-11-86; OHD 15-2002, f. & cert. ef. 10-4-02; PH 30-2004(Temp), f. & cert. ef. 9-17-04 thru 3-13-05; PH 37-2004, f. & cert. ef. 12-7-04; PH 11-2014, f. 4-15-14, cert. ef. 5-1-14

333-024-0230

Methods of Testing

(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).

Stat. Auth.: ORS 433.285

Stats. Implemented: ORS 433.285

Hist.: HD 18-1981(Temp), f. & ef. 9-11-81; HD 3-1982, f. & ef. 2-25-82; HD 17-1983, f. & ef. 10-12-83; HD 10-1986, f. & ef. 6-11-86; HD 28-1994, f. 10-28-1994, cert. ef. 11-1-94; OHD 15-2002, f. & cert. ef. 10-4-02; PH 30-2004(Temp), f. & cert. ef. 9-17-04 thru 3-13-05; PH 37-2004, f. & cert. ef. 12-7-04; PH 11-2014, f. 4-15-14, cert. ef. 5-1-14

333-024-0231

Procedures for Follow-Up of Specimens Administered Too Early, Improperly Collected, and Those That Show Abnormal Results

(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.]

Stat. Auth.: ORS 433.285

Stats. Implemented: ORS 433.285

Hist.: HD 6-1985, f. 4-26-85, ef. 5-1-85; HD 10-1986, f. & ef. 6-11-86; OHD 15-2002, f. & cert. ef. 10-4-02; PH 30-2004(Temp), f. & cert. ef. 9-17-04 thru 3-13-05; PH 37-2004, f. & cert. ef. 12-7-04; PH 11-2014, f. 4-15-14, cert. ef. 5-1-14

333-024-0232

Demographic Data

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

Hist.: HD 6-1985, f. 4-26-85, ef. 5-1-85; OHD 15-2002, f. & cert. ef. 10-4-02; PH 30-2004(Temp), f. & cert. ef. 9-17-04 thru 3-13-05; PH 37-2004, f. & cert. ef. 12-7-04; PH 11-2014, f. 4-15-14, cert. ef. 5-1-14

333-024-0235

Religious Exemption from Newborn Screening Testing

(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.

Stat. Auth.: ORS 431.180

Stats. Implemented: ORS 433.285

Hist.: HD 18-1981(Temp), f. & ef. 9-11-81; HD 3-1982, f. & ef. 2-25-82; HD 17-1983, f. & ef. 10-12-83; HD 10-1986, f. & ef. 6-11-86; HD 8-1991, f. & cert. ef. 6-19-91; OHD 15-2002, f. & cert. ef. 10-4-02; PH 30-2004(Temp), f. & cert. ef. 9-17-04 thru 3-13-05; PH 37-2004, f. & cert. ef. 12-7-04; PH 11-2014, f. 4-15-14, cert. ef. 5-1-14

333-024-0240

Fees

(1)(a) The person responsible for submitting 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 (2)(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.

(3) For Oregon practitioners, newborn screening test kits purchased by prepayment on or after May 1, 2014:

(a) $32 per one-specimen kit; or

(b) $64 per two-specimen kit; or

(c) $64 per three-specimen kit (neonatal intensive care unit (NICU) and special baby care unit (SBCU) use only).

(4) Specimens which are submitted in an inadequate quantity or any unsatisfactory condition shall be subject to the fee of $5 per repeat specimen except for newborn screening specimens, which may be subject to a charge of $32 per specimen. Additional specimens from the same infant or patient specifically required or requested by the state public health laboratory, but not because the original specimen was inadequate or unsatisfactory, shall be exempt from additional fees.

(5) Kits requested for testing for congenital disorders shall be prepaid by the requestor in the amount as specified in section (3) of this rule. Kit requests must be accompanied by payment for the full amount of the order.

(6) No Oregon infant shall be denied testing for congenital disorders because of inability of the infant’s parent or legal guardian to pay the fee for a test or kit:

(a) A practitioner or parent or legal guardian requesting exemption from fees shall complete a statement indicating the following:

STATEMENT OF FEE EXEMPTION

The undersigned parent or legal guardian of________________, born on___________, attests that they are unable to pay the fee/charge for labor and delivery services and for testing for congenital disorders because of lack of sufficient funds, insurance or Medicaid coverage.

________________________________________________

(Signature of parent or legal guardian)

_____________________

(Date)

(b) The above completed statement shall be completed by the parent or legal guardian on the original specimen identification form which accompanies the dried blood specimen used to test the infant for congenital disorders.

(c) Exemption statements must be received by the state public health laboratory within 90 days of the first newborn screening.

(d) Upon receipt of the statement in subsection (6)(a) of this rule, and confirmation of Oregon Health Authority records, the Oregon Health Authority will issue a refund check. The state public health laboratory will issue a refund check to the payer of record. The state public health laboratory will replace kits, damaged or unused, which are returned to the laboratory.

(7) For tests performed for or on behalf of Oregon state or local government agencies, as determined by the administrator to have a significant public health impact, a lesser fee, calculated to recover costs, may be charged.

(8) All specimens submitted to the state public health laboratory shall be collected according to procedures, protocols, and shipping instructions specified on the Oregon State Public Health Laboratory’s website.

[Publications: Publications referenced are available from the agency.]

Stat. Auth.: ORS 431.310 & 433.285

Stats. Implemented: ORS 431.310 & 433.285

Hist.: HB 18-1981(Temp), f. & ef. 9-11-81; HB 3-1982, f. & ef. 2-25-82; HD 12-1982, f. 6-11-82, ef. 7-1-82; HD 27-1982(Temp), f. 12-15-82, ef. 12-16-82; HD 9-1983, f. 6-24-83, ef. 7-1-83; HD 11-1983(Temp), f. & ef. 7-11-83; HD 17-1983, f. & ef. 10-12-83; HD 10-1986, f. & ef. 6-11-86; HD 7-1987, f. & ef. 7-15-87; HD 12-1990, f. & cert. ef. 5-22-90; HD 8-1991, f. & cert. ef. 6-19-91; HD 28-1994, f. 10-28-1994, cert. ef. 11-1-94; HD 12-1997, f. 9-26-97, cert. ef. 10-1-97; OHD 3-1998, f. 3-31-98, cert. ef. 4-1-98; OHD 15-2002, f. & cert. ef. 10-4-02; PH 30-2004(Temp), f. & cert. ef. 9-17-04 thru 3-13-05; PH 37-2004, f. & cert. ef. 12-7-04; PH 7, 2014, f. & cert. ef. 1-30-14; PH 11-2014, f. 4-15-14, cert. ef. 5-1-14

Notes
1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official, record copy of this publication is contained in the original Administrative Orders and Rulemaking Notices filed with the Secretary of State, Archives Division. Discrepancies, if any, are satisfied in favor of the original versions. Use the OAR Revision Cumulative Index found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2013.

2.) Copyright Oregon Secretary of State: Terms and Conditions of Use

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