reglab/statecodes huggingface dataset:
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-1150 - Client Rights

Current through Register Vol. 63, No. 7, July 1, 2024
Applicants and clients have the following rights:
(1) To receive CAREAssist services free of
			 discrimination based on race, color, sex, gender, ethnicity, national origin,
			 religion, age, class, sexual orientation, physical or mental ability.
(2) To be informed about services
			 and options available in the CAREAssist programs for which they may be
			 eligible.
(3) To have their
			 CAREAssist records be treated confidentially in accordance with OAR chapter
			 943, division 14.
(4) To have
			 access to a written grievance process posted on the CAREAssist website.
(5) To receive language assistance
			 services, including access to translation and interpreter services at no cost
			 if the individual has limited English proficiency.
Stat. Auth.: ORS 413.042, 431.250, 431.830
Stats. Implemented: ORS 431.250,
				  431.830
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-1160 - Termination from CAREAssist

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The
			 Authority may terminate a client or restrict benefits for any of the following:
(a) Failure to continue to meet eligibility
			 requirements;
(b) Submitting
			 false, fraudulent or misleading information to the Authority in order to obtain
			 or retain benefits;
(c) Placement
			 in a custodial institution, such as a state or federal prison, that is legally
			 obligated to provide medical services; or
(d) Failure to notify the Authority of
			 changes in accordance with OAR
			 333-022-1100.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-1170 - Hearings

Current through Register Vol. 63, No. 7, July 1, 2024
A client who has benefits denied, restricted, or terminated has
				a right to a contested case hearing in accordance with ORS chapter
				183.
Stat. Auth.: ORS 413.042, 431.250, 431.830
Stats. Implemented: ORS 431.250, 431.830
HIV Case
				  Management
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-2000 - Purpose

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The Oregon HIV
			 Case Management Program provides case management and supportive services,
			 through Ryan White Part B case management agencies, that include but are not
			 limited to client-centered services that ensure timely and coordinated access
			 to primary medical care, medications, treatment adherence counseling and other
			 support services for HIV-positive individuals.
(2) Case management and supportive services
			 will be available as long as the Oregon Health Authority (Authority) continues
			 to receive Ryan White Program, Part B funds for this purpose.
(3) If insufficient funds are available for
			 case management and supportive services, the Authority may reduce case
			 management services or reduce funding for supportive services.
Stat. Auth.: ORS 413.042, 431.250, 431.830
Stats. Implemented: ORS 431.250,
				  431.830
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-2010 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
(1) "Agency" refers
			 to a contracted provider delivering Ryan White funded services.
(2) "AIDS" means acquired immunodeficiency
			 syndrome.
(3) "Authority" means
			 the Oregon Health Authority.
(4)
			 "Family" means all individuals counted by an agency in determining the
			 individual or client's family size.
(5) "Federal Poverty Level" or "FPL" means
			 the annual poverty income guidelines, published by the United States Department
			 of Health and Human Services.
(6)
			 "Gross monthly income" means income before taxes or other withholdings.
(7) "HIV" means the human
			 immunodeficiency virus, the causative agent of AIDS.
(8) "HIV case management service area" means
			 all Oregon counties except Multnomah, Washington, Clackamas, Columbia and
			 Yamhill.
(9) "Ryan White Program,
			 Part B" means The Ryan White HIV/AIDS Program authorized and funded under Title
			 XXVI of the Public Health Services Act, as amended by the Ryan White HIV/AIDS
			 Treatment Extension Act of 2009 (Public Law
			 111-87, October 30, 2009).
(10) "Ryan White Part B case management
			 services agency" or "agency" means a contractor of the Authority that is
			 responsible for providing case management services and administering supportive
			 services to individuals living with HIV/AIDS in a specific jurisdiction.
(11) "Supportive services" means
			 financial assistance that can be authorized on behalf of an individual enrolled
			 in Ryan White Part B case management services.
Stat. Auth.: ORS 413.042, 431.250, 431.830
Stats. Implemented: ORS 431.250,
				  431.830
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-2020 - Eligibility

Current through Register Vol. 63, No. 7, July 1, 2024
To be eligible for the HIV Case Management Program an
				individual must:
(1) Be HIV positive
			 or have AIDS; and
(2) Reside in an
			 agency's jurisdiction within the HIV case management service area, unless
			 another agency agrees to provide services and the Authority authorizes the
			 provision of services by that other agency
Stat. Auth.: ORS 413.042, 431.250, 431.830
Stats. Implemented: ORS 431.250,
				  431.830
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-2030 - Enrollment Process

Current through Register Vol. 63, No. 7, July 1, 2024
(1) To enroll in
			 the HIV Case Management Program an individual must go through an intake process
			 with a local Ryan White Part B case management services agency. A list of the
			 agencies may be obtained on the Authority's website at www.healthoregon.org/hiv
			 [File Link Not Available].
(2)
			 During the intake process an individual must provide information to an agency
			 that enables the agency to verify at least the following:
(a) Identity;
(b) HIV status;
(c) Residency in the HIV case management
			 service area;
(d) Income;
(e) Household member information;
			 and
(f) Health insurance
			 information, if applicable.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-2040 - Approval or Denial of Enrollment

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The agency will make a determination as
			 to whether the individual is eligible for case management services within 30
			 days of receiving all documentation in accordance with OAR
			 333-022-2030.
(2) If the agency determines that
			 an individual cannot be enrolled in the HIV Case Management Program an
			 individual will be notified in accordance with ORS 183.415.
(3) An individual who has been denied may
			 reapply at any time.
Stat. Auth.: ORS 413.042, 431.250, 431.830
Stats. Implemented: ORS 431.250,
				  431.830
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-2050 - Determination of Service Needs

Current through Register Vol. 63, No. 7, July 1, 2024
Once enrolled in the HIV Case Management Program, a client must
				participate in a screening and assessment process with an agency to review his
				or her needs and resources, for the purpose of developing a plan to address the
				needs identified. The purpose of this assessment is to identify actions to
				remove barriers to HIV care and treatment.
Stat. Auth.: ORS 413.042, 431.250, 431.830
Stats. Implemented: ORS 431.250,
				  431.830
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-2060 - Client Rights

Current through Register Vol. 63, No. 7, July 1, 2024
Individuals applying for or clients enrolled in the HIV Case
				Management Program have the following rights:
(1) To receive HIV case management services
			 free of discrimination based on race, color, sex, gender, ethnicity, national
			 origin, religion, age, class, sexual orientation, physical or mental ability.
(2) To be informed about services
			 and options available in the HIV Case Management Program.
(3) To have HIV case management services and
			 other program records maintained confidentially in accordance with OAR chapter
			 943, division 14.
(4) To have
			 access to a written grievance process provided by the agency.
(5) To receive language assistance services
			 including access to translation and interpretation services, at no cost if the
			 individual or client has limited English proficiency, in order to access HIV
			 case management services.
Stat. Auth.: ORS 413.042, 431.250, 431.830
Stats. Implemented: ORS 431.250,
				  431.830
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-2070 - Client Responsibilities

Current through Register Vol. 63, No. 7, July 1, 2024
A client enrolled in the HIV Case Management Program is
				expected to:
(1) Participate in
			 screening, assessment, care plan development and implementation activities;
(2) Provide accurate eligibility
			 information at all times;
(3)
			 Inform the case manager of changes in address, phone number, income, family
			 size, legal name change, or health insurance coverage within 15 days;
(4) Make and keep appointments, or
			 cancel or change an appointment within 24 hours of the scheduled time; and
(5) Other responsibilities as
			 designated by the agency.
Stat. Auth.: ORS 413.042, 431.250, 431.830
Stats. Implemented: ORS 431.250,
				  431.830
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-2080 - Supportive Services

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A client
			 enrolled in the HIV Case Management Program may be eligible for supportive
			 services if income is at or below 250 percent of the FPL.
(2) Authorization by an agency of supportive
			 services is discretionary and a decision to provide such services will be based
			 on the following factors:
(a) The agency is
			 funded to provide the services;
(b) The funds are available in the agency
			 budget;
(c) The services are
			 allowable per the contract with the Authority;
(d) No other payer exists to provide the
			 needed services, with the exception of those that qualify for Veteran's
			 Administration or Indian Health Services who may still qualify to receive Ryan
			 White services;
(e) The client is
			 eligible and currently active in the HIV Case Management Program; and
(f) The client's need for the
			 service has been determined by the agency and documented in the client's file.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-2090 - Client Enrollment Review

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 client must participate with the agency at least every six months in reviewing
			 the client's eligibility and enrollment information for HIV case management
			 services, and at any time the agency deems it necessary within an eligibility
			 period.
(2) An individual who does
			 not provide an agency with the information necessary to verify continued
			 eligibility may not receive supportive services until continued eligibility is
			 documented.
Stat. Auth.: ORS 413.042, 431.250, 431.830
Stats. Implemented: ORS 431.250,
				  431.830
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-2100 - Incarcerated Applicants or Clients

Current through Register Vol. 63, No. 7, July 1, 2024
(1) An individual who is incarcerated may not
			 be enrolled in the HIV Case Management Program and may not continue to be
			 enrolled in the program except as described in section (2) of this rule.
(2) An agency may enroll or
			 continue to provide services to an individual who is incarcerated in order to
			 facilitate an HIV positive inmate's transition from a correctional facility to
			 the community under the following circumstances:
(a) The incarcerated person will be released
			 within 180 days; and
(b) There are
			 no other transitional case management or discharge planning services provided
			 by the correctional facility.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-2110 - Termination

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A client
			 enrolled in the HIV Case Management Program may be terminated from the program
			 for any of the following:
(a) Failure to
			 continue to meet eligibility requirements;
(b) Placement in a custodial institution for
			 more than 180 days, such as a state or federal prison that is legally obligated
			 to provide medical services;
(c)
			 Cannot be located or is unresponsive to program requests for more than 60 days;
(d) Submitting false, fraudulent
			 or misleading information in order to obtain or retain benefits;
(e) Fraudulent use of supportive services; or
(f) Consistent documented
			 violations of the responsibilities outlined in OAR
			 333-022-2070.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-2120 - Hearings

Current through Register Vol. 63, No. 7, July 1, 2024
A client who has been terminated has a right to a contested
				case hearing in accordance with ORS chapter 183.
Stat. Auth.: ORS 413.042, 431.250, 431.830
Stats. Implemented: ORS 431.250,
				  431.830
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 22 - HUMAN IMMUNODEFICIENCY VIRUS › Section 333-022-3000 - Oregon Housing Opportunity in Partnership Program

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The Oregon Housing Opportunities in
			 Partnership (OHOP) program provides housing services to eligible applicants who
			 have received a medical diagnosis of HIV or AIDS. OHOP assists clients in
			 achieving and maintaining housing stability so as to avoid or reduce
			 homelessness and improve their access to, and engagement in, HIV care and
			 treatment. OHOP is designed to promote client housing stability and act as a
			 bridge to long-term assistance programs, such as Section 8, or to
			 self-sufficiency. Participation in OHOP is voluntary and conditional.
(2) The OHOP program is funded through grants
			 from the U.S. Department of Housing and Urban Development and other funds. OHOP
			 is a needs-based program and not an entitlement program.
(3) The OHOP program is administered and
			 operated in accordance with the OHOP Program Policy and Procedures Manual,
			 Version 2, dated June 2022, adopted and incorporated by reference. The Manual
			 may be obtained by visiting
www.healthoregon.org/hiv
.
To view attachments referenced in rule text,
click here to view
				  rule
.
Statutory/Other Authority: ORS
				  413.014 &
				  431.250
Statutes/Other Implemented: ORS
				  431.250
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 23 - PRESCRIPTION DRUG MONITORING PROGRAM › Section 333-023-0800 - Purpose

Current through Register Vol. 63, No. 7, July 1, 2024
The purpose of the Prescription Drug Monitoring Program rules
				(OAR 333-023-0800  through 333-023-0830) is to define operational processes of a
				prescription drug monitoring program.
Statutory/Other Authority: ORS
				  431A.855
Statutes/Other Implemented: ORS
				  431A.855
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 23 - PRESCRIPTION DRUG MONITORING PROGRAM › Section 333-023-0810 - Reporting Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Not
			 later than 72 hours after dispensing a controlled substance a pharmacy shall
			 electronically report to the Authority the following information for
			 prescription drugs dispensed that are classified in schedules II through IV
			 under the federal Controlled Substances Act,
			 21 U.S.C.
			 811 and
			 812,
			 as modified by the State Board of Pharmacy by rule under ORS
			 475.035:
(a) Patient's full name, address, phone
			 number, date of birth, and sex;
(b)
			 Pharmacy Drug Enforcement Administration Registration Number (or other
			 identifying number in lieu of such registration number);
(c) Prescriber name and Drug Enforcement
			 Administration Registration Number (or other identifying number in lieu of such
			 registration number);
(d)
			 Identification of the controlled substance using a national drug code
			 number;
(e) Prescription
			 number;
(f) Date the prescription
			 was written;
(g) Date the drug was
			 dispensed;
(h) Number of metric
			 units dispensed;
(i) Number of days
			 supplied;
(j) Number of refills
			 authorized by the prescriber and the number of the fill of the
			 prescription;
(k) ICD-10, if it is
			 provided by the prescriber with the prescription; and
(l) Reason for prescription, if it is
			 provided by the prescriber with the prescription.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 23 - PRESCRIPTION DRUG MONITORING PROGRAM › Section 333-023-0815 - Notification to Patients

Current through Register Vol. 63, No. 7, July 1, 2024
Using language provided by the Authority, a pharmacy shall
				notify each patient receiving a controlled substance about the Prescription
				Drug Monitoring Program before or when the controlled substance is dispensed to
				the patient. The notification shall include that the prescription will be
				entered into the system.
Statutory/Other Authority: ORS
				  431A.855
Statutes/Other Implemented: ORS
				  431A.855
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 23 - PRESCRIPTION DRUG MONITORING PROGRAM › Section 333-023-0820 - Information Access

Current through Register Vol. 63, No. 7, July 1, 2024
(1) System Access.
			 Only the following individuals or entities may access the system:
(a) Practitioners and pharmacists authorized
			 to prescribe or dispense controlled substances;
(b) Delegates of practitioners or
			 pharmacists;
(c) Designated
			 representatives of the Authority and any vendor contracted to establish or
			 maintain the system;
(d) State
			 Medical Examiner and designees of the State Medical Examiner; or
(e) Medical, dental, and pharmacy directors.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 23 - PRESCRIPTION DRUG MONITORING PROGRAM › Section 333-023-0825 - Practitioner Registration Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A practitioner with an active United
			 States Drug Enforcement Agency (DEA) registration to prescribe in Oregon must
			 register with the Prescription Drug Monitoring Program in accordance with OAR
			 333-023-0820(8)
 
			 in order to have access to the Program's electronic system.
(2) A practitioner who becomes licensed on or
			 after July 1, 2018, and who has an active DEA registration must register with
			 the Program as specified in section (1) of this rule, within 30 calendar days
			 of Oregon licensure or DEA registration, whichever is later.
Statutory/Other Authority: OL 2018, ch. 45
Statutes/Other Implemented: OL 2018, ch.
				  45
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 23 - PRESCRIPTION DRUG MONITORING PROGRAM › Section 333-023-0830 - Approval of Health Information Technology Systems

Current through Register Vol. 63, No. 7, July 1, 2024
(1) An eligible entity may apply to the
			 Authority to allow its Health Information Technology System access to the
			 Prescription Drug Monitoring Program data. To apply for approval, an eligible
			 entity must complete and provide the following to the Prescription Drug
			 Monitoring Program:
(a) An application
			 provided by the Authority that includes contact information for the eligible
			 entity's Chief Information Officer, his or her designee, or equivalent, and the
			 Compliance Officer, his or her designee, or equivalent that oversees the Health
			 Information Technology System;
(b)
			 An attestation that:
(A) The eligible
			 entity's Health Information Technology System complies with state and federal
			 privacy and security regulations;
(B) The eligible entity provides users
			 training on the Health Information Technology System related to the limits of
			 access and allowable use of Prescription Drug Monitoring Program data;
(C) The eligible entity agrees to
			 periodic participation in audit activities with the Authority; and
(D) The eligible entity agrees to terms and
			 conditions of use of the system that defines the limits of access, allowable
			 use of patient information, and penalties for misuse of the system;
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0005 - Purpose

Current through Register Vol. 63, No. 7, July 1, 2024
These rules (OAR
				333-024-0005  through
				333-024-0055  and OAR
				333-024-0260  and
				333-024-0265)  are for
				the purpose of carrying out ORS Chapter 438, the declarative purpose of which
				is to insure the quality of medical laboratory work in order to protect the
				health and welfare of the people of the State of Oregon by establishing a
				regulatory program for clinical laboratories.
Stat. Auth.: ORS 438.450
Stats. Implemented: ORS 438.030 &
				  438.450
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0012 - Licensure

Current through Register Vol. 63, No. 7, July 1, 2024
(1) It shall be
			 unlawful:
(a) For any Owner or Director of a
			 clinical laboratory to operate or maintain a clinical laboratory without a
			 license or without a temporary permit issued under this rule or to perform or
			 permit the performance of any laboratory specialty for which the laboratory is
			 not licensed, unless the laboratory has been issued a valid certificate from
			 the federal government under the
Clinical Laboratory Improvement
			 Amendments of 1988
,
Public Law
			 100-578
,
42.U.S.C. 201
and
263a
, except as specified herein;
(b) For any person to serve in the capacity
			 of Director of a high complexity clinical laboratory without being qualified as
			 a Clinical Laboratory Director under OAR
			 333-024-0021;
(c) For any person to serve in the capacity
			 of Director of a moderate complexity clinical laboratory without being
			 qualified as a Clinical Laboratory Director under OAR
			 333-024-0022;
			 and
(d) For any person other than a
			 physician or clinician to direct or perform microscopic procedures listed in
			 OAR
			 333-024-0016(1)(b)
 
			 in a Physician Performed Microscopy Laboratory.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0016 - Licensure Categories

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The four
			 categories of clinical laboratories are:
(a)
			 A waived laboratory which may perform only the following; dipstick or tablet
			 reagent urinalysis (nonautomated), fecal occult blood, ovulation test-visual
			 color comparison tests for human luteinizing hormone, urine pregnancy
			 test-visual color comparison tests, erythrocyte sedimentation rate
			 (nonautomated), hemoglobin-copper sulfate (nonautomated), blood glucose (by
			 glucose monitoring devices cleared by the Food and Drug Administration
			 specifically for home use), spun microhematocrit, and hemoglobin and glucose by
			 Hemocue, Chemtrak Accumeter cholesterol, body fluid occult blood, nitrazine pH
			 paper for all body fluids except blood or any other tests which are categorized
			 as waived for CLIA laboratories, by the Health Care Financing Administration
			 and Centers for Disease Control and Prevention:
(A) A waived laboratory is exempt from
			 personnel requirements, proficiency testing and routine on-site
			 inspections;
(B) A waived
			 laboratory shall follow manufacturer's instructions for test
			 performance:
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0020 - Licensure for Performance of Laboratory Specialties

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Licensure for the performance of surgical
			 pathology, autopsy pathology, exfoliative cytology, and immunohematology
			 (except as provided in section (4) of this rule) shall be granted only to a
			 laboratory whose Director is a physician or dentist specifically qualified in
			 these fields.
(2) A clinical
			 laboratory testing for substances of abuse shall be licensed under ORS
			 438.435(4) and comply with OAR
			 333-024-0305  through
			 333-024-0350,
			 except when performing tests for the purpose of diagnosis, prevention of
			 disease or treatment of patients by physicians, dentists and other persons who
			 are authorized by license to diagnose or treat humans.
(3) Licensure for the performance of
			 substances of abuse testing in clinical laboratories shall be granted only to a
			 laboratory whose Director qualifies under OAR
			 333-024-0320(1).
Stat. Auth.: ORS 438.120
Stats. Implemented: ORS
				  438.120
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0021 - Qualifications and Responsibilities of Directors for High Complexity Laboratories

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The
			 Director shall meet at least one of the qualifications defined by the
			 following:
(a) Is a pathologist certified in
			 clinical or anatomical pathology by the American Board of Pathology, the
			 American Osteopathic Board of Pathology, or is eligible for such certification
			 (Board eligible);
(b) Is certified
			 or board eligible by the American Board of Oral Pathology. An oral pathologist
			 shall only direct an oral pathology laboratory;
(c) Is a physician who:
(A) Is eligible for certification by the
			 American Board of Medical Microbiology, the American Board of Clinical
			 Chemistry, the American Society of Cytology, the American Board of Dermatology,
			 or other national accrediting board related to a laboratory specialty as may be
			 approved by the Division; and
(B)
			 Has had two or more years of general laboratory training and
			 experience.
(d) Has an
			 earned degree of Doctor of Science, Doctor of Public Health, or Doctor of
			 Philosophy or an acceptable degree, as determined by the Division, from an
			 accredited college or university with a major in the chemical, physical, or
			 biological sciences and possesses special qualifications as follows: is
			 certified or is eligible for certification by the American Board of Medical
			 Microbiology, American Board of Bioanalysis, the American Board of Clinical
			 Chemistry, or other national accrediting board related to a laboratory
			 specialty or possesses other special qualifications as approved by the
			 Division; and has one or more years experience supervising high complexity
			 testing;
(e) Was responsible for
			 the direction of a clinical laboratory for at least 12 months within the five
			 years preceding January 1, 1970, and has had at least two years of pertinent
			 clinical laboratory experience as determined by the Division;
(f) Was serving as a laboratory director in
			 Oregon and either previously qualified or could have qualified as a laboratory
			 director in Oregon on or before February 28, 1992, and is a doctor of medicine,
			 doctor of osteopathy or doctor of podiatric medicine, and has two or more years
			 of general laboratory training or experience;
(g) Was qualified as a clinical laboratory
			 director under federal regulations prior to February 28, 1992.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0022 - Qualifications and Responsibilities for Director of Moderate Complexity Laboratories

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The
			 director shall meet at least one of the qualifications in
			 333-024-0021  or one of the following:
(a) Is a doctor of
			 medicine, doctor of osteopathy or doctor of podiatric medicine; and
(A) Has one or more years of directing or
			 supervising non-waived laboratory testing; or
(B) Has at least 20 continuing medical
			 education credit hours in laboratory practice; or
(C) Has 1 year of laboratory training in
			 non-waived testing during a residency.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0023 - Qualifications and Responsibilities of Consultants, Supervisors and Testing Personnel for Moderate and High Complexity Laboratories

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Moderate complexity laboratory technical
			 and clinical consultants shall meet the minimal qualifications and fulfill the
			 responsibilities described in the
Clinical Laboratory Improvement
			 Amendments of 1988,  42 CFR, Part 493, Subpart M
.
(2) High complexity laboratory clinical
			 consultants, general and technical supervisors, and cytology general
			 supervisors shall meet the minimal qualifications and fulfill the
			 responsibilities as described in the
Clinical Laboratory Improvement
			 Amendments of 1988,  42 CFR, Part 493, Subpart M
.
(3) All testing personnel shall meet the
			 minimal qualifications and fulfill the responsibilities as described in the
Clinical Laboratory Improvement Amendments of 1988,  42 CFR, Part 493, Subpart M
.
Publications: Publications referenced are available from the
				  agency.
Stat. Auth.: ORS 438.070
Stats. Implemented: ORS
				  438.070
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0026 - 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 according to manufacturer's requirements or a minimum of
			 every six months.
(2) Work bench
			 space shall be ample, clean, well-organized, well-lighted, and convenient to
			 sink, water and electrical outlets.
(3) The laboratory shall be ventilated to
			 protect the health of the personnel and patients against accidental release of
			 hazardous vapors or aerosols.
(4)
			 Laboratory procedure manuals and policies shall be available for the use of the
			 personnel in the laboratory and shall be reviewed by the Director initially and
			 when there is a change in methods or policy.
(5) The premises shall be free from
			 unnecessary physical, chemical, and biological hazards. All materials
			 containing pathogenic organisms shall be:
(a)
			 Autoclaved at 121°C for 30 minutes to ensure nonviability prior to being
			 discarded; or
(b) Incinerated in a
			 State-approved incinerator; or
(c)
			 Disposed using another Division approved method.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0035 - Internal Quality Control for Moderate and High Complexity Laboratories

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Laboratories
			 that perform testing using unmodified, moderate complexity test systems,
			 cleared by the Food and Drug Administration (FDA) through the 510(k) or
			 Premarket Approval (PMA) process must, until September 1, 1996:
(a) Follow the manufacturer's instructions
			 for test system operation and test performance;
(b) Have a procedure manual as defined in OAR
			 333-024-0035(4);
(c) Perform and document control procedures
			 using at least two levels of control materials each day of testing;
(d) Perform and document applicable specialty
			 and subspecialty control procedures as specified in OAR
			 333-024-0037;
(e) Follow the manufacturer's instructions
			 for calibration:
(A) Calibration must be
			 performed at least once every six months, or more frequently if required by
			 manufacturers;
(B) Use calibration
			 materials specified by the manufacturer;
(C) Maintain documentation of all calibration
			 and calibration verification for a minimum of two years. Documentation must
			 define the number, type, concentration of calibration materials, and frequency
			 required;
(f) Perform
			 calibration verification at least every 6 months to verify the laboratory's
			 established reportable range for patient test values using calibration or
			 control materials, including at least a minimal value (zero), a mid-point
			 value, and a maximum value at the upper limit of that range;
(g) Perform and document that remedial action
			 has been taken when problems or errors are identified as specified in OAR
			 333-024-0035(19);
			 and
(h) Comply with requirements as
			 specified in OAR
			 333-024-0035  (4-8), (11-13) and (16).
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0037 - Specialty and Subspecialty Quality Control

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
Bacteriology
quality
			 control requirements are:
(a) The laboratory
			 must check positive and negative reactivity with control organisms:
(A) Each day of use for catalase, coagulase,
			 betalactamase, oxidase reagents and DNA probes;
(B) Each week of use for Gram and acid-fast
			 stains, bacitracin, optochin, ONPG, X and V discs or strips; and
(C) Each month of use for antisera.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0040 - External Quality Control (Proficiency Testing Programs and On-Site Inspections)

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 Physician performed microscopy, moderate and high complexity laboratories
			 shall:
(a) At the laboratory's own expense,
			 be required to participate successfully in a proficiency testing program
			 approved by the Health Care Financing Administration. Lists of currently
			 approved programs are available from the Division. Continued or consistent
			 failure, two out of three testing events, may result in the laboratory's
			 license for that specialty, subspecialty or test being suspended or revoked by
			 the Division;
(b) Authorize release
			 of proficiency test results and provide documentation of corrective action to
			 the Division;
(c) Assure
			 proficiency testing is performed on each physician performed microscopy,
			 moderate and high complexity regulated analyte listed in the
Clinical
			 Laboratory Improvement Amendments of 1988,   42 CFR, Part 493, Subpart I
,
			 available on request from the Division;
(d) Meet the proficiency testing requirements
			 as described in the
Clinical Laboratory Improvement Amendments of 1988,
			 42 CFR, Part 493, subpart H
, available on request from the
			 Division;
(e) Notify the Division
			 within six months if the analysis of a specialty, subspecialty or test has been
			 discontinued or added to patient testing.;
(f) Assure that individuals performing
			 gynecologic cytology participate successfully in a proficiency testing program
			 approved by the Health Care Financing Administration;
(g) Be required to participate successfully
			 in the proficiency testing programs conducted by the Division involving the
			 laboratory specialty, subspecialty or tests in which the laboratory performs
			 tests;
(h) Analyze test samples
			 submitted by the Division prior to, during, or subsequent to
			 inspection.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0043 - Quality Assurance

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Each
			 laboratory performing physician performed microscopy, moderate or high
			 complexity testing must establish and follow written policies and procedures
			 for a comprehensive quality assurance program which is designed to monitor and
			 evaluate the ongoing and overall quality of the total testing process
			 (pre-analytic, analytic, post-analytic).
(2) The laboratory's quality assurance
			 program must evaluate the effectiveness of its policies and procedures;
			 identify and correct problems; assure the accurate, reliable and prompt
			 reporting of test results; and assure the adequacy and competency of the
			 staff.
(3) The laboratory must meet
			 the requirements of this rule as they apply to the services offered, complexity
			 of testing performed, test results reported, and the unique practices of each
			 testing entity.
(4) The laboratory
			 must monitor, evaluate, and revise, if necessary, based on the results of its
			 evaluations, the following:
(a) The criteria
			 established for patient preparation, specimen collection, labeling,
			 preservation and transportation;
(b) The information solicited and obtained on
			 the laboratory's test requisition for its completeness, relevance, and
			 necessity for the testing of patient specimens;
(c) The use and appropriateness of the
			 criteria established for specimen rejection;
(d) The completeness, usefulness, and
			 accuracy of the test report information necessary for the interpretation or
			 utilization of test results;
(e)
			 The timely reporting of test results based on testing priorities (STAT,
			 routine, etc.); and
(f) The
			 accuracy and reliability of test reporting systems, appropriate storage of
			 records and retrieval of test results.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0045 - Venereal Disease Testing

Current through Register Vol. 63, No. 7, July 1, 2024
Tests for syphilis approved by the Division are as
				follow:
(1) Venereal Disease Research
			 Laboratory (VDRL) slide tests;
(2)
			 Fluorescent Treponemal Antibody -- Absorption (FTA-ABS) test;
(3) Rapid Plasma Reagin (RPR) and Reagin
			 Screen Test (RST) macroscopic flocculation card tests;
(4) Hemagglutination-Treponemal Test for
			 Syphilis (HATTS);
(5)
			 Microhemagglutination Assay for Antibodies to
Treponema
			 pallidum
(MHA-TP) test;
(6) Unheated Serum Reagin (USR)
			 test;
(7) Toluidine Red Unheated
			 Serum Test (TRUST).
Stat. Auth.: ORS 438.010 & 438.020
Stats. Implemented: ORS
				  438.010
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0050 - Records and Reports

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 Personnel policies, practices, and procedures that support sound laboratory
			 practice shall be available in written form. A current record shall be
			 maintained on each employee and shall include a resume of training and
			 experience.
(2) Complete records
			 for each specimen examined, including quality control, shall be kept for not
			 less than two years, immunohematology records not less than five years,
			 cytology and pathology records not less than ten years. Such records shall
			 contain:
(a) Laboratory number or other
			 identification of the specimen;
(b)
			 The name or other identifier of the person from whom the specimen was taken, if
			 available;
(c) The name of the
			 physician or other authorized person or clinical laboratory submitting the
			 specimen;
(d) The date and time the
			 specimen was collected or date and time it was received in the
			 laboratory;
(e) The type of test
			 performed;
(f) The results of the
			 tests in units of measurement where applicable;
(g) The signature, initials, or
			 identification of the examiner;
(h)
			 The date and time the test results were reported; and
(i) Other information as needed to aid in the
			 interpretation of laboratory results.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0053 - Accreditation Organizations and Accredited Laboratories

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Accreditation organizations shall:
(a) Provide the Division with;
(A) Documentation of current deemed status
			 from the Health Care Financing Administration;
(B) A list of all laboratories and
			 accreditation expiration dates;
(C)
			 A list of scheduled surveys and proposed survey dates;
(D) Copies of routine survey findings, upon
			 request;
(E) Copies of all
			 complaint investigations performed.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0055 - Incompetence

Current through Register Vol. 63, No. 7, July 1, 2024
A clinical 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 these rules relating to internal and external quality control;
(3) Failure to comply with the ORS 438 or OAR
			 333-024-0005  through
			 333-024-0055  and OAR
			 333-024-0260  and
			 333-024-0265;
(4) Work assigned to personnel not qualified
			 to perform in that specialty;
(5)
			 Repeated erroneous reporting of test results.
Stat. Auth.: ORS 438.160
Stats. Implemented: ORS
				  438.160
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0210 - Testing for Metabolic Diseases: Infants Tested for Metabolic Diseases

Current through Register Vol. 63, No. 7, July 1, 2024
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).
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0215 - Person Responsible for Submitting Specimens for Newborn Screening Testing

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0220 - Testing for Metabolic Diseases: Manner of Submitting Specimens

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
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 333-024-0225 - Testing for Metabolic Diseases: Time of Collecting Specimens for Testing Infants

Current through Register Vol. 63, No. 7, July 1, 2024
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.
Statutory/Other Authority: ORS
				  433.285
Statutes/Other Implemented: ORS
				  433.285