reglab/statecodes huggingface dataset:
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 4 - Certificate of Need Regulations › Subchapter 9 - Standards for Psychiatric and Chemical Dependency Service Beds › Section 310:4-9-3 - Population-based need

Current through Vol. 41, No. 20, July 1, 2024
The applicant must demonstrate that existing psychiatric and
				  chemical dependency service beds are not and will not be adequate to meet the
				  needs in the service area described in 310:4-9-2.
(1)
Need.
The applicant must
				demonstrate that there are persons who need services in the area but are unable
				to obtain those services due to the inadequacy of existing psychiatric and
				chemical dependency service beds.
(2)
Impact.
The applicant must
				demonstrate the probable impact of the proposed beds on the ratio of
				psychiatric and chemical dependency beds to the population statewide. The
				statewide ratio must not exceed one hundred forty-five (145) beds per one
				hundred thousand (100,000) persons, while moving towards an optimal target
				ratio of one hundred seventeen (117) beds per one hundred thousand (100,000)
				persons.
(3)
Ratio.
The applicant must demonstrate the probable impact of the proposed beds on the
				ratio of psychiatric and chemical dependency beds to the population in the
				service area. The application cannot cause an excessive increase in the bed to
				population ratio of a service area. The determination of whether or not an
				increase is excessive is based on the percentage of increase a project will
				cause in an area's bed to population ratio, and on a comparison of the area's
				bed to population ratio against the statewide ratio.
(4)
Population projection.
The
				most recent published population figures are used for the application. The
				source of population projections for current and future years is based on year
				2000 census data as published by the Oklahoma Department of Commerce.
(5)
Target
				population.
If the applicant proposes a special service area under
				310:4-9-2, then the applicant must demonstrate that the target population will
				have access to the proposed services through public or private transportation.
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 4 - Certificate of Need Regulations › Subchapter 9 - Standards for Psychiatric and Chemical Dependency Service Beds › Section 310:4-9-4 - Availability of alternative services

Current through Vol. 41, No. 20, July 1, 2024
The applicant must demonstrate that alternative or substitute
				  services are not and will not be available or are and will be inadequate to
				  meet the needs of the population.
(1)
Alternatives.
The applicant's demonstration must include
				consideration of residential, halfway house, outpatient, day hospitalization,
				or other less restrictive care settings in the service area.
(2)
Mean occupancy.
An overall
				mean occupancy rate of seventy-five percent (75%) must be maintained in
				psychiatric and chemical dependency beds in the service area described in
				310:635-9-2, as a prerequisite to the approval of additional beds whether in
				new or existing facilities. This mean must be based upon data from all
				psychiatric and chemical dependency beds in the service area using month
				reports submitted to the Department. This mean must be calculated using data
				for the most recent six (6) month period for which reports are available as of
				the first day of the month during which an application is initially filed.
(3)
Outstanding beds.
The applicant must demonstrate that the proposed beds are needed in addition to
				any beds previously approved or exempted from review under the State
				Certificate of Need law but not yet in operation in the service area.
(4)
Availability.
The
				applicant must demonstrate the availability of appropriate linkages such as
				referral protocols or joint venture agreements with similar or complementary
				services.
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 4 - Certificate of Need Regulations › Subchapter 9 - Standards for Psychiatric and Chemical Dependency Service Beds › Section 310:4-9-5 - Financial resources

Current through Vol. 41, No. 20, July 1, 2024
(a) The applicant
				must demonstrate adequate financial resources for the new or expanded services
				and for the continued operation thereof.
(b) Sufficient capital must be available to
				initiate and operate the proposed project.
(c) Financial arrangements must be reasonable
				and secure.
(d) The project must be
				financially viable through three years beyond completion.
(e) Proposed charges must be in line with
				prevailing rates of similar institutions providing similar services in the
				general area.
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 4 - Certificate of Need Regulations › Subchapter 9 - Standards for Psychiatric and Chemical Dependency Service Beds › Section 310:4-9-6 - Staffing

Current through Vol. 41, No. 20, July 1, 2024
The applicant must demonstrate that sufficient personnel will
				  be retained or employed to meet the needs of all residents and to comply with
				  all requirements for licensure and/or certification, if applicable. That
				  demonstration must include documentation of the availability or plans for
				  recruitment of the following personnel as applicable to meet the program's
				  needs.
(1) The medical administrator
				(supervisor) or treatment coordinator must be a psychiatrist in a psychiatric
				program, and may be an internist or family practice physician for chemical
				dependency programs. This person may be retained on contract, or used through
				referral for non-medical subacute programs. The number of medical
				administrators or treatment coordinators must be sufficient to meet program
				needs.
(2) The
				Director/Administrator may be in lieu of or in addition to the medical
				administrator, subject to training and experience.
(3) The numbers of case workers, family
				therapists, psychologists, and social workers must be adequate to meet the
				demands of the program design.
(4)
				The activities assistant will organize and supervise occupational and
				recreational programming.
(5) The
				applicant must provide for at least one R.N. on duty at all times, with
				additional R.N.s adequate to meet program needs.
(6) Psychiatric technicians/mental health
				workers may be non-licensed staff in addition to licensed nursing staff, and
				the number corresponding with the intensity of illness to be treated.
(7) Medical records clerks
				sufficient to meet program needs.
(8) The applicant must provide an education
				specialist for school age patients.
(9) Clerical and support staff sufficient to
				meet program needs.
(10) Ancillary
				support personnel sufficient to meet program needs.
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 4 - Certificate of Need Regulations › Subchapter 9 - Standards for Psychiatric and Chemical Dependency Service Beds › Section 310:4-9-7 - Other

Current through Vol. 41, No. 20, July 1, 2024
(a) A ten (10) bed psychiatric or chemical
				dependency unit is assumed to be the minimum size to sustain services and
				staffing for an acute care hospital based psychiatric or chemical dependency
				unit.
(b) If coordination with a
				teaching or training program in the area is a part of the proposed project, the
				applicant must submit documentation of the participation by, and the probable
				impact on, health personnel teaching or training programs.
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 4 - Certificate of Need Regulations › Subchapter 9 - Standards for Psychiatric and Chemical Dependency Service Beds › Section 310:4-9-8 - Temporary emergency admissions

Current through Vol. 41, No. 20, July 1, 2024
(a) Any
				temporary emergency must be fully documented by the physician and the hospital
				to include:
(1) an explanation of the
				emergency;
(2) the services
				rendered to the patient;
(3) an
				explanation of why an adult bed was used; and
(4) the length of stay in the bed ordinarily
				used for an adult.
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 5 - Controlled Industrial Waste Management Council Procedures [Revoked] › Section 310:5-1-3 - Rulemaking hearings [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Revoked at 12 Ok Reg 2287,
				eff 6-26-95
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 6 - Electrical Hearing Board Procedures [Revoked] › Section 310:6-1-7 - Public information, submissions, requests and documents [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Revoked at 20 Ok Reg 1607,
				eff 6-12-03
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 7 - Plumbing Hearing Board Procedures [Revoked] › Section 310:7-1-7 - Public information, submissions, requests and documents [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Revoked at 20 Ok Reg 1609,
				eff 6-12-03
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 7 - Plumbing Hearing Board Procedures [Revoked] › Section 310:7-1-10 - Petition for rule adoption [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Revoked at 20 Ok Reg 1609,
				eff 6-12-03
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 8 - Rules of Practice for Advisory Groups Special Health Services › Subchapter 1 - Oklahoma Emergency Medical Services Advisory Council › Section 310:8-1-1

Current through Vol. 41, No. 20, July 1, 2024
Added at 8 Ok Reg 3197,
				  eff 7-18-91 (emergency); Added at 9 Ok Reg 1483, eff
				  5-1-92
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 8 - Rules of Practice for Advisory Groups Special Health Services › Subchapter 1 - Oklahoma Emergency Medical Services Advisory Council › Section 310:8-1-2

Current through Vol. 41, No. 20, July 1, 2024
Added at 8 Ok Reg 3197,
				  eff 7-18-91 (emergency); Added at 9 Ok Reg 1483, eff 5-1-92; Amended at 11 Ok
				  Reg 891, eff 12-17-93 (emergency); Amended at 11 Ok Reg 2613, eff 6-25-94;
				  Amended at 12 Ok Reg 2289, eff 6-26-95
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 8 - Rules of Practice for Advisory Groups Special Health Services › Subchapter 1 - Oklahoma Emergency Medical Services Advisory Council › Section 310:8-1-3

Current through Vol. 41, No. 20, July 1, 2024
Added at 8 Ok Reg 3197,
				  eff 7-18-91 (emergency); Added at 9 Ok Reg 1483, eff 5-1-92; Amended at 12 Ok
				  Reg 2289, eff 6-26-95
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 8 - Rules of Practice for Advisory Groups Special Health Services › Subchapter 1 - Oklahoma Emergency Medical Services Advisory Council › Section 310:8-1-4

Current through Vol. 41, No. 20, July 1, 2024
Added at 8 Ok Reg 3197,
				  eff 7-18-91 (emergency); Added at 9 Ok Reg 1483, eff 5-1-92; Amended at 11 Ok
				  Reg 891, eff 12-17-93 (emergency); Amended at 11 Ok Reg 2613, eff 6-25-94;
				  Amended at 12 Ok Reg 2289, eff 6-26-95
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 8 - Rules of Practice for Advisory Groups Special Health Services › Subchapter 1 - Oklahoma Emergency Medical Services Advisory Council › Section 310:8-1-5

Current through Vol. 41, No. 20, July 1, 2024
Added at 8 Ok Reg 3197,
				  eff 7-18-91 (emergency); Added at 9 Ok Reg 1483, eff 5-1-92; Amended at 11 Ok
				  Reg 891, eff 12-17-93 (emergency); Amended at 11 Ok Reg 2613, eff 6-25-94;
				  Amended at 12 Ok Reg 2289, eff 6-26-95
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 8 - Rules of Practice for Advisory Groups Special Health Services › Subchapter 1 - Oklahoma Emergency Medical Services Advisory Council › Section 310:8-1-6

Current through Vol. 41, No. 20, July 1, 2024
Added at 8 Ok Reg 3197,
				  eff 7-18-91 (emergency); Added at 9 Ok Reg 1483, eff 5-1-92; Amended at 11 Ok
				  Reg 891, eff 12-17-93 (emergency); Amended at 11 Ok Reg 2613, eff 6-25-94;
				  Amended at 12 Ok Reg 2289, eff 6-26-95
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 9 - Health Care Information › Subchapter 1 - General Provisions › Section 310:9-1-1 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
The purpose of this Chapter is to establish the rules for a
				  uniform set of health care data as established by Section
				  1-117
				  of Title 63 of the Oklahoma Statutes.
Added at 16 Ok Reg 2451,
				  eff 6-25-99
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 9 - Health Care Information › Subchapter 1 - General Provisions › Section 310:9-1-3 - Fees and charges

Current through Vol. 41, No. 20, July 1, 2024
(a) The fee for
				special reports shall be $50.00 per staff hour for creating or generating
				reports.
(b) The fee for Public Use
				Data Files shall be as follows:
(1)
Most Current Two (2) Years/each
:
(A) Participating Hospitals $ 0.00 -
				1st copy at no charge
(B) Non-Profit/Research $ 50.00
(C) For Profit/Commercial $7,500.00 full data
				year or $0.030/rec + $50/hr for custom datasets
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 9 - Health Care Information › Subchapter 3 - Required Information › Section 310:9-3-1 - Required information to be collected from information providers

Current through Vol. 41, No. 20, July 1, 2024
(a) The Department is required by law to
				collect the following types of information from information providers:
(1) Financial information including, but not
				limited to, consumption of resources to provide services, reimbursement, costs
				of operation, revenues, assets, liabilities, fund balances, other income,
				rates, charges, units of service, wage and salary data;
(2) Service information including, but not
				limited to,
(A) occupancy, capacity, and
				special and ancillary services;
(B)
				Physician profiles in the aggregate by clinical specialties and nursing
				services;
(C) Discharge data,
				including but not limited to, completed discharge data sets or comparable
				information for each patient discharged from the facility after the effective
				date of this act; and
(D)
				Ambulatory care data including, but not limited to, provider-specific and
				encounter data.
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 9 - Health Care Information › Subchapter 3 - Required Information › Section 310:9-3-2 - Data files

Current through Vol. 41, No. 20, July 1, 2024
(a) When a data
				file is received from an information provider, the Department will notify the
				facility acknowledging receipt of the data.
(b) As hospital discharge or ambulatory care
				data files are received by the Department, the data will be processed and
				checked for errors. This process will include error checking for out of range,
				or invalid data elements as specified in the data submission manual. Upon
				processing the submitted data file, the Department will send the information
				provider:
(1) A standard information provider
				report developed from the provider's data; and
(2) A list of errors in that information
				provider's data file and will request the information provider correct errors
				associated with their data within 30 days of receipt electronically to the
				Department.
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 9 - Health Care Information › Subchapter 3 - Required Information › Section 310:9-3-3 - Periodic schedule for submission of information

Current through Vol. 41, No. 20, July 1, 2024
(a) Hospital discharge data files must be
				submitted to the Department within 60 days after the end of each calendar
				quarter, beginning calendar year 2020.
(b) Ambulatory surgery data files must be
				submitted to the Department within 60 days after the end of each calendar
				quarter, beginning with calendar year 2020.
(c) Emergency department data files must be
				submitted to the Department within 45 days after the end of each month,
				beginning with calendar year 2020.
(d) The Department may grant an extension on
				written request from the information provider on a case-by-case basis.
Added at 16 Ok Reg 2451,
				  eff 6-25-99; Amended at 18 Ok Reg 2472, eff
				  6-25-01
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 9 - Health Care Information › Subchapter 5 - Collection and Release of Information › Section 310:9-5-1 - Confidentiality

Current through Vol. 41, No. 20, July 1, 2024
(a) All information collected from any source
				will remain confidential and will not be public records as defined in the Open
				Records Act except as provided in 63 O.S. 1998 Supp. Section 1-119. Under no
				circumstances shall the information in the database or any records from which
				this database is maintained be used for any purpose other than the compilation
				of aggregate data or the creation of anonymous medical case histories for
				statistical reporting and data analysis. Prior to release of any information,
				all identifying information shall be removed which might directly or indirectly
				reveal the identity of any person. This information may not be released
				voluntarily or in response to any legal process unless the Department is
				directed to release it by a court of competent jurisdiction, granted after
				application showing good cause.
(b)
				The Department will develop internal procedures to ensure the collection,
				analysis and dissemination of information is in compliance with all provisions
				of state and federal laws and regulations, including this Chapter.
(c) State agencies, boards and commissions
				are required to make information authorized under the Oklahoma Health Care
				Information System Act available to the Department without charge to the
				Department. Except as otherwise provided by the Health Care Information System
				Act, information which is required by state or federal law to be confidential
				will not be transferred to any entity by the Department unless a separate
				written agreement for such transfer has been executed by the Department with
				the state agency, board or commission.
Added at 16 Ok Reg 2451,
				  eff 6-25-99
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 9 - Health Care Information › Subchapter 5 - Collection and Release of Information › Section 310:9-5-2 - Release and dissemination of information

Current through Vol. 41, No. 20, July 1, 2024
After approval by the Department, aggregate compilations
				  prepared for release or dissemination from the data collected shall be public
				  record. However, reports prepared at the request of an individual information
				  provider containing information concerning only its transactions, shall not be
				  public record.
Added at 16 Ok Reg 2451,
				  eff 6-25-99
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 9 - Health Care Information › Subchapter 5 - Collection and Release of Information › Section 310:9-5-2.1 - Public Use Data File

Current through Vol. 41, No. 20, July 1, 2024
(a) The Department
				will annually make available for purchase a Public Use Data File(s) (PUDF)
				containing a calendar year of record level data with anonymous case files
				(i.e., direct patient identifiers removed).
(b) The hospital inpatient discharge data
				PUDF includes the following data elements:
(1) Record Identifier (Synthetic)
(2) Patient state of residence
(3) Patient zip code
(4) Patient county of residence
(5) Patient gender
(6) Patient race
(7) Patient marital status
(8) Patient age group
(9) Hospital ID
(10) Hospital Type
(11) Admission year
(12) Admission month
(13) Admission day of week
(14) Discharge year
(15) Discharge month
(16) Discharge day of week
(17) Length of stay in days
(18) Type and source of admission
(19) Patient discharge status
(20) Payer classification
(21) Total charges
(22) Diagnosis Related Group (DRG)
(23) Major Disease Category (MDC)
(24) Birth weight group
(25) Admitting diagnosis
(26) External cause of injury codes (E-code)
(27) Principal diagnosis
(28) Other diagnosis codes
(29) Principal procedure code
(30) Other procedure codes
(31) Present upon Admission (POA)
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 9 - Health Care Information › Subchapter 5 - Collection and Release of Information › Section 310:9-5-2.2 - Custom data sets

Current through Vol. 41, No. 20, July 1, 2024
The Department will compile custom data sets (CDS) based on
				  the data elements contained in the PUDF.
(1) Requests for CDS must be made in writing
				to the Department using the Special Request Form.
(2) Entities requesting custom data sets from
				the PUDF must sign and complete the Data Use Agreement. The signed Data Use
				Agreement must be included with the request.
(3) The application fee must be received by
				the Department with the request.
Added at 18 Ok Reg 2472,
				  eff 6-25-01
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 9 - Health Care Information › Subchapter 5 - Collection and Release of Information › Section 310:9-5-3 - Standard information provider reports [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 16 Ok Reg 2451,
				  eff 6-25-99
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 9 - Health Care Information › Subchapter 5 - Collection and Release of Information › Section 310:9-5-4 - Standard reports

Current through Vol. 41, No. 20, July 1, 2024
(a) The charge for
				standard reports will be reproduction costs that are based on the Department's
				fee schedule.
(b) Standard reports
				may not be published or sold by another entity without written consent of the
				Department.
(c) Standard reports
				will include, but are not limited to, aggregate information regarding:
(1) Patterns and trends in the health status
				of Oklahomans;
(2) Utilization,
				costs and outcomes; and
(3)
				Capacity of the various components of the health care industry to provide
				needed services.
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 9 - Health Care Information › Subchapter 5 - Collection and Release of Information › Section 310:9-5-5 - Custom reports

Current through Vol. 41, No. 20, July 1, 2024
(a) Requests for
				custom reports are handled on a case-by-case basis. The Department reserves the
				right to refuse any request for a custom report that could threaten the
				confidentiality of an individual.
(b) All custom reports, except reports
				prepared at the request of an individual information provider containing
				information concerning only its transactions, are public record.
(c) Requests for custom reports must be made
				in writing to the Department using the Special Request Form.
(d) Special reports may not be published or
				sold without written consent of the Department.
(e) The application fee must be received by
				the Department with the request.
Added at 16 Ok Reg 2451,
				  eff 6-25-99; Amended at 18 Ok Reg 2472, eff
				  6-25-01
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 1 - General Provisions [REVOKED] › Section 310:10-1-1 - General purpose [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 1 - General Provisions [REVOKED] › Section 310:10-1-2 - Scope [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 1 - General Provisions [REVOKED] › Section 310:10-1-3 - Definitions [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 1 - General Provisions [REVOKED] › Section 310:10-1-4 - Incorporations by reference [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 3 - Federalwide Assurance of Protection for Human Subjects [REVOKED] › Section 310:10-3-1 - Adherence to ethical principles [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 3 - Federalwide Assurance of Protection for Human Subjects [REVOKED] › Section 310:10-3-2 - Conditions of federalwide assurance [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 3 - Federalwide Assurance of Protection for Human Subjects [REVOKED] › Section 310:10-3-3 - Compliance with 45 C.F.R. Part 46 [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 3 - Federalwide Assurance of Protection for Human Subjects [REVOKED] › Section 310:10-3-4 - Authority of IRB [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 3 - Federalwide Assurance of Protection for Human Subjects [REVOKED] › Section 310:10-3-5 - Informed consent [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 3 - Federalwide Assurance of Protection for Human Subjects [REVOKED] › Section 310:10-3-6 - IRB procedures [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 3 - Federalwide Assurance of Protection for Human Subjects [REVOKED] › Section 310:10-3-7 - Assurance training [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 3 - Federalwide Assurance of Protection for Human Subjects [REVOKED] › Section 310:10-3-8 - Investigator training [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 3 - Federalwide Assurance of Protection for Human Subjects [REVOKED] › Section 310:10-3-9 - Compliance and knowledge of local context [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 3 - Federalwide Assurance of Protection for Human Subjects [REVOKED] › Section 310:10-3-10 - Assurance of protection for human subjects [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 3 - Federalwide Assurance of Protection for Human Subjects [REVOKED] › Section 310:10-3-11 - Institutional support of the IRB [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 3 - Federalwide Assurance of Protection for Human Subjects [REVOKED] › Section 310:10-3-12 - Unaffiliated investigation [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 3 - Federalwide Assurance of Protection for Human Subjects [REVOKED] › Section 310:10-3-13 - Update of federalwide assurance [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 5 - Compliance With the Registration of the Oklahoma State Department of Health Institutional Review Board [REVOKED] › Section 310:10-5-1 - FDA regulated research [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 5 - Compliance With the Registration of the Oklahoma State Department of Health Institutional Review Board [REVOKED] › Section 310:10-5-2 - Ethical principles [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 5 - Compliance With the Registration of the Oklahoma State Department of Health Institutional Review Board [REVOKED] › Section 310:10-5-3 - Compliance with 45 C.F.R. Part 46 [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 5 - Compliance With the Registration of the Oklahoma State Department of Health Institutional Review Board [REVOKED] › Section 310:10-5-4 - Authority of the OSDH IRB [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 5 - Compliance With the Registration of the Oklahoma State Department of Health Institutional Review Board [REVOKED] › Section 310:10-5-5 - Informed consent [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 5 - Compliance With the Registration of the Oklahoma State Department of Health Institutional Review Board [REVOKED] › Section 310:10-5-6 - IRB procedures [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 5 - Compliance With the Registration of the Oklahoma State Department of Health Institutional Review Board [REVOKED] › Section 310:10-5-7 - Compliance and knowledge of local context [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 5 - Compliance With the Registration of the Oklahoma State Department of Health Institutional Review Board [REVOKED] › Section 310:10-5-8 - IRB Training [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 5 - Compliance With the Registration of the Oklahoma State Department of Health Institutional Review Board [REVOKED] › Section 310:10-5-9 - Provision of investigator training [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 5 - Compliance With the Registration of the Oklahoma State Department of Health Institutional Review Board [REVOKED] › Section 310:10-5-10 - Institutional support of the IRB [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 5 - Compliance With the Registration of the Oklahoma State Department of Health Institutional Review Board [REVOKED] › Section 310:10-5-11 - Update of IRB Registration [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 5 - Compliance With the Registration of the Oklahoma State Department of Health Institutional Review Board [REVOKED] › Section 310:10-5-12 - IRB membership requirements [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-1 - Responsibility for research integrity [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-2 - Usage [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-3 - Research Integrity Officer [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-4 - Whistleblower [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-5 - Respondent [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-6 - Deciding official [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-7 - Responsibility to report misconduct [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-8 - Protecting the whistleblower [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-9 - Protecting the respondent [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-10 - Cooperation with inquiries and investigations [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-11 - Preliminary assessment of allegations [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-12 - Conducting the inquiry [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-13 - The inquiry report [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-14 - Inquiry decision, notification, and confidentiality [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-15 - Time limit for completing the inquiry report [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-16 - Conducting the investigation [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-17 - The investigation report [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-18 - Requirements for reporting to ORI [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-19 - Institutional administrative actions [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 10 - Human Subjects Protection [REVOKED] › Subchapter 7 - Research Integrity [REVOKED] › Section 310:10-7-20 - Record retention [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2046,
				  eff 6-27-02
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 15 - Clinical Trials on the Use of Cannabidiol › Subchapter 1 - Purpose and Definitions › Section 310:15-1-1 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
The rules in this Chapter implement the Commissioner of
				  Health's authorities established in Enrolled House Bill Number 2154, from the 1
				  
				  st Session of the 55 
				  th Oklahoma Legislature (2015) known
				  as
"
Katie and Cayman's Law
"
and codified at 63 O.S.
				  §§
									2-801
				  through
				  2-805.
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 15 - Clinical Trials on the Use of Cannabidiol › Subchapter 1 - Purpose and Definitions › Section 310:15-1-2 - Definitions

Current through Vol. 41, No. 20, July 1, 2024
The following words and terms, when used in this Chapter,
				  shall have the following meaning, unless the context clearly indicates
				  otherwise.
"Clinical Trial"
means a trial at an academic
				  medical center of the use of cannabidiol at an academic medical center on
				  patients pursuant to the requirements of Katie and Cayman's Law, codified at 63
				  O.S. §§
									2-801
				  through
				  2-805.
"O.S."
means Oklahoma Statute.
"Severe forms of epilepsy"
means refractory
				  epilepsy that is not adequately treated by traditional medical therapies,
				  including Lennox-Gastaut Syndrome and Dravet Syndrome, also known as Severe
				  Myoclonic Epilepsy of Infancy.
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 15 - Clinical Trials on the Use of Cannabidiol › Subchapter 3 - Physician Application and Reporting › Section 310:15-3-1 - Physician application

Current through Vol. 41, No. 20, July 1, 2024
Any physician, who has been designated a principal
				  investigator of a clinical trial concerning
Lennox-Gastaut
				  Syndrome
, also known as
Severe Myoclonic Epilepsy of
				  Infancy
; any other severe form of epilepsy not adequately treated by
				  traditional medical therapies (63 O.S. §
									2-101(23)
				  ), or any other form of refractory epilepsy that is not adequately treated by
				  traditional medical therapies, spasticity due to multiple sclerosis or due to
				  paraplegia; intractable nausea and vomiting; or appetite stimulation with
				  chronic wasting diseases (63 O.S. §
									2-801(5)
				  ) on individuals, and who requests approval from the Commissioner of Health, or
				  designee shall:
(1) Submit an
				application on a form provided by the Commissioner of Health, which shall
				include the name, address and other contact information for the principal
				investigator;
(2) Submit a
				statement from either the Oklahoma State Board of Medical Licensure or the
				Oklahoma State Board of Osteopathic Examiners that the physician is licensed
				and in good standing with said licensure board;
(3) Submit a copy of the documents from the
				United States Food and Drug Administration naming the physician as the
				principal investigator;
(4) Submit
				a copy of the license obtained by the United States Drug Enforcement
				Administration;
(5) Submit and
				maintain a current Oklahoma State Bureau of Narcotics and Dangerous Drugs
				Control registration;
(6)
				Demonstrate registration with the Oklahoma State Bureau of Narcotics and
				Dangerous Drugs Control;
(7) Submit
				the names, addresses and other contact information of any subinvestigators who
				will be assisting the principal investigator and include with the submission:
(A) A copy of the license obtained by the
				United States Drug Enforcement Administration; and
(B) Information demonstrating registration of
				the subinvestigator with the Oklahoma State Bureau of Narcotics and Dangerous
				Drugs Control;
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 15 - Clinical Trials on the Use of Cannabidiol › Subchapter 3 - Physician Application and Reporting › Section 310:15-3-2 - Physician reporting

Current through Vol. 41, No. 20, July 1, 2024
(a) Any physician
				approved by the Commissioner of Health or designee to perform a clinical trial,
				pursuant to this Chapter shall submit annual reports, and a final report, to
				the Commissioner of Health. The report shall include:
(1) Data from the clinical trial;
				and
(2) Summary of findings from
				the clinical trial.
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 96 - Oklahoma Advance Directive Registry › Subchapter 1 - General Provisions › Section 310:96-1-1 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
The purpose of this Chapter is to establish and maintain the
				  Advance Directives Registry which shall be accessible through the OSDH website
				  for the purpose of storing Advance Directives of individuals and regulating
				  access to the Registry.
Added at 27 Ok Reg 2506,
				  eff 7-25-10
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 96 - Oklahoma Advance Directive Registry › Subchapter 1 - General Provisions › Section 310:96-1-2 - Definitions

Current through Vol. 41, No. 20, July 1, 2024
When used in this Chapter, the following words or terms shall
				  have the following meaning unless the context of the sentence requires another
				  meaning:
"Registry"
means the Oklahoma Advance Directive
				  Registry
Added at 27 Ok Reg 2506,
				  eff 7-25-10
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 96 - Oklahoma Advance Directive Registry › Subchapter 3 - Submission Requirments › Section 310:96-3-1 - Advance Directive Forms

Current through Vol. 41, No. 20, July 1, 2024
The Advance Directive Form submitted for initial filing or
				  amendment in the Registry may be substantially in the format contained in Title
				  63 O.S. §
									3101.4
				  or in the format available on the Oklahoma State Department of Health
				  Website.
Added at 27 Ok Reg 2506,
				  eff 7-25-10
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 96 - Oklahoma Advance Directive Registry › Subchapter 3 - Submission Requirments › Section 310:96-3-2 - Document format

Current through Vol. 41, No. 20, July 1, 2024
The Advance Directive forms submitted for filing in the
				  Registry shall be in a PDF (Portable Document Format)
				  document.
Added at 27 Ok Reg 2506,
				  eff 7-25-10
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 96 - Oklahoma Advance Directive Registry › Subchapter 5 - Release of Advance Directives › Section 310:96-5-1 - Release of Advance Directives

Current through Vol. 41, No. 20, July 1, 2024
Release of the Advance Directive form on file with the
				  Registry shall be limited to the subject of the record or an individual
				  authorized by the subject of the record as identified in the Registry or a
				  health care provider treating the subject of the record.
Added at 27 Ok Reg 2506,
				  eff 7-25-10
Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 99 - Secondhand Tobacco Smoke [Expired] › Subchapter 1 - General Provisions [Expired] › Section 310:99-1-1 - Purpose, authority and public policy statement [EXPIRED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 19 Ok Reg 2823,
				  eff 7-1-02 through 7-14-03
				  (emergency)1
1For information about 7-23-02
				  Tempory Injunction and expiration of emergency rules, see Editor's Note at
				  beginning of this Chapter 99.