reglab/statecodes huggingface dataset:
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 274 - IMMUNIZATION INFORMATION SYSTEM (IIS) RULES › Section 144-274-4 - Establishment Of The Immunization Information System

Current through 2024-29, July 17, 2024
A.
				All children born in Maine and registered in the Electronic Birth Certificate
				system shall have their demographic data entered into the Immunization
				Information System (hereinafter referred to as the "IIS").
B. The Department may use any birth record,
				Medicaid record, school record, or immunization record for the purposes of
				obtaining an individual's Immunization and Demographic Information and entering
				that Information into the IIS.
C.
				An Immunization Provider who administers immunizations with vaccines provided
				by the Department shall record or report all immunizations administered
				directly into the Immunization Information System, or through other methods as
				approved by the Department, within five (5) working days of administering the
				immunization.
D. All Patients will
				be informed during an initial immunization encounter with an Immunization
				Provider of the inclusion of their immunization record and demographic
				information into the IIS, and will be provided with the opportunity to opt-out
				of the IIS. All Patients will automatically have their immunization and
				demographic information maintained in the IIS, unless a Patient states in
				writing on a form prescribed by the Department, that he or she wants to opt out
				of the IIS.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 274 - IMMUNIZATION INFORMATION SYSTEM (IIS) RULES › Section 144-274-5 - Confidentiality Of The Immunization Information System

Current through 2024-29, July 17, 2024
A.
				Identifying information contained in the IIS shall only be disclosed to
				Authorized Users and the individual that it identifies, except in the case of
				an authorized exchange (as specified in Section 10-C ), or in the event of a
				public health emergency, as defined by statute.
B. Authorized Users must sign a user
				agreement in a form prescribed by the Department that sets forth the terms for
				using the IIS. Any such Agreement shall include a confidentiality clause, as
				well as provisions related to penalties for unauthorized disclosure.
C. Authorized Users shall not disclose
				information from the IIS about an individual except to another Authorized User
				when allowed by these rules, or by state and federal laws addressing patient
				confidentiality.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 274 - IMMUNIZATION INFORMATION SYSTEM (IIS) RULES › Section 144-274-6 - Individual's Right To Opt Out Of The Immunization Information System

Current through 2024-29, July 17, 2024
A. Any individual may choose to be excluded
				from the IIS, thereby limiting future access to his or her Immunization Records
				and Demographic Information from the IIS, by submitting a signed and witnessed
				document to his or her Immunization Provider on a form prescribed by the
				Department. The Department's form shall contain, at a minimum, the following
				information:
(1) the Patient's
				name;
(2) the Patient's
				address;
(3) the Patient's date of
				birth;
(4) the Patient's
				signature;
(5) the Witness's
				signature
(6) the Patient's reason
				for the requested exclusion; and
(7) the Department address.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 274 - IMMUNIZATION INFORMATION SYSTEM (IIS) RULES › Section 144-274-7 - Individual Access To The Immunization Information System

Current through 2024-29, July 17, 2024
A. An individual may review his or her
				individual Demographic Information and Immunization Record contained in the IIS
				by requesting a copy from his or her Immunization Provider.
B. In the event an individual discovers an
				error in his or her Immunization Record or Demographic Information, or in the
				event the Demographic Information changes, the individual is responsible for
				providing the correct information to the Immunization Provider. The
				Immunization Provider is responsible for making any such corrections or updates
				to the individual's Record.
C. In
				the event that an individual does not have an Immunization Provider, that
				individual shall make any requests to review or correct his or her Demographic
				Information or Immunization Record directly to the Department in a manner
				prescribed by the Department.
D.
				Requests for changes to Immunization Records must be supported by official
				immunization documentation as deemed acceptable by the Department.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 274 - IMMUNIZATION INFORMATION SYSTEM (IIS) RULES › Section 144-274-8 - Authorized User Access To The Immunization Information System

Current through 2024-29, July 17, 2024
A. As a condition of using the IIS,
				Immunization Providers and contracted entities shall submit to the Commissioner
				or his designee, on an annual basis, a signed agreement on a form prescribed by
				the Department. Signing these forms binds the Provider to the terms and
				conditions of these rules and to such other terms and conditions as deemed
				appropriate by the Commissioner or his designee.
B. All authorized users shall maintain the
				confidentiality of their individual access codes and passwords, and shall not
				share or exchange such codes with any other person, regardless of whether or
				not that other person is an Authorized User.
C. Immunization Providers and contracted
				entities must immediately inform the Department when any person in their
				organization with a user code and password leaves employment, and when any
				other changes in staffing require corresponding changes in user
				permissions.
D. Use of the IIS by
				authorized users will be limited by user roles that are assigned on an
				individual need-to-know basis.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 274 - IMMUNIZATION INFORMATION SYSTEM (IIS) RULES › Section 144-274-9 - Department Access To The Immunization Information System

Current through 2024-29, July 17, 2024
A. Except as otherwise provided herein, the
				Commissioner or his designee may access an individual's Demographic Information
				and Immunization Records only in the following circumstances:
(1) at the request or with permission of an
				Immunization Provider;
(2) at the
				written and notarized request of the individual;
(3) for the purpose of investigating vaccine
				fraud;
(4) for the purposes of
				preventing and controlling outbreaks of vaccine preventable communicable
				disease;
(5) for the purposes of
				assuring data quality and providing aggregate data as specified in section
				10;
(6) for the purpose of
				providing reminder/recall and other health related services;
(7) when deemed necessary by the Commissioner
				in the event of a public health emergency; or
(8) as deemed necessary by the Department to
				perform repairs, maintenance and updates of the Immunization Information
				System.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 274 - IMMUNIZATION INFORMATION SYSTEM (IIS) RULES › Section 144-274-11 - Liability, Penalties, And Protections

Current through 2024-29, July 17, 2024
A.
				Intentional or knowing violation of any of these rules by an Immunization
				Provider may result in a request for disciplinary action by the appropriate
				licensing and regulatory board which has regulatory authority over the
				Immunization Provider.
B. Whoever
				violates any of these rules or fails, neglects or refuses to perform any duties
				imposed upon that person by these rules is subject to criminal prosecution
				under Title 22 M.R.S.A. Section47.
C. Nothing in these rules shall be construed
				to authorize the imposition of civil penalties upon any Immunization Provider
				which in good faith engages in an unauthorized disclosure of Immunization
				Information System information.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 276 - RULES FOR INFLUENZA IMMUNIZING AGENT DISTRIBUTION REPORT › Section 144-276-I - Statement of Purpose

Current through 2024-29, July 17, 2024
The purpose of these rules is to identify the
				  responsibilities of manufacturers or distributors of influenza immunizing
				  agents to or within the State of Maine, establish the procedures by which the
				  Department will estimate the supply and demand for influenza immunizing agents,
				  and establish the circumstances in which information relating to the
				  distribution of influenza immunizing agents in Maine may be publicly
				  disclosed.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 276 - RULES FOR INFLUENZA IMMUNIZING AGENT DISTRIBUTION REPORT › Section 144-276-II - Definitions

Current through 2024-29, July 17, 2024
A. "Manufacturer" means a manufacturer of
				influenza vaccine sold or distributed in the State of Maine and includes any
				subsidiary or affiliate of such manufacturer
B. "Distributor" means anyone who offers for
				sale, sells, supplies or distributes, directly or indirectly, influenza
				immunizing agents to licensed health care providers and licensed health care
				facilities in the State of Maine.
C.
				"Influenza season" means the time period from September 1st through the
				following May 1st.
D. "Department"
				means the Department of Health and Human Services, Maine Center for Disease
				Control and Prevention.
E. "Type"
				means the trade name for an influenza vaccine.
F. "Quantity" means the amount of influenza
				vaccine.
G. "Dosage" means cc or ml
				for delivered influenza vaccine.
H.
				"Influenza immunizing agents" means a vaccine, antitoxin, or other substance
				used to increase an individual's immunity to influenza.
I. "Licensed health care provider or
				facility" means a hospital licensed pursuant to Title 22 MRSA, chapter 405 or
				non-hospital health care facility public or private, proprietary or non profit
				entity or institution providing health services licensed or certified under
				Title 22 MRSA, including, but not limited to, a radiological facility licensed
				under Chapter 160, a health care facility licensed under Chapter 405 and 405 D,
				an independent radiology center, a federally qualified health center, rural
				health clinic or rehabilitative agency, certified, recommended for
				certification or otherwise approved by the Department of Health and Human
				Services, Division of Regulatory and Licensing Services, a home health provider
				licensed under Chapter 419, a residential care facility licensed under Chapter
				1665, a hospice provider licensed under Chapter 1681, a state institution as
				defined under Title 34-B MRSA, Chapter 1, a mental health facility licensed
				under Title 34-B MRSA Chapter 1, and a retail store drug outlet licensed under
				Title 32 MRSA Chapter 117.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 276 - RULES FOR INFLUENZA IMMUNIZING AGENT DISTRIBUTION REPORT › Section 144-276-III - Timing and Content

Current through 2024-29, July 17, 2024
Each manufacturer or distributor of influenza immunizing
				  agents sold, shipped or otherwise distributed in the State of Maine shall
				  report the following information to the Department in a format approved by the
				  Department on a biweekly basis during influenza season and on a monthly basis
				  at all other times:
A. The contact
				name, company name, address, phone number and the email address of the
				manufacturer or distributor of influenza immunizing agents;
B. The contact name, business type, type of
				provider, address, phone number and email address of the licensed healthcare
				provider or facility that will receive influenza immunizing agents from the
				manufacturer or distributor;
C. The
				date that the manufacturer and/or distributor ships or distributes influenza
				immunizing agents and the date that the delivery is received by the licensed
				healthcare provider or licensed facility that ordered influenza immunizing
				agents; and
D. The type, quantity,
				and dosage of influenza immunizing agents distributed to the licensed
				healthcare provider or facility.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 276 - RULES FOR INFLUENZA IMMUNIZING AGENT DISTRIBUTION REPORT › Section 144-276-IV - Supply and Demand

Current through 2024-29, July 17, 2024
The Department shall estimate the supply and demand for
				  influenza immunizing agents at the beginning of each influenza season by
				  assessing past usage and aggregate orders; reviewing information disseminated
				  by manufacturers, distributors and the United States Department of Health and
				  Human Services, Centers for Disease Control and Prevention, identifying the
				  number and location of high priority populations; identifying possible
				  geographic and provider type disparities; and reviewing historical demand
				  patterns.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 276 - RULES FOR INFLUENZA IMMUNIZING AGENT DISTRIBUTION REPORT › Section 144-276-VI - Confidentiality

Current through 2024-29, July 17, 2024
A. Information obtained by the Department
				under this section is confidential and may not be disclosed by the Department
				except that the Department may provide information obtained under this section
				to a licensed health care provider or facility located in the State in order to
				facilitate access to influenza immunizing agents for patients of that licensed
				health care provider or facility that are residents of the State.
B. Any licensed healthcare provider or
				facility which receives any influenza immunizing agent distribution information
				pursuant to 22 M.R.S.A. §1065 or these rules shall restrict its use of
				such information to facilitating access to influenza immunizing agents for
				those patients of that licensed healthcare provider or facility that are
				residents of the State.
C. Subject
				to the provisions of Title 1 M.R.S.A. §§401 - 521, information
				submitted to the Department pursuant to 22 M.R.S.A. §1065 or these rules
				may be designated as confidential. The designation must be clearly indicated on
				the reporting form. The Commissioner shall establish procedures to insure that
				information so designated is segregated from public records of the Department.
				Upon receipt of a public access request for any of the information designated
				by the submitter as confidential, the Commissioner shall notify the data
				submitter within 10 days of the request. The Department may accommodate the
				public access request unless the data submitter notifies the Department within
				10 days of being notified of its objection to the release of the data and
				institutes appropriate measures to safeguard the data from public release. The
				burden shall be upon the data submitter to demonstrate that any data claimed as
				confidential is not a public record and not subject to disclosure pursuant to 1
				M.R.S.A. §§401 - 521
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 279 - RULES RELATING TO THE MAINE NEWBORN HEARING PROGRAM › Section 144-279-1.0 - PURPOSE

Current through 2024-29, July 17, 2024
1.1 These rules implement the Maine Newborn
				Hearing Program as established pursuant to Public Law 647, 22 MRSA c. 1686. The
				rules are adopted under the authority of
				 22 MRSA
				§8825 of the Maine Revised
				Statutes.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 279 - RULES RELATING TO THE MAINE NEWBORN HEARING PROGRAM › Section 144-279-4.0 - DATA ELEMENTS

Current through 2024-29, July 17, 2024
4.1 Hospitals,
				birthing facilities and other providers of infant hearing screening shall
				provide the following information to the Maine Newborn Hearing Program on a
				weekly to bi-monthly basis:
A. The number of
				infants born in that hospital or location and the number of infants who
				participated in hearing screenings during the birth admission.
B. The number of infants who participated in
				hearing screening at that hospital or location who received a "pass result"
				from the screening.
C. The number
				of infants who participated in hearing screening at that hospital or location
				who received a "refer pattern" from the screening.
D. The number of infants recommended for
				follow-up rescreening at that hospital or location.
E. The number of infants recommended for
				follow-up rescreening at another location.
F. The number of infants recommended for
				monitoring related to high-risk indicators.
G. The number of infants recommended for
				diagnostic audiologic evaluation.
H. The number of infants whose parents
				declined the newborn hearing screening.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 279 - RULES RELATING TO THE MAINE NEWBORN HEARING PROGRAM › Section 144-279-5.0 - RESPONSIBILITY FOR HEARING SCREENING OF INFANTS BORN IN MAINE BUT NOT IN A HOSPITAL

Current through 2024-29, July 17, 2024
5.1 In the event an
				infant is born outside a birthing hospital and the Department has received
				confirmation of the birth, the Department shall be responsible to provi de
				information to the parents regarding the importance of screening the hearing of
				newborns and of receiving follow-up care. The information provided must explain
				the process of hearing screening, the likelihood of a child having a hearing
				loss, the potential for later onset of hearing loss related to high risk
				indicators, follow-up procedures and community resources. The Department shall
				be responsible to provide information, which includes a description of the
				normal auditory, speech and language development process in children. Within
				three months of birth, the Department shall provide information to the parents
				of the newborn regarding the availability of hearing
				screening.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 279 - RULES RELATING TO THE MAINE NEWBORN HEARING PROGRAM › Section 144-279-6.0 - PARENTAL REFUSAL OF NEWBORN HEARING SCREENING

Current through 2024-29, July 17, 2024
6.1 In the event of a parental refusal for
				newborn hearing screening, the birthing hospital or birthing center shall be
				responsible to document such refusal, and such documentation shall be made part
				of the newborn's medical record. The birthing hospital, whenever practical and
				reasonable, shall obtain the parents' written refusal of hearing screening and
				provide a copy to the Maine Newborn Hearing Program.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 279 - RULES RELATING TO THE MAINE NEWBORN HEARING PROGRAM › Section 144-279-7.0 - PROGRAM'S RESPONSIBILITY TO MAINTAIN CONFIDENTIALITY OF ALL DATA

Current through 2024-29, July 17, 2024
7.1 All data reported to the Program, which
				contains either direct or indirectly individually identifiable information
				shall be confidential and is not considered a public record.
7.2 Any report produced from data collection
				will be in a form that does not allow direct or indirect identification of
				individuals.
7.3 Information
				submitted to the Maine Newborn Hearing Program shall only be available to
				qualified organizations or individuals with a documented history of scientific
				research, or other researchers determined to be appropriate by the Program. All
				information shall be subject to confidentiality agreements as deemed
				appropriate by the Program.
7.4 A
				standard Institutional Review Board process conforming to all applicable state
				and federal laws is required for any proposed research plan that involves the
				use of any Maine Newborn Hearing Program data. Approval by the Maine Bureau of
				Health Institutional Review Board must be documented prior to the release of
				any data.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 279 - RULES RELATING TO THE MAINE NEWBORN HEARING PROGRAM › Section 144-279-8.0 - CONTACT WITH FAMILIES

Current through 2024-29, July 17, 2024
8.1 The program may
				contact families to provide information about available services.
8.2 The family is not required to accept any
				referral or service.
8.3 Referral
				to outside agencies will be made only upon consent or request of
				parent.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 279 - RULES RELATING TO THE MAINE NEWBORN HEARING PROGRAM › Section 144-279-9.0 - ADVISORY BOARD

Current through 2024-29, July 17, 2024
9.1 The Advisory
				Board shall oversee the administration of the Program, advise the Commissioner
				of the Department of Human Services on issues relating to the Program, and
				recommend procedures for hearing screening, evaluation, treatment and services.
				The Board will report each year to the joint standing committees of the
				Legislature having jurisdiction over health and human services matters and
				education matters on the program, the percentages of children being screened
				and evaluated and those children being offered and receiving intervention and
				treatment services. The report shall be made available to the public.
9.2 The Advisory Board shall consist of an
				odd number of members, numbering at least 15, appointed by the Governor,
				including but not limited to the following: an audiologist, a physician, a
				speech-language pathologist, a nurse, a certified teacher of the deaf and a
				person who provides early intervention services to children who are deaf or
				hard-of-hearing through the Governor Baxter School for the Deaf, a person who
				is culturally Deaf, a person who is hard-of-hearing or deaf and a parent of a
				hearing impaired child, a representative of the hospitals, a representative of
				health carriers, a representative of the Child Development Services System
				established in Title 20-A, section 7724 and a representative of the
				Department.
9.3 Advisory Board
				members may be reimbursed for reasonable and necessary expenses incurred to
				attend board meetings but are not entitled to per diem payments. The Department
				of Human Services shall provide financial and staff support for the
				Board.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 280 - RULES RELATING TO THE MAINE BIRTH DEFECTS PROGRAM › Section 144-280-1 - PURPOSE

Current through 2024-29, July 17, 2024
These rules implement the Maine Birth Defects Program, as
				  established pursuant to Title 22, Chapter 1687 of the Maine Revised
				  Statutes.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 280 - RULES RELATING TO THE MAINE BIRTH DEFECTS PROGRAM › Section 144-280-2 - DEFINITIONS

Current through 2024-29, July 17, 2024
1. "
Birth hospital
" means any
				hospital licensed under the provisions of Title 22 of the Maine Revised
				Statutes which provides health care services to pregnant woman and those who
				give birth.
2. "
Birthing
				center
" means any non-hospital health facility, institution, or place
				designed to accommodate mothers giving birth away from home at the culmination
				of normal, uncomplicated pregnancies.
3. "
Birth defect
" means a major
				structural abnormality which impacts upon a fetus, newborn or infant's ability
				to function or survive. For reporting purposes, only those birth defects
				included in the Appendix to these rules need be reported.
4. "
Reportable birth defects
"
				means those birth defects which hospitals, physicians and other health care
				providers licensed under the provisions of Title 22 or Title 32 of the Maine
				Revised Statutes are required to report. These reportable birth defects are
				identified in the Appendix to these rules.
5. "
Specialty provider
" means
				those licensed under Title 32 who have additional certification by or
				eligibility for one of the disciplines of the American boards of certification
				and is registered and certified by the appropriate specialty boards.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 280 - RULES RELATING TO THE MAINE BIRTH DEFECTS PROGRAM › Section 144-280-3 - RESPONSIBILITY FOR REPORTING

Current through 2024-29, July 17, 2024
1. All
				administrators of hospitals licensed by the Department of Health and Human
				Services and all health professionals licensed pursuant to MRS Title 32 engaged
				by a birthing center are responsible to report all cases involving a diagnosis
				of a reportable birth defect involving any fetus or infant born in the State of
				Maine to a Maine resident. Reporting shall be made to the Maine Department of
				Health and Human Services, Maine Center for Disease Control and Prevention,
				Maine Birth Defects Program ("Maine Birth Defects Program"). This reporting
				requirement extends to any live born or stillborn infant diagnosed at birth or
				to any infant one year of age or younger admitted to the hospital or outpatient
				office/clinic for diagnosis or treatment related to a reportable birth
				defect.
2. Each administrator of a
				hospital or other health facility subject to licensing requirements established
				under either M.R.S.A. Title 22 or Title 32, which provides health care for
				pregnant woman or for infants, shall designate a contact person responsible for
				coordinating the reporting of birth defects by the facility to the Maine Birth
				Defects Program. Such designee should be a clinical person with appropriate
				experience in either obstetrics or newborn care, unless the Birth Defects
				Program authorizes another designee. Each such administrator shall advise the
				Birth Defects Program of the identity of the contact person for his or her
				facility.
3. The designated contact
				person shall also be responsible for the submission of appropriate reports to
				the Maine Birth Defects Program regarding any infant or fetus diagnosed with a
				reportable birth defect.
4. The
				administrator of any hospital licensed pursuant to M.R.S.A. Title 22 shall also
				designate a contact person within its medical records department to coordinate
				the provision of all relevant medical records and other information pertaining
				to an infant or fetus diagnosed with a reportable birth defect to the Maine
				Birth Defects Program. The administrator shall also furnish the name of such
				contact person to the Program.
5.
				Each hospital or birthing center subject to these Rules will be provided a
				report form by the Birth Defects Program, which will identify the required
				reporting data pertaining to the mother and infant/fetus, along with a listing
				of reportable birth defects under these Rules.
6. The administrator of each hospital
				licensed by the Department of Health and Human Services or licensed health
				professionals engaged by a birthing center subject to these Rules is
				responsible for assuring that all facility staff, with responsibility for
				obstetrical or newborn care, are informed of their respective responsibilities
				under these Rules.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 280 - RULES RELATING TO THE MAINE BIRTH DEFECTS PROGRAM › Section 144-280-4 - RESPONSIBILITY OF THOSE PROVIDING PEDIATRIC SERVICES

Current through 2024-29, July 17, 2024
1.
				Any primary care physician, specialty physician or other health care provider
				licensed pursuant to Title 32 of the Maine Revised Statutes who diagnoses a
				reportable birth defect in a newborn or infant in the first year of life shall
				report to the Maine Birth Defects Program such birth defect. The physician or
				other health care provider shall report on a form provided by the Birth Defects
				Program, if possible.
2. The
				reporting requirements under this subsection extend to the presence of a birth
				defect in any fetus, newborn or infant delivered by Maine residents.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 280 - RULES RELATING TO THE MAINE BIRTH DEFECTS PROGRAM › Section 144-280-5 - RESPONSIBILITY OF THOSE PROVIDING OBSTETRICAL SERVICES

Current through 2024-29, July 17, 2024
1. Any physician or other health care
				provider licensed pursuant to Title 32 of the Maine Revised Statutes who
				diagnose a fetus with a reportable birth defect shall submit a report regarding
				the birth defect to the Maine Birth Defects Program, regardless of the outcome
				of the pregnancy.
2. In the event
				the subject pregnancy results in other than a live birth, any such physician or
				other health care provider who provides care to the mother shall submit to the
				Birth Defects Program a report confirming the presence of a birth defect in the
				fetus or stillborn.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 280 - RULES RELATING TO THE MAINE BIRTH DEFECTS PROGRAM › Section 144-280-6 - TIMING OF REPORTING THE PRESENCE OF A BIRTH DEFECT IN AN INFANT OR FETUS

Current through 2024-29, July 17, 2024
1. The required report is be to submitted to
				the Maine Birth Defects Program, either within 24 hours of the time the infant
				is discharged or transferred, or within 7 days of the diagnosis of a reportable
				birth defect, whichever occurs first.
2. Diagnosis of a birth defect in a fetal
				death shall be reported within 7 days of the diagnosis or confirmation of a
				reportable birth defect.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 280 - RULES RELATING TO THE MAINE BIRTH DEFECTS PROGRAM › Section 144-280-7 - CONFIDENTIALITY OF ALL REPORTING DATA

Current through 2024-29, July 17, 2024
1. All data
				reported to the Maine Birth Defects Program, which contains either direct or
				indirect individually identifiable information, shall be
				confidential.
2. Except as
				otherwise provided in these Rules, individually identifiable information
				submitted to the Birth Defects Program shall only be available to qualified
				organizations with a documented history of scientific research or other
				researchers determined to be appropriate by the Program. In any event,
				disclosure of any individually identifiable information will be in conformity
				with applicable state and federal law.
3. Any organization or individual which
				requests individually identifiable information from the Birth Defects Program
				may be required to execute such confidentiality agreements as the Program deems
				appropriate.
4.Institutional Review
				Board approval is required for any research plan which involves either the use
				or release of any information contained in the Birth Defects Program. Any such
				Institutional Review Board must be established in conformity with applicable
				regulations established by the U.S. Department of Health and Human Services
				including but not limited to
45 CFR, Subtitle A, Part 46, §§
				46.101-46.409. (Revised as of Oct. 1, 2002).
5. In the event a proposed research plan
				involves contacting family members, written consent of the parent or guardian
				of any infant or fetus will be required as a predicate for use or release of
				any information from the Birth Defects Program.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 280 - RULES RELATING TO THE MAINE BIRTH DEFECTS PROGRAM › Section 144-280-8 - CONTACT WITH FAMILIES

Current through 2024-29, July 17, 2024
1. The Birth
				Defects Program may contact families to provide information about available
				services.
2. Referrals shall be
				made to the Department of Health and Human Services, Children with Special
				Health Needs Program and/or Public Health Nursing within 30 Days upon
				confirmation of the birth defect, and in compliance with part C of The I.D.E.A.
				(Individuals with Disabilities Education Act) the Maine Birth Defects Program
				will refer a newborn with a confirmed birth defect that has the potential to
				develop a developmental delay to the Part C agency.
3. No family will be required to accept any
				services offered by the Birth Defects Program, including any nursing visit or
				referral.
4. In the event of a
				prenatal diagnosis of a reportable birth defect, the Birth Defects Program will
				not contact the family, unless requested to do so by the family or physician or
				other health care provider subject to these Rules.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 280 - RULES RELATING TO THE MAINE BIRTH DEFECTS PROGRAM › Section 144-280-9 - PARENTAL OBJECTION TO PARTICIPATION

Current through 2024-29, July 17, 2024
1. In the
				event of parental objection on the basis of sincerely held religious beliefs,
				neither the hospital, birthing center,
n
or health care
				provider subject to these Rules may be required to report the presence of any
				birth defect.
2. Parental objection
				to reporting and participation in the Birth Defects Programbased on sincerely
				held religious beliefs shall be clearly documented in writing, and incorporated
				into the medical records of the mother, infant and newborn.
3. In the event of documented parental
				objection to participation in the Birth Defects Program, based upon sincerely
				held religious beliefs, the Program shall not collect or gather any medical
				records relating to birth defects of the fetus, newborn or infant.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 280 - RULES RELATING TO THE MAINE BIRTH DEFECTS PROGRAM › Appendix 144-280-A

Current through 2024-29, July 17, 2024
Central Nervous System
Anencephalus
Spina bifida without
						  anencephalus
Hydrocephalus without Spina Bifida
Encephalocele
Microcephalus
Eye
Anophthalmia/microphthalmia
Congenital
						  cataract
Aniridia
Ear
Anotia/microtia
Cardiovascular
Common
						  truncus
Transportation of great arteries
Tetralogy of
						  Fallot
Ventricular septal defect
Atrial septal
						  defect
Endocardial cushion defect
Pulmonary valve
						  atresia and stenosis
Tricuspid valve atresia and
						  stenosis
Ebstein's anomaly
Aortic valve
						  stenosis
Hypoplastic left heart syndrome
Patent ductus
						  arteriosus
(include only if weight=>2500 grams or note if unable
						  to exclude <2500 grams infants.)
Coarctation of aorta
Orofacial
Cleft palate without
						  cleft lip
Cleft lip with and without cleft palate
Choanal atresia
Gastrointestinal
Esophageal atresia/tracheoesophageal fistula
Rectal and large
						  intestinal atresia/stenosis
Pyloric stenosis
Hirshsprung's disease (congenital megacolon)
Biliary
						  atresia
Genitourinary
Renal
						  agenesis/hypoplasia
Bladder exstrophy
Obstructive
						  genitourinary defect
Hypospadias and Epispadias
Musculoskeletal
Reduction deformity, upper limbs
Reduction deformity, lower limbs
Gastroschisis
Omphalocele
Congenital hip
						  dislocation
Diaphragmatic hernia
Chromosomal
Trisomy 13
Down syndrome
						  (Trisomy 21)
Trisomy 18
Other
Fetal alcohol syndrome
Amniotic bands
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 281 - RULES AND REGULATIONS FOR SPINAL SCREENING › Section 144-281-1 - Frequency of Screening

Current through 2024-29, July 17, 2024
Screening will be conducted at a minimum, according to the
				  following time schedule; girls, once in Grade 6 and once in Grade 8; and boys,
				  once in Grades 8 or 9.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 281 - RULES AND REGULATIONS FOR SPINAL SCREENING › Section 144-281-2 - Manner in which schools conduct the screening

Current through 2024-29, July 17, 2024
A.
				Screening will be carried out by qualified screening personnel.
B. The procedure for screening shall be
				followed according to the most current standards of practice, as outlined in
				the booklet entitled Spinal Screening for Maine's Schools.
C. Spinal Screening may be conducted in
				conjunction with routine school physicals. However, all rules and regulations
				applying to spinal screening must be met.
D. Students will be screened in clothing that
				permits an unclothed clear view of the back, waist, and upper hip areas, and
				shoes must be removed.
E. It is
				recommended that a chaperone of the same sex as the student be in attendance
				during the spinal screening.
F.
				Neither schools nor their agents may charge for the screening.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 281 - RULES AND REGULATIONS FOR SPINAL SCREENING › Section 144-281-3 - Qualifications for screening personnel

Current through 2024-29, July 17, 2024
A. Spinal
				screening shall be conducted by qualified school personnel such as state
				certified school nurses, and physical education teachers, who have been
				selected by the school superintendent and who have completed a spinal screening
				training course endorsed by the Department of Human Services. In addition,
				other individuals may request certification to screen, from the Bureau of
				Health, Department of Human Services by virtue of their professional training
				or specific training in Spinal Screening.
B. A spinal screening certification is valid
				for four (4) years. Screening personnel must maintain a current spinal
				screening certificate to conduct screenings.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 281 - RULES AND REGULATIONS FOR SPINAL SCREENING › Section 144-281-4 - Method by which prior notice of screening or notice of defect/possible defect shall be sent to the parent or guardian of the child

Current through 2024-29, July 17, 2024
Written notification of screening shall be sent to the
				  parent/guardian of each child at least 1 week prior to screening. On the day of
				  the screening, all students will be screened unless they have returned a signed
				  statement to the contrary from the parent/guardian.
Following the screening, parents/guardians must receive
				  written notification of the screening results if signs of a spinal curvature
				  have been detected.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 281 - RULES AND REGULATIONS FOR SPINAL SCREENING › Section 144-281-5 - Notation of the screening and follow-up activity shall be kept in the child's school health records

Current through 2024-29, July 17, 2024
Screening results and referral outcome shall be kept in the
				  child's permanent school health record.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 283 - NEWBORN BLOODSPOT SCREENING RULE › Section 144-283-1 - PURPOSE

Current through 2024-29, July 17, 2024
A. This rule implements
				22 MRS §§
										1532,
				1533
				and 22-A MRS §210 which require the Department of Health and Human
				Services (Department) to (1) establish a bloodspot screening program for
				newborns to detect certain congenital genetic disorders which, if left
				untreated, can cause intellectual and developmental disability, serious illness
				or death, and (2) establish a statewide genetics program; and (3) authorize the
				Department to assess fees upon healthcare providers to cover the costs of
				bloodspot screening. This rule requires the responsible hospital, birthing
				center, physician, midwife, principal birthing attendant, or other healthcare
				provider to ensure NBS specimens are taken from each infant either born in the
				State of Maine or residing in Maine within three months of birth, unless the
				infant's parent(s) object on religious grounds.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 283 - NEWBORN BLOODSPOT SCREENING RULE › Section 144-283-2 - DEFINITIONS

Current through 2024-29, July 17, 2024
A. As used in this rule, unless the context
				indicates otherwise, the following terms have the following meanings:
1.
Birthing center
means any
				non-hospital health facility, institution, or place designed to accommodate
				mothers giving birth away from home at the culmination of normal, uncomplicated
				pregnancies.
2.
Child
				Development Services (CDS) system
means an Intermediate Educational Unit
				that provides both early intervention (birth through two years of age) and Free
				Appropriate Public Education (FAPE for ages three through five years of age)
				under the supervision of the Maine Department of Education.
3.
Core condition
means a
				disorder included in the Recommended Uniform Screening Panel (RUSP) for which
				Maine NBS specimens must be tested using established laboratory
				markers/analytes. See Appendix A.
4.
Designated courier
means a
				professional delivery service responsible for transporting newborn blood
				samples daily, Monday through Saturday, for a contracted laboratory.
5.
Designated screening
				laboratory
means the laboratory with which the Department contracts to
				analyze NBS specimens and report the NBS screening results to the
				Department.
6.
Department
means the Department of Health and Human Services Maine
				Center for Disease Control and Prevention.
7.
Healthcare provider
means a
				physician, advanced practice nurse, midwife or other licensed professional
				acting as primary healthcare provider for the infant.
8.
Principal birthing attendant
means any adult who acts as the primary attendant during a delivery that occurs
				at a site other than a hospital or birthing center.
9.
Residual filter paper specimen
means the portion of NBS specimen that remains after screening is
				complete.
10.
Secondary
				condition
means a disorder that can be detected in the differential
				diagnosis of a core condition. See Appendix A.
11.
Time-critical condition
means a disorder that may manifest with acute symptoms in the first days
				of life and require immediate treatment to reduce the risk of morbidity and
				mortality. See Appendix B.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 283 - NEWBORN BLOODSPOT SCREENING RULE › Section 144-283-4 - RESPONSIBILITY FOR NEWBORN BLOODSPOT SPECIMEN COLLECTION FROM INFANTS BORN IN MAINE BUT NOT IN A HOSPITAL OR BIRTHING CENTER

Current through 2024-29, July 17, 2024
A. If an
				infant is delivered outside a hospital or birthing center by a midwife or
				principal birthing attendant who is qualified to draw blood, that person must
				collect an NBS specimen by a heel stick in accordance with Section
				7, complete the filter paper form, and
				ship the specimen and form to the designated screening laboratory within 24
				hours after collection of the specimen.
B. The midwife or principal birthing
				attendant must record in the infant's record the fact that the NBS specimen was
				collected, including the date and time of collection, and that the filter paper
				form was completed and forwarded to the designated screening
				laboratory.
C. If the midwife or
				principal birthing attendant is not qualified to draw blood, he or she must:
1. Inform the parent(s) about the screening
				tests and the relevant State law;
2. Direct the parent(s) to see an individual
				qualified to draw blood and have the infant tested within 24-48 hours of
				life;
3. Contact the parent(s) by
				the third day of life to verify that the infant has been tested; and 4.Keep a
				written record of each of the actions required under this rule.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 283 - NEWBORN BLOODSPOT SCREENING RULE › Section 144-283-5 - RESPONSIBILITY FOR NEWBORN BLOODSPOT SPECIMEN COLLECTION FROM INFANTS NOT BORN IN MAINE

Current through 2024-29, July 17, 2024
A. If an infant is
				not born in the State of Maine but is, or subsequently becomes, a resident of
				Maine, the first primary healthcare provider in Maine who examines the infant
				in the first three months of life must verify whether the infant has been
				screened, and if no NBS testing has been done, the provider must collect and
				submit an NBS specimen for testing. The healthcare provider may rely upon the
				information in the infant's medical record to determine whether screening has
				been done.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 283 - NEWBORN BLOODSPOT SCREENING RULE › Section 144-283-6 - RESPONSIBILITY OF THOSE PROVIDING PEDIATRIC SERVICES

Current through 2024-29, July 17, 2024
A.
				The primary healthcare provider licensed to practice in Maine who examines an
				infant for the first time in the first three months of life and who is subject
				to this rule must determine whether the child has received an NBS test by
				checking the infant's medical records, asking the parent(s) or, if necessary,
				contacting the Department. If the healthcare provider determines that no
				screening has been performed, the provider must, within five working days of
				the initial examination, screen the infant by collecting a blood specimen as
				outlined in this rule.
B. Any
				physician or other healthcare provider subject to this rule who has identified
				a case of a child presenting with a genetic condition or metabolic disorder
				listed in this rule must notify the Department of such condition within five
				working days of the identification.