In this subtitle the following words have the meanings indicated.
“Advisory Council” means the State Advisory Council on Hereditary and Congenital Disorders.
“Commission” means the State Commission on Hereditary and Congenital Disorders.
“Congenital disorder” means a significant structural or functional abnormality of the body that is present at birth.
“Congenital disorder” does not include a condition that results from:
An intrauterine infection; or
A birth injury.
“Hereditary disorder” means any disorder that:
Is transmitted through the genetic material deoxyribonucleic acid (DNA); or
Arises through the improper processing of the information in the genetic material.
The General Assembly finds that:
Everyone in this State is entitled to the highest level of health care attainable and protection from inadequate health services;
Hereditary and congenital disorders are often costly and tragic and sometimes deadly burdens to the health and well-being of the citizens of this State;
Detection through screening for hereditary and congenital disorders can:
Lead to alleviation of the disability of some hereditary and congenital disorders; and
Further the understanding of and accumulation of medical knowledge about other hereditary and congenital disorders that may lead to their eventual alleviation or cure;
Hereditary and congenital disorders differ in severity, in that:
Some have little effect on the normal functioning of an individual; and
Some may be alleviated, wholly or partly, through medical intervention and treatment;
Most, if not all, individuals are carriers of some hereditary disorder and are substantially unaffected by that fact;
A carrier of a hereditary disorder should not be discriminated against or stigmatized;
Medical knowledge of the discovery, diagnosis, treatment, and cure of hereditary and congenital disorders is expanding rapidly and often at an uneven rate, so that hereditary and congenital disorders are discovered long before their treatment or cure can be found;
Legislation designed to alleviate the problems associated with specific hereditary and congenital disorders may tend to be inflexible in the face of rapidly expanding medical knowledge;
The policy of this State on hereditary and congenital disorders should be:
Made with full public knowledge, in light of expert opinion; and
Reviewed constantly to consider changing medical knowledge and ensure full public protection;
Participation in a hereditary and congenital disorders program should be wholly voluntary, and all information obtained about any individual in a hereditary and congenital disorders program should be kept confidential; and
A commission is needed:
To ensure that the policies and programs of this State for hereditary and congenital disorders comply with the principles established in this subtitle; and
To preserve and protect the freedom, health, and well-being of the citizens of this State from improper treatment or advice, discrimination, violation of privacy, or undue anxiety that results from any hereditary and congenital disorders program.
There is a State Advisory Council on Hereditary and Congenital Disorders.
The Advisory Council consists of 11 voting members and 4 nonvoting members.
Of the 11 voting members:
1 shall be a member of the Senate appointed by the President of the Senate;
1 shall be a member of the House of Delegates appointed by the Speaker of the House;
4 shall be professional individuals in the field of hereditary or congenital disorders appointed by the Secretary; and
5 shall be individuals appointed by the Secretary, none of whom may be:
A health professional or spouse of a health professional; or
An individual or spouse of an individual involved in the administration or ownership of any health care institution or health insurance organization.
Except as provided in subparagraph (iv) of this paragraph, the Secretary shall appoint 1 professional member from a list of qualified individuals submitted to the Secretary by each of the following organizations:
Children’s National Health System;
The Medical and Chirurgical Faculty of the State of Maryland;
The faculty of the University of Maryland School of Medicine; and
The faculties of the Johns Hopkins Medical Institutions.
The number of names on a list shall be 3.
An organization shall submit its list:
At least 3 months before the expiration of the term of the professional member who represents the organization; and
If a vacancy is for a reason other than expiration of the term, at any time before the Secretary makes the appointment, if the organization complies with the reasonable request of the Secretary for the list.
If a list is not submitted to the Secretary as required under subparagraph (iii) of this paragraph, within 3 months after a request is made by the Secretary, the Secretary may appoint any professional individual who meets the requirements under subsection (b) of this section.
The 4 nonvoting members shall be representatives of the Department, appointed by the Secretary.
Each professional individual selected for the Advisory Council shall be knowledgeable in the diagnosis and treatment of hereditary and congenital disorders.
The term of a voting member is 4 years.
The terms of the voting members are staggered as required by the terms provided for voting members of the Advisory Council on July 1, 1982. The terms of those members end as follows:
3 in 1983;
3 in 1984;
3 in 1985; and
2 in 1986.
At the end of a term, a voting member continues to serve until a successor is appointed and qualifies.
A voting member who is appointed after a term has begun serves only for the rest of the term and until a successor is appointed and qualifies.
A voting member who serves 2 consecutive full 4–year terms may not be reappointed for 4 years after completion of those terms.
When a vacancy occurs, a successor shall be appointed promptly.
From among its voting members, the Advisory Council shall elect every 2 years a chairman and a vice chairman.
A majority of the full authorized voting membership of the Advisory Council is a quorum to do business.
The Advisory Council shall meet at least twice a year, at the times and places that it determines.
A member of the Advisory Council:
May not receive compensation; but
Is entitled to reimbursement for expenses under the Standard State Travel Regulations, as provided in the State budget.
The Secretary shall designate the staff necessary to carry out this subtitle.
The Advisory Council may establish subcommittees.
To preserve and protect the health and welfare of the citizens of this State, the Advisory Council may:
Gather and give out information to further the public’s understanding of hereditary and congenital disorders;
Reevaluate continually the need for and the effectiveness of State hereditary and congenital disorders programs;
Make any necessary recommendation to end any unjustified discrimination that might result from identification of an individual as a carrier of a hereditary disorder, but this item does not affect any right of anyone to seek or have any other redress for this discrimination;
Advise the Secretary as to the need for rules, regulations, and standards for the detection and management of hereditary and congenital disorders;
Participate actively in the development of the rules and regulations adopted by the Department; and
Assist the Department in prioritizing its efforts.
Subject to the requirements of this section, the Department may adopt rules, regulations, and standards for the detection and management of hereditary and congenital disorders.
Before the Department adopts a rule, regulation, or standard, the Department shall consult:
The public, especially communities and groups who particularly are affected by hereditary and congenital disorders programs;
Where appropriate, experts in the medical, psychological, ethical, social, and economic effects of programs for the detection and management of hereditary and congenital disorders; and
The Advisory Council.
Before the Department adopts a rule, regulation, or standard, the Department shall consider:
The incidence of each hereditary or congenital disorder; and
The cost of detection and management of each hereditary or congenital disorder.
The rules, regulations, and standards of the Department shall require the Department and each person who conducts a hereditary and congenital disorders program to keep in code and treat as a confidential medical record all information that is gathered in the program and identifies an individual. However, this requirement does not prevent the disclosure of information if the individual or, if the individual is a minor or disabled person, a parent or guardian of the person:
Is informed of the scope of information to be released and the purpose of the release; and
Consents to the release.
The rules, regulations, and standards of the Department shall provide that, subject to the restrictions on disclosure of confidential information, information on the operation of a hereditary and congenital disorders program shall be open and freely available to the public.
The rules, regulations, and standards of the Department shall provide that procedures for a hereditary and congenital disorders program shall:
Be accurate;
Provide maximum information;
Be set forth clearly; and
Be reviewed regularly.
The rules, regulations, and standards of the Department shall:
Require that, before an individual participates in a hereditary and congenital disorders program, the person who conducts the program shall inform the individual or, if the individual is a minor or disabled person, a parent or guardian of the person of the requirement that participation in the program be wholly voluntary and of any risk that is involved in participation;
Prohibit the testing of an individual for a hereditary or congenital disorder unless the individual or, if the individual is a minor or disabled person, a parent or guardian of the person:
Is informed fully of the purpose of the test and the nature and consequences of being affected by a hereditary or congenital disorder or being a carrier of a hereditary disorder;
Is given a reasonable opportunity to object; and
Does not object to the test; and
Require unambiguous diagnostic results to be made available through a physician or other source of health care to the individual or, if the individual is a minor or disabled person, to a parent or guardian of the person.
The rules, regulations, and standards of the Department shall provide that a hereditary and congenital disorders program may not:
Require participation in the program;
Require restriction of childbearing; or
Be prerequisite for eligibility for any service or other program.
The rules, regulations, and standards of the Department shall provide that:
Each participant in a hereditary and congenital disorders program shall be:
Protected from undue physical or mental harm; and
Informed of the nature, cost, benefits, and risks of any therapy or maintenance program available for an individual affected by a hereditary or congenital disorder; and
Each participant in a screening program for a hereditary or congenital disorder shall have available counseling services that:
Are nondirective;
Emphasize informing the individual; and
Do not require restriction of childbearing.
Only the Department may adopt rules, regulations, and standards under this subtitle.
The Secretary:
Is responsible for the operation of hereditary and congenital disorders programs within the rules, regulations, and standards that the Department adopts;
Shall disburse and collect any funds available to the Department;
Shall enforce the rules, regulations, and standards that the Department adopts; and
Shall keep the Advisory Council informed of:
The progress of hereditary and congenital disorders programs; and
Any need for a change in the Department’s rules, regulations, and standards.
The Department shall establish a coordinated statewide system for screening all newborn infants in the State for certain hereditary and congenital disorders associated with severe problems of health or development, except when the parent or guardian of the newborn infant objects.
Except as provided in § 13–112 of this subtitle, the Department’s public health laboratory is the sole laboratory authorized to perform tests on specimens from newborn infants collected to screen for hereditary and congenital disorders as determined under subsection (d)(2) of this section.
The system for newborn screening shall include:
Laboratory testing and the reporting of test results; and
Follow–up activities to facilitate the rapid identification and treatment of an affected child.
In consultation with the State Advisory Council on Hereditary and Congenital Disorders, the Department shall:
Establish protocols for a health care provider to obtain and deliver test specimens to the Department’s public health laboratory;
Determine the screening tests that the Department’s public health laboratory is required to perform;
Maintain a coordinated statewide system for newborn screening that carries out the purpose described in subsection (c) of this section that includes:
Communicating the results of screening tests to the health care provider of the newborn infant;
Locating newborn infants with abnormal test results;
Sharing newborn screening information between hospitals, health care providers, treatment centers, and laboratory personnel;
Delivering needed clinical, diagnostic, and treatment information to health care providers, parents, and caregivers; and
Notifying parents and guardians of newborn infants that laboratories other than the Department’s public health laboratory are authorized to perform postscreening confirmatory or diagnostic tests on newborn infants for hereditary and congenital disorders; and
Adopt regulations that set forth the standards and requirements for newborn screening for hereditary and congenital disorders that are required under this subtitle, including:
Performing newborn screening tests;
Coordinating the reporting, follow–up, and treatment activities with parents, caregivers, and health care providers; and
Establishing fees for newborn screening that do not exceed an amount sufficient to cover the administrative, laboratory, and follow–up costs associated with the performance of screening tests under this subtitle.
The Department shall screen for each core condition listed in the U.S. Department of Health and Human Services’ Recommended Uniform Screening Panel.
Subject to subparagraph (iii) of this paragraph, the Department shall implement testing for a core condition within 1 year and 6 months after the core condition is added to the Recommended Uniform Screening Panel.
If the Department is unable to implement testing within 1 year and 6 months after a core condition is added to the Recommended Uniform Screening Panel due to a delay in the procurement of equipment or supplies needed to implement the testing, the Department shall report to the Senate Finance Committee and the House Health and Government Operations Committee, in accordance with § 2–1257 of the State Government Article, within 1 year and 3 months after the addition of the core condition to the Recommended Uniform Screening Panel and every 3 months thereafter until the testing for the core condition is implemented.
A report required under subsubparagraph 1 of this subparagraph shall include the reason for the delay and the anticipated timeline for implementation.
Notwithstanding any other provision of law, if the Secretary of Health and Human Services issues federal recommendations on critical congenital heart disease screening of newborns, the Department shall adopt the federal screening recommendations.
The Department may screen for any condition recommended by the Advisory Council and approved by the Secretary.
The Secretary shall pay all fees collected under the provisions of this subtitle to the Comptroller.
The Comptroller shall distribute the fees to the Newborn Screening Program Fund established under § 13–113 of this subtitle.
The Secretary may contract or delegate the screening required under § 13–111 of this subtitle to another entity with the approval of the State Advisory Council on Hereditary and Congenital Disorders.
Subject to subsection (c) of this section, a laboratory other than the Department’s public health laboratory may perform postscreening confirmatory or diagnostic tests on newborn infants for hereditary and congenital disorders.
Before offering or performing a postscreening test on a newborn infant for hereditary and congenital disorders under subsection (b) of this section, a laboratory shall:
Obtain and maintain a license issued by the Secretary as required by Title 17 of this article; and
Meet all the standards and requirements for a laboratory to perform tests on newborn infants for hereditary and congenital disorders that are established by the Secretary.
In this section, “Fund” means the Newborn Screening Program Fund.
There is a Newborn Screening Program Fund.
The purpose of the Fund is to provide funding for the screening of newborn infants in the State for certain hereditary and congenital disorders.
The Secretary shall administer the Fund.
The Fund is a special, nonlapsing fund that is not subject to § 7–302 of the State Finance and Procurement Article.
The State Treasurer shall hold the Fund separately, and the Comptroller shall account for the Fund.
The Fund consists of:
Revenue distributed to the Fund under § 13–111(f) of this subtitle;
Money appropriated in the State budget to the Fund;
Interest earnings of the Fund; and
Any other money from any other source accepted for the benefit of the Fund.
The Fund may be used only to cover the administrative, laboratory, and follow–up costs associated with the performance of newborn screening tests conducted under this subtitle.
The State Treasurer shall invest the money of the Fund in the same manner as other State money may be invested.
Any interest earnings of the Fund shall be credited to the Fund.
Expenditures from the Fund may be made only in accordance with the State budget.
The accounts and transactions of the Fund shall be subject to audit by the legislative auditor as provided in § 2–1220 of the State Government Article.