SENATE AMENDED
PRIOR PRINTER'S NOS. 1980, 2599, 2885, PRINTER'S NO. 4030
2958
No. 1625 Session of 1999
INTRODUCED BY SCHULER, PISTELLA, JAMES, GEORGE, TIGUE, STERN,
ORIE, COY, GODSHALL, NAILOR, SEYFERT, WOJNAROSKI,
E. Z. TAYLOR, HESS, S. MILLER, KENNEY, FRANKEL, ARMSTRONG,
CURRY, DeWEESE, COSTA, STURLA, SNYDER, TRELLO, HARHAI,
SATHER, SAYLOR, SHANER, WILT, ZIMMERMAN, DALEY, CALTAGIRONE,
YOUNGBLOOD, SANTONI, THOMAS, STEELMAN, BAKER, MUNDY,
YUDICHAK, GRUCELA AND RUBLEY, JUNE 9, 1999
SENATOR MOWERY, PUBLIC HEALTH AND WELFARE, IN SENATE, AS
AMENDED, OCTOBER 3, 2000
AN ACT
1 Providing for surveillance INFORMATION, research and services <--
2 relating to the prevention of birth defects, for powers and
3 duties of the Department of Health, for a Statewide registry,
4 for reporting requirements and for confidentiality of
5 information; and imposing penalties.
6 The General Assembly finds and declares as follows:
7 (1) Birth defects represent a significant public health
8 concern and too little is known about the causes and
9 occurrences of these problems.
10 (2) These conditions lead to severe mental anguish on
11 the part of parents and relatives and frequently lead to high
12 medical care costs.
13 (3) A system to obtain more information about these
14 conditions could result in the identification of causal
15 problems and lead to development of preventive measures to
1 decrease incidence in the future.
2 (4) Birth defects can be caused by adverse health
3 conditions during pregnancy or genetic mutations. Prevention
4 efforts are slowed by lack of information about the number
5 and causes of birth defects.
6 (5) Each year in this Commonwealth, 3 to 4% of the
7 140,000 live births have at least one birth defect. Many
8 birth defects are preventable.
9 (6) One in five infant deaths is due to birth defects,
10 making them the leading cause of infant mortality.
11 (7) Birth defects of the heart and circulatory system
12 are the most common, affecting roughly one in 115 newborns.
13 (8) Severe birth defects may require special lifelong
14 medical treatment. Because many conditions cannot be fully
15 corrected, birth defects are major cause of childhood and
16 adult disability.
17 (9) The average lifetime medical care costs for a child
18 with a major birth defect is $60,000 to $300,000.
19 (10) Therefore, it is the intent of the General Assembly
20 to establish and maintain a Birth Defects Surveillance and <--
21 Registry Program INFORMATION SYSTEM in the Commonwealth to <--
22 accomplish the following:
23 (i) To maintain an ongoing systematic collection,
24 analysis and interpretation of health data essential to
25 the planning, implementation and evaluation of public
26 health practice.
27 (ii) To provide information on the incidence,
28 prevalence and trends of birth defects, stillbirths and
29 miscarriages.
30 (iii) To provide information to determine whether
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1 environmental hazards are associated with birth defects,
2 stillbirths and miscarriages.
3 (iv) To develop prevention education and advocacy
4 strategies for reducing the incidence of birth defects
5 and to guide and assess the progress of these prevention
6 strategies.
7 (v) To provide a case registry AN INFORMATION SYSTEM <--
8 for analytic research to identify risk factors.
9 The General Assembly of the Commonwealth of Pennsylvania
10 hereby enacts as follows:
11 Section 1. Short title.
12 This act shall be known and may be cited as the Birth Defects
13 Surveillance INFORMATION SYSTEM Act. <--
14 Section 2. Definitions.
15 The following words and phrases when used in this act shall
16 have the meanings given to them in this section unless the
17 context clearly indicates otherwise:
18 "Birth defect." An anomaly, functional or structural, that
19 presents in infancy or later in life and that is caused by
20 events preceding birth, whether inherited or acquired.
21 "Department." The Department of Health of the Commonwealth.
22 "Secretary." The Secretary of Health of the Commonwealth.
23 Section 3. Birth defects surveillance INFORMATION system and <--
24 registry.
25 (a) General rule.--The secretary shall establish and
26 maintain a permanent system for the collection of information
27 necessary to accomplish the purposes of this act.
28 (b) Components of system.--The system shall operate
29 Statewide and shall include the following:
30 (1) Forms.
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1 (2) Registry ANONYMITY. <--
2 (3) Systematic review of medical records.
3 (4) Analysis.
4 (5) Monitoring and investigation of clusters.
5 (6) Reports.
6 (7) Evaluation of additional services.
7 (c) Reporting required.--The secretary shall require all
8 licensed health care facilities and health care providers to
9 report within 30 days of initial diagnosis all occurrences of
10 children suspected or diagnosed as having birth defects.
11 (d) Sources of reporting.--The information to be reported <--
12 shall be obtained from the following sources: vital records,
13 hospital records, existing data sources, special data sources
14 and clinical examinations.
15 (e) (D) Maternal and Child Health Advisory Council.-- <--
16 (1) The department shall utilize the services of the <--
17 Maternal and Child Health Advisory Council, which is hereby
18 established within the department, to advise on the
19 implementation of the birth defects surveillance system and
20 THE DEPARTMENT SHALL UTILIZE THE SERVICES OF THE MATERNAL AND <--
21 CHILD HEALTH ADVISORY COUNCIL TO ADVISE ON THE IMPLEMENTATION
22 OF THE BIRTH DEFECTS INFORMATION SYSTEM AND registry.
23 (2) The Governor shall make appointments to the council <--
24 from a list of 20 candidates, five of whom shall be
25 recommended by the President pro tempore of the Senate, five
26 of whom shall be recommended by the Minority Leader of the
27 Senate, five of whom shall be recommended by the Speaker of
28 the House of Representatives, and five of whom shall be
29 recommended by the Minority Leader of the House of
30 Representatives. The persons submitting the recommendations
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1 shall assure the inclusion of professionals from the
2 disciplines of maternal and child health, including at least
3 one pediatric physician, public health, epidemiology,
4 hospital administration and biostatistics.
5 Section 4. Reporting requirements.
6 (a) Births.--Any infant who is born to a resident of this
7 Commonwealth or who is born within the bounds of this
8 Commonwealth and who shows evidence of a birth defect either at
9 birth or at any time during the first year of life shall be
10 reported to the department.
11 (b) Stillbirths.--Any stillbirth occurring within the bounds
12 of this Commonwealth shall be reported to the department.
13 (c) Post mortem examinations.--The director of each clinical
14 laboratory shall report to the department the results of any
15 post mortem examination from an infant indicating the existence
16 of a birth defect not known to have been previously reported.
17 (d) Exception.--This section shall not apply if the parents
18 or guardian of the infant object to the reporting on religious <--
19 grounds.
20 Section 5. Confidentiality of information.
21 All information collected and analyzed under this act shall
22 be REMAIN ANONYMOUS AND confidential insofar as the identity of <--
23 the patient is concerned and shall be used solely for the
24 purpose provided for in this act. All Federal and State laws
25 relating to the privacy of information shall apply to the data
26 and information that is collected under this system.
27 Section 6. Access to information.
28 Access to the information collected and analyzed under this
29 act shall be limited to authorized program staff and to persons
30 with a valid scientific interest upon approval of the secretary.
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1 Such persons must be engaged in demographic, epidemiological or
2 other similar studies related to health and must agree in
3 writing to maintain confidentiality.
4 Section 7. Record of access.
5 The department shall maintain an accurate record of all
6 persons who are given access to the information in the system.
7 The record shall include: the name of the person authorizing
8 access; name, title, and organizational affiliation of persons
9 given access; dates of access; and the specific purpose for
10 which information is to be used.
11 Section 8. Research.
12 All research proposed to be conducted by persons other than
13 department staff using the information in the system shall be
14 reviewed and approved by the secretary in accordance with the
15 established national guidelines for the protection of human
16 subjects.
17 Section 9. Violation of confidentiality.
18 Any person who violates the confidentiality of information
19 under this act, discloses any information provided pursuant to
20 this act or who uses information provided under this act in a
21 manner other than as approved by the secretary shall:
22 (1) Be denied further access to any confidential
23 information maintained by the department.
24 (2) Be subject to a civil penalty of $5,000.
25 The penalty provided in this section shall not be construed as
26 restricting any remedy provided by law for the benefit of the
27 department or any individual.
28 Section 10. Grants and contracts.
29 In the administration of section 3, the secretary may make
30 grants to and enter into contracts with public and nonprofit
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1 private entities.
2 Section 11. Annual Report.
3 The department shall submit to the Governor and the General
4 Assembly an annual report relating to the registry under section
5 3. The report shall include the following:
6 (1) The department's findings and recommendations on the
7 administration and operation of the registry.
8 (2) Data relevant to the incidence of birth defects in
9 this Commonwealth in summary form, reported in accordance
10 with the confidentiality requirements under section 5.
11 Section 12. Effective date.
12 This act shall take effect July 1, 2000, or immediately,
13 whichever is later.
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