California Legislature—2015–16 Regular Session

Assembly BillNo. 170


Introduced by Assembly Member Gatto

January 22, 2015


An act to amend Section 125000 of, and to add Section 125003 to, the Health and Safety Code, relating to newborn screening.

LEGISLATIVE COUNSEL’S DIGEST

AB 170, as introduced, Gatto. Newborn screening: genetic diseases: blood samples collected.

Existing law requires the State Department of Public Health to establish a program for the development, provision, and evaluation of genetic disease testing, and the program is required to provide genetic screening and followup services for persons who have the screening. The program includes statewide screening of newborn children through the collection of blood samples, unless the parent or guardian objects on the grounds of religious beliefs or practices.

This bill would authorize a parent or guardian of a minor child and the newborn child, once he or she is legally an adult, to request that the department destroy, not use for research purposes, or both, the blood sample, and the department would be required to do so. The bill would also require the department to prepare and provide informational materials, to be distributed as specified, regarding the newborn child blood sample collected pursuant to the program that includes, but is not limited to, information on storage, retention, and use of the blood sample, and the right of specified persons to request that the blood sample be destroyed, not used for research purposes, or both.

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

The people of the State of California do enact as follows:

P2    1

SECTION 1.  

Section 125000 of the Health and Safety Code
2 is amended to read:

3

125000.  

(a) It is the policy of the State of California to make
4every effort to detect, as early as possible, phenylketonuria and
5other preventable heritable or congenital disorders leading to
6intellectual disability or physical defects.

7The department shall establish a genetic disease unit, that shall
8coordinate all programs of the department in the area of genetic
9disease. The unit shall promote a statewide program of information,
10testing, and counseling services and shall have the responsibility
11of designating tests and regulations to be used in executing this
12program.

13The information, tests, and counseling for children shall be in
14accordance with accepted medical practices and shall be
15administered to each child born in California once the department
16has established appropriate regulations and testing methods. The
17information, tests, and counseling for pregnant women shall be in
18accordance with accepted medical practices and shall be offered
19to each pregnant woman in California once the department has
20established appropriate regulations and testing methods. These
21regulations shall follow the standards and principles specified in
22Section 124980. The department may provide laboratory testing
23facilities or contract with any laboratory that it deems qualified to
24conduct tests required under this section. However, notwithstanding
25former Section 125005, provision of laboratory testing facilities
26by the department shall be contingent upon the provision of funding
27therefor by specific appropriation to the Genetic Disease Testing
28Fund enacted by the Legislature. If moneys appropriated for
29purposes of this section are not authorized for expenditure to
30provide laboratory facilities, the department may nevertheless
31contract to provide laboratory testing services pursuant to this
32section and shall perform laboratory services, including, but not
33limited to, quality control, confirmatory, and emergency testing,
34necessary to ensure the objectives of this program.

35(b) The department shall charge a fee for any tests performed
36pursuant to this section. The amount of the fee shall be established
37and periodically adjusted by the director in order to meet the costs
38of this section.

P3    1(c) The department shall inform all hospitals or physicians and
2surgeons, or both, of required regulations and tests and may alter
3or withdraw any of these requirements whenever sound medical
4practice so indicates. To the extent practicable, the department
5shall provide notice to hospitals and other payers in advance of an
6increase in the fees charged for the program.

7(d) This section shall not apply if a parent or guardian of the
8newborn child objects to a test on the ground that the test conflicts
9with his or her religious beliefs or practices.

10(e) The genetic disease unit is authorized to make grants or
11contracts or payments to vendors approved by the department for
12all of the following:

13(1) Testing and counseling services.

14(2) Demonstration projects to determine the desirability and
15feasibility of additional tests or new genetic services.

16(3) To initiate the development of genetic services in areas of
17need.

18(4) To purchase or provide genetic services from any sums as
19are appropriated for this purpose.

20(f) The genetic disease unit shall evaluate and prepare
21recommendations on the implementation of tests for the detection
22of hereditary and congenital diseases, including, but not limited
23to, biotinidase deficiency and cystic fibrosis. The genetic disease
24unit shall also evaluate and prepare recommendations on the
25availability and effectiveness of preventative followup
26interventions, including the use of specialized medically necessary
27dietary products.

28It is the intent of the Legislature that funds for the support of the
29evaluations and recommendations required pursuant to this
30subdivision, and for the activities authorized pursuant to
31subdivision (e), shall be provided in the annual Budget Act
32appropriation from the Genetic Disease Testing Fund.

33(g) Health care providers that contract with a prepaid group
34practice health care service plan that annually has at least 20,000
35births among its membership, may provide, without contracting
36with the department, any or all of the testing and counseling
37services required to be provided under this section or the
38regulations adopted pursuant thereto, if the services meet the
39quality standards and adhere to the regulations established by the
40department and the plan pays that portion of a fee established under
P4    1this section that is directly attributable to the department’s cost of
2administering the testing or counseling service and to any required
3testing or counseling services provided by the state for plan
4members. The payment by the plan, as provided in this subdivision,
5shall be deemed to fulfill any obligation the provider or the
6provider’s patient may have to the department to pay a fee in
7connection with the testing or counseling service.

8(h) The department may appoint experts in the area of genetic
9screening, including, but not limited to, cytogenetics, molecular
10biology, prenatal, specimen collection, and ultrasound to provide
11expert advice and opinion on the interpretation and enforcement
12of regulations adopted pursuant to this section. These experts shall
13be designated agents of the state with respect to their assignments.
14These experts shall receive no salary, but shall be reimbursed for
15expenses associated with the purposes of this section. All expenses
16of the experts for the purposes of this section shall be paid from
17the Genetic Disease Testing Fund.

begin insert

18(i) A parent or legal guardian of a minor may request the
19department to destroy, not use for research purposes, or both, the
20blood sample of the minor collected as a newborn, and the
21department shall do so.

end insert
begin insert

22(j) An individual who is at least 18 years of age may request
23the department to destroy, not use for research purposes, or both,
24his or her blood sample that was collected, and the department
25shall do so.

end insert
26

SEC. 2.  

Section 125003 is added to the Health and Safety Code,
27to read:

28

125003.  

(a) The department shall prepare and provide
29informational materials regarding newborn child blood samples
30collected pursuant to this article that include, but are not limited
31to, all of the following:

32(1) Storage, retention, and use of the blood sample.

33(2) The parent or legal guardian’s right to request that his or her
34minor child’s blood sample be destroyed, not used for research
35purposes, or both, and the information necessary to make that
36request.

37(3) The right of an individual who is at least 18 years of age to
38request that his or her blood sample be destroyed, not used for
39research purposes, or both, and the information necessary to make
40that request.

P5    1(b) The informational materials prepared and provided by the
2department shall be distributed as follows:

3(1) Every birth attendant engaged in providing perinatal care
4shall provide a pregnant woman, prior to the estimated date of
5delivery, with a copy of the informational materials provided by
6the department.

7(2) Every perinatal licensed health facility shall provide each
8pregnant woman admitted for delivery with a copy of the
9informational materials provided by the department, prior to
10collection of the blood sample, if that information has not been
11provided pursuant to paragraph (1).

12(3) The local registrar of births shall provide a copy of the
13informational material provided by the department to each person
14 registering the birth of a newborn that occurred outside of a
15perinatal licensed health facility when the newborn was not
16admitted to a perinatal licensed health facility within the first 30
17days of age. The local health officer and the department shall be
18notified of each of these registrations by the local registrar.

19(c) For the purposes of this section, the following terms shall
20have the following meanings:

21(1) “Birth attendant” means a person licensed or certified by
22the state to provide maternity care and to deliver pregnant women
23or to practice medicine.

24(2) “Perinatal licensed health facility” means a health facility
25licensed by the state and approved to provide perinatal, delivery,
26newborn intensive care, newborn nursery, or pediatric services.



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