Amended in Assembly March 11, 2015

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 addbegin delete Sectionend deletebegin insert Sectionsend insert 125003begin insert and 125004end insert to, the Health and Safety Code, relating to newborn screening.

LEGISLATIVE COUNSEL’S DIGEST

AB 170, as amended, 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 wouldbegin insert instead prohibit the department from both testing a newborn child and storing, retaining, or using a blood sample collected unless the parent or guardian has given fully informed consentend insertbegin insert, as specified. The billend insert authorize a parent or guardian of a minor child and the newborn child, once he or she isbegin delete legally an adult,end deletebegin insert at least 18 years of age,end insert to request that the departmentbegin delete destroy,end deletebegin insert destroy orend insert 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 bebegin delete destroyed,end deletebegin insert destroyed orend insert not used for research purposes, or both.begin insert The bill would require the department to prepare and provide a standard informed consent form, to be distributed as specified, that sets forth clearly and in detail specified information.end insert

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 Californiabegin insert if the fully informed
16consent of the parent or guardian of a newborn child is obtained
17andend insert
once the department has established appropriate regulations
18and testing methods. The information, tests, and counseling for
19pregnant women shall be in accordance with accepted medical
20practices and shall be offered to each pregnant woman in California
21once the department has established appropriate regulations and
22testing methods. These regulations shall follow the standards and
23principles specified in Section 124980. The department may
24provide laboratory testing facilities or contract with any laboratory
25that it deems qualified to conduct tests required under this section.
26However, notwithstanding former Section 125005, provision of
27laboratory testing facilities by the department shall be contingent
28upon the provision of funding therefor by specific appropriation
P3    1to the Genetic Disease Testing Fund enacted by the Legislature.
2If moneys appropriated for purposes of this section are not
3authorized for expenditure to provide laboratory facilities, the
4department may nevertheless contract to provide laboratory testing
5services pursuant to this section and shall perform laboratory
6services, including, but not limited to, quality control, confirmatory,
7and emergency testing, necessary to ensure the objectives of this
8program.

9(b) The department shall charge a fee for any tests performed
10pursuant to this section. The amount of the fee shall be established
11and periodically adjusted by the director in order to meet the costs
12of this section.

13(c) The department shall inform all hospitals or physicians and
14surgeons, or both, of required regulations and tests and may alter
15or withdraw any of these requirements whenever sound medical
16practice so indicates. To the extent practicable, the department
17shall provide notice to hospitals and other payers in advance of an
18increase in the fees charged for the program.

begin delete

19(d) This section shall not apply if a parent or guardian of the
20newborn child objects to a test on the ground that the test conflicts
21with his or her religious beliefs or practices.

end delete
begin insert

22(d) (1) A test shall not be performed on any newborn child
23unless the parent or guardian is fully informed of the purpose and
24benefits of testing for preventable heritable and congenital
25disorders and is given a reasonable opportunity to refuse a
26newborn child screening test on the ground that the test conflicts
27with his or her religious beliefs or practices.

end insert
begin insert

28(2) A newborn child blood sample shall not be stored, retained,
29and used by the department unless the parent or guardian is fully
30informed of the benefits of research regarding preventing heritable
31and congenital disorders and is given a reasonable opportunity
32to object to the storage, retention, and use of the newborn child
33blood sample collected.

end insert

34(e) The genetic disease unit is authorized to make grants or
35contracts or payments to vendors approved by the department for
36all of the following:

37(1) Testing and counseling services.

38(2) Demonstration projects to determine the desirability and
39feasibility of additional tests or new genetic services.

P4    1(3) To initiate the development of genetic services in areas of
2need.

3(4) To purchase or provide genetic services from any sums as
4are appropriated for this purpose.

5(f) The genetic disease unit shall evaluate and prepare
6recommendations on the implementation of tests for the detection
7of hereditary and congenital diseases, including, but not limited
8to, biotinidase deficiency and cystic fibrosis. The genetic disease
9unit shall also evaluate and prepare recommendations on the
10availability and effectiveness of preventative followup
11interventions, including the use of specialized medically necessary
12dietary products.

13It is the intent of the Legislature that funds for the support of the
14evaluations and recommendations required pursuant to this
15subdivision, and for the activities authorized pursuant to
16subdivision (e), shall be provided in the annual Budget Act
17appropriation from the Genetic Disease Testing Fund.

18(g) Health care providers that contract with a prepaid group
19practice health care service plan that annually has at least 20,000
20births among its membership, may provide, without contracting
21with the department, any or all of the testing and counseling
22services required to be provided under this section or the
23regulations adopted pursuant thereto, if the services meet the
24quality standards and adhere to the regulations established by the
25department and the plan pays that portion of a fee established under
26this section that is directly attributable to the department’s cost of
27administering the testing or counseling service and to any required
28testing or counseling services provided by the state for plan
29members. The payment by the plan, as provided in this subdivision,
30shall be deemed to fulfill any obligation the provider or the
31provider’s patient may have to the department to pay a fee in
32connection with the testing or counseling service.

33(h) The department may appoint experts in the area of genetic
34screening, including, but not limited to, cytogenetics, molecular
35biology, prenatal, specimen collection, and ultrasound to provide
36expert advice and opinion on the interpretation and enforcement
37of regulations adopted pursuant to this section. These experts shall
38be designated agents of the state with respect to their assignments.
39These experts shall receive no salary, but shall be reimbursed for
40expenses associated with the purposes of this section. All expenses
P5    1of the experts for the purposes of this section shall be paid from
2the Genetic Disease Testing Fund.

3(i) A parent or legal guardian of a minor may request the
4department tobegin delete destroy,end deletebegin insert destroy orend insert not use for research purposes,
5or both, the blood sample of the minor collected as a newborn, and
6the department shall do so.

7(j) An individual who is at least 18 years of age may request
8the department tobegin delete destroy,end deletebegin insert destroy orend insert not use for research purposes,
9or both, his or her blood sample that was collected, and the
10department shall do so.

11

SEC. 2.  

Section 125003 is added to the Health and Safety Code,
12to read:

13

125003.  

(a) The department shall prepare and provide
14informational materials regarding newborn child blood samples
15collected pursuant to this article that include, but are not limited
16to, all of the following:

17(1) Storage, retention, and use of the blood sample.

18(2) The parent or legal guardian’s right to request that his or her
19minor child’s blood sample bebegin delete destroyed,end deletebegin insert destroyed orend insert not used
20for research purposes, or both, and the information necessary to
21make that request.

22(3) The right of an individual who is at least 18 years of age to
23request that his or her blood sample bebegin delete destroyed,end deletebegin insert destroyed orend insert
24 not used for research purposes, or both, and the information
25necessary to make that request.

begin insert

26(b) The department shall provide to a parent or legal guardian
27the standard informed consent form provided in Section 125004
28regarding the options for newborn child screening and retention
29of newborn child blood samples collected pursuant to this article.

end insert
begin delete

30(b)

end delete

31begin insert(end insertbegin insertc)end insert The informational materialsbegin insert and the standard informed
32consent formend insert
prepared and provided by the department shall be
33distributed as follows:

34(1) Every birth attendant engaged in providing perinatal care
35shall provide a pregnant woman, prior to the estimated date of
36delivery, with a copy of the informational materialsbegin insert and a copy of
37the standard informed consent formend insert
provided by the department.

38(2) Every perinatal licensed health facility shall provide each
39pregnant woman admitted for delivery with a copy of the
40informational materialsbegin insert and a copy of the standard informed
P6    1consent formend insert
provided by the department, prior to collection of
2the blood sample, if that informationbegin insert or standard informed consent
3formend insert
has not been provided pursuant to paragraph (1).

4(3) The local registrar of births shall provide a copy of the
5informational materialbegin insert and a copy of the standard informed consent
6formend insert
provided by the department to each person registering the
7birth of a newborn that occurred outside of a perinatal licensed
8health facility when the newborn was not admitted to a perinatal
9licensed health facility within the first 30 days of age. The local
10health officer and the department shall be notified of each of these
11registrations by the local registrar.

begin delete

12(c)

end delete

13begin insert(end insertbegin insertd)end insert For the purposes of this section, the following terms shall
14have the following meanings:

15(1) “Birth attendant” means a person licensed or certified by
16the state to provide maternity care and to deliver pregnant women
17or to practice medicine.

18(2) “Perinatal licensed health facility” means a health facility
19licensed by the state and approved to provide perinatal, delivery,
20newborn intensive care, newborn nursery, or pediatric services.

21begin insert

begin insertSEC. 3.end insert  

end insert

begin insertSection 125004 is added to the end insertbegin insertHealth and Safety Codeend insertbegin insert,
22to read:end insert

begin insert
23

begin insert125004.end insert  

(a) The department shall prepare a standard informed
24consent form setting forth clearly and in detail all of the following:

25(1) A brief, plain language explanation of, and the purpose for,
26the newborn child screening test and retention of newborn child
27blood samples collected pursuant to this article.

28(2) A description of the benefits of both early newborn child
29screening and the associated research undertaken regarding
30preventable heritable or congenital disorders.

31(3) That the parent or legal guardian of the newborn child may
32consent to the newborn child screening test.

33(4) That the parent or legal guardian of the newborn child has
34the right to refuse a newborn child screening test on the ground
35that the test conflicts with his or her religious beliefs or practices.

36(5) That if the parent or legal guardian of the newborn child
37refuses to have the newborn child screening test done, he or she
38accepts all responsibility and liability for the possible
39consequences.

P7    1(6) A description of the health risks associated with foregoing
2the newborn child screening test.

3(7) That the parent or legal guardian of the newborn child may
4consent to the storage, retention, and use of the blood sample.

5(8) That the parent or legal guardian of the newborn child may
6request the department to destroy or not use for research purposes,
7or both, the blood sample collected and screened.

8(b) A copy of the standard informed consent form shall be
9maintained with the newborn child’s medical records.

end insert


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