Amended in Assembly April 21, 2015

Amended in Assembly March 25, 2015

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 add Sections 125003 and 125004 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 delete instead prohibit the department from both testing a newborn child unless the parent or guardian is fully informed, as specified, and from storing, retaining, or using for medical research a blood sample collected unless the parent or guardian provides informed consent, as specified.end deletebegin insert provide that the program for testing the blood sample of a newborn child and the authority to store, retain, or use the sample for medical research would not apply to a parent or guardian of the newborn child who objects to the testing program. The bill would require the department to provide information about the testing program, and to obtain a form signed by the parent or guardian acknowledging receiving information regarding the storage, retention, and use of the newborn child’s blood sample for medical research.end insert The bill would authorize a parent or guardian of a minorbegin delete childend deletebegin insert child,end insert and the newborn child, once he or she is at least 18 years of age, to request that the department destroybegin delete orend deletebegin insert the blood sample,end insert not usebegin insert itend insert for research purposes, or both,begin delete the blood sample,end delete andbegin insert the bill would requireend insert the departmentbegin delete would be required to do soend deletebegin insert to comply with the requestend insert. The bill would also require the department to prepare and provide informational materialsbegin delete, to be distributed as specified,end delete regardingbegin insert the same information aboutend insert the newbornbegin delete childend deletebegin insert child’send insert blood sample collected pursuant to thebegin delete program that includes, but is not limited to,end deletebegin insert program,end insert information on storage, retention, and use of the blood samplebegin delete, end deletebegin insert for medical research, end insertand the right of specified persons to request that the blood sample be destroyed or not used for research purposesbegin delete, or both.end deletebegin insert in a separate, single-end insertbegin insertpage format.end insert The bill wouldbegin insert alsoend insert require the department to prepare and provide a standardbegin delete informed consentend deletebegin insert informational acceptanceend insert form,begin delete to be distributed as specified,end delete that includes, among other things,begin delete an explanation of the newborn child screening test and a space for the parent or legal guardian of the newborn child to indicate his or her consent to the storage, retention, and use of the blood sample for medical research.end deletebegin insert a brief, plain language explanation of, and the purpose for, the newborn child screening test and retention of newborn child blood samples. The bill would require the informational acceptance form to be provided to, and signed by, the parent or guardian when either version of the informational materials is provided. The bill would require specified persons to distribute the informational material and the informational acceptance form, including requiring the local registrar of births to provide a copy of the informational material and a copy of the standard informational acceptance form to each person registering the birth of a newborn that occurred outside of a perinatal licensed health facility, as specified. The bill would also require the local registrar to notify the local health officer and the department of each of these registrations by the local registrar. By imposing additional duties on local registrars of births, this bill would impose a state-mandated local program.end insert

begin insert

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

end insert
begin insert

This bill would provide that, if the Commission on State Mandates determines that the bill contains costs mandated by the state, reimbursement for those costs shall be made pursuant to these statutory provisions.

end insert

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: begin deleteno end deletebegin insertyesend insert.

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

P3    1

SECTION 1.  

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

3

125000.  

(a) (1) It is the policy of the State of California to
4make every effort to detect, as early as possible, phenylketonuria
5and other preventable heritable or congenital disorders leading to
6intellectual disability or physical defects.

7(2) The department shall establish a genetic disease unit, that
8shall coordinate all programs of the department in the area of
9genetic disease. The unit shall promote a statewide program of
10information, testing, and counseling services and shall have the
11responsibility of designating tests and regulations to be used in
12executing this program.

13(3) The information, tests, and counseling for children shall be
14in accordance with accepted medical practices and shall be
15administered to each child born in California. The department shall
16provide information about the tests and shall obtainbegin delete the informed
17consent ofend delete
begin insert a signed informational acknowledgment form for the
18receipt of information byend insert
the parent or guardian of a newborn child
19begin delete forend deletebegin insert regardingend insert the storage, retention, and use of the newborn child’s
20blood sample for medical research. The department shall establish
21appropriate regulations and testing methods. The information,
22tests, and counseling for pregnant women shall be in accordance
23with accepted medical practices and shall be offered to each
24pregnant woman in California once the department has established
25appropriate regulations and testing methods. These regulations
26shall follow the standards and principles specified in Section
27124980. The department may provide laboratory testing facilities
28or contract with any laboratory that it deems qualified to conduct
29tests required under this section. However, notwithstanding former
P4    1Section 125005, provision of laboratory testing facilities by the
2department shall be contingent upon the provision of funding
3therefor by specific appropriation to the Genetic Disease Testing
4Fund enacted by the Legislature. If moneys appropriated for
5purposes of this section are not authorized for expenditure to
6provide laboratory facilities, the department may nevertheless
7contract to provide laboratory testing services pursuant to this
8section and shall perform laboratory services, including, but not
9limited to, quality control, confirmatory, and emergency testing,
10necessary to ensure the objectives of this program.

11(b) The department shall charge a fee for any tests performed
12pursuant to this section. The amount of the fee shall be established
13and periodically adjusted by the director in order to meet the
14begin insert reasonableend insert costs of this section.

15(c) The department shall inform all hospitals or physicians and
16surgeons, or both, of required regulations and tests and may alter
17or withdraw any of these requirements whenever sound medical
18practice so indicates. To the extent practicable, the department
19shall provide notice to hospitals and other payers in advance of an
20increase in the fees charged for the program.

begin delete

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

27(2) A newborn child blood sample shall not be stored, retained,
28and used by the department for medical research unless the parent
29or guardian is fully informed of the benefits of research regarding
30preventing heritable and congenital disorders and provides
31informed consent to the storage, retention, and use of the newborn
32child blood sample collected.

end delete
begin insert

33(d) This section shall not apply to a parent or guardian of a
34newborn child who objects to a test.

end insert

35(e) The genetic disease unit is authorized to make grants or
36contracts or payments to vendors approved by the department for
37all of the following:

38(1) Testing and counseling services.

39(2) Demonstration projects to determine the desirability and
40feasibility of additional tests or new genetic services.

P5    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) begin insert(1)end insertbegin insertend insert 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.

begin delete

13 It

end delete

14begin insert(2)end insertbegin insertend insertbegin insertItend insert is the intent of the Legislature that funds for the support
15of the evaluations and recommendations required pursuant to this
16subdivision, and for the activities authorized pursuant to
17subdivision (e), shall be provided in the annual Budget Act
18appropriation from the Genetic Disease Testing Fund.

19(g) Health care providers that contract with a prepaid group
20practice health care service plan that annually has at least 20,000
21births among its membership, may provide, without contracting
22with the department, any or all of the testing and counseling
23services required to be provided under this section or the
24regulations adopted pursuant thereto, if the services meet the
25quality standards and adhere to the regulations established by the
26begin delete department andend deletebegin insert department,end insert the plan pays that portion of a fee
27established under this section that is directly attributable to the
28department’sbegin insert reasonableend insert cost of administering the testing or
29counseling service andbegin insert attributableend insert to any required testing or
30counseling services provided by the state for plan members. The
31payment by the plan, as provided in this subdivision, shall be
32deemed to fulfill any obligation the provider or the provider’s
33patient may have to the department to pay a fee in connection with
34the testing or counseling service.

35(h) The department may appoint experts in the area of genetic
36screening, including, but not limited to, cytogenetics, molecular
37biology, prenatal, specimen collection, and ultrasoundbegin insert,end insert to provide
38expert advice and opinion on the interpretation and enforcement
39of regulations adopted pursuant to this section. These experts shall
40be designated agents of the state with respect to their assignments.
P6    1These experts shallbegin insert notend insert receivebegin delete noend deletebegin insert aend insert salary, but shall be reimbursed
2for expenses associated with the purposes of this section. All
3expenses of the experts for the purposes of this section shall be
4paid from the Genetic Disease Testing Fund.

5(i) A parent or legal guardian of a minor may request the
6departmentbegin delete toend delete destroybegin insert the blood sample of the minor collected as
7a newborn,end insert
or not usebegin insert itend insert for research purposes, or both,begin delete the blood
8sample of the minor collected as a newborn,end delete
begin insert end insert and the department
9shallbegin delete do so.end deletebegin insert comply with that request.end insert

10(j) An individual who is at least 18 years of age may request
11the departmentbegin delete toend delete destroybegin insert his or her blood sample that was
12collected as a newborn,end insert
or not usebegin insert itend insert for research purposes, or both,
13begin deletehis or her blood sample that was collected,end delete and the department
14shallbegin delete do so.end deletebegin insert comply with that request.end insert

15

SEC. 2.  

Section 125003 is added to the Health and Safety Code,
16to read:

17

125003.  

(a) The department shall prepare and provide
18informational materials regarding newborn child blood samples
19collected pursuant to this article that include, but are not limited
20to, all of the following:

21(1) Storage, retention, and use of the blood sample.

22(2) The parent or legal guardian’s right to request that his or her
23minor child’s blood sample be destroyed or not used for research
24purposes, or both, and the information necessary to make that
25request.

26(3) The right of an individual who is at least 18 years of age to
27request that his or her blood sample be destroyed or not used for
28research purposes, or both, and the information necessary to make
29that request.

begin insert

30(b) These informational materials shall be confined to a single
31page and presented in a separate document from informational
32materials pertaining to the newborn screening program.

end insert
begin delete

33(b)

end delete

34begin insert(c)end insert The department shall provide to a parent or legal guardian
35the standardbegin delete informed consentend deletebegin insert informational acceptanceend insert form
36provided in Section 125004 regarding the options for newborn
37child screening and retention of newborn child blood samples
38collected pursuant to this article.

begin delete

39(c)

end delete

P7    1begin insert(d)end insert The informational materials and the standardbegin delete informed
2consentend delete
begin insert informational acceptanceend insert form prepared and provided by
3the department shall be distributed as follows:

4(1) Every birth attendant engaged in providing perinatal care
5shall provide a pregnant woman, prior to the estimated date of
6delivery, with a copy of the informational materials and a copy of
7the standardbegin delete informed consentend deletebegin insert informational acceptanceend insert form
8provided by the department.

9(2) Every perinatal licensed health facility shall provide each
10pregnant woman admitted for delivery with a copy of the
11informational materials and a copy of the standardbegin delete informed
12consentend delete
begin insert informational acceptanceend insert form provided by the department,
13prior to collection of the blood sample, if that information or
14standardbegin delete informed consentend deletebegin insert informational acceptanceend insert form has not
15been provided pursuant to paragraph (1).

16(3) The local registrar of births shall provide a copy of the
17informational material and a copy of the standardbegin delete informed consentend delete
18begin insert informational acceptanceend insert form provided by the department to each
19person registering the birth of a newborn that occurred outside of
20a perinatal licensed health facility when the newborn was not
21admitted to a perinatal licensed health facility within the first 30
22days of age. The local health officer and the department shall be
23notified of each of these registrations by the local registrar.

24(d) For the purposes of this section, the following terms shall
25have the following meanings:

26(1) “Birth attendant” means a person licensed or certified by
27the state to provide maternity care and to deliver pregnant women
28or to practice medicine.

29(2) “Perinatal licensed health facility” means a health facility
30licensed by the state and approved to provide perinatal, delivery,
31newborn intensive care, newborn nursery, or pediatric services.

32

SEC. 3.  

Section 125004 is added to the Health and Safety Code,
33to read:

34

125004.  

(a) The department shall prepare a standardbegin delete informed
35consentend delete
begin insert informational acceptanceend insert form that includes all of the
36following:

37(1) A brief, plain language explanation of, and the purpose for,
38the newborn child screening test and retention of newborn child
39blood samples collected pursuant to this article.

P8    1(2) A description of the benefits of both early newborn child
2screening and the associated research undertaken regarding
3preventable heritable or congenital disorders.

begin insert

4(3) A description of the California Biobank Program,
5specifically as it pertains to the Genetic Disease Screening
6Program, and subsequent storage, retention, and use of the
7newborn child’s blood sample for medical research.

end insert
begin delete

8(3)

end delete

9begin insert(4)end insert A space for the parent or legal guardian of the newborn child
10to acknowledge receipt of informational materials regarding the
11newborn child screening testbegin insert, and the storage, retention, and use
12of the newborn child’s blood sample for medical researchend insert
.

begin delete

13(4) A space for the parent or legal guardian of the newborn child
14to indicate his or her consent to the storage, retention, and use of
15the blood sample for medical research.

end delete
begin delete

16(5) A space for the parent or legal guardian of the newborn child
17to indicate his or her request for information about the right to
18refuse a newborn child screening test on the ground that the test
19conflicts with his or her religious beliefs or practices.

end delete
begin delete

20(6)

end delete

21begin insert(5)end insertbegin insert(a)end insertbegin insertend insert A space for the parent or legal guardian of the newborn
22child to sign and date the form.

begin delete

23(b) The department shall not store, retain, or use for medical
24research a newborn child’s blood sample collected and used for
25the newborn screening test unless the parent or guardian of the
26newborn child has first indicated his or her consent on the
27completed standard informed consent form.

end delete
begin delete

28(c)

end delete

29begin insert(b)end insert A copy of the standardbegin delete informed consentend deletebegin insert informational
30acceptanceend insert
form shall be maintained with the newborn child’s
31medical records.

begin delete

32(d)

end delete

33begin insert(c)end insert As used in this article,begin delete “informed consent”end deletebegin insert end insertbegin insert“informational
34acceptance form”end insert
means a writtenbegin delete authorizationend deletebegin insert acknowledgment
35of received informational materials,end insert
signed and dated by a parent
36or legal guardian of a newborn child.

37begin insert

begin insertSEC. 4.end insert  

end insert
begin insert

If the Commission on State Mandates determines that
38this act contains costs mandated by the state, reimbursement to
39local agencies and school districts for those costs shall be made
P9    1pursuant to Part 7 (commencing with Section 17500) of Division
24 of Title 2 of the Government Code.

end insert


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