Amended in Senate July 8, 2015

Amended in Assembly May 28, 2015

Amended in Assembly April 30, 2015

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, 125004, and 125005 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 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. The bill would authorize a parent or guardian of a minor child, and the newborn child, once he or she is at least 18 years of age, to request that the department destroy the blood sample, not use it for research purposes, or both, and the bill would require the department to comply with the request.begin insert The bill would require the department, if the individual making a request to destroy the blood sample or to not use it for research purposes provides his or her e-mail address, to send an e-mail to the individual acknowledging that the department received the request.end insert The bill would also require the department to prepare and provide informational materials regarding the same information about the newborn child’s blood sample collected pursuant to the program, information on storage, retention, and use of the blood sample for medical research, and the right of specified persons to request that the blood sample be destroyed or not used for research purposes in a separate, single-page format. The bill would also require the department to prepare and provide a standard informational acceptance form, that includes, among other things, 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.

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.

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.

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

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 obtain a signed
17informational acknowledgment form for the receipt of information
18by the parent or guardian of a newborn child regarding the storage,
19retention, and use of the newborn child’s blood sample for medical
20research. The department shall establish appropriate regulations
21and testing methods. The information, tests, and counseling for
22pregnant women shall be in accordance with accepted medical
23practices and shall be offered to each pregnant woman in California
24once the department has established appropriate regulations and
25testing methods. These regulations shall follow the standards and
26principles specified in Section 124980. The department may
27provide laboratory testing facilities or contract with any laboratory
28that it deems qualified to conduct tests required under this section.
29However, notwithstanding former Section 125005, provision of
30laboratory testing facilities by the department shall be contingent
31upon the provision of funding therefor by specific appropriation
32to the Genetic Disease Testing Fund enacted by the Legislature.
33If moneys appropriated for purposes of this section are not
34authorized for expenditure to provide laboratory facilities, the
35department may nevertheless contract to provide laboratory testing
P4    1services pursuant to this section and shall perform laboratory
2services, including, but not limited to, quality control, confirmatory,
3and emergency testing, necessary to ensure the objectives of this
4program.

5(b) The department shall charge a fee for any tests performed
6pursuant to this section. The amount of the fee shall be established
7and periodically adjusted by the director in order to meet the
8reasonable costs of this section.

9(c) The department shall inform all hospitals or physicians and
10surgeons, or both, of required regulations and tests and may alter
11or withdraw any of these requirements whenever sound medical
12practice so indicates. To the extent practicable, the department
13shall provide notice to hospitals and other payers in advance of an
14increase in the fees charged for the program.

15(d) This section shall not apply if a parent or guardian of a
16newborn child objects to a test on the ground that the test conflicts
17with his or her religious beliefs or practices.

18(e) The genetic disease unit is authorized to make grants or
19contracts or payments to vendors approved by the department for
20all of the following:

21(1) Testing and counseling services.

22(2) Demonstration projects to determine the desirability and
23feasibility of additional tests or new genetic services.

24(3) To initiate the development of genetic services in areas of
25need.

26(4) To purchase or provide genetic services from any sums as
27are appropriated for this purpose.

28(f) (1) The genetic disease unit shall evaluate and prepare
29recommendations on the implementation of tests for the detection
30of hereditary and congenital diseases, including, but not limited
31to, biotinidase deficiency and cystic fibrosis. The genetic disease
32unit shall also evaluate and prepare recommendations on the
33availability and effectiveness of preventative followup
34interventions, including the use of specialized medically necessary
35dietary products.

36(2) It is the intent of the Legislature that funds for the support
37of the evaluations and recommendations required pursuant to this
38subdivision, and for the activities authorized pursuant to
39subdivision (e), shall be provided in the annual Budget Act
40appropriation from the Genetic Disease Testing Fund.

P5    1(g) Health care providers that contract with a prepaid group
2practice health care service plan that annually has at least 20,000
3births among its membership, may provide, without contracting
4with the department, any or all of the testing and counseling
5services required to be provided under this section or the
6regulations adopted pursuant thereto, if the services meet the
7quality standards and adhere to the regulations established by the
8 department, the plan pays that portion of a fee established under
9this section that is directly attributable to the department’s
10reasonable cost of administering the testing or counseling service
11and attributable to any required testing or counseling services
12provided by the state for plan members. The payment by the plan,
13as provided in this subdivision, shall be deemed to fulfill any
14obligation the provider or the provider’s patient may have to the
15department to pay a fee in connection with the testing or counseling
16service.

17(h) The department may appoint experts in the area of genetic
18screening, including, but not limited to, cytogenetics, molecular
19biology, prenatal, specimen collection, and ultrasound, to provide
20expert advice and opinion on the interpretation and enforcement
21of regulations adopted pursuant to this section. These experts shall
22be designated agents of the state with respect to their assignments.
23These experts shall not receive a salary, but shall be reimbursed
24for expenses associated with the purposes of this section. All
25expenses of the experts for the purposes of this section shall be
26paid from the Genetic Disease Testing Fund.

27(i) A parent or legal guardian of a minor may request the
28departmentbegin insert toend insert destroy the blood sample of the minor collected as
29a newborn, or not use it for research purposes, or both, and the
30department shall comply with that request.begin insert If the parent or legal
31guardian making the request provides his or her e-mail address,
32the department shall send an e-mail acknowledging that the
33department received the request.end insert

34(j) An individual who is at least 18 years of age may request
35the departmentbegin insert toend insert destroy his or her blood sample that was collected
36as a newborn, or not use it for research purposes, or both, and the
37department shall comply with that request.begin insert If the individual making
38the request provides his or her e-mail address, the department
39shall send an e-mail acknowledging that the department received
40the request.end insert

P6    1

SEC. 2.  

Section 125003 is added to the Health and Safety Code,
2to read:

3

125003.  

(a) The department shall prepare and provide
4informational materials regarding newborn child blood samples
5collected pursuant to this article that include, but are not limited
6to, all of the following:

7(1) A brief, plain language explanation of, and the purpose for,
8the newborn child screening test and the storage, retention, and
9use of newborn child blood samples collected pursuant to this
10article.

11(2) A description of the benefits of both early newborn child
12screening and the associated research undertaken regarding
13preventable heritable or congenital disorders.

14(3) A description of the California Biobank Program, specifically
15as it pertains to the Genetic Disease Screening Program, and
16subsequent storage, retention, and use of the newborn child’s blood
17sample for medical research.

18(4) An explanation of the parent’s or legal guardian’s right to
19request that his or her minor child’s blood sample be destroyed or
20not used for research purposes, or both, and the information
21necessary to make that request.

22(5) A statement that an individual who is at least 18 years of
23age has the right to request that his or her blood sample be
24destroyed or not used for research purposes, or both, and the
25information necessary to make that request.

26(b) These informational materials shall be confined to a single
27page and presented in a separate document from the standard
28informational acceptance form required in Section 125004.

29

SEC. 3.  

Section 125004 is added to the Health and Safety Code,
30to read:

31

125004.  

(a) The department shall prepare a standard
32informational acceptance form that includes all of the following:

33(1) A brief, plain language explanation of, and the purpose for,
34the newborn child screening test and retention of newborn child
35blood samples collected pursuant to this article.

36(2) An explanation of the parent’s or legal guardian’s right to
37request that his or her minor child’s blood sample be destroyed or
38not used for research purposes, or both, and the information
39necessary to make that request.

P7    1(3) A space for the parent or legal guardian of the newborn child
2to acknowledge receipt of informational materials regarding the
3storage, retention, and use of the newborn child’s blood sample
4for medical research.

5(4) A space for the parent or legal guardian of the newborn child
6to sign and date the form.

7(b) The standard informational acceptance form shall be
8confined to a single page and presented in a separate document
9from the informational materials required in Section 125003.

10(c) A copy of the standard informational acceptance form shall
11be maintained in the medical record of the mother of the newborn
12child.

13(d) As used in this article, “informational acceptance form”
14means a written acknowledgment of received informational
15materials, signed and dated by a parent or legal guardian of a
16newborn child.

17(e) In the event that there is no signed standard informational
18acceptance form retained in the mother’s medical record, the
19newborn child shall be administered the genetic screening test and
20the newborn child blood sample shall be stored and retained for
21medical research pursuant to Section 125000.

22

SEC. 4.  

Section 125005 is added to the Health and Safety Code,
23to read:

24

125005.  

(a) The department shall provide a parent or legal
25guardian with the informational materials described in Section
26125003 and the standard informational acceptance form described
27in Section 125004 regarding the retention of newborn child blood
28samples collected pursuant to this article.

29(b) The informational materials and standard informational
30acceptance form described in Section 125004 shall be distributed
31as follows:

32(1) A birth attendant engaged in providing perinatal care shall
33provide a pregnant woman, prior to the estimated date of delivery,
34with a copy of the informational materials and a copy of the
35 standard informational acceptance form provided by the
36department.

37(2) If the informational materials or standard informational
38acceptance form has not been provided pursuant to paragraph (1),
39a perinatal licensed health facility shall provide each pregnant
40woman admitted for delivery with a copy of the informational
P8    1materials and a copy of the standard informational acceptance form
2provided by the department.

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

12(c) For the purposes of this section, the following terms shall
13have the following meanings:

14(1) “Birth attendant” means a person licensed or certified by
15the state to provide maternity care and to deliver pregnant women
16or to practice medicine.

17(2) “Perinatal licensed health facility” means a health facility
18licensed by the state and approved to provide perinatal, delivery,
19newborn intensive care, newborn nursery, or pediatric services.

20

SEC. 5.  

If the Commission on State Mandates determines that
21this act contains costs mandated by the state, reimbursement to
22local agencies and school districts for those costs shall be made
23pursuant to Part 7 (commencing with Section 17500) of Division
244 of Title 2 of the Government Code.



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