Cal. Code Regs. Tit. 17, § 6505 - Collection of Newborn Screening Specimens

(a) For each newborn born in a perinatal licensed health facility, the perinatal licensed health facility staff shall:

(1) Collect the newborn screening specimen, using the Instructions for Collecting Adequate Blood Specimens on the CALIFORNIA NEWBORN SCREENING TEST REQUEST FORM (NBS-TRF) (CDPH-4409) pursuant to § 6501.5(a) and § 6504.4(b). This specimen collection shall occur after 12 hours but no later than 48 hours of age prior to discharge or transfer of the newborn unless the newborn's condition is life-threatening and the collection cannot be done safely. Physicians attending critically ill newborns who require special care may postpone collection of a newborn screening specimen until the newborn's emergency condition is stabilized. The receiving perinatal licensed health facility staff shall then collect the newborn screening specimen using the Instructions for Collecting Adequate Blood Specimens on the CALIFORNIA NEWBORN SCREENING TEST REQUEST FORM (NBS-TRF) (CDPH-4409) pursuant to § 6501.5(a) and § 6504.4(b) as soon as the newborn's condition is stabilized. Any specimen collected on a newborn prior to 12 hours of age is an early specimen and another specimen shall be collected after 12 hours of age pursuant to § 6505(a)(2) and § 6506.6.

(2) Collect a newborn screening specimen prior to red blood cell transfusion when the newborn is stable, even if the newborn is under 12 hours of age, using the Instructions for Collecting Adequate Blood Specimens on the CALIFORNIA NEWBORN SCREENING TEST REQUEST FORM (NBS-TRF) (CDPH-4409) pursuant to § 6501.5(a) and § 6504.4(b).

(3) Ensure that specimens are given, on the same-day or next business day of the designated carrier, to a carrier contracted with the Department or contracted with a newborn screening laboratory or to another sameday or overnight delivery service for transport to the assigned newborn screening laboratory.

(4) Not collect a newborn screening specimen under this section if the parent or legal guardian has executed a refusal of the newborn screening test on the CALIFORNIA NEWBORN SCREENING TEST REQUEST FORM (NBS-TRF) (CDPH-4409) pursuant to § 6501.2.

(b) For infants not born in a perinatal licensed health facility, but admitted to a perinatal licensed health facility at any time after birth, the perinatal licensed facility staff shall:

(1) Obtain a newborn screening specimen within 48 hours of admission, using the Instructions for Collecting Adequate Blood Specimens on the CALIFORNIA NEWBORN SCREENING TEST REQUEST FORM (NBS-TRF) (CDPH-4409) pursuant to § 6501.5(a) and § 6504.4(b), unless a religious refusal pursuant to § 6501.2 is executed, or a newborn screening result is found in the infant's medical record, or the physician has a record that the screening specimen has been collected.

(2) Collect a newborn screening specimen prior to red blood cell transfusion, even if the newborn is under 12 hours of age, using the Instructions for Collecting Adequate Blood Specimens on the CALIFORNIA NEWBORN SCREENING TEST REQUEST FORM (NBS-TRF) (CDPH-4409) pursuant to § 6501.5(a) and § 6504.4(b).

(3) Ensure that specimens are given, on the same or next business day of the designated carrier, to a carrier contracted with the Department or contracted with a newborn screening laboratory or to another same-day or overnight delivery service for transport to the assigned newborn screening laboratory.

(c) For infants not born in a perinatal licensed health facility and not admitted to a perinatal licensed health facility after birth, out-of-hospital newborn screening providers shall:

(1) Collect a newborn screening specimen between 12 and 48 hours of birth using the Instructions for Collecting Adequate Blood Specimens on the CALIFORNIA NEWBORN SCREENING TEST REQUEST FORM (NBS-TRF) (CDPH-4409) pursuant to § 6501.5(a) and § 6504.4(b) unless a religious refusal pursuant to § 6501.2 is executed, or a newborn screening result is found in the infant's medical record.

(2) Ensure that specimens are given, on the same or next business day of the designated carrier, to a carrier contracted with the Department or contracted with a newborn screening laboratory or to another same-day or overnight delivery service for transport to the assigned newborn screening laboratory.

(d) For infants born outside of a perinatal licensed health facility and not subsequently admitted to a perinatal licensed health facility, when the birth is being registered at the county registrar's office, the person in the county registrar's office required to register the birth shall notify the Department of the birth the next business day after the birth is registered using the NOTIFICATION OF REGISTRATION OF BIRTH WHICH OCCURRED OUT OF A LICENSED HEALTH FACILITY (NBS-OH) CDPH 4460 (01/09) pursuant to § 6501.5(d).

(e) A newborn screening specimen may be collected on a child over 1 year of age with prior authorization from the Department.

(f) The blood specimen and information obtained during the testing process becomes the property of the State and may be used for program evaluation or research by the Department or Department-approved scientific researchers without identifying the person or persons from whom these results were obtained.

Notes

Cal. Code Regs. Tit. 17, § 6505

1. New section filed 4-11-80; designated effective 9-1-80 (Register 80, No. 15). For history of former section, see Registers 78, No. 34 and 74, No. 18.
2. Amendment of subsection (i) filed 8-29-80 as an emergency; effective upon filing (Register 80, No. 35). A certificate of compliance must be filed within 120 days or emergency language will be repealed on 12-28-80.
3. Certificate of Compliance transmitted to OAL 12-15-80 and filed 1-12-81 (Register 81, No. 3).
4. Repealer and new section filed 11-21-86; effective thirtieth day thereafter (Register 86, No. 47).
5. Amendment of subsections (b), (c), (f) and (i), and new subsection (j) filed by the Department of Health Services with the Secretary of State on 12-22-89 as an emergency; operative 12-22-89. Submitted to OAL for printing only pursuant to Health and Safety Code Section 309(g) (Register 90, No. 4).
6. Change without regulatory effect amending NOTE filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).
7. Amendment of section heading, repealer of former subsections (a)-(i), new subsections (a)-(e), subsection relettering, amendment of newly designated subsection (f) and amendment of NOTE filed 4-4-2016 as an emergency; operative 4-4-2016 pursuant to Health and Safety Code section 124977(d). Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 124977 (Register 2016, No. 15). Pursuant to Health and Safety Code section 124977(d)(2), these regulations shall remain in effect until revised or repealed by the Department of Public Health.
8. Statement of Compliance pursuant to Health and Safety Code section 124977(d)(1) as to 4-4-2016 order with amendments filed 4-17-2017. Exempt from OAL review pursuant to Health and Safety Code section 124977(d)(2). Submitted to OAL for filing and printing only pursuant to Government Code section 11343.8 (Register 2017, No. 16). Pursuant to Health and Safety Code section 124977(d)(2), these regulations shall remain in effect until revised or repealed by the department.
9. Amendment of subsections (a)(1)-(2), (a)(4), (b)(1)-(2) and (c)(1) filed 6-6-2019 as an emergency; operative 6-6-2019 pursuant to Health and Safety Code section 124977(d). Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 124977 (Register 2019, No. 23). Pursuant to Health and Safety Code section 124977(d)(2), these regulations shall remain in effect until revised or repealed by the department.
10. Statement of Compliance pursuant to Health and Safety Code section 124977(d)(1) as to 6-6-2019 order filed 9-30-2019. Exempt from OAL review pursuant to Health and Safety Code section 124977(d)(2). Submitted to OAL for filing and printing only pursuant to Government Code section 11343.8 (Register 2019, No. 40).

Note: Authority cited: Sections 124977, 124980, 124996, 125000, 125001 and 131200, Health and Safety Code. Reference: Sections 124975, 124980, 125000, 125001, 125025, 131050, 131051 and 131052, Health and Safety Code.

1. New section filed 4-11-80; designated effective 9-1-80 (Register 80, No. 15). For history of former section, see Registers 78, No. 34 and 74, No. 18.
2. Amendment of subsection (i) filed 8-29-80 as an emergency; effective upon filing (Register 80, No. 35). A certificate of compliance must be filed within 120 days or emergency language will be repealed on 12-28-80.
3. Certificate of Compliance transmitted to OAL 12-15-80 and filed 1-12-81 (Register 81, No. 3).
4. Repealer and new section filed 11-21-86; effective thirtieth day thereafter (Register 86, No. 47).
5. Amendment of subsections (b), (c), (f) and (i), and new subsection (j) filed by the Department of Health Services with the Secretary of State on 12-22-89 as an emergency; operative 12-22-89. Submitted to OAL for printing only pursuant to Health and Safety Code Section 309(g) (Register 90, No. 4).
6. Change without regulatory effect amendingNote filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).
7. Amendment of section heading, repealer of former subsections (a)-(i), new subsections (a)-(e), subsection relettering, amendment of newly designated subsection (f) and amendment of Note filed 4-4-2016 as an emergency; operative 4-4-2016 pursuant to Health and Safety Code section 124977(d). Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 124977 (Register 2016, No. 15). Pursuant to Health and Safety Code section 124977(d)(2), these regulations shall remain in effect until revised or repealed by the Department of Public Health.
8. Statement of Compliance pursuant to Health and Safety Code section 124977(d)(1) as to 4-4-2016 order with amendments filed 4-17-2017. Exempt from OAL review pursuant to Health and Safety Code section 124977(d)(2). Submitted to OAL for filing and printing only pursuant to Government Code section 11343.8 (Register 2017, No. 16). Pursuant to Health and Safety Code section 124977(d)(2), these regulations shall remain in effect until revised or repealed by the department.
9. Amendment of subsections (a)(1)-(2), (a)(4), (b)(1)-(2) and (c)(1) filed 6-6-2019 as an emergency; operative 6/6/2019 pursuant to Health and Safety Code section 124977(d). Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 124977 (Register 2019, No. 23). Pursuant to Health and Safety Code section 124977(d)(2), these regulations shall remain in effect until revised or repealed by the department.
10. Statement of Compliance pursuant to Health and Safety Code section 124977(d)(1) as to 6-6-2019 order filed 9/30/2019. Exempt from OAL review pursuant to Health and Safety Code section 124977(d)(2). Submitted to OAL for filing and printing only pursuant to Government Code section 11343.8 (Register 2019, No. 40).