California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 3 - Newborn Screening Program › Article 2 - Testing and Follow-up Program Requirements › Section 6506 - Verification of Receipt of Newborn Screening Specimens by the Department

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Perinatal licensed
						health facility staff and-out-of-hospital newborn screening providers shall check
						the Department Screening Information System (SIS) within 7 days after the date of
						birth to verify that the newborn screening specimen has been received by the
						Department. This applies to all infants for whom perinatal licensed health
						facilities and out-of-hospital newborn screening providers have responsibility for
						newborn screening pursuant to §
												6505(a), (b) and (c).
						If a specimen has not been received and there is not a copy of the CALIFORNIA
						NEWBORN SCREENING TEST REQUEST FORM (NBS-TRF) (CDPH-4409) pursuant to §
												6501.2 or §
												6501.5(a) present in
						the newborn's medical record, the staff shall enter a missing specimen report into
						the Screening Information System (SIS), and if the newborn has not been discharged,
						collect a newborn screening specimen on the CALIFORNIA NEWBORN SCREENING TEST
						REQUEST FORM (NBS-TRF) (CDPH-4409) pursuant to §
												6501.5(a) and §
												6504.4(b) within 24
						hours. This specimen shall be given to a carrier contracted with the Department or
						another overnight carrier for transport to the assigned newborn screening laboratory
						on the same or next business day of the designated carrier.
(b) If a collected specimen has not been received,
						the staff shall enter a missing specimen report into the SIS.
(c) If a perinatal licensed health facility or a
						group of perinatal licensed health facilities has an internal computerized system in
						place to identify specimens received by their designated newborn screening
						laboratory, and this system has the same criteria to verify receipt of newborn
						screening specimens as the Department's Screening Information System (SIS) as
						described in §
												6500.71(a) and (b),
						then their system rather than SIS may be used to verify receipt of their
						specimens.
1. New
						  Section filed 4-11-80; designated effective 9-1-80 (Register 80, No.
						  15).
2. Repealer and new section filed 11-21-86; effective thirtieth day
						  thereafter (Register 86, No. 47).
3. Change without regulatory effect
						  amending section heading, section and NOTE filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
4. Amendment of section heading,
						  repealer and new section 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.
5. 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.
6. Amendment of subsection (a), new subsection (b) and
						  subsection relettering 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.
7. 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,
							 125000,
							 125001
							 and
							 131200,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 125000,
							 125001,
							 125025,
							 131050,
							 131051
							 and
							 131052,
							 Health and Safety Code.