New Jersey Administrative Code › Title 8 - HEALTH › Chapter 18 - NEWBORN BIOCHEMICAL SCREENING PROGRAM › Subchapter 1 - NEWBORN BIOCHEMICAL SCREENING › Section 8:18-1.4 - Responsibilities of the chief executive officer

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The chief executive
				officer shall:
1. Cause the development and
				implementation of written policies and procedures, to be reviewed by the Department
				and revised as required, for the early detection and treatment of biochemical
				disorders, pursuant to
				26:2-110 and 111;
2. Designate a staff person to coordinate hospital
				or agency screening practice and function as a contact person with the Follow-up
				Program;
3. Assure that a satisfactory
				specimen is submitted to the testing laboratory for each infant born in the
				hospital, or admitted to the hospital within the first 28 days of life with no
				satisfactory specimen having been previously collected.
4. Assure that the infant's parent is informed of
				the purpose and need for newborn screening and given newborn screening educational
				materials provided by the Follow-up Program;
5. Assure that specimen collection forms are
				properly stored upright in a cool and dry environment prior to use;
6. Assure that specimens are taken utilizing
				correct specimen collection techniques as described on the back of the specimen
				collection form;
7. Assure that
				specimens conform to the following criteria for satisfactory specimens:
i. The specimen collection forms shall be filled
				in completely, accurately and legibly;
ii. The sample shall be collected on S & S 903
				blotter paper (located on the right side of the collection form);
iii. The blotter paper shall be attached to the
				forms; and
iv. The specimen quantity
				shall be sufficient to run all assays;
8. Assure that satisfactory specimens are
				collected according to the following criteria:
i.
				The circles on the blotting paper shall be completely and evenly
				saturated;
ii. The specimen shall not be
				contaminated or diluted;
iii. The blood
				shall not be clotted or caked; and
iv.
				The blotting paper shall not be torn, scratched, or distorted because of faulty or
				improper collection techniques;
9. Assure that specimens are taken before the
				infant is 48 hours old. If an infant is transferred or discharged from a facility
				prior to 48 hours of life, a specimen shall be collected prior to discharge unless
				there are medical reasons to prevent specimen collection;
10. Assure that the parent shall be instructed
				directly and in writing of the need to collect a repeat specimen between the third
				and seventh day of life if the infant is less than 24 hours of age;
11. Assure that every effort is made to obtain a
				specimen prior to any anticipated blood transfusion;
12. Assure that, in the event of prolonged
				hospitalization for specialized medical care, a specimen is taken when the infant is
				48 hours old, and that:
i. If an infant is on
				prolonged hyperalimentation, the "hyperalimentation" box on the specimen collection
				form is checked and "NICU," "SICU," or "SCN" is written in the "Remarks" box on the
				form; and
ii. A repeat specimen is taken
				on infants with prolonged hospitalization at seven days and 14 days, and at either
				42 days or discharge, whichever comes first, and "NICU," "SICU," or "SCN" is written
				in the "Remarks" box on the form;
13. Assure that in the case of inter-hospital
				transfer of the infant, the transferring hospital shall provide written notification
				to the receiving hospital indicating whether or not a specimen has been taken prior
				to transfer. Following transfer, the chief executive officer of the receiving
				hospital shall assume responsibility for collection of the specimen in accordance
				with these regulations;
14. Assure that
				the date and time of specimen collection are recorded on the infant's permanent
				health record;
15. Assure that
				biohazardous specimens are thoroughly dried and then placed in a paper envelope
				provided by the testing laboratory;
16.
				Assure that all specimens are forwarded to the testing laboratory within 24 hours of
				collection by next day delivery, or in the event service is unavailable with respect
				to Sundays and Federally designated holidays, then as soon thereafter as is
				practicable, using an account number the Department shall establish with an
				overnight package delivery service, which number the Department shall make available
				upon request;
17. Assure that all test
				results forwarded to the chief executive officer or his designee by the testing
				laboratory are included in the infant's permanent health record;
18. Transmit or cause to be transmitted a copy of
				test results to the physician of record;
19. Assure that repeat specimens are collected
				when requested by the testing laboratory for specimens not satisfactory for testing
				according to criteria in (a)7 and 8 above, or specimens for which assay results
				cannot be interpreted because of any of the following conditions:
i. Transfusion(s) given before specimen
				collection;
ii. Antibiotics given before
				specimen collection (if effects cannot be removed);
iii. Ethylene diamine tetra-acetic acid (EDTA) in
				the specimen secondary to improper collection using an EDTA collection
				device;
iv. Incomplete elution from
				blotter during assay;
v. Specimen
				received 14 days or more after collection date; and
vi. Specimen collected before infant is 24 hours
				of age;
20. Assure that
				written documentation is recorded in the infant's permanent medical record of
				efforts made to secure a repeat specimen within 14 days of receipt of the laboratory
				report when an initial specimen is not satisfactory for testing and a repeat
				specimen is not obtained;
21. Assure
				that infants weighing 1,500 grams or less have repeat screening specimens taken at
				seven days, 14 days, 42 days of age or at discharge, whichever comes first;
				and
22. Cause the development and
				implementation of written policies and procedures, to be reviewed by the Department
				and revised as required, for the timely processing of supplemental newborn screening
				specimen collection test kits in accordance with directions contained in the kits if
				a parent timely provides such a kit to the health care facility of which the chief
				executive officer is in charge;
i. At minimum, the
				policies and procedures required pursuant to (a)22 above shall address memorializing
				the time and date of receipt of test kits from parents, obtaining parents' informed
				consent to the collection of specimens in accordance with the instructions in the
				test kit, and ensuring that appropriate personnel execute or arrange for the
				execution of such forms and collect or arrange for the collection of such specimens,
				and otherwise take such steps that are within the health care facility's ability as
				may be required by a qualified laboratory to assist in and enable the performance of
				supplemental newborn screening in accordance with instructions accompanying a test
				kit, subject to applicable standards of care depending upon the particular health
				situations of newborns from whom supplemental screening specimens are to be
				collected.