N.J. Admin. Code § 8:18-1.4

Current through Register Vol. 56, No. 23, December 2, 2024

Section 8:18-1.4 - Responsibilities of the chief executive officer

(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.

N.J. Admin. Code § 8:18-1.4

Amended by R.2000 d.200, effective 5/15/2000.
See: 31 N.J.R. 3943(b), 32 N.J.R. 1785(b).
Rewrote (a).
Amended by R.2004 d.333, effective 9/7/2004.
See: 35 N.J.R. 4193(a), 36 N.J.R. 4135(a).
In (a), rewrote 16.
Recodified from N.J.A.C 8:19-2.4 and amended by R.2005 d.346, effective 10/17/2005.
See: 37 N.J.R. 1661(a), 37 N.J.R. 4018(a).
Rewrote (a)10, 12, and 19iii.
Amended by R.2007 d.43, effective 2/5/2007.
See: 38 N.J.R. 1973(a), 38 N.J.R. 3095(a), 39 N.J.R. 396(a).
In (a)20, deleted "and" from the end; in (a)21, substituted "; and" for a period at the end; and added (a)22.