reglab/statecodes huggingface dataset:
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 17 - EARLY INTERVENTION SYSTEM › Subchapter 16 - CENTRAL DIRECTORY AND PUBLIC AWARENESS › Section 8:17-16.2 - Public awareness

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Department shall maintain a continuous,
				ongoing public awareness program throughout all areas of the State, including rural
				areas.
(b) The public awareness program
				shall include information about the State early intervention system, the Child Find
				System, including the purpose and scope of the system, how to make referrals, and
				how to access a comprehensive and multidisciplinary evaluation and other early
				intervention services; and the central directory.
(c) The public awareness program shall focus on
				the early identification of children who are eligible to receive early intervention
				services and include:
1. The preparation and
				dissemination of informational materials to all primary referral sources, especially
				hospitals, physicians, and DCF, to be given to parents, especially to inform parents
				with premature children, or children with other physical risk factors associated
				with learning or developmental complications, for those sources to disseminate to
				parents;
2. Informational materials that
				are disseminated to all major child services organizations, including public
				agencies at the State and local level, private practitioners, practitioner
				associations, parent groups, and advocate associations on the nature and
				availability of the early intervention services available pursuant to Part C and
				Part B, and procedures for assisting such sources in disseminating such information
				to parents of children with disabilities; and
3. Brochures, newsletters, fact sheets, displays,
				public service announcements, news stories, and other media that are used to reach
				the largest possible audience.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 17 - EARLY INTERVENTION SYSTEM › Subchapter 17 - SUPERVISION AND MONITORING OF PROGRAMS › Section 8:17-17.1 - General supervision

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Department shall
				be responsible for the general administration, supervision, and monitoring of
				programs and activities receiving assistance pursuant to Part C; and monitoring
				programs and activities used by the State to carry out this chapter, whether or not
				the programs and activities are receiving assistance pursuant to Part C, to ensure
				compliance.
(b) The Department shall:
1. Monitor provider agencies, institutions, and
				organizations under contract with the Department to implement Part C;
2. Enforce obligations that Part C, its
				implementing regulations, and this chapter impose on provider agencies;
3. Provide technical assistance as necessary to
				provider agencies and practitioners; and
4. Develop and monitor compliance with corrective
				action plans to address deficiencies identified through monitoring.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 17 - EARLY INTERVENTION SYSTEM › Subchapter 17 - SUPERVISION AND MONITORING OF PROGRAMS › Section 8:17-17.2 - Collection and maintenance of information

Current through Register Vol. 56, No. 14, July 15, 2024
Consistent with the terms and conditions of a letter of
				  agreement, or, as applicable, a grant funded by the Department and implemented by
				  the provider agency, the agency shall submit to the Department activity reports,
				  progress notes, service verification logs, and other operational information for the
				  Department to monitor the implementation by provider agencies of all requirements of
				  this chapter.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 17 - EARLY INTERVENTION SYSTEM › Subchapter 18 - REPORTING AND DATA COLLECTION › Section 8:17-18.1 - Data reporting

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The NJEIS shall
				issue annually, in the manner specified by the U.S. Secretary of Education, an early
				intervention service report that addresses the delivery of services to eligible
				children and their families by the NJEIS.
(b) The report shall contain all of the data
				required by the U.S. Secretary of Education pursuant to the annual State Plan
				including:
1. The number of children with
				disabilities by race and ethnicity who are receiving early intervention services;
				and
2. The number of children with
				disabilities, by race and ethnicity, who, from birth until the third birthday,
				stopped receiving early intervention services because of program completion or for
				other reasons.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 17 - EARLY INTERVENTION SYSTEM › Subchapter 18 - REPORTING AND DATA COLLECTION › Section 8:17-18.2 - Data collection

Current through Register Vol. 56, No. 14, July 15, 2024
Data collection shall be consistent with the terms and conditions
				  of the letter of agreement or, as applicable, the grant binding the provider agency
				  to the Department.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 17 - EARLY INTERVENTION SYSTEM › Appendix E1

Current through Register Vol. 56, No. 14, July 15, 2024
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New Jersey Administrative Code › Title 8 - HEALTH › Chapter 18 - NEWBORN BIOCHEMICAL SCREENING PROGRAM › Subchapter 1 - NEWBORN BIOCHEMICAL SCREENING › Section 8:18-1.1 - Purpose and scope

Current through Register Vol. 56, No. 14, July 15, 2024
This subchapter constitutes the rules governing the
				  implementation of
				  26:2-110 and 111 ( P.L. 1988, c.24), an
				  act providing for the testing of newborn children for the purpose of early detection
				  and treatment of biochemical disorders.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 18 - NEWBORN BIOCHEMICAL SCREENING PROGRAM › Subchapter 1 - NEWBORN BIOCHEMICAL SCREENING › Section 8:18-1.3 - Diseases and conditions tested

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The testing required
				by 26:2-111 and this subchapter shall be
				done by the testing laboratory according to recognized clinical laboratory
				procedures.
(b) Diseases and conditions
				to be tested shall include, but not be limited to:
1. Phenylketonuria;
2. Galactosemia;
3. Hypothyroidism;
4. Sickle cell anemia; and
5. Other hemoglobinopathies; as designated by the
				Commissioner.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 18 - NEWBORN BIOCHEMICAL SCREENING PROGRAM › Subchapter 1 - NEWBORN BIOCHEMICAL SCREENING › Section 8:18-1.5 - Responsibilities of the birth attendant

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The birth attendant
				shall:
1. Submit or cause to be submitted to the
				testing laboratory an initial blood specimen taken before the infant is 48 hours old
				from all infants born outside of, and not admitted to, a hospital;
2. Follow the specimen collection and submission
				procedures specified in
				8:18-1.4(a)5  through 8
				and 15 through 16;
3. Collect or cause
				to be collected a repeat specimen when requested by the testing laboratory, and
				shall submit or cause such repeat specimen to be submitted to the testing laboratory
				within 24 hours of collection; and
4. If
				a repeat specimen is not obtained, place on the infant's medical record written
				documentation of efforts made to secure or cause to be secured a repeat specimen
				within 14 days of receipt of the laboratory report.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 18 - NEWBORN BIOCHEMICAL SCREENING PROGRAM › Subchapter 1 - NEWBORN BIOCHEMICAL SCREENING › Section 8:18-1.6 - Responsibilities of the responsible physician

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The responsible
				physician shall:
1. Interpret all test
				results;
2. Comply with the specimen
				collection and submission procedures specified in
				8:18-1.4(a)5  through 8
				and 15 through 16;
3. Promptly collect
				or cause to be collected repeat specimens requested by the testing laboratory and
				submit the specimens to the testing laboratory;
4. Promptly collect or cause to be collected
				repeat specimens as recommended by the testing laboratory in the case of abnormal
				test results;
5. If a repeat specimen is
				not obtained within the time frame recommended on the test report, assure that
				written documentation is recorded in the infant's medical record of efforts made to
				secure a repeat specimen within 14 days of receipt of the laboratory
				report;
6. Include in the infant's
				health record the test results received from the chief executive officer or from the
				testing laboratory;
7. In the case of
				confirmed abnormal test results, arrange for diagnostic evaluation;
8. Provide case information, specimens, hard copy
				of test results, and other information requested by the Follow-up Program;
				and
9. Remain responsible for the
				follow-up until the responsibility is actively accepted by another
				physician.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 18 - NEWBORN BIOCHEMICAL SCREENING PROGRAM › Subchapter 1 - NEWBORN BIOCHEMICAL SCREENING › Section 8:18-1.7 - Responsibilities of the home health agency

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The home health
				agency shall:
1. Follow the specimen collection
				procedures specified in
				8:18-1.4(a)5  through 8
				and 15 through 16;
2. Provide
				notification to the hospital or birth attendant that the specimen has been
				collected; and
3. 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.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 18 - NEWBORN BIOCHEMICAL SCREENING PROGRAM › Subchapter 1 - NEWBORN BIOCHEMICAL SCREENING › Section 8:18-1.8 - Responsibilities of the public health officer

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The public health
				officer shall:
1. Provide assistance to the
				Follow-up Program, when requested, in locating families of infants;
2. Collect or cause a repeat specimen to be
				collected when notified of the need for a repeat specimen by the Follow-up Program.
				The specimen shall be submitted within 24 hours of collection;
3. Submit written documentation, within 14 days of
				receipt of the laboratory report to the infant's permanent medical record of efforts
				made to secure or cause to be secured such repeat specimen if a repeat specimen is
				not obtained within the time frame recommended by the Follow-up Program;
				and
4. Provide notification to the
				hospital or birth attendant that the specimen has been collected.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 18 - NEWBORN BIOCHEMICAL SCREENING PROGRAM › Subchapter 1 - NEWBORN BIOCHEMICAL SCREENING › Section 8:18-1.9 - Responsibilities of the testing laboratory

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The testing
				laboratory shall:
1. Determine if a specimen is
				satisfactory, according to the criteria listed in
				8:18-1.4(a)7, 8, and
				19;
2. Request a repeat specimen from
				the submitter for unsatisfactory specimens;
3. Test satisfactory specimens for disease and
				conditions, according to recognized clinical laboratory procedures;
4. Issue result reports of within acceptable
				limits to the chief executive officer or to the responsible physician, that is, the
				submitter of the specimen; and
5. Issue
				reports of abnormal results to the submitter of the specimen and to the responsible
				physician.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 18 - NEWBORN BIOCHEMICAL SCREENING PROGRAM › Subchapter 1 - NEWBORN BIOCHEMICAL SCREENING › Section 8:18-1.10 - Responsibilities of the Follow-up Program

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Follow-up
				Program shall:
1. Make every reasonable effort to
				follow abnormal test results to case disposition as specified in the Follow-up
				Program Procedures Manual;
2. Assist
				families of children with abnormal test results to access health care as
				necessary;
3. Identify and maintain
				contact with medical consultants (neurologists, endocrinologists, geneticists,
				hematologists) for each disease tested;
4. Identify treatment resources to families and
				assure that they are receiving care;
5.
				Provide educational support for activities carried out under this rule;
				and
6. In conjunction with the testing
				laboratory:
i. Monitor compliance with this
				subchapter;
ii. Identify problems in
				compliance and assist in their remediation; and
iii. Prepare and distribute an annual report, to
				include outcome data, descriptive statistics, program evaluation and
				recommendations.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 18 - NEWBORN BIOCHEMICAL SCREENING PROGRAM › Subchapter 1 - NEWBORN BIOCHEMICAL SCREENING › Section 8:18-1.11 - Responsibility of the Department

Current through Register Vol. 56, No. 14, July 15, 2024
The Commissioner shall determine an adequate laboratory fee and
				  appropriate funding for testing, follow-up and treatment services which will enable
				  the Department to carry out the responsibilities pursuant to P.L. 1988, c.24, §
				  3 (26:2-111 ). The fee is specified under
				  8:45-2.1.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 18 - NEWBORN BIOCHEMICAL SCREENING PROGRAM › Subchapter 1 - NEWBORN BIOCHEMICAL SCREENING › Section 8:18-1.12 - Exemption from testing

Current through Register Vol. 56, No. 14, July 15, 2024
(a) This subchapter
				shall not apply in the case of any infant or child whose parent or guardian objects
				to the testing on the grounds that testing would conflict with his or her religious
				tenets or practices.
(b) In case of
				refusal to test pursuant to (a) above, the chief executive officer or responsible
				physician or birth attendant or home health agency shall assure that documentation
				of refusal to test becomes part of the infant's permanent medical record.
(c) The chief executive officer or responsible
				physician or birth attendant or home health agency shall assure that a copy of
				documentation of refusal to test is forwarded to the testing laboratory.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 18 - NEWBORN BIOCHEMICAL SCREENING PROGRAM › Subchapter 1 - NEWBORN BIOCHEMICAL SCREENING › Section 8:18-1.13 - Confidentiality of reports

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The reports made
				pursuant to this subchapter are to be used only by the Department of Health and
				Senior Services and other agencies that may be designated by the Commissioner and
				shall not otherwise be divulged or made public so as to disclose the identity of any
				person and shall be deemed "information relating to medical history, diagnosis,
				treatment or evaluation" within the meaning of Executive Order No. 26, § 4b1
				(McGreevey, August 13, 2002), and, therefore, not "government records" subject to
				public access or inspection within the meaning of
				47:1A-1 et seq., particularly N.J.S.A
				47:1A-1.1.
(b) Inasmuch as the annual
				report issued by the Department pursuant to
				8:18-1.10(a)6  iii
				contains de-identified information and aggregate data, this section shall not apply
				to the annual report.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 18 - NEWBORN BIOCHEMICAL SCREENING PROGRAM › Subchapter 1 - NEWBORN BIOCHEMICAL SCREENING › Section 8:18-1.14 - Provision of notice of availability of supplemental newborn screening; Acknowledgement; retention

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A health care
				provider who provides care to an expectant parent or to a newborn infant shall, as
				applicable with respect to the expectant parent or the parent of the newborn
				(hereinafter both referred to as the "parent"):
1.
				Provide the Notice to the parent;
2.
				Provide the parent with a reasonable opportunity to read the Notice;
3. Make reasonable efforts to ensure that the
				parent understands the information provided in the Notice;
4. Obtain the signature of the parent on the
				Acknowledgment;
5. Retain the executed
				Acknowledgement in the patient's medical record; and
6. Permit the parent to keep the Notice.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 19 - NEWBORN HEARING SCREENING PROGRAM › Subchapter 1 - NEWBORN HEARING SCREENING › Section 8:19-1.2 - Hearing development literature supplied to parents

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Upon or prior to the
				admission of a newborn to a birthing facility in the State, the birthing facility
				shall provide all parents of the newborn with literature provided by the Department
				describing the normal development of auditory function and the New Jersey Early
				Hearing Detection and Intervention Program.
(b) The literature will be designed to provide
				parents with an understanding of the implications of hearing loss on the development
				of speech and language and provide information regarding normal auditory response
				behaviors.
(c) The Department shall
				furnish the literature to birthing facilities in languages that are most
				representative of the New Jersey population.
(d) The literature is available for download from
				the EHDI program website.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 19 - NEWBORN HEARING SCREENING PROGRAM › Subchapter 1 - NEWBORN HEARING SCREENING › Section 8:19-1.3 - Universal newborn hearing screening

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Each newborn shall
				receive hearing screening in accordance with this chapter by no later than the
				infant attaining the 28th day of life unless the infant has not been medically
				cleared to receive hearing screening before or as of the infant attaining the 28th
				day of life, in which case the infant shall receive hearing screening as soon as the
				infant is medically cleared for hearing screening.
(b) Subject to (b)1 below, the birthing facility,
				audiologist, midwife or responsible physician, as applicable, performing initial
				hearing screening in accordance with (a) above shall have discretion to determine
				the type of physiologic hearing screening measure to be used.
1. The birthing facility, audiologist or
				responsible physician, as applicable, shall use ABR in screening infants who, prior
				to the first discharge home, have been patients in the neonatal intensive care unit
				of one or more birthing facilities for a combined total of longer than five
				days.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 19 - NEWBORN HEARING SCREENING PROGRAM › Subchapter 1 - NEWBORN HEARING SCREENING › Section 8:19-1.4 - Transferred infants

Current through Register Vol. 56, No. 14, July 15, 2024
(a) If, before an infant
				receives initial hearing screening, the infant is transferred to another in-State
				birthing facility that holds a community perinatal center level-of-care designation
				(that is, CPC-basic, CPC-intermediate, CPC-intensive or regional perinatal center)
				pursuant to 8:43G-19.1(b)  and
				19.16, 19.17 and 19.18 that is higher than the community perinatal center
				level-of-care designation of the transferring facility, the birthing facility that
				holds the higher community perinatal center level-of-care designation shall either
				perform hearing screening of the infant or ensure that the infant receives hearing
				screening, in accordance with this chapter.
1. If
				an infant is transferred between birthing facilities with equivalent community
				perinatal center level-of-care designations, the birthing facility that discharges
				the infant to home shall either perform hearing screening of the infant or ensure
				that the infant receives hearing screening in accordance with this
				chapter.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 19 - NEWBORN HEARING SCREENING PROGRAM › Subchapter 1 - NEWBORN HEARING SCREENING › Section 8:19-1.5 - Personnel performing newborn hearing screening

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Each birthing
				facility shall designate a licensed audiologist or physician who shall oversee the
				birthing facility's newborn hearing screening program, and who shall ensure the
				implementation of the following:
1. Training and
				supervision of the individuals performing the screening in accordance with (b) and
				(c) below;
2. Recording of screening
				results;
3. Reporting EBC
				data;
4. Educating and counseling
				parents;
5. Developing effective
				strategies for communicating the hearing screening results to parents and
				responsible physicians;
6. Coordinating
				follow-up services including referrals for re-screening or audiologic evaluation as
				appropriate; and
7. Annually reviewing
				policies and procedures.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 19 - NEWBORN HEARING SCREENING PROGRAM › Subchapter 1 - NEWBORN HEARING SCREENING › Section 8:19-1.6 - Reporting by means of the Electronic Birth Certificate

Current through Register Vol. 56, No. 14, July 15, 2024
(a) For each live
				newborn born at, or transferred to, a birthing facility that has elected to
				participate in the reporting of births to the State Registrar of Vital Statistics
				electronically by means of the Electronic Birth Certificate Registration System, the
				birthing facility shall report, within one week of the newborn's discharge or
				transfer, the EBC fields or information identified below by means of the Electronic
				Birth Certificate Registration System in the manner prescribed by the State
				Registrar of Vital Statistics for the submission of EBCs:
1. The mother's first name;
2. The mother's last name;
3. The child's first name;
4. The child's last name;
5. Sex;
6. Race;
7. Primary language;
8. Hearing screening results for each
				ear;
9. The screening methodology used
				for each ear;
10. The date of screening
				for each ear; and
11. The existence or
				occurrence of the following neonatal conditions and procedures, as applicable:
i. Family history of hearing loss;
ii. Congenital infections of toxoplasmosis,
				rubella, cytomegalovirus, herpes or syphilis;
iii. Persistent pulmonary hypertension;
iv. Stigmata and/or syndromes associated with
				hearing loss;
v.
				Hyperbilirubinemia;
vi.
				Meningitis;
vii. Exchange
				transfusion;
viii. Extracorporeal
				membrane oxygenation;
ix. Ototoxic
				medication;
x. Mechanical ventilation
				(indicate number of days);
xi. One- and
				five-minute Apgar scores;
xii.
				Birthweight; and/or
xiii. NICU admission
				and discharge dates.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 19 - NEWBORN HEARING SCREENING PROGRAM › Subchapter 1 - NEWBORN HEARING SCREENING › Section 8:19-1.7 - Exemption from screening

Current through Register Vol. 56, No. 14, July 15, 2024
(a) This chapter shall
				not apply in the case of any newborn whose parent objects to hearing screening on
				the grounds that screening would conflict with the parent's bona fide religious
				tenets or practices.
(b) In case of
				refusal to screening pursuant to (a) above, the birthing facility, or in the event
				of a home birth, the attending physician or midwife, shall ensure that documentation
				of refusal to have the newborn's hearing screened is signed by the parent, becomes
				part of the infant's permanent medical record, and, if the birth occurs at a
				birthing facility that has elected to participate in the submission of birth
				certificates electronically by means of the Electronic Birth Certificate
				Registration System, is documented in the EBC.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 19 - NEWBORN HEARING SCREENING PROGRAM › Subchapter 1 - NEWBORN HEARING SCREENING › Section 8:19-1.8 - High-risk indicators

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Upon receiving
				notice pursuant to
				8:19-1.9(f)1  of the
				presence in an infant of risk indicators that the JCIH Position Statement identifies
				as requiring audiologic monitoring to detect progressive or late-onset hearing loss,
				the infant's responsible physician shall ensure the monitoring of these infants in
				accordance with the time intervals and other protocols identified in the JCIH
				Position Statement.
(b) Birthing
				facilities that treat infants and children up to the third birthday with ototoxic
				medications shall implement ototoxic drug screening procedures, established pursuant
				to 8:19-1.3(d)14.
(c) If risk indicators for late-onset hearing loss
				are identified after discharge from the birthing facility and at any time until a
				child's third birthday, the responsible physician and any audiologist who may have
				seen the child identifying the presence of the risk indicators shall report the risk
				indicators to the EHDI program by means of the Newborn Hearing Follow-up Report, and
				advise the parent of the need to have an audiologic evaluation, when indicated (in
				terms of the child's age), by the JCIH Position Statement.
1. Audiologists who identify the presence of a
				risk indicator for late-onset hearing loss shall inform the child's responsible
				physician of this condition and the need for follow-up.
2. Once informed of the newly identified risk
				indicator for late-onset hearing loss, the responsible physician shall advise the
				child's parent of the importance of the child receiving audiologic evaluation in
				accordance with (c) above.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 19 - NEWBORN HEARING SCREENING PROGRAM › Subchapter 1 - NEWBORN HEARING SCREENING › Section 8:19-1.9 - Hearing screening follow-up

Current through Register Vol. 56, No. 14, July 15, 2024
(a) If hearing screening
				and/or rescreening is performed on both ears of an infant prior to discharge, then,
				prior to the infant's discharge home, the birthing facility shall:
1. Notify the responsible physician of the results
				by written documentation, and
2. Notify
				the parent of the results via face-to-face communication along with written
				documentation.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 19 - NEWBORN HEARING SCREENING PROGRAM › Subchapter 1 - NEWBORN HEARING SCREENING › Section 8:19-1.10 - Procedure for conduct and reporting of newborn hearing screening and follow-up

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The individuals who
				conduct outpatient hearing screening, rescreening or audiologic evaluation for the
				reasons identified in
				8:19-1.3 and 1.9 shall:
1. Perform screening, rescreening or audiologic
				evaluation of both ears, regardless of whether the infant previously obtained a
				non-passing result of only one ear upon prior hearing screening or
				rescreening;
2. Use ABR if the infant
				previously obtained a non-passing result upon the use of ABR;
3. Use ABR or OAE if the infant previously
				obtained a non-passing result upon the use of OAE;
4. Complete the Newborn Hearing Follow-up Report
				with ear-specific results, to the extent possible; and
5. Submit the completed Newborn Hearing Follow-up
				Report to the EHDI program and report the results to the infant's responsible
				physician, within 10 business days of the conduct of the outpatient screening,
				rescreening or audiologic evaluation.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 19 - NEWBORN HEARING SCREENING PROGRAM › Subchapter 1 - NEWBORN HEARING SCREENING › Section 8:19-1.11 - Documenting and reporting a diagnosed hearing loss

Current through Register Vol. 56, No. 14, July 15, 2024
(a) When a permanent
				hearing loss is confirmed in a child who is a New Jersey resident, the individual
				making the diagnosis shall complete and submit the forms identified in (a)1 and 2
				below, as applicable, within 10 business days of the diagnosis:
1. For children from birth to the third birthday,
				a Newborn Hearing Follow-up Report form to the EHDI program; and
2. For children from birth to the 21st birthday, a
				Special Child Health Services Registration form to the Special Child Health Services
				Registry;
i. The person submitting a Special Child
				Health Services Registration form pursuant to (a)2 above shall specify, in the
				"diagnosis" section of the form, the type and degree of hearing loss, the affected
				ear(s), and, if applicable and known, the syndrome related to the child's hearing
				loss.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 19 - NEWBORN HEARING SCREENING PROGRAM › Subchapter 1 - NEWBORN HEARING SCREENING › Section 8:19-1.12 - Central newborn hearing registry

Current through Register Vol. 56, No. 14, July 15, 2024
Special Child Health and Early Intervention Services shall
				  establish and maintain a central registry of infants identified as having or being
				  at risk of developing a hearing loss. The information in the central registry shall
				  be used for the purposes of compiling statistical information and providing
				  follow-up counseling, intervention and educational services to the parents of the
				  infants listed in the registry.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 19 - NEWBORN HEARING SCREENING PROGRAM › Subchapter 1 - NEWBORN HEARING SCREENING › Section 8:19-1.13 - Confidentiality of reports

Current through Register Vol. 56, No. 14, July 15, 2024
The reports made pursuant to the Act and this chapter are to be
				  used only by the Department and such other agencies as may be designated by the
				  Commissioner and shall not otherwise be divulged or made public, so as to disclose
				  the identity of any person to whom they relate; and to that end, such reports shall
				  be deemed "information relating to medical history, diagnosis, treatment or
				  evaluation" within the meaning of Executive Order No. 26, § 4b1 (McGreevey
				  2002), and, therefore, not "government records" subject to public access or
				  inspection within the meaning of
				  47:1A-1 et seq., particularly
				  47:1A-1.1.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 19 - NEWBORN HEARING SCREENING PROGRAM › Subchapter 1 - NEWBORN HEARING SCREENING › Section 8:19-1.14 - Non-liability for divulging confidential information

Current through Register Vol. 56, No. 14, July 15, 2024
No individual or organization providing information to the
				  Department for the purpose of the Newborn Hearing Screening Program shall be deemed
				  to be, or held liable for, divulging confidential information.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 20 - BIRTH DEFECTS REGISTRY › Subchapter 1 - LIVE BIRTHS › Section 8:20-1.1 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
The following words and terms when used in this chapter shall
				  have the following meanings unless the context clearly indicates otherwise.
"Bilirubin" means the orange-yellow pigment found in bile, which
				  is formed when hemoglobin, the red-colored pigment of red blood cells that carries
				  oxygen to tissues, breaks down into heme and globin.
"Birth defect" means an abnormality of the body's structure or
				  inherent function which is present at birth, whether such abnormality is manifest at
				  the time of delivery or becomes apparent later in life.
"Child" means an individual from birth through five years of
				  age.
"Clinical laboratory" shall have the meaning given in the New
				  Jersey Clinical Laboratory Improvement Act,
				  45:9-42.2 6 et seq.
"Commissioner" means the Commissioner of the New Jersey Department
				  of Health and Senior Services.
"Department" means the New Jersey Department of Health and Senior
				  Services.
"Direct or conjugated bilirubin" means the substance that is
				  produced when heme is converted to bilirubin, which is then carried by albumin in
				  the blood to the liver. In the liver, the bilirubin is chemically attached or
				  conjugated to another molecule before it is released in the bile.
"Exchange transfusion" means a simultaneous withdrawal of the
				  newborn's blood and transfusion with the donor's blood.
"Fractionated bilirubin" means the total and direct bilirubin with
				  the calculation of indirect bilirubin.
"Health care professional" means a physician, dentist, certified
				  nurse midwife or other health care professional licensed pursuant to Title 45 of the
				  Revised Statutes.
"Indirect or unconjugated bilirubin" means the unconjugated,
				  lipid-soluble form of bilirubin that circulates in loose association with the plasma
				  proteins.
"International Classification of Diseases, Ninth Revision,
				  Clinical Modification" or "ICD-9-CM" means the document published by the World
				  Health Organization, which promotes the international comparability in the
				  collection, processing, classification, and presentation of mortality statistics,
				  and which is incorporated herein by reference, as amended and supplemented. The
				  ICD-9-CM is available for download at the National Center for Health Statistics'
				  webpage at
http://www.cdc.gov/nchs/products/elec_prods/subject/icd96ed.htm
.
"Kernicterus" means a condition marked by the deposit of bile
				  pigments in the nuclei of the brain and spinal cord and by degeneration of nerve
				  cells.
"Newborn" means an infant from birth up to and including 30 days
				  of age.
"Total serum bilirubin" means direct bilirubin plus indirect
				  bilirubin.
"Transcutaneous bilirubin measurement" means a procedure that
				  measures the total serum bilirubin in newborns without a blood sample.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 20 - BIRTH DEFECTS REGISTRY › Subchapter 1 - LIVE BIRTHS › Section 8:20-1.3 - Reporting requirements for hearing loss

Current through Register Vol. 56, No. 14, July 15, 2024
Physicians and audiologists shall complete and file a Special
				  Health Services Registration form for any child from birth through 21 years of age
				  diagnosed with any permanent hearing loss, as required by
				  8:19-1.11.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 20 - BIRTH DEFECTS REGISTRY › Subchapter 2 - AUTISM › Section 8:20-2.1 - Purpose and scope

Current through Register Vol. 56, No. 14, July 15, 2024
This subchapter is intended to implement the requirements of
				  P.L.
				  2007, c. 170 (26:2-185 et seq.) by providing for the
				  reporting of diagnoses of autism and for the creation and maintenance of an
				  up-to-date Autism Registry of all reported cases of autism that occur in New Jersey
				  for use in conducting thorough and complete epidemiologic surveys of autism.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 1 - FOOD, DRUG, COSMETIC, AND DEVICE LABELING › Section 8:21-1.1 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
The following words and terms shall have the following meanings,
				  when used in this subchapter:
"Certificate of Free Sale" is a document completed and issued by
				  the Department of Health certifying that a company is in compliance with State and
				  Federal standards. The certificate also attests that a specific food, drug,
				  cosmetic, or medical device product regulated under Title 24 of the New Jersey
				  Statutes and manufactured, distributed, and offered for sale in this State is
				  labeled in conformance with the applicable food, drug, cosmetic, or medical device
				  laws. Such documents shall include Certificates to Foreign Government, Certificates
				  of Exportability, Good Manufacturing Practices (GMP) Certificates, Letters of Free
				  Sale, Certificates of Free Sale and Free Use, Health Certificates for Food/Feed,
				  origin certificates and other documents meeting the requirements at
				  N.J.A.C.
				  8:21-1.10. Issuance of the Certificate of Free
				  Sale attests to the results of the most recently conducted sanitary inspection of
				  the manufacturer or distributor of the product or products.
"Consumer" means an individual who secures a cosmetic for his or
				  her self application and has not received any special training or experience in its
				  use.
"Cosmetic" means "cosmetic" as defined in N.J.S.A. 24:1-1h.
"Label" means "label" as defined in N.J.S.A. 24:1-1j.
"Labeling" means "labeling" as defined in N.J.S.A. 24:1-1k.
"Person" means an individual or firm, partnership, company,
				  corporation, trustee, association, or any public or private entity.
"Professional" means an individual qualified through special
				  training and experience and licensed by the State to perform beauty culture
				  services.
"Professional use only" means for use only by a professional, or
				  words of similar import.
"Retail" means sale or distribution directly to the
				  consumer.
"Retail establishment" means any place used in the production,
				  preparation, processing, manufacture, packing, storage, or handling of cosmetics for
				  sale or distribution directly to the consumer.
"Wholesale establishment" means any place used in the production,
				  preparation, processing, manufacture, packing, storage, or handling of cosmetics for
				  sale or distribution to a person other than the consumer.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 1 - FOOD, DRUG, COSMETIC, AND DEVICE LABELING › Section 8:21-1.2 - General labeling requirements

Current through Register Vol. 56, No. 14, July 15, 2024
The general labeling requirements of
				  21 CFR
				  1.1,
				  1.3,
				  1.4,
				  1.20,
				  1.21,
				  1.23,
				  1.24
				  are incorporated herein by reference.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 1 - FOOD, DRUG, COSMETIC, AND DEVICE LABELING › Section 8:21-1.3 - Food labeling

Current through Register Vol. 56, No. 14, July 15, 2024
The food labeling requirements of 21 CFR 101, 102, 104, and 105
				  are incorporated herein by reference.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 1 - FOOD, DRUG, COSMETIC, AND DEVICE LABELING › Section 8:21-1.4 - Drug labeling

Current through Register Vol. 56, No. 14, July 15, 2024
The drug labeling requirements of 21 CFR 201 are incorporated
				  herein by reference.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 1 - FOOD, DRUG, COSMETIC, AND DEVICE LABELING › Section 8:21-1.5 - Cosmetic labeling

Current through Register Vol. 56, No. 14, July 15, 2024
The cosmetic labeling requirements of 21 CFR 701 are incorporated
				  herein by reference.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 1 - FOOD, DRUG, COSMETIC, AND DEVICE LABELING › Section 8:21-1.6 - Labeling, sale, and distribution of cosmetics for professional use only

Current through Register Vol. 56, No. 14, July 15, 2024
(a) For the purposes of
				this section, a cosmetic labeled for professional use only which is offered for sale
				or distribution to a consumer shall be deemed to be misbranded within the meaning of
				24:5-18.1 at the time such cosmetic is
				offered for such sale or distribution.
(b) No person shall distribute or sell, or have in
				his or her possession with intent to distribute or sell, any cosmetic labeled for
				professional use only except to professional barbers, professional beauticians,
				licensed beauty salons, licensed schools of beauty culture, other beauty culture
				professions, or licensed wholesale establishments.
(c) Any person who offers a cosmetic labeled for
				professional use only for sale or distribution shall make reasonable inquiries
				regarding a person's professional status or affiliation as necessary to determine
				their qualifications to purchase such products so that the retail sale or
				distribution of such cosmetic may be prevented. This requirement shall not apply to
				the sale or distribution of cosmetics labeled for professional use only between
				wholesale establishments.
(d) Cosmetics
				labeled for professional use only when displayed for sale in a combined
				retail-wholesale establishment shall be kept separate and apart from retail
				merchandise. Where such cosmetics are accessible to the general public, posters
				measuring at least 8 1/2 by 11 inches with lettering measuring at least one-half
				inch in height shall be conspicuously displayed in all such display areas and
				contain the following statement, "NOTICE--FOR SALE ONLY TO LICENSED
				PROFESSIONALS."
(e) A cosmetic labeled
				for professional use only shall be exempt from all the provisions of this section if
				it can be shown through factual and scientific evidence in the possession of the
				person offering such product for sale or distribution prior to such offering that:
1. Such cosmetic does not require professional
				skill or knowledge for its safe or effective use;
2. Such cosmetic does contain necessary warnings,
				cautions, and directions for its safe and effective use in such terms as to render
				it likely to be read and understood by the consumer under customary conditions of
				purchase and use; and
3. Such cosmetic
				is labeled in compliance with all State and Federal requirements for retail
				sale.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 1 - FOOD, DRUG, COSMETIC, AND DEVICE LABELING › Section 8:21-1.7 - Cosmetic product warning statements

Current through Register Vol. 56, No. 14, July 15, 2024
The requirements that apply to feminine deodorant sprays,
				  cosmetics in self-pressurized containers, and coal tar hair dyes posing a risk of
				  cancer of 21 CFR 740, Cosmetic Product Warning Statements are incorporated herein by
				  reference.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 1 - FOOD, DRUG, COSMETIC, AND DEVICE LABELING › Section 8:21-1.8 - Definition of soap

Current through Register Vol. 56, No. 14, July 15, 2024
(a) "Soap," as quoted in
				N.J.S.A. 24:1-1h(2), shall apply only to products that meet all of the following
				conditions:
1. More than 50 percent of the
				nonvolatile matter in the product consists of a salt resulting from an alkali-fatty
				acid chemical reaction commonly known as saponification and detergent properties of
				the product are due to the alkali-fatty acid salt; and
2. The product is labeled, sold and represented
				only as soap.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 1 - FOOD, DRUG, COSMETIC, AND DEVICE LABELING › Section 8:21-1.9 - Device labeling

Current through Register Vol. 56, No. 14, July 15, 2024
The device labeling requirements of 21 CFR 801 are incorporated
				  herein by reference.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 1 - FOOD, DRUG, COSMETIC, AND DEVICE LABELING › Section 8:21-1.10 - Certificate of Free Sale application process, fees, appeal process

Current through Register Vol. 56, No. 14, July 15, 2024
(a) An entity desiring
				to obtain a Certificate of Free Sale shall make application to the Commissioner of
				the Department of Health for a Certificate of Free Sale or any other certificate or
				affidavit, on forms approved by the Department, in accordance with the requirements
				of this section. Certificate of Free Sale application forms may be obtained by
				writing to the following address:
Public Health and Food Protection Program
Consumer, Environmental, and Occupational Health Service
Department of Health
PO Box 369
Trenton, NJ 08625-0369
(b) Each application shall be for a single
				Certificate of Free Sale that will address up to, but no more than, 25 specific
				food, drug, cosmetic or medical device products regulated under Title 24 of the New
				Jersey Statutes and manufactured, distributed and offered for sale in this State and
				labeled in conformance with the applicable food, drug, cosmetic or medical device
				laws.
(c) Applicants for a Certificate
				of Free Sale shall:
1. Submit a self-addressed and
				stamped envelope, air bill or equivalent;
2. Provide the applicant's business name and
				mailing address and the name and telephone number of a contact person;
3. Type and complete the application
				form;
4. Certify that the product or
				products for which a Certificate of Free Sale is sought is for sale or available for
				sale and not under embargo, seizure or other restraint;
5. Submit the nonrefundable fee specified at (f)
				below by means of certified check or money order, made payable to the Department of
				Health;
6. Submit complete product
				labels for each product for which a Certificate of Free Sale is sought;
i. Labels shall meet the requirements of
				applicable State and Federal labeling requirements; and
7. Provide other documentation as requested by the
				DHSS to substantiate that the product is not under embargo, seizure or other
				restraint and to attest to the validity of the product and its contents.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 1 - FOOD, DRUG, COSMETIC, AND DEVICE LABELING › Section 8:21-1.11 - Certificate of Free Sale inspection procedure, fees

Current through Register Vol. 56, No. 14, July 15, 2024
(a) An entity seeking a
				Certificate of Free Sale may request the Department to conduct an
				inspection.
(b) Entities requesting an
				inspection should submit the request with the application for a Certificate of Free
				Sale provided for at
				8:21-1.10.
(c) The subject of an inspection attendant to the
				issuance of a Certificate of Free Sale will depend on the food, drug, cosmetic or
				medical device proposed to be exported and the particular requirements of the
				receiving country as to the content of the Certificate of Free Sale. Typically, an
				inspection may consist of raw material verification, sampling, review of records and
				laboratory analyses, and, as necessary, a site visit of the subject premises to
				evaluate the safe and sanitary conduct of operations.
(d) The fee schedule for sanitary inspections is
				as follows:
1. $ 500.00 for inspections lasting
				eight hours or less;
2. $ 1,000 for
				inspections lasting greater than eight hours, up to 21 hours;
3. $ 1,500 for inspections lasting greater than 21
				hours, up to 29 hours;
4. $ 2,500 for
				inspections lasting greater than 29 hours, up to 42 hours;
5. $ 3,000 for inspections lasting greater than 42
				hours, up to 50 hours;
6. $ 4,000 for
				inspections lasting greater than 50 hours, up to 63 hours;
7. $ 4,500 for inspections lasting greater than 63
				hours, up to 71 hours;
8. $ 5,500 for
				inspections lasting greater than 71 hours, up to 84 hours;
9. $ 6,000 for inspections lasting greater than 84
				hours, up to 92 hours; and
10. $ 7,000
				for inspections lasting greater than 92 hours, up to 113 hours.