reglab/statecodes huggingface dataset:
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 2 - OPERATION OF CLINICAL LABORATORIES › Section 8:44-2.5 - Tests performed

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The clinical
				laboratory shall perform only those laboratory tests and procedures that are within
				the specialties or subspecialties for which the laboratory is licensed.
(b) All clinical laboratories shall enroll and
				successfully participate in a proficiency testing program provided by either the
				Department of Health and Senior Services, or by a proficiency testing provider that
				the Centers for Medicare and Medicaid Services (CMS) has approved to perform
				proficiency testing pursuant to the Clinical Laboratory Improvement Amendments of
				1988,
				42 U.S.C. §
										263a, and the regulations CMS promulgates pursuant
				thereto at 42 CFR Part 493.
1. A list of
				CMS-approved proficiency testing providers is available at
http://www.cms.hhs.gov/CLIA/downloads/ptlist.pdf
,
				as amended and supplemented, or upon request to the Department.
2. Enrollment in a proficiency testing program
				with a provider other than the Department pursuant to (b) above shall encompass all
				clinical laboratory specialties, analytes and/or subspecialties for which a given
				laboratory is approved to perform tests that the Department has designated as
				requiring proficiency testing.
3.
				Laboratories shall:
i. Enroll and participate in
				proficiency testing surveys appropriate to their level of service;
ii. Receive and examine and/or analyze specimens
				delivered by mail or messenger, at such times as designated by the proficiency
				testing provider; and
iii. Maintain
				records of all proficiency testing results in surveys in which they participate and
				make such records, including results, interpretations and cumulative performance
				data routinely available to the Department of Health and Senior Services.
4. The Department of Health and Senior
				Services shall reserve authority to regrade data from proficiency testing providers
				other than the Department (that is, survey scores and cumulative performance
				interpretations) through the Clinical Laboratory Improvement Service according to
				its own licensing standards.
5. Any
				report issued by proficiency testing providers other than the Department by itself
				shall not be construed as determinative of compliance with the New Jersey licensing
				standards.
6. An exception to the
				enrollment requirements of this subsection may be made, provided the Department of
				Health and Senior Services determines that an appropriate proficiency testing survey
				is not readily available.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 2 - OPERATION OF CLINICAL LABORATORIES › Section 8:44-2.7 - Management

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The clinical
				laboratory shall maintain records and facilities which are adequate and appropriate
				for the services offered.
(b)
				Workrecords of quantitative tests must be maintained and these records must indicate
				final results together with all corresponding instrument readings and calculations.
				Where instrumentation produces tracings or print-outs of results, these tracings or
				print-outs must be retained and may serve as the workrecord.
(c) A compilation shall be kept of all automated
				and manual methods for tests which are performed in or offered by the laboratory.
				Each procedure shall be reviewed and dated by the technical supervisor at least
				annually. For those tests which are normally performed on automated test equipment,
				provision shall be made and documented for performing such tests by alternate
				methods, or for storing the test specimens, in the event this equipment becomes
				inoperable.
(d) Space and facilities
				shall be adequate to properly perform the services which are performed in or offered
				by the laboratory.
1. Workbench space shall be
				ample, well-lighted, and convenient to sink, water, gas, and suction and electrical
				outlets as necessary.
2. Work areas
				shall be arranged so as to minimize problems in transportation and
				communication.
3. The laboratory shall
				be properly ventilated.
4. Volatile
				chemicals and inflammable solvents shall be properly stored as specified by
				O.S.H.A.
5. Temperature and humidity
				shall be controlled within limits required for proper performance of tests and
				operation of instruments affected by these variations.
6. Voltage levels at electrical sources to which
				automated equipment is connected shall be monitored and recorded.
7. Adequate fire precautions and occupational
				safety and health laws shall be known, posted, and observed insuring that there is
				freedom from physical, chemical, and biological hazards.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 2 - OPERATION OF CLINICAL LABORATORIES › Section 8:44-2.9 - Amendments

Current through Register Vol. 56, No. 14, July 15, 2024
The Public Health Council on the advice of the Commissioner may
				  promulgate, enforce and may amend or repeal these regulations that at any given time
				  shall be no less stringent than the complete interim or revised national laboratory
				  regulations in effect at that time.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 2 - OPERATION OF CLINICAL LABORATORIES › Section 8:44-2.10 - Public Health Council

Current through Register Vol. 56, No. 14, July 15, 2024
The Public Health Council on the advice of the Commissioner may
				  promulgate, enforce and may amend or repeal these regulations that at any given time
				  shall be no less stringent than the complete interim or revised national laboratory
				  regulations in effect at that time.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 2 - OPERATION OF CLINICAL LABORATORIES › Section 8:44-2.11 - Reporting by laboratory supervisors

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Laboratory
				supervisors shall:
1. Immediately report results
				of laboratory examinations of specimens of humans, animals, or birds indicating or
				suggesting the existence of communicable diseases to the Department of Health, to
				the physician or veterinarian submitting the specimen and, excepting results
				pertaining to venereal diseases, simultaneously forward a copy thereof to the health
				officer having jurisdiction where the patient is located;
2. Immediately report results of laboratory
				examinations of specimens of persons being considered for release from isolation or
				quarantine from any disease listed, whether said report be positive or negative, to
				the physician submitting the specimen and simultaneously forward a copy thereof to
				the health officer having jurisdiction where the patient is located;
3. Promptly report to the Department of Health the
				results of comparative and evaluation examinations made of specimens which may be
				sent to the laboratory by the Department.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 2 - OPERATION OF CLINICAL LABORATORIES › Section 8:44-2.12 - Inspection and registration concerning handling of live microorganisms or viruses pathogenic for humans, or birds

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Laboratories or
				other places where live microorganisms or viruses pathogenic for humans, animals, or
				birds are handled, cultivated or kept shall be subject to inspection and
				reinspection at any time by authorized representatives of the Department of
				Health.
(b) The director of a laboratory
				or person in charge of any other place where live microorganisms or viruses
				pathogenic for humans, animals, or birds are handled, cultivated or kept shall, on
				forms provided by the Department of Health, register such laboratory or place with
				the Department between the dates of March 1, 1954 and April 1, 1954. Such
				laboratories or other places established on or after April 1, 1954 shall register
				with the Department prior to handling, cultivating, keeping, selling, transporting
				or otherwise disposing of live microorganisms or viruses covered by this Section.
1. Laboratories or other places required to be
				registered under the provisions of this Chapter shall promptly forward all
				information requested by the Department.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 2 - OPERATION OF CLINICAL LABORATORIES › Section 8:44-2.13 - Sale, transportation or other disposal of live microorganisms or viruses pathogenic for humans, animals, or birds

Current through Register Vol. 56, No. 14, July 15, 2024
Live microorganisms or viruses pathogenic for humans or birds
				  shall not be sold, knowingly transported or otherwise disposed of in viable form
				  without written permission of the Department of Health, excepting:
(a) Such products manufactured and clearly
				identified, as required by law, by manufacturers of biologics licensed by the United
				States government and in compliance with Federal postal and other regulations;
				or
(b) Diseased tissue, exudate, or
				other specimens which are enroute to laboratories for the sole purpose of laboratory
				examination as an aid in diagnosis or control of disease and which are transported
				in compliance with Federal postal regulations or under conditions as may be
				prescribed by the Department and sent by physicians licensed to practice medicine
				and surgery in this State, by veterinarians licensed to practice veterinary medicine
				in this State or by licensed health officers of this State in the performance of
				their official duties.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 2 - OPERATION OF CLINICAL LABORATORIES › Section 8:44-2.14 - Collection stations and patient service centers

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A clinical
				laboratory that operates a collection station in a physician's office, also known as
				in-office phlebotomy, shall be limited to collecting specimens from patients of the
				medical practice in which the collection station is located, and shall comply with
				the following provisions:
1. The collection
				station shall be licensed under this chapter and the license shall be prominently
				displayed in the collection station area;
2. No reimbursement, fees or any other type of
				direct or indirect payment shall be made to the physician including, but not limited
				to, payment of rent or other consideration for the space used for the collection
				station;
3. Laboratory staff in the
				collection station shall perform no services for the physician that are normally the
				responsibility of the physician's office staff, such as taking patient vital signs
				or other nursing functions, drawing specimens or performing testing for the
				physician office laboratory or performing clerical services;
4. Laboratory staff in the collection station
				shall not be shared with, jointly employed or retained as independent contractors by
				the physician or persons affiliated with the office where the collection station is
				located;
5. Except as necessary for the
				reporting of test results, the laboratory shall not provide office supplies,
				equipment, waste disposal services, test kits for the physician's own use,
				electronic medical records systems or other goods or services to the physician;
				and
6. A copy of the signed lease or
				agreement shall be made available to the Department upon request.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 3 - LIMITED PURPOSE LABORATORY › Section 8:44-3.1 - Limited purpose laboratory; definition and minimum protocols

Current through Register Vol. 56, No. 14, July 15, 2024
(a) "Limited purpose
				laboratory" means a facility operated by a not-for-profit organization receiving
				grant funds from the Department of Health and Senior Services, hereinafter known as
				the Department, to operate a counseling and testing site to conduct rapid FDA
				licensed point-of-care tests for Human Immunodeficiency Virus (HIV).
(b) A limited purpose laboratory shall establish
				the following protocols at a minimum:
1. Follow-up
				protocols to ensure that Food and Drug Administration (FDA) approved confirmatory
				testing is performed;
2. A protocol for
				the review of test results by the laboratory director and general
				supervisor;
3. Protocols to ensure that
				individuals with abnormal results are referred to an appropriate source of medical
				care and prevention services; and
4.
				Personnel policies, practices and procedures that adequately support sound rapid FDA
				licensed point-of-care testing practices.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 3 - LIMITED PURPOSE LABORATORY › Section 8:44-3.2 - Applicability of subchapter

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The subchapter
				applies to limited purpose laboratories as defined in
				8:44-3.1(a).
(b) If a limited purpose laboratory is operated at
				more than one site, each site shall require a separate license.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 3 - LIMITED PURPOSE LABORATORY › Section 8:44-3.3 - Director

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A limited purpose
				laboratory shall be under the direction of a laboratory director as specified in
				8:44-2.3(b)2, 3, 4, and
				5, and 2.3(c).
(b) The laboratory
				director can direct multiple limited purpose laboratories which share a quality
				assurance program and laboratory policies and these shall count as one clinical
				laboratory for the purpose of
				8:44-2.3(b)  1. The
				laboratory director can direct no more than five limited purpose laboratories whose
				quality assurance program and laboratory policies are not identical and these shall
				count as one clinical laboratory for the purpose of
				8:44-2.3(b)1.
(c) The laboratory director shall, at a minimum,
				serve the limited purpose laboratory on a regular part-time basis to ensure that the
				provisions of this subchapter are met.
(d) The laboratory director shall be readily
				available for personal or telephone consultation with staff.
(e) The laboratory director shall be responsible
				for the proper performance of all testing procedures and for ensuring the competency
				of all persons performing point of care testing.
(f) The laboratory director shall arrange for a
				qualified substitute director, prior to the director's absence.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 3 - LIMITED PURPOSE LABORATORY › Section 8:44-3.4 - Supervision

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A limited purpose
				laboratory shall be supervised by a person, designated as the general supervisor,
				who can be, but is not limited to being, a physician, professional registered nurse,
				counseling and testing site coordinator, or health educator, approved by the
				laboratory director, who, under the general direction of the laboratory director,
				supervises testing personnel and the report of findings, and in the absence of the
				laboratory director, is responsible for the proper performance of all laboratory
				procedures.
1. Limited purpose laboratory records
				including, but not limited to, patient accession, testing, test results, quality
				control and temperature monitoring, shall be reviewed at least monthly by the
				laboratory director, general supervisor, or qualified designee of the laboratory
				director.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 3 - LIMITED PURPOSE LABORATORY › Section 8:44-3.5 - Screening tests performed

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A limited purpose
				laboratory shall perform only those tests and procedures that are expressly approved
				by the Department pursuant to
				8:44-3.1(a).
(b) A limited purpose laboratory shall perform
				proficiency testing in accordance with
				8:44-2.5(b)  for each
				location where testing is performed except where multiple limited purpose
				laboratories are operated by the same non-profit organization and share the same
				laboratory director, quality assurance program, policies and procedures and testing
				personnel, proficiency testing can be performed at one limited purpose laboratory
				location.
(c) A limited purpose
				laboratory or sponsoring organization may promote the testing services offered by
				the limited purpose laboratory by advertising, community outreach program and any
				other means of public notice.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 3 - LIMITED PURPOSE LABORATORY › Section 8:44-3.6 - Management of a limited purpose laboratory

Current through Register Vol. 56, No. 14, July 15, 2024
A limited purpose laboratory shall maintain records and
				  facilities that are adequate and appropriate for the services offered. There shall
				  be documentation of appropriate training for staff involved in the implementation of
				  these procedures and methods. The training shall address all areas included in the
				  CDC Quality Assurance Guidelines and shall include protocols for the management of
				  occupational exposures to bloodborne pathogens following Appendix A Practice
				  Recommendations for Health-Care Facilities Implementing the U.S. Public Health
				  Service Guidelines for Management of Occupational Exposures to Bloodborne Pathogens,
				  published in Volume 50/No. RR-11 of Morbidity and Mortality Weekly Report issued by
				  the CDC and available at
http://www.cdc.gov/mmwr/indrr
2001.html,
				  incorporated herein by reference, as amended and supplemented.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 3 - LIMITED PURPOSE LABORATORY › Section 8:44-3.7 - Procedure manual

Current through Register Vol. 56, No. 14, July 15, 2024
A procedure manual shall be kept for all protocols and all
				  procedures used for the rapid FDA licensed point-of-care test for Human
				  Immunodeficiency Virus (HIV) performed or offered by the limited purpose laboratory.
				  Each protocol or procedure shall be reviewed and dated by the laboratory director at
				  least annually.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 3 - LIMITED PURPOSE LABORATORY › Section 8:44-3.9 - Collection of specimens

Current through Register Vol. 56, No. 14, July 15, 2024
Properly trained personnel designated by the laboratory director
				  of the limited purpose laboratory may collect blood or material for screening and/or
				  confirmatory procedures from an individual patient, under the direction of the
				  laboratory director.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 3 - LIMITED PURPOSE LABORATORY › Section 8:44-3.10 - Disposable equipment

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Syringes, needles,
				lancets, or other bloodletting devices capable of transmitting infection from one
				person to another shall not be reused and shall be in conformance with
				26:2H-5.1 2 et seq., New Jersey Safety
				Needle Act, and with the Federal regulations at
				29 C.F.R.
				1910.1030.
(b) Management and disposal of all regulated
				medical waste shall be in conformance with the New Jersey Regulated Medical Waste
				Management Act,
				13:1E-48.1 et seq., and N.J.A.C.
				7:26-3, Regulation Medical Waste.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 3 - LIMITED PURPOSE LABORATORY › Section 8:44-3.11 - Records of specimens

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A limited purpose
				laboratory shall maintain a record indicating the daily accession of specimens, each
				of which is numbered or otherwise appropriately identified. Records shall contain
				the following information:
1. The number or other
				identification of the specimen;
2. The
				name or other identification that can be linked to a person or anonymous client from
				whom the specimen was taken;
3. The date
				the specimen was collected and tested;
4. The time the test is started and when the test
				is read, for time dependent tests;
5.
				The results of the test including all duplicate or invalid test results;
6. The identity of the person performing the
				test;
7. The name and address of the
				laboratory where confirmatory testing is performed; and
8. Date confirmatory test specimen sent and date
				test results received by the referring limited purpose laboratory.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 3 - LIMITED PURPOSE LABORATORY › Section 8:44-3.12 - Examinations and reports

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A limited purpose
				laboratory shall perform tests at the request of a licensed physician or other
				person qualified by law to order tests. The request need not be patient specific and
				can be a standing order.
(b) The results
				of the rapid FDA licensed point-of-care test for Human Immunodeficiency Virus (HIV)
				performed by a limited purpose laboratory shall be conveyed to the patient by a New
				Jersey Department of Health and Senior Services trained HIV counselor.
(c) When requested, the original or true duplicate
				of the results shall be sent promptly to the physician who is designated by the
				individual patient to receive a report.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 3 - LIMITED PURPOSE LABORATORY › Section 8:44-3.13 - Report records

Current through Register Vol. 56, No. 14, July 15, 2024
True duplicate copies or a suitable record of test reports shall
				  be filed in the limited purpose laboratory in a manner which permits ready
				  identification and accessibility. All reports shall be preserved for a period of at
				  least two years after the date of the test.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 3 - LIMITED PURPOSE LABORATORY › Section 8:44-3.14 - Quality control and quality assurance

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Quality controls
				imposed on and practiced by the limited purpose laboratory shall provide for and
				include written records to assure the following:
1. Preventive maintenance, periodic inspection,
				and testing for proper operation of equipment as may be appropriate based on the
				frequency of the testing sessions and on the number of tests performed; evaluation
				of reagents; surveillance of results; and remedial action to be taken in response to
				detected defects;
2. Adequacy of
				facilities, equipment, and methods for performance of the procedures for which
				licensure is approved; proper lighting for accuracy and precision; convenient
				location of essential utilities; monitoring of temperature-controlled spaces and
				equipment to assure proper performance; and evaluation of analytical measuring
				devices with respect to all critical operating characteristics;
3. Labeling of all reagents and solutions to
				indicate identity, recommended storage requirements, expiration date, and other
				pertinent information. Materials of substandard reactivity and deteriorated
				materials shall not be used. All outdated material shall be discarded
				immediately;
4. The availability at all
				times, in the immediate bench area of personnel engaged in examining specimens and
				performing related procedures, of current laboratory manuals or other complete
				written descriptions and instructions relating to:
i. The methods used by those personnel, properly
				designated and dated to reflect the most recent supervisory reviews;
ii. Reagents; and
iii. Control procedures;
5. Written approval by the laboratory director of
				all changes in laboratory procedures;
6.
				Maintenance and availability of records to laboratory personnel and to the
				Department, reflecting dates and, where appropriate, the nature of inspection,
				validation, remedial action, monitoring, evaluation and changes and dates of changes
				in laboratory procedures; and
7.
				Acceptance by the limited purpose laboratory of only specimens that have been
				properly collected, labeled, processed, in such a manner as to assure identity of
				the specimen with respect to the requested tests.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 3 - LIMITED PURPOSE LABORATORY › Section 8:44-3.15 - Initial and renewal licensure fees

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Licensure fees for
				the limited purpose laboratory are not specified in
				8:45-1.3.
(b) Initial and annual renewal licensure fees for
				the limited purpose laboratory shall be prescribed as $ 100.00 per
				location.
(c) Limited purpose
				laboratories shall remit an additional fee of $ 50.00 for renewal applications when
				the renewal application does not meet the November 1 deadline specified in
				8:45-1.2(b)  and it is
				submitted after December 31.
(d) Limited
				purpose laboratories shall pay a fee of $ 50.00 for replacement of a license due to
				change of address.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 3 - LIMITED PURPOSE LABORATORY › Section 8:44-3.16 - Compliance

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The limited purpose
				laboratory shall comply with the provisions set forth in this subchapter and the
				following:
1. Licensure requirements as specified
				in 8:45-1.1 and
				8:45-1.2; and
2. Inspections of the limited purpose laboratory
				by any authorized representative of the Department of Health and Senior
				Services.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 45 - CLINICAL LABORATORY SERVICES › Subchapter 1 - LICENSURE OF CLINICAL LABORATORIES › Section 8:45-1.1 - Initial licensure

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Application for an
				initial license to conduct a clinical laboratory, as required under the provisions
				of Chapter 166, P.L. 1975, commonly known as the New Jersey Clinical Laboratory
				Improvement Act, shall be made on forms provided for that purpose by the New Jersey
				State Department of Health.
(b) Each
				license to operate a clinical laboratory will specify those laboratory procedures or
				categories of procedures which the laboratory is authorized to perform.
(c) No license issued under these regulations
				shall be transferable.
(d) A new license
				shall be obtained whenever the location, ownership or director of a clinical
				laboratory is changed.
(e) The license
				shall be conspicuously displayed by the licensee on the premises of a clinical
				laboratory.
(f) A separate license shall
				be required for each location.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 45 - CLINICAL LABORATORY SERVICES › Subchapter 1 - LICENSURE OF CLINICAL LABORATORIES › Section 8:45-1.2 - Annual renewal of licensure

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All clinical
				laboratory licenses shall be issued on or before January 1 in each calendar year and
				shall expire December 31 in each calendar year.
(b) The Department will provide applications for
				licensure renewal on or before October 1 of each year to be completed properly and
				returned to the Department, together with appropriate licensure renewal fee, on or
				before the succeeding November 1. The Department will mail license renewals to
				clinical laboratories not later than January 1, of the succeeding year.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 45 - CLINICAL LABORATORY SERVICES › Subchapter 1 - LICENSURE OF CLINICAL LABORATORIES › Section 8:45-1.3 - Licensure fees

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Initial and annual renewal licensure fees
				shall be identical and are prescribed by the following table. Fees noted shall be
				payable per each specialty.
Total Number of Employees of Entire
						  Laboratory[LESS THAN] 1 [GREATER THAN]
Specialty
1-9
10-29
30-49
50-89
90
						  or more
Urinalysis
$ 200.00
$ 250.00
$
						  300.00
$ 350.00
$ 400.00
Mycobacteriology
$ 200.00
$ 250.00
$
						  300.00
$ 350.00
$ 400.00
Parasitology
$ 200.00
$ 250.00
$
						  300.00
$ 350.00
$ 400.00
Mycology
$ 200.00
$ 250.00
$
						  300.00
$ 350.00
$ 400.00
Bacteriology
$ 200.00
$ 250.00
$
						  300.00
$ 350.00
$ 400.00
Virology
$ 200.00
$ 250.00
$
						  300.00
$ 350.00
$ 400.00
Serology
$ 200.00
$ 250.00
$
						  300.00
$ 350.00
$ 400.00
Hematology
$ 200.00
$ 250.00
$
						  300.00
$ 350.00
$ 400.00
Immunohematology
$ 200.00
$ 250.00
$
						  300.00
$ 350.00
$ 400.00
Routine Chemistry
$ 200.00
$
						  250.00
$ 300.00
$ 350.00
$ 400.00
Endocrinology
$ 200.00
$ 250.00
$
						  300.00
$ 350.00
$ 400.00
Toxicology
$ 200.00
$ 250.00
$
						  300.00
$ 350.00
$ 400.00
Cytology
$ 200.00
$ 250.00
$
						  300.00
$ 350.00
$ 400.00
Cytogenics and/or
$ 200.00
$
						  250.00
$ 300.00
$ 350.00
$ 400.00
tissue typing
Collection Station
$ 200.00 per
						  site
only
Waived Tests only
$ 200.00 per site
[LESS THAN] 1 [GREATER THAN] Exclusive of
						  director, trainees in approved medical technologist
schools, clerical and maintenance employees.
						  Part-time employees are to be
included, prorated to full-time
						  equivalents.
(b)
				Laboratories shall remit an additional fee of $ 100.00 for renewal applications
				submitted after December 31 in order for the Department to process the renewal
				application.
(c) Laboratories shall pay
				a fee of $ 100.00 for replacement of a license due to a change of address.
(d) Notwithstanding (a), (b), and (c) above,
				during the period of the COVID-19 Public Health Emergency, clinical laboratories may
				open collection stations without paying the related licensure fees in (a) above, if
				they meet the requirements of
				N.J.A.C.
				8:44-2.14(d).
(e) This temporary waiver/modification is
				effective only during the period of the Public Health Emergency declared by Governor
				Philip D. Murphy in Executive Order No. 103. This temporary rule waiver/modification
				shall expire 45 days after the Public Health Emergency has ended. Upon the
				expiration of this temporary rule waiver/modification, all collection stations will
				need to comply with the licensure and fee requirements set forth at
				N.J.A.C.
				8:44-2.14 and this section.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 45 - CLINICAL LABORATORY SERVICES › Subchapter 2 - LABORATORY CHARGES › Section 8:45-2.1 - Fees; generally

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The following fees-for-service apply to
				laboratory tests that the Department of Health performs:
Laboratory Test
Inborn Errors of Metabolism
$ 90.00
(PKU, T4 Galactosemia, Sickle Cell, Biotinidase
Deficiency, CAH, Cystic Fibrosis, MSUD, MCAD, SCAD,
, LCAD, VLCAD, Citrullinemis, Argininosuccinic
						  Acidemia,
PA, MMA, GA-1, IVA, HMG, 3-MMC)
Toxoplasmosis
$ 15.00
Rubella Screen
$ 10.00
Blood Lead
$ 12.00
Mycobacteriology (TB)
$ 30.00
Water Bacteriology
$ 15.00
Bacteriology Culture
$ 30.00
Susceptibility Studies (TB)
$ 30.00
Isolation of Special Pathogens
$ 30.00
Parasitology
$ 15.00
Lyme Disease
$ 20.00
(b)
				Effective November 1, 1992, the following additional fee-for-service charges shall
				also apply:
Bacteriology
Lyme Disease
$ 20.00
Specimen Transport Kits (each kit)
$ 1.00
(c) The
				following fee-for-service applies:
Newborn Screening Program:
$ 150.00
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 50 - STANDARDS FOR INDOOR ENVIRONMENT CERTIFICATION AND FOR LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Subchapter 1 - GENERAL PROVISIONS › Section 8:50-1.1 - Purpose

Current through Register Vol. 56, No. 14, July 15, 2024
The purpose of this chapter is to implement the obligations of
				  the Department of Health and Senior Services pursuant to
				  P.L.
				  2007, c. 1, an Act
				  concerning contaminated property, supplementing Title 52 of the Revised Statutes,
				  and amending and supplementing P.L. 1983, c. 330 (Act) at §§ 1 and 2,
				  52:27D-130.4 and 130.5.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 50 - STANDARDS FOR INDOOR ENVIRONMENT CERTIFICATION AND FOR LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Subchapter 1 - GENERAL PROVISIONS › Section 8:50-1.2 - Scope

Current through Register Vol. 56, No. 14, July 15, 2024
(a) This chapter
				establishes procedures by which to:
1. Obtain
				licensure as an indoor environmental consulting firm;
2. Conduct an indoor environmental health
				assessment of buildings to be used as either child care centers or educational
				facilities;
3. Conduct an indoor
				environmental health assessment of certain facilities required to obtain a
				construction permit for the reconstruction, alteration, conversion or repair of a
				building to be used as a child care center or educational facility if that building
				was either:
i. Used for industrial, storage or
				high hazard purposes, as a nail salon, for dry cleaning or as a gasoline station;
				or
ii. Located on a contaminated site, a
				site suspected of contamination or a site that is subject to the Industrial Site
				Recovery Act, 13:1K-6 et seq., and the rules
				promulgated pursuant thereto at N.J.A.C. 7:26B; and
4. Obtain a safe building interior certification.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 50 - STANDARDS FOR INDOOR ENVIRONMENT CERTIFICATION AND FOR LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Subchapter 2 - LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Section 8:50-2.1 - Application for license

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A person or entity
				that seeks to apply for an indoor environmental consultant license shall submit the
				completed application forms at chapter Appendix A, incorporated herein by reference,
				which shall be signed by an authorized representative of the entity.
(b) The applicant shall submit with the
				application a nonrefundable application fee of $ 2,000 by certified check or money
				order made payable to the Treasurer, State of New Jersey.
(c) The applicant shall submit with the
				application documentation in support of the application pursuant to (d) below using
				electronic media, such as a compact disk or a flash drive.
1. Licensees shall provide documents that are not
				susceptible to submission by electronic media due to size or other unwieldiness,
				such as maps or drawings, in hardcopy with the electronic media
				submission.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 50 - STANDARDS FOR INDOOR ENVIRONMENT CERTIFICATION AND FOR LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Subchapter 2 - LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Section 8:50-2.2 - Granting of license

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Department shall
				grant an application for licensure of an indoor environmental consultant after
				consideration of the materials the applicant submits pursuant to
				8:50-2.1, upon a finding that the
				applicant meets the education and experience requirements in
				8:50-2.1(d)2, the
				insurance requirements at
				8:50-2.1(g)  and upon
				being satisfied, upon a review of the applicant's history in the field and
				experience with governmental agencies, that the granting of licensure would not be
				inimical to the public interest.
(b) A
				license issued pursuant to this chapter shall:
1.
				Be in writing;
2. Be valid for two years
				from the date of issuance;
3. Contain
				the date of expiration;
4. Contain the
				name and business address of the consultant to whom it is issued;
5. Be signed by the Commissioner or his or her
				designee; and
6. Be
				non-transferable.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 50 - STANDARDS FOR INDOOR ENVIRONMENT CERTIFICATION AND FOR LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Subchapter 2 - LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Section 8:50-2.3 - Identification of license

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The licensee shall
				make available for inspection at each worksite either the original or a true
				photocopy of the license on request of the Department, the contracting agency and/or
				the owner or the owner's representative.
(b) The licensee shall use the license number on
				all business correspondence.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 50 - STANDARDS FOR INDOOR ENVIRONMENT CERTIFICATION AND FOR LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Subchapter 2 - LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Section 8:50-2.4 - Renewal of indoor environmental consultant license

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Department shall
				transmit a renewal application to licensees in good standing 60 days prior to the
				expiration of each licensee's license.
(b) If the licensee submits the renewal
				application and the fee specified in (c) below to the Department at least 30 days
				prior to expiration date of the licensee's existing license, the license shall
				continue without expiration until the Commissioner renders a determination on the
				renewal application.
(c) An applicant
				for renewal of an indoor environmental consultant license shall submit a
				nonrefundable application fee of $ 2,000 by certified check or money order made
				payable to the Treasurer, State of New Jersey, with the application for
				renewal.
(d) Renewal of a license is
				contingent upon the satisfaction of outstanding fines, penalties or other
				obligations imposed on the applicant pursuant to the Act or this chapter.
(e) The Department shall treat an application for
				renewal of a license that is filed untimely pursuant to (b) above as an initial
				application and the extension period applicable to timely filed applications for
				renewal established pursuant to (b) above shall not apply.
(f) The replacement cost of an altered, defaced,
				mutilated or lost license is $ 50.00.
1. The
				Commissioner or his or her designee shall review a request for license replacement
				to verify the identity of the licensee and may condition issuance of a replacement
				license upon the requester's submission of supporting documentation as necessary to
				confirm the requester's identity.
2. In
				support of an application for a replacement license, the licensee shall provide a
				written description, to the best of the licensee's knowledge, information and
				belief, of the disposition of the original license, to which writing the licensee
				shall append the following statement: "I certify that the foregoing statements made
				by me are true. I am aware that if any of the foregoing statements made by me are
				willfully false, I am subject to punishment."; and below which statement the
				licensee shall place his or her original signature.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 50 - STANDARDS FOR INDOOR ENVIRONMENT CERTIFICATION AND FOR LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Subchapter 2 - LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Section 8:50-2.5 - Suspension, denial or revocation of a license

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Department may
				suspend, deny or revoke licensure of a person or entity that violates the Act or
				this chapter.
(b) An individual whose
				license the Department has revoked shall be ineligible to reapply for licensure for
				two years from the date of revocation.
(c) If the Commissioner proposes to deny, revoke
				or suspend a license and/or assess an administrative penalty, the individual,
				applicant or licensee shall have the right to an informal conference, a hearing or
				both, pursuant to N.J.A.C. 8:50-5.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 50 - STANDARDS FOR INDOOR ENVIRONMENT CERTIFICATION AND FOR LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Subchapter 2 - LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Section 8:50-2.6 - Licensee recordkeeping obligation

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Licensees shall
				retain records and documents pertaining to any assessment the licensee conducts in
				accordance with the Act or this chapter for a period of five years from the date of
				completion of the assessment unless the Department establishes and directs the
				licensee to observe, a longer period of retention in a particular case.
(b) Licensees shall make records and documents
				retained pursuant to (a) above available for inspection upon request of the
				Department.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 50 - STANDARDS FOR INDOOR ENVIRONMENT CERTIFICATION AND FOR LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Subchapter 3 - EVALUATION AND ASSESSMENT OF BUILDINGS AND LEASED SPACES FOR USE AS CHILD CARE CENTERS AND EDUCATIONAL FACILITIES › Section 8:50-3.2 - Reporting the results of the indoor environmental health assessment in child care centers and educational facilities

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Licensees shall
				report results of IEHAs using the forms provided at chapter Appendix B, incorporated
				herein by reference, by means of electronic media, such as a compact disk or flash
				drive.
1. Licensees shall provide documents that
				are not susceptible to submission by electronic media due to size or other
				unwieldiness, such as maps or drawings, in hardcopy with the electronic media
				submission.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 50 - STANDARDS FOR INDOOR ENVIRONMENT CERTIFICATION AND FOR LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Subchapter 4 - PROCEDURES FOR DETERMINING MAXIMUM CONTAMINANT LEVELS AND ISSUANCE OF CERTIFICATION OF SAFE BUILDING INTERIOR › Section 8:50-4.1 - Determination of maximum contaminant levels (MCLs) for child care centers and educational facilities

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Department will
				determine MCLs identified in child care centers and educational facilities using
				site-specific data reported in the IEHA and/or additional data collected and
				analyzed by the Department, by calculating cancer and non-cancer risk using the
				formulae in (b) below and corresponding to the following:
1. The risk for cancer shall be less than one in
				10,000 (10[LESS THAN]-4[GREATER THAN]); and
2. The risk for non-cancer health effects shall be
				a target hazard quotient of less than one.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 50 - STANDARDS FOR INDOOR ENVIRONMENT CERTIFICATION AND FOR LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Subchapter 4 - PROCEDURES FOR DETERMINING MAXIMUM CONTAMINANT LEVELS AND ISSUANCE OF CERTIFICATION OF SAFE BUILDING INTERIOR › Section 8:50-4.2 - Procedure for issuance of safe building interior certification

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Department shall
				issue a certification of safe building interior provided an applicant adheres to the
				evaluation and assessment procedures in this chapter and submits:
1. The completed application form at chapter
				Appendix B indicating that the building interior meets the applicable standards for
				cancer and non-cancer health effects at
				8:50-4.1(a), subject to
				(b) below; and
2. The fee established at
				(e) below.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 50 - STANDARDS FOR INDOOR ENVIRONMENT CERTIFICATION AND FOR LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Subchapter 5 - COMPLIANCE AND ENFORCEMENT › Section 8:50-5.1 - Scope of subchapter

Current through Register Vol. 56, No. 14, July 15, 2024
This subchapter establishes procedures for the enforcement of
				  compliance with the Act at §§ 1 and 2,
				  52:27D-130.4 and 130.5, and this
				  chapter.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 50 - STANDARDS FOR INDOOR ENVIRONMENT CERTIFICATION AND FOR LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Subchapter 5 - COMPLIANCE AND ENFORCEMENT › Section 8:50-5.2 - Compliance

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All individuals,
				applicants and licensees falling within the scope of this chapter shall comply with
				this chapter.
(b) All child care centers
				and educational facilities shall comply with this chapter.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 50 - STANDARDS FOR INDOOR ENVIRONMENT CERTIFICATION AND FOR LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Subchapter 5 - COMPLIANCE AND ENFORCEMENT › Section 8:50-5.3 - Statement of imminent hazard

Current through Register Vol. 56, No. 14, July 15, 2024
If the Commissioner determines that there is an imminent threat
				  to public health, safety or welfare, the Commissioner may order a licensee, a child
				  care facility and/or an educational facility to cease and desist operations and/or
				  to take other measures as the Commissioner determines to be necessary to remove,
				  abate and/or remediate the imminent threat, until the imminent threat is removed,
				  abated and remediated.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 50 - STANDARDS FOR INDOOR ENVIRONMENT CERTIFICATION AND FOR LICENSURE OF INDOOR ENVIRONMENTAL CONSULTANTS › Subchapter 5 - COMPLIANCE AND ENFORCEMENT › Section 8:50-5.4 - Right of entry

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Department
				representatives shall have the right of entry and are empowered to enter and inspect
				all premises to investigate and ascertain compliance or non-compliance with this
				chapter.
(b) No person shall require
				Department representatives in pursuance of their official duties to provide notice
				or seek permission to conduct inspections or investigations.
(c) No person shall impede or refuse entry to
				Department representatives in the course of their official duties for any reason,
				including reasons of regulatory or contractual specification.