reglab/statecodes huggingface dataset:
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-8 - Reproductive Tissue Banks › Section 52-8.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
As used in this Part:
(a) Anonymous donor means a donor whose
					 identity is unknown to the recipient.
(b) Artificial insemination means the
					 placement of semen within the body of a recipient.
(c) Assisted reproductive procedure means a
					 medical procedure intended to result in conception, including, but not limited
					 to, in vitro fertilization (including intracytoplasmic sperm injection), embryo
					 transfer and gamete intrafallopian transfer.
(d) Client-depositor means an individual who
					 deposits reproductive tissue prior to intended or potential use in artificial
					 insemination or assisted reproductive procedures performed solely on themself
					 or their regular sexual partner.
(e) Directed donor means a donor who is known
					 to the recipient and who directs his or her reproductive tissue for use by a
					 particular recipient. This includes a man providing semen to a surrogate, but
					 who is not the regular sexual partner of the recipient.
(f) Donor means a person who provides
					 reproductive tissue for use in artificial insemination or assisted reproductive
					 procedures performed on recipients other than that person or that person's
					 regular sexual partner, and includes directed donors.
(g) Reproductive tissue bank means a facility
					 which acquires, processes, stores, distributes and/or releases reproductive
					 tissue to an insemination/implantation site for use in artificial insemination
					 or assisted reproductive procedures. Reproductive tissue banks include, but are
					 not limited to, semen banks, oocyte donation programs and embryo
					 banks.
(h)
					 Insemination/implantation site means a location at which artificial
					 insemination or assisted reproductive procedures are performed, using
					 reproductive tissue from anonymous donors, directed donors and/or
					 client-depositors. Licensed insemination/implantation sites may undertake,
					 without additional licensure, semen processing, limited to washing,
					 concentrating and storing of semen from patients of physicians associated with
					 the licensed insemination/implantation sites or the patients' regular sexual
					 partners, as well as limited semen storage (less than six months'
					 duration).
(i) Recipient means a
					 woman who receives reproductive tissue from a donor or
					 client-depositor.
(j) Semen
					 processing facility means a tissue processing facility that processes semen for
					 use by other licensed reproductive tissue banks and insemination/implantation
					 sites.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-8 - Reproductive Tissue Banks › Section 52-8.2 - Licensure

Current through Register Vol. 46, No. 28, July 10, 2024
Reproductive tissue banks, insemination/implantation
						sites and semen processing facilities shall not operate unless licensed as
						tissue banks pursuant to Subpart 52-2 of this Part.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-8 - Reproductive Tissue Banks › Section 52-8.3 - Administrative responsibility

Current through Register Vol. 46, No. 28, July 10, 2024
The reproductive tissue bank director shall assume
						overall responsibility for operation of the reproductive tissue bank. The
						reproductive tissue bank director shall meet the requirements of section
						52-2.5(a)(2) 
						of this Part. The training and/or experience requirements specified in section
						52-2.5 
						of this Part shall be in the field of reproductive endocrinology, andrology,
						human fertility or a closely related field. The reproductive tissue bank
						director shall develop and implement policies and procedures consistent with
						this Subpart for the operation of the bank. If the reproductive tissue bank
						director is not a physician, a medical director who meets the requirements of
						section
						52-2.5(a)(3) 
						of this Part shall be retained. Except for insemination/implantation sites,
						reproductive tissue banks shall have a medical advisory committee, composed of
						at least five members with experience and expertise in the fields of human
						fertility, infectious disease, clinical pathology or related fields, who shall
						be responsible for monitoring the medical efficacy of the reproductive tissue
						bank and reviewing operating policies and procedures. If the bank acquires
						reproductive tissue from donors, a qualified microbiologist, clinical
						pathologist or infectious disease specialist, and a geneticist shall serve
						either as members of or consultants to the committee.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-8 - Reproductive Tissue Banks › Section 52-8.4 - Direction and medical direction

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Medical direction of a reproductive
					 tissue bank shall be provided by the medical director in consultation with the
					 medical advisory committee, if applicable.
(b) Except for insemination/implantation
					 sites, the reproductive tissue bank director, in consultation with the medical
					 director, if not the same person, and the medical advisory committee shall
					 monitor the efficacy of the reproductive tissue banking program and shall, as a
					 minimum, develop:
(1) medical criteria for
					 donor participation;
(2) quality
					 standards for sperm, oocytes, embryos and other reproductive tissue, as
					 applicable; and
(3) guidelines for
					 determining a maximum number of offspring per donor to minimize the probability
					 of consanguinity.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-8 - Reproductive Tissue Banks › Section 52-8.5 - Donor qualifications

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 The reproductive tissue bank shall initially screen and periodically assess
					 donors for conditions that may adversely affect the quality of reproductive
					 tissue or impair the recipient's and/or the offspring's health. Reproductive
					 tissue donor screening shall, except as provided in section
					 52-8.6(g) 
					 of this Subpart, be performed prior to the initial collection of reproductive
					 tissue for clinical use, and shall include a physical examination, as well as
					 an examination for indications of sexually transmissible diseases.
(b) A complete medical history, both
					 individual and family, including first-degree and second-degree relatives,
					 shall be obtained from each reproductive tissue donor prior to any collection
					 of tissue for clinical use, and shall include, but not be limited to, incidence
					 of the following:
(1) major malformations of
					 complex cause that result in serious functional or cosmetic defects, including,
					 but not limited to spina bifida or heart malformations;
(2) major genetic disorders, including:
(i) autosomal dominant or X-linked disorders
					 for which age of onset extends beyond the age of the donor;
(ii) autosomal dominant disorders with
					 reduced penetrance; and
(iii)
					 autosomal recessive disorders;
(3) for semen donors, systemic disease which
					 may affect the decision to use the semen;
(4) for semen donors, infectious skin disease
					 that may create a risk of contamination of the semen;
(5) history of sexually transmissible
					 disease, including herpes simplex virus type 2;
(6) more than one sexual partner within the
					 last six months;
(7) previous
					 exclusion from blood donation for reasons of infectious disease;
(8) receipt of a blood transfusion within the
					 past year;
(9) for semen donors,
					 known episodes of trichomoniasis in a sexual partner;
(10) history of an occupation with increased
					 risk of radiation or chemical exposure, or known such exposure;
(11) known history of alcohol
					 abuse;
(12) history of behavior or
					 factors which place the donor at increased risk for human immunodeficiency
					 virus (HIV), hepatitis B virus (HBV) or hepatitus C virus (HCV) infection, as
					 determined by the United States Public Health Service (USPHS);
(13) all conditions listed in section
					 52-3.4(a) 
					 of this Part; and
(14) other
					 conditions as determined by the reproductive tissue bank director, medical
					 director and medical advisory committee.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-8 - Reproductive Tissue Banks › Section 52-8.6 - Required laboratory tests

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 For reproductive tissue banks located within New York State, all required
					 clinical laboratory testing shall be performed by a laboratory operating under
					 a permit issued by the department. For out-of-state reproductive tissue banks,
					 all required clinical laboratory testing shall be performed by a laboratory
					 which is approved by that state's regulating authority, the Centers for
					 Medicare and Medicaid Services, or by the department.
(b) The following laboratory tests shall be
					 performed prior to donor acceptance and, except as specified in subdivision (g)
					 of this section, initial collection of donor semen for clinical use:
(1) Blood shall be tested for:
(i) determination of ABO and Rh blood groups;
					 and
(ii) antibodies to HIV-1, human
					 immunodeficiency virus type 2 (HIV-2), human T-lymphotropic virus type I
					 (HTLV-I), hepatitis B core antigen (HBc), and to hepatitis C virus (HCV), and
					 for hepatitis B surface antigen (HBsAg) and syphilis.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-8 - Reproductive Tissue Banks › Section 52-8.8 - Informed consent

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Reproductive tissue banks shall obtain written informed consent from the donor
					 for participation in the donation program, after the director or a designee has
					 provided information to the donor on the procedures for collection, storage and
					 use of semen, oocytes or embryos, and the risks of any drugs, surgical
					 procedures and/or anesthesia administered. The informed consent shall include:
(1) a statement that the donor has been
					 informed that his or her name and address will be kept on file by the
					 reproductive tissue bank, and advised of the restrictions on release of
					 donor-identifying information specified in section
					 52-8.9  of this
					 Subpart;
(2) authorization for
					 performance of genetic and infectious disease marker testing, consistent with
					 statutory requirements for genetic testing;
(3) notification of all currently known ways
					 in which the donor's reproductive tissue and resulting embryos may be used. If
					 the reproductive tissue bank accepts reproductive tissue with restrictions on
					 the manner in which embryos created may be used, the consent also shall include
					 a statement that the reproductive tissue bank has informed the donor that it
					 will make a good faith effort to ensure that the donor's restrictions are
					 respected, but that it cannot guarantee that the recipients of the reproductive
					 tissue will abide by the donor's restrictions;
(4) authorization for disclosure of the
					 donor's medical history information to potential recipients and their
					 physicians, consistent with statutory requirements for the disclosure of
					 genetic and other medical information;
(5) an explanation of the oocyte donor's
					 extent of responsibility for any costs of any medical complications associated
					 with oocyte donation; and
(6) a
					 statement that the reproductive tissue donor has the right to withdraw his/her
					 consent to donation up until such time that a specific recipient has begun an
					 assisted reproduction cycle in reliance on the availability of tissue from that
					 donor.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-8 - Reproductive Tissue Banks › Section 52-8.9 - Required records

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Reproductive tissue bank records shall be open to inspection by the department
					 and shall be kept for at least seven years after release of reproductive tissue
					 for artificial inseminations or assisted reproductive procedures not resulting
					 in a live birth, and 25 years for inseminations or assisted reproductive
					 procedures known to have resulted in a live birth. For all donated reproductive
					 tissue, the donor's name, address, and any other information which would
					 directly or indirectly identify the donor shall not be disclosed or released by
					 the reproductive tissue bank to any person or entity, except upon the written
					 informed consent of the donor, or except to authorized employees of the
					 department or as permitted by law. The recipient's name, address, and any other
					 information which would directly or indirectly identify the recipient shall not
					 be disclosed or released by the insemination/implantation site to any person or
					 entity, except upon the written informed consent of the recipient, or except to
					 authorized employees of the department, or as permitted by law.
(b) In addition to the recordkeeping
					 requirements of section
					 52-2.9(c) 
					 of this Part, each reproductive tissue bank shall maintain applicable
					 donor/client-depositor records which include:
(1) for donors, pertinent family history of
					 any genetic disorders;
(2)
					 documentation of donor and client-depositor written informed consent;
(3) for semen donors, outcome of any prior
					 artificial insemination or other assisted reproductive procedures, if known,
					 including number of successful pregnancies, if any, and any reports from
					 insemination/implantation sites which would affect the donor's acceptability;
					 and
(4) documented approval of the
					 reproductive tissue bank director, or his/her designee, of the acceptability of
					 the donor.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-8 - Reproductive Tissue Banks › Section 52-8.10 - Quality assurance and safety

Current through Register Vol. 46, No. 28, July 10, 2024
The requirements of section
						52-3.5 
						of this Part shall be met.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-8 - Reproductive Tissue Banks › Section 52-8.11 - Compliance with standards

Current through Register Vol. 46, No. 28, July 10, 2024
A reproductive tissue bank shall allow admission to
						representatives of the department for the purpose of inspecting the premises
						and evaluating operating procedures, equipment, and records, including lists of
						physicians or facilities to whom or to which reproductive tissue has been
						released, to determine compliance with the standards in this Part. If the
						commissioner determines that a significant likelihood exists that adequate
						safeguards are not implemented at a reproductive tissue bank, the department
						may require that reproductive tissue not be released pending a hearing. Such
						hearing shall commence within 15 days of any suspension pursuant to this
						section.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-9 - Human Milk Banks › Section 52-9.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
As used in this Part:
(a) Human milk bank means an organized
					 service for the selection of donors and the collection, processing, storage or
					 distribution of human breast milk for infants or children other than the
					 donor's own infant.
(b) Donor means
					 a lactating woman who voluntarily contributes milk to a human milk bank for use
					 by an infant or child other than her own. A donor shall not receive
					 remuneration for the donation of milk.
(c) Human milk transfer station means the
					 location at which containers of human breast milk are held temporarily between
					 the donation site and the human milk bank.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-9 - Human Milk Banks › Section 52-9.2 - Construction

Current through Register Vol. 46, No. 28, July 10, 2024
Terms not defined in this Subpart are defined in Subpart
						5-21 of this Part. Human milk banks shall apply for licensure and otherwise
						comply with Subpart 52-2 of this Part, and shall meet all general technical
						standards for tissue banks specified in Subpart 52-3 of this
						Part.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-9 - Human Milk Banks › Section 52-9.3 - Administrative responsibility

Current through Register Vol. 46, No. 28, July 10, 2024
The director of a human milk bank shall ensure the
						development and implementation of policies and procedures consistent with this
						Part for the operation of the bank, and the appointment of a medical director
						and a medical advisory committee composed of physicians with experience in
						pediatrics, neonatology, blood banking, nutrition and/or other appropriate
						fields, including at least one member with expertise in infectious diseases, as
						well as other allied health personnel.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-9 - Human Milk Banks › Section 52-9.4 - Medical direction

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Medical direction of a human milk bank shall be provided by a physician, who
					 may also be the director of the bank, in consultation with the medical advisory
					 committee. Such physician shall be licensed and currently registered with the
					 New York State Education Department, and possess a minimum of four years'
					 experience in neonatology, pediatrics, blood banking or a related
					 field.
(b) The medical director and
					 the medical advisory committee shall establish operating procedures and monitor
					 the medical efficacy of milk banking services, and shall, consistent with this
					 Part, develop:
(1) medical criteria for donor
					 participation;
(2) quality
					 standards for the milk, including methodologies and criteria for
					 heat-processing; and
(3) policies
					 for priority distribution of milk when demand exceeds the supply.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-9 - Human Milk Banks › Section 52-9.5 - Donor qualifications

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 The human milk bank shall initially screen and periodically assess the donor
					 for conditions and behavior that may affect the quality or nutritional value of
					 milk, or impair the donor's health, including, but not limited to, the donor
					 qualification requirements in Subpart 52-3 of this Part, and for:
(1) the use of medications, tobacco, alcohol
					 and/or other substances in quantities likely to be harmful if transmitted
					 through human milk to a recipient;
(2) systemic chronic diseases or nutritional
					 deficiencies;
(3) acute and chronic
					 infectious diseases;
(4) emotional
					 conditions and/or behavioral disturbances;
(5) history of jaundice in the donor's own
					 infant after one week of age;
(6)
					 sources of exposures which may be associated with environmental
					 contaminants;
(7) duration of
					 breast feeding; and
(8) general
					 ability to understand and follow directions regarding sanitary collection and
					 storage of the milk, and contraindications to donation.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-9 - Human Milk Banks › Section 52-9.6 - Collection and storage of human milk

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The human milk bank shall supply
					 presterilized, leak-proof containers and container seals to the
					 donor.
(b) Containers shall be
					 accompanied by an affixed tag which shall show the donor's identification
					 number, and the date and time the milk was collected. When frozen milk is held
					 at a transfer station, this tag shall also identify the station, and the date
					 and time of receipt and transport of the milk.
(c) Milk shall be transported and stored so
					 that it is protected from contamination, thawing and refreezing. Milk in liquid
					 form shall be maintained at a temperature between one and six degrees Celsius,
					 but shall be stored in liquid form for no longer than 48 hours. If milk is
					 frozen, it shall be maintained at minus 20 degrees Celsius or below for a
					 maximum storage period of six months, unless the medical advisory committee
					 specifically approves a longer storage period. Household freezers with
					 automatic defrost cycles shall not be used for such storage. Frozen milk shall
					 be utilized within 48 hours of thawing and discarded thereafter if not
					 utilized.
(d) The physical
					 facilities of the human milk bank shall minimize the potential for
					 contamination, as follows:
(1) the human milk
					 bank shall be located in a distinct, identifiable area with a separate
					 refrigerator and/or freezer provided for human milk; and
(2) refrigerators and freezers shall be
					 equipped with a thermometer calibrated at least annually against a National
					 Institute of Standards and Technology (NIST)- certified thermometer, or with a
					 thermometer that has been tested against, and found to be in agreement with, a
					 NIST-certified thermometer. The thermometer shall be either visually or
					 mechanically monitored daily for fluctuations in temperature affecting the
					 quality of the milk. Temperature records shall be maintained and made available
					 for inspection for at least one year after collection of the milk.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-9 - Human Milk Banks › Section 52-9.7 - Maintenance of records

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The
					 human milk bank shall maintain an individual file on each milk donor. For all
					 donated human milk, the donor's name, address and any other information which
					 would directly or indirectly identify the donor shall not be disclosed or
					 released by the human milk bank to any person or entity except upon the written
					 consent of the donor or except to the department. Records to be kept by the
					 human milk bank shall include, but not be limited to, those required in Subpart
					 52-2 of this Part and documentation of instructions given to the donor for
					 collecting, storing and preserving the wholesomeness of donated milk.
(b) Records of milk donations shall be filed
					 by donor identification number and shall include, but not be limited to:
(1) information from the identification tag
					 affixed to the container at the time of collection, showing the date and time
					 of collection, amount collected, and, if applicable, the identification of the
					 transfer station with recorded date, and time of receipt and transport of the
					 milk;
(2) results of all clinical
					 laboratory tests performed on the donor preparatory to and during participation
					 in the milk banking program;
(3)
					 the date of pasteurization of the milk, if applicable; and
(4) the date the milk was distributed or
					 used, and, if applicable, identifying information regarding milk pooled from
					 multiple donors.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-9 - Human Milk Banks › Section 52-9.8 - Distribution of human milk

Current through Register Vol. 46, No. 28, July 10, 2024
Facilities shall distribute human milk only upon receipt
						of a written order from a licensed physician.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-10 - Stem Hematopoietic Progenitor Cell Banks › Section 52-10.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
As used in this Part:
(a) Bone marrow means the human tissue filing
					 cavities of bone, consisting of fully mature and precursor hematopoietic cells
					 intended for hematopoietic reconstitution.
(b) Hematopoietic progenitor cells means
					 human precursor hematopoietic cells derived from bone marrow, peripheral blood
					 or other tissue sources.
(c)
					 hematopoietic progenitor cell bank means hematopoietic progenitor cell
					 procurement service, hematopoietic progenitor cell processing facility,
					 hematopoietic progenitor cell storage facility or hematopoietic progenitor cell
					 transplantation facility.
(d) Bone
					 marrow transplantation service means a coordinated program of inpatient and
					 outpatient care in a hospital approved by the commissioner as a provider of
					 bone marrow transplantation services pursuant to section
					 709.8 
					 of this Title. Such services may accept only stem cells collected in
					 substantial compliance with the criteria established in this Part and Subpart
					 58-5 of this Title, except in documented emergencies.
(e) Department means the New York State
					 Department of Health.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-10 - Stem Hematopoietic Progenitor Cell Banks › Section 52-10.2 - Licensure and compliance with standards

Current through Register Vol. 46, No. 28, July 10, 2024
No hematopoietic progenitor cell bank shall operate in
						New York State unless licensed by the department under Subpart 52-2 of this
						Part. All of the provisions of Subparts 52-1 and 52-2 of this Part shall apply
						to a hematopoietic progenitor cell bank, except for the recordkeeping
						requirements contained in section
						52-2.9  of this
						Part. All hematopoietic progenitor cell banks shall comply with the standards
						and requirements set forth in Subpart 58- 5 of this Title.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-11 - Nontransplant Anatomic Banks › Section 52-11.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
For the purposes of this Subpart, unless the context
						indicates otherwise, the following terms shall have the following
						meanings:
(a) Whole body means the
					 intact corporeal remains of an individual after the time of death.
(b) Whole body acquisition service means a
					 nontransplant anatomic bank that solicits, retrieves, performs donor selection,
					 preserves, transports, allocates, distributes, acquires, processes, stores, or
					 arranges for the storage of whole bodies or body segments, solely for education
					 and/or research purposes.
(c) Whole
					 body user means a nontransplant anatomic bank located in New York State that
					 obtains whole bodies and/or body segments from a whole body acquisition
					 service. A whole body user shall store and/or use whole bodies or body segments
					 solely for education and/or research purposes, under the direct oversight of
					 the legally authorized donee. A whole body user may not transfer whole bodies
					 or body segments to any other entity, except as authorized in writing by the
					 whole body acquisition service.
(d)
					 Body segment means a portion of a whole body detached for purposes of study,
					 evaluation, education and/or research. Body segments consist of contiguous
					 mixed tissues whose relationships have been altered only at the segment
					 boundaries.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-11 - Nontransplant Anatomic Banks › Section 52-11.2 - Construction

Current through Register Vol. 46, No. 28, July 10, 2024
Terms not defined in this Subpart are defined in Subpart
						52-1 of this Part. Nontransplant anatomic banks shall apply to the department
						for licensure and otherwise comply with all applicable provisions of Subpart
						52-2 of this Part.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-11 - Nontransplant Anatomic Banks › Section 52-11.3 - Informed consent

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Nontransplant anatomic banks that recover bodies, body segments, organs or
					 tissues from deceased donors, including whole body acquisition services, shall
					 obtain documented informed consent to the donation from a person authorized to
					 consent to such donation in accordance with Public Health Law, section
					 4301, or, for recoveries outside New York
					 State, applicable statutes in the state where the nontransplant anatomic parts
					 were recovered.
(b) Nontransplant
					 anatomic banks that recover body segments, organs or tissues from living donors
					 shall obtain documented informed consent from the donors.
(c) If specific direction is not provided in
					 the consent document, it shall be presumed that whole bodies, body segments,
					 and other nontransplant anatomic parts have been donated to entities authorized
					 to receive the bodies of deceased persons pursuant to subdivision (1) of Public
					 Health Law section 4211 and in accordance with the priorities established
					 therein. Such entities may transfer or authorize the transfer of whole bodies,
					 body segments and other nontransplant anatomic parts to other donees specified
					 in subdivisions (1) and (2) of Public Health Law section 4302 for purposes of:
(1) medical or dental education;
(2) medical or dental research;
					 and/or
(3) the advancement of
					 medical or dental science, therapy or transplantation.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-11 - Nontransplant Anatomic Banks › Section 52-11.4 - Retrieval and acquisition of nontransplant anatomic parts

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The retrieval of nontransplant anatomic
					 parts shall only be performed on:
(1) the
					 premises of a general hospital;
(2)
					 the premises of a whole body acquisition service licensed in accordance with
					 this Subpart; or
(3) for
					 nontransplant anatomic parts other than whole bodies and body segments, the
					 premises of a comprehensive tissue procurement service licensed in accordance
					 with Subpart 52-2 of this Part.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-11 - Nontransplant Anatomic Banks › Section 52-11.5 - Use of nontransplant anatomic parts

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Whenever a whole body is donated for
					 educational purposes, unless another lawful donee is specified in the donor
					 consent, the whole body user shall be an entity authorized to receive the
					 bodies of deceased persons pursuant to Public Health Law, section
					 4211 in accordance with the priorities
					 established therein.
(b) A whole
					 body user shall not transfer the whole body or body segment to any other
					 entity, except as authorized in writing by the whole body acquisition service
					 from which the whole body or body segment was obtained.
(c) A whole body user shall have at least one
					 staff member with a graduate degree in the health sciences, and training
					 specific to human dissection or to the activity to be performed.
(d) In addition to the records required in
					 section
					 52-2.9(i) 
					 of this Part, a whole body user shall maintain complete and accurate records of
					 receipt, use and disposition of whole bodies, body segments, organs and
					 tissues. These records shall include, but not be limited to:
(1) identification of the whole body, or, in
					 the case of a body segment, a description and source of the body
					 segment;
(2) a copy of any contract
					 or letter of agreement between the whole body acquisition service and whole
					 body user, and documentation of the method of final disposition of whole bodies
					 or body segments; and
(3) in the
					 case of whole body transfers, a copy of a properly executed burial transit
					 permit.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-11 - Nontransplant Anatomic Banks › Section 52-11.6 - Disposition of nontransplant anatomic parts

Current through Register Vol. 46, No. 28, July 10, 2024
(a) All users of nontransplant anatomic
					 parts, including whole body users, shall dispose of whole body remains, body
					 segments, organs and tissue in accordance with existing state standards for
					 such disposition. Users may return whole bodies or body segments to the whole
					 body acquisition service from which the material was originally
					 obtained.
(b) Disposition of whole
					 bodies and body segments shall be consistent with instructions provided in the
					 consent document.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-11 - Nontransplant Anatomic Banks › Section 52-11.7 - Safety

Current through Register Vol. 46, No. 28, July 10, 2024
A nontransplant anatomic bank shall implement written
						safety and infection control policies and procedures to ensure protection from
						unnecessary physical, chemical and biological hazards.
(a) Decontamination and disposal techniques
					 for regulated medical waste shall be utilized. All hazardous and regulated
					 waste materials shall be handled, stored and discarded pursuant to Part 70 of
					 this Title and/or 6 NYCRR Subpart 360-10 as appropriate, or in the case of
					 out-of-state banks, in accordance with the hazardous waste disposal
					 requirements of the state in which the disposal occurs.
(b) If autoclave equipment is used for
					 sterilization, the pressure, temperature, and duration of each cycle shall be
					 recorded, and such records maintained for one year. For each run, these
					 parameters shall be within the manufacturer's recommended operating procedures.
					 If any one or more of these parameters fall outside the manufacturer's
					 standards, all material shall be reautoclaved. Chemical, biological, and
					 physical detection systems shall be used in conjunction with these other
					 measurements of autoclave performance.
(c) Eating, drinking, smoking, and the
					 application of cosmetics or contact lenses shall not be permitted in work
					 areas. Refrigerators and freezers used for storing nontransplant anatomic
					 parts, specimens, or reagents shall not be used for any other
					 purpose.
(d) Gloves and laboratory
					 coats, gowns or other protective clothing shall be worn while handling
					 nontransplant anatomic parts or specimens, sufficient to protect against the
					 transmission of disease and exposure to toxic substances. Such protective
					 clothing shall not be worn outside the work area and shall be disposed of in an
					 appropriate receptacle.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-11 - Nontransplant Anatomic Banks › Section 52-11.8 - Reporting requirements

Current through Register Vol. 46, No. 28, July 10, 2024
Whenever requested, a nontransplant anatomic bank shall
						submit reports to the department containing such information and data
						concerning its activities as may be required by this Part. Such reports shall
						be signed by the director of the nontransplant anatomic bank.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 53 - Drinking Water State Revolving Fund › Section 53.1 - Purpose, scope and applicability

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The purpose of this Part is to provide
				  rules and procedures for the New York State Department of Health to provide
				  financial assistance to public water systems from the New York State Drinking
				  Water State Revolving Fund created by chapter 413 of the Laws of 1996 of the
				  State of New York. This is a cooperative program in conjunction with the New
				  York State Environmental Facilities Corporation. That agency's regulations can
				  be found in 21 NYCRR, Part 2604.
(b) This Part applies to all public water
				  systems in New York State seeking or receiving financing from the fund and to
				  the activities of the department in the discharge of its duties related to the
				  fund.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 53 - Drinking Water State Revolving Fund › Section 53.3 - Pre-application procedure

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
				  Prospective applicants seeking financial assistance from the fund must first
				  submit a pre-application to the department in the format required by the
				  department. Information required for the pre-application includes:
(1) a written request from an individual with
				  sufficient authority to act on behalf of the applicant that the project be
				  listed in the intended use plan;
(2) a description of the project, including a
				  discussion of the existing deficiencies of the public water system and the
				  corrective effect the proposed project will have on that system's drinking
				  water quality;
(3) a project
				  schedule and project cost estimate; and
(4) such other information and material as
				  the pre-applicant deems necessary for the department to determine a project's
				  eligibility for assistance from the fund.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 53 - Drinking Water State Revolving Fund › Section 53.4 - Priority ranking system scoring criteria

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The total numerical score for the project
				  or project segment being scored shall be the sum of the scores for technical
				  and non-technical criteria as well as any additional points awarded pursuant to
				  subdivision (d) of this section.
(1) The
				  technical criteria are:
(i) MCL/treatment
				  technique violations;
(ii) other
				  sanitary code violations; and
(iii)
				  system reliability and dependability issues.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 53 - Drinking Water State Revolving Fund › Section 53.5 - Priority ranking and intended use plan

Current through Register Vol. 46, No. 28, July 10, 2024
(a) With the exception of category G
				  projects, all completed pre-applications received by the department will be
				  evaluated and assigned a score based on the priority ranking scoring system
				  described in section
				  53.4 
				  of this Part, provided, however, that:
(1)
				  the department will not assign a score to any project it has determined to be
				  ineligible for assistance; and
(2)
				  after review of a pre-application the department may determine that one or more
				  proposed project components are not essential to addressing critical public
				  water system deficiencies. In that event, the department will sever any
				  non-essential components from the essential project component and score them as
				  separate projects.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 53 - Drinking Water State Revolving Fund › Section 53.6 - General project requirements

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Each
				  recipient shall ensure that any project for which it receives assistance from
				  the fund:
(1) achieves or maintains
				  compliance with the requirements of Part 5 of this Title;
(2) employs sound and appropriate management
				  practices; and
(3) otherwise
				  complies with all applicable requirements of the act, the State Act, this Part,
				  the project financing and loan agreement and all instructions issued by the
				  department and the corporation.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 53 - Drinking Water State Revolving Fund › Section 53.7 - Remedies

Current through Register Vol. 46, No. 28, July 10, 2024
(a) If the
				  department or the corporation determines that the project or the recipient is
				  not in compliance with the terms of the project financing and loan agreement,
				  and, following written notice to the recipient, the project is not brought into
				  compliance, the corporation may, on its own or at the department's direction,
				  refuse to approve fund disbursement requests until the project is brought into
				  compliance.
(b) Nothing in this
				  section shall be construed to limit the rights of the department or the
				  corporation to take actions including, but not limited to, administrative
				  enforcement actions and actions for breach of contract against a recipient
				  which fails to carry out its obligations under this Part or the project
				  financing and loan agreement.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 53 - Drinking Water State Revolving Fund › Section 53.8 - Severability

Current through Register Vol. 46, No. 28, July 10, 2024
If any provisions of this Part or the application thereof
					 to any person or circumstance is adjudged invalid by a court of competent
					 jurisdiction, such judgment shall not affect or impair the validity of the
					 other provisions of this Part or the application thereof to other persons and
					 circumstances.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 54 - Requirements For Self-defense Spray Devices › Section 54.1 - Purpose

Current through Register Vol. 46, No. 28, July 10, 2024
The purpose of this rule is to protect public health,
					 safety and welfare by specifying the type of self-defense spray device that may
					 lawfully be purchased, possessed or used in New York State.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 54 - Requirements For Self-defense Spray Devices › Section 54.2 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Camouflaged
				  means designed to have the appearance of an object other than a self-defense
				  spray device.
(b) Net weight means
				  the weight of the contents of a self-defense spray device.
(c) Oleoresin capsicum means the oleoresin
				  extracted from fruits or plants of the genus Capsicum. The oleoresin contains
				  the active ingredient capsaicin and related compounds classified as
				  capsaicinoids.
(d) Safety device
				  means a self-defense spray device feature that is designed to prevent
				  unintentional discharges.
(e)
				  Self-defense spray device means a pocket-sized spray device which contains and
				  releases a chemical or organic substance which is intended to produce temporary
				  physical discomfort or disability through being vaporized or otherwise
				  dispensed in the air or any like device containing tear gas, pepper or similar
				  disabling agent.