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 51 - Uniform Hearing Procedures › Section 51.17 - Disqualification for bias

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
				  hearing officer and, in hearings governed by Public Health Law section 230, a
				  committee member, shall be disqualified for bias. For purposes of this section,
				  bias shall exist only when there is an expectation of pecuniary or other
				  personal benefit from a particular outcome of the case or when there is a
				  substantial likelihood that the outcome of the case will be affected by a
				  person's prior knowledge of the case, prior acquaintance with the parties,
				  witnesses, representatives, or other participants in the hearing, or other
				  predisposition with regard to the case. The appearance of impropriety shall not
				  constitute bias and shall not be a grounds for disqualification. Hearing
				  officers and committee members are presumed to be free from bias.
(b) A hearing officer or committee member may
				  disqualify himself/herself for bias on his/her own motion. A party seeking
				  disqualification for bias had the burden of demonstrating bias. The party
				  seeking disqualification shall submit to the hearing officer an affidavit
				  pursuant to SAPA section 303 setting forth the facts establishing bias. Mere
				  allegations of bias shall be insufficient to establish bias.
(c) The hearing officer shall rule on the
				  request for disqualification.
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 52-2 - Tissue Banks And Nontransplant Anatomic Banks-licensure › Section 52-2.2 - Provisional licensure

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The
					 department may issue a provisional license which shall be valid for a period
					 determined by the department to be sufficient to enable the department to
					 assess the compliance of the tissue bank or nontransplant anatomic bank with
					 this Part. The provisional license may be renewed pending issuance or denial of
					 a license.
(b) Except for a limited
					 tissue procurement service, a tissue bank initially applying for a license may
					 be issued a provisional license provided it meets the following conditions:
(1) a valid and complete license application
					 has been filed;
(2) unless the site
					 is a tissue transplantation facility or insemination/implantation site or a
					 tissue storage facility whose tissue storage activity is limited to virally
					 inactivated tissue, a medical advisory committee, consisting of at least five
					 individuals with experience in tissue banking and/or transplantation medicine,
					 including at least one member with expertise in infectious diseases, has been
					 designated;
(3) if the tissue bank
					 has been inspected by the department, the tissue bank has provided satisfactory
					 evidence of correction of any deficiencies found; and
(4) the owners and/or persons with a
					 controlling interest, tissue bank director, medical director, tissue bank
					 compliance officer and transplantation service director, as required, meet the
					 requirements of this Part and possess the education and experience necessary to
					 ensure that the tissue bank is operated in substantial compliance with 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 52-2 - Tissue Banks And Nontransplant Anatomic Banks-licensure › Section 52-2.3 - Ownership or controlling interest reporting requirements

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Except for a tissue bank owned and
					 operated by a facility established pursuant to Public Health Law, article 28,
					 any change in the direct or indirect ownership status of five percent or more
					 or in a controlling interest in a tissue bank or nontransplant anatomic bank,
					 shall be reported to the department on a new application within 30 days of the
					 change. Such application shall be reviewed in accordance with section
					 52-2.5 
					 of this Subpart. Any change in the direct or indirect ownership status or of a
					 person with a controlling interest which requires Public Health Council
					 approval pursuant to Public Health Law, article 28, shall be reported to the
					 department within 30 days of the change.
(b) All changes in tissue bank director,
					 medical director, nontransplant anatomic bank director, or tissue bank
					 compliance officer shall be reported to the department in writing within five
					 days of the change, and a new application reflecting all changes since the
					 prior application must be submitted within 30 days of the change. Such
					 application shall be reviewed in accordance with section
					 52-2.5 
					 of this Subpart.
(c) If any person
					 or corporation with an ownership or controlling interest in a tissue bank or
					 nontransplant anatomic bank of five percent or more has been convicted of a
					 criminal offense related to the operation of such a bank, a laboratory or of
					 any programs established by title XVIII, XIX or XX of the Federal Social
					 Security Act, such conviction shall be disclosed within 30 days of its
					 occurrence. Conviction does not necessarily bar ownership; the department shall
					 review the conviction under the requirements of the Public Health Law to
					 determine whether the conviction may affect the ability of the bank to operate
					 in compliance with Public Health Law, article 5, title V and article 43-B, and
					 applicable State and Federal regulations regarding the operation of tissue
					 banks.
(d) Ownership of or
					 controlling interest in any other tissue bank, nontransplant anatomic bank,
					 laboratory or health care facility holding a New York State or New York City
					 license shall be disclosed within 30 days of any change in such
					 status.
(e) Failure to comply with
					 the reporting and application requirements of this section shall result in
					 termination of the license.
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 52-2 - Tissue Banks And Nontransplant Anatomic Banks-licensure › Section 52-2.6 - Financial disclosure and fees for services

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Each tissue bank and nontransplant
					 anatomic bank shall establish and maintain complete and accurate books,
					 financial records, documents and accounts, which shall be kept for a period of
					 at least seven years. The department shall have access to all such records and
					 any financial statements and audits of the bank, during normal business hours
					 at an office of the bank located within the State of New York or, if no such
					 office is available, at a mutually agreeable and reasonable venue for the
					 purposes of inspection, auditing and copying.
(b) Upon request, a tissue bank or
					 nontransplant anatomic bank shall provide the department with:
(1) a statement of the expenses of the bank,
					 including, but not limited to, salaries, rents, equipment, utilities and
					 travel;
(2) a statement of the
					 revenues of the bank, including fees, grants, endowment funds and any other
					 revenues; and
(3) a list of fees
					 charged for all tissue services, tissues, and nontransplant anatomic parts
					 provided by the 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 52-2 - Tissue Banks And Nontransplant Anatomic Banks-licensure › Section 52-2.7 - Administration and direction

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Every tissue bank other than a tissue transplantation facility or limited
					 tissue procurement service shall have a tissue bank director. The tissue bank
					 director shall develop and implement policies and procedures for the operation
					 of the bank, consistent with this Subpart and the Subparts for each category of
					 tissue. If the tissue bank director is not a physician, a medical director who
					 is a physician shall be retained.
(b) Except for transplantation facilities,
					 insemination/implantation sites, and limited tissue procurement services, every
					 tissue bank shall have a medical advisory committee, composed of persons with
					 training and experience in tissue banking or a closely related field, as well
					 as at least one member with infectious disease expertise, and with the
					 qualifications specified in the Subpart(s) for each category of tissue, if
					 any.
(c) Medical direction of a
					 tissue bank, other than a tissue transplantation facility or limited tissue
					 procurement service, shall be provided by a physician, designated as the
					 medical director, in consultation with the medical advisory committee, if
					 applicable.
(d) The tissue bank
					 director, if one is required, in consultation with the medical director, if not
					 the same person, and the medical advisory committee, if one is required, shall
					 monitor the medical efficacy of the tissue banking program and shall, as a
					 minimum, develop:
(1) medical criteria for
					 allogeneic donor participation;
(2)
					 quality control and quality assurance standards; and
(3) procedures to assure that tissues from
					 allogeneic donors are distributed based on medical need and not preferentially
					 distributed according to the donor's or recipient's membership in a category
					 based on race, color, creed, ii national origin, marital status, social
					 organization or income except if medically indicated.
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 52-2 - Tissue Banks And Nontransplant Anatomic Banks-licensure › Section 52-2.8 - Administration of a tissue transplantation facility

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Each tissue transplantation service
					 director shall develop and implement policies and procedures for operation of
					 the tissue transplantation service consistent with this Subpart and the
					 Subparts for each category of tissue.
(b) The tissue transplantation service
					 director shall, at a minimum, develop:
(1)
					 quality assurance procedures and standards; and
(2) procedures to assure that tissues are
					 issued for transplantation based on medical need and not preferentially
					 distributed according to the donor's or recipient's membership in a category
					 based on race, color, creed, national origin, marital status, social
					 organization or income, except if medically indicated.
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 52-2 - Tissue Banks And Nontransplant Anatomic Banks-licensure › Section 52-2.10 - Compliance with standards

Current through Register Vol. 46, No. 28, July 10, 2024
Tissue banks, including tissue transplantation
						facilities, insemination/implantation sites, human milk transfer stations and
						nontransplant anatomic banks, shall allow admission to representatives of the
						department for the purpose of inspecting the premises and evaluating the
						operating procedures, equipment and records, including financial records and
						lists of physicians or facilities to whom or to which human tissue is released,
						to determine compliance with the standards in this Part. No tissue bank or
						nontransplant anatomic bank may acquire, process, store or distribute tissue or
						nontransplant anatomic parts in New York State unless the bank has been issued
						a license by the department, or as otherwise specified in this Part. If the
						commissioner determines that a bank's failure to comply with the standards set
						forth in this Part creates a significant likelihood that the health, safety and
						welfare of potential patients and other persons in contact with tissue or
						nontransplant anatomic parts from the bank is in jeopardy, the department may
						require that tissue not be released pending a hearing. The 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 52-3 - General Technical Standards For Tissue Banks › Section 52-3.1 - Compliance with fda regulations and manufacturers' instructions

Current through Register Vol. 46, No. 28, July 10, 2024
(a) All antisera,
					 reagents, devices, methods and procedures for tissue processing or
					 transplantation-related testing shall be approved by the FDA, if such approval
					 is available for the particular class or type of antiserum, reagent, device,
					 method or procedure.
(b) All
					 reagents shall be stored in labeled containers under conditions appropriate for
					 each reagent as directed by the manufacturer and shall be removed from use
					 after the expiration date. The reactivity, specificity and potency of each
					 reagent shall be determined whenever a new lot is employed. All methods shall
					 conform to the manufacturer's instructions unless otherwise approved by the
					 department upon submission of evidence that another method is equal or superior
					 to the method described in the manufacturer's instructions.
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 52-3 - General Technical Standards For Tissue Banks › Section 52-3.2 - Sterilization of instruments

Current through Register Vol. 46, No. 28, July 10, 2024
All instruments, including collection containers, used
						for both sterile and clean, nonsterile retrieval of tissues shall be either
						licensed by the FDA for single use or be sterilized prior to each use. Heat
						sterilization shall be by autoclaving at 121.5 degrees Celsius for 15 minutes
						after the chamber of the autoclave has been evacuated and has reached that
						temperature, or by dry heat for two hours at 170 degrees Celsius, or by such
						other procedures as may be approved by the department upon submission of
						evidence that such other procedures are at least equally
						effective.
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 52-3 - General Technical Standards For Tissue Banks › Section 52-3.3 - Qualifications of donors

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
					 comprehensive or limited tissue procurement service shall obtain a signed
					 informed consent from the living donor of tissue for clinical use.
(b) For potential cadaveric donors who have
					 not left a signed, witnessed organ/tissue donor card (see section 4303  of the Public Health Law) or a will,
					 the procurement service shall obtain informed consent to an anatomical gift
					 from the next of kin or guardian of the decedent, as required by section
					 405.25 
					 of this Title, before retrieving tissue. Informed consent forms shall clearly
					 specify the tissues and/or nontransplant anatomic parts to be retrieved.
					 Consent obtained by telephone shall be recorded or documented in writing by the
					 tissue procurement service requesting the donation.
(c) The acceptability of a cadaveric donation
					 shall be determined by medical history information obtained from medical
					 records, attending physicians on other health care professionals, and from
					 interviewing a family member and/or other person close to the decedent. In the
					 event that no family member or other person close to the decedent is available,
					 eye tissue may be accepted, providing that the final tissue container or
					 accompanying paperwork is clearly labeled to alert the transplanting surgeon
					 that such interview was not conducted. An evaluation of the donor's condition
					 shall be made by a qualified tissue retrieval team member, including an
					 examination for signs of injected drug use, infection, or trauma at the site of
					 donation that may affect the quality of the donated tissue.
(d) The acceptability of a donation from a
					 living donor shall be determined by a physical examination of and health
					 history interview with the donor.
(e) A trained, qualified supervisor shall
					 determine whether a donor is suitable for tissue retrieval on the day of the
					 retrieval, according to criteria developed by the medical director in
					 consultation with the medical advisory committee. The medical director, as
					 defined in Subpart 52-1 of this Part, shall be responsible for determining
					 whether:
(1) the living donor and his/her
					 donated tissue are acceptable, prior to the retrieval of the tissue, according
					 to criteria developed by the medical director in consultation with the medical
					 advisory committee; and
(2) the
					 cadaveric donor and his/her donated tissue are acceptable, prior to the release
					 of tissue, according to criteria developed by the medical director in
					 consultation with the 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 52-3 - General Technical Standards For Tissue Banks › Section 52-3.5 - Quality assurance and safety requirements

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Quality assurance.
(1) Records shall document that the following
					 quality control procedures are in place at the tissue bank, except for a
					 limited tissue procurement service:
(i)
					 preventive maintenance, periodic inspections and testing for proper operation
					 of equipment, including annual calibration of thermometers used to monitor the
					 temperature of tissue in storage, against a National Institute of Standards and
					 Technology (NIST)-certified thermometer, or a thermometer that has been tested
					 against and found to be in agreement with an NIST-certified
					 thermometer;
(ii) monitoring of all
					 temperature-controlled spaces and equipment to assure proper
					 performance;
(iii) validation of
					 computer systems, microprocessor-controlled equipment and associated
					 software;
(iv) validation of
					 processing and testing methodologies; and
(v) supervisory review of test results prior
					 to labeling of the tissue.
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 52-3 - General Technical Standards For Tissue Banks › Section 52-3.6 - Hiv antibody testing and notification

Current through Register Vol. 46, No. 28, July 10, 2024
No tissue bank shall inform any tissue donor or
						consenting next-of-kin of the results of HIV antibody testing solely on the
						basis of the enzyme-linked immunosorbent assay (ELISA) or other screening test
						for HIV antibodies unless such results are negative. Any reactive screening
						test shall be repeated in duplicate. If two or more separate screening tests
						are reactive, the sample shall be considered repeatedly reactive. Notification
						that a donor is positive shall be made only if the results have been reactive
						or equivocal for more than one screening test and the confirmatory HIV test has
						been unequivocally reactive. HIV test results that are substantiated as
						positive shall be reported to living donors. Equivocal or negative results
						based on confirmatory testing may be reported to the donor, if living, or
						person legally authorized to consent on behalf of such donor, provided that the
						person is not informed that the donor is seropositive. Appropriate counseling
						of living donors or the consenting next-of-kin regarding the significance of
						all test results shall be made available or arranged for by the comprehensive
						tissue procurement service. Reporting of any HIV results to living donors or
						consenting next-of-kin, other than results of negative screening tests, shall
						be conducted in person, unless repeated efforts to encourage the individual(s)
						to come in have failed, in which case notification may be made by certified
						restricted delivery mail.
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 52-3 - General Technical Standards For Tissue Banks › Section 52-3.7 - Reporting requirements

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The
					 tissue bank shall have a written procedure for documenting errors or accidents
					 in retrieval, testing, processing, storage or distribution of tissue that may
					 affect the safety of any product. If the error or accident is not detected
					 prior to issuance of the tissue, specimens, or test results to a hospital or
					 other tissue bank, transplantation facility or insemination/implantation site,
					 the error or accident shall be reported immediately to the receiving facility.
					 All such errors and accidents shall also be reported to the department's
					 Wadsworth Center within seven calendar days of discovery.
(b) All New York State-licensed tissue banks
					 that directly perform or arrange for the performance of transmissible disease
					 testing of donors shall:
(1) make the results
					 of such testing available, upon request, to other tissue banks receiving tissue
					 from the same donor; and
(2)
					 report, within 24 hours, all positive test results that affect donor
					 suitability to the comprehensive tissue procurement service, if a different
					 facility, except that positive culture results need not be reported if
					 contamination can be traced to a specific step in tissue processing not
					 affecting other tissues processed from the same 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 52-3 - General Technical Standards For Tissue Banks › Section 52-3.8 - Special circumstances

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 The department may exempt a tissue bank from a specific standard contained in
					 this Part, provided:
(1) the tissue bank has
					 applied to the department for an exemption for limited circumstances prior to
					 the noncompliance with the standard; and
(2) the tissue bank has demonstrated to the
					 department that application of the standard to the bank under the limited
					 circumstances for which an exemption is sought:
(i) is inconsistent with the provision of the
					 particular service, as documented in properly conducted current medical or
					 scientific research, or current scientific literature;
(ii) is incompatible with a requirement
					 imposed by a Federal or other state's government unit which is similar to the
					 standard for which an exemption is sought, and the department determines that
					 the requirement imposed by the Federal or other state's governmental unit's
					 requirement adequately protects the public health, safety, and welfare, based
					 upon commonly accepted medical standards, properly conducted medical or
					 scientific research, or current scientific literature; or
(iii) would prevent provision of services
					 necessitated by a medical emergency or special medical conditions. Persons
					 seeking an exemption pursuant to this subparagraph shall describe the nature of
					 the emergency or special medical conditions and the exemption requested, for
					 review on a case-by-case basis by the department. All such emergencies or
					 special medical conditions shall be documented in the medical record, and any
					 action taken in response which is contrary to the requirements of this Part
					 shall be approved by the director of the tissue transplantation
					 service.
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 52-4 - Cardiovascular Tissue Banks › Section 52-4.1 - 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) Cardiovascular tissue
					 donor means a human being, living or dead, who is the source of cardiovascular
					 tissue for transplantation, including autogeneic tissue.
(b) Critical work area means an area where
					 sterile tissue containers or aseptically retrieved tissue are exposed to the
					 environment.
(c) Critical surface
					 means a surface which comes into contact with aseptically retrieved tissue,
					 sterile tissue containers or sterile container covers.
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 52-4 - Cardiovascular Tissue Banks › Section 52-4.2 - 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. Cardiovascular tissue 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 52-4 - Cardiovascular Tissue Banks › Section 52-4.3 - Tissue procurement services

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A facility that engages in donor
					 selection and solicitation, and retrieval of cardiovascular tissue shall be
					 licensed by the department as a comprehensive tissue procurement
					 service.
(b) A facility whose
					 tissue acquisition activities are limited to donor selection and solicitation
					 by its own staff shall be licensed by the department as a limited tissue
					 procurement service.
(c)
					 Comprehensive tissue procurement services retrieving cardiovascular tissue from
					 cadaveric donors shall maintain written standard operating procedures that
					 assure that the retrieval environment, including, but not limited to, walls,
					 floors and permanent equipment, is suitable for retrieval and adequate to
					 prepare an aseptic field. A working sink shall be available.
(d) Cardiovascular tissue retrieval shall be
					 performed only by trained retrieval technicians under the supervision of the
					 director of a licensed comprehensive tissue procurement service. The director
					 of the licensed comprehensive tissue procurement service shall be responsible
					 for developing policies, procedures and standards for the educational
					 background, training, certification and continuing education of retrieval
					 technicians. Documentation of compliance with this requirement and the
					 standards developed shall be maintained.
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 52-4 - Cardiovascular Tissue Banks › Section 52-4.4 - Donor qualifications

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 In addition to all the requirements of this Subpart, limited tissue procurement
					 services and comprehensive tissue procurement services shall comply with the
					 donor qualification requirements in Subpart 52-3 of this Part.
(b) Unless specifically authorized by the
					 tissue bank medical director, cardiovascular tissue shall not be released for
					 allogeneic transplant from donors with any of the following conditions:
(1) a disease of unknown etiology;
(2) malaria within the last three years or
					 travel to a malarially endemic area within the last six months;
(3) active or untreated
					 tuberculosis;
(4) history or
					 presence of bacterial endocarditis or semilunar valvular heart disease, except
					 for mitral valve prolapse;
(5)
					 previous cardiac valvular surgery, if donation of the affected valve is
					 considered;
(6) insulin-dependent
					 diabetes mellitus;
(7) death due to
					 drowning, if immersion was for longer than six hours; or
(8) history of rheumatic fever.
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 52-4 - Cardiovascular Tissue Banks › Section 52-4.5 - Retrieval of tissue

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Cardiovascular tissue shall be retrieved using aseptic technique in an
					 operating room or other aseptic premises approved by the tissue bank medical
					 director.
(b) Retrieval of
					 cardiovascular tissue from a cadaveric donor shall occur within a time limit
					 after cessation of cardiac function specified in written policies approved by
					 the medical director of the comprehensive tissue procurement service.
(c) Cardiovascular tissue shall be stored and
					 transported to the tissue processing facility at a temperature between one and
					 10 degrees Celsius.
(d) Aseptic
					 processing of cardiovascular tissue shall begin within 48 hours of cessation of
					 cardiac function.
(e) If an ante
					 mortem blood sample is not available from a cadaveric donor, a post mortem
					 sample of sufficient quantity to perform required laboratory testing shall be
					 drawn via a cardiac insertion or from a large vein or artery.
(f) Tissue specimen containers and packaging
					 materials shall be sterile and nontoxic.
(g) Each tissue and blood specimen container
					 shall be labeled legibly at the time of retrieval with the tissue bank
					 identification, and donor identification code or unique tissue identification
					 number. The date, time and anatomic site of retrieval shall be recorded on
					 accompanying documents.
(h) Unless
					 a sample for culture is to be collected at the tissue processing facility, a
					 segment or sample of contiguous heart or vascular tissue shall be placed in a
					 separate, appropriately labeled sterile container intended for culturing for
					 aerobic and anaerobic contamination.
(i) Tissue and blood specimen containers
					 shall be labeled so as to maintain cardiovascular tissue identification
					 throughout all phases of processing, storage and distribution, in a manner not
					 subject to significant deterioration under conditions of transport and
					 storage.
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 52-4 - Cardiovascular Tissue Banks › Section 52-4.6 - Tissue processing facilities

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A facility which processes cardiovascular
					 tissue shall be licensed by the department as a tissue processing facility.
					 Such facilities shall make available to the department a statement of the
					 procedures used in the preparation, testing and preservation of the tissue or
					 tissues distributed, or offered for use. The premises, equipment, procedures,
					 records, circulars of instruction and tissues shall be available for inspection
					 and/or testing by the department as required. Copies of all brochures and other
					 informational materials and instructions, including descriptions of methods of
					 tissue handling, shall be available to the department. Each container of tissue
					 shall be clearly labeled with the donor identification code or a unique tissue
					 identification number, unit size and expiration date, if applicable.
(b) Aseptic processing of cardiovascular
					 tissue shall be performed in separately defined work areas with:
(1) floors, walls and ceilings with nonporous
					 smooth surfaces that are easily cleaned;
(2) temperature and humidity
					 controls;
(3) an air supply
					 filtered through high efficiency particulate air filters with positive pressure
					 differentials between rooms;
(4) a
					 system for monitoring environmental conditions;
(5) a system for cleaning and disinfecting a
					 room and equipment to produce aseptic conditions; and
(6) adequate space for staff, and storage of
					 garments and equipment.
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 52-4 - Cardiovascular Tissue Banks › Section 52-4.7 - Required laboratory tests on donors and donated tissue

Current through Register Vol. 46, No. 28, July 10, 2024
All required clinical laboratory testing shall be
						performed by a laboratory operating under a permit issued by the department.
						For out-of-state cardiovascular tissue procurements, all required clinical
						laboratory testing shall be performed by a laboratory which is approved by that
						state's regulatory authority, the United States Health Care Financing
						Administration, or by the department.
(a) Blood samples from all allogeneic
					 cardiovascular tissue donors shall be tested for antibodies to human
					 immunodeficiency virus type 1 (HIV-1), human immunodeficiency virus type 2
					 (HIV-2), human T-lymphotropic virus type I (HTLV-I), and hepatitis C virus
					 (HCV), as well as for hepatitis B surface antigen (HBsAg) and for syphilis, for
					 purposes of donor selection.
(b)
					 Testing of each cardiovascular tissue unit for aerobic and anaerobic
					 contamination from each retrieval site shall be performed prior to final
					 packaging, using standard laboratory procedures. Whenever fresh tissue is
					 transplanted, the results of cultures shall be made available to the
					 transplantation surgeon on a daily basis until the final reading has been
					 completed.
(c) All cardiovascular
					 tissue from living donors intended for allogeneic use shall be quarantined for
					 six months. After such time and prior to distribution of the tissue for
					 transplantation, the donor shall be retested for HBsAg and antibodies to HCV,
					 HIV-1 and HIV-2 and tested for antibodies to hepatitis B core antigen
					 (anti-HBc).
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 52-4 - Cardiovascular Tissue Banks › Section 52-4.8 - Processing and storage of tissue

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Fresh cardiovascular tissue shall be
					 stored in an isotonic storage medium demonstrated to maximize tissue viability
					 in a sealed, sterile container at a temperature between one and 10 degrees
					 Celsius for a period not to exceed 24 hours from retrieval. Storage shall take
					 place in a refrigerator reserved for cardiovascular or other tissue intended
					 for transplantation, equipped with a thermometer calibrated at least annually
					 against a National Institute of Standards and Technology (NIST)-certified
					 thermometer, or a thermometer that has been tested against, and found to be in
					 agreement with, an NIST-certified thermometer. The temperature shall be
					 visually monitored and recorded daily unless the refrigerator is equipped with
					 a calibrated mechanical temperature monitor and alarm system to detect an
					 increase in temperature to above 10 degrees Celsius or a decrease in
					 temperature to below one degree Celsius..
(b) Cardiovascular tissue processing for
					 cryopreservation shall be initiated under aseptic conditions within 24 hours of
					 retrieval. Until processing, tissue shall be stored at between one and 10
					 degrees Celsius. Once processed, cardiovascular tissue shall be stored frozen
					 at a target temperature of minus 100 degrees Celsius or lower with a suitable
					 cryoprotectant in labeled containers until distributed or issued for use, in
					 either:
(1) a freezer reserved for
					 cardiovascular or other tissue intended for transplantation, equipped with an
					 audible alarm to detect an increase in temperature to above the limit
					 established by the director and a recording thermometer calibrated at least
					 annually against an NIST-certified thermometer, or a thermometer that has been
					 tested against, and found to be in agreement with, an NIST-certified
					 thermometer; or
(2) a liquid
					 nitrogen tank reserved for cardiovascular or other tissue intended for
					 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 52-4 - Cardiovascular Tissue Banks › Section 52-4.9 - Distribution of tissue products

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Except as provided in section
					 52-3.4 
					 of this Part, a cardiovascular tissue shall not be made available for
					 allogeneic transplantation if:
(1) The donor's
					 blood tests repeatedly reactive in approved screening tests for HBsAg, or
					 antibodies to HIV-1, HIV-2, HTLV-I, or HCV; or
(2) the donor's blood reacts positively to
					 approved tests for syphilis, unless confirmatory testing is negative.
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 52-4 - Cardiovascular Tissue Banks › Section 52-4.10 - Required records of tissue acquisition, testing, processing and storage

Current through Register Vol. 46, No. 28, July 10, 2024
Each cardiovascular tissue bank shall maintain donation
						records as required by 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 52-4 - Cardiovascular Tissue Banks › Section 52-4.11 - Records to be kept by the tissue transplantation facility

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The director of each tissue
					 transplantation service shall be responsible for records kept by the tissue
					 transplantation facility. In addition to the records specified in Subpart 52-2
					 of this Part, the following records shall be kept, separate from recipient
					 records, by the tissue transplantation facility:
(1) if performed, results of testing for
					 bacterial and fungal contamination after tissue thawing and prior to
					 engraftment;
(2) a disposition log
					 allowing accurate tracking of tissue to each recipient; and
(3) records of appropriate storage and
					 temperature monitoring of cardiovascular tissue.
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 52-4 - Cardiovascular Tissue Banks › Section 52-4.12 - Disposition of unused tissue

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Thawed cardiovascular tissue that is not used by the tissue transplantation
					 facility within 24 hours of thawing shall be used for education or research
					 purposes authorized by Public Health Law section 4302, or discarded pursuant to
					 Part 70 of this Title. Packaging of cardiovascular tissue for destruction shall
					 be designed to obscure the contents.
(b) Cardiovascular tissue returned by the
					 tissue transplantation facility for possible reissuance shall meet all storage
					 and transport requirements of this Part. The cardiovascular tissue bank shall
					 not reissue tissue returned by the tissue transplantation facility, unless
					 written criteria approved by the tissue bank medical director are
					 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 52-4 - Cardiovascular Tissue Banks › Section 52-4.13 - Tissue storage facilities

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
					 facility which stores cardiovascular tissue shall be licensed by the department
					 as a tissue storage facility. The cardiovascular tissue bank shall keep the
					 department fully informed of the number and type of tissue storage facilities
					 operating under its direction.
(b)
					 All cardiovascular tissue shall be stored and monitored in accordance with the
					 provisions of sections
					 52-4.8
					 and
					 52-4.9(b), (c) and
					 (d)  of this Subpart.
(c) Temperature records or liquid nitrogen
					 level records shall be available for inspection by the department for the
					 entire period of cardiovascular tissue storage and for one year
					 afterwards.
(d) Cardiovascular
					 tissue products shall be distributed in accordance with the requirements of
					 this Part, and all records related to the inspection, distribution and
					 transport of tissues shall be open to inspection by the department and shall be
					 kept for at least seven years or six months after the expiration date of the
					 tissue, whichever is the longer time.
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 52-5 - Musculoskeletal Tissue Banks › Section 52-5.1 - 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) Batch means a specific
					 quantity of tissue that is intended to have uniform characteristics and quality
					 within specific limits, and is produced according to the same processing
					 protocol and during the same processing cycle.
(b) Musculoskeletal tissue donor means a
					 human being, living or dead, who is the source of musculoskeletal tissue,
					 including autogeneic tissue, for transplantation.
(c) Critical work area means an area where
					 sterile tissue containers or aseptically retrieved tissue are exposed to the
					 environment.
(d) Critical surface
					 means a surface which comes into contact with aseptically retrieved tissue,
					 sterile tissue containers or sterile container covers.
(e) Controlled work area means an area where
					 unsterilized tissue, in-process materials and tissue containers are
					 handled.
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 52-5 - Musculoskeletal Tissue Banks › Section 52-5.2 - 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. Musculoskeletal tissue 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 52-5 - Musculoskeletal Tissue Banks › Section 52-5.3 - Tissue procurement services

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A facility that engages in donor
					 selection and solicitation, and retrieval of musculoskeletal tissue shall be
					 licensed by the department as a comprehensive tissue procurement
					 service.
(b) A facility whose
					 tissue acquisition activities are limited to donor selection and solicitation
					 by its own staff shall be licensed by the department as a limited tissue
					 procurement service.
(c)
					 Comprehensive tissue procurement services retrieving musculoskeletal tissue
					 aseptically from cadaveric donors shall maintain written standard operating
					 procedures that assure that the retrieval environment, including, but not
					 limited to, walls, floors and permanent equipment, is suitable for retrieval
					 and adequate to prepare an aseptic field. A working sink shall be
					 available.
(d) Musculoskeletal
					 tissue retrieval shall be performed only by trained retrieval technicians under
					 the supervision of the director of a licensed comprehensive tissue procurement
					 service. The director of the licensed comprehensive tissue procurement service
					 shall be responsible for developing policies, procedures and standards for the
					 educational background, training, certification and continuing education of
					 retrieval technicians. Documentation of compliance with this requirement and
					 the standards developed shall be maintained.
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 52-5 - Musculoskeletal Tissue Banks › Section 52-5.4 - Donor qualifications

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 In addition to all the requirements of this Subpart, limited tissue procurement
					 services and comprehensive tissue procurement services shall comply with the
					 donor qualification requirements in Subpart 52-3 of this Part.
(b) Unless specifically authorized by the
					 tissue bank medical director, musculoskeletal tissue shall not be released for
					 allogeneic transplant from donors with any of the following conditions:
(1) evidence of rheumatoid
					 arthritis;
(2) a disease of unknown
					 etiology; or
(3) malaria within the
					 last three years or travel to a malarially endemic area within the last six
					 months.