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 52-5 - Musculoskeletal Tissue Banks › Section 52-5.5 - Retrieval of tissue

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Musculoskeletal tissue, including tissue for which assurance of sterility
					 cannot be maintained, such as mandible, shall be retrieved using aseptic
					 technique in an operating room or other aseptic premises approved by the tissue
					 bank medical director.
(b)
					 Retrieval of musculoskeletal tissue from cadaveric donors 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) Musculoskeletal tissue
					 retrieved from cadaveric donors shall be transported to the tissue processing
					 facility at a temperature of 10 degrees Celsius or lower.
(d) 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.
(e)
					 Tissue specimen containers and packaging materials shall be sterile and
					 nontoxic.
(f) 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.
(g) A segment or sample of musculoskeletal
					 tissue that is not intended for viral inactivation shall be placed in a
					 separate, appropriately labeled sterile container intended for culturing for
					 aerobic and anaerobic contamination.
(h) Tissue and blood specimen containers
					 shall be labeled so as to maintain musculoskeletal 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 52-5 - Musculoskeletal Tissue Banks › Section 52-5.6 - Tissue processing facilities

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A facility which processes
					 musculoskeletal 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 musculoskeletal 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 52-5 - Musculoskeletal Tissue Banks › Section 52-5.7 - 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 musculoskeletal 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
					 musculoskeletal tissue donors shall be tested for antibodies to human
					 immunodeficiency virus type 1 (HIV-1), human immunodeficiency virus type 2
					 (HIV-2), and hepatitis C virus (HCV), as well as for hepatitis B surface
					 antigen (HBsAg) and for syphilis, and, unless the tissue is to be virally
					 inactivated, antibodies to human T-lymphotropic virus type I (HTLV- I), for
					 purposes of donor selection.
(b)
					 Testing of each musculoskeletal tissue unit for aerobic and anaerobic
					 contamination 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 musculoskeletal 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 52-5 - Musculoskeletal Tissue Banks › Section 52-5.8 - Processing and storage of tissue

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Fresh musculoskeletal 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 14 days from retrieval. Storage shall take
					 place in a refrigerator reserved for musculoskeletal or other tissue intended
					 for transplantation, or blood intended for transfusion, 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, a 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) Musculoskeletal tissue
					 processing for freezing shall be performed under aseptic conditions within 48
					 hours of retrieval. Until processing, tissue shall be stored at between one and
					 10 degrees Celsius. Once processed, musculoskeletal tissue shall be stored
					 frozen at a target temperature of minus 40 degrees Celsius or lower in labeled
					 containers until released for use, in either:
(1) a freezer reserved for musculoskeletal or
					 other tissue intended for transplantation, or blood intended for transfusion,
					 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 a NIST-certified thermometer, or a thermometer that has
					 been tested against, and found to be in agreement with, a NIST-certified
					 thermometer; or
(2) a liquid
					 nitrogen tank reserved for musculoskeletal 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 52-5 - Musculoskeletal Tissue Banks › Section 52-5.9 - 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, musculoskeletal 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, HCV, or, unless the tissue is to be virally inactivated,
					 antibodies to HTLV-I; 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 52-5 - Musculoskeletal Tissue Banks › Section 52-5.10 - Required records of tissue acquisition, testing, processing and storage

Current through Register Vol. 46, No. 28, July 10, 2024
In addition to the recordkeeping requirements of Subpart
						52-2 of this Part, each musculoskeletal tissue bank shall maintain tissue
						records which include:
(a) spark
					 testing for vacuum in the case of freeze-dried tissue; and
(b) if the tissue is sterilized by ethylene
					 oxide, amount of ethylene oxide, ethylene glycol and ethylene chlorhydrin
					 residue for each type of musculoskeletal tissue within a batch.
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 52-5.11 - Records to be kept by a 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 musculoskeletal 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 52-5 - Musculoskeletal Tissue Banks › Section 52-5.12 - Disposition of unused tissue

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 All musculoskeletal tissue determined to be unsuitable for transplantation, or
					 education or research purposes authorized by Public Health Law section 4302
					 shall be discarded pursuant to Part 70 of this Title. Packaging of
					 musculoskeletal tissue for destruction shall be designed to obscure the
					 contents.
(b) Musculoskeletal
					 tissue returned by the tissue transplantation facility for possible reissuance
					 shall meet all storage and transport requirements of this Part. The
					 musculoskeletal 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 52-5 - Musculoskeletal Tissue Banks › Section 52-5.13 - Tissue storage facilities

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
					 facility which stores musculoskeletal tissue shall be licensed by the
					 department as a tissue storage facility. The musculoskeletal tissue bank shall
					 keep the department fully informed of the number and type of tissue storage
					 facilities operating under its direction.
(b) All musculoskeletal tissue shall be
					 stored and monitored in accordance with the provisions of sections
					 52-5.8
					 and
					 52-5.9(b), (c),
					 (d) and (e)  of this Subpart.
(c) Temperature records or liquid nitrogen
					 level records shall be available for inspection by the department for the
					 entire period of musculoskeletal tissue storage and for one year
					 afterwards.
(d) Musculoskeletal
					 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 52-6 - Skin Banks › Section 52-6.1 - 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) Skin donor means a human
					 being, living or dead, who is the source of skin tissue including autogeneic
					 tissue for transplantation.
(b)
					 Transplantation means the grafting of skin from a donor to a recipient,
					 including the grafting of skin that has been manipulated and integrated into an
					 artificial skin substitute, and the grafting of skin from an autogenic
					 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 52-6 - Skin Banks › Section 52-6.2 - 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. Skin 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 52-6 - Skin Banks › Section 52-6.3 - 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 skin 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 skin 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 aseptic retrieval and adequate to prepare an aseptic
					 field. A working sink shall be available.
(d) Skin 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 52-6 - Skin Banks › Section 52-6.4 - 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, skin 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; or
(3) drowning as a terminal event.
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 52-6 - Skin Banks › Section 52-6.5 - Retrieval of tissue

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Skin shall
					 be retrieved using aseptic technique in an operating room or other aseptic
					 premises approved by the tissue bank medical director. In all cases, a vigorous
					 surgical scrub and disinfectant solution nontoxic to epithelial cells shall be
					 used in preparing the donation site for skin retrieval in accordance with
					 standard operating room practice.
(b) Retrieval of skin from cadaveric donors
					 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) If
					 an ante mortem blood sample is not available from a cadaveric donor, a post
					 mortem sample of sufficient quantity to perform required testing shall be drawn
					 via a cardiac insertion or from a large vein or artery.
(d) Skin specimen containers and packaging
					 materials shall be sterile and nontoxic.
(e) Each skin 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.
(f)
					 Fresh-cut skin shall be maintained in a sterile, isotonic solution or other
					 nutrient medium during the skin removal procedure, and transported to the
					 tissue processing facility at the completion of the procedure.
(g) Skin samples for testing for microbial
					 contamination shall be recovered from each anatomical site and placed in a
					 separate, appropriately labeled container.
(h) Skin and blood specimen containers shall
					 be labeled so as to maintain 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 52-6 - Skin Banks › Section 52-6.6 - Tissue processing facilities

Current through Register Vol. 46, No. 28, July 10, 2024
A facility which processes skin 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 storage 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.
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 52-6 - Skin Banks › Section 52-6.7 - 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 skin 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 skin donors shall be tested for antibodies to human immunodeficiency
					 virus type 1 (HIV-1), human immunodeficiency virus type 2 (HIV-2), and
					 hepatitis C virus (HCV), as well as for hepatitis B surface antigen (HBsAg) and
					 for syphilis, and, unless the tissue is to be virally inactivated, antibodies
					 to human T-lymphotropic virus type I (HTLV-I), for purposes of donor
					 selection.
(b) Microbial testing of
					 skin from each anatomical site for aerobic and anaerobic contamination shall be
					 performed using standard laboratory procedures. Whenever fresh skin 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 skin tissue from
					 living donors intended for allogeneic use shall be quarantined for at least six
					 months. After such time and prior to the 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 52-6 - Skin Banks › Section 52-6.8 - Processing and storage of tissue

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Fresh skin shall be stored in a sealed,
					 sterile container with an isotonic solution or nutrient medium demonstrated to
					 maximize tissue viability, at a temperature between one and 10 degrees Celsius
					 for a period not to exceed 14 days from retrieval. Storage shall take place in
					 a refrigerator reserved for skin or other tissue intended for transplantation,
					 or blood intended for transfusion, 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, a NIST-certified thermometer. The
					 temperature shall be visually monitored 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) If performed, skin processing for
					 cryopreservation shall occur under aseptic conditions within three days of
					 retrieval. Until processing, skin shall be stored at between one and 10 degrees
					 Celsius. Once processed, skin shall be stored frozen at a target temperature of
					 minus 40 degrees Celsius or lower with a suitable cryoprotectant in labeled
					 containers until released for use, in either:
(1) a freezer reserved for skin or other
					 tissue intended for transplantation, or blood intended for transfusion,
					 equipped with an audible alarm to detect an increase in temperature to above
					 the limit established by the director and a thermometer calibrated at least
					 annually against a NIST-certified thermometer, or a thermometer that has been
					 tested against, and found to be in agreement with, a NIST-certified
					 thermometer; or
(2) a liquid
					 nitrogen tank reserved for skin 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 52-6 - Skin Banks › Section 52-6.9 - 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, skin 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,
					 HCV, or, unless the tissue is to be virally inactivated, antibodies to HTLV-I;
					 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 52-6 - Skin Banks › Section 52-6.10 - Required records of tissue acquisition, testing, processing and storage

Current through Register Vol. 46, No. 28, July 10, 2024
Each skin 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 52-6 - Skin Banks › Section 52-6.11 - Records to be kept by a 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) a disposition log allowing accurate
					 tracking of tissue to each recipient; and
(2) records of appropriate storage and
					 temperature monitoring of skin.
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 52-6 - Skin Banks › Section 52-6.12 - Disposition of unused tissue

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Skin that is not used by the tissue transplantation facility immediately after
					 thawing may be refrigerated at between one and 10 degrees Celsius in isotonic
					 or nutrient medium demonstrated to maximize tissue viability for a period of up
					 to seven days. Such skin may be issued for transplantation to the same patient
					 to whom the skin was originally assigned, but shall not be refrozen. Thawed
					 skin that is not used within seven days shall be discarded, or used for
					 education or research purposes authorized by Public Health Law section
					 4302.
(b) Skin determined to be
					 unsuitable for transplantation, or education or research purposes shall be
					 discarded pursuant to Part 70 of this Title. Packaging of skin for destruction
					 shall be designed to obscure the contents.
(c) Skin returned by the tissue
					 transplantation facility for possible reissuance shall meet all storage and
					 transport requirements of this Part. The skin 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 52-6 - Skin Banks › Section 52-6.13 - Tissue storage facilities

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
					 facility which stores skin shall be licensed by the department as a tissue
					 storage facility. The skin bank shall keep the department fully informed of the
					 number and type of tissue storage facilities operating under its
					 direction.
(b) All skin shall be
					 stored and monitored in accordance with the provisions of sections
					 52-6.8,
					 and
					 52-6.9(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 skin storage and for one year afterwards.
(d) Skin products shall be distributed in
					 accordance with the requirements of this Part, and all records related to the
					 inspection, distribution and transport of skin 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 52-7 - Eye Banks › Section 52-7.1 - 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) Eye donor means a human
					 being, living or dead, who is the source of ocular tissue intended for
					 transplantation.
(b) Enucleation
					 means the removal of the whole eye globe.
(c) Corneal excision means the in situ or
					 laboratory removal of the cornea or corneal-scleral rim.
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 52-7 - Eye Banks › Section 52-7.2 - 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. Eye 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 52-7 - Eye Banks › Section 52-7.3 - 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 ocular eye 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 ocular 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 enucleation or excision and
					 adequate to prepare a clean surgical field. A working sink shall be
					 available.
(d) Ocular tissue
					 retrieval shall be performed only by trained retrieval technicians under the
					 supervision of the director of a licensed eye bank. The director of the
					 licensed eye bank 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 52-7 - Eye Banks › Section 52-7.4 - 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, ocular tissue shall not be released for
					 transplant from donors with any of the following conditions or factors:
(1) evidence of disseminated malignant
					 disease, such as lymphoma or leukemia;
(2) malignant disease of the eye;
(3) active hepatitis B or C, or hepatitis of
					 unknown etiology;
(4) syphilis
					 within the past 12 months;
(5) any
					 disease of unknown etiology;
(6)
					 congenital rubella;
(7) subacute
					 sclerosing panencephalitis;
(8)
					 Reye's syndrome; or
(9) bacterial
					 or fungal endocarditis.
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 52-7 - Eye Banks › Section 52-7.5 - Retrieval of tissue

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Prior to
					 enucleation, eyes shall be maintained in accordance with procedures approved by
					 the tissue bank medical director. Eyes shall be kept moist during the interval
					 between cessation of circulatory function and enucleation.
(b) Enucleation and corneal excision shall be
					 performed in a clean surgical field using standard operating room
					 technique.
(c) Enucleation and/or
					 corneal excision shall occur within 12 hours after cessation of circulatory
					 function unless otherwise specifically authorized by the tissue bank medical
					 director.
(d) Eyes shall be stored
					 and transported to the tissue processing facility at a temperature between two
					 and six degrees Celsius.
(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 storage
					 solutions 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) Tissue
					 and blood specimen containers shall be labeled so as to maintain 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 52-7 - Eye Banks › Section 52-7.6 - Tissue processing facilities

Current through Register Vol. 46, No. 28, July 10, 2024
A facility which processes ocular 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, brochures and
						other informational materials, instructions, manufactured media and tissues
						shall be available for inspection and/or testing by the department as required.
						Copies of all general circulars of information 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 and collection
						date.
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 52-7 - Eye Banks › Section 52-7.7 - 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 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 ocular tissue donors shall be tested for antibodies to human
					 immunodeficiency virus type 1 (HIV-1), human immunodeficiency virus type
					 (HIV-2) and hepatitis C virus (HCV), as well as for hepatitis B surface antigen
					 (HBsAg), for purposes of donor selection.
(b) All ocular tissue from living donors,
					 except corneal tissue, shall be quarantined for six months. After such time and
					 prior to the 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 52-7 - Eye Banks › Section 52-7.8 - Processing and storage of tissue

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Until processing, eyes shall be stored at
					 a temperature of between two and six degrees Celsius.
(b) The corneal-scleral segment shall be
					 examined grossly for clarity, epithelial defects, foreign objects,
					 contamination and scleral color for evidence of jaundice.
(c) Slit-lamp examination of whole eyes or
					 the corneal-scleral rim of excised tissue shall be performed to detect
					 epithelial and stromal pathology, including edema, cell density, opacities,
					 scars and guttata. A system, as determined by the tissue bank medical director,
					 shall be in place to categorize tissue adequacy for transplantation.
(d) Eyes and ocular tissue shall be preserved
					 using aseptic technique, in:
(1) a moist
					 chamber kept at a temperature of between two and six degrees Celsius;
(2) a short-term preservation medium stored
					 and used in accordance with the manufacturer's instructions and/or with written
					 procedures approved by the tissue bank director;
(3) a long-term culture medium used in
					 accordance with written procedures approved by the tissue bank
					 director;
(4) a frozen or
					 dehydrated state, if corneal tissue is used for epikeratoplasty;
(5) the frozen state, as scleral grafts
					 immersed in antibiotic solution; or
(6) any other method in accordance with
					 written procedures approved by the tissue bank medical director and currently
					 accepted by leading authorities in eye transplant medicine.
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 52-7 - Eye Banks › Section 52-7.9 - Distribution of tissue products

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Except as specified in section
					 52-3.4 
					 of this Part, ocular tissue shall not be made available for transplantation if
					 the donor's blood tests repeatedly reactive in approved screening tests for
					 HBsAg or antibodies to HIV-1, HIV-2 or HCV.
(b) The eye bank shall distribute tissue for
					 transplantation only to another eye bank or to a licensed tissue
					 transplantation facility in possession of a written order by a licensed
					 physician.
(c) Tissue shall be
					 transported by the eye bank or its agents, or by staff or agents of the tissue
					 transplantation facility. A signed form shall be kept on file at the eye bank
					 documenting the identification of tissue distributed, including the names of
					 both the person(s) releasing the tissue and the person(s) receiving the
					 tissue.
(d) Tissue in transit from
					 a tissue processing or storage facility to a tissue transplantation facility
					 shall be maintained at the appropriate storage temperature specified in section
					 52-7.8 
					 of this Subpart. Tissue stored at a transplantation facility shall be
					 maintained at the appropriate storage temperature until immediately prior to
					 transplantation.
(e) Tissue shall
					 be visually inspected prior to use by the transplant surgeon who shall
					 determine the suitability of the tissue for transplantation.
(f) Tissue shall be issued by the tissue
					 transplantation facility only upon a written order by a licensed physician or
					 other person authorized by law to order tissue for transplant. Documentation of
					 such order shall be on a dedicated tracking record or on the recipient's
					 medical record. Documentation shall allow accurate tracking of tissue to each
					 recipient.
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 52-7 - Eye Banks › Section 52-7.10 - Required records of tissue acquisition, testing, processing and storage

Current through Register Vol. 46, No. 28, July 10, 2024
In addition to the recordkeeping requirements of Subpart
						52-2 of this Part, each eye bank must maintain tissue records which
						include:
(a) documentation of gross
					 ocular tissue evaluation; and
(b)
					 documentation of slit-lamp examination.
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 52-7 - Eye Banks › Section 52-7.11 - Laboratory tests to be performed prior to tissue transplantation

Current through Register Vol. 46, No. 28, July 10, 2024
The tissue transplantation service shall culture the
						corneal-scleral rim at the time of tissue transplantation for aerobic and
						anaerobic bacterial contamination.
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 52-7 - Eye Banks › Section 52-7.12 - Records to be kept by a 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) results of bacterial culture;
(2) records of appropriate storage and
					 temperature monitoring of ocular tissue; and
(3) a dedicated record allowing accurate
					 tracking of tissue to each recipient.
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 52-7 - Eye Banks › Section 52-7.13 - Disposition of unused tissue

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 All tissue unsuitable for transplantation, education, or research purposes
					 authorized by Public Health Law section 4302 shall be discarded pursuant to
					 Part 70 of this Title. Packaging of tissue for destruction shall be designed to
					 obscure the contents.
(b) If
					 tamper-resistant seals are broken or proper temperature has not been
					 maintained, tissue shall not be issued for transplantation.
(c) Tissue returned by the tissue
					 transplantation facility for possible reissuance shall meet all storage and
					 transport requirements of this Part. The tissue bank shall not reissue tissue
					 returned by the tissue transplantation facility, unless written criteria
					 approved by the tissue bank medical director are met.