reglab/statecodes huggingface dataset:
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-2 - Blood Banks and Laboratories Performing Immunohematology Testing › Section 58-2.23 - HIV-1 and HIV-2 antibody testing results

Current through Register Vol. 46, No. 28, July 10, 2024
No blood bank shall inform any blood or plasma donor or
						his/her heath care provider of the results of HIV-1, HIV-2 or HIV-1/HIV-2
						combination antibody screening tests unless such results are negative, with the
						exception of autogeneic donors, whose heath care provider may be informed of
						screening test results if there is insufficient time prior to surgery for
						completion of supplemental testing, provided that such heath care provider is
						instructed that the donor may not be informed that he or she is positive for
						HIV-1 or HIV-2 antibodies based on the incomplete results. Initial reactive
						screening tests shall be repeated in duplicate. If two of three screening tests
						are reactive, the sample shall be considered repeatedly reactive, and
						supplemental testing shall be performed. Notification that a donor is positive
						shall be made only if the results have been reactive for more than one
						screening test, and the supplemental HIV antibody test result has been
						unequivocally positive. Appropriate counseling of donors regarding the
						significance of all test results must be available. HIV results must be
						reported to donors if the results are substantiated as positive, or upon
						supplemental testing show an increased likelihood of representing
						seroconversion to positive, as determined by the director of the laboratory
						performing the supplemental testing. This report must be made in person unless
						repeated efforts to encourage a donor to come in have failed, in which case
						notification may be made by certified restricted delivery mail. HIV results
						that are substantiated as negative, or upon supplemental testing are
						indeterminate but do not show an increased likelihood of representing
						seroconversion to positive, as determined by the director of the laboratory
						performing the supplemental testing, may be reported to donors by mail,
						provided that such donors are not informed that they are seropositive. Any
						notification of HIV results to donors who were repeatedly reactive on initial
						screening tests, regardless of the results of supplemental testing, must
						include an offer of appropriate counseling.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-2 - Blood Banks and Laboratories Performing Immunohematology Testing › Section 58-2.24 - Disposal of untransfused blood units

Current through Register Vol. 46, No. 28, July 10, 2024
Units deemed unsuitable for transfusion, those not
						transfused for any reason, and those designated for disposal for any reason,
						shall be disposed of by an appropriate method in accordance with all applicable
						regulations and requirements. All expired blood components shall be transferred
						to a separate storage location within 24 hours of expiration. All such
						components shall be destroyed, discarded, or removed for non-transfusion
						purposes within 72 hours of expiration, or returned to the collection facility
						within one week of expiration.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-2 - Blood Banks and Laboratories Performing Immunohematology Testing › Section 58-2.25 - Intraoperative and postoperative blood recovery and normovolemic hemodilution

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Blood recovered
					 intraoperatively or postoperatively from a person or collected for normovolemic
					 hemodilution shall not be transfused into another person.
(b) Methods for intraoperative or
					 postoperative recovery of blood and for normovolemic hemodilution shall be safe
					 and aseptic, and shall ensure accurate identification of all blood collected.
					 The equipment used shall be operated according to the manufacturer's
					 instructions, shall be pyrogen-free, shall include a filter capable of
					 retaining particles potentially harmful to the recipient, and shall prevent air
					 embolism. If the blood is warmed prior to reinfusion, the warming system shall
					 be equipped with a visible thermometer and an alarm to ensure that the blood is
					 not warmed above the temperature specified in a written protocol, in
					 conformance with the system manufacturer's instructions.
(c) A complete written protocol for
					 collection and processing of recovered blood and for normovolemic hemodilution,
					 approved by the director of transfusion services, shall be maintained and
					 followed. The protocol shall include criteria for selection of suitable
					 patients and determination of dosage of ancillary agents used, as well as
					 procedures for prevention and management of adverse reactions.
(d) If recovered blood or blood collected for
					 normovolemic hemodilution is removed from the immediate premises for processing
					 or storage, identification procedures shall be in place to ensure its
					 transfusion into the intended recipient.
(e) If not immediately transfused, recovered
					 blood shall be stored under one of the following conditions:
(1) at one to 24 degrees Celsius for up to
					 six hours after initiating the collection; or
(2) at one to six degrees Celsius under
					 monitored conditions for up to 24 hours, provided that storage at one to six
					 degrees Celsius is begun within six hours of initiating the collection and the
					 blood is washed under sterile conditions.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-2 - Blood Banks and Laboratories Performing Immunohematology Testing › Section 58-2.26 - Exceptions

Current through Register Vol. 46, No. 28, July 10, 2024
(a) When, for
					 indications generally accepted by the medical community, an allogeneic donor
					 who would not otherwise qualify to donate blood or blood components is found to
					 be uniquely suited to meet a given patient's needs, exceptions may be made to
					 the requirements in sections
					 58-2.2(b) and
					 (c),
					 58-2.3(a),
					 58-2.4(c),
					 and
					 58-2.15(c),
					 (d) and (e)  of this Subpart. Such exceptions
					 shall be approved in writing by both the medical director of the blood bank
					 collecting the blood or his/her physician designee, and the director of the
					 transfusion service transfusing the blood or his/her physician designee. If
					 donation under such circumstances presents an increased risk to the donor's
					 health or safety, the donor shall be informed of the risk and must consent in
					 writing to such donation. If the donation presents an increased risk to the
					 recipient's health or safety, the written authorizations of the recipient's
					 health care provider and the recipient or person legally authorized to consent
					 on behalf of the recipient are also required. All such exceptions granted shall
					 be reported to the department annually in a format designated by the
					 department.
(b) Exceptions to the
					 requirements of this Subpart, other than the exception specified in subdivision
					 (a) of this section, may be granted by the department on a case-by-case basis
					 and for a limited time only, if necessitated by a medical emergency or special
					 medical conditions. Persons seeking an exception shall apply to the department
					 as soon as possible and shall describe the nature of the emergency or special
					 medical conditions and the exception requested. All such emergencies or special
					 medical conditions must be documented in the medical record, and any action
					 taken in response which is contrary to the requirements of this Subpart must be
					 approved by the director of transfusion services. If it is not possible to
					 request an exception in advance or if the department has not responded before
					 an action contrary to the requirements of this Subpart had to be taken, the
					 director of transfusion services must report the action taken to the department
					 as soon as possible thereafter but not later than the end of the next business
					 day after the action was taken.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-2 - Blood Banks and Laboratories Performing Immunohematology Testing › Section 58-2.28 - Incorporation by reference

Current through Register Vol. 46, No. 28, July 10, 2024
The provisions of the Code of Federal Regulations which
						have been incorporated by reference in this Subpart have been filed in the
						Office of the Secretary of State of the State of New York, the publication so
						filed being the booklet entitled: Code of Federal Regulations, Title 21, Parts
						630 and 640, revised as of May 22, 2015 and April 1, 2016, respectively,
						published by the Office of the Federal Register, National Archives and Records
						Administration. The regulations incorporated by reference may be examined at
						the Records Access Office, New York State Department of Health, Corning Tower,
						Empire State Plaza, Albany, New York 12237 or can be directly obtained from the
						Superintendent of Documents, US Government Printing Office, Washington, D.C.
						20402.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-3 - Clinical Laboratory Inspection And Reference Fees › Section 58-3.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Gross annual
					 receipts for clinical laboratories able to segregate income. For independent
					 laboratories or laboratories operated within facilities which can segregate
					 their laboratory income from total facility income, gross annual receipts shall
					 mean the total income of the laboratory from all sources for all clinical
					 laboratory tests performed pursuant to its permit, less any amounts paid to
					 reference laboratories for such tests which are referred.
(b) Gross annual receipts for clinical
					 laboratories unable to segregate laboratory income.
(1) For laboratories operated by health
					 maintenance organizations, facilities with operating certificates issued
					 pursuant to section 2805  of the Public Health Law, and other
					 similar facilities which are reimbursed by third-party payors for laboratory
					 services as part of an all inclusive facility per diem rate and which cannot
					 segregate laboratory income from total facility income, gross annual receipts
					 shall mean the amount computed by multiplying the total annual cost of the
					 laboratory, by a fraction, the numerator of which is the gross revenue of the
					 facility and the denominator of which is the gross cost of operating the
					 facility. This amount must be further adjusted by subtracting any amounts paid
					 to reference laboratories for such tests which are referred. Laboratories must
					 obtain prior department approval to use this method by documenting that they
					 are unable to segregate income.
(2)
					 For all other clinical laboratories unable to segregate their annual income
					 from tests performed pursuant to their New York State permit, gross annual
					 receipts shall mean the amount the laboratory would have received had it billed
					 the prevailing rate for these services. The prevailing rate shall mean the fee
					 schedule for clinical laboratory services as listed on pages 5-1 through 5-14
					 of the Medicaid Management Information System Provider Manual for Laboratories,
					 March 1982 edition, as published by the New York State Department of Social
					 Services. Copies of this publication are available from the Department of
					 Social Services, 40 North Pearl Street, Albany, NY 12243, and a copy is
					 available for inspection and copying from the records access officer of the
					 Department of Health, Corning Tower, Empire State Plaza, Albany, NY 12237.
					 Laboratories must obtain prior department approval to use this method by
					 documenting that they are unable to identify laboratory income.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-3 - Clinical Laboratory Inspection And Reference Fees › Section 58-3.2 - Laboratory inspection and reference fee

Current through Register Vol. 46, No. 28, July 10, 2024
Each laboratory issued a permit by the department
						pursuant to section 575  of the Public Health Law shall be
						charged an annual laboratory inspection and reference fee.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-3 - Clinical Laboratory Inspection And Reference Fees › Section 58-3.3 - Reporting

Current through Register Vol. 46, No. 28, July 10, 2024
(a) On or before
					 May 1st of each State fiscal year (April 1st to March 31st), the department
					 will advise each laboratory of the total estimated cost of the clinical
					 laboratory improvement program for the previous State fiscal year.
(b) On or before May 15th, each laboratory
					 will certify and report its gross annual receipts for the previous calendar
					 year on forms to be provided by the department. If requested by the laboratory,
					 this report shall be deemed confidential and exempt from disclosure under the
					 Freedom of Information Law (article 6 of the Public Officers Law), pursuant to
					 the authority in section 89 (5)  of the Public Officers
					 Law. Knowing and/or willful failure to report or inaccurate reporting shall
					 result in nonrenewal of the laboratory permit.
(c) On or before June 1st, the department
					 shall bill each laboratory for its inspection and reference fee and shall
					 advise each laboratory of the total gross receipts reported by all
					 laboratories.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-3 - Clinical Laboratory Inspection And Reference Fees › Section 58-3.4 - Quarterly payments

Current through Register Vol. 46, No. 28, July 10, 2024
At least quarterly payments must be made. If the
						laboratory elects to make quarterly payments, equal quarterly payments must be
						made by June 30th, September 30th, December 31st and March 10th of the State
						fiscal year to which the billing relates. Nothing herein precludes full payment
						from being made before these dates.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-3 - Clinical Laboratory Inspection And Reference Fees › Section 58-3.5 - Suspension or nonrenewal of laboratory permit

Current through Register Vol. 46, No. 28, July 10, 2024
Knowing and/or willful failure to meet the quarterly
						payment requirement will result in suspension or nonrenewal of the laboratory
						permit.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-3 - Clinical Laboratory Inspection And Reference Fees › Section 58-3.6 - Fees

Current through Register Vol. 46, No. 28, July 10, 2024
On or before September 15th, the department will review
						the annual cost of the clinical laboratory inspection program as initially
						estimated. Fees will be adjusted when any change results in an increase or
						decrease in fees of more than $100 per laboratory. If an adjustment is
						required, the department shall notify the laboratories of any additional fees
						or credits by October 15th. Any additional fees are payable not later than 30
						days after the date of the notification statement. Credits shall be applied to
						the next regular payment.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-3 - Clinical Laboratory Inspection And Reference Fees › Section 58-3.7 - Gross annual receipts

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
					 laboratory which has no gross annual receipts to report because it did not
					 operate in New York State the previous permit year shall pay a first year
					 accreditation fee of $1,000 regardless of the number of months remaining in the
					 permit year. When applying for renewal of that permit, the laboratory shall
					 report its gross receipts for the calendar months in which it operated and
					 these receipts shall be projected to a 12-month basis for the purpose of
					 computing gross annual receipts.
(b) A laboratory which has no permit, but
					 accepted business which required it to have a New York State permit, had gross
					 annual receipts in the previous permit year, and applies for a permit after
					 commencement of the permit year shall pay a fee computed as an annual fee but
					 prorated for the months remaining in the permit year, or $1,000, whichever is
					 greater.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-3 - Clinical Laboratory Inspection And Reference Fees › Section 58-3.8 - Out-of-state laboratory seeking permit

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Prior to any onsite inspection, an
					 out-of-state laboratory possessing or seeking a New York State permit shall pay
					 to the department, by certified check, bank check, teller's check or money
					 order, a fee calculated by the department and consisting of the following
					 components:
(1) a transportation expense,
					 which shall be either the actual travel expense if travel is by common carrier,
					 or a mileage expense at the rate negotiated between the State and the union
					 representing the employees scheduled to conduct the inspection; and
(2) a per diem expense as specified by the
					 New York State Comptroller for the inspecting employees, multiplied by the
					 number of additional days estimated by the department to be necessary for
					 travel and the actual inspection.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-3 - Clinical Laboratory Inspection And Reference Fees › Section 58-3.9 - Effective dates

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Until March
					 31, 1986, the following dates shall have the following meanings:
(1) In section
					 58-3.3(a),
					 May 1st shall mean the effective date of this regulation.
(2) In section
					 58-3.3(b),
					 May 15th shall mean a date 10 days after the effective date of this
					 regulation.
(3) In section
					 58-3.3(c),
					 June 1st shall mean a date 45 days after the effective date of this
					 regulation.
(4) In section
					 58-3.4, June
					 30th, September 30th, December 31st and March 10th shall mean dates to be
					 negotiated by the department and each laboratory for the payment of quarterly
					 installments of the 1985-86 fee; provided, however, that full payment must be
					 made by March 10, 1986.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-4 - Source Plasma Donation Centers › Section 58-4.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Source plasma is defined as the fluid portion of human blood collected by
					 plasmapheresis and intended as source material for further manufacturing use.
					 This definition excludes single donor plasma products intended for intravenous
					 use (i.e., transfusion).
(b) Source
					 plasma donation center means a facility where source plasma is collected by
					 plasmapheresis, and total protein and hematocrit testing is performed on
					 prospective donors. Source plasma donation center does not include collection
					 of single source donor plasma intended for intravenous use (i.e.,
					 transfusion).
(c) Responsible
					 physician means an individual who is:
(1)
					 Licensed and registered to practice medicine by the New York State Education
					 Department;
(2) In good standing
					 with the New York State Education Department and the Office of Medical
					 Professional Conduct of the New York State Department of Health;
(3) Adequately trained and qualified to
					 direct and control personnel and relevant procedures concerning the
					 determination of donor eligibility; collection of blood and blood components;
					 the immunization of a donor; and the return of red blood cells or other blood
					 components to the donor during collection of blood component(s) by apheresis;
					 and
(4) Designated by the
					 collection establishment to perform the activities described in paragraph
					 (c)(3) of this section.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-4 - Source Plasma Donation Centers › Section 58-4.2 - Registration of source plasma donation centers

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Each
					 source plasma donation center must apply for registration on forms provided by
					 the Department, which shall include: the necessary demographic information of
					 the source plasma donation center; current license and registration of the
					 responsible physician overseeing collection activities; name, address and
					 credentials of the laboratory director; name and address of the owner of the
					 donation center; and other such information as the department may
					 require.
(b) A source plasma
					 donation center registration shall not be issued unless the responsible
					 physician meets all criteria in section
					 58-4.1(c)  of this
					 Subpart, the laboratory director meets the requirements in section
					 58-4.1(e)  of this
					 Subpart, the registration fees have been paid and the registration application
					 is complete.
(c) The source plasma
					 donation center registration shall be valid for a period of two years from the
					 date of issuance and may be renewed for successive two-year periods thereafter.
					 The original application and each renewal application shall be accompanied by a
					 registration fee of six hundred dollars. A renewal application must be received
					 at least sixty (60) days prior to registration expiration.
(d) Source plasma donation centers shall only
					 perform hematocrit and total protein donor eligibility tests. Any other
					 clinical laboratory testing shall require a clinical laboratory permit pursuant
					 to Section 574  of the
					 Public Health Law.
(e) The
					 responsible physician and laboratory director shall be jointly responsible for
					 ensuring compliance with this Subpart. The responsible physician shall be
					 responsible for ensuring compliance with the Code of Federal Regulations, Title
					 21, Parts 630 and 640. The laboratory director will be responsible for ensuring
					 compliance with the Code of Federal Regulations, Title 42, Part 493.
(f) Source plasma donation centers shall
					 notify the Department no later than sixty (60) calendar days after any change
					 in the responsible physician, laboratory director, owner, or location. Failure
					 to provide proper notice pursuant to this subdivision may result in the
					 revocation of the source plasma donation center's registration.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-4 - Source Plasma Donation Centers › Section 58-4.3 - Incorporation by Reference

Current through Register Vol. 46, No. 28, July 10, 2024
The provisions of the Code of Federal Regulations which
						have been incorporated by reference in this Subpart have been filed in the
						Office of the Secretary of State of the State of New York, the publication so
						filed being the booklet entitled: Code of Federal Regulations, Title 21, Parts
						630 and 640, revised as of May 22, 2015 and April 1, 2016, respectively, and
						Title 42, Part 493, revised as of August 10, 2022, published by the Office of
						the Federal Register, National Archives and Records Administration and Code of
						Federal Regulations. The regulations incorporated by reference may be examined
						at the Records Access Office, New York State Department of Health, Corning
						Tower, Empire State Plaza, Albany, New York 12237 or can be directly obtained
						from the Superintendent of Documents, US Government Printing Office,
						Washington, D.C. 20402.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-4 - Source Plasma Donation Centers › Section 58-4.4 - Enforcement

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Registration under this Subpart may be denied, suspended, revoked or annulled
					 by the department upon a determination that a registrant:
(1) failed to comply with the requirements of
					 this Subpart;
(2) provided services
					 that constitute an unwarranted risk to human health;
(3) intentionally provided any false or
					 misleading information to the Department relating to registration or performing
					 donor eligibility and collection procedures; or
(4) has demonstrated incompetence or shown
					 consistent errors in the performance of donor eligibility or collection
					 procedures.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-5 - Hematopoietic Progenitor Cell Banks › Section 58-5.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
As used in this Part:
(a) Bone marrow means the human tissue
					 filling cavities of bone, consisting of fully mature and precursor
					 hematopoietic cells intended for transplantation.
(b) Hematopoietic progenitor cells means
					 human precursor hematopoietic cells derived from bone marrow, peripheral blood
					 or other tissue sources, such as cord blood obtained from the placenta or
					 umbilical cord.
(c) Hematopoietic
					 progenitor cell bank means hematopoietic progenitor cell procurement service,
					 hematopoietic progenitor cell processing facility or hematopoietic progenitor
					 cell transplantation facility.
(d)
					 Hematopoietic progenitor cell procurement service means a facility which
					 performs donor selection and bone marrow aspiration or other hematopoietic
					 progenitor cell collection, and pre-processing storage of hematopoietic
					 progenitor cells from autogeneic and/or allogeneic donors.
(e) Hematopoietic progenitor cell processing
					 facility means a facility which processes bone marrow or other hematopoietic
					 progenitor cell samples, including purging, storage, and distribution of
					 hematopoietic progenitor cells from autogeneic and/or allogeneic
					 donors.
(f) Hematopoietic
					 progenitor cell transplantation facility means a facility which temporarily
					 stores and transplants hematopoietic progenitor cells, and includes facilities
					 which infuse autogeneic hematopoietic progenitor cells and bone marrow
					 transplantation services approved by the commissioner pursuant to section
					 709.8 
					 of this Title.
(g) Hematopoietic
					 progenitor cell transplantation service means a specific unit conducting
					 hematopoietic progenitor cell transplantation within a hematopoietic progenitor
					 cell transplantation facility. Such a service shall be independently supervised
					 by a qualified director.
(h)
					 Department means the New York State Department of Health.
(i) Commissioner means the commissioner of
					 the New York State Department of Health.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-5 - Hematopoietic Progenitor Cell Banks › Section 58-5.4 - Donor qualifications

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Except in the case of an autogeneic donation, a complete donor history shall be
					 obtained prior to hematopoietic progenitor cell donation. A summary of the
					 donor history obtained by a hematopoietic progenitor cell procurement service
					 shall be provided to the physician performing the transplant for a
					 determination of the cells' suitability for transplantation. The donor history,
					 or in the case of cord blood donation, the history of the donor's biologic
					 mother and, if available, the donor's biologic father, shall include, but not
					 be limited to, information concerning:
(1) any
					 acute respiratory disease;
(2) any
					 infectious skin disease that creates a risk of contamination of the
					 hematopoietic progenitor cells;
(3)
					 any disease transmissible by hematopoietic progenitor cells insofar as can be
					 determined by donor history;
(4)
					 active tuberculosis or history of therapy therefor;
(5) history of malaria or travel to or
					 residence in malarially endemic areas for periods of time considered to bear
					 increased risks for malaria exposure, as determined by criteria established by
					 the procurement or collection facility, consistent with criteria developed by
					 the United States Public Health Service;
(6) known coagulation of platelet
					 disorders;
(7) any medical
					 condition, which may be affected adversely by the collection
					 procedure;
(8) any medical
					 condition, including a malignancy, that would adversely affect the quality of
					 the hematopoietic progenitor cells collected;
(9) receipt of an organ transplant or a
					 transfusion of blood or blood components within the past 12 months;
(10) indications of drug or alcohol abuse;
					 and
(11) other medical conditions
					 or circumstances as determined by the medical advisory committee and medical
					 director of the procurement service.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-5 - Hematopoietic Progenitor Cell Banks › Section 58-5.5 - Sterilization of instruments

Current through Register Vol. 46, No. 28, July 10, 2024
Syringes, needles, lancets, or other phlebotomy or
						hematopoietic progenitor cell collection devices capable of transmitting
						infection from one person to another and licensed for single use by the Food
						and Drug Administration shall be appropriately discarded after such use.
						Reusable devices shall be heat-sterilized prior to each use. Heat sterilization
						shall be by autoclaving at 121.5° C 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° C, or by such other similarly acceptable procedure in
						accordance with current medical standards generally accepted by leading
						authorities in transplantation medicine.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-5 - Hematopoietic Progenitor Cell Banks › Section 58-5.6 - Collection and handling of hematopoietic progenitor cells

Current through Register Vol. 46, No. 28, July 10, 2024
(a) All hematopoietic progenitor cell
					 specimens obtained by bone marrow aspiration shall be collected by the medical
					 director of the procurement service or other qualified physician, physician's
					 assistant, or a nurse practitioner under the supervision of the medical
					 director. Hematopoietic progenitor cells obtained by peripheral blood apheresis
					 shall be collected by an individual trained in pheresis in accordance with the
					 requirements of section
					 58-2.15 
					 of this Part. Cord blood collection shall be performed by staff with documented
					 training, experience and proficiency in the techniques utilized.
(b) Hematopoietic progenitor cell collection
					 apparatus and containers shall be clean, pyrogen-free and sterile.
(c) Phlebotomy and bone marrow aspiration
					 puncture sites shall be prepared by a procedure which conforms to current
					 medical standards generally accepted by leading authorities in transplantation
					 medicine.
(d) Hematopoietic
					 progenitor cell collection systems shall meet the following minimum
					 requirements:
(1) hematopoietic progenitor
					 cells shall be collected under aseptic conditions using an approved system
					 adequately protected against contamination;
(2) additives shall be used as required to
					 ensure the continued suitability of hematopoietic progenitor cells for
					 transplantation and retention of viability. All changes in additives shall be
					 validated on-site, and such validation shall be documented;
(3) each container shall be legibly labeled
					 or tagged at the time of collection with;
(i)
					 the donor's identification code and date of collection;
(ii) if known, the recipient/patient's name,
					 the name of the hospital where the patient is to be transplanted, and the
					 patient's hospital registration number, social security number, birth date or
					 similar identifying information;
(4) each final container shall be legibly
					 labeled or tagged at the time of issuance with:
(i) if performed, the results of laboratory
					 tests for syphilis, HBsAg and antibodies to HBV, HCV, HIV-1, HIV-2, HTLV-I and
					 CMV, unless the results were forwarded to the hematopoietic progenitor cell
					 transplantation service in advance or included in records accompanying the
					 hematopoietic progenitor cells; and
(ii) a biohazard label, if the donor has
					 tested reactive or positive for any of the tests required in section
					 58-5.4(c) or
					 (d)(1)  of this Subpart; and
(5) if microbial culturing is
					 performed, suspected contamination shall be reported to the transplantation
					 service.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-5 - Hematopoietic Progenitor Cell Banks › Section 58-5.7 - Hematopoietic progenitor cell processing facilities

Current through Register Vol. 46, No. 28, July 10, 2024
(a) If hematopoietic progenitor cells are to
					 be frozen, the following requirements apply:
(1) unless otherwise specifically authorized
					 in writing by the director of the hematopoietic progenitor cell processing
					 facility, hematopoietic progenitor cells shall be frozen within 48-hours of
					 collection using cryopreservation techniques generally accepted by experts in
					 transplantation medicine and meeting the requirements of this
					 Subpart;
(2) until used,
					 hematopoietic progenitor cells shall be stored continuously within a
					 temperature range of minus 196° C to minus 80° C, under one of the following
					 conditions:
(i) in a mechanical freezer
					 reserved for hematopoietic progenitor cells, equipped with an automatic
					 temperature recording device, an audible alarm and a back-up system in the
					 event of unexpected mechanical failure; or
(ii) in a liquid nitrogen freezer reserved
					 for hematopoietic progenitor cells, equipped with an automatic liquid nitrogen
					 level monitor, an audible alarm and a back-up system in the event of unexpected
					 liquid nitrogen loss;
(3) frozen hematopoietic progenitor cells in
					 transit from a processing facility to a transplantation facility or other
					 facility shall be:
(i) maintained, at a
					 minimum, on dry ice or in a liquid nitrogen dry shipper. Storage/transport
					 procedures for the frozen hematopoietic progenitor cells shall be validated,
					 and such validation shall be documented;
(ii) transported as fast as reasonably
					 possible and without any unnecessary delay; and
(iii) used immediately upon arrival or stored
					 as required in paragraph (2) of this subdivision until thawed for use;
					 and
(4) hematopoietic
					 progenitor cell specimens shall be inspected visually at the time of freezing
					 and thawing. If the color or physical appearance is abnormal, the cells shall
					 not be released for transplantation unless authorized, in writing, by the
					 transplantation service director.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-5 - Hematopoietic Progenitor Cell Banks › Section 58-5.8 - Required records

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Complete and accurate records of hematopoietic progenitor cells released for
					 transplantation shall be kept for seven years by the hematopoietic progenitor
					 cell procurement service, processing facility and transplantation service using
					 the sample. Such records shall be open to inspection by the department. For all
					 donated hematopoietic progenitor cells, the donor's name, address, and any
					 other information that would directly or indirectly identify the donor shall
					 not be disclosed or released by the bank to any person or entity, except upon
					 the written consent of the donor or the person authorized by law to make the
					 donation, or to authorized employees of the department, or as permitted by law.
					 The recipient's name, address, and any other information that would directly or
					 indirectly identify the recipient shall not be disclosed or released by the
					 hematopoietic progenitor cell bank to any person or entity, except upon the
					 written consent of the recipient, or except to authorized employees of the
					 department, or as permitted by law.
(b) Records to be kept by the hematopoietic
					 progenitor cell procurement service shall include, but not be limited to, the
					 following information:
(1) donor's full name,
					 address, age, sex, and identification code, as well as documentation of donor
					 or donor's mother informed consent;
(2) date and volume of hematopoietic
					 progenitor cells collected;
(3) any
					 adverse reaction of the donor and its outcome;
(4) medical history and results of all
					 required clinical laboratory tests and of the physical examination
					 performed;
(5) disposition of
					 hematopoietic progenitor cells;
(6)
					 documentation of sterility testing and viability and recovery checks if
					 performed; and
(7) medical
					 director's authorization for the collection.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-5 - Hematopoietic Progenitor Cell Banks › Section 58-5.9 - Quality assurance and safety requirements

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Quality assurance.
(1) The hematopoietic progenitor cell
					 procurement service and hematopoietic progenitor cell processing facility shall
					 keep records which indicate that a quality assurance program is maintained in
					 the following areas:
(i) preventive
					 maintenance, periodic inspections and testing for proper operation of
					 equipment;
(ii) monitoring of all
					 temperature-controlled spaces and equipment to ensure proper
					 performance;
(iii) validation of
					 microprocessor-controlled equipment and associated software, including test
					 plan protocols, results of parallel testing, and supervisory review;
					 and
(iv) validation of
					 hematopoietic progenitor cell processing and testing methodologies.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-5 - Hematopoietic Progenitor Cell Banks › Section 58-5.10 - Compliance with standards

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Hematopoietic progenitor cell procurement services and/or processing facilities
					 shall allow admission to representatives of the department for the purpose of
					 inspecting the premises and evaluating operating procedures, equipment and
					 records, including financial records and lists of physicians or facilities to
					 whom or to which hematopoietic progenitor cells are released, to determine
					 compliance with the standards in this Subpart. If the commissioner determines
					 that a significant likelihood exists that adequate safeguards are not
					 implemented, the department may require that cells not be released pending a
					 hearing. Such hearing shall commence within 15 days of any suspension pursuant
					 to this section.
(b) Whenever
					 requested, a hematopoietic progenitor cell bank shall submit to the department
					 reports containing such information and data concerning the bank's activities
					 as may be required by this Subpart. Such reports shall be signed by the
					 director of the hematopoietic progenitor cell bank.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-5 - Hematopoietic Progenitor Cell Banks › Section 58-5.11 - Licensure

Current through Register Vol. 46, No. 28, July 10, 2024
No person shall own or operate a hematopoietic progenitor
						cell procurement service, processing facility or transplantation facility in
						New York State unless licensed by the department under Subpart 52-2 of this
						Title. All provisions of Subpart 52-2 of this Title shall apply to a
						hematopoietic progenitor cell procurement service, processing facility and/or
						transplantation facility, except for the recordkeeping requirements contained
						in section
						52-2.9  of this
						Title.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-5 - Hematopoietic Progenitor Cell Banks › Section 58-5.12 - Special circumstances

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 The department may exempt a hematopoietic progenitor cell bank from a specific
					 standard contained in this Subpart, provided:
(1) the hematopoietic progenitor cell bank
					 has requested an exemption under limited circumstances prior to the
					 noncompliance with the standard; and
(2) the hematopoietic progenitor cell bank
					 has demonstrated to the department that application of the standard to such
					 bank under the limited circumstances for which the 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 the exemption is sought, and the department determines that
					 the requirement imposed by the Federal or other state' s governmental unit
					 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 or impair the provision
					 of services necessitated by a medical emergency or special medical condition.
					 Hematopoietic progenitor cell banks seeking an exemption pursuant to this
					 subparagraph shall describe the nature of the emergency or special medical
					 condition 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 Subpart shall be approved by the director
					 of the hematopoietic progenitor cell transplantation service.