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 58-1 - Clinical Laboratories › Section 58-1.1 - Permit

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Permit means a
					 clinical laboratory or blood bank permit issued by the Department of Health.
(1) No clinical laboratory or blood bank
					 shall be issued a permit in any category sought unless:
(i) its laboratory director or assistant
					 director(s) holds a certificate of qualification, pursuant to Part 19 of this
					 Title, in each category for which the permit is sought;
(ii) the clinical laboratory or blood bank
					 has been physically inspected and has provided satisfactory evidence of
					 correction of any deficiencies found;
(iii) the clinical laboratory or blood bank
					 has successfully participated in all required proficiency assessments or
					 remedial activities in the categories sought;
(iv) all tests performed in New York State or
					 on specimens from New York State are either:
(a) classified as approved, cleared, or
					 exempt by the United States Food and Drug Administration (FDA); or
(b) approved by the
					 Department.
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 58-1 - Clinical Laboratories › Section 58-1.3 - Clinical laboratory and blood bank supervision

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A clinical laboratory or blood bank shall
					 have one or more supervisors who, under the general direction of the laboratory
					 director, supervise technical personnel and the reporting of findings, perform
					 tests or procedures requiring special scientific skills, and, in the absence of
					 the laboratory director, are responsible for the proper performance of all
					 laboratory procedures.
(b) A
					 laboratory director who qualifies pursuant to the provisions of section
					 19.2  of this Title shall also be
					 deemed qualified as a supervisor.
(c) Depending upon the size and functions of
					 the clinical laboratory or blood bank, the Department may authorize the
					 laboratory director to also serve as the supervisor of the clinical laboratory
					 or blood bank.
(d) A supervisor
					 shall be on the laboratory premises during all hours in which tests are
					 performed. An exception to this requirement shall be applicable if all the
					 following conditions have been met:
(i) the
					 clinical laboratory or blood bank has not demonstrated a pattern of
					 noncompliance with fundamental standards of practice, nor have any laboratory
					 practices been identified that could lead to immediate jeopardy of public
					 health;
(ii) the clinical
					 laboratory or blood bank has not demonstrated a pattern of unacceptable and/or
					 unsatisfactory proficiency testing performance;
(iii) the supervisor is immediately
					 accessible by telephone or synchronous two-way electronic audio-visual
					 communication to all testing personnel at all times testing is
					 performed;
(iv) the supervisor is
					 assigned on-site hours as determined by the laboratory director to ensure
					 adequate supervision for the scope, complexity and volume of testing being
					 carried out at each site, which shall not be less than eight hours per
					 week;
(v) documentation is
					 maintained that defines and delegates supervisory responsibilities including
					 whether these responsibilities are performed on-site versus off-site;
(vi) when more than one supervisor is
					 employed by the clinical laboratory or blood bank, documentation is maintained
					 that defines which supervisor is responsible for a specific time
					 period;
(vii) the individual who
					 serves as the supervisor may only serve in this capacity at five clinical
					 laboratories or blood banks; and
(viii) the clinical laboratory or blood bank
					 meets any other requirements prescribed in the clinical laboratory standards of
					 practice related to the proper supervision of testing.
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 58-1 - Clinical Laboratories › Section 58-1.4 - Qualifications of laboratory supervisor

Current through Register Vol. 46, No. 28, July 10, 2024
The laboratory supervisor must meet one of the following
						requirements:
(a) The supervisor is a
					 physician licensed to practice medicine or osteopathy in the State of New York
					 or in the state or jurisdiction in which the supervisor practices or an
					 individual who has earned a doctoral degree from an accredited institution with
					 a chemical, physical or biological science as the supervisor's major subject
					 (accredited, as used herein, refers to accreditation by a nationally recognized
					 accrediting agency or association, as determined by the United States
					 Commissioner of Education), and either holds a certificate of qualification or
					 qualifies as a clinical laboratory technologist as described in section
					 58-1.5  of this Subpart. The
					 supervisor shall, subsequent to graduation, have had at least one year of
					 pertinent experience in an acceptable laboratory.
(i) As used in this section, "acceptable
					 laboratory" means a clinical laboratory or blood bank as defined in Section 571  of the
					 Public Health Law, with a laboratory director who meets or would meet the
					 requirements of Part 19 of this Title and where such facility meets or would
					 meet the Department's standards as outlined in this Subpart. This may include,
					 but is not limited to: the anatomic and clinical pathology facilities of a
					 hospital or health department; a testing unit of a university or medical
					 research institution; an independent clinical laboratory or blood bank; a
					 privately operated forensic testing laboratory; or a facility providing
					 training and/or experience in the testing of human
					 specimens.
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 58-1 - Clinical Laboratories › Section 58-1.5 - Duties and qualifications of clinical laboratory technical personnel

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Duties of a
					 clinical laboratory technologist. A clinical laboratory technologist performs
					 tests pursuant to established and approved protocols which require the exercise
					 of independent judgment and responsibility, with minimal supervision by the
					 laboratory director or supervisor, in only those specialties or subspecialties
					 in which they are qualified by education, training and experience.
(b) Qualifications of a clinical laboratory
					 technologist. A clinical laboratory technologist practicing in New York State
					 shall possess a valid license, issued by the New York State Education
					 Department to practice as a clinical laboratory technologist, if such license
					 is required under Article 165 of the State Education Law. A clinical laboratory
					 technologist practicing in a clinical laboratory or blood bank located outside
					 of New York State may qualify provided the clinical laboratory technologist
					 possesses an equivalent license issued by the state or jurisdiction in which
					 the laboratory is located, or meets one of the following requirements:
(1) Successful completion of a course of
					 study which meets all academic requirements for a bachelor's, or higher, degree
					 in medical technology or laboratory science from an accredited institution;
					 or
(2) Successful completion of a
					 course of study which meets all academic requirements for a bachelor's, or
					 higher, degree in one of the chemical, physical, or biological sciences from an
					 accredited institution, and, in addition, at least six months of acceptable
					 supervised experience and/or relevant training.
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 58-1 - Clinical Laboratories › Section 58-1.6 - Physical facilities

Current through Register Vol. 46, No. 28, July 10, 2024
No specimen shall be examined unless the portion of the
						laboratory premises and the equipment used therein have been approved by the
						department as adequate for proper performance of the type of tests for which
						the laboratory is authorized.
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 58-1 - Clinical Laboratories › Section 58-1.7 - Acceptance of specimens

Current through Register Vol. 46, No. 28, July 10, 2024
(a) No
					 establishment other than a clinical laboratory under permit shall accept
					 specimens for the purpose of obtaining information for the diagnosis,
					 prevention, or treatment of a disease or the assessment of a health condition.
					 This subdivision shall not be deemed to prohibit the acceptance of specimens
					 solely for teaching and research purposes.
(b) Except as otherwise provided in section
					 58-1.9 
					 of this Subpart, a clinical laboratory shall examine specimens only at the
					 request of licensed physicians or other persons authorized by law to use the
					 findings of laboratory examinations in their practice or the performance of
					 their official duties.
(1) If the request is
					 oral, the physician or other authorized person shall submit a written request
					 to the laboratory within 48 hours. If the laboratory does not receive the
					 written request within that period, it shall note that fact in the record of
					 daily accession.
(2) Other persons
					 authorized by law to request the examination of specimens shall include but not
					 be limited to:
(i) dentists and podiatrists,
					 provided such examination is within the scope of practice of dentistry or
					 podiatry;
(ii) chiropractors,
					 provided such examination is within the scope of practice of chiropractic, as
					 determined by the executive secretary of the State Board of Chiropractic,
					 Cultural Education Center, Empire State Plaza, Albany, NY 12201;
(iii) physician's assistants, provided such
					 examination is authorized by the supervising physician, and licensed midwives
					 in accordance with their written protocols;
(iv) nurse practitioners, provided such
					 examination is authorized under article 139 of the State Education
					 Law;
(v) police officers, provided
					 such examination is incident to arrest charges for alcohol or drug impairment;
					 and
(vi) judges ordering paternity
					 tests under the Family Court Act.
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 58-1 - Clinical Laboratories › Section 58-1.8 - Results of tests to be reported only to physicians or other authorized persons

Current through Register Vol. 46, No. 28, July 10, 2024
No person shall report the result of any test,
						examination or analysis of a specimen submitted for evidence of human disease
						or medical condition except to a physician, his agent, or other person
						authorized by law to employ the results thereof in the conduct of his practice
						or in the fulfillment of his official duties. Upon request by a patient or the
						patient's personal representative, clinical laboratories may provide a patient
						access to completed test reports that can be identified as belonging to that
						patient as provided in section
						34-2.11 
						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 58-1 - Clinical Laboratories › Section 58-1.9 - Testing to be done on premises except in certain instances

Current through Register Vol. 46, No. 28, July 10, 2024
All specimens accepted by a laboratory for specified
						tests shall be tested on its premises. However, specimens for infrequently
						performed tests or those not included within specialties or subspecialties
						stated on its permit or those requiring specialized equipment and skill may be
						forwarded to and accepted by another laboratory under permit issued by the
						commissioner or to a laboratory which is operated by a government agency or a
						non- profit research institution or to any other laboratory approved by the
						department. The reports of the results of such tests shall be sent by the
						testing laboratory to the forwarding laboratory, except that the forwarding
						laboratory may authorize the testing laboratory to send the report as provided
						in section
						58-1.8 
						of this Part, in which event the testing laboratory shall send a duplicate of
						the said report to the forwarding laboratory. Where the results of a test have
						been reported to it by the testing laboratory, the forwarding laboratory shall
						send a transcript of such report as provided in section
						58-1.8 
						of this Part and shall indicate thereon the name of the laboratory actually
						performing the test.
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 58-1 - Clinical Laboratories › Section 58-1.10 - Specimens: identification and examination

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Every specimen received for testing shall
					 be numbered or otherwise appropriately identified and listed in an accession
					 book, or another system acceptable to the department.
(b) Every tissue specimen shall be examined
					 and reported upon by a qualified pathologist who is certified or eligible for
					 certification for pathologic anatomy by the American Board of Pathology or
					 whose qualifications, in the opinion of the Public Health Council pursuant to
					 Part 19 of this Title, are equivalent of such certification. Preliminary
					 examination or "screening" of specimens for cytopathology may be made only by
					 an individual who has had special training in cytology acceptable to the
					 department.
(c) A clinical
					 laboratory or blood bank shall at any time during its regular working hours
					 permit the inspection of its premises and records by a representative of the
					 department and shall examine and report promptly on all specimens submitted by
					 the department for the purpose of determining the competency of the
					 laboratory.
(d) If the component to
					 be tested for in a specimen is perishable, labile, or otherwise subject to
					 deterioration, such specimen shall be tested as promptly as possible after
					 collection. If a specimen is transported or stored, it shall be properly
					 preserved, refrigerated, frozen or otherwise appropriately treated to maintain
					 it in as close to its original state as is possible by then current
					 technics.
(e) A specimen received
					 by a laboratory shall not be tested or reported on if:
(1) the apparent condition of the specimen
					 indicates that it is unsatisfactory for testing or that it is inappropriate for
					 the test requested;
(2) it has been
					 collected, labeled, preserved or otherwise handled in such a manner that it has
					 become unsatisfactory or unreliable as a test specimen;
(3) it is perishable and the time lapse
					 between the collection of the specimen and its receipt by the laboratory is of
					 such duration that the test finding may no longer be reliable; or
(4) the date and, in the case of tests
					 specified by the department, the hour when the specimen was taken by the
					 physician or other authorized person is not furnished with the
					 specimen.
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 58-1 - Clinical Laboratories › Section 58-1.13 - General requirements for performance of anatomic pathology and cytopathology procedures

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Facilities.
(1) Laboratory space.
(i) Work areas must be clean, well-lighted
					 and well-ventilated.
(ii) Utilities
					 (water, gas, suction, electricity) must be available, as needed.
(iii) Microscopic work area(s), including
					 space and furniture, must be conducive to high-quality performance.
(iv) Cytopreparation area(s) must be separate
					 from screening and clinical/secretarial area(s) so that personnel are protected
					 from hazardous fumes and screening areas are free from distractions.
(v) There must be sufficient space for
					 quality control, administrative, and clerical functions.
(vi) Storage of records and specimens must be
					 in compliance with section 581.1 - 1(c) and (d) of this Subpart.
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 58-1 - Clinical Laboratories › Section 58-1.14 - Reporting of certain communicable diseases

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The commissioner shall designate those
					 communicable diseases, as defined by section
					 2.1  of the Sanitary Code, that
					 require prompt action, and shall make available on the Department's website a
					 list of such communicable diseases.
(b) Laboratories performing tests for
					 screening, diagnosis or monitoring of communicable diseases requiring prompt
					 action pursuant to subdivision (a) of this section, for New York State
					 residents and/or New York State health care providers, shall:
(i) immediately report to the commissioner
					 all positive results for such communicable diseases in a manner and format as
					 prescribed by the commissioner; and
(ii) report all results, including positive,
					 negative and indeterminate results, to the commissioner in a time and manner
					 consistent with Public Health Law § 576-c.
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 58-2.2 - Qualifications of donors

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The medical
					 director shall be responsible for the determination that blood may be collected
					 safely from a donor and that the donor's blood is acceptable for collection.
					 This determination shall be made by the medical director or trained staff
					 members under the medical director's supervision on the day of collection of
					 the blood. In addition, autogeneic collections prior to anticipated surgery or
					 other medical procedure shall require the written authorization of the donor's
					 health care provider and written consent of the donor. If autogeneic blood is
					 to be subsequently used for allogeneic transfusion, all requirements in
					 subdivision (f) of this section must be met.
(b) Only those persons may be accepted as
					 donors of blood for allogeneic use who are in good health as indicated by:
(1) freedom from infectious skin lesions at
					 the phlebotomy site and from any infectious skin disease generalized to an
					 extent that creates a risk of contamination of the blood;
(2) freedom from any disease transmissible by
					 blood transfusion, insofar as can be determined by history and examinations
					 required in this Subpart;
(3)
					 freedom from active tuberculosis. A person with a history of tuberculosis may
					 be accepted as a blood donor following completion of drug therapy;
(4) freedom from syphilis. However, blood for
					 plasma fractionation into heat-treated or pathogen-inactivated derivatives may
					 be accepted;
(5) freedom from a
					 history of viral hepatitis for a duration specified by the United States Public
					 Health Service;
(6) freedom from a
					 history of malaria or travel to or residence in malarially endemic areas for
					 periods of time considered to increase risks for malaria exposure, as
					 determined by the United States Public Health Service. However, plasma for
					 transfusion or fractionation may be accepted from donors with a history of
					 malaria or travel to a malarially endemic area;
(7) freedom from signs and symptoms of human
					 immunodeficiency virus (HIV) infection; and
(8) freedom from other medical
					 contraindications.
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 58-2.4 - Collection of blood

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Collection
					 of blood for transfusion shall be performed under the direction of the medical
					 director. Medical services for emergency care of the donor shall be available.
					 Blood for transfusion shall be collected only on the premises of a blood bank,
					 at a blood donation center approved by the department, in a self-contained
					 blood collection vehicle operated by a blood bank, or at a temporary collection
					 operation conducted by a blood bank. Each blood bank shall inform the
					 department, upon request, of the location of all blood collection activities
					 and the provisions made for the handling of medical emergencies. Prior to
					 collection of blood for testing, a signed form must be obtained from the donor
					 or person legally authorized to consent on behalf of such donor, in which the
					 donor or the person legally authorized to consent acknowledges that he/she has
					 been provided with written materials stating that HIV testing for donor
					 screening purposes shall be performed in conjunction with all
					 donations.
(b)
Quantity
					 limitations.
Allogeneic and autogeneic donors may give a maximum of
						550 milliliters of whole blood in addition to pilot samples sufficient for all
						testing to be performed.
(c)
Frequency limitations.
No allogeneic blood donor may donate more than 550
						milliliters of whole blood within an eight-week period, unless approved to do
						so by a physician who examines the potential donor at the time of the proposed
						second donation. In no event may an allogenic blood donor donate more than
						twice within a 16-week period. The foregoing prohibition on donations does not
						apply to allogeneic blood donors diagnosed with hemochromatosis. For autogeneic
						collections, the frequency of donation shall be as specified in section
						58-2.2(e)(3) 
						of this Subpart.
(d)
					 Persons collecting blood for transfusion shall be trained, under the direction
					 of the medical director, to recognize donor reactions. Whenever donor
					 collection procedures are performed, a nurse or other qualified person
					 specially trained to recognize and address donor reactions shall be immediately
					 available, and a physician shall be available by telephone for
					 consultation.
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 58-2.5 - Sterilization of instruments

Current through Register Vol. 46, No. 28, July 10, 2024
For both allogeneic and autogeneic transfusions,
						syringes, needles, lancets, or other blood- letting devices capable of
						transmitting infection from one person to another, shall either be licensed by
						the F.D.A. for single use or be heat-sterilized prior to each use. Heat
						sterilization shall be by autoclaving at 121.5 degrees Celsius for 15 minutes
						after the chamber of the autoclave has been evacuated and has reached that
						temperature, or by dry heat for two hours at 170 degrees Celsius or by such
						other procedure as may be approved by the department.
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 58-2.9 - Issuance of blood, blood components and derivatives

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Unless they are needed to meet a medical
					 emergency, blood and blood components shall be transported in a leak-resistant,
					 crush-resistant and puncture-resistant container featuring a prominent label
					 which:
(1) identifies the contents as "human
					 blood" or "biomedical product";
(2)
					 describes the contents, the packing agent, if any, and any special precautions
					 necessary in handling such blood; and
(3) contains the name, address and 24-hour
					 telephone number of the person or entity to be contacted in the event that the
					 container is found to be leaking or damaged or to have been
					 misdirected.
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 58-2.10 - Required records and confidentiality

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Complete and accurate records of blood,
					 blood components and derivatives released for allogeneic or autogeneic
					 transfusion shall be kept for seven years or six months after the expiration
					 date of the individual product, whichever is later, by the blood bank preparing
					 the product and by the institution using the product. Such records shall be
					 open to inspection by the department and shall include the information
					 specified in sections
					 58-2.11
					 and
					 58-2.12 
					 of this Subpart. For all collected or distributed blood, blood components and
					 derivatives, the donor's name, address, telephone number, social security
					 number and any other information which would directly or indirectly identify
					 the blood donor of any specific unit shall not be disclosed by the blood bank
					 to any person or entity except upon the written consent of the donor or except
					 to the department and other agencies which issue clinical laboratory and/or
					 blood bank permits to the facility whose records are requested.
(b) Blood banks and transfusion services
					 shall file a Blood Services Activity Report annually with the
					 department.
(c) Records shall be
					 maintained of all tests, controls, reagents and current procedures, in a manner
					 acceptable to the department in conformance with generally accepted laboratory
					 principles.
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 58-2.11 - Records to be kept when blood is collected for autogeneic or allogeneic transfusion

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Every
					 blood bank shall maintain records of each container of blood or blood
					 components collected or prepared therein. The records shall contain the
					 following information:
(1) donor's full name,
					 address, age, sex and identifying code;
(2) date and amount of blood
					 collected;
(3) any adverse reaction
					 of the donor;
(4) signature of or
					 other unique identifier provided by the phlebotomist;
(5) results of all tests performed on a
					 sample from the donor or a unit;
(6) disposition of the blood or blood
					 components;
(7) for autogeneic
					 donation, documentation of written or verbal consent of the donor-patient's
					 health care provider if donation takes place prior to anticipated surgery or
					 medical procedure, of the physician responsible for collection or his/her
					 designee, and of the donor-patient. If the blood is to be considered for
					 allogeneic use, the donor shall sign a consent form giving consent for such
					 use, specifying procedures for release of the unit by the health care provider,
					 and stating that to the best of the donor's knowledge, the blood is safe for
					 use by others; and
(8) if a donor
					 is determined to be unsuitable for donation based on donor history, laboratory
					 test results or implication in a case of transfusion-transmitted disease
					 according to the protocol of the blood collection service, a record of the
					 donor's name and identifying information. Blood from such a donor shall not be
					 released, even if results of testing on subsequent donations are negative,
					 unless the donor has been approved for reentry into the donor pool by the
					 director of the blood bank or designee who is a physician.
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 58-2.12 - Records to be kept when blood, blood components or derivatives are issued for allogeneic or autogeneic transfusion

Current through Register Vol. 46, No. 28, July 10, 2024
(a) For blood and blood components, records
					 of the following information, as applicable, shall be kept in the blood bank
					 and made available to the department for inspection:
(1) source;
(2) unit identification code upon receipt
					 and, if different, upon issuance;
(3) unit ABO and Rh groups;
(4) expiration date;
(5) results of all pretransfusion
					 testing;
(6) disposition of the
					 unit, including remote storage location, if any, and intended recipient's name
					 or, if the name is unknown, identification code;
(7) identification of the station code or
					 person taking possession of the unit;
(8) documentation of visual
					 inspection;
(9) date and time of
					 issuance; and
(10) results of all
					 tests associated with the investigation of all transfusion reactions, with the
					 conclusions reached and the report signed, or approved by electronic
					 equivalent, by the director of the blood bank or a qualified physician
					 designated by the director of the blood 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 58-2 - Blood Banks and Laboratories Performing Immunohematology Testing › Section 58-2.13 - Distribution facilities

Current through Register Vol. 46, No. 28, July 10, 2024
A blood bank may operate a distribution facility,
						provided the department is notified, in advance, of the location and activities
						to be performed at the site.
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 58-2.14 - Reserved

Current through Register Vol. 46, No. 28, July 10, 2024
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 58-2.15 - Collection of blood components by apheresis

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Notwithstanding any requirements in this
					 Subpart to the contrary for blood collection by means other than apheresis,
					 blood banks collecting blood components by apheresis must comply with
					 applicable requirements in Title 21 CFR Parts 630 and 640 and any additional
					 requirements in this section.
(b)
Direction
. The director of a blood bank collecting,
					 processing, and/or distributing blood components for transfusion shall be a
					 licensed physician who holds a Certificate of Qualification in Blood Banking
					 Collection - Comprehensive pursuant to Part 19 of this Title. The director may
					 serve as the responsible physician for purposes of  Title 21 CFR Part 630 ;
					 however, if the director is not the responsible physician, the responsible
					 physician shall be a physician licensed in New York State. Except for testing
					 procedures for clinical testing, the director may delegate approval of new or
					 revised standard operating procedure manuals or other procedural guides as
					 required by section
					 58-2.8 
					 of this Title.
(c)
Informed
					 consent
. The consent of a prospective donor shall be obtained in
					 writing. The donor shall be informed of the risks of apheresis and the risks of
					 any sedimenting agents or medications to be used. The blood bank director or
					 responsible physician shall approve information provided to the donor regarding
					 risks or hazards of the procedure and such approval may not be
					 delegated.
(d) Qualifications and
					 care of the donor.
(1) Only those persons may
					 be accepted as blood donors for apheresis who are in good health as indicated
					 by the qualifications of a whole blood donor specified in section
					 58-2.2 
					 of this Subpart, with the following exceptions:
(i) Ingestion of aspirin-containing
					 medications within two days of donation shall preclude donation of
					 platelets.
(ii) Cytapheresis of
					 donors who do not meet the requirements of this subsection shall be performed
					 only if the harvested cells are expected to be of particular value to an
					 intended recipient, and only if the supervising physician has confirmed in
					 writing the particular value of these cells and has certified that the donor's
					 health permits cytapheresis.
(iii)
					 Medications or sedimenting agents to facilitate cytapheresis shall not be used
					 in donors whose medical history suggests that these may exacerbate previous or
					 intercurrent disease. Guidelines for use of such agents shall be established by
					 the medical 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 58-2 - Blood Banks and Laboratories Performing Immunohematology Testing › Section 58-2.16 - Required standards for transfusions

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
Transfusion services.
Every institution which performs transfusions or supplies
						blood to a limited transfusion service or ambulance transfusion service shall
						designate a physician who is a member of the staff as director of transfusion
						services. Such physician must be licensed and currently registered in New York
						State. The premises, equipment, procedure manuals, records, and all blood,
						blood components and derivatives shall be available for inspection by the
						department.
(1) It shall be the
					 responsibility of the chief executive officer or other person in charge of each
					 institution and of the director of transfusion services to determine that:
(i) the rules and regulations of the Council
					 on Human Blood and Transfusion Services and the Administrative Rules and
					 Regulations of the department and related requirements are complied
					 with;
(ii) attending and other
					 staff members and nurses are properly instructed regarding all required
					 procedures;
(iii) records required
					 by the aforesaid rules and regulations are maintained;
(iv) serious unexpected reactions and
					 incidents involving blood components that have been issued by the transfusion
					 service are reported to the department's Wadsworth Center, with sufficient
					 detail to facilitate evaluation and investigation, within seven calendar days
					 of the reaction or incident, or its discovery and, if required, to Federal
					 authorities; and
(v) a written
					 policy exists regarding use of blood components negative for cytomegalovirus
					 antibody, irradiated components, leukocyte-reduced components and other
					 specialty components. Such a policy shall include recommended indications for
					 component use and a protocol for component processing and issuance. There shall
					 also be a written policy on recommended indications for transfusion of whole
					 blood, fresh frozen plasma and platelets.
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 58-2.17 - Laboratory tests to be performed prior to allogeneic or autogeneic transfusion

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Tests shall be
					 performed to determine the ABO and Rho (D) groups of each recipient in
					 accordance with procedures approved by the department pursuant to this Subpart.
					 ABO grouping tests shall include both forward and reverse grouping, except that
					 reverse grouping is not required for infants under four months of age. Prior to
					 transfusion, the ABO group of all units of whole blood and red blood cell
					 components, as well as the Rh group of all such units labeled as Rh-negative,
					 shall be confirmed using a sample obtained from an attached segment. Any
					 discrepancies shall be reported in writing to the collecting facility and
					 resolved prior to issuance of the blood for transfusion purposes.
(b) Serum or plasma from each recipient or,
					 in the case of an infant under four months of age, the infant's mother, shall
					 be tested for unexpected alloantibodies using reagent red blood cells that meet
					 F.D.A. standards, are intended for this purpose and are not pooled. Methods of
					 testing for unexpected alloantibodies shall demonstrate sensitizing and
					 hemolytic antibodies.
(c) Except in
					 cases necessitating emergency release of group-compatible blood, or in the case
					 of transfusion of a volume of blood or blood components exceeding the
					 recipient's expected normal blood volume in a 24-hour period, compatibility
					 between recipient and donor blood shall be determined. If a clinically
					 significant antibody has been detected, or if there is a history of presence of
					 such an antibody, compatibility testing shall include an antiglobulin phase
					 crossmatch. If no clinically significant antibody has been detected, and there
					 is no known history of presence of such an antibody, the crossmatching
					 procedure to be used may be determined by the director of transfusion services,
					 but shall, at minimum, consist of an immediate spin test or use of a validated
					 computer system, except that crossmatching is not required for infants under
					 four months of age.
(d) In the case
					 of patients requiring repeated blood transfusions, or those pregnant or
					 transfused with allogeneic red blood cell-containing components within the
					 previous three months, fresh blood specimens shall be drawn for compatibility
					 testing and antibody screening at intervals of not more than three days prior
					 to the day of transfusion, except for neonates, to whom no time limits
					 apply.
(e) A pre-transfusion sample
					 of recipient blood, including serum or plasma, shall be retained for seven days
					 after each transfusion for further testing in the event of an adverse
					 reaction.
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 58-2.18 - Records to be kept when blood or blood component transfusions are performed

Current through Register Vol. 46, No. 28, July 10, 2024
The following information shall be included on the
						recipient's chart or in records maintained in the blood bank:
(a) date of the transfusion;
(b) name(s) of the person(s) who performed
					 the transfusion and who attended the recipient during the
					 transfusion;
(c) for each unit:
(1) blood component transfused;
(2) unit identification code;
(3) unit ABO and Rh groups;
(4) start time and completion time;
					 and
(5) description of any adverse
					 reaction and the results of related investigation;
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 58-2.19 - Records to be kept when derivatives are infused

Current through Register Vol. 46, No. 28, July 10, 2024
The following information shall be included on the
						recipient's chart or in records maintained in the blood bank or
						pharmacy:
(a) product name,
					 manufacturer, lot number, and expiration date;
(b) documentation of visual inspection prior
					 to infusion;
(c) name of person
					 administering the product;
(d)
					 documentation of identification of the recipient;
(e) date of infusion and quantity of material
					 infused; and
(f) description of any
					 adverse reaction and the results of related investigation.
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 58-2.20 - Ambulance transfusion services

Current through Register Vol. 46, No. 28, July 10, 2024
(a) No person shall own or operate an
					 ambulance transfusion service in New York State unless approved by the
					 department. An inspection may be conducted prior to departmental approval.
					 Ambulance transfusion services shall comply with the provisions in this Part
					 governing transfusions in general.
(b) Ambulance transfusion services shall have
					 a written agreement with all hospitals issuing blood components to the
					 ambulance transfusion service for possible administration during transport to
					 another hospital, except in cases when no ground or air, as needed, ambulance
					 transfusion service with an agreement in place is available. The agreement
					 shall be subject to the prior approval of the department. The agreement shall:
(1) specify the division of responsibilities
					 for ensuring compliance with the provisions of this Subpart;
(2) include a statement that ambulance
					 transfusion service personnel will have adequately completed training in
					 administering blood components according to a curriculum approved by the
					 department; and
(3) include the
					 written approval of the issuing facility's director of transfusion services and
					 the director of the ambulance transfusion 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 58-2 - Blood Banks and Laboratories Performing Immunohematology Testing › Section 58-2.21 - Limited transfusion services

Current through Register Vol. 46, No. 28, July 10, 2024
(a) No person shall own or operate a limited
					 transfusion service in New York State unless approved by the department. An
					 inspection may be conducted prior to departmental approval. Limited transfusion
					 services shall comply with the provisions in this Part governing transfusions
					 in general.
(b) Limited transfusion
					 services shall have a written agreement with an issuing facility holding a
					 permit in blood services-transfusion. The agreement shall specify the division
					 of responsibilities for ensuring compliance with the provisions of this Part.
					 The agreement shall be subject to the prior approval of the department. The
					 agreement shall include:
(1) the written
					 approval of the issuing facility's director of transfusion services and the
					 director of the limited transfusion service;
(2) the procedures for transport and storage
					 of blood and means to ensure compliance with such procedures;
(3) a description of the transfusion
					 committee of the issuing facility, its responsibilities and
					 composition;
(4) procedures for
					 training of personnel at the limited transfusion service;
(5) requirements for handling adverse
					 reactions, including training of personnel, availability of a physician,
					 24-hour coverage, and reporting and investigation of such reactions;
(6) procedures for administration of
					 transfusions, including staffing requirements; and
(7) recordkeeping procedures as required in
					 sections
					 58-2.18
					 and
					 58-2.19 
					 of this Subpart, clearly describing responsibilities for maintenance of records
					 and their location.
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 58-2.22

Current through Register Vol. 46, No. 28, July 10, 2024