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 58-8 - Human Immunodeficiency Virus (hiv) Testing › Section 58-8.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
For the purposes of this Subpart, unless the context
						indicates otherwise, the terms below shall have the following meanings:
(a) Department means the New York State
					 Department of Health.
(b) Donor
					 means a human being, living or dead, who is the source or potential source of a
					 body, organ, tissue or fluid for transfusion, transplantation, transfer,
					 artificial insemination or implantation.
(c) FDA means the Food and Drug
					 Administration of the United States Department of Health and Human
					 Services.
(d) HIV antibody
					 screening means the performance of tests to detect HIV antibodies, which tests
					 are not sufficiently specific to ensure definitive evidence of HIV
					 infection.
(e) HIV identification
					 testing means the performance of tests or characterize HIV or HIV viral
					 components, including, but not limited to, HIV protiens and HIV nucleic acid.
					 HIV identification testing shall also include cultivation of the infectious
					 virus.
(f) HIV confirmatory testing
					 means the performance of one or more supplemental tests to substantiate or
					 refute results of HIV testing procedures that are not sufficiently specific to
					 ensure definitive evidence of HIV infection.
(g) HIV diagnostic testing means the
					 performance of HIV tests for purposes of diagnosing, assessing or monitoring
					 HIV infection in persons who may have been exposed to HIV, are at risk of
					 exposure to HIV, or are known to be HIV-infected, but shall not include testing
					 of donors. HIV testing of individuals in conjunction with an application for
					 insurance shall be considered HIV diagnostic testing whenever test results are
					 communicated to the applicant or his/her medical provider by the insurance
					 company's medical director or a consulting physician or a physician under the
					 medical director's supervision.
(h)
					 Preliminary finding of HIV infection means results of antibody screening that
					 have been neither substantiated nor refuted by HIV confirmatory
					 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 58-8 - Human Immunodeficiency Virus (hiv) Testing › Section 58-8.2 - Hiv testing and recordkeeping requirements

Current through Register Vol. 46, No. 28, July 10, 2024
In addition to other applicable requirements in this
						Part, and Parts 52 and 63 of this Title, clinical laboratories, blood banks and
						tissue banks with a New York State clinical laboratory permit to perform HIV
						testing shall meet the following requirements:
(a) Specimens for testing patients, donors
					 and insurance applicants shall be only of the type approved by the FDA or
					 acceptable to the department for use with the particular method or test
					 kit.
(b) All tests shall employ
					 reagents, methods, techniques and procedures approved by the FDA or acceptable
					 to the department in conformance with generally accepted laboratory
					 principles.
(c) If the test result
					 is to be communicated to the test subject or other person legally authorized to
					 receive the result, results for specimens found reactive in accordance with the
					 test manufacturer's interpretation of HIV antibody screening test results shall
					 be confirmed with HIV confirmatory testing.
(d) Confirmatory testing shall be performed
					 as soon as practicable in all cases when notification of a preliminary finding
					 of HIV infection is made.
(e) A
					 standard operating procedure manual (SOPM) shall be developed and maintained
					 current, and shall include, in addition to documentation required elsewhere in
					 this Part and Part 52 of this Title, algorithms for use of each HIV test method
					 or test kit, and policies and processes for accepting specimens, reporting
					 results, and ensuring compliance with confidentiality requirements and, as
					 applicable, reporting requirements of article 21, title III and article 27-F of
					 the Public Health Law and New York State Insurance Law, section
					 2611(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 58-8 - Human Immunodeficiency Virus (hiv) Testing › Section 58-8.3 - Confidentiality

Current through Register Vol. 46, No. 28, July 10, 2024
Each clinical laboratory, blood bank, tissue bank or
						organ procurement organization performing, or causing the performance or
						receiving the results of HIV testing shall establish and implement procedures
						for confidentiality, disclosure and re-disclosure consistent with applicable
						Federal and State law and regulations, including article 27-F of the Public
						Health Law and New York State Insurance Law, section 2611(c). No bill, claim
						for reimbursement or invoice issued by a clinical laboratory, blood or tissue
						bank or its agent shall disclose the nature of the service rendered to a named
						individual by using the acronym HIV, or the words human immunodeficiency virus
						or similar identifying words, unless disclosure is authorized by law and the
						intended recipient of the bill, claim or invoice is an entity subject to New
						York State or Federal confidentiality, disclosure and re-disclosure
						requirements.
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 58-8 - Human Immunodeficiency Virus (hiv) Testing › Section 58-8.4 - Hiv result reporting requirements

Current through Register Vol. 46, No. 28, July 10, 2024
(a) No
					 clinical laboratory shall notify a physician or other person legally authorized
					 to receive the result that an HIV test is positive solely on the basis of HIV
					 antibody screening, except that a clinical laboratory may report a preliminary
					 finding of HIV infection as provided in section
					 58-1.8 
					 of this Part . Results for specimens found non-reactive by HIV antibody
					 screening may be reported to the physician who ordered the testing or other
					 person legally authorized to receive the result.
(b) For HIV diagnostic testing, a report of
					 preliminary finding of HIV infection shall prominently and clearly state that
					 the finding is preliminary, that results of confirmatory testing will follow,
					 and that such confirmatory results must be considered in making a diagnosis
					 related to HIV infection.
(c) No
					 blood, tissue or organ donor, or consenting next of kin shall be notified that
					 an HIV test result is positive solely on the basis of HIV antibody
					 screening.
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 58-8 - Human Immunodeficiency Virus (hiv) Testing › Section 58-8.5 to 58-8.7 - Repealed

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 59 - Chemical Analyses Of Blood, Urine, Breath Or Saliva For Alcoholic Content › Section 59.2 - Techniques and methods for determining blood and urine alcohol

Current through Register Vol. 46, No. 28, July 10, 2024
(a) All blood and
				  urine alcohol determinations shall be made by quantitative methods and reported
				  as whole blood alcohol concentration (BAC) to the second decimal place as
				  found; for example, 0.137 percent found shall be reported as 0.13 percent
				  weight per volume. If specimens other than whole blood are analyzed, the
				  following conversions shall apply:
(1) three
				  fourths of the determined concentration of alcohol in the urine shall be
				  equivalent to the corresponding BAC; and
(2) nine tenths of the determined
				  concentration of alcohol in the serum or plasma shall be equivalent to the
				  corresponding BAC.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 59 - Chemical Analyses Of Blood, Urine, Breath Or Saliva For Alcoholic Content › Section 59.3 - Blood, urine and saliva alcohol analysis; permits

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Individuals performing chemical analyses
				  for blood, urine and saliva alcohol content may apply to the commissioner for a
				  permit.
(b) A permit for the
				  performance of chemical analyses for blood, urine and saliva alcohol content
				  shall be issued by the commissioner to an applicant who:
(1) is a high school graduate and has one
				  year of laboratory experience acceptable to the commissioner; or
(2) has satisfactorily completed two years of
				  college study and has six months of laboratory experience acceptable to the
				  commissioner; and
(3) demonstrates
				  to the satisfaction of the commissioner proficiency in the chemical analyses of
				  the alcoholic content of blood and any other sample type that the commissioner
				  requires; and
(4) has access to
				  appropriate laboratory facilities for the performance of such
				  analyses.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 59 - Chemical Analyses Of Blood, Urine, Breath Or Saliva For Alcoholic Content › Section 59.5 - Breath analysis; techniques and methods

Current through Register Vol. 46, No. 28, July 10, 2024
The following breath analysis techniques and methods shall
					 be a component of breath analysis instrument operator training provided by
					 training agencies and shall be used by operators performing breath analysis for
					 evidentiary purposes:
(a) A breath
				  sample shall be collected at the direction and to the satisfaction of a police
				  officer and shall be analyzed with breath analysis instruments meeting the
				  criteria set forth in section
				  59.4 
				  of this Part.
(b) The subject shall
				  be observed for at least 15 minutes prior to the collection of the breath
				  sample, during which period the subject must not have ingested alcoholic
				  beverages or other fluids, regurgitated, vomited, eaten, or smoked, or have
				  placed anything in his/her mouth; if the subject should regurgitate, vomit,
				  smoke or place anything in his/her mouth, an additional 15- minute waiting
				  period shall be required.
(c) A
				  system purge shall precede both the testing of each subject and the analysis of
				  the reference standard.
(d) The
				  result of an analysis of a reference standard with an alcoholic content greater
				  than or equal to 0.08 percent must agree with the reference standard value
				  within the limits of plus or minus 0.01 percent weight per volume, or such
				  limits as set by the commissioner. An analysis of the reference standard shall
				  precede or follow the analysis of the breath of the subject in accordance with
				  the test sequence established by the training agency. Readings for the
				  reference standard, a blank and the subject's breath, shall be
				  recorded.
(e) Results of an
				  analysis of breath for alcohol shall be expressed in terms of percent weight
				  per volume, to the second decimal place as found; for example, 0.237 percent
				  found shall be reported as 0.23 percent.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 59 - Chemical Analyses Of Blood, Urine, Breath Or Saliva For Alcoholic Content › Section 59.6 - Breath analysis permit program

Current through Register Vol. 46, No. 28, July 10, 2024
Training agencies shall submit an application for approval
					 of a breath analysis permit program or a training program for breath analysis
					 to the commissioner. Other agencies seeking approval of such programs shall
					 submit an application to the commissioner through the Office of Public Safety
					 of the Division of Criminal Justice Services. The application shall
					 include:
(a) a description of the
				  techniques and methods to be utilized;
(b) the make and model of the breath analysis
				  instruments used;
(c) an outline of
				  the material presented in the breath analysis instrument operator and technical
				  supervisor training program;
(d)
				  the name of the individual primarily responsible for each training program and
				  for the breath analysis program;
(e) the name and qualifications of one or
				  more individuals meeting the requirements for technical supervisor under
				  section
				  59.9 
				  of this Part; and
(f) such other
				  information as the commissioner shall require.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 59 - Chemical Analyses Of Blood, Urine, Breath Or Saliva For Alcoholic Content › Section 59.7 - Breath analyzer operator permits

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
				  permit valid for two years shall be issued by the commissioner to breath
				  analysis instrument operators who have completed an approved program based upon
				  standards acceptable to the training agency and certified by the commissioner.
				  Such program shall consist of a minimum of 24 hours of instruction and training
				  with identified learning objectives, supervised by one or more individuals
				  certified as technical supervisors, and shall include:
(1) three hours of instruction on the effects
				  of alcohol on the human body;
(2)
				  five hours of instruction on operational principles of the selected techniques
				  and methods, including a functional description and a detailed operational
				  description of the breath analysis instrument(s) with a
				  demonstration;
(3) five hours of
				  instruction on the legal aspects of chemical tests generally, and of the
				  particular techniques and methods to be employed;
(4) three hours of instruction on
				  supplemental information to include nomenclature appropriate to the field of
				  chemical tests for alcohol;
(5) six
				  hours of laboratory participation using approved breath analysis instruments
				  and simulators, or other reference standards;
(6) a passing score on a one-hour formal
				  examination designed to evaluate whether the operator has met the course
				  learning objectives; and
(7) a
				  demonstration of analytical proficiency on each breath analysis instrument for
				  which the operator is seeking certification.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 59 - Chemical Analyses Of Blood, Urine, Breath Or Saliva For Alcoholic Content › Section 59.8 - Revocation or suspension of permits

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The commissioner or the training agencies
				  may at any time and from time to time require breath analysis instrument
				  operators or technical supervisors to demonstrate their ability to operate
				  properly the breath analysis instrument(s) for which they hold a
				  permit.
(b) The operator's permit
				  may be revoked by the commissioner based on information acquired by the
				  commissioner, or a training agency, that the operator does not conduct breath
				  tests in accordance with techniques and methods as instructed by the training
				  agency, that the operator's performance is unreliable, or the operator is
				  incompetent. Upon revocation, the operator shall return any and all permits to
				  the commissioner.
(c) The training
				  agency may suspend the permit of any operator under its supervision when, in
				  its judgment, the operator does not conduct breath tests in accordance with
				  techniques and methods as established by the training agency, the operator's
				  performance is unreliable or the operator is incompetent. The training agency
				  shall immediately notify the commissioner in writing of any such suspension and
				  furnish a copy of such notice to the suspended operator, who shall not be
				  permitted to operate the breath analysis instrument until such time as the
				  suspension is removed.
(d) An
				  operator whose permit has been suspended by the training agency may appeal to
				  the commissioner who shall decide whether suspension shall be affirmed or set
				  aside. The commissioner may reinstate the permit of the operator making such
				  appeal under such conditions as the commissioner deems necessary.
(e) An operator whose permit has been revoked
				  shall not be eligible for a new permit within 12 months from the date of
				  revocation or at such other time as may be determined by the
				  commissioner.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 59 - Chemical Analyses Of Blood, Urine, Breath Or Saliva For Alcoholic Content › Section 59.9 - Technical supervisor; qualifications and certification

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The commissioner may authorize
				  certification of an applicant as technical supervisor for a period of four
				  years, provided such applicant submits satisfactory evidence through the
				  training agency that he/she meets the following qualifications:
(1) thirty semester hours of college credits,
				  including eight semester hours of chemistry;
(2) certification as an operator of the
				  breath analysis instrument(s) to be supervised, or possession of equivalent
				  experience or training to qualify as an operator; and
(3) satisfactory completion of a technical
				  supervisor's course, the content of which shall include:
(i) advanced survey of current information
				  concerning alcohol and its effect on the human body (one hour);
(ii) operational principles and theories
				  applicable to the program (two hours);
(iii) breath analysis instrument maintenance
				  and calibration (two hours);
(iv)
				  legal aspects of chemical testing (one hour); and
(v) principles of instruction (two hours);
				  or
(4) training and
				  experience equivalent to a technical supervisor's course and acceptable to the
				  commissioner.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 59 - Chemical Analyses Of Blood, Urine, Breath Or Saliva For Alcoholic Content › Section 59.10 - Certification criteria for ignition interlock devices

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A manufacturer of ignition interlock
				  devices shall apply to the department to certify a device for use in New York
				  State. The application shall be on a form or format specified by the department
				  with documents appended as necessary to provide the requisite information, and
				  shall include, but not be limited to:
(1)
				  name and address of the manufacturer, and contact information including,
				  identification of a person to respond to department inquiries;
(2) name and model of the ignition interlock
				  device;
(3) a detailed description
				  of the ignition interlock device, including: instructions for its installation
				  and operation; technical specifications, including, but not limited to,
				  accuracy; calibration stability; data security; and capability for data
				  collection and recording, tamper detection, and retesting, and unsupervised
				  operation in a range of environmental conditions;
(4) the manufacturer's statement that all
				  ignition interlock devices of the same make and model sold or offered for sale
				  or lease, for which certification is sought, meet the requirements of this
				  Part; and
(5) a certificate or
				  other document from an insurance carrier licensed in New York State
				  demonstrating that the manufacturer holds product liability insurance with
				  minimum liability limits of $1 million per occurrence and $3 million aggregate.
				  The documentation shall include the issuing company's statement that at least
				  30 days notice will be provided to the department whenever the issuing company
				  intends to cancel the insurance before the policy's expiration date. Liability
				  coverage shall include defects in product design and materials, as well as in
				  manufacture, calibration, installation and removal of devices.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 59 - Chemical Analyses Of Blood, Urine, Breath Or Saliva For Alcoholic Content › Section 59.11 - Testing of ignition interlock devices

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The department may require a testing
				  laboratory, as defined in section
				  59.1  of
				  this Part, to submit its credentials for department review prior to accepting
				  any report submitted by the testing laboratory in support of an ignition
				  interlock device manufacturer's application for certification.
(b) The testing laboratory shall provide,
				  directly to the department, a detailed report of test data and findings of the
				  ignition interlock device's performance on each standard, generated by the
				  testing laboratory, documenting that at least two representative instruments of
				  an ignition interlock device model have successfully met the requirements of
				  section
				  59.10(c) 
				  of this Part.
(c) The testing
				  laboratory's report shall minimally include: a description of tests performed;
				  data and findings for each test conducted, with numerical readouts as
				  appropriate; a description of the effectiveness of the ignition interlock
				  device's security provisions, if any, for detection and recording of attempted
				  tampering and preventing circumvention; the reliability of the device's data
				  recording features; and a description of the effectiveness of the device over a
				  range of environmental conditions. The report shall include a dated and signed
				  attestation by the person supervising such testing that identifies the ignition
				  interlock device model and manufacturer, and states that all tests on the named
				  device model were conducted in accordance with NHTSA specifications.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 59 - Chemical Analyses Of Blood, Urine, Breath Or Saliva For Alcoholic Content › Section 59.12 - Continued ignition interlock device certification

Current through Register Vol. 46, No. 28, July 10, 2024
(a) An ignition interlock device
				  certification shall remain in effect until:
(1) the manufacturer files a written request
				  for discontinuance;
(2) the
				  department issues to the manufacturer a written notice of suspension or
				  revocation of approval; or
(3) the
				  manufacturer modifies the device so that it does not meet the Federal model
				  specifications for breath alcohol ignition interlock devices in effect when it
				  was certified.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-1 - Wic Program-violations And Hearings Involving Applicants, Participants, Food Vendors And Local Agencies › Section 60-1.2 - Notification to applicants and participants of a right to a conference and fair hearing

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Local
					 agencies shall notify applicants and participants in writing at the time of
					 application and at the time of denial of participation or disqualification from
					 the program of the right to a conference and if there is no resolution of the
					 issue at the conference, a fair hearing and the method by which a conference
					 and fair hearing may be requested. For individuals who are disqualified, the
					 notification shall be served at least 15 days prior to termination of
					 participation.
(b) The written
					 notification of the denial of participation or disqualification from the WIC
					 program shall be on a form supplied or approved by the department and shall
					 include:
(1) a description of the adverse
					 action and the reason(s) for it;
(2) a statement indicating that the request
					 for a conference and if there is no resolution of the issues at the conference,
					 a fair hearing may be made verbally or in writing to the department for a fair
					 hearing and to the local agency for a conference and may be made by the
					 participant or applicant or other representative of same;
(3) a listing of the office locations and
					 phone numbers where requests for a conference and fair hearing may be
					 made;
(4) notification that the
					 participant must request a conference within seven days and a fair hearing
					 within 60 days from the date the notice of adverse decision is served. Failure
					 to make a timely request for a conference shall result in a waiver of the right
					 to a conference. Failure to make a timely request for a fair hearing shall
					 result in a waiver of the right to a fair hearing;
(5) an explanation of the rules and
					 regulations governing participation in the WIC program and a citation of those
					 rules and regulations;
(6) an
					 explanation of the purposes and procedures of fair hearings and
					 conferences;
(7) a statement that
					 the participant or representative may present positions or arguments at the
					 conference and fair hearing and that a representative may be a relative,
					 friend, legal counsel or other spokesperson; and
(8) for participants whose benefits are being
					 terminated during the certification period, a statement that if an appeal is
					 made within 15 days of the notification of the termination, the benefits shall
					 continue until the fair hearing decision is made or the certification periods
					 ends, whichever occurs first.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-1 - Wic Program-violations And Hearings Involving Applicants, Participants, Food Vendors And Local Agencies › Section 60-1.3 - Conferences for applicants and participants

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Within seven days from the date a notice
					 of denial of participation or disqualification is served, the aggrieved person
					 may contact the local agency, either orally or in writing, to request a
					 conference with a representative of the agency to discuss the determination or
					 action of the agency, obtain an explanation of the reasons therefor, inspect
					 any pertinent information in the agency's file and to present information to
					 show that the agency's determination is incorrect.
(b) The local agency shall promptly, after
					 receipt of a request for a conference, send the aggrieved person a notice
					 containing the date, time and place of the conference and informing him/her
					 that he/she may speak for himself/herself or be represented by an attorney,
					 his/her parent or guardian, relative, friend or other spokesperson.
(c) The local agency shall conduct the
					 conference at a date no later than 10 days after receipt of the request for a
					 conference.
(d) If, as a result of
					 a conference, the representative of the local agency finds that the information
					 upon which the local agency based its determination or action is incorrect, or
					 if for any other reason the representative decides that the determination or
					 action is inappropriate, he/she may reverse or modify the local agency's
					 determination. If, however, such representative finds that the determination or
					 action of the agency is appropriate, such determination or action shall become
					 effective as scheduled unless the aggrieved party requests a fair hearing from
					 the department, whereupon the adverse action shall be stayed in appropriate
					 cases until the fair hearing decision is rendered.
(e) The representative of the local agency
					 shall make a decision at the conclusion of the conference and shall at that
					 time inform the aggrieved person and the person's representative, if any, of
					 the decision.
(f) The right to a
					 conference shall not in any way affect the aggrieved person's right to a fair
					 hearing.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-1 - Wic Program-violations And Hearings Involving Applicants, Participants, Food Vendors And Local Agencies › Section 60-1.4 - Circumstances entitling applicants and participants to a fair hearing

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The following
					 persons shall, upon request, be entitled to a fair hearing:
(1) applicants or participants who are
					 determined during certification procedures to be ineligible to participate in
					 the WIC program;
(2) participants
					 who are disqualified or terminated from the WIC program for any reason at any
					 time after certification;
(3)
					 applicants with a special nutritional risk condition who have not been notified
					 of their eligibility or ineligibility for WIC program benefits within 10 days
					 of application, and all other applicants who have not been notified within 20
					 days of application;
(4) persons
					 with a special nutritional risk condition who have not been determined eligible
					 for WIC program benefits and who have not received food instruments within 10
					 days of application, and all other persons determined eligible who have not
					 received food instruments within 20 days of application; and
(5) a person aggrieved by any other adverse
					 action affecting his/her benefits or participation in the WIC
					 program.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-1 - Wic Program-violations And Hearings Involving Applicants, Participants, Food Vendors And Local Agencies › Section 60-1.5 - Procedure for applicants and participants obtaining a fair hearing

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Every applicant
					 and participant aggrieved by an adverse action of a local agency may request a
					 fair hearing by contacting, either orally or in writing, the department within
					 60 days from the date of service of the agency determination or adverse action.
					 Requests for a fair hearing may be made on behalf of the applicant or
					 participant by a parent, guardian or other representative.
(b) If a participant being disqualified from
					 the WIC program requests a fair hearing within 15 days from the date of service
					 of the agency determination to terminate, benefits shall be continued until the
					 administrative law judge makes a determination or the certification period
					 expires, whichever occurs first; provided, however, that such benefits shall
					 not be continued when a participant is determined to be categorically
					 ineligible, an initial certification is not granted or a certification period
					 expires.
(c) A request for a fair
					 hearing shall not be denied or dismissed unless:
(1) the request is not received within the
					 required 60-day time limit provided in subdivision (a) of this
					 section;
(2) the petitioner or
					 his/her representative fails to appear at the scheduled date, time and place of
					 the hearing without good cause;
(3)
					 the petitioner or his/her representative withdraws the request for a fair
					 hearing in writing or states for the record at the hearing that he/she wishes
					 to withdraw;
(4) the petitioner or
					 his/her representative cannot be located at his last known address after the
					 request for a fair hearing is received;
(5) the petitioner has been determined to be
					 categorically ineligible. Categorical ineligibility shall be documented and the
					 documentation shall be maintained on file at the local agency;
(6) the petitioner has been denied
					 participation at a previous hearing and cannot provide evidence to the local
					 agency that circumstances have changed since the denial of WIC program
					 eligibility;
(7) the local agency
					 grants the relief requested by the petitioner; or
(8) the sole basis of the hearing is
					 petitioner's request for retroactive benefits.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-1 - Wic Program-violations And Hearings Involving Applicants, Participants, Food Vendors And Local Agencies › Section 60-1.6 - Fair hearings for applicants and participants

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A fair hearing shall be scheduled within
					 21 days from the date the department receives the request for a
					 hearing.
(b) A written notice of
					 hearing shall be sent by certified mail to the petitioner, his/her
					 representative, if any, and the local agency at least 10 days prior to the
					 scheduled date of the hearing.
(c)
					 The notice of hearing shall:
(1) specify the
					 date, time and place of the hearing;
(2) state briefly the issues which are to be
					 the subject of the hearing;
(3)
					 explain the manner in which the fair hearing will be conducted;
(4) apprise the petitioner of the right to be
					 represented by an attorney, parent or guardian, relative, friend or other
					 spokesperson; to testify, present documentary evidence, advance arguments,
					 produce witnesses, and question or refute any testimony or evidence, including
					 an opportunity to cross-examine adverse witnesses; and to examine prior to and
					 during the hearing the documents and records supporting the determination or
					 action under appeal;
(5) state that
					 failure to appear at the hearing shall constitute waiver of the petitioner's
					 right to a hearing; and
(6) as
					 appropriate pursuant to sections
					 60-1.2(b)(8)
					 and
					 60-1.5(b) 
					 of this Subpart, advise a petitioner participant that WIC program benefits may
					 be continued pending the fair hearing decision.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-1 - Wic Program-violations And Hearings Involving Applicants, Participants, Food Vendors And Local Agencies › Section 60-1.7 - Participant violations of the wic program and penalties

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A person who applies for or is receiving
					 WIC benefits shall be considered in violation of the WIC program if that person
					 or any individual acting on his or her behalf:
(1) knowingly and deliberately misrepresents
					 circumstances to obtain benefits;
(2) sells supplemental foods or food
					 instruments to, or exchanges them with, other individuals or
					 entities;
(3) receives from food
					 vendors unauthorized food, cash or credit towards purchase of unauthorized food
					 or other items of value in lieu of authorized supplemental foods;
(4) physically or verbally abuses or
					 threatens physical abuse of State, local agency, food vendor staff or other
					 participants;
(5) uses WIC food
					 instruments outside of valid dates;
(6) participates in the WIC program with more
					 than one local agency;
(7) alters
					 the food package quantity or period of issue on the check;
(8) falsely reports food instruments lost or
					 stolen;
(9) steals WIC food
					 instruments;
(10) redeems WIC food
					 instruments at non-WIC food vendors; or
(11) countersigns the check before the food
					 price is entered on the check.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-1 - Wic Program-violations And Hearings Involving Applicants, Participants, Food Vendors And Local Agencies › Section 60-1.9 - Local agency violation of the wic program

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A local agency shall be considered in
					 violation of the WIC program if it:
(1) fails
					 to submit to the department, obtain approval for, or fully implement a
					 nutrition education plan;
(2)
					 diverts money budgeted for administrative expenses to nonbudgeted
					 administrative items;
(3) fails to
					 monitor food vendors under contract at a frequency prescribed by the
					 department;
(4) fails to submit
					 reports as required by the department;
(5) fails to contract with a food vendor when
					 directed to do so by the department; or
(6) otherwise does not comply with the terms
					 of its agreement with the department.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-1 - Wic Program-violations And Hearings Involving Applicants, Participants, Food Vendors And Local Agencies › Section 60-1.10 - Conferences for food vendors

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 If a local agency has reasonable grounds for believing that a participating
					 vendor has committed an abuse of the WIC program, it shall send written notice
					 to the department advising it of its findings together with any
					 documentation.
(b) Upon receipt of
					 the notice of suspected abuse, or on its own initiative, the department shall
					 investigate the matter. If the department determines that an abuse has been
					 committed and that a conference is advisable, it shall send a written notice to
					 the vendor of the following:
(1) the specific
					 abuse;
(2) that the vendor may have
					 a conference with a designee of the commissioner at a specified date, time and
					 place to discuss the matter;
(3)
					 that the vendor may be represented by legal counsel at the
					 conference;
(4) that the vendor
					 will be given an explanation of the charges and an opportunity to refute,
					 explain or acknowledge the alleged abuse;
(5) that upon either the department's or the
					 vendor's request a verbatim record or tape recording of the conference will be
					 maintained; and
(6) that if the
					 vendor fails to appear at the conference or to respond in writing to the notice
					 of conference within 15 days to arrange for an alternate date, the vendor will
					 be disqualified from the program.
A copy of the notice of conference shall be sent to the
						local agency together with a statement that a representative of such agency may
						participate in the conference.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-1 - Wic Program-violations And Hearings Involving Applicants, Participants, Food Vendors And Local Agencies › Section 60-1.11 - Hearings involving food vendors for violations of section 60-1.8 of this subpart and local agencies for violation of section 60-1.9 of this subpart where a monetary penalty is sought

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Any food vendor or local agency which the
					 department seeks to fine or fine and disqualify from the WIC program for
					 violations of section
					 60-1.8 
					 or section
					 60-1.9 
					 of this Subpart shall be afforded a right to a hearing under the terms of this
					 section. A disqualification without a contemporaneous monetary penalty is
					 governed by the provisions of section
					 60-1.12.
(b) A written notice of hearing shall be sent
					 by certified mail to the applicant and other parties involved at least 15 days
					 prior to the scheduled date of the hearing. Such notice shall:
(1) specify th date, time and place of the
					 hearing;
(2) state briefly the
					 issues which are to be the subject of the hearing;
(3) explain the manner in which the hearing
					 will be conducted;
(4) apprise the
					 respondent of its right to be represented by an attorney, to testify, present
					 documentary evidence, produce witnesses, cross-examine adverse witnesses, and
					 to examine the case record prior to the hearing; and
(5) state that failure to appear at the
					 hearing shall constitute waiver of the respondent's right to a hearing and that
					 a default order may be issued against the respondent, fining the respondent up
					 to a maximum of $1,000 per violation and/or disqualifying the vendor from
					 participating in the WIC program for up to three years and permanently
					 terminating the local agency from participating in the WIC program.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-1 - Wic Program-violations And Hearings Involving Applicants, Participants, Food Vendors And Local Agencies › Section 60-1.13 - Vendor applicant enrollment criteria

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Any food store (excluding pharmacies)
					 which applies for participation in the WIC program shall be enrolled via a
					 State Health Department approved one-year expirable contract if all of the
					 following criteria are met. If all the criteria are not met, the vendor may not
					 be enrolled.
(1) Current and valid food stamp
					 authorization.
(2)
(i) The vendor/participant ratio in the ZIP
					 code area of the applicant vendor is more than 75 participants per vendor,
					 or
(ii) There is a participating
					 WIC vendor within a 10-block or 1/2 mile walking distance of the applicant
					 vendor who redeems more than $3,000 in WIC checks per month, or
(iii) The applicant vendor had annual total
					 sales in the previous calendar year of more than three million dollars in New
					 York State.
(3) If the
					 applicant vendor has assumed ownership of a store that had been participating
					 in the WIC program within 60 days from the date the application is made, the
					 criteria set forth in paragraph (2) of this subdivision will not apply unless
					 the store under the previous owner redeemed fewer than 25 checks per
					 month.
(4) The applicant vendor
					 shall stock WIC acceptable foods, as determined by the New York State
					 Department of Health, in the minimum quantities prescribed in the vendor
					 application document at the time of enrollment.
(5) Applicant vendor's prices shall be
					 reasonable as compared to other vendors contracted with the local agency.
					 Reasonable shall be defined by calculating the applicant vendor's selling price
					 of their most commonly prescribed formula check type for an infant and the two
					 most commonly prescribed check types containing multiple foods for a woman or
					 child. The prices that are used for these calculations should reflect the
					 vendor's average prices for each type of item. Calculations should not be made
					 based solely on the highest priced item. The cost of the checks should be
					 within 10 percent of the project average for these check types as identified on
					 the last project summary by vendor report. The project summary by vendor report
					 identifies the project average for each check type by calculating the cost of
					 each check type redeemed during the reporting month by vendors contracted with
					 the applicant's local agency.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-2 - Drug Substitution › Section 60-2.1 - Establishment and publication of a list of safe, effective and therapeutically equivalent prescription drugs

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A list of safe, effective and
					 therapeutically equivalent prescription drugs which may be substituted for the
					 drug product prescribed, is hereby established and published as Safe, Effective
					 and Therapeutically Equivalent Prescription Drugs as updated and revised
					 pursuant to section 206  of Public Health Law.
(b) The list contains drug products,
					 identified by manufacturers, each of which has been certified or approved by
					 the commissioner of the Federal Food and Drug Administration as being safe and
					 effective for its labeled indications for use and bioequivalent where
					 bioequivalence is a real or potential issue, and are considered therapeutically
					 equivalent provided they are:
(1) marketed
					 under approved new drug applications or abbreviated new drug applications;
					 and
(2) are shown to be
					 bioequivalent in those instances where positive evidence of bioequivalency is
					 necessary.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-2 - Drug Substitution › Section 60-2.2 - Omissions from the list of safe, effective and therapeutically equivalent prescription drugs

Current through Register Vol. 46, No. 28, July 10, 2024
The omission of a drug product from the list of drug
						products in no way automatically implies that such product is known to be
						therapeutically nonequivalent to other similar products nor that it is
						ineffective. Such omission shall indicate that an appropriate bioequivalence
						standard for all pharmaceutical equivalents of such drug has not yet been
						established, or that appropriate evidence that the standard has been met by
						such product has not been submitted to the Food and Drug
						Administration.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-2 - Drug Substitution › Section 60-2.3 - Identification of manufacturer

Current through Register Vol. 46, No. 28, July 10, 2024
The label affixed to the immediate container in which the
						drug is sold or dispensed shall indicate the name and strength of the drug
						product and its manufacturer, unless the prescriber specifically states
						otherwise.