Source: http://rules.cityofnewyork.us/tags/dohmh?page=4
Timestamp: 2020-08-09 20:51:27
Document Index: 110048884

Matched Legal Cases: ['§2021', '§225', 'art 16', '§16', 'art 16', '§ 16', '§ 558', '§556', '§3000']

DOHMH | NYC Rules
Proposed Rules: Closed to Comments (View Public Comments Received:8)
Section 274 of the federal Atomic Energy Act of 1954 [42 USC §2021 et seq.] (“Atomic Energy Act”) authorizes “Agreement States” to regulate byproduct material, source material and special nuclear material in quantities not sufficient to form a critical mass. New York State is an “Agreement State” within the meaning of the Atomic Energy Act, and the New York City Department of Health and Mental Hygiene (“Department” or “DOHMH”) operates a component of the New York State Agreement. Under this Agreement State structure, the DOHMH, through its Office of Radiological Health (“ORH”), regulates radioactive material for medical, research and academic purposes within the five boroughs of New York City.
New York State (NYS) Public Health Law §§225(5)(p) and (q) allows the NYS Commissioner of Health and the NYS Public Health and Planning Council to establish regulations with respect to ionizing radiation and nonionizing electromagnetic radiation and to authorize appropriate officers or agencies to register radiation installations, issue licenses for the transfer, receipt, possession and use of radioactive materials, other than special nuclear materials in quantities sufficient to form a critical mass, render such inspection and other radiation protection services as may be necessary in the interest of public health, safety and welfare. The NYS regulations are set out in Part 16 of the NYS Sanitary Code.
The Sanitary Code, in 10 NYCRR §16.1(b)(3), allows New York City to establish its own radiation licensure requirements in place of State regulations, so long as the local requirements are consistent with Sanitary Code requirements.
New York City Charter (“Charter”) Section 556(c)(11) authorizes the Department to supervise and regulate the public health aspects of ionizing radiation, the handling and disposal of radioactive wastes, and the activities within the city affecting radioactive material.
Article 175 of the New York City Health Code (“Health Code”) applies to all radiation-producing equipment and radioactive material within NYC. The Article contains general provisions applicable to both radiation equipment registrants and radioactive materials licensees, and specific requirements for such equipment and materials. The purpose of Article 175 is to protect the public, as well as workers in radiation installation facilities, from the potential hazards of ionizing radiation. The Article’s requirements for radiation control reflects the coordination of radiation control activities with the U.S. Nuclear Regulatory Commission (“NRC”), the U.S. Food and Drug Administration, the NYS Department of Health and the NYS Department of Environmental Conservation, and other relevant city, state and federal agencies.
The proposed reenacted Article 175 of the Health Code incorporates federal requirements contained in Title 10 of the Code of Federal Regulations (“CFR”) and reflects and is consistent with state regulations contained in the NYS Sanitary Code [10 NYCRR Part 16], and sets forth ORH-specific best practices requirements. By law, the City must maintain compatibility with applicable federal requirements and consistency with applicable state regulations. The Health Code may, and Article 175 as proposed does, in certain instances, mandate more stringent requirements as to health and safety radiation control measures than those required by federal and state authorities.
In NYC, there are about 6500 registered facilities with radiation-producing machines and 375 licensed sites with radioactive material for medical, academic and research purposes. Of the registered facilities, approximately 6440 are diagnostic X-ray facilities and 60 are therapeutic X-ray facilities. ORH inspects these facilities at varying frequencies depending on the type of usage. Current inspection fees are unchanged under this proposed reenactment.
Prior to this rulemaking, Article 175 of the Health Code has not been substantially updated, particularly as to its radiation equipment requirements, since its last enactment in 1994. Similar to that last reenactment, the Department has based much of this proposed reenacted text on the model code maintained by the Conference of Radiation Control Program Directors (CRCPD). The CRCPD is a 501(c)(3) nonprofit professional organization whose primary membership is made up of radiation professionals in state and local government that regulate the use of radiation sources in their jurisdictions. CRCPD's mission is "to promote consistency in addressing and resolving radiation protection issues, to encourage high standards of quality in radiation protection programs, and to provide leadership in radiation safety and education".[1] Since the reenactment of Article 175 in 1994, improved best practices have been developed and implemented for radiation control measures. Many of these measures are reflected in the current CRCPD model code, which has provided the basis for much of the text related to radiation equipment in the new proposed Article 175.
As noted above, Article 175 of the Health Code incorporates federal requirements from Title 10 of the CFR. New York State is an Agreement State with the U.S. NRC which means that the NRC has delegated authority to NYS to regulate radioactive material at non-reactor sites within its jurisdiction. The New York State Agreement is comprised of the regulatory programs of three agencies:
1. the New York State Department of Health,
2. the New York State Department of Environmental Conservation, and
3. the New York City Department of Health and Mental Hygiene.
Under the NYS Agreement and § 16.1 of the State Sanitary Code, the Department, through its Office of Radiological Health (ORH), regulates radioactive material for medical, research and academic purposes within the five boroughs of New York City. Each Agreement State program is required to maintain compatibility with the NRC regulatory program. The NRC regulatory program utilizes Compatibility Categories to specify the type of wording to be used in the corresponding State program regulations.[2]
As noted above, the last significant revision of Article 175 requirements occurred over 20 years ago. Since then, NRC has made numerous updates of its requirements contained in Title 10 of the CFR. In order for the Department to maintain its compatibility status with the NRC regulatory program, each time the NRC has updated its regulations in Title 10 of the CFR, the Board has had to make corresponding updates to Article 175, which has been an inefficient and time–consuming process. In many instances, and because of the compatibility designations, the Board updated Article 175 by reproducing the actual CFR text directly into its requirements. The Board believes that continuing to update its rules this way is redundant and unnecessary and that it makes more sense to incorporate by reference the relevant CFR regulations, which will still provide the same legal force and effect as if the Board had actually reproduced such requirements directly into Article 175. This incorporation by reference process avoids duplication and provides uniform, accurate guidance to the regulated community, as well as making for a less unwieldy and more manageable Code.
Accordingly, the Department proposes the Board repeal and reenact Article 175 primarily to:
update the quality assurance requirements to reflect industry-wide best practices for the installation, operation and maintenance of both diagnostic and therapeutic radiation equipment required to be registered with the Department, and which is used for medical, academic and research purposes, and
more efficiently adopt and enforce NRC requirements for the possession and use of radioactive materials required to be licensed by the Department by incorporating by reference applicable federal regulations contained in Title 10 of the CFR for radioactive materials.
This repeal and reenactment of Article 175 of the Health Code is proposed pursuant to Sections 556, 558 and 1043 of the Charter and applicable state and federal law. Section 556 of the Charter grants the Department jurisdiction to regulate matters affecting health in New York City. Specifically, Section 556(c)(11) of the Charter authorizes the Department to supervise and regulate the public health aspects of ionizing radiation within the five boroughs of New York City. Sections 558(b) and (c) of the Charter empower the Board of Health to amend the Health Code and to include in the Health Code all matters to which the Department’s authority extends. Section 1043 of the Charter grants rule-making powers to the Department.
[1] See, http://c.ymcdn.com/sites/www.crcpd.org/resource/collection/665D6792-2EB4-4AF6-8134-1173A394FE28/Constitution10-25-04.pdf (describing the goals of the CRCPD to, among other things, promote radiological health in all aspects and phases and to promote and foster uniformity of radiation control laws and regulations).
[2] See, https://scp.nrc.gov/procedures/sa200.pdf (providing NRC compatibility categories and health and safety components assigned for determining whether an agreement state is maintaining a compatible radiation safety control program with NRC).
Proposed resolution to repeal and reenact Article 175 (Radiation Control) of the New York City Health Code
p-dohmh_6-12-18_e_art._175.pdf
Read more about Repeal and Reenact Radiation Control Rule (Article 175 of the NYC Health Code)
These amendments to the Health Code are promulgated pursuant to §§ 558 and 1043 of the Charter. Sections 558(b) and (c) of the Charter empower the Board of Health to amend the Health Code and to include in the Health Code all matters to which the authority of the Department of Health and Mental Hygiene (the “Department” or “DOHMH”) extends. Section 1043 grants the Department rule-making authority.
The Department is responsible under the Charter for supervising matters affecting the health of New Yorkers. This includes supervision of the reporting and control of chronic diseases and conditions hazardous to life and health.[1] The Department also has specific responsibilities with regard to mental health. Pursuant to section 552 of the Charter, the Department’s Division of Mental Hygiene (MHy) is the local government unit (LGU) for the City of New York under New York State Mental Hygiene Law, and the executive deputy commissioner who directs the Division is the City’s director of community services. As the LGU, MHy is responsible for administering, planning, contracting, monitoring, and evaluating community mental health and substance use services within the City of New York. It also is charged with identifying needs and planning for the provision of services for high-need individuals, such as persons with schizophrenia and other psychotic illnesses. In 2013, the Board of Health amended the Health Code to require hospitals to report when persons between the age of 18 and 30 are first admitted with a psychotic illness so that DOHMH can make appropriate linkages to services through the NYC Supportive Transition and Recovery Team (NYC START). The Department of Health and Mental Hygiene has successfully implemented hospital reporting with time-limited linkage to care for individuals 18 – 30 years of age with a first-episode psychosis hospital admission. However, in order to best account for and intervene in episodes of early psychosis and address health disparities, it is necessary to expand the age criteria for the reporting requirement to those aged 16 and over, collect data on race and ethnicity, and retain collected information past the current 30 day time limit.
Current Linkages to Care for First-Episode Psychosis
When the Health Code was amended in 2013 to address inadequate linkages to care for people with first-episode psychosis, we pointed out that New Yorkers with psychotic illnesses often do not seek care or become disengaged from care in part due to:
Fragmentation in the current mental health treatment system (patients being lost to care in transitions from hospitalization);
Exchange of patient information unsupported by technology infrastructure or current administrative practices;
Mental health treatment providers lacking resources to ensure links are established between patients and community supports; and
Challenges such as stigma, denial, fear, lack of support, and confusion related to benefits and insurance
While NYC START has improved these linkages to care for those who are reported with first-episode psychosis and accept services, we seek to further amend the Health Code to improve the health of all New Yorkers with first-episode psychosis. In particular, there are three areas that need to be addressed in order to more fully account for the needs of individuals with psychosis:
Currently, the Department may only retain identifiable information of individuals reported with first-episode psychosis for 30 days unless they accept care through NYC START, making psychosis the only reportable illness that places a limit on the amount of time the information can be seen by the Department. After 30 days, this information must be de-identified and cannot be used to follow up with the individual or to identify possible re-reporting. Given the many reasons that people with first-episode psychosis disengage from care, it is necessary to retain this information past 30 days to ensure that outreach can continue to those who have been unreachable during the initial 30-day period, to comprehensively assess the needs of communities, and to work with providers to develop successful interventions.
DOMMH estimates that approximately 2,000 new cases of psychotic illness develop each year in New York.[2],[3] Our analysis of NYC hospital admissions found that 6 % of probable first-episode admissions occurred among persons between 16 and 17 years of age.[4] There has been an expansion in the availability of specialized services for individuals 16 to 30 years of age. However, due to restrictions in the Health Code limiting the reporting age to between 18 and 30, we do not currently account for individuals who develop first-episode psychosis before the age of 18.
Race and ethnicity are currently not among the list of required information that hospitals must identify when making a report of first-episode psychosis. Because there are racial disparities in the diagnosis and treatment of psychotic disorders, however, this information is especially pertinent to collect and utilize to improve interventions and address health inequity.[5]
To improve interventions, linkages to care, and outcomes for New Yorkers experiencing first-episodes of psychosis, the Department proposes that the Board of Health amend Article 11 of the Health Code. The proposed changes would facilitate participation in early intervention services by requiring hospitals to report when individuals over 16 and under 31 years of age are admitted with a first-episode of psychotic illness. The proposed changes would further facilitate the creation of a database of reported cases of first-episode psychosis that would permit the Department to monitor trends of the illness.
Evaluating these trends can be used to:
Develop targeted, culturally-competent interventions in the NYC START program
Measure outcomes of first-episode psychosis care, and thereby direct more efficient interventions to health care institutions, health care providers and people with psychosis.
Reporting will continue to be required within 24 hours of admission and will include hospital name, patient name, age, gender, address, telephone, date of admission, insurance type, diagnosis, race, and ethnicity. All patient information reported to the Department will be kept confidential and will not be shared with anyone other than the patient or treating provider.
[1] Charter §556(c)(2).
[2] Kirkbride JB et al. Int J Epi. 2009; 38-1255-64.
[3] Bladwin P et al. Schiz Bull 2005 31;3, 624-38.
[4] DOHMH internal analysis of NYC hospital admissions in 2009 for probable first-episode psychosis among 16 – 29 year olds.
[5] Schwartz, R et al. World J Psychiatry. 2014 4(4): 133-140
reporting of first-episode psychosis
NYC START program
Proposed resolution to amend Article 11 (Reportable Diseases, Conditions) of the New York City Health Code regarding first episode psychosis.
p-dohmh_6-12-18_d_art._11.pdf
Read more about Amendment to Reportable Diseases, Conditions (Article 11 of the NYC Health Code) regarding First Episode Psychosis
In 2016, the New York State Public Health Law was amended[1] to allow certain entities, including child care providers, to obtain non-patient specific epinephrine auto-injectors and to administer them in an emergency. This new State law creates the opportunity for such programs to have this critical, lifesaving medication available. Accordingly, the amendments clarify requirements for emergency medical care and add a requirement that child care and child supervision programs maintain on site at least two unexpired epinephrine auto-injectors in each dosage appropriate for children who may be in the program, stored so they are easily accessible to staff and inaccessible to children. Programs will be required to have on site, whenever children are present, at least one staff person trained to recognize signs and symptoms of anaphylactic shock and to administer epinephrine as appropriate. The amendment also requires programs to monitor the auto-injectors’ expiration dates and call 911 after any administration, as required by the medication directions. Programs will be required to obtain parental consent at the time each child is enrolled in the program, and to train all staff in preventing and responding to emergencies related to food allergies.
[1] NYS Public Health §3000-C. Epinephrine Auto-injector devices. Effective March 28, 2017.
Read more about Amendment to Child Care Programs and Family Shelter-Based Drop-off Child Supervision Programs (Article 47 of the NYC Health Code)
Read more about Amendment of Child Care Programs and Family Shelter-Based Drop-off Child Supervision Programs (Article 47 of the NYC Health Code)