This notice is intended to serve only as a notice of emergency adoption. This agency intends to adopt this emergency rule as a permanent rule and will publish a notice of proposed rule making in the State Register at some future date. The emergency rule will expire September 2, 2020.
Text of rule and any required statements and analyses may be obtained from: Katherine Ceroalo, DOH, Bureau of Program Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 4737488, email: regsqna@health.ny.gov
Regulatory Impact Statement
Statutory Authority:
The statutory authority for the regulatory amendments to Part 2 of Title 10 of the Official Compilation of Codes, Rules and Regulations of the State of New York is Section 225 of the Public Health Law (PHL), which authorizes the Public Health and Health Planning Council (PHHPC), subject to the approval of the Commissioner of Health (Commissioner), to establish and amend the State Sanitary Code (SSC) provisions related to any matters affecting the security of life or health or the preservation and improvement of public health in the State of New York. Additionally, Section 2103 of the PHL requires all local health officers to report cases of communicable disease to the New York State Department of Health (Department).
The statutory authority for the proposed new section 58-1.14 of Title 10 of the Official Compilation of Codes, Rules and Regulations of the State of New York is section 576 of the PHL, which authorizes the Department to adopt regulations prescribing the requirements for the proper operation of a clinical laboratory, including the methods and the manner in which testing or analyses of samples shall be performed and reports submitted.
The statutory authority for the proposed amendments to section 405.3 of Title 10 of the Official Compilation of Codes, Rules and Regulations of the State of New York is section 2803 of the PHL, which authorizes PHHPC to adopt and amend rules and regulations, subject to the approval of the Commissioner, to implement the purposes and provisions of PHL Article 28, and to establish minimum standards governing the operation of health care facilities.
Legislative Objectives:
The legislative objective of PHL § 225 is, in part, to protect the public health by authorizing PPHPC, with the approval of the Commissioner, to amend the SSC to address public health issues related to communicable disease.
The legislative objective of PHL § 576 is, in part, to promote public health by establishing minimum standards for clinical laboratory testing and reporting of test results, including to the Department for purposes of taking prompt action to address outbreaks of disease.
The legislative objective of PHL § 2803 includes among other objectives authorizing PHHPC, with the approval of the Commissioner, to adopt regulations concerning the operation of facilities licensed pursuant to Article 28 of the PHL, including general hospitals.
Needs and Benefits:
The 2019 Coronavirus (COVID-19) is a disease that has caused mild to severe respiratory symptoms, including fever, cough, and difficulty breathing. People infected with COVID-19 have had symptoms ranging from those that are mild (like a common cold) to severe pneumonia that requires medical care in a hospital and can be fatal.
COVID-19 was found to be the cause of an outbreak of illness in Wuhan, Hubei Province, China in December 2019. A short time later, on January 30, 2020, the World Health Organization (WHO) designated the COVID-19 outbreak as a Public Health Emergency of International Concern. On January 31, 2020, the Secretary of Health and Human Services determined that as a result of confirmed cases of COVID-19 in the United States, a public health emergency exists and has existed since January 27, 2020, nationwide.
The situation continues to rapidly evolve throughout the world and the United States. In particular, the United States has quickly progressed from identifying travel-associated cases and person-to-person transmission of COVID-19 among close contacts of travel-associated cases, to the identification of community spread of the disease in certain parts of California, Oregon, and Washington states.
As of March 1, 2020, New York State has reported cases of COVID-19. Given the rate spread to date, the Centers for Disease Control and Prevention (CDC) expects that it is likely widespread transmission of COVID-19 will occur in the United States.
In light of this situation, these regulations update, clarify and strengthen the Department's authority as well as that of local health departments to take specific actions to control the spread of disease, including actions related to investigation and response to a disease outbreak, as well as the issuance of isolation and quarantine orders.
The following is a summary of the amendments to the Department's regulations:
Part 2 Amendments:
-Relocate and update definitions, and add new definitions.
• Repeal and replace current section 2.6, related to investigations, to make existing clarify local health department authority.
-Sets forth specific actions that local health departments must take to investigate a case, suspect case, outbreak, or unusual disease.
-Requires individuals and entities subject to a public health investigation to cooperate with the Department and local health departments.
-Clarifies authority for the Commissioner to lead investigation activities.
-Codifies in regulation the requirement that local health departments send reports the Department during an outbreak.
• New section 2.13 added to clarify isolation and quarantine procedures.
-Clarify that the State Department of Health has the authority to issue isolation and quarantine orders, as do local departments of health.
-Clarifies locations where isolation or quarantine may be appropriate.
-Sets forth requirements for the content of isolation and quarantine orders.
-Specifies other procedures that apply when a person is isolated or quarantined.
-Explicitly states that violation of an order constitutes grounds for civil and/or criminal penalties.
-Relocates and updates existing regulatory requirements that require the attending physician to report cases and suspected cases to the local health authority, and to requires physicians to provide instructions concerning how to protect others.
Part 58 Amendments:
• New section 58-1.14 added clarifying reporting requirements for certain communicable diseases.
-Requires the Commissioner to designate those communicable disease that require prompt action, and to make available a list of such disease on the State Department of Health website.
-Requires clinical laboratories to immediately report positive test results for communicable diseases identified as requiring prompt attention, in a manner and format identified by the Commissioner.
-Requires clinical laboratories to report all test result, including negative and indeterminate results, for communicable diseases identified as requiring prompt attention, via the Electronic Clinical Laboratory Reporting System (ECLRS).
Part 405 Amendments:
• Mandates hospitals to report syndromic surveillance data during an outbreak of a highly contagious communicable disease.
• Permits the Commissioner to direct hospitals to take patients during an outbreak of a highly contagious communicable disease, which is consistent with the federal Emergency Medical Treatment and Labor Act (EMTALA).
Costs:
Costs to Regulated Parties:
The requirement that hospital submit syndromic surveillance reports when request during an outbreak is not expected to result in any substantial costs. Hospitals are already regularly and voluntarily submitting data to the Department, and nearly all of them submit such reports electronically. With regard to the Commissioner directing general hospitals to accept patients during an outbreak of a highly contagious communicable disease, hospitals are already required to adhere to the federal Emergency Medical Treatment and Labor Act (EMTALA). Accordingly, both of these proposed amendments will not impose any substantial additional cost to hospitals.
Clinical laboratories must already report communicable disease testing results using the ECLRS and must also immediately report communicable diseases pursuant to PHL § 2102. The regulation simply clarifies existing requirements and is not anticipated to imposes any substantial additional costs beyond those costs that laboratories would incur in the absence of these regulations.
Although there are costs associated with disease investigation and response for any outbreak, these regulations clarify and strengthen the existing authorities and responsibilities of local governments. As such, these regulations do not impose any substantial additional costs beyond what local health departments would incur in the absence of these regulations.
Costs to Local and State Governments:
Although there are costs associated with disease investigation and response for any outbreak, these regulations clarify and strengthen the existing authorities and responsibilities of local governments. As such, these regulations do not impose any substantial additional costs beyond what local health departments would incur in the absence of these regulations. Further, making explicit the Department's authority to lead investigation activities will result in increased coordination of resources, likely resulting in a cost-savings for State and local governments.
Any clinical laboratories operated by a local government must already report communicable disease testing results using the ECLRS and must also immediately report communicable diseases pursuant to PHL § 2102. The regulation simply clarifies existing requirements and is not anticipated to imposes any substantial additional costs beyond those costs that laboratories would incur in the absence of these regulations.
To the extent that the State Department of Health and local health departments issue isolation and quarantine orders in response to COVID19, such actions will impose costs upon the state. As the scope of any outbreak is difficult to predict, the cost to the State of issuing such orders cannot be predicted at this time.
Paperwork:
Some hospitals may be required to make additional syndromic surveillance reports that they are not already making. Otherwise, these regulations do not require any additional paperwork.
Local Government Mandates:
Under existing regulation, local health departments already have the authority and responsibility to take actions to control the spread of disease within their jurisdictions. The proposed amendments clarify these existing authorities and duties.
Duplication:
There is no duplication in existing State or federal law.
Alternatives:
The alternative would be to leave in place the current regulations on disease investigation and isolation and quarantine. However, many of these regulatory provisions have not been updated in fifty years and should be modernized to ensure appropriate response to a disease outbreak, such as COVID-19.
Federal Standards:
States and local governments have primary authority for controlling disease within their respective jurisdictions. Accordingly, there are no federal statutes or regulations that apply to disease control within NYS.
Compliance Schedule:
The regulations will become effective upon filing with the Department of State.