HLT-39-06-00006-E Neonatal Herpes Reporting and Laboratory Specimen Submission
2/7/07 N.Y. St. Reg. HLT-39-06-00006-E
NEW YORK STATE REGISTER
VOLUME XXIX, ISSUE 6
February 07, 2007
RULE MAKING ACTIVITIES
DEPARTMENT OF HEALTH
EMERGENCY RULE MAKING
I.D No. HLT-39-06-00006-E
Filing No. 85
Filing Date. Jan. 22, 2007
Effective Date. Jan. 22, 2007
Neonatal Herpes Reporting and Laboratory Specimen Submission
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of sections 2.1 and 2.5 of Title 10 NYCRR.
Statutory authority:
Public Health Law, sections 224(4), 225(5)(a), (g), (h) and (i)
Finding of necessity for emergency rule:
Preservation of public health and general welfare.
Specific reasons underlying the finding of necessity:
Neonatal herpes is a serious disease that can cause permanent neurological impairments to an infant and neonatal death. Most cases of neonatal herpes are acquired from perinatal transmission from an infected mother, with additional cases acquired by exposure in utero or postnatal exposure to persons with herpes in the community.
Unlike most serious communicable diseases, neonatal herpes is not reportable in New York State. Little data exists to accurately estimate the incidence of the disease, but national data suggest that there are approximately 80 neonates infected each year in New York State. Approximately the same number of cases are estimated to occur in New York State exclusive of New York City, and in New York City.
Current diagnostic and therapeutic advances enable the disease to be detected in infected neonates. Without timely antiviral therapy, 80% of the infected neonates will die and one to two-thirds of the survivors will have lasting neurodevelopment impairment.
The new reporting requirements will enable the NYSDOH to have more comprehensive and complete information on neonatal herpes cases. Given the ability to detect and treat cases if identified in a timely fashion, it is imperative to better estimate the incidence of neonatal herpes infection. This information will also enable the NYSDOH to systematically monitor outbreaks of neonatal herpes and prevent further transmission. Data can also be used to identify gaps in knowledge by clinicians and the public about maternal and other routes of transmission of herpes to the neonate, as well as the detection and treatment of cases of neonatal herpes, and provide necessary education.
By adopting this rule, neonatal herpes will be added to the list of communicable diseases. Immediate adoption of this rule is necessary for accurate identification and monitoring of neonatal herpes and for preservation of the public health and general welfare.
Subject:
Neonatal herpes infection reporting and laboratory specimen submission.
Purpose:
To diagnose, prevent and effectively manage and call public attention to this disease.
Text of emergency rule:
Subdivision (a) of Section 2.1 is amended to read as follows:
Section 2.1. Communicable diseases designated: cases, suspected cases and certain carriers to be reported to the State Department of Health.
(a) When used in the Public Health Law and in this Chapter, the term infectious, contagious or communicable disease, shall be held to include the following diseases and any other disease which the commissioner, in the reasonable exercise of his or her medical judgment, determines to be communicable, rapidly emergent or a significant threat to public health, provided that the disease which is added to this list solely by the commissioner's authority shall remain on the list only if confirmed by the Public Health Council at its next scheduled meeting:
Amebiasis
Anthrax
Arboviral infection
Babesiosis
Botulism
Brucellosis
Campylobacteriosis
Chancroid
Chlamydia trachomatis infection
Cholera
Cryptosporidiosis
Cyclosporiasis
Diphtheria
E. coli 0157:H7 infections
Ehrlichiosis
Encephalitis
Giardiasis
Glanders
Gonococcal infection
Group A Streptococcal invasive disease
Group B Streptococcal invasive disease
Hantavirus disease
Hemolytic uremic syndrome
Hemophilus influenzae (invasive disease)
Hepatitis (A; B; C)
Herpes infection in infants aged 60 days or younger (neonatal)
Hospital-associated infections (as defined in section 2.2 of this Part)
Influenza (laboratory-confirmed)
Legionellosis
Listeriosis
Lyme disease
Lymphogranuloma venereum
Malaria
Measles
Melioidosis
Meningitis
Aseptic
Hemophilus
Meningococcal
Other (specify type)
Meningococcemia
Monkeypox
Mumps
Pertussis (whooping cough)
Plague
Poliomyelitis
Psittacosis
Q Fever
Rabies
Rocky Mountain spotted fever
Rubella
Congenital rubella syndrome
Salmonellosis
Severe Acute Respiratory Syndrome (SARS)
Shigellosis
Smallpox
Staphylococcal enterotoxin B poisoning
Streptococcus pneumoniae invasive disease
Syphilis, specify stage
Tetanus
Toxic Shock Syndrome
Trichinosis
Tuberculosis, current disease (specify site)
Tularemia
Typhoid
Vaccinia disease: (as defined in Section 2.2 of this Part)
Viral hemorrhagic fever
Yersiniosis
* * *
Section 2.5 is amended to read as follows:
2.5 Physician to submit specimens for laboratory examination in cases or suspected cases of certain communicable diseases. A physician in attendance on a person affected with or suspected of being affected with any of the diseases mentioned in this section shall submit to an approved laboratory, or to the laboratory of the State Department of Health, for examination of such specimens as may be designated by the State Commissioner of Health, together with data concerning the history and clinical manifestations pertinent to the examination:
Anthrax
Babesiosis
Botulism
Brucellosis
Campylobacteriosis
Chlamydia trachomatis infection
Cholera
Congenital rubella syndrome
Conjunctivitis, purulent, of the newborn (28 days of age or less)
Cryptosporidiosis
Cyclosporiasis
Diphtheria
E. coli 0157:H7 infections
Ehrlichiosis
Giardiasis
Glanders
Gonococcal infection
Group A Streptococcal invasive disease
Group B Streptococcal invasive disease
Hantavirus disease
Hemophilus influenzae (invasive disease)
Hemolytic uremic syndrome
Herpes infection in infants aged 60 days or younger (neonatal)
Legionellosis
Listeriosis
Malaria
Melioidosis
Meningitis
Hemophilus
Meningococcal
Meningococcemia
Monkeypox
Plague
Poliomyelitis
Q Fever
Rabies
Rocky Mountain spotted fever
Salmonellosis
Severe Acute Respiratory Syndrome (SARS)
Shigellosis
Smallpox
Staphylococcal enterotoxin B poisoning
Streptococcus pneumoniae invasive
Syphilis
Tuberculosis
Tularemia
Typhoid
Viral hemorrhagic fever
Yellow Fever
Yersiniosis
This notice is intended
to serve only as a notice of emergency adoption. This agency intends to adopt the provisions of this emergency rule as a permanent rule, having previously published a notice of proposed rule making, I.D. No. HLT-39-06-00006-P, Issue of September 27, 2006. The emergency rule will expire March 21, 2007.
Text of emergency rule and any required statements and analyses may be obtained from:
William Johnson, Department of Health, Division of Legal Affairs, Office of Regulatory Reform, Corning Tower, Rm. 2415, Empire State Plaza, Albany, NY 12237, (518) 473-7488, fax: (518) 486-4834, e-mail: regsqna@health.state.ny.us
Regulatory Impact Statement
Statutory Authority:
Sections 225(4) and 225(5)(a), (g), (h), and (i) of the Public Health Law (“PHL”) authorize the Public Health Council to establish and amend State Sanitary Code provisions relating to designation of communicable diseases dangerous to public health, designation of diseases for which specimens shall be submitted for laboratory examination, and the nature of information required to be furnished by physicians in each case of communicable disease. PHL Section 206(1) (d) authorizes the commissioner to “investigate the causes of disease, epidemics, the sources of mortality, and the effect of localities, employments and other conditions, upon the public health.” PHL Section 206(1) (e) permits the commissioner to “obtain, collect and preserve such information relating to marriage, birth, mortality, disease and health as may be useful in the discharge of his duties or may contribute to the promotion of health or the security of life in the state.” PHL Article 21 requires local boards of health and health officers to guard against the introduction of such communicable diseases as are designated in the sanitary code by the exercise of proper and vigilant medical inspection.
Legislative Objectives:
This regulation meets the legislative objective of protecting the public health by adding neonatal herpes to reportable disease requirements, thereby permitting enhanced monitoring of disease, prompt identification of cases and unusual or dramatic increases in disease reporting that might indicate an outbreak, and the ability to implement measures, if necessary, to prevent further transmission.
Needs and Benefits:
Neonatal herpes, defined as herpes infection in infants aged 60 days or less, is a serious disease associated with neurological devastation of the infant and neonatal death. Neonatal herpes can result from infection with either herpes simplex virus (HSV) type 1 (HSV-1) or HSV type 2 (HSV-2). The disease can be localized to skin, eye and mouth (SEM disease), involve the central nervous system (CNS), or manifest as disseminated infection involving multiple organs. Most infants with CNS or disseminated disease have neurological sequelae, and the mortality rate in the absence of therapy is very high (80%) for these babies.
There are three ways that neonatal herpes infection can occur: (1) congenital (in utero) from an infected mother to the fetus; (2) perinatal from an infected mother to the neonate at delivery; or (3) following delivery (postnatal acquisition).
Congenital infection:
Intrauterine infection represents approximately 5% of cases of neonatal herpes infection. It can result from an ascending infection from the cervix or vulva or as a consequence of transplacental transmission. The risk of herpes transmission to the neonate is greatest, approximately 50 percent, if the pregnant women develops a primary infection in the third trimester.
Perinatal infection:
Neonatal infection with HSV most often occurs during delivery. In 85% of cases, HSV infection is transmitted to the neonate during labor when the baby comes into direct contact with infected maternal secretions in the birth canal. The risk of neonatal herpes is increased if the woman has obvious lesions at delivery. Delivery by Caesarean section appears to decrease the risk of HSV transmission in the presence of an active lesion.
Post-partum infection:
Postnatal acquisition of HSV accounts for approximately 10% of all cases of neonatal herpes and occurs as a consequence of the baby coming into contact with an environmental source of herpes, such as a family member or caregiver with orolabial herpes or lesions at other sites (e.g. breast, herpetic whitlow).
Based on national estimates, neonatal herpes is one of the most common of all congenital and perinatal infections in the United States, infecting approximately 1/1,500 to 1/3,200 live births each year. Based on these estimates, it can be estimated that of the 133,532 births in New York State in 2003, exclusive of New York City, there could have been approximately 40 neonatal herpes cases. Another 40 cases could be estimated to have occurred among the 119,469 births in New York City.
Diagnostic tests and therapies exist to properly identify and treat infected mothers and detect early cases of neonatal herpes. Type-specific serologic tests for herpes are commercially available and amplification tests such as polymerase chain reaction (PCR) have increased the sensitivity of diagnostic testing. Antiviral therapy can be used to reduce viral shedding of an infected pregnant woman and to treat an infected neonate. Cesarean delivery of infants born to mothers presenting with genital lesions can also reduce the likelihood of perinatal transmission.
Making neonatal herpes a reportable disease will assist in the diagnosis, prevention and effective management of neonatal herpes and call public attention to this disease. Multi-center studies of neonatal herpes show that delays in instituting appropriate therapies persist. Clinicians need to be educated to include neonatal herpes in the differential diagnosis for a febrile neonate, and recognize clinical signs. Educating expecting parents with known genital herpes about risks to the newborn can also promote early intervention. New York State reporting of neonatal herpes is needed to:
Accurately measure the incidence of this disease by transmission category;
Increase awareness of the disease by providers and the public;
Investigate cases of neonatal herpes to systematically assess and address gaps in provider knowledge of prevention and treatment strategies;
Identify outbreaks of postnatally-acquired neonatal herpes in a timely fashion, identify the source, and intervene to prevent subsequent infection.
Neonatal herpes is currently a reportable condition in seven states (Connecticut, Florida, Louisiana, Massachusetts, Nebraska, South Dakota and Washington). The New York City Department of Health and Mental Hygiene recently amended the New York City Health Code to require reporting of neonatal herpes.
Costs:
Costs to Regulated Parties:
The costs associated with implementing the reporting of this disease are minimal as reporting processes and forms already exist. Hospitals, practitioners and clinical laboratories are accustomed to reporting communicable disease to public health authorities.
In the event of post-partum cases of neonatal herpes, it is imperative to the public health that suspect cases be reported immediately and investigated thoroughly to curtail additional exposure and potential morbidity and mortality.
Costs to Local and State Governments:
The staff who will be involved in reporting and tracking neonatal herpes at the State and local health departments are the same as those currently involved with other communicable diseases listed in 10 NYCRR Section 2.1 and existing disease reporting processes will be used. Therefore, minimal incremental cost is expected. The time expended by a local health department to report a neonatal herpes case is estimated to be low to receive the report, obtain any missing information, and enter the report into the surveillance data system.
The additional cost to local or state governments associated with investigating and implementing control strategies to curtail the spread of neonatal herpes, particularly post-partum cases of neonatal herpes, could become significant depending upon the extent of any outbreak. Suspect cases are to be reported to the local health department, who should immediately notify the Regional Epidemiologist or the New York State Department of Health (NYSDOH) after-hours duty officer.
By monitoring and preventing the spread of neonatal herpes, savings may include reducing costs associated with public health control activities, morbidity, treatment and premature death.
Costs to the Department of Health:
The NYSDOH already collects communicable disease reports from local health departments, checks the reports for accuracy and transmits them to the federal Centers for Disease Control and Prevention. The addition of neonatal herpes to the list of communicable diseases should lead to slight to moderate additional costs, mostly related to investigating cases. Existing staff should be able to handle the incremental increase in workload.
Paperwork:
The existing general communicable disease reporting form (DOH-389) will be revised. This form is familiar to and is already used by regulated parties.
Local Government Mandates:
Under Part 2 of the State Sanitary Code (10 NYCRR Part 2), the city, county or district health officer receiving reports of neonatal herpes will be required to immediately forward such reports to the State Health Commissioner.
Duplication:
There is no duplication of this initiative in existing State or federal law.
Alternatives:
No other alternatives are available. Reporting of cases of neonatal herpes is of critical importance to public health. There is an urgent need to conduct surveillance, identify cases in a timely manner, and reduce the potential for further exposure to contacts.
Federal Standards:
Currently there are no federal standards requiring the reporting of neonatal herpes.
Compliance Schedule:
Reporting of neonatal herpes is currently mandated, pursuant to the authority vested in the Commissioner of Health by 10 NYCRR Section 2.1(a). This mandate will be extended upon emergency adoption of this regulation by the Public Health Council, and filing of a Notice of Emergency Adoption of this regulation with the Secretary of State and made permanent by publication of a Notice of Adoption of this regulation in the New York State Register.
Regulatory Flexibility Analysis
Effect on Small Business and Local Government:
This proposed rule will apply to physicians, hospitals, nursing homes, diagnostic and treatment centers and clinical laboratories. There are approximately 65,000 licensed and registered physicians in New York State; it is not known how many of them practice in small businesses. Three hospitals, 100 nursing homes, 237 diagnostic and treatment centers, and 1,000 clinical laboratories employ less than 100 persons and qualify as small businesses.
Implementation will require reporting of neonatal herpes in all 57 counties of the State outside of New York City. New York City has already passed regulations making neonatal herpes a reportable disease.
Compliance Requirements:
Existing reporting forms will be revised. Clinical laboratories that are small businesses will utilize the revised NYSDOH electronic reporting format.
Professional Services:
No additional professional staff will be needed to complete the required forms manually and mail to the county health department.
Compliance Costs:
No initial capital costs of compliance are anticipated. The reporting of neonatal herpes should have a negligible to modest effect on the estimated cost of disease reporting. The cost of complying with required reporting includes staff time to complete the necessary forms and mail to the respective local health department. The cost of reporting neonatal herpes by laboratories should be modest given the estimated small number of cases.
Minimizing Adverse Impact:
There are no alternatives to the reporting or laboratory testing requirements. Adverse impacts have been minimized since revised forms and reporting staff will be utilized by regulated parties. Electronic reporting will save time and expense. The approaches suggested in the State Administrative Procedure Act Section 202-b(1) were rejected as inconsistent with the purpose of the regulation.
Feasibility Assessment:
The NYSDOH estimates minimal increases in workload and costs associated with the requirement to report neonatal herpes.
Small Business and Local Government Participation:
Local governments have been consulted in the process through ongoing communication on this issue with local health departments and the New York State Association of County Health Officers (NYSACHO).
Rural Area Flexibility Analysis
Effect on Rural Areas:
The proposed rule will apply statewide. It is assumed that the distribution of neonatal herpes will be less in rural counties than in more urban or metropolitan areas similar to the population distribution.
Compliance Requirements:
Compliance requirements are the same in rural areas as those in all other areas of the state. Existing reporting forms will be revised. Clinical laboratories will use the revised NYSDOH electronic reporting format.
Professional Services:
No additional professional staff should need to be hired to complete the required forms and mail to the county health department. Rural providers are expected to use existing staff to comply with the requirements of this regulation.
Compliance Costs:
No initial capital costs of compliance are anticipated. See cost statement in Regulatory Impact Statement for additional information.
Minimizing Adverse Impact:
There are no alternatives to the reporting requirements. Adverse impacts have been minimized since familiar forms and existing staff will be utilized by regulated parties. The approaches suggested in State Administrative Procedure Act Section 202-b(2) were rejected as inconsistent with the purpose of the regulation.
Rural Area Input:
The New York State Association of County Health Officers (NYSACHO), including representatives of rural counties, has been informed about this change and has voiced no objections.
Job Impact Statement
This regulation adds neonatal herpes to the list of diseases that clinical laboratories, clinicians, and hospitals must report to public health authorities and for which clinicians must submit laboratory specimens. The staff who are involved in reporting neonatal herpes at the local and State health departments are the same as those currently involved with reporting, monitoring and investigating other communicable diseases. Implementation should not significantly increase the demands on existing staff nor increase the need to hire additional staff for laboratories, hospitals, and providers. The NYSDOH has determined that this regulatory change will not have a substantial adverse impact on jobs and employment.
