Wisconsin Division of Public Health Disease Surveillance Manual
PURPOSE OF THIS MANUAL
The Division of Public Health, Bureau of Communicable Diseases and Preparedness, Communicable Diseases Epidemiology Section is the organizational unit within the Department of Health and Family Services charged with the responsibility of executing the statutory mandates regarding the reporting, surveillance and control of communicable diseases. These responsibilities are accomplished through the cooperative efforts of hospital infection control personnel, physicians and health care providers, local health departments, and the Wisconsin State Laboratory of Hygiene.
The purpose of this manual is to provide a comprehensive resource document to assist local health departments and other health care providers in clarifying their responsibilities for disease reporting, epidemiologic surveillance and outbreak investigations. This manual should answer most of the procedural questions related to these activities. Questions beyond the scope of the manual should be directed to the attention of the state epidemiologist or Communicable Disease Epidemiology Section staff.
I. INTRODUCTION
A. List of Agency Acronyms:
BCDP Bureau of Communicable Diseases and Preparedness
BEOH Bureau of Environmental and Occupational Health
BLHS& EMS Bureau of Local Health Support & Emergency Medical Services
CDC Centers for Disease Control and Prevention
CDES Communicable Disease Epidemiology Section
DATCP Wisconsin Department of Agriculture, Trade and Consumer Protection
DHFS Department of Health and Family Services
DPH Wisconsin Division of Public Health
LHD Local Health Department
WSLH Wisconsin State Laboratory of Hygiene
B. Definition of Terms"Bureau" is the Bureau of Communicable Diseases and Preparedness, Wisconsin Division of Public Health, Department of Health and Family Services.
"Case" is an illness or condition determined to be a communicable disease on the basis of clinical or laboratory criteria or both.
"Date of Onset" is the day on which a case or suspected case experienced the first sign or symptom of a communicable disease.
"Department" is the Department of Health and Family Services.
"Follow-up investigation" is the inquiry made by the LHD into the cause of illness in a particular case or cases and the control and prevention measures taken as a result of that inquiry.
"Follow-up report forms" are the forms provided by the DPH and/or CDC and completed by the LHD subsequent to the follow-up investigation.
"Food worker" is a person who handles food utensils or who prepares, processes, or serves food or beverages for people other than members of his or her immediate household.
"Health care facility" is a hospital, nursing home, home health agency or a provider of outpatient health care.
"High risk activities" are defined as food handling, patient care or child care occupations.
"Individual Case Report Form" is the form provided by the DPH for the purpose of reporting communicable
"Laboratory" is any facility certified by the Department under Wisconsin State Statute 252.22, and Wisconsin Administrative Code HSS 165.02.
"Local Health Officer" has the meaning prescribed in Wisconsin State Statute 251.06, and applies to the person who is designated as the local health officer for the place of residence of a case or suspected case of communicable disease.
"Local Health Department" is a county, city or village full-time health department.
"Morbidity Report" -- Same as "Acute and Communicable Diseases Case Report Form
"Outbreak" is the occurrence of unrelated cases of a communicable disease in a particular area and period of time that is in excess of the expected number of cases.
"Report Form" -- See "Acute and Communicable Diseases Case Report Form".
"Reporting" is the act of a health care provider (physician, infection control, etc.) notifying the LHD a communicable disease has occurred.
"Secretary" is the Secretary of the Department of Health and Family Services.
"State Epidemiologist" is the person designated by the Secretary of DHFS as the person in charge of communicable disease control for the state.
"State Health Officer" has the meaning prescribed in Wisconsin State Statute 250.01, and applies to the person as appointed by the Secretary.
"Surveillance" is the comprehensive process by LHDs and the DPH of collecting initial and follow-up reports, consolidating of the information into meaningful graphs, tables and charts, interpretation of the data and distribution of the results.
"Suspected case" means a person thought to have a particular communicable disease on the basis of clinical or laboratory criteria or both.
C. Wisconsin Statutes Applicable to Communicable Disease
Chapter 250
Health; Administration and Supervision
250.01 Definitions 250.02 State health officials 250.03 Public health system 250.04 Powers and duties 250.05 Sanitarians: qualifications, duties, registration 250.06 Public health nurses Chapter 251
Local Health Officials
251.01 Definitions 251.02 Local health department: establishment 251.03 Local board of health: members 251.05 Local health department: levels of service, duties 251.06 Local health officer: qualifications, duties 251.08 Jurisdiction of local health department Chapter 252
Communicable Diseases
252.01 Definitions 252.02 Powers of department 252.03 Duties of local health officers 252.04 Immunization program 252.05 Reports of cases 252.06 Isolation and quarantine 252.07 Tuberculosis 252.1 Public health dispensaries 252.11 Sexually transmitted disease 252.18 Handling foods 252.19 Communicable diseases: suspected cases, protection of public 252.21 Communicable diseases; schools: duties of teachers, parents, officers 252.22 Laboratories, approval of 252.25 Violation of law relating to health D. Wisconsin Statutes Related to Human Immunodeficiency Virus (HIV)
Chapter
48
Children’s Code
48.371
Access to certain information by substitute care provider
Chapter
49
Public Assistance
49.45
Medical assistance; administration
(25)
Case management services
49.686
AZT and pentamidine reimbursement program
Chapter
101
Department of Commerce – Regulation of Industry, Buildings and Safety
101.02
Powers, duties and jurisdiction of department
(19)
Form to document significant exposure
Chapter
102
Worker's Compensation
Chapter
103
Employment Regulations
103.15
Restrictions on HIV related testing for purposes of employment
Chapter
115
State Superintendent; General Classifications and Definitions; Children with disabilities
115.35
Health education program
Chapter
118
General School Operations
118.25
Pupil records
(1)
Definitions
(2)
Confidentiality
(3)
Maintenance of records
Chapter
146
Miscellaneous Health Provisions
146.50
Emergency medical services personnel; licensure; certification; training
(12)
Confidentiality of records
146.81
Health care records: definitions
146.82
Confidentiality of patient health care records
Chapter
149
Mandatory Health Insurance Risk-Sharing Plan
149.10
Definitions
149.12
Eligibility determination
Chapter
155
Power of Attorney for Health Care
155.01
Definitions
155.05
Power of attorney for health care
Chapter
250
Health, Administration and Supervision
250.01
Definitions
250.04
Powers and duties of the dependent
Chapter
252
Communicable Diseases
252.01
Definitions
252.02
Powers of department
252.05
Report of Cases
252.12
Services relating to acquired immunodeficiency syndrome
(1)
Definitions
(2)
Distribution of funds
(3)
Confidentiality of information
252.13
Blood tests for HIV
252.14
Discrimination related to acquired immunodeficiency syndrome
252.15
Restrictions on use of a test for HIV
(1)
Definitions
(2)
Informed consent for testing or disclosure
(3)
Written consent to disclosure
(4)
Record maintenance
(5)
Confidentiality of test
(5m)
Autopsies: Testing of certain corpses
(5r)
Sale of tests without approval prohibited
(6)
Expanded disclosure of test results prohibited
(7)
Reporting of positive test results
(8)
Civil liberty
(9)
Criminal penalty
252.16
Continuation coverage premium subsidies
252.17
Medical leave premium subsidies
Chapter
609
Defined Network Plans
609.81
Coverage related to HIV infection
Chapter
631
Insurance Contract Generally
631.90
Restrictions on use of tests for HIV
631.93
Prohibited provisions concerning HIV infection
Chapter
632
Insurance Contracts in Specific Lines
632.68
Regulation of vertical settlement contracts
6232.895
Mandatory coverage; drugs for treatment of HIV
Chapter
901
Evidence - General Provisions
901.05
Admissibility of certain test results
Chapter
938
Juvenile Justice Code
938.296
Testing for HIV infection and certain diseases
938.346
Notice to victims of juveniles’ acts
938.371
Access to certain information by substitute care provider
Chapter
939
Crimes – General Provisions
939.622
Committing a serious sex crime while infected with acquired immunodeficiency syndrome, HIV or a sexually transmitted disease
Chapter
968
Commencement of Criminal Proceedings
968.38
Testing for HIV infection and certain diseases
E. Administrative Codes Applicable to Communicable Disease
Chapter
HFS 138
Subsidy of Health Insurance Continuation Coverage Premiums for Persons with HIV Infection
138.01
Authority and purpose
138.02
Applicability
138.03
Definitions
138.04
Participation in the health insurance premium subsidy program
138.05
Payment of health insurance premiums
Chapter
HFS 139
Qualifications for Public Health Professionals Serving Local Health Agencies
139.03
Definitions
139.04
General requirement
139.05
Health officers
139.06
Public health professionals serving as health officers for the purpose of communicable disease control
139.07
Public health professionals who direct environmental health programs
139.08
Public health nurses
Chapter
HFS 144
Immunization of Students
144.02
Definitions
144.03
Minimum immunization requirements
144.04
Waiver for health reasons
144.05
Waiver for reasons of religious or personnel conviction
144.08
Responsibilities of local public health agencies
Chapter
HFS 145
Control of Communicable Diseases
Subchapter I
General Provisions
Subchapter II
Tuberculosis
Subchapter III
Sexually Transmitted Diseases
Chapter
HFS 165
Laboratory Certification
Chapter
INS 3
Casualty Insurance
3.53
HIV testing
Appendix A
Wisconsin Notice and Consent for Human Immunodeficiency Testing
Chapter
INS 6
General Chapter
6.67
Unfair discrimination in life and disability insurance
F. Regional Office Contacts
Regional Offices of the Division can provide assistance with accessing information and appropriate staff members of the Central Office contacts.
Southern
Mary Young
2817 International La. Suite 120
Madison, WI 53704
608-243-2351
608-243-2365 Fax
Southeastern
Robert Harris
819 N. 6th. St. Room 860
Milwaukee, WI 53203-1697
414-227-4860
414-227-2010 FaxNortheastern
Dennis Hibray
200 N. Jefferson St. Suite 511
Green Bay, WI 54301
920-448-5220
920-448-5223 FaxWestern
Larry Gilbertson
610 Gibson St. Suite 3
Eau Claire, WI 54701-3679
715-836-5362
715-836-6686 FaxNorthern
Terri Timmers
1853 N. Stevens St.
Rhinelander, WI 54501
715-365-2700
715-365-2705 Fax
G. EPINET - Wisconsin Disease Surveillance Manual
All communicable disease case reports should be followed up for the purposes of prevention and control in a manner consistent with those methods listed in the most current edition of Control of Communicable Diseases Manual, Heymann DL, (ed), 18 th ed. 2004, Washington, D.C.
Disease follow-up investigation forms are included in this manual and found on the Wisconsin Health Alert Network (HAN)* and are a valuable tool for the investigator to interview a case or suspect case of disease. The follow-up investigation form outlines a minimum of demographic, clinical, epidemiologic and laboratory information needed to begin assessing public health implications of the case. Each follow-up report form provides a framework to determine the epidemiologic circumstances of the illness. Some follow-up forms have worksheets available to better assist the investigator.
In the United States , requirements for reporting diseases are mandated by state laws or regulations, and the list of reportable diseases in each state varies. In Wisconsin , Wisconsin State Statute 252.05 and Wisconsin Administrative Code HSS 145 require reporting of Communicable Diseases. The list of reportable diseases in Wisconsin appears on the back of the DPH 4151 and is included in this manual. Additionally, state health departments report cases of selected diseases (Table 1) to the Centers for Disease Control and Prevention (CDC) National Notifiable Disease Surveillance System (NNDSS), on a weekly basis. These data are published weekly in the Morbidity Mortality Weekly Report (MMWR) and an updated final report is published annually in the Summary of Notifiable Diseases.
With the EPINET manual, we have tried to adhere as closely as possible to the case definitions developed by the CDC and the Council of State and Territorial Epidemiologists (CSTE), published in “Case Definitions for Infectious Conditions Under Public Health Surveillance”, MMWR 1997; 46(RR-10). As uniform case definitions are adopted by the states, the incidence of reported diseases in different geographic areas may be more meaningfully compared at the local, state, and national levels.
* Many of the communicable diseases listed in this manual have follow-up forms or worksheets requested by either the Bureau of Communicable Diseases and Preparedness or the Centers for Disease Control and Prevention (CDC). All these report forms can now be found on the Wisconsin HEALTH ALERT NETWORK (HAN). After you login, go into TOPICS, click COMMUNICABLE, then under EPINET click on REPORT FORMS.
H. Report Forms
Please submit the appropriate follow-up form to the Division of Public Health (DPH) with the Acute and Communicable Disease Case Report Form (DPH 4151).
DISEASE
CDC
DPH
CDES
AIDS
4264
HIV INFECTION
4338
Pediatric Cases (< 13 years old) ONLY
50.42B
BABESIOSIS
101
BOTULISM, INFANT
52.73
CAT SCRATCH FEVER
102
CHANCROID
4243
CHLAMYDIA
4243
EHRLICHIOSIS
55.1
ENCEPHALITIS, ARBOVIRAL
103
GENITAL HERPES
4243
GONNORRHEA
4243
HEPATITIS A
53.1
HEPATITIS B
53.1
HEPATITIS C
53.1
HEPATITIS D
53.1
KAWASAKI SYNDROME
55.54
LEGIONELLA
52.56
105
LEPROSY
52.18
9077
LISTERIOSIS
106
LYME DISEASE
107
MALARIA
54.1
MEASLES
4077
PLEVIC INFLAMMATORY DISEASE (PID)
4243
PERTUSSIS
4236
PSITTACOSIS
9075
REYE SYNDROME
55.8
ROCK MOUNTAIN SPOTTED FEVER
55.1
RUBELLA, CONGENITAL SYNDROME
71.17
4243
SYPHILIS
or
4061
TETANUS
71.15
TOXIC SHOCK SYNDROME
52.3
TRICHINOSIS
54.7
4000
TUBERCULOSIS
42001
TYPHOID FEVER
52.5
WATERBORNE DISEASE OUTBREAKS
52.12
These forms can be found on the HAN. Login, then click on TOPICS, click COMMUNICABLE, then click EPINET and go into REPORT FORMS, another screen will appear and under Associated Links, click Report Forms and the table above will appear and click the appropriate disease form number.
I. Diseases Reportable at the State and National Level
1. Wisconsin Disease Surveillance Category I
The following diseases are of urgent health importance and shall be reported IMMEDIATELY by telephone to the patient’s local health officer upon identification of a case or a suspected case. Complete and mail an Acute and Communicable Diseases Case Report (DPH 4151) within 24 hours. Public health intervention is expected as indicated in the footnotes. See Wisconsin Administrative Code HSS 145.04 (3) (a).
Anthrax 1,4,5
Botulism 1,4
Botulism, Infant 1,2,4,5
Cholera 1,3,4,5
* Diphtheria 1,3,4,5
Foodborne or Waterborne Outbreaks 1,2,3,4
* Haemophilus influenzae invasive disease, (including epiglottitis) 1,2,3,5
Hantavirus 1,2,4,5
* Hepatitis A 1,2,3,4,5
* Measles 1,2,3,4,5
Meningococcal disease 1,2,3,4,5
Pertussis (“Whooping cough”) 1,2,3,4,5
Plague 1,4,5
* Poliomyelitis 1,4,5
Rabies (Human) 1,4,5
Ricin toxin 4,5
* Rubella 1,2,4,5
Rubella (Congenital syndrome) 1,2,5
Smallpox 1,4,5
Tuberculosis 1,2,3,4,5
Yellow Fever 1,4
2. Wisconsin Disease Surveillance Category II
The following diseases shall be reported to the local health officer on an Acute and Communicable Disease Case Report (DPH 4151) or other means within 72 hours of the identification of a case or suspect case. Public health intervention is expected. See Wisconsin Administrative Code HSS 145.04 (3) (b).
Amebiasis 1,3,
Arboviral infection (encephalitis / meningitis) 1,2,4
Babesiosis 2,4,5
Blastomycosis 2,4
Brucellosis 1,4
Campylobacter 3,4
Cat Scratch Disease (Bartonella species) 2,5
Cryptosporidiosis 1,2,3,4
Cyclosporiasis 1,4,5
E. coli 0157:H7 1,2,3,4
and other enterohemorhagic E. coli,
enteropathogenic E. coli,
enteroinvasive E. coli,
enterotoxigenic E. coli 1,2,3,4
Encephalitis, viral (other than arboviral)
Ehrlichiosis 1,2,5
Giardiasis 3,4
Hemolytic Uremic Syndrome 1,2,4
* Hepatitis B 1,2,3,4,5
Hepatitis C 1,2
Hepatitis D 2,3,4,5
Hepatitis E 3,4
Histoplasmosis 5
Kawasaki disease 2
Legionellosis 1,2,4
Leprosy 1,2,3,4,5
Leptospirosis 4
Listeriosis 2,4
Lyme disease 1,2
Malaria 1,2,4
Meningitis, bacterial (other than Haemophilus influenzae or
meningococcal disease) 2,5
Meningitis, viral (other than arboviral)
* Mumps 1,2, 4,5
Mycobacterial disease (nontuberculous)
Psittacosis 1,2,4
Q fever 2,4,5
Reye syndrome 2
Rheumatic fever (newly diagnosed and meeting the Jones criteria) 5
Rocky Mountain Spotted Fever 1,2,4,5
Salmonellosis 1,3,4
Sexually transmitted diseases:
Chancroid 1,2,4,5
Chlamydia trachomatis infection 1,2,4,5
Genital herpes infection (1 st episode identified by health provider) 2
Gonorrhea 1,2,4,5
Pelvic inflammatory disease 1,2,5
Syphilis 1,2,5
Trichomoniasis 2
Shigellosis 1,3,4
Streptococcus group A invasive disease 1,5
Streptococcus group B invasive disease 1,5
Streptococcus pneumoniae (pneumococcus) invasive disease 2
* Tetanus 1,2
Toxic shock syndrome 1,2 Toxic substance related diseases:
Infant methemoglobinemia
Lead intoxication (specify Pb levels)
Other metal and pesticide poisonings
Toxoplasmosis
Trichinosis 1,2,4
Tularemia 1,4
Typhoid fever 1,2,3,4
Typhus fever 4,5
Varicella (chickenpox) - reported by number of cases only
Yersiniosis 3,4* For diseases proceeded by an asterisk (*) in Categories I and II give vaccination history.
3. Wisconsin Disease Surveillance Category III
The following diseases shall be reported to the state epidemiologist on an AIDS case report (DPH 4264) or a Wisconsin Human Immunodeficiency Virus (HIV) Infection Confidential Case Report (DPH 4338) or by other means within 72 hours after identification of a case or suspected case. See s.252.15 (7) (b), Stats., and s. HFS 145.04 (3) (b).
Acquired Immune Deficiency Syndrome (AIDS) 1,2,4
Human Immunodeficiency Virus (HIV) infection 2,4
CD4+ T-lymphocyte count <200 / m L, or CD4+ T-lymphocyte percentage of total lymphocytes of <14
Key:
- Infectious diseases designated as notifiable at the national level.
- Wisconsin or CDC follow-up form is required. LHDs have templates of these forms in the Epinet Manual and on the HAN.
- High-risk assessment by LHD is needed to determine if patient or member of patient's household is employed as a food worker, day care or health care.
- Source investigation by LHD is needed.
- Immediate treatment is recommended, i.e., antibiotic or biologic for the patient or contact or both.
II. DISEASE SURVEILLANCE PROCEDURES AND RESPONSIBILITIES
A. Surveillance Procedures
Disease surveillance encompasses more than just reporting diseases and is an essential element in any disease prevention and control program. The CDES uses two approaches in disease surveillance:
1. Passive disease surveillance relies upon physicians and other health care providers to fulfill their statutory requirement of disease reporting.
2. Active disease surveillance is a more aggressive and labor intensive approach to identifying cases of disease. It involves the daily, weekly or monthly contacting of physicians, hospitals, schools, or other agencies to "actively" search for cases. This type of surveillance has defined objectives, and usually continues for a relatively short period until the objectives are met. Active disease surveillance coincides with periods of high disease frequency and usually yields a much higher percentage of actual identified cases. It is also used during an outbreak to find additional cases of disease.
The traditional sources of surveillance information are listed in Table A.
Table A
- Morbidity Reports (Acute and Communicable Diseases Case Report)
- Laboratory reports of infection
- Outbreak investigation reports
- Mortality reports (death certificates)
- Active surveillance for specific diseases
- Special surveys (i.e., hospital admissions, disease registers, serologic surveys)
- Absentee data from school or work for selected diseases
Since most surveillance date are based on clinical cases, it is important to keep in mind the chain of events shown in Table B that must occur before a clinical case is confirmed.
Table B
Major Elements Needed for Surveillance of Clinical Illness:
- Occurrence of clinical illness
- Sufficient severity to seek medical care
- Laboratory support of diagnosis
- Reporting of the disease to the LHD
- Collection and analysis of data by LHD or CDES
- Reporting of the disease to the BCDP / CDES:
Physicians, clinics, hospitals, laboratories, or others aware of a person with an acute or communicable disease should notify the LHD using the Acute and Communicable Diseases Case Report
The LHD should collect missing data, initiate a disease specific epidemiologic follow-up investigation, assure that adequate prevention and control measures are taken and immediately notify the CDES and / or Regional Office.
For further information on the procedures for reporting, content of the report, urgency of the report, handling of reports by the local health officer, and categories of disease to b reported, please refer to Wisconsin Administrative Code HSS 145, Control of Communicable Diseases.
A. Surveillance Responsibilities
1. Local Health Department responsibilities:
Each LHD should maintain a surveillance system in its jurisdiction that is compatible with the statewide system.
The LHD is expected to:
- Maintain a supply of communicable disease reporting forms for distribution to physicians, primary care practitioners, hospitals, clinics, schools, day care centers and/or others needing the forms.
- Receive, evaluate and transmit completed reports to the state epidemiologist.
- Investigate each communicable disease to gather epidemiologic and laboratory data for local, state and national surveillance.
- Conduct a detailed follow-up to prevent future cases, identify the etiologic agent or agents, and identify the mode of transmission or risk factors associated with transmission.
- Consult with the state epidemiologist or BCDP staff whenever any unusual circumstances occur regarding the disease.
- Implement control measures for specific diseases consistent with Section 9, Methods of Control, contained in the latest edition of Control of Communicable Diseases Manual, or with specific measures issued by the state epidemiologist.
2. Local Health Support & Emergency Medical Services Regional Office responsibilities:
Professional and support staff assistance is available at the Local Health Support & Emergency Medical Services Regional Office. It is expected that:
- Regional Program Consultants from the Immunization Program (IP) and Sexually Transmittable Diseases (STD) Program will respond to the majority of questions on immunizable diseases and STD surveillance for their respective geographic areas.
- Regional Program Consultants will remain current on the BCDP surveillance activities and communicable disease guidelines. See Epinet Introduction: Regional Staff Contacts.
- Nursing consultants will serve as a conduit of information from the LHD to the appropriate program staff in the region of the BCDP.
- Regional support staff will:
- Provide storage, shipping and handling for immune globulin (IG) for viral hepatitis and handling of vaccine or other biologics;
- Maintain a limited supply of Acute and Communicable Diseases Case Report forms for provision to LHD on an emergency basis;
- Refer telephone and written correspondence to appropriate regional staff, or directly to the BCDP.
3. State Epidemiologist Responsibilities:
The state epidemiologist has overall responsibility for state disease surveillance activities and is expected to:
- Provide consultation, technical assistance, and training regarding epidemiologic methods and disease control recommendations to LHDs.
- Provide guidelines consistent with state and national objectives, policies and current medical literature.
- Maintain a records system for receiving surveillance reports and consolidation of the information into meaningful tables, graphs and charts, provide analysis of the data, and prepare and disseminate summary reports.
- Act as liaison with the CDC, WSLH, and other Wisconsin laboratories, the University of Wisconsin-Madison Medical School and the Medical College of Wisconsin to assure rapid and accurate flow of information regarding disease control and specimen collection of communicable diseases throughout Wisconsin .
- Assign appropriate state staff to perform epidemiologic investigations where surveillance data indicate a suspected disease outbreak.
- Assure that appropriate forms and information are supplied to LHDs as needed.
III. EPIDEMIOLOGIC INVESTIGATIONS
- Disease Outbreaks
When foodborne or waterborne outbreaks occur it is the responsibility of the LHD or Regional Office to immediately notify the BCDP / CDES office. The LHD would then consult the FOODBORNE AND WATERBORNE DISEASE OUTBREAK INVESTIGATION MANUAL found on the Health Alert Network HAN).
- Requesting Outbreak Assistance
There is no standard formula that will answer the question of when outbreak assistance should be requested.
As a general rule, the Division of Public Health does not provide on-site assistance to LHDs for routine communicable disease outbreaks. However, if an outbreak is suspected and the LHD needs technical, material or personnel assistance for an epidemiologic investigation, the health officer should contact the state epidemiologist. Consultation with the state epidemiologist should always be sought when: (1) the pattern of illness appears to be unusual, (2) the etiology of an unusual disease occurrence is not known, or (3) severe disabling (hospitalizations, death) consequences are occurring.