Statement of Basis and Purpose and Specific Statutory Authority for Amendments to Rules and Regulations Pertaining to Preparations for a Bioterrorist Event, Pandemic Influenza, or an Outbreak by a Novel and Highly Fatal Infectious Agent or Biological Toxin Adopted by the Colorado Board of Health on July 16, 2003 Basis and Purpose The rules are established to assure that local public health agencies and medical care providers in the state prepare for the complex and dramatic problems that would ensue following the recognition of a bioterrorist attack or an epidemic of pandemic influenza. The modifications to these rules build on the Preparedness rules adopted in 2001 that required county and district health departments, general and critical access hospitals, managed care organizations, regional emergency medical and trauma services advisory councils, and the Colorado Department of Public Health and Environment to develop preparedness plans. The modifications further the state's preparedness in the following ways: 1) Colorado's 39 public health nursing services, which serve 40 Colorado counties, are added to the entities required to develop notification lists, mutual aid agreements, and disaster emergency plans; 2) These regulations allow for flexibility in how each agency complies with the regulation; 3) These requirements build on the initial requirements and help assure that written plans are timely and effective. Specific Statutory Authority These rules are promulgated pursuant to the following statutes: Section 25-1-107(1)(a), C.R.S. and Sections 25-1-108(1)(c)(I) and (VI), C.R.S.

Preparations for a Bioterrorist Event, Pandemic Influenza, or an Outbreak by a Novel and Highly Fatal Infectious Agent or Biological Toxin In Section 24-32-2103, C.R.S., emergency epidemic is defined as cases of an illness or condition, communicable or noncommunicable, caused by bioterrorism, pandemic influenza, or novel and highly fatal infectious agents or biological toxins.

Regulation 1. Preparations by Local Public Health Agencies for an Emergency Epidemic 1. Each county and district public health department in this state subject to Section 25-1-501 et seq., C.R.S., is required to maintain an up-to-date notification list for an emergency epidemic. The list shall include general or critical access hospitals and the local emergency management agencies within the jurisdiction of the local public health department. The county or district public health department is required to conduct notification tests by a broadcast fax or another communications method for rapid notification at least twice per year.

2. Each county and district public health department in this state subject to Section 25-1-501 et seq., C.R.S., must sign a uniform mutual aid agreement with all other county and district public health departments and local health officers and county public health nursing services subject to Section 25-1-501 and 25-1-601 et seq., C.R.S., that obligates the county or district public health department and local health officers and county public health nursing services to render aid during an emergency epidemic unless the county, district public health department or local health officer and county public health nursing service needs to withhold resources necessary to provide reasonable protection for its own jurisdiction.

3. Each county and district public health department subject to Section 25-1-501 et seq., C.R.S., shall prepare a plan that the agency will implement when the governor declares a disaster emergency that is the result of an occurrence or imminent threat of an emergency epidemic. The plan must be able to be integrated with the Local Emergency Operations Plan(s) (LEOP) and the regional Public Health Preparedness and Response Plan. In addition, the county or district public health department shall provide a copy of the plan submitted pursuant to these regulations to the local offices of emergency management, to all general or critical access hospitals, and to all regional emergency medical and trauma services advisory councils within the jurisdiction of the local public health agency.

A) Organization and assignment of potentially all employees of the agency under an approved incident management system to work on controlling the emergency epidemic;

B) Having sufficient supplies and a process for the provision of personal protective equipment against bacterial and viral infections to county and district public health department employees who are assigned to work in areas where they may be exposed to ill and contagious persons or to infectious agents and waste; personal protective equipment shall, at a minimum, be the equipment and supplies used to achieve standard precautions;

C) Procurement and storage of at least five days supply of doxycycline or other antibiotic, as determined by the state health department, to be used as chemoprophylaxis for all county and district public health department employees. The plan shall include procurement of another antibiotic for a small number of county and district public health department employees who may be unable to take doxycycline;

D) An emergency, after-hours call-down list of persons who may be needed to organize and respond to an emergency epidemic; such list shall include persons with experience and E) Creation of an agency operations center within the agency that integrates with the local emergency operations center(s) or provide staffing to and participation in, activities of the local emergency operations center(s) for the purpose of (i) centralizing telephone, radio, and other electronic communications; (ii) compiling surveillance data; and (iii) maintaining a log of operations, decisions, resources, and orders necessary to control the epidemic;

F) Creation of a system or participation in an organized system to: (i) monitor the situation, including infection control, in each hospital within the agency's jurisdiction, doing this on- site as necessary and with assistance from the state health department as appropriate;

1. (ii) assess and manage infection control in the community outside of the hospital; and (iii) assess and manage, in coordination with hospitals and the county coroner, the disposal of human corpses;

G) The organization, staffing, security, and logistics of the distribution and delivery of antibiotics, antiviral medications, vaccines, or other medications needed in an emergency epidemic following the provisions of State Emergency Function #8, “Health, Medical and Mortuary”;

H) Identification of public spokespersons responsible for providing information to the citizens of their jurisdiction about how to protect themselves, what actions are being taken to control the epidemic, and when the epidemic is over; and I) Implementation of a back-up communications system that will allow communication with the local emergency response structure if and when telephone communications are disabled or not functioning;

Regulation 2. Preparations by General or Critical Access Hospitals for an Emergency Epidemic 1. Each general or critical access hospital in this state is required to maintain an up-to-date notification list for an emergency epidemic. The list shall include any satellite clinics, acute care facilities, or trauma centers operated by the hospital; offices of physicians and health care providers on the staff of the hospital, as available; and the local public health agency serving the county in which the hospital is located. The hospital is required to conduct notification tests by a broadcast fax or by another communications method for rapid notification at least twice per year.

2. Each general or critical access hospital in this state shall prepare a plan that the hospital will implement when the governor declares a disaster emergency that is the result of an occurrence or imminent threat of an emergency epidemic. The plan must be able to be integrated with the Local Emergency Operations Plan (LEOP). In addition, the general or critical access hospital shall provide a copy of the plan submitted pursuant to these regulations to the local public health agency, the local office of emergency management, and the regional emergency medical and trauma services advisory council in the region in which the hospital is located.

A) Organization, assignment and reassignment, under an approved incident management system of all medical staff and all employees of the hospital who may be called on to work during an emergency epidemic;

B) Having sufficient supplies and a process for the provision of personal protective equipment against bacterial and viral infections to all staff and employees who are assigned to work in areas where they may be exposed to ill and contagious persons or to infectious agents and waste; personal protective equipment shall, at a minimum, be the equipment and supplies used to achieve standard precautions;

C) Procurement and storage of at least five days supply of doxycycline or other antibiotic, as determined by the state health department, to be used as chemoprophylaxis for all employees. The plan shall include procurement of another antibiotic for a small number of employees who may be unable to take doxycycline;

D) An emergency call-down list of off-duty or retired health care providers who may be asked to work or volunteer as needed to respond to an emergency epidemic;

E) Creation of a facility operations center within the hospital that integrates with the local emergency operations center(s) or provide staffing to and participation in activities of the local emergency operations center(s) for the purposes of: (i) centralizing telephone, radio, and other electronic communications; (ii) compiling morbidity and mortality data including the number of patients, number of available beds, and number of working staff and employees; (iii) receiving and responding to executive orders of the governor regarding the emergency epidemic; and (iv) maintaining a log of operations, decisions, and resources necessary to maintain operations during the epidemic;

F) Creation of a system or participation in an organized system to assess and manage: (i) infection control within the hospital; and (ii) in coordination with local health departments and the county coroner, the disposal of human corpses;

G) Security of the hospital facility necessary to control large and unruly crowds;

H) Rapid transport of human diagnostic specimens to the state laboratory or as otherwise directed by the Colorado Department of Public Health and Environment;

I) Prevention of the spread of the epidemic disease within the hospital from persons ill with the condition causing the emergency epidemic to staff, employees, and other patients of the hospital; and J) Coordination and communication with other hospitals and pre-hospital care agencies to assure that patients with extreme, life-threatening or emergency medical or traumatic conditions are not unnecessarily diverted from the hospital.

Regulation 3. Preparations by Managed Care Organizations for an Emergency Epidemic 1. Each managed care organization licensed in this state by the division of insurance and that operates medical facilities or pharmacies is required to maintain an up-to-date notification list for an emergency epidemic. The list shall include any satellite clinics, acute care facilities, or trauma centers operated by the organization, as well as offices of physicians and health care providers working as full-time contractors or staff of the organization. The organization is required to conduct notification tests by a broadcast fax or another communications method for rapid notification at least twice per year.

2. Each managed care organization operating medical facilities or pharmacies in this state shall prepare a plan that the organization would implement when the governor declares a disaster emergency that is the result of an occurrence or imminent threat of an emergency epidemic. The plan must be able to be integrated with the Local Emergency Operations Plan (LEOP). The plan shall address the following areas:

A) Rapid transport of human diagnostic specimens to the state laboratory from facilities that are operated by the organization;

B) A rapid method of determining the inventory of broad spectrum antibiotics in facilities and pharmacies that are operated by the organization, including pill counts of doxycycline or other antibiotic, as determined by the state health department;

C) A rapid method of securing and protecting antibiotics, antiviral medications, vaccines, and personal protective equipment within facilities and pharmacies that are operated by the organization; personal protective equipment shall, at a minimum, be the equipment and supplies used to achieve standard precautions; and D) Delivery or transfer of the supplies listed in paragraph C to authorized personnel as directed by executive orders of the governor.

Regulation 4. Preparations by Regional Emercency Medical and Trauma Services Advisory Councils for an Emergency Epidemic 1. Each regional emergency medical and trauma services advisory council in this state is required to maintain an up-to-date notification list of organizations for an emergency epidemic. The list shall include all pre-hospital care organizations within the jurisdiction of the regional emergency medical and trauma services advisory council. The council is required to conduct or participate in notification tests by a broadcast fax or by another communications method for rapid notification of these organizations at least twice per year.

2. Each regional emergency medical and trauma services advisory council shall advise the pre-hospital care organizations within its jurisdiction to develop a plan that the organization would implement when the governor declares a disaster emergency that is the result of an occurrence or imminent threat of an emergency epidemic. The organizations shall be advised that the plan should address the following areas:

A) Organization, assignment, reassignment, and alteration of normal work schedules of all staff and all employees of the organization under an approved incident management system who may be called on to work during an emergency epidemic;

B) Having sufficient supplies and a process for the provision of personal protective equipment against bacterial and viral infections to all staff and employees who are assigned to work in areas where they may be exposed to ill and contagious persons or to infectious agents and waste; personal protective equipment shall, at a minimum, be the equipment and supplies used to achieve standard precautions;

C) Procurement and storage of at least five days supply of doxycycline or other antibiotic, as determined by the state health department, to be used as chemoprophylaxis for all employees. The plan should include procurement of another antibiotic for a small number of employees who may be unable to take doxycycline;

D) An emergency call-down list of off-duty or retired emergency medical service providers who may be asked to work or volunteer as needed to respond to an emergency epidemic. Regulation 5. Preparations by the Colorado Department of Public Health and Environment for an Emergency Epidemic 1. The Department of Public Health and Environment (“the Department”) is required to maintain an up-to- date notification list of contacts for an Emergency Epidemic. The list shall include the Governor's Office, members of the Governor's Expert Emergency Epidemic Response Committee, general or critical access hospitals, county and district public health departments, regional emergency medical and trauma services advisory councils, and the state Office of Emergency Management. The Department is required to conduct notification tests by a broadcast fax or by another communications system for rapid notification of these contacts at least twice per year.

2. The Department shall prepare an internal emergency response plan that the Department will implement when there is an occurrence or imminent threat of an emergency epidemic. The plan must be able to be integrated with the State Emergency Operations Plan (SEOP) and the regional Public Health Preparedness and Response Plans. The plan shall address the following areas:

A) Organization and assignment of potentially all employees of the Department under an approved incident management system to work on controlling the emergency epidemic;

B) Having sufficient supplies and a process for the provision of personal protective equipment against bacterial and viral infections to Department employees who are assigned to work in areas where they may be exposed to ill and contagious persons or to infectious agents and waste; personal protective equipment shall, at a minimum, be the equipment and supplies used to achieve standard precautions;

C) Procurement and storage of at least five days supply of doxycycline or other antibiotic, as determined by the state health department, to be used as chemoprophylaxis for all Department employees. The plan shall include procurement of another antibiotic for a small number of employees who may be unable to take doxycycline;

D) An emergency, after-hours call-down list of persons who may be needed to organize and respond to an emergency epidemic; such list shall include persons with experience and E) Creation and furnishing of an agency operations center within the Department that integrates with the State Emergency Operations Center and the federal joint operations center (if established) for the purpose of (i) centralizing telephone, radio, and other electronic communications; (ii) compiling surveillance data; and (iii) maintaining a log of operations, decisions, resources, and orders necessary to control the epidemic;

F) Creation of a system or participation in an organized system to: (i) monitor the situation in each hospital where the emergency epidemic is occurring; (ii) assess and manage infection control in the community outside of the hospital; and (iii) assess and manage, in coordination with hospitals and the county coroner, the disposal of human corpses in accordance with state emergency function #8;

G) Assurance of the appropriate distribution and delivery of antibiotics, antiviral medications, vaccines, or other medications needed in an emergency epidemic to locations identified in regional public health response plans;

H) Identification of public spokespersons responsible for providing information to the citizens of the state about how to protect themselves, what actions are being taken to control the epidemic, and when the epidemic is over; and I) Implementation of a back-up communications system that will be used to communicate with the state Office of Emergency Management and local health agencies if and when telephone communications are disabled or not functioning.

4. The Department shall provide to each county and district public health department subject to Section 25-1-501 et seq., C.R.S., and to the state Office of Emergency Management a copy of the plan submitted pursuant to these regulations. The plan shall be provided upon request to general and critical access hospitals, managed care organizations, regional emergency medical and trauma services advisory councils, local offices of emergency management and public health nursing services.

Regulation 6. Assessing Compliance With These Regulations For the purposes of determining eligibility for the protections of Section 24-32-2111.5, C.R.S., the Department of Public Health and Environment may review plans submitted to the Board of Health pursuant to Regulations One through Four and Seven and may examine and inspect faxes transmitted or documentation of other communications methods used for rapid notification of contacts and agencies pursuant to Regulations One through Four and Seven. Each county and district public health department, local health officer and county public health nursing service subject to Section 25-1-501 and 25-1-601 et seq., C.R.S., general or critical access hospital, managed care organization, regional emergency medical and trauma services advisory council, shall certify that the plan required by Regulations One through Four and Seven fully meet the requirements.

Regulation 7. Preparations by Public Health Nursing Services for an Emergency Epidemic 1. Each local health officer and county public health nursing service in this state subject to Section 25-1- 601 et seq., C.R.S., is required to maintain an up-to-date notification list for an emergency epidemic. The list shall include general or critical access hospitals and the local emergency management agencies within the jurisdiction of the local health officer and county public health nursing service. The local health officer and county public health nursing service is required to conduct notification tests by a broadcast fax or another communications method for rapid notification at least twice per year.

2. Each local health officer and county public health nursing service in this state subject to Section 25-1- 601 et seq., C.R.S., must sign a uniform mutual aid agreement with all other county and district public health departments and local health officers and county public health nursing services subject to Section 25-1-501 and 25-1-601 et seq., C.R.S., that obligates the county or district public health department and local health officers and county public health nursing services to render aid during an emergency epidemic unless the county district public health department or local health officer and county public health nursing service needs to withhold resources necessary to provide reasonable protection for its own jurisdiction.

3. Each local health officer and county public health nursing service subject to Section 25-1-601 et seq., C.R.S., shall prepare a plan that will be implemented when the governor declares a disaster emergency that is the result of an occurrence or imminent threat of an emergency epidemic. The plan must be able to be integrated with the Local Emergency Operations Plan(s) (LEOP) and the regional Public Health Preparedness and Response Plan. In addition, the local health officers and county public health nursing services shall provide a copy of the plan submitted pursuant to these regulations to the local offices of emergency management, to all general or critical access hospitals, and to all regional emergency medical and trauma services advisory councils within the jurisdiction of the public health nursing service.

A) Organization and assignment of potentially all employees of the public health nursing service under an approved incident management system to work on controlling the emergency epidemic;

B) Having sufficient supplies and a process for the provision of personal protective equipment against bacterial and viral infections to public health nursing services employees who are assigned to work in areas where they may be exposed to ill and contagious persons or to infectious agents and waste; personal protective equipment shall, at a minimum, be the equipment and supplies used to achieve standard precautions;

C) Procurement and storage of at least five days supply of doxycycline or other antibiotic, as determined by the state health department, to be used as chemoprophylaxis for all public health nursing services employees. The plan shall include procurement of another antibiotic for a small number of public health nursing services employees who may be unable to take doxycycline;

D) An emergency, after-hours call-down list of persons who may be needed to organize and respond to an emergency epidemic; such list shall include persons with experience and E) Provide staffing to and participation in activities of the local emergency operations center (s) for the purpose of (i) centralizing telephone, radio, and other electronic communications;

1. (ii) compiling surveillance data; and (iii) maintaining a log of operations, decisions, resources, and orders necessary to control the epidemic;

F) Creation of a system or participation in an organized system to: (i) monitor the situation, including infection control, in each hospital within the public health nursing service's jurisdiction, doing this on-site as necessary and with assistance from the state health department as appropriate; (ii) assess and manage infection control in the community outside of the hospital; and (iii) assess and manage, in coordination with hospitals and the county coroner, the disposal of human corpses;

G) The organization, staffing, security, and logistics of the distribution and delivery of antibiotics, antiviral medications, vaccines, or other medications needed in an emergency epidemic following the provisions of State Emergency Function #8, “Health, Medical and Mortuary”;

H) Identification of public spokespersons responsible for providing information to the citizens of their jurisdiction about how to protect themselves, what actions are being taken to control the epidemic, and when the epidemic is over; and I) Implementation of a back-up communications system that will allow communication with the local emergency response structure if and when telephone communications are disabled or not functioning;