6 CCR 1009-1
DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT RULES AND REGULATIONS PERTAINING TO EPIDEMIC AND COMMUNICABLE DISEASE CONTROL 6 CCR 1009-1 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Regulation 1. Reportable Diseases For the purpose of these regulations, the diseases named in lists A and B below are declared to be dangerous to the public health and shall be reportable in accordance with the provisions of these regulations.
The Colorado Board of Health also requires the reporting of any unusual illness, or outbreak, or epidemic of illnesses, which may be of public concern whether or not known to be, or suspected of being, communicable. Such illnesses, outbreaks, or epidemics include, but are not limited to: 1) those which may be a risk to the public and which may affect large numbers of persons such as illnesses transmitted through food, water, or from person to person; 2) cases of a newly recognized entity, including novel influenza; 3) those related to a health care setting or contaminated medical devices or products; and 4) those related to environmental contamination by any infectious agent or toxic product of such an agent. The occurrence of a single case of any unusual disease or manifestation of illness which the health care provider determines or suspects may be caused by or related to a bioterrorist agent or incident must be reported immediately by telephone to the state or local health department by the health care provider and the hospital, emergency department, clinic, health care center, and laboratory in which the person is examined, tested, and/or treated. The same immediate reporting is required for any unusual cluster of illnesses that may be caused by or related to a bioterrorist agent or incident. Bioterrorist agents include, but are not limited to, anthrax, plague, smallpox, tularemia, botulism, viral hemorrhagic fever and brucellosis.
List A - Require Report Within 24 Hours (Confirmed or Suspected): Animal bites by dogs, cats, bats, skunks, foxes, Pertussis raccoons, coyotes, or other wild carnivores Anthrax Poliomyelitis Botulism Plague Cholera Rabies in man (suspected)
Meningitis or other invasive disease caused by Active Tuberculosis disease Haemophilus influenzae Meningitis or other invasive disease caused by Typhoid Fever Neisseria meningitidis List B - Require Report Within 7 Days Bites by mammals not Leprosy included in List A Brucellosis* Listeriosis Campylobacteriosis Lyme Disease Chancroid Lymphogranuloma venereum Chlamydia Trachomatis Malaria* Cryptosporidiosis Cyclospora Mumps* Encephalitis* Psittacosis Escherichia coli O157:H7** Q Fever* and shiga toxin-producing Escherichia coli Giardiasis* Relapsing Fever* Gonorrhea, any site Rocky Mountain Spotted Fever Hantavirus Rubella, congenital* Healthcare-associated Salmonellosis infections*** Hepatitis B* Shigellosis Hepatitis C * Tetanus* Hepatitis, other viral Toxic Shock Syndrome Hemolytic Uremic Syndrome if Transmissible spongiform ≤ 18 yrs encephalopathy* Influenza-associated Trichinosis* hospitalization Influenza-associated death if Tularemia* <18 yrs Legionellosis* Varicella* * Reports shall be based on the physician’s diagnosis, whether or not supporting laboratory data are available. ** This includes any shiga-toxin test or O157 antigen test that is positive, even if no culture is performed. If the laboratory does not have the capacity to perform H (flagellar) antigen tests, then Escherichia coli 0157 should be reported. *** Condition reportable only by facilities that are voluntarily participating in applied public health projects. Appendix A includes a definition of healthcare-associated infections, a list of included infections, and a list of included health facility types. Manner of Reporting All cases are to be reported with patient’s name, date of birth, sex, race, ethnicity, and address (including city and county) and name and address of responsible physician or other health care provider; and such other information as is needed to locate the patient for follow up. For animal bites by dogs, cats, bats, skunks, foxes, raccoons, coyotes, and other wild carnivores, the name and locating information of the owner of the biting animal shall be reported, if known, by the health care provider. For healthcare- associated infections, except as provided in § 25-3-601, C.R.S., facilities choosing to voluntarily participate in applied public health projects on a project by project basis shall make medical records available for review by the Department upon request within a reasonable time frame. All cases of diseases in list A, and all cases of diseases marked with a single asterisk (*) in list B shall be reported based on the attending physician or other health care provider’s diagnosis, whether or not supporting laboratory data are available. All other diseases in list B shall be reported only when the physician or other health care provider’s diagnosis is supported by laboratory confirmation. Reports on hospitalized patients may be made part of a report by the hospital as a whole. The Department shall develop systems and forms for reporting for physicians, other health care providers and hospitals. When hospitals and laboratories transmit disease reports electronically using systems and protocols developed by the department that ensure protection of confidentiality, such reporting is acceptable and is considered good faith reporting.
Regulation 2. Reporting by Individuals Cases of diseases listed in Regulation 1 shall be reported by the attending physician or other health care provider and by other persons either treating or having knowledge of a reportable disease, including, but not limited to coroners, persons in charge of hospitals or other institutions licensed by the Colorado Department of Public Health and Environment, (or their designees), persons in charge of schools (including school nursing staff) and licensed day care centers. Regulation 3. Laboratory Reporting Cases of diseases listed in Regulation 1 shall also be reported with the information required in Regulation 1 by laboratories whether or not associated with a hospital, and by out of state laboratories that maintain an office or collection facility in Colorado or arrange for collection of specimens in Colorado. For test results required to be reported by laboratories in Regulation 3 that are not listed in Regulation 1, unless the information or timeframe for reporting is otherwise specified, the laboratory shall report within 7 days the patient’s name, date of birth, sex, race, ethnicity, and address (including city and county); the name and address of responsible physician or other health care provider; and such other information as is needed to locate the patient for follow-up. Results must be reported by the laboratory, which performs the test, but an in-state laboratory which sends specimens to an out-of-state laboratory referral laboratory is also responsible for reporting results. A case shall be reported by a laboratory when a result diagnostic of or highly correlated with clinical illness is found for any of the following organisms or diseases. Test results indicating acute infection or chronic infectiousness for any of the following should be reported. Laboratory assays which demonstrate only immunity should not be reported (for example, a single elevated rubella antibody titer obtained during routine prenatal screening should not be reported). Bacillus anthracis Neisseria gonorrhoeae Bordetella pertussis Plasmodium species Borrelia burgdorferi Poliomyelitis Brucella species Q Fever Campylobacter species Rabies Chlamydia psittaci Relapsing Fever (Borrelia species)
In addition to the above list, a laboratory shall report a case when any of the following specific laboratory results are found:
Group A streptococci - positive culture from a normally sterile site* Group B streptococci - positive culture from a normally sterile site* Methicillin resistant Staphylococcus aureus (MRSA) - positive culture from a normally sterile site (30 day timeframe for reporting)* Clostridium difficile - any positive test (30 day timeframe for reporting)* Haemophilus influenzae - positive culture from a normally sterile site Hepatitis A - positive IgM anti-HAV Hepatitis B - positive HBsAg, IgM anti-HBc, HBeAg, or HBV DNA Hepatitis C - positive serum antibody titer, including signal to cut-off ratio or more specific positive tests Neisseria meningitidis - positive culture from a normally sterile site Streptococcus pneumoniae - positive culture from a normally sterile site Escherichia coli, Klebsiella species, and Enterobacter species that are intermediate or resistant to at least one carbapenem (including imipenem, meropenem, doripenem, or ertapenem) AND resistant to all third- generation cephalosporins tested (ceftriaxone, cefotaxime, and ceftazidime); OR Escherichia coli, Klebsiella species, and Enterobacter species that test positive for carbapenemase production (by any method, including the Modified Hodge Test, disk diffusion, or PCR) Acinetobacter baumannii (including Acinetobacter baumannii complex and Acinetobacter baumannii- calcoaceticus complex) that are intermediate or resistant to at least one carbapenem (including imipenem, meropenem, doripenem, or ertapenem) isolated from a normally sterile site or urine (30 day timeframe for reporting)* * Condition reportable only in the Denver Metropolitan Area (Adams, Arapahoe, Denver, Douglas, and Jefferson Counties.) + Condition reportable only in the 7 county Denver Metropolitan Area (Adams, Arapahoe, Boulder, Broomfield, Denver, Douglas, and Jefferson Counties.)
** This includes any shiga-toxin test or O157 antigen test that is positive, even if no culture is performed. If the laboratory does not have the capacity to perform H (flagellar) antigen tests, then Escherichia coli 0157 should be reported. ++ Including California Encephalitis Serogroup, Chikungunya, Colorado Tick Fever, Dengue, Eastern Equine Encephalitis, Japanese Encephalitis, La Cross Encephalitis, Powassan, Saint Louis Encephalitis, Western Equine Encephalitis, and Yellow Fever. Reference laboratories that receive specimens from other laboratories shall report results separately for each submitting facility.
Regulation 4 Treatment and Control of Tuberculosis The emergence of multiple drug-resistant tuberculosis in this country and state dictates a coherent and consistent strategy in order to protect the public health from this grave threat. The underlying principles of disease control expressed in the following rules are as follows: use of the most rapid and modern diagnostic methods by laboratories, rapid reporting, full patient compliance with medical treatment, and prevention of spread of tuberculosis in health care settings. The tuberculosis statute (C.R.S. 25-4-501 et seq) covers subject matters not included in these regulations.
A. All confirmed or suspected cases of active tuberculosis disease, regardless of whether confirmed by laboratory tests, shall be reported to the state or local health department or health agency within 24 hours by physicians, health care providers, hospitals, other similar private or public institutions, or any other person providing treatment to the confirmed or suspected case. The reports shall include the following information: the patient’s name, date of birth, sex, race, ethnicity, address (including city and county), name and address of the reporting physician or agency; and such other information as is needed to locate the patient for follow-up. If reported by a physician, the physician shall also give the evidence upon which the diagnosis of tuberculosis was made, the part of the body affected, and the stage of disease.
B. Physicians, health care providers, and health care facilities shall report within 7 days the following ppd skin test result if it occurs in a health care worker, correctional facility worker, or detention facility worker: a positive ppd (defined as = 5 mm induration) if the worker has had prolonged or frequent face-to-face contact with an infectious tuberculosis case.
C. Laboratories shall report within 24 hours any result diagnostic of or highly correlated with active tuberculosis disease, including cultures positive for Mycobacterium tuberculosis and sputum smears positive for acid fast bacilli, and shall report the results of tests for antimicrobial susceptibility performed on positive cultures for tuberculosis.
D. Results must be reported by the laboratory which performs the test, but an in-state laboratory which sends specimens to an out-of-state referral laboratory is also responsible for reporting the results.
E. A laboratory may fulfill its requirement to report (in parts C and D of this regulation) by submitting a sputum specimen from the patient to either the State Public Health Laboratory, or for facilities located in Boulder, Broomfield, Denver, Adams, Douglas, Arapahoe, and Jefferson counties, to the Denver Public Health laboratory. The reporting requirement is not fulfilled if the laboratory submits an isolate from a culture to either of the public health laboratories or if the laboratory delays sending the sputum specimen for more than 2 days after collection of the specimen.
F. When a laboratory performs a culture that is positive for Mycobacterium tuberculosis, the laboratory shall store the isolate until it receives notification from the state or local health department that the patient has completed a full and appropriate course of treatment for active tuberculosis disease. In lieu of such storage, the laboratory may fulfill this requirement by submitting the isolate to either the state public health laboratory, or for facilities located in Boulder, Broomfield, Denver, Adams, Douglas, Arapahoe, and Jefferson counties, to the Denver Public Health Laboratory.
G. The State or local health department is authorized to perform evaluations of the timeliness of laboratory diagnostic processes. The data collected in an evaluation may include the mean, median, and range for the following indices: the length of time from specimen collection to isolation; the length of time from isolation of an organism to identification of the organism as Mycobacterium tuberculosis; and the length of time from isolation until susceptibility test results are finalized. The state or local health department shall provide the laboratory and hospital the results of its evaluation, including comparison of the laboratory indices to norms for other similar laboratories.
H. The Board of Health determines that to prevent the emergence of multiple drug- resistant tuberculosis, it is necessary and appropriate and good medical practice that persons with active tuberculosis disease receive directly observed treatment for their disease. All medical providers and health care organizations are required to provide directly observed therapy for patients with active tuberculosis disease for the full course of therapy, unless a variance for a particular patient from this requirement is approved by the tuberculosis control program of the State Department of Public Health and Environment or Denver Public Health. Directly observed therapy is not required for patients with extrapulmonary tuberculosis disease provided that the presence of pulmonary tuberculosis has been investigated and excluded. In applicable situations, a variance shall be granted in accordance with C.R.S. 25-4-506(3).
Medical providers and health care organizations shall report to the state or local health department within seven days the name of any patient on directly observed therapy who has missed one dose. When requested by medical providers and health care organizations, the state or local health department shall provide directly observed treatment to outpatients with active tuberculosis disease and this shall fulfill the requirement for the medical providers and health care organizations.
I. All hospitals and health care facilities providing in-patient treatment to persons with active tuberculosis disease shall notify the state or local health department immediately after plans are made to discharge the patient from the facility. The notification is intended to discuss the treatment plan for the patient and to assure adequate follow-up and coordination among providers so that the standard of directly observed treatment is met.
J. All licensed hospitals and nursing home facilities shall maintain a register of the tuberculosis skin test results of health care workers in their facility, including physicians and physician extenders who are not employees of the facility but provide care to or have face-to-face contact with patients in the facility. The facility shall maintain such tuberculosis skin test results as confidential medical information. Pursuant to C.R.S. 25-4-508, authorized personnel of the department of public health and environment may inspect and have access to such register in the course of an investigation intended to identify sources and contacts of a case of active tuberculosis disease and to control tuberculosis.
K.
Regulation 5. Investigations to Confirm the Diagnosis, Treatment, and Causes of Epidemic and Communicable Diseases and to Determine Appropriate Methods of Epidemic and Communicable Disease Control Investigations may be conducted to confirm the diagnosis, treatment, and causes of reportable conditions and shall be considered official duties of the health department or health agency. Such investigations may include, but are not limited to:
These requirements shall not apply if the State and local health agencies mutually agree not to share information on reported cases.
Sharing of medical information on persons with reportable diseases between authorized personnel of State and local health departments shall be restricted to information necessary for the treatment, control, investigation, and prevention of epidemic and communicable diseases dangerous to the public health. Regulation 7. Food Handling and Infected Persons No person, while infected with a disease in a communicable form which can be transmitted by foods or who is afflicted by a boil, or an infected wound,shall work in a food processing, milk producing, milk processing or food service setting in any capacity in which there is a likelihood of such person contaminating food or food contact surfaces with pathogenic organisms or transmitting diseases to other persons. The employer is responsible for ensuring the absence from work of an employee with an infectious disease for which there is evidence of transmission to persons in a food service, food processing, milk producing, or milk processing setting, as determined by the State Department of Health. Regulation 8. Reporting of Diseases Among Animals and Waiver Process for Rabies Inoculation A. Every veterinarian, livestock owner, veterinary diagnostic laboratory director, or other person having the care of, or knowledge of, the existence of animals having or suspected of having any disease which may endanger the public health such as rabies, anthrax, encephalitis, bovine spongioform encephalopathy, etc., shall promptly report the facts to the local health department or health agency or the State Department of Health.
B. Pursuant to C.R.S. § 25-4-607 (2), a veterinarian licensed in Colorado may issue a written waiver as provided in this section exempting an animal from a rabies vaccination order if the veterinarian, in his or her professional opinion, determines the rabies inoculation is contraindicated due to the animal’s medical condition. The terms “waiver” and “exemption” as used in this section are interchangeable. A veterinarian may issue a waiver if:
C. A waiver may not exceed a period of three years from the date of issuance. If the medical condition persists beyond a three year period and, in the professional opinion of a veterinarian licensed in the State of Colorado, the exemption continues to be appropriate, a new waiver may be issued.
D. Upon receiving a complaint regarding the validity of a rabies inoculation exemption, the executive director or his/her designee(s) may review Exemption from Rabies Vaccination forms and examine the veterinary records pertaining to the medical condition to determine if the medical condition legitimately contraindicates rabies inoculation. if appropriate, the executive director or his/her designee(s) may refer the case to the State Board of Veterinary Medicine. Regulation 9. Confidentiality All personal medical records and reports held or viewed by the state or local health department in compliance with these regulations shall be confidential information subject to C.R.S. 25-1-122(4). Reasonable efforts shall be made by the department to consult with the attending physician or medical facility caring for the patient prior to any further follow-up by State or local health departments or health agencies Regulation 10. Cleaning and Sterilization of Needles, Instruments, Probes, and Devises Used by Acupuncturists, Tattoo Artists, and Persons Performing Ear or Other Percutaneous Piercing This regulation is promulgated pursuant to CRS 25-1-107(1)(A) and 12-29.5-111 which state that the Department has the authority to investigate and control the causes of epidemic and communicable diseases and that the Department shall promulgate rules relating to the proper cleaning and sterilization of needles used in the practice of acupuncture and the sanitation of acupuncture offices. Because bloodborne infections may be transmitted by any contaminated instrument which enters sterile tissue of a patient/client, this regulation is not restricted to acupuncturists. All parts of the premises of an acupuncture, tattoo, or ear/percutaneous piercing establishment shall be kept in a clean, sanitary, neat, and orderly condition at all times. All tables, counters, and chairs used in connection with these procedures shall be constructed of a material which is easily cleaned and capable of being sanitized with a chemical germicide.
Prior to and after each treatment of acupuncture and each application of tattoo or ear/percutaneous piercing, the applicator shall wash his/her hands at a sink with both hot and cold running water and with soap having bactericidal qualities.
Equipment items shall be defined as any needle, instrument, probe, or device utilized by acupuncturists, tattoo artists, or persons performing ear/percutaneous piercing that punctures the skin or enters sterile tissue of any patient/client.
The use of sterile, single-use, disposable equipment items is encouraged. Equipment items which have been used to puncture the skin or enter sterile tissue of a patient/client shall be considered infectious waste. Prior to disposal, such items must be placed in puncture-resistant containers. Such items should not be recapped, bent, broken, removed from disposable syringes, or otherwise manipulated by hand after use. Other solid waste, such as soiled linen, contaminated with blood or other body fluids must be placed in sealed, sturdy, impervious bags to prevent leakage of the contained items. All infectious waste must be disposed of in a manner consistent with CRS 25-15-401 et seq. and regulations of the Board of Health concerning infectious waste disposal. Equipment items must be cleaned and sterilized before such items may be reused. Equipment items should first be thoroughly cleaned to remove adherent, organic material (e.g. blood and proteins). Persons involved in cleaning and decontaminating instruments should wear heavy-duty rubber gloves to prevent hand injuries. Equipment items must then be sterilized by steam (autoclaving), gas (chemical vapor), or dry heat sterilization. Sterilizers must be installed, maintained, and operated in conformance with the manufacturer’s instructions and specifications. The adequacy of sterilization cycles must be verified by the periodic use of spore-testing devices, i.e. weekly for most practices, and the operator should keep records which demonstrate the frequency and results of such testing. Liquid chemical germicides (commonly referred to as “cold sterilization” solutions), ultrasound, and ultraviolet light cabinets are not acceptable sterilization methods for metal or heat-stable equipment items. Non-heat- stable equipment items which enter normally sterile tissue should receive high level disinfection using chemical germicides that are registered with the U.S. Environmental Protection Agency as “sterilants”. The manufacturer’s instructions for use of the germicide and the manufacturer’s specifications for compatibility of the equipment item with germicides should be closely followed. Each office, clinic, business, or facility which utilizes equipment items shall be responsible for insuring that all personnel who use, clean, sterilize, store, dispose, or otherwise handle equipment items are adequately trained and supervised.
All communicable diseases shall be reported by acupuncturists, tattoo artists, and persons performing ear/percutaneous piercing to the state or local health department in accordance with Regulations 1 through 4 of these rules.
Regulation 11. Sexually Transmitted Infections In addition to all manifestations of chlamydia, syphilis and gonorrhea, the Colorado Board of Health finds that the following diseases are contagious, are sexually transmissible, are dangerous to the public health, and pursuant to C.R.S. 25-4-401(1) are determined to be sexually transmitted infections. The Board recognizes that non-sexual transmission may occur for some of these diseases, and that in individual cases, based on clinical and epidemiologic information, the attending physician may conclude the patient’s disease was not sexually acquired:
Healthcare-associated infections include:
Regulation 3 eff. 03/30/2008.
Regulation 8 eff. 03/02/2010.
Regulations 1, 3, 11 eff. 04/14/2010.
Regulations 1, 3, Appendix A eff. 12/30/2010.
Regulations 1, 3 eff. 11/30/2012.
Regulations 1 – 3, 5, 9 eff. 10/15/2014.