6 CCR 1009-1
DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT 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.] _________________________________________________________________________ Adopted by the Board of Health on November 20, 2024.
Regulation 1. Reportable Diseases, Conditions, and Related Events For the purpose of these regulations, the diseases, conditions, and related events named in the Reportable Diseases, Conditions, and Related Events Table (Appendix A) are declared to be potentially dangerous to public health and shall be reportable in accordance with these regulations. In addition, any language specifying “(the) Department” refers to the Colorado Department of Public Health and Environment. The diseases, conditions, and related events named in Appendix A and throughout this rule pertain to those diagnosed or detected in humans, with the exception of those outlined in Regulation 8 - Reporting of Diseases Among Animals and Waiver Process for Rabies Inoculation. The 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, animal, or other vector to person, or from person to person; 2) cases of a newly recognized entity, including novel influenza; 3) those related to a healthcare 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 healthcare provider determines or suspects may be caused by or related to a bioterrorist agent or incident must be reported immediately by telephone to the Department or county, district, or municipal public health agency by the healthcare provider and the hospital, emergency department, clinic, healthcare 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 that cause illness include, but are not limited to, anthrax, plague, smallpox, tularemia, botulism, viral hemorrhagic fever and brucellosis. Manner of Reporting All cases are to be reported with patient’s name, date of birth, sex assigned at birth, race, ethnicity, phone number, physical address (including city and county), email address, preferred language and name and address and phone number of responsible physician or other healthcare provider; and such other information as is needed to locate the patient for follow up. All laboratory information reported shall include specimen accession number. The patient’s pregnancy status shall be reported for cases of syphilis, HIV, hepatitis B, and hepatitis C. The patient’s relevant treatment and gender identity shall be reported for sexually transmitted infections. Gender identity is defined as an individual’s personal sense of being male, female, or transgender. For reports from a publicly funded anonymous testing site, as provided in § 25-4-411, C.R.S., the patient’s name and address are not required. When hospitalization is a criteria for reporting (e.g., a hospitalized patient with a positive test result for COVID-19, influenza, or RSV), the report shall provide hospital admission date(s) and the name of the facility where the patient is hospitalized. When requested by the department, the report shall also include discharge date(s), ventilator and intensive care unit (ICU) use, and other fields as needed. Reports on hospitalized patients may be made part of a report by the hospital as a whole instead of reports from individual providers.
For animal bites by owned dogs, and cats, the name and locating information of the owner of the biting animal shall be reported, if known, by the healthcare provider. For bites by bats, skunks, foxes, raccoons, coyotes, and other wild carnivores, as well as non-bite bat exposures, the location information of the wild animal shall be reported, if known, by the healthcare provider. Reporting requirements for healthcare-associated infections are provided by § 25-3-601 et seq., C.R.S. and are reported to the National Healthcare Safety Network (NHSN). Methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections are listed below in Appendix A because they are not covered by § 25-3-601, C.R.S., and reporting requirements are satisfied by reporting to NHSN. Facilities reporting outbreaks of healthcare-associated infections, and those choosing to voluntarily participate in applied public health projects related to healthcare-associated infections as indicated in Appendix A and Healthcare-Associated Infections (Appendix B), shall make medical records available for review by the Department upon request within a reasonable time frame. See Appendix A to determine time frames for reporting (from diagnosis or test result), who shall report, the reporting area, whether laboratory information is required for a report, and whether an isolate or clinical material must be sent to the Department, State Public Health Laboratory. The Department shall develop systems and forms for reporting for physicians, other healthcare providers and hospitals. When hospitals and laboratories transmit disease reports electronically using systems and protocols developed by the Department or Federal agencies that ensure protection of confidentiality, such reporting is acceptable and is considered good faith reporting. Regulation 2. Reporting by Individuals Where Reporter = ‘P’ in the Appendix A, known or suspected cases and outbreaks of diseases shall be reported by the physician or other healthcare 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 Department (or their designees), persons in charge of schools (including school nursing staff), licensed child care centers, persons in charge of institutions of higher education or their designee, or any other person providing testing and/or counseling to a person with a sexually transmitted infection.
Regulation 3. Laboratory Reporting Where Reporter = ‘L’ in Appendix A, cases of diseases shall be reported with the information required in Regulation 1 by the laboratory, or by an outpatient clinic that performs laboratory testing on site, whether or not associated with a hospital. The following laboratories shall also report: 1) out-of-state laboratories that maintain an office or collection facility in Colorado or arrange for collection of specimens in Colorado; and 2) in-state laboratories that send specimens to out-of-state referral laboratories. The case shall be reported by a laboratory when a result diagnostic of or highly correlated with clinical illness is found. 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). For organisms so noted in Appendix A, testing laboratories shall routinely submit bacterial culture isolates or patient clinical material that yields positive findings to the Department, State Public Health Laboratory. Clinical material is defined as: (i) a culture isolate containing the infectious organism for which submission of material is required, or (ii) if an isolate is not available, material containing the infectious organism for which submission of material is required, in the following order of preference: (A) a patient specimen; (B) nucleic acid; or (C) other laboratory material.
All specimens shall be accompanied by a test order with the following information: (a) Patient's name, date of birth, sex assigned at birth, race, ethnicity, phone number, physical address (including city and county), email address, and preferred language; pregnancy status shall be reported for cases of syphilis, HIV, hepatitis B and hepatitis C (b) Name and address and phone number of responsible physician or other healthcare provider (c) Name of disease or condition (d) Laboratory information - test name, collection date, specimen accession number, and specimen type. Laboratories should make an effort to report all test results and patient information electronically, whenever possible, as specimen submission to the Department, State Public Health Laboratory does not constitute disease reporting. Regulation 4. Treatment and Control of Tuberculosis The emergence of multi-drug-resistant tuberculosis in this country and state dictates a coherent and consistent strategy in order to protect public health. 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 healthcare settings. The tuberculosis statute (§ 25-4-501, et seq., C.R.S.) 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 Department or county, district, or municipal public health agency within one working day by physicians, healthcare providers, hospitals, private and public laboratories, 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 assigned at birth, race, ethnicity, phone number, physical address (including city and county), email address, preferred language, name and address, and phone number of the reporting physician or other healthcare provider 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 or why tuberculosis is being considered, the suspected or confirmed affected body, and whether it is confirmed or suspected tuberculosis disease. For the purposes of this reporting requirement, “suspected” is defined as anyone being considered for tuberculosis disease as part of the differential diagnosis, leading to the ordering and performing of any tuberculosis testing.
B. Physicians, healthcare providers, and healthcare facilities shall report within four calendar days the following tuberculin skin test (TST) or Interferon-Gamma Release Assay (IGRA) result if it occurs in a healthcare worker, correctional facility worker, or detention facility worker:; a positive TST (defined as = or > 5 mm induration); or positive IGRA test (based on manufacturer’s interpretation criteria) if the worker has had prolonged or frequent face-to-face contact with an infectious tuberculosis case.
C. Laboratories shall report within one working day any result diagnostic of or highly correlated with active tuberculosis disease, including culture and nucleic acid amplification tests (NAAT) positive for Mycobacterium tuberculosis (MTB) or similar confirmatory testing, and sputum smears positive for acid-fast bacilli. Laboratories shall report the results of tests for antimicrobial susceptibility performed on positive cultures for tuberculosis.
D. Results must be reported by the laboratory that 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. When a laboratory performs a culture that is positive for Mycobacterium tuberculosis, the laboratory shall submit a sample of the isolate to the Department, State Public Health Laboratory no later than one working day after the observation of positive findings.
F. The Department or county, district, or municipal public health agency 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 antimicrobial susceptibility test results are finalized. The Department or county, district, or municipal public health agency shall provide the laboratory and hospital the results of its evaluation, including comparison of the laboratory indices to norms for other similar laboratories.
G. The Board of Health determines that to prevent the emergence of multi-drug-resistant tuberculosis (MDR-TB), it is necessary, appropriate, and standard medical practice for persons with active tuberculosis disease to receive directly observed therapy (DOT) throughout the treatment for their disease. All healthcare providers and healthcare organizations are required to provide DOT 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 Department or tuberculosis clinic at the Public Health Institute at Denver Health. DOT is highly recommended as it remains standard practice, but is not required for patients with extrapulmonary tuberculosis disease, provided that the presence of pulmonary tuberculosis has been thoroughly investigated and excluded, including microscopy testing. In applicable situations, a variance shall be granted in accordance with § 25-4-506(3), C.R.S. Healthcare providers and healthcare organizations shall report to the Department or county, district, or municipal public health agency within seven calendar days the name of any patient on DOT who has missed one dose. When requested by healthcare providers and healthcare organizations, the county, district, or municipal public health agency will ensure the provision of DOT to outpatients with active tuberculosis disease and this shall fulfill the requirement for the healthcare providers and healthcare organizations.
H. All healthcare providers within all correctional and healthcare facilities providing inpatient testing or treatment to persons with suspected and confirmed active tuberculosis disease shall notify and include the Department or county, district, or municipal public health agency when they begin their discharge planning process and involve the Department or county, district, or municipal public health agency in the transition planning process prior to discharging the patient from the facility to ensure a safe and appropriate discharge plan is in place for the safety of the patient and the community. Public health will be involved in the discharge planning to ensure continuity of care, safe discharge for the patient and community, appropriate medication regimen, arrangement of home visits, and directly observed therapy.
I. All licensed hospitals and nursing home facilities shall maintain a registry of the TST and/or IGRA test results of healthcare 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 TST and IGRA test results as confidential medical information. Pursuant to § 25-4-508, C.R.S., authorized personnel of the Department may inspect and have access to such a register in the course of an investigation intended to identify sources and contacts of a case of active tuberculosis disease and to control tuberculosis. J.
A. Review of pertinent, relevant medical records by authorized personnel, if necessary to confirm the diagnosis; to investigate causes; to identify other cases related to the outbreak or the reported communicable disease in a region, community, or workplace; to determine if a patient with a reportable disease has received adequate treatment to render the person non-infectious or a person exposed to a case has received prophylaxis, if appropriate. Such review of records may occur without patient consent and shall be conducted at reasonable times and with such notice as is reasonable under the circumstances. Such review of records may include negative or inconclusive laboratory results. Where feasible, facilities are encouraged to provide remote electronic access to authorized health department staff for this purpose.
B. Performing follow-up interview(s) with the case or persons knowledgeable about the case to collect information pertinent and relevant to the cause(s) of or risk factors for the reportable condition.
C. Medical examination and testing of persons with the explicit consent of such persons.
D. Obtaining from public or private businesses or institutions the lists of persons with a similar or common potential exposure to a reported case; such exposure may be current or have occurred in the past.
E. Interviewing or administering questionnaire surveys confidentially to any resident of a community or any agent, owner, operator, employer, employee of a public or private business or institution, that is either epidemiologically associated with a reported case or has had a similar exposure as a reported case.
F. Collecting and analyzing samples or measurements of items that may be related to the cause of the outbreak or reportable disease.
G. Taking photographs or videos related to the purpose of the investigation. If the photographs/videos are taken in a business, the employer shall have the opportunity to review the photographs/videos taken or obtained for the purpose of identifying those which contain or might reveal a trade secret.
H. Entering a public or private entity, such as a business or school, for the purpose of conducting investigations of those processes, conditions, structures, machines, apparatus, devices, equipment, records (including but not limited to current and former employee/student rosters and contact information, schedules, health and medical information, job duties and descriptions, and patron or client contact information), and materials and supplies within the place of employment which are relevant, pertinent, and necessary to the investigation; such investigations shall be conducted during regular working hours or at other reasonable times and with such notice as is reasonable under the circumstances.
I. Review of workers' compensation claims.
J. Review of toxic tort or product liability claims filed with state or federal courts within the state.
K. Review of previously conducted environmental or product sampling data that may be related to the cause of the outbreak or reportable disease.
Regulation 6. Information Sharing Whenever a county, district, or municipal public health agency learns of a case of a reportable disease or an epidemic or communicable disease exposure potentially threatening to public health, it shall notify the Department or the local jurisdiction in which the case resides in a timely manner, usually within the timeframe for reporting in Regulation 1 and Appendix A. Utilizing the statewide disease reporting system developed and in use by the Department and county, district, and municipal public health agencies fulfills the notification requirement.
The Department shall, in turn, notify the appropriate county, district, or municipal public health agency in a timely manner, usually within the timeframe for reporting in Regulation 1 and Appendix A, whenever it learns of a case of a reportable disease or of an epidemic or communicable disease exposure potentially threatening to public health in the local agency’s jurisdiction. Utilizing the statewide disease reporting system developed and in use by the Department and county, district, and municipal public health agencies fulfills the notification requirement.
These requirements shall not apply if the Department and county, district, or municipal public health agencies mutually agree not to share information on reported cases. Sharing of medical information on persons with reportable diseases between authorized personnel of the Department and county, district, or municipal public health agencies shall be restricted to information necessary for the treatment, control, investigation, and prevention of epidemic and communicable diseases dangerous to public health.
Regulation 7. Food Handling and Infected Persons No person, while infected with a disease in a communicable form that 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 Department. 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 public health such as rabies, anthrax, plague, tularemia, encephalitis, bovine spongiform encephalopathy, coronaviruses that cause novel or severe human disease, including SARS-CoV-2, novel influenza viruses, etc., shall promptly report the facts to the Department or county, district, or municipal public health agency.
B. Pursuant to § 25-4-607 (2), C.R.S., 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 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 their 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 their designee(s) may refer the case to the Board of Veterinary Medicine. Regulation 9. Confidentiality All personal medical records and reports held or viewed by the Department or county, district, or municipal public health agency in compliance with these regulations shall be confidential information subject to §§ 25-1-122(4) and 25-4-406(1), C.R.S. This information is to be used by the public health agencies as source material for necessary disease control efforts and the development of prevention programs.
Regulation 10. Use of Sterile Needles, and Cleaning and Disinfection of Other Instruments, Probes, and Devices Used by Practitioners of Acupuncture and Adjunctive Therapies (promulgated by the Executive Director)
This regulation is promulgated pursuant to § 12-200-1115, C.R.S., which states the Department shall promulgate rules relating to the proper use of sterile needles used in the practice of acupuncture and the sanitation of acupuncture offices.
All parts of the premises of an acupuncture establishment shall be kept in a clean, sanitary, neat, and orderly condition at all times. All surfaces (e.g., tables, counters, chairs, etc.) used in connection with procedures shall be cleaned and disinfected with a disinfectant registered by the U.S. Environmental Protection Agency (EPA) that is approved for use in healthcare settings. Cleaning and disinfection shall occur following each use and according to the disinfectant manufacturer label instructions. Puncturing devices shall be defined as any needle, instrument, probe, or other devices utilized by practitioners of acupuncture, or adjunctive therapies, that punctures the skin or enters tissue of any patient/client. Needles and other puncturing devices shall be sterile and disposable single-use items that are appropriately discarded immediately after use in an appropriate sharps container, and shall never be used on more than one patient/client. The Food and Drug Administration (FDA) requires that sterile needles be used and always labeled for single patient use. Equipment shall be defined as any item utilized by practitioners of acupuncture, or adjunctive therapies, that serve as vehicles for needles or other puncturing devices. These items do not puncture the skin or enter the tissue. Equipment shall either be disposable, single-use items (preferred), or thoroughly cleaned and disinfected between each patient/client use according to the manufacturers’ instructions. If there are no manufacturers’ instructions for how to clean and disinfect the equipment, the equipment shall not be used on more than one patient and disposed of properly. Acupuncture and adjunctive therapies where sterile needles and puncturing devices are used shall only be performed by licensed practitioners. Prior to and after each treatment of acupuncture, the practitioner shall perform hand hygiene by either washing their hands with soap and water or using an alcohol-based hand sanitizer.
Regulation 11. Sexually Transmitted Infections The Board of Health recognizes that non-sexual transmission may occur for some infections, and in individual cases, based on clinical and epidemiologic information, the responsible physician or other healthcare provider may conclude the patient’s infection was not sexually acquired. Information concerning testing, treatment, causes, or the prevention of sexually transmitted infections (STIs) shall be shared, to the minimum extent necessary to achieve the public health purpose, between the appropriate county, district, or municipal public health agency, contracted agency, Ryan White Comprehensive Human Immunodeficiency Virus (HIV) Resources Emergency Act-funded agency, other health agency or person providing direct services related to STIs and the Department, as provided by § 25-4-406(1)(b), C.R.S.
With respect to Regulation 5, investigations related to STIs will be limited to the information necessary to confirm the diagnosis, treatment, source of infection, and identification of measures that may be used to prevent additional STIs. The Department shall destroy personal identifying information of all persons with CD4 or viral load results if the investigation subsequent to the report finds no evidence of a STI. Section 25-4-411 (1)(a), C.R.S., requires the Department to conduct an anonymous counseling and testing program for persons considered to be at high risk for the acquisition of HIV. The provision of confidential counseling and testing for HIV is the preferred screening service for detection of HIV infection. Local boards of health who provide HIV counseling and testing through a contractual agreement with the Department shall consider the need for an anonymous HIV testing option in their jurisdiction, upon petition. The consideration of this option must provide an opportunity for public comment in a public forum, including anonymous testimony presented in writing or through an organization. Local boards of health electing to provide confidential HIV testing with an anonymous option must do so in conjunction with publicly-funded HIV testing and counseling projects. Operational Standards A. All persons providing HIV testing and counseling at a publicly funded HIV testing and counseling project in a non-health-care setting will have completed an HIV testing and counseling course approved by the Department.
B. All persons performing partner services will have completed courses concerning introduction to STI interviewing and partner notification, and other related courses as specified by the Department.
C. Of all HIV tests performed at a publicly funded HIV testing and counseling project, 99% of those persons testing HIV positive will receive test results and appropriate post-test counseling related to those test results. Publicly funded HIV testing sites shall make a good faith effort to inform all persons of their test results and shall provide pertinent HIV prevention counseling and referrals.
D. All persons newly diagnosed with HIV will be referred for partner services and assessed for linkage to care services. A minimum of 75% of those offered partner services will receive an interview and appropriate referrals. Partner services standards will be determined by the best practices guidance and code of conduct standards for STI prevention providers developed by the Department. These standards shall be made publicly accessible.
E. Operational and evaluation standards for HIV testing and counseling sites will be determined by the best practices guidance developed by the Department.
F. In accordance with § 25-4-404(2), C.R.S., the Department shall create and maintain guidelines, subject to approval by the Board of Health, concerning the public health procedures described in §§ 25-4-412 and 25-4-413, C.R.S. These guidelines will include code of conduct standards for the delivery of partner services and clients’ rights, responsibilities and protections. Regulation 12. Congenital Syphilis All healthcare facilities and providers including but not limited to, hospitals, urgent care clinics, community health clinics, freestanding emergency departments, medical offices, correctional facilities, and licensed medical professionals that medically evaluate and treat anyone who is pregnant for any reason shall take all necessary steps to offer syphilis testing using a standardized algorithm for all patients in their care who are pregnant, unless a documented syphilis test has already occurred that meets the requirement or the patient declines testing, in each circumstance that follows:
A. During the first trimester of pregnancy or at the patient’s initial prenatal visit.
B. During the third trimester of pregnancy (between 28 - 32 weeks gestational age or up to 32 weeks gestational age).
C. At the time of delivery.
D. When there is a fetal death after 20 weeks' gestation. Appendix A. Reportable Diseases, Conditions, and Related Events Table Disease/Event Pathogen/Organism Time* Reporter1 Specimen Send Clinical Source(s)2 Material3 Acinetobacter baumannii, Carbapenem-resistant Acinetobacter baumannii 4 days L All Required carbapenem-resistant (CRAB)4 (species in the A.baumannii complex, e.g., A. baumanii, A. calcoaceticus, A. lactucae, A.
Acute flaccid myelitis 4 days P Upon request Amebae, free-living Acanthamoeba spp. (excluding keratitis), 4 days L & P All Required Balamuthia mandrillaris, Naegleria fowleri Animal bites and exposures 5,6 24 hrs P Not applicable Bites: by dogs, cats, bats, skunks, foxes, raccoons, coyotes, or other wild carnivores Exposures: any bat exposure Animal bites by mammals not listed 4 days P Not applicable above5 Anthrax5 Bacillus anthracis Immed L & P All Required Arboviral Disease Eastern equine encephalitis, Japanese 4 days L All Upon request encephalitis, LaCrosse encephalitis virus, California encephalitis serogroup, Powassan virus, St. Louis encephalitis virus and Western equine encephalitis virus Bioterrorism agent or incident, known Any pathogen Immed L & P All Required or suspected Blastomycosis Blastomyces species 4 days L & P All Upon request Botulism5 Clostridium botulinum Immed L & P All Upon request Brucellosis5 Brucella species 4 days L & P All Required Campylobacteriosis Campylobacter species 4 days L & P All Upon request Candida auris7 Candida auris 1 working L & P All Required day Candidemia8-Metro Candida species 30 days L Blood Upon request Carbapenemase-producing Positive phenotypic test for carbapenemase 1 working L All Required organisms9 production or detection of a carbapenemase day gene Chagas disease Trypanosoma cruzi 4 days L & P All Upon request Chancroid Haemophilus ducreyi 4 days L & P All Upon request Chikungunya Chikungunya virus 4 days L All Upon request Chlamydia, any site Chlamydia trachomatis 4 days L & P All Upon request Cholera5 Vibrio cholerae Immed L & P All Required Creutzfeld-Jakob Disease (CJD) and 4 days P All Upon request other transmissible spongiform encephalopathies (TSEs)5 Clostridioides difficile8-Metro 10 Clostridioides difficile 30 days L All Upon request Coccidioidomycosis Coccidioides species 4 days L & P All Upon request Colorado tick fever Colorado tick fever virus 4 days L All Upon request Disease/Event Pathogen/Organism Time* Reporter1 Specimen Send Clinical Source(s)2 Material3 COVID-1911 • SARS-CoV-2 (positive molecular and 4 days L (ELR only) All Upon request rapid antigen tests)
Cryptosporidiosis Cryptosporidium species 4 days L & P All Upon request Cyclosporiasis Cyclospora species 4 days L & P All Upon request Congenital cytomegalovirus (CMV) if Cytomegalovirus (positive results) 4 days L & P All Upon request <1 year of age Congenital cytomegalovirus (CMV) if CMV DNA by NAAT or culture (negative results) 4 days L (ELR only) Urine Upon request <1 year of age Dengue Dengue virus 4 days L All Upon request Diphtheria5 Corynebacterium diphtheriae Immed L & P All Required Encephalitis5 4 days P All Upon request Enterobacterales, carbapenem- Carbapenem-resistant Enterobacterales 4 days L All Required resistant (CRE)12 including, but not limited to, Escherichia species, Klebsiella species, Enterobacter species Citrobacter species, Serratia species, Raoultella species, Providencia species, Proteus species, Morganella species Enterobacterales, extended-spectrum Escherichia species, Klebsiella species. 30 days L All Upon request beta-lactamase (ESBL)8-Boulder,13 Raoultella species Escherichia species, coli invasive Escherichia species 30 days L Sterile only Upon request infections8-Boulder Escherichia coli O157:H7 and Shiga Shiga toxin-producing Escherichia coli14 4 days L & P All Required toxin-producing Escherichia coli Giardiasis Giardia lamblia 4 days L & P All Upon request Glanders Burkholderia mallei 1 working L & P All Upon request day Gonorrhea, any site, including Neisseria gonorrhoeae 4 days L & P All Upon request disseminated gonorrhea Group A streptococci15,8-Metro Streptococcus pyogenes 4 days L Sterile only Required Group B streptococci8-Metro Streptococcus agalactiae 30 days L Sterile only Required Haemophilus influenza Haemophilus influenzae 1 working L & P Sterile only Required day Hantavirus disease5 Hantavirus 4 days L & P All Upon request Healthcare-associated infections16 30 days P Not applicable Hemolytic uremic syndrome if <18 4 days P Upon request years of age5 Disease/Event Pathogen/Organism Time* Reporter1 Specimen Send Clinical Source(s)2 Material3 Hepatitis A5 • Hepatitis A virus (+IgM anti-HAV, +PCR or 1 working L & P All Upon request +NAAT) day • Liver function test values for AST, ALT, and total bilirubin that were performed at or closest to the time of the positive hepatitis A result Hepatitis B • Hepatitis B virus (+HBsAg, +IgM anti-HBc, 4 days L & P All Upon request +HBeAg, or +HBV DNA)
Hepatitis B in children <3 years of age HBsAg and anti-HBs positive, negative, and 4 days L All Upon request inconclusive lab results Hepatitis C17 • Hepatitis C virus (+ serum antibody titer 4 days L & P All Upon request and/or + confirmatory assays)
Hepatitis D Hepatitis D virus (+anti-HDV IgM, +anti-HDV 4 days L & P All Upon request total, +HDAg, +HDV DNA, or +HDV RNA)
Hepatitis, other viral • Positive results 4 days P Upon request • Liver function test values for AST, ALT, and total bilirubin Histoplasmosis Histoplasma species 4 days L & P All Upon request Human immunodeficiency virus (HIV)/ • Human immunodeficiency virus 4 days • L & P All Upon request acquired immunodeficiency syndrome • CD4 counts (any value) • L & P (AIDS) • HIV viral load (any value) • L & P • HIV genotype • L Influenza11 • Influenza virus (positive molecular and 4 days L (ELR only) All Upon request rapid antigen tests)
Mpox (monkeypox) Mpox virus (orthopox virus) 1 working L & P All Upon request day Multisystem Inflammatory Syndrome in 4 days P Upon request Children (MIS-C) if <21 years Mumps5 Mumps virus (acute infection) 4 days L & P All Upon request Mycobacterium, nontuberculous Mycobacterium species (except tuberculosis 30 days L All Upon request (NTM) 8-Metro complex, M. leprae, and M. gordonae)
Outbreaks - known or suspected of all Any pathogen Immed L & P Upon request types - including those transmitted from food, water, animals, vectors, environmental contamination, person- to-person, and related to a healthcare setting5 Pertussis (whooping cough)5 Bordatella pertussis 1 working L & P All Upon request day Plague5 Yersinia pestis Immed L & P All Required Poliomyelitis5 Poliovirus Immed L & P All Upon request Pseudomonas, carbapenem- Pseudomonas aeruginosa 4 days L All Upon request resistant20 Psittacosis Chlamydia psittaci 4 days L & P All Upon request Q fever5 Coxiella burnetii 4 days L & P All Upon request Rabies: human (suspected)5 Rabies virus (Lyssavirus) Immed L & P All Upon request Respiratory syncytial virus (RSV)11 • Respiratory syncytial virus (positive 4 days L (ELR only) All Upon request molecular and rapid antigen tests)
Tularemia5 Francisella tularensis 1 working L & P All Required day Typhoid fever5 Salmonella Typhi 1 working L & P All Required day Varicella (chicken pox)5 Varicella virus 4 days L & P All Upon request Vibriosis Vibrio species, non-cholera 4 days L All Required Viral hemorrhagic fever Crimean-Congo hemorrhagic virus, Ebola virus, Immed L & P All Required Lassa fever virus, Lujo virus, Marburg virus, Guanarito virus, Junin virus, Machupo virus, Sabia virus, Rift Valley fever West Nile virus (acute infection) West Nile virus 4 days L All Upon request Yellow fever Yellow fever virus 4 days L All Upon request Yersiniosis8-Seven Yersinia non-pestis species 4 days L All Required Zika virus Zika virus 4 days L All Upon request All cases are to be reported with patient's name, date of birth, sex assigned at birth, race, ethnicity, phone number, physical address (including city and county), email address, preferred language and name and address and phone number of responsible physician or other healthcare provider; and such other information as is needed in order to locate the patient for follow up. The patient’s pregnancy status shall be reported for cases of syphilis, HIV, hepatitis B and hepatitis C. In addition, all laboratory information reported shall include specimen accession number.
*Time: 1) “Immed” = by phone, within 4 hours of suspected diagnosis. 2) Unless the term “working day” is specified, “days” refers to calendar days.
1 Reporter: The party responsible for reporting is indicated by one of the following: L = Laboratory (whether or not associated with a hospital; by out-of-state laboratories that maintain an office or collection facility in Colorado or arrange for collection of specimens in Colorado; and by in-state laboratories which send specimens to an out-of- state laboratory referral laboratory), P = healthcare provider or other person knowing of or suspecting a case (including but not limited to coroners, persons in charge of hospitals or other institutions licensed by the Department (or their designees), persons in charge of schools (including nursing staff) and licensed child care centers), L & P = Both.
2 Specimen sources: A condition is reportable when the pathogen is isolated or detected from any specimen source unless otherwise indicated. A normally “sterile site” is defined as blood, cerebrospinal fluid (CSF), pleural fluid (includes chest fluid, thoracentesis fluid), peritoneal fluid (includes abdominal fluid, ascites), pericardial fluid, bone (includes bone marrow), joint or synovial fluid, needle aspirate or culture of any specific joint, internal body sites (sterilely obtained from biopsy/tissue/abscess/ aspirate/fluid/swab from lymph node, brain, heart, liver, spleen, vitreous fluid, kidney, pancreas, vascular tissue, or ovary). Skin and skin abscesses are not considered sterile sites.
3 Testing laboratories shall routinely submit bacterial culture isolates or patient clinical material that yields positive findings to the Department, State Public Health Laboratory. The isolate or clinical material shall be received at the Department, State Public Health Laboratory no later than one working day after the observation of positive findings. Clinical material is defined as: (i) A culture isolate containing the infectious organism for which submission of material is required, or (ii) If an isolate is not available, material containing the infectious organism for which submission of material is required, in the following order of preference: (A) a patient specimen; (B) nucleic acid; or (C) other laboratory material. All specimens shall be accompanied by the following information:
4 Acinetobacter baumannii (including species in the A. baumannii complex, e.g., A. baumannii, A. calcoaceticus, A. lactucae, A. nosocomialis, A. pittii, A. seifertii, etc.) that are resistant to at least one carbapenem (including imipenem, meropenem, or doripenem). 5 Report shall be based on the diagnosis or suspected diagnosis of the attending physician or other healthcare provider, whether or not supporting laboratory data are available. 6 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 healthcare provider or reporter.
7 Candida auris identified, or any suspected Candida auris. Clinical material may not be available for screening tests.
8 Condition reportable only among residents of a specific catchment area. 8-Metro Condition reportable only among residents of Denver Metropolitan Area (Adams, Arapahoe, Denver, Douglas, and Jefferson Counties)
10 Any positive tests shall be reported. All positive results from multi-step algorithms (including non- toxin detecting tests such as antigen tests (e.g., glutamate dehydrogenase or GDH, and cultures, etc.) shall also be reported, regardless of where the test falls within the algorithm. 11 All positive results for all test types including molecular tests, antigen tests, and sequencing lineage or mutation profile results are reportable. Positives will be reported by laboratories capable of electronic laboratory reporting (ELR) and only reported by ELR. Serology/antibody testing and at-home antigen tests are not reportable.
12 Enterobacterales including, but not limited to, Escherichia species, Klebsiella species, Enterobacter species, Citrobacter species, Serratia species, and Raoultella species that are resistant to at least one carbapenem (including imipenem, meropenem, doripenem, or ertapenem); or Providencia species, Proteus species, Morganella species that are resistant to at least one carbapenem (including meropenem, doripenem, or ertapenem; but not including imipenem); or Enterobacterales of any genus and species that test positive for production of carbapenemase (e.g., KPC, NDM, VIM, IMP, OXA-48, others). 13 Escherichia species, Klebsiella species, or Raoultella species resistant to at least one extended- spectrum cephalosporin (ceftazidime, cefotaxime or ceftriaxone) or Escherichia species, Klebsiella species, or Raoultella species that test positive for production of an extended-spectrum beta-lactamase (ESBL) demonstrated by a recognized test (e.g., broth microdilution, disk diffusion).
14 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 O157 should be reported.
15 If group A streptococci is isolated from a wound or surgical tissue/specimen and is accompanied by necrotizing fasciitis or streptococcal toxic shock syndrome, the case shall be reported and the isolate shall be submitted.
16 Reportable only by facilities that are voluntarily participating in applied public health projects. Appendix B includes a definition of healthcare-associated infections, a list of included infections, and a list of included health facility types.
17 All associated results, including negative (nonreactive) and positive (reactive) HCV confirmatory assays from persons who have been diagnosed with or who have laboratory evidence of HCV infection are reportable (e.g., antigen or nucleic acid amplification for HCV RNA [including qualitative, quantitative or genotype testing]). Negative HCV test results will be reported by laboratories capable of electronic laboratory reporting (ELR) and only reported by ELR. 18 Submission of urine specimens is not required. If respiratory samples are available on patients positive for legionellosis by urine antigen test, submit a respiratory sample. 19 Reporting requirement is fulfilled through the Department’s access to the National Healthcare Safety Network (NHSN) for those healthcare facilities that are required to report methicillin- resistant Staphylococcus aureus (MRSA) bacteremia to the Centers for Medicare & Medicaid services (CMS). In these instances these healthcare facilities shall confer rights to the Department to access the NHSN data for these conditions. 20 Pseudomonas aeruginosa resistant to at least one of the following carbapenems: imipenem, meropenem, or doripenem; OR P. aeruginosa that tests positive for production of a carbapenemase (i.e., KPC, NDM, VIM, IMP, OXA, others).
21 Staphylococcus aureus that are non-susceptible to vancomycin, which include isolates with minimum inhibitory concentration (MIC) of ≥4 mcg/ml.
22 Clinical material shall be submitted from laboratories when the material is from residents of the 5- county metro area (Adams, Arapahoe, Denver, Douglas and Jefferson counties). For Toxic Shock Syndrome, submission of Streptococcus pyogenes isolates from residents of the 5-county metro area is required.
23 All associated results for syphilis shall be reported for positive syphilis test findings including treponemal tests (Enzyme Immunoassay [EIA], Chemoluminescence Assay [CIA], Fluorescent Treponemal Antibody Absorption [FTA-ABS], Polymerase Chain Reaction [PCR], Multiplex Flow Immunoassay [MFI], Treponema pallidum Particle Agglutination [TP-PA], Treponema pallidum Antibody [TPA]) and Non-treponemal Tests (Rapid Plasma Reagin [RPR], Venereal Disease Research Laboratory [VDRL], Cerebrospinal Fluid [CSF] Quantitative Titers). Negative syphilis test results will be reported by laboratories capable of electronic laboratory reporting (ELR) and only reported by ELR.
24 Including (+) AFB sputum smear, culture (regardless of specimen site) and nucleic acid amplification tests (NAAT). See regulation 4f.
25 All positive interferon gamma release assays (IGRAs) will be reported by labs capable of electronic laboratory reporting (ELR), and only reported by ELR. Appendix B. Healthcare-Associated Infections Definition of a healthcare-associated infection: a localized or systemic condition that results from an adverse reaction to the presence of an infectious agent or its toxins that was not present or incubating at the time of admission to the health facility.
Examples of healthcare-associated infections include:
Bloodstream infections Bone and joint infections Cardiovascular system infections Central nervous system infections Eye, ear, nose, throat, or mouth infections Gastrointestinal system infections Pneumonia Reproductive tract infections Skin and soft tissue infections Surgical site infections Systemic infections Urinary tract infections Antimicrobial resistant infections Health facility types include:
Acute care hospitals Ambulatory surgical centers Birth centers Convalescent centers Dialysis treatment clinics/end-stage renal disease facilities Hospices Hospitals Inpatient rehabilitation facilities Long-term acute care hospitals Long-term care facilities Other hospitals (e.g., Psychiatric, Maternity, Specialty) Outpatient clinics (community clinics; community clinics with emergency centers; rural health clinics; outpatient rehabilitation facilities; outpatient physical therapy, occupational therapy or speech pathology services; and private physician offices)
_________________________________________________________________________ Editor’s Notes History Regulations 1, 3 eff. 05/30/2007.
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.
Regulations 1-4, 8, 10, Appendices A-B eff. 11/14/2015. Entire rule eff. 05/15/2017.
Entire rule eff. 07/15/2018.
Regulations 1, 4, 8.B, 9, 10 paragraph 1, 11, 11.F, Appendix A eff. 06/14/2019. Regulations 1, 3, 4, 5, 8, Appendix A eff. 10/15/2021.
Regulation 1, Appendix A emer. rules eff. 02/15/2023.
Regulations 1-5, 8, 10, 11, Appendices A, B eff. 06/14/2023. Entire rule eff. 01/14/2025.