Reporting and Testing of Infectious, Environmental, and Occupational Diseases (216-RICR-30-05-1)


216-RICR-30-05-1 ACTIVE RULE

1.1 Authority

These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.1 for the purpose of adopting prevailing standards for confidentiality and reporting of infectious, occupational, and environmentally related diseases in Rhode Island.

1.2 Incorporated Materials

A. These regulations hereby adopt and incorporate HIPAA Privacy Rule and Public Health: Guidance from CDC and the U.S. Department of Health and Human Services May 2, 2003/52 (S-1); 1-12. by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.

B. These regulations hereby adopt and incorporate The American Society of Microbiology Sentinel Level Clinical Laboratory Protocols for Suspected Biological Threat Agents and Emerging Infectious Diseases 2013 for Botulinum Toxin, Novel Influenza Viruses, Smallpox, and Staph Enterotoxin B by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.

C. These regulations hereby adopt and incorporate The American Society of Microbiology Sentinel Level Clinical Laboratory Protocols for Suspected Biological Threat Agents and Emerging Infectious Diseases 2016 for Bacillus anthracis, Brucella, Burkholderia (mallei and pseudomallei), Coxiella burnetii, Yersinia pestis, and Francisella tularensis by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.

D. These regulations hereby adopt and incorporate The American National Standards Institute CLSI M48-A “Laboratory Detection and Identification of Mycobacteria Approved Guideline” 2008 by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.

1.3 Definitions

A. "Asbestos" means that unique group of naturally occurring minerals that separate into fibers of high tensile strength, resistant to heat, wear, and chemicals, described as the following types: chrysotile, amosite, crocidolite, tremolite, anthopyllite, and actinolite, and every product containing any of these materials that have been chemically treated and/or altered which after manufacture are used for such products and end uses including but not limited to insulation, textiles, paper, cement, sheets, floor tile, wall covering, decorations, coating, sealants, cement pipe and reinforced plastics and other compounds.

B. "Asbestos-related disease" means any illness or disease, other than for benign conditions of the pleura, suspected of being related to asbestos exposure, including, but not limited to, mesothelioma, asbestosis, and lung cancer believed to be caused by asbestos exposure.

C. "Carrier" means a person or animal that harbors a specific infectious agent without discernible clinical disease and serves as a potential source of infection.

D. "Case" or "patient" means a person who is suspected or confirmed to be ill, infected, exposed to, or diagnosed with a reportable disease.

E. "Clinical laboratory" means a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, radiobioassay, cytological, pathological, genomic, or any other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings.

F. "Controlled substance" means a drug, substance, or immediate precursor in schedules I-V listed by R.I. Gen Laws Chapter 21-28.

G. “Culture Independent Diagnostic Test” (CIDT) means any laboratory assay that detects the molecular or antigenic signature of pathogens independent of generating an isolate, including but not limited to microscopy, immunoassays, and Nucleic Acid Amplification Test (NAAT)s.

H. "Diagnosis of AIDS" means the most current surveillance case definition for AIDS published by the Centers for Disease Control & Prevention (CDC).

I. "Diagnosis of HIV" means the most current surveillance case definition for HIV infection published by the CDC.

J. "Director" means the Director of Health or his/her designee.

K. "Disease report" means an official notice to the appropriate authority of the occurrence of a specified disease in humans or animals, in accordance with the requirements stated in these Regulations.

L. "Emergency service worker" means a worker responding on behalf of a licensed ambulance/rescue service, fire department, or law enforcement agency.

M. "Health care facility" means those facilities licensed by the Department in accordance with the provisions of R.I. Gen Law Chapter 23-17.

N. "Health care provider" means a physician, physician assistant, or certified nurse practitioner licensed to practice in Rhode Island.

O. "Infectious disease" means an illness due to a specific infectious agent or its toxic products that arises through transmission of that agent or its products from an infected person, animal, or inanimate reservoir to a susceptible host.

P. "Occupational disease" means a disease or condition which is believed to be caused or aggravated by conditions in the individual's workplace.

Q. "Occupational health representative" means an individual, within a health care facility, trained to respond to occupational, particularly blood borne, exposures.

R. “RIDOH” means the Rhode Island Department of Health.

S. "Surveillance" means the practice of monitoring the occurrence and spread of disease. Included are the systematic collection and evaluation of: morbidity and mortality reports; special reports of field investigations, epidemics and individual cases; isolations and identifications of infectious agents in laboratories; data concerning the availability and use of vaccines; immune globulin, pesticides and other substances used in disease control; information regarding immunity levels in segments of the population, and of other relevant epidemiologic data. The procedure applies to all jurisdictional levels of public health, from local to international.

1.4 Confidentiality Provisions

A. All information concerning cases or suspected cases shall be held in confidence in accordance with the provisions of R.I. Gen Laws § 5-37-3 and all other applicable state and federal statutes and regulations.

B. Pursuant to the HIPAA Privacy Rule, disclosures to RIDOH without individual authorization are permitted for the purpose of preventing or controlling disease, injury, or disability, including but not limited to public health surveillance, investigation, and intervention.

1.4.1 Persons and Entities Responsible for Reporting Diseases

A. The following individuals and entities attending the case or suspected case are required to report the diseases listed in § 1.5.3 of this Part:

1. Physicians

2. Physician assistants

3. Certified registered nurse practitioners

4. Clinical laboratories

5. Hospitals (from both inpatient and outpatient settings)

a. When a diagnosis or suspected diagnosis of a case is made within a hospital, the facility administrator, or his/her designee (e.g., infection control practitioner), must ensure the reporting of the case in accordance with the procedures outlined in these Regulations.

6. All other health care facilities, including but not limited to: organized ambulatory care facility, school-based health center, college/university- health center, freestanding emergency care facility, home care/home nursing care provider, hospice, birth center, nursing facility, rehabilitation hospital center, freestanding ambulatory surgical center, kidney disease treatment center, blood centers, and prison health services.

a. When a diagnosis or suspected diagnosis of a case is made within a licensed health care facility, the facility administrator or medical director, or his/her designee (e.g., infection control practitioner), must ensure the reporting of the case in accordance with the procedures outlined in these Regulations.

7. Veterinarians who have knowledge of: a single case of rare and/or unusual veterinary diagnosis that has the potential to cause illness in humans, or knowledge of outbreaks of unusual zoonotic vectorborne diseases that can cause illness in humans;

B. It is recommended that the following individuals and entities report the diseases listed in § 1.5.3 of this Part:

1. Certified school nurse-teachers who have knowledge of a single case of rare and/or unusual diagnoses, or knowledge of outbreaks of diseases;

2. Dentists who have knowledge of a single case of rare and/or unusual diagnoses, or knowledge of outbreaks of disease;

3. Other entities or persons (such as day care centers, drug treatment facilities, travel clinics, social service agencies that serve the homeless, camp counselors, funeral directors, transportation authority, assisted living facilities, community-based organizations that screen for infectious diseases, etc.) who have knowledge of a single case of rare and/or unusual diagnoses or knowledge of outbreaks of diseases.

C. Exemptions

1. Reporting of the diseases listed in § 1.5.3 of this Part shall not be required in the following cases:

a. In research protocols and all other situations where the person conducting the research or ordering the test is unaware of the identity of the person being tested.

b. Anonymous HIV testing

1.5 Timeframe, Methods, and Reportable Conditions

1.5.1 Timeframes

A. The lists cited in § 1.5.3 of this Part pertain to individuals and facilities required to report pursuant to § 1.4.1 of this Part. Cases due to the diseases listed below shall be reported to the RIDOH within the timelines indicated. Reportable diseases are grouped as follows:

1. Immediately reportable diseases shall be reported within twenty-four hours of recognition or strong suspicion of disease.

2. All other reportable conditions shall be reported within four days of recognition or suspicion.

1.5.2 Methods

A. Case reports must be submitted on a RIDOH case report form as specified by the RIDOH website. The minimal information required when submitting a case report form includes: disease being reported, patient’s full name, address, city, state, zip code, phone number, date of birth, gender, race and ethnicity, date of onset, and physicians’ name and phone number.

B. Clinical laboratories, including those outside of Rhode Island, performing examinations on any specimens derived from Rhode Island residents that yield evidence of infection due to the diseases listed in § 1.5.3 of this Part shall report such evidence of infection directly to RIDOH.

C. The minimal information required when submitting a laboratory report includes: a laboratory contact, test results, date of specimen collection, patient’s full name, date of birth, sex, address, patient’s phone number, and name of ordering health care provider.

D. Reporting methods include, but are not limited to the following:

1. Mail to: Rhode Island Department of Health, Division of Preparedness, Response, Infectious Diseases, and Emergency Medical Services, 3 Capitol Hill, Providence RI 02908-5097

2. Fax to RIDOH using fax numbers on the reporting forms.

3. Telephone: Between 8:30 am - 4:30 pm (Monday-Friday): (401) 222-2577. For telephone reporting for immediately reportable diseases after hours call (401) 272-5952.

4. Electronic reporting of clinical and laboratory results to RIDOH.

5. Organizations that house reportable disease data must allow RIDOH to access the database for data mining from various data sources, including, but not limited to: electronic laboratory reports, medical records, health information exchange feeds, syndromic surveillance feeds, immunization and other disease registries, and billing data.

1.5.3 Reportable Disease and Conditions

A. For the conditions listed below, invasive disease must be confirmed by isolation from blood, cerebral spinal fluid, pericardial fluid, pleural fluid, peritoneal fluid, joint fluid, urine, or other normally sterile site.

B. Pregnant women with a reportable infectious disease listed in § 1.5.3 of this Part that can be transmitted to the unborn child or infant must be reported within four days of recognition. For example, HIV, Zika, syphilis, Hepatitis B, Hepatitis C, rubella, etc.

C. If testing is positive for any of the reportable conditions listed below and is performed with a Culture Independent Diagnostic Test (CIDT), the laboratory must perform reflexive culture or transport the original specimen to another laboratory to perform culture. If the culture is positive, the isolate must be recovered and sent to the RI State Health Laboratories for those organisms as indicated in §§ 1.4.3(D) and (E) of this Part. Both positive and negative culture results must be reported to RIDOH.

D. Immediately Reportable Diseases and Conditions must be reported within 24 hours.

1. Animal bites

2. Anthrax (Bacillus anthracis and Bacillus cereus biovar anthracis)

a. Laboratories must submit isolate to the RI State Health Laboratories

3. Arboviral infections (e.g., West Nile, Eastern Equine Encephalitis, Powassan, Zika, Chikungunya, Yellow Fever)

4. Botulism (Clostridium botulinum)

a. Laboratories must submit the specimen to the RI State Health Laboratories

5. Brucellosis (Brucella species)

a. Laboratories must submit isolate to the RI State Health Laboratories

6. Cholera (Vibrio cholerae)

a. Laboratories must submit isolate to the RI State Health Laboratories

7. Ciguatera

8. Clostridium perfringens epsilon toxin

9. Diphtheria (Corynebacterium diptheriae)

a. Laboratories must submit isolate to the RI State Health Laboratories

10. Encephalitis (any infectious cause)

11. Glanders (Burkholderia mallei)

a. Laboratories must submit isolate to the RI State Health Laboratories

12. Hantavirus (All species)

13. Hepatitis A

a. Laboratories must report aspartate aminotransferase (AST), alanine aminotransferase (ALT), and Bilirubin Total and Bilirubin Direct

14. Measles (Rubeola)

a. Laboratories must submit the specimen to the RI State Health Laboratories

15. Melioidosis (Burkholderia pseudomallei)

a. Laboratories must submit isolate to the RI State Health Laboratories

16. Meningococcal Disease- invasive (Neisseria meningitidis)

a. Laboratories must submit isolate to the RI State Health Laboratories

17. Novel coronavirus

18. Outbreaks and clusters as defined in §1.5.4 of this Part

19. Paralytic shellfish poisoning

20. Plague (Yersinia pestis)

a. Laboratories must submit isolate to the RI State Health Laboratories

21. Poliomyelitis (polio virus)

22. Q-Fever (Coxiella burnetii)

a. Laboratories must submit specimen to the RI State Health Laboratories

23. Rabies (animal)

a. Laboratories must submit the animal to the RI State Health Laboratories

24. Rabies (human)

a. Laboratories must submit specimen to the RI State Health Laboratories

25. Ricin poisoning

26. Scombroid poisoning

27. Smallpox (Variola)

a. Laboratories must submit specimen to the RI State Health Laboratories

28. Staphylococcal enterotoxin B poisoning

29. Staphylococcus aureus invasive infections: Vancomycin Resistant Staphylococcus aureus (VRSA) or Vancomycin Intermediate Staphylococcus aureus (VISA)

a. Laboratories must submit isolate to the RI State Health Laboratories

30. Tularemia (Francisella tularensis)

a. Laboratories must submit isolate to the RI State Health Laboratories

31. Typhoid fever (Salmonella typhi)

a. Laboratories must submit isolate to the RI State Health Laboratories

32. Unexplained deaths (possibly due to unidentified infectious causes)

33. Vibriosis (all Vibrio species)

a. Laboratories must submit isolate to the RI State Health Laboratories

34. Viral hemorrhagic fevers (Ebola, Lassa, Marburg, etc.)

a. Laboratories must submit specimen to the RI State Health Laboratories

E. Other Reportable Conditions must be reported within four days

1. Acute Flaccid Myelitis

2. Anaplasmosis (Anaplasma phagocytophilium)

a. Laboratories must submit stained smear to the RI State Health Laboratories

3. Babesiosis (all species)

4. Campylobacteriosis (Campylobacter all species)

a. Laboratories must submit isolate to the RI State Health Laboratories

5. Carbapenem-resistant Gram-negative bacteria

a. Laboratories must submit isolate to the RI State Health Laboratories

6. Chancroid (Haemophilus ducreyi)

7. Chlamydia trachomatis (genital and ophthalmic)

8. Coccidioidomycosis (Coccidioides immitis)

9. Cryptosporidiosis (Cryptosporidium all species)

10. Cyclosporiasis (Cyclospora cayetanensis)

11. Dengue virus

12. Ehrlichiosis (Ehrlichia chaffeensis)

a. Laboratories must submit stained smear to the RI State Health Laboratories

13. Escherichia coli, Shiga toxin-producing (STEC)

a. Laboratories must submit isolate to the RI State Health Laboratories

14. Giardiasis (Giardia lamblia)

15. Gonorrhea (Neisseria gonorrhoeae)

16. Granuloma Inguinale (Klebsiella granulomatis)

17. Haemophilus influenzae disease, all serotypes- invasive

a. Laboratories must submit isolate to the RI State Health Laboratories

18. Hansen's disease or Leprosy (Mycobacterium leprae)

19. Hemolytic uremic syndrome (HUS)

20. Hepatitis B, C, D, E, and unspecified viral hepatitis

a. Laboratories must report all positive results

b. Laboratories must report aspartate aminotransferase (AST), alanine aminotransferase (ALT), and Bilirubin Total and Bilirubin Direct

c. Physicians must report all acute Hepatitis cases

d. Physicians must report pregnancy in a chronic Hepatitis B or Hepatitis C- positive woman using forms required by RIDOH

21. Human Immunodeficiency Virus (HIV) 1 and 2 /Acquired Immunodeficiency Syndrome (AIDS)

a. Laboratories must report every CD4 cell count and HIV viral load test result performed on an HIV-positive individual

b. Physicians must report pregnancy in an HIV-positive woman using forms required by RIDOH

22. Influenza associated deaths (all ages)

23. Influenza associated hospitalizations

24. Influenza novel virus infections

a. Laboratories much submit all unsubtypable Influenza A specimens
to the RI State Health Laboratories

25. Latent Tuberculosis Infection (LTBI) (Mycobacterium tuberculosis)

26. Legionellosis (Legionella pneumophila)

a. Laboratories must submit isolate to the RI State Health Laboratories

27. Leptospirosis (Leptospira interrogans)

28. Listeriosis- invasive (Listeria monocytogenes)

a. Laboratories must submit isolate to the RI State Health Laboratories

29. Lyme disease (Borrelia burgdorferi)

30. Lymphogranuloma Venereum (Chlamydia trachomatis)

31. Malaria (Plasmodium species)

a. Laboratories must submit stained smear to the RI State Health Laboratories

32. Meningitis (aseptic, bacterial, viral, or fungal)

33. Mumps (Paramyxovirus)

a. Laboratories must submit the specimen to the RI State Health Laboratories

34. Ornithosis/Psittacosis (Chlamydophila psittaci)

35. Pelvic inflammatory disease (PID): all cases, based upon clinical diagnosis

36. Pertussis (Bordetella pertussis)

37. Pneumococcal Disease- invasive (Streptococcus pneumoniae)

38. Rickettsiosis, including Rocky Mountain Spotted Fever (Rickettsia- all species)

39. Rubella (including congenital rubella)

a. Laboratories must submit the specimen to the RI State Health Laboratories

40. Salmonellosis (Salmonella- all species)

a. Laboratories must submit isolate to the RI State Health Laboratories

41. Shigellosis (Shigella- all species)

a. Laboratories must submit isolate to the RI State Health Laboratories

42. Streptococcal Disease-Group A- invasive

a. Laboratories must submit isolate to the RI State Health Laboratories

43. Streptococcal Disease- Group B- invasive

44. Streptococcal Toxic Shock Syndrome (Streptococcus pyogenes)

45. Syphilis- all stages including neurosyphilis and congenital syphilis (Treponema pallidum)

46. Tetanus (Clostridium tetani)

47. Toxic Shock Syndrome (non-Streptococcal)

48. Transmissible spongiform encephalopathies (including Creutzfeldt Jakob Disease)

49. Trichinosis (Trichinella species)

50. Tuberculosis Disease (Mycobacterium tuberculosis)

a. Laboratories must submit isolate to the RI State Health Laboratories

51. Varicella (Varicella-Zoster virus)

52. Yersiniosis (Yersinia enterocolitica)

a. Laboratories must submit isolate to the RI State Health Laboratories

1.5.4 Reporting of Outbreaks

A. Any person or entity who is required to report and has knowledge of an outbreak of infectious disease or a cluster of unexplained illness, infectious or non-infectious, whether or not listed in these regulations, shall immediately report the facts to RIDOH.

B. Outbreaks required to be reported include, but are not limited to:

1. Exotic diseases and unusual group expressions of illness which may be of public health concern.

2. A single case of a disease long absent from a population or the first invasion by a disease not previously recognized in that area.

3. Outbreaks or clusters identified by significant increases in the usual occurrence of the disease in the same area, among the specified population, at the same season of the year.

4. The occurrence of two or more cases of a similar illness resulting from the ingestion of a common food or water source.

5. A cluster of similar illness in institutional settings, including but not limited to nursing homes, hospitals, schools, and day care centers.

6. A single case of rare and/or unusual diagnoses, including but not limited to avian influenza, smallpox, Ebola, SARS, Zika, Borrelia miyamotoi, Candida auris, or human rabies.

7. Outbreaks of unusual diseases or illness that may indicate acts of terrorism using biological agents, including but not limited to anthrax and botulism. See complete list of biological agents in § 1.7.2(A)(1) of this Part.

8. Any condition compatible with exposure to nuclear, radiological, or chemical substances, which could be indicative of radiological or chemical terrorism events.

9. Clusters of overdoses or adverse reactions to a drug, whether prescription or illicit.

1.6 Special Disease Surveillance Projects

A. Reporting will be required for surveillance related to special and/or complex surveillance systems (e.g., Zika, latent TB infection, influenza, new and emerging disease threats, and evaluation and validation projects related to surveillance) at the discretion of RIDOH.

B. Reporting will be required for any additional surveillance systems that are developed and implemented to prepare for or respond to public health threats at the discretion of RIDOH at any time.

1.7 Instructions for Laboratories

1.7.1 General Instructions

A. Whenever a RI licensed clinical laboratory performs tests or has the sample(s) tested out of state for those diseases cited in § 1.5.3 of this Part, the laboratory shall submit to RIDOH all positive findings.

B. Negative laboratory results for those diseases cited in § 1.5.3 of this Part, must be reported for public health surveillance and investigation purposes at the discretion of RIDOH.

C. The report shall consist of a copy of the laboratory findings submitted to the physician or other licensed health care provider who ordered the test. This report shall indicate the name of the case, address of the case, gender, date of birth, telephone number, race, ethnicity, and name of attending physician.

D. All genotyping, molecular detection, and phylogenetic testing results on reportable conditions must be reported to RIDOH.

1.7.2 Reporting of Agents of Bioterrorism

A. An immediate report must be made to RIDOH by telephone when an ordering provider requests a test for a potential agent of bioterrorism. After normal business hours, the RIDOH’s after-hours on-call physician must be informed.

1. Potential agents of bioterrorism are:

a. Anthrax (Bacillus anthracis)

b. Botulism (Clostridium botulinum)

c. Brucellosis (Brucella species)

d. Clostridium perfringens epsilon toxin

e. Glanders (Burkholderia mallei)

f. Melioidosis (Burkholderia pseudomallei)

g. Plague (Yersinia pestis)

h. Q-fever (Coxiella burnetii)

i. Ricin Poisoning

j. Smallpox (Variola)

k. Staphylococcal enterotoxin B poisoning

l. Tularemia (Francisella tularensis)

m. Viral hemorrhagic fevers (Ebola, Lassa, Marburg, etc.)

2. Clinical laboratories that isolate a potential agent of bioterrorism from a clinical specimen shall perform testing in accordance with the most current American Society of Microbiology (ASM) Sentinel Laboratory protocol as incorporated in §§ 1.2(B) and (C) of this Part, and, if unable to definitively rule out the agent, must submit the isolate to the RI State Health Laboratories for confirmation or further testing.

1.7.3 Reporting of Acid Fast Bacilli (AFB) and Mycobacterium tuberculosis (MTB)

A. Clinical laboratories receiving clinical specimens for the purposes of performing testing for the presence of Acid Fast Bacilli (AFB) or Mycobacterium tuberculosis (MTB) testing must submit a specimen to the RI State Health Laboratories for analysis.

1. This requirement is waived for a RI licensed hospital laboratory, provided a written memorandum of agreement is in place between the State Health Laboratories and the hospital laboratory.

2. In order to obtain a memorandum of agreement, a hospital laboratory’s mycobacteriology testing methodology and practice must be consistent with national consensus standards as incorporated in § 1.2(D) of this Part.

a. Licensed hospital laboratories that have a written memorandum of agreement with the State Health Laboratories and are performing MTB testing by any methodology shall report all positive results to RIDOH.

b. Positive culture results on an individual must be accompanied by all prior AFB smear results performed by the respective laboratory, and associated with the current episode of illness, whether positive or negative.

B. As part of LTBI surveillance, Interferon Gamma Release Assay (IGRA) positive results must be reported.

1.7.4 Reporting Perinatal Exposure to HIV

Persons and entities described in § 1.4.1 of this Part must report all positive and negative HIV virologic laboratory tests on infants, zero through 12 months of age.

1.8 Reporting of Environmental Exposures and Occupational Diseases

1.8.1 Persons and Entities Attending the Case or Suspected Case Responsible for Reporting Environmental Exposures and Occupational Diseases

A. Physicians

B. Physician assistants

C. Certified registered nurse practitioners

D. Clinical laboratories

E. Hospitals (from both inpatient and outpatient settings)

1. When a diagnosis or suspected diagnosis of a case is made within a hospital, the facility administrator, or his/her designee (e.g., infection control practitioner), must report occupational diseases and exposures.

1.8.2 Environmental Exposures and Occupational Diseases that Must be Reported

A. Diseases diagnosed related to exposure to:

1. Arsenic

2. Asbestos

3. Beryllium

4. Cadmium

5. Carbon monoxide

6. Lead

7. Mercury

B. Any of the following occupational diseases:

1. Chemical Pneumonitis

2. Metal fume fever

3. Simple asphyxiation

4. Silicosis

C. Any cluster of occupational disease.

1.8.3 Methods and Timeframes for Reporting

A. Reporting of Asbestos-related Diseases

1. Mail report of diagnosis to RIDOH’s Center for Healthy Homes and Environment, 3 Capitol Hill, Providence, RI 02908-5097, within six months of diagnosis.

2. Send the patient or next of kin a dated notification of the suspected role of asbestos as it relates to the patient's condition within six months of diagnosis by certified mail with a return receipt requested.

B. Reporting of Non-occupational Acute Carbon Monoxide Poisoning

1. Submit the CO Poisoning Reporting form to RIDOH’s Center for Healthy Homes and Environment according to the instructions on the form within four working days following diagnosis.

C. Reporting of Childhood Lead Poisoning and Exposure Results

1. Childhood blood lead sample results shall be reported to RIDOH’s Center for Healthy Homes and Environment in accordance with the specifications in RIDOH’s Lead Poisoning Prevention regulation (Part 50-15-3 of this Title).

D. Reporting of Blood Lead Sample Results and all other Environmental Exposures and Occupational Diseases

1. Submit all blood lead sample results to RIDOH’s Center for Healthy Homes and Environment.

2. For all other environmental exposures and occupational diseases, submit the Environmental Exposure and Occupational Disease reporting form to RIDOH’s Center for Healthy Homes and Environment within 30 days following diagnosis according to the instructions on the form.

E. Clinical laboratories shall submit the results of biomonitoring tests for evaluating environmental or occupational exposures to RIDOH electronically or in hard copy.



Title 216 Rhode Island Department of Health
Chapter 30 Infectious Diseases
Subchapter 05 Infectious Diseases
Part 1 Reporting and Testing of Infectious, Environmental, and Occupational Diseases (216-RICR-30-05-1)
Type of Filing Adoption
Regulation Status Active
Effective 03/22/2018

Regulation Authority :

R.I. Gen. Laws §23-1.1

Purpose and Reason :

In accordance with the Administrative Procedures Act, R.I. Gen. Laws Section 42-35-3(a)(1), the following is a concise statement regarding this rulemaking for the rules and regulations for Reporting and Testing of Infectious, Environmental, and Occupational Diseases (216-RICR-30-05-1). This adoption consolidates the Rules and Regulations Pertaining to the Reporting and Testing of Infectious, Environmental, and Occupational Diseases [R23-10-DIS] and the Rules and Regulations Pertaining to HIV Counseling, Testing, Reporting, and Confidentiality [R23-6.3-HIV], into one set of regulations, provides clarity, updates the list of reportable diseases, and removes any language that duplicates existing statute without additional interpretation. This consolidation is meant to delineate the reporting and testing of infectious, environmental, and occupational diseases of public health importance. Section 1.3(G) of the regulations has been revised to include the full name of the Nucleic Acid Amplification Test for clarity. Section 1.4(B) has been revised to clarify disclosure of information to RIDOH. Section 1.5.3(D)(2) has been revised to include an additional species of anthrax required to be reported. Section 1.5.3(D)(3) was revised to remove superfluous language. Section 1.5.3(E)(11) was revised to reflect the correct terminology for Dengue virus. Section 1.5.3(E)(27) was revised to reflect the correct species of leptospirosis that must be reported. Section 1.5.4(B)(6) was revised to include Candida auris as an example of a reportable rare/unusual diagnosis. Section 1.6 was revised to clarify evaluation and reporting for additional surveillance systems developed by RIDOH. Section 1.7.1(B) was revised to clarify the applicability of the requirement to diseases referenced in section 1.5.3 of the regulations. Section 1.7.3(A)(2) was revised to correct a citation to section 1.2(D) of the regulations. RIDOH has determined that these revisions implemented in the final rule are consistent with, and a logical outgrowth of, the rule proposed in the public comment notice issued for these regulations. In response to public comment, sections 1.4.1(A) and 1.8.1 were revised to clarify the applicability of the requirement to individuals and entities attending the case or suspected case, and add college/university health centers to the list of health care facilities listed in 1.4.1 which must report. Additionally, a new section was created for 1.4.1(B), specifying that the entities listed therein are recommended to report diseases listed in section 1.5.3 In response to public comment, section 1.5.3(E)(21) was revised to eliminate the requirement for submission of original HIV/AIDS specimens to the RI State Health Laboratory, and section 1.5.3(E)(24) was revised to include submission of unsubtypable Influenza A specimens to the RI State Health Laboratory. In response to public comment, section 1.8.2(A) and 1.8.2(B) were revised to include, respectively, diseases diagnosed related to exposure to beryllium and chemical pneumonitis. During public comment, it was suggested that section 1.8.2(B) be revised to require the reporting of the following occupational diseases: occupational asthma, occupational lung disease with special emphasis on Flock Lung Disease, cumulative trauma disorders, occupational hearing disorders, occupational skin disease, disease related to chemical exposures, and diseases related to exposure to nanoparticles. In response to this suggestion, RIDOH has revised section 1.8.2(A) to include diseases related to exposure to beryllium, and has revised section 1.8.2(B) to include chemical pneumonitis. However, RIDOH has determined that the additional suggested occupational diseases were non-specific in nature and would create overly broad categories of diseases, the reporting of which would incur a burdensome cost to regulated entities and could lead to confusion as to what is an appropriately reportable condition. Therefore, RIDOH has determined not to implement these additional suggested revisions into the regulations. During public comment, it was suggested that the reporting requirements of section 1.5.3 be withdrawn or revised due to a supposed conflict with federal/state regulations, specifically prohibitions against non-physician ordering of tests, or culturing of organisms following positive CIDT for a reportable condition, in the absence of a documented request from a licensed physician or other authorized medical personnel. RIDOH has determined that this suggested revision will not be implemented because, upon review, it was determined that cited federal regulations did not prevent the testing of non-physician ordered tests, only the reimbursement thereof for Medicare patients, and that cited state regulations for Licensing Clinical Laboratories and Stations had subsequent language in section 13.4 which allows for culturing of organisms in the absence of a documented request from authorized medical personnel. In the case of lack of federal reimbursement for testing, RIDOH has determined that the public health impact of such reporting is worth the cost incurred. During public comment, it was suggested that the requirement for follow-up testing be removed for specimens that have undergone culture independent diagnostic testing (CIDT) because it is comparable or superior to culture-based testing. RIDOH has determined that this suggested revision will not be implemented, as RIDOH is in agreement with the Association of Public Health Laboratories (APHL), which has determined that the recovery of cultured isolates remains an essential component to public health efforts to monitor trends and respond to foodborne illness outbreaks. Without such isolates, information on foodborne pathogen serotypes, subtypes, virulence factors, and antimicrobial susceptibility will be scant, if available at all. Loss of culture-based DNA fingerprinting will make outbreak detection and source trace back nearly impossible. This would result in ongoing transmission of illness with increased morbidity and mortality. During public comment, it was suggested that the requirement to comply with culture reflex testing to CIDT-based tests should be removed as it would delay reporting of results to physicians who request to be notified only upon issuance of finals results. RIDOH has determined not to implement this suggested revision, as in this situation the culture would be done for public health purposes only and would not have to be reported to the physician, and the CIDT result would be considered a final result and could be reported when completed without waiting for the culture result. During public comment, it was suggested that revisions be made to the terminology in section 1.7.3 pertaining to the reporting requirements for tuberculosis. RIDOH has determined not to implement this suggested revision because section 1.7.3 is written to be consistent with R.I. Gen. Law 23-10-7 and reflects current public health best practice methods in Rhode Island. During public comment, it was suggested that revisions be made to the terminology in section 1.8.2(A) pertaining to the reporting requirements for Environmental Exposures and Occupational Diseases, to require a statement that laboratories report elevated or abnormal test results instead of diagnoses of diseases. RIDOH has determined that this suggested revision will not be implemented because RIDOH believes the intent of section 1.8.2(A) clearly means that for all reportable conditions, laboratories do not diagnose diseases, but report abnormal or positive results. In the development of this rule, consideration was given to: 1) alternative approaches; 2) overlap or duplication with other statutory and regulatory provisions; and 3) significant economic impact on small business. No alternative approach, duplication, or overlap was identified based on available information. RIDOH has determined that the benefits of this rule justify its costs.

There are no electronic rulemaking documents for rules filed prior to August 14, 2018. For rulemaking documents for rules filed prior to this date, please contact the appropriate agency's Rules Coordinator.