10-144 C.M.R. ch. 258, § 2 - NOTIFIABLE DISEASES AND CONDITIONS REPORTING REQUIREMENTS

A. Required reporting: The Department may designate any communicable, occupational or environmental disease or condition as a Notifiable Disease or Condition and establish requirements for reporting cases and suspected cases of such diseases and conditions, By exercising this authority granted by 22 MRS §802(1), the Department may measure the public health impact, to intervene as early as possible; and limit the potential for the spread of communicable, occupational or environmental diseases and conditions or widespread exposure to a toxic agent or environmental hazard. Required reporting of all Notifiable Diseases and Conditions, including emerging diseases and potential outbreaks, and laboratory submissions or clinical isolates must be conducted in accordance with this rule.

B. Who Must Report

1. All persons or entities listed in this subsection who attend a confirmed or strongly suspected case or death from any Notifiable Disease or Condition must report the case and the information required under Section 2(C) to the Department.

a. Health Care Providers, including but not limited to physicians attending a case, suspecting a case, or knowing or suspecting a death from a Notifiable Disease or Condition;

b. Medical Laboratories;

c. Health Care Facilities, including but not limited to the Infection Preventionist or designated person responsible for reporting on behalf of hospitals, nursing homes, and medical clinics;

d. Child Care Facility administrators or owners;

e. Correctional Facility administrators of the medical department;

f. Educational Institution administrators, including but not limited to the medical department within an educational institution;

g. Local Health Officers; and

h. Veterinarians and Veterinary Medical Laboratories.

2. Public Health Emergencies

In the event of a declared Extreme Public Health Emergency or Health Emergency, the Department may use the Health Alert Network System (HAN) and may also publish notice or use other public or targeted means to notify other entities and individuals required to report specific information identified by the Department.

C. What to Report

1. Health care providers, medical laboratories, health care facilities, childcare facilities, educational institutions, and correctional facilities subject to this rule must report in the form and manner prescribed by the Department, the following information:

a. Notifiable Disease or Condition (recognition, strong suspicion, death or diagnostic laboratory findings);

b. Date of the first onset of symptoms;

c. Patient name;

d. Patient birth date;

e. Patient race;

f. Patient ethnicity;

g. Patient sex;

h. Patient residence address, city, county and zip code;

i. Patient phone number;

j. Date of report;

k. Ordering healthcare provider name, address and phone number;

l. Name of healthcare facility (if any);

m. Name of person reporting;

n. All diagnostic laboratory findings and dates of tests relevant to the Notifiable Disease or Condition, regardless of clinical significance, including test results from a clinical isolate or specimen that are indicative of the presence of a Notifiable Disease or Condition;

o. Other information pertinent to the case as requested by the Department; and

p. Non-Compliant Person or Public Health Threat: When the report is about a Non-Compliant Person or a Public Health Threat, pertinent details of how the person is are not complying with medical care, any public health recommendations, and description of the condition or behavior that is putting others at significant risk of exposure to a Notifiable Disease or Condition.

q. Additional Medical Laboratory Reporting Requirements: All medical laboratories must forward all clinical isolates and specimens of Notifiable Diseases or Conditions to HETL.

2. Health officers must report any information related to cases and suspected cases of diseases described in this rule identified as a Public Health Threat or established as relating to a declared Extreme Public Health Emergency, that is relayed to the health officer by health care providers, hospital administrators, or persons in charge of public or private institutions.

3. Veterinarians and veterinary medical laboratories must report any diseases likely to cause complications, disability or death in a human as a result of transmission from an animal to a human, as well as the following information:

a. Clinical diagnosis of Notifiable Disease or Condition (recognition, strong suspicion or death) that may be transmitted directly or indirectly from animal(s) to humans;

b. Date of first symptoms of identified animal(s);

c. Name of veterinarian/laboratory reporting;

d. Diagnostic laboratory findings and dates of tests on animals tested;

e. Other information pertinent to the case as requested by the Department including but not limited to conditions associated with an outbreak or epidemic; and

f. If animal species, specify the species.

4. Other professionals identified in the HAN and any other Department-issued public health notice must report any new information required to be reported in the context of an Extreme Public Health Emergency or Health Emergency specified at that time by the Department.

5. Reporting of human immunodeficiency virus (HIV) test results, includes:

a. All reactive/repeatedly reactive initial HIV immunoassay results and all results (e.g. positive, negative, indeterminate) from all supplemental HIV immunoassays (HIV-1/2 antibody differentiation assay, HIV-1 Western blot, HIV-2 Western blot or HIV-1 Immunofluorescent assay);

b. All HIV nucleic acid (RNA or DNA) detection tests (qualitative and quantitative), including tests on individual specimens for confirmation of nucleic acid amplification testing (NAAT) screening results;

c. All CD4 lymphocyte counts and percentages, unless known to be ordered for a condition other than HIV;

d. HIV genotypic resistance testing, nucleotide sequence results; and

e. Positive HIV detection tests (including, but not limited to culture, P24 antigen).

D. When to Report

1. Category I diseases and conditions specified in Appendix A of this rule must be reported to the Department immediately, but no later than eight (8) hours from the diagnosis or laboratory lab test result.

2. All Category II diseases and conditions specified in Appendix A of this rule and Non-Compliant Persons, or Public Health Threats must be reported as soon as possible, but no later than 48 hours from the diagnosis or laboratory test result for a Notifiable Disease or Condition, or the identification of a Non-Compliant Person or Public Health Threat.

3. A potential outbreak, including those involving exposure to a communicable disease, toxic agent, environmental hazard, or a potential epidemic, must be reported immediately to the Department, in accordance with Section 4 of this rule.

4. Temporary Notifiable Diseases or Conditions. The Department is authorized to require, by public health notice, the temporary reporting of any disease or condition in the State of Maine, in order to study and control any apparent outbreak, condition or unusual occurrence of communicable disease. The Department may require reporting of a Temporary Notifiable Disease or Condition, if the Department determines that the disease or condition to be reported can cause serious morbidity or mortality and the report of the disease or condition is necessary to enable the Department to monitor, prevent, or control the disease or condition to protect public health.

a. The Department will issue public notice through HAN for Temporary Notifiable Diseases and Conditions and will include the planned mechanism for surveillance of the disease or condition, the persons and entities who report, a time frame for reporting, and information regarding the submission of test results and clinical materials from cases and suspected cases to HETL. Information specified in the HAN will also be made available on the Department's publicly accessible website.

b. The Department will maintain a public health advisory, in regard to a single disease or condition for not more than 24 consecutive months and will not issue an advisory for more than three Temporary Notifiable Diseases or Conditions in a calendar year. If a disease or condition becomes permanent through rulemaking, then it is excluded from the limit of three Temporary Diseases or Conditions.

E. How to Report

1. All reports must be made to the Department in accordance with this rule.

2. Laboratory reporting must be done electronically through HL7 messaging as specified in this subsection. Electronic reporting required for laboratories is in addition to other reporting requirements specified in this rule.

3. Suspicion of Category I diseases, or conditions, and unusual infectious illnesses or outbreaks, must be reported immediately, or within eight hours, by telephone by calling 1-800-821-5821. Telephonic reporting required for Category I diseases is in addition to electronic reporting required for laboratories.

4. Category II diseases or conditions must be reported within 48 hours.

Standard forms for written reports accepted for a case or suspected case of a Category II disease, condition and unusual infectious illness, may be transmitted by fax to 1-800-293-7534. When other means of reporting are not available, written reports may be mailed to the following address:

Maine Center for Disease Control and Prevention- Division of Disease Surveillance

11 State House Station

286 Water Street

Augusta, ME 04333-0011

5. Temporary Notifiable Disease and Condition Reporting. When the Department issues a public notice that requires a case or suspected case of a Temporary Notifiable Disease or Condition to be reported, such reports of the Temporary Notifiable Disease or Condition must be made to the Department immediately (or within eight hours) by telephone, by calling 1-800-821-5821, unless stated otherwise in the public notice.

6. All licensed laboratories must send all reportable disease data electronically to the Department. Electronic reporting must be in accordance with the standards set forth by the Department and consistent with the current US CDC standards specified in HL7 2.5.1 (https://www.cdc.gov/elr/technicalstandards.html).

a. Prior to reporting data electronically, a licensed laboratory must obtain approval from the Department and must work with the Department to test the messaging protocol and develop a plan for production validation.

b. A licensed laboratory must have a reporting continuity plan in the event of emergency situations disrupting electronic communications. At least two other alternative methodologies should be incorporated, such as facsimile, mail, or courier service.

c. Electronic reporting must meet the timelines specified in Section 2(D) above.

d. The Department may charge $20 per report that Maine CDC staff manually enters for laboratories or reporting facilities that did not submit electronically as required by this rule, but no more than a maximum of $250 per year for noncompliance with reporting requirements.

F. Confidentiality

1. Relationship to Federal and State Confidentiality Laws In compliance with the Health Information Portability and Accountability Act of 1996 [ P.L. 104-91 ], its implementing regulations, and State law, persons and entities who are required to preserve the confidentiality of protected health information nonetheless must disclose such information to public health authorities such as the Department for the purpose of preventing or controlling communicable, occupational or environmental disease.

2. Release of Information for Public Health Purposes

a. The names and any related information reported to the Department pursuant to this rule which may identify individuals are confidential and may be released only to other public health and school officials or agencies for public health purposes, or to other offices of the Department of Health and Human Services for adult or child protection purposes, in accordance with 22 MRS Chapters 958-A or 1071.

b. In the event of a Public Health Threat or Health Emergency declared by the Department or Extreme Public Health Emergency declared by the Governor, or in the event of an actual or threatened epidemic or outbreak, the identifying information may also be released to private health care providers and health and human services agencies for the purpose of carrying out public health responsibilities of the Department pursuant to this rule and 22 MRS §824. Any other information not reasonably related to public health responsibilities of the Department, may not be disclosed.

c. In the case of reporting Non-Compliant Persons and Public Health Threats, information identifying the reporter or complainant is confidential and may not be disclosed, unless disclosure is required for the Department's investigation of matters of public health, or by court order.

d. No person may disclose the results of an HIV test except as permitted by 5 MRS §19203 and/or 22 MRS §833.

3. Release of Health Information to the General Public

Data released to the public or the media may not contain potentially identifying information, unless otherwise specified in this rule. The Department will consider the type and amount of information, any direct identifiers and geographic factors when determining whether the information may potentially identify individuals and will restrict or suppress such identifying information prior to releasing any other health information.

All information submitted to the Department pursuant to this rule which does not contain individually identifiable health information and that is not restricted data may be made available to the public in accordance with 22 MRS §824 and the Department's data release policy and protocols, available to the public, upon request.

G. Accessing and Utilizing Healthcare Information and Records in the Designated Health Information Exchange

The Department may directly access and receive healthcare information or records of persons and entities listed in Section 2(B) of this rule, as well as other persons or entities identified by the Department, or abstracts of such information or records, including information or records that identify or permit identification of any patient. Such information may be obtained from sources including, but not limited to, the State-designated statewide health information exchange as described in 22 MRS §1711-C(18), for the purpose of investigating cases, outbreaks, epidemics, exposures, or potential epidemics or exposures of Notifiable Conditions and Diseases.

Information obtained from the statewide health information exchange will assist the Department in confirming information received during the investigation of cases and outbreaks and provide information regarding symptom onset, potential exposure history, and other clinical information that will facilitate the investigation of cases of Notifiable Diseases and Conditions. All personal health information obtained pursuant to this subsection is confidential pursuant to Section 2(F) of this rule.

H. Failure to Report Notifiable Diseases or Conditions

1. If the person or entity required to report under this rule fails to report information according to this rule, the Department will make a reasonable attempt to contact that person or entity by telephone or email, as a reminder that the requisite information has not been reported to the Department and to establish a plan for compliance.

2. In the event that the person or entity fails to comply with the plan for compliance established pursuant to Subsection H(1) above, the Department may send a written notification providing a final deadline for compliance and will notify the person or entity that failure to comply with reporting requirements for Category I diseases may result in the Department pursuing the following enforcement action(s):

a. Referral to the Board of Licensure of Medicine; and/or

b. Referral to the Office of the Attorney General to commence judicial proceedings for civil relief. Such civil relief may include injunctive relief and civil fines pursuant to 22 MRS §825.

Notes

10-144 C.M.R. ch. 258, § 2