.03 Reportable Diseases, Conditions, Outbreaks, and Unusual Manifestations; Submitting Clinical Materials.

A. A person, as set forth in Regulation .04 of this chapter, shall report the diseases or conditions listed in §C of this regulation, or any other condition as requested by the Secretary.

B. Upon a positive laboratory finding for a disease or condition listed in §C of this regulation, or upon request of the Secretary, the director of a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) shall:

(1) Submit clinical material to the Department's public health laboratory; and

(2) Include information about the clinical material on a form provided by the Secretary.

C. List of Reportable Diseases and Conditions.

HEALTH CARE PROVIDERS, INSTITUTIONS, AND OTHERS1	LABORATORIES		TIME FRAME FOR REPORTING2
Diseases and Conditions	Laboratory Evidence of	Submit Clinical Materials to the Department3	Immediate	Within 1 Working Day
(1) An outbreak of a disease of known or unknown etiology that may be a danger to the public health4	Similar etiological agents from a grouping or clustering of patients		X
(2) A single case of a disease or condition not otherwise included in this table of known or unknown etiology, that may be a danger to the public health	An etiologic agent suspected to cause that disease or condition			X
(3) An unusual manifestation of a communicable disease in an individual	An etiologic agent suspected to cause that disease			X
(3-1) An exposure or potential exposure of a person to a biological agent as defined in COMAR 10.10.11.03B(8)	An exposure or potential exposure of a person to a biological agent as defined in COMAR 10.10.11.03B(8)		X
(4) Acquired immunodeficiency syndrome (AIDS)6	Refer to COMAR 10.18		Refer to COMAR 10.18
(5) Amebiasis	Entamoeba histolytica			X
(6) Anaplasmosis	Anaplasma phagocytophilum			X
(7) Animal bites	Not Applicable		X
(8) Anthrax	Bacillus anthracis	X	X
(9) Arboviral infections including, but not limited to:      (a) Dengue fever;      (b) Eastern equine encephalitis;      (c) LaCrosse virus infection;      (d) St. Louis encephalitis;      (e) Western equine encephalitis;      (f) West Nile virus infection;      (g) Yellow fever	Any associated arbovirus including, but not limited to:      (a) Dengue virus;      (b) Eastern equine encephalitis virus;      (c) LaCrosse virus;      (d) St. Louis encephalitis virus;      (e) Western equine encephalitis virus;      (f) West Nile virus;      (g) Yellow fever virus	X	X
(10) Babesiosis	Babesia species			X
(11) Botulism	Clostridium botulinum, botulinum toxin, or other botulism producing Clostridia	X	X
(12) Brucellosis	Brucella species	X	X
(13) Campylobacteriosis	Campylobacter species	X		X
(14) Chancroid	Haemophilus ducreyi			X
(15) Chlamydia trachomatis infection, including lymphogranuloma venereum (LGV)	Chlamydia trachomatis	X (if LGV strain)		X
(16) Cholera	Vibrio cholerae	X	X
(17) Coccidioidomycosis	Coccidioides immitis			X
(18) Creutzfeldt-Jakob disease	14-3-3 protein from CSF or any brain pathology suggestive of CJD			X
(19) Cryptosporidiosis	Cryptosporidium species			X
(20) Cyclosporiasis	Cyclospora cayatensis			X
(21) Diphtheria	Corynebacterium diphtheriae	X	X
(22) Ehrlichiosis	Ehrlichia species			X
(23) Encephalitis, infectious	Isolation from or demonstration in brain tissue, central nervous system tissue, or cerebrospinal fluid, of any pathogenic organism	X (Infectious agents as indicated elsewhere in §C of this regulation and viral agents except for HSV)		X
(24) Epsilon toxin of Clostridium perfringens	Clostridium perfringens, epsilon toxin		X
(25) Escherichia coli O157:H7 infection	Escherichia coli O157:H7	X	X
(26) Giardiasis	Giardia species			X
(27) Glanders	Burkholderia mallei	X	X
(28) Gonococcal infection	Neisseria gonorrhoeae			X
(29) Haemophilus influenzae invasive disease	Haemophilus influenzae, isolated from a normally sterile site	X	X
(30) Hantavirus infection	Hantavirus	X	X
(31) Harmful algal bloom related illness	Not Applicable			X
(32) Hemolytic uremic syndrome, post-diarrheal	Not Applicable			X
(33) Hepatitis A acute infection	Hepatitis A virus IgM		X
(34) Hepatitis, viral (B, C5, D, E, G, all other types, and undetermined)	Hepatitis B, C5, D, E, and G virus, other types			X
(35) Human immunodeficiency virus (HIV)6	Refer to COMAR 10.18		Refer to COMAR 10.18
(36) Influenza- associated pediatric mortality	Influenza virus-associated pediatric mortality in persons younger than 18 years old (if known)			X
(37) Influenza: novel influenza A virus infection	Isolation of influenza virus from humans of a novel or pandemic strain	X	X
(38) Isosporiasis	Cystoisospora belli (synonym Isospora belli)			X
(39) Kawasaki syndrome	Not Applicable			X
(40) Legionellosis	Legionella species	X (if isolate from human)	X
(41) Leprosy	Mycobacterium leprae	X		X
(42) Leptospirosis	Leptospira interrogans	X		X
(43) Listeriosis	Listeria monocytogenes	X		X
(44) Lyme disease	Borrelia burgdorferi			X
(45) Malaria	Plasmodium species	X		X
(46) Measles (rubeola)	Measles virus		X
(47) Melioidosis	Burkholderia pseudomallei	X	X
(48) Meningitis, infectious	Isolation or demonstration of any bacterial, fungal, or viral species in cerebrospinal fluid	X (Infectious agents as indicated elsewhere in §C of this regulation and viral agents except for HSV)		X
(49) Meningococcal invasive disease	Neisseria meningitidis (including serogroup, if known), isolated from a normally sterile site	X	X
(50) Microsporidiosis	Various microsporidian protozoa, including but not limited to Encephalitozoon species			X
(51) Mumps (infectious parotitis)	Mumps virus			X
(52) Mycobacteriosis, other than tuberculosis and leprosy	Mycobacterium species, other than Mycobacterium tuberculosis complex or Mycobacterium leprae			X
(53) Pertussis	Bordetella pertussis		X
(54) Pertussis vaccine adverse reactions	Not Applicable			X
(55) Pesticide related illness	Cholinesterase below the normal laboratory range			X
(56) Plague	Yersinia pestis	X	X
(57) Pneumonia in a health care worker resulting in hospitalization	Various organisms			X
(58) Poliomyelitis	Poliovirus	X	X
(59) Psittacosis	Chlamydophila psittaci (formerly Chlamydia psittaci)			X
(60) Q fever	Coxiella burnetii	X	X
(61) Rabies (human)	Rabies virus		X
(62) Ricin toxin poisoning	Ricin toxin (from Ricinus communis castor beans)		X
(63) Rocky Mountain spotted fever	Rickettsia rickettsii			X
(64) Rubella (German measles) and congenital rubella syndrome	Rubella virus		X
(65) Salmonellosis (nontyphoidal)	Salmonella species, including serogroup, if known	X		X
(66) Severe acute respiratory syndrome (SARS)	SARS-associated coronavirus (SARS-CoV)	X	X
(67) Shiga-like toxin producing enteric bacterial infections	Shiga toxin, shiga-like toxin, or the toxin-producing bacterium	X	X
(68) Shigellosis	Shigella species, including species or serogroup, if known	X		X
(69) Smallpox and other orthopoxvirus infections	Variola virus, vaccinia virus, and other orthopox viruses	X	X
(70) Staphylococcal enterotoxin B poisoning	Staphylococcus enterotoxin B		X
(71) Streptococcal invasive disease, Group A	Streptococcus pyogenes, Group A, isolated from a normally sterile site	X		X
(72) Streptococcal invasive disease, Group B	Streptococcus agalactiae, Group B, isolated from a normally sterile site	X		X
(73) Streptococcus pneumoniae invasive disease	Streptococcus pneumoniae, isolated from a normally sterile site	X		X
(74) Syphilis7	Treponema pallidum7			X
(75) Tetanus	Clostridium tetani			X
(76) Trichinosis	Trichinella spiralis			X
(77) Tuberculosis, active disease and suspected active tuberculosis8	Mycobacterium tuberculosis complex8	X	X
(77-1) Tuberculosis, latent infection (LTBI)9	Mycobacterium tuberculosis complex, latent infection9			X
(78) Tularemia	Francisella tularensis	X	X
(79) Typhoid or Paratyphoid fever (case, carrier, or both, of Salmonella Typhi or Paratyphi)	Salmonella Typhi	X	X
(80) Vancomycin-intermediate Staphylococcus aureus (VISA) infection or colonization	Intermediate resistance of the S. aureus isolate to vancomycin	X		X
(81) Vancomycin-resistant Staphylococcus aureus (VRSA) infection or colonization	Resistance of the S. aureus isolate to vancomycin	X		X
(82) Varicella (chicken pox), fatal cases only	Varicella-zoster virus (Human herpesvirus 3)			X
(83) Vibriosis, non-cholera10	All non-cholera Vibrio species10	X		X
(84) Viral hemorrhagic fevers (all types)	All hemorrhagic fever viruses, including but not limited to Crimean-Congo, Ebola, Marburg, Lassa, Machupo viruses		X
(85) Yersiniosis	Yersinia species	X		X

Footnotes:

^1. As required to report in Regulation .04A(1)—(3), (5), and (6) of this chapter.

^2. The time frame for reporting is specified in Regulation .04C of this chapter.

^3. Clinical material shall be submitted according to §B of this regulation.

^4. Any grouping or clustering of patients having similar disease, symptoms, or syndromes that may indicate the presence of a disease outbreak.

^5. Suspected hepatitis C as indicated by:

(a) Any hepatitis C antibody results that are positive;

(b) Any hepatitis C virus RNA results associated with the results in (a) of this footnote that are qualitative or quantitative, if the results are:

(i) Positive; or

(ii) Negative; and

(c) Any hepatitis C virus RNA results associated with the results in (a) of this footnote if the hepatitis C virus is:

(i) Detected; or

(ii) Undetected.

^6. Acquired immunodeficiency syndrome (AIDS) and human immunodeficiency virus (HIV), including CD4+ lymphocyte count and viral load, are reportable under COMAR 10.18.

^7. Suspected syphilis as indicated by:

(a) Any treponemal or non-treponemal results that are qualitative or quantitative, if the results are:

(i) Positive;

(ii) Reactive; or

(iii) Inconclusive; and

(b) Any negative or non-reactive results associated with the positive, reactive, or inconclusive results in (a) of this footnote.

^8. Tuberculosis confirmed by culture and suspected tuberculosis as indicated by:

(a) A laboratory confirmed acid-fast bacillus on smear;

(b) An abnormal chest radiograph suggestive of active tuberculosis;

(c) A laboratory confirmed biopsy report consistent with active tuberculosis; or

(d) Initiation of two or more anti-tuberculosis medications.

^9. Latent tuberculosis infection as indicated when:

(a) There is a positive result on an Interferon Gamma Release Assay, Tuberculin Skin Test, or any other test indicating tuberculosis infection; and

(b) Active or suspected tuberculosis has been ruled out.

^10. Vibriosis, non-cholera, identified in any specimen taken from teeth, gingival tissues, or oral mucosa is not reportable.