Del. Admin. Code tit. 16, Department of Health and Social Services, Division of Public Health, Health Promotion and Disease Prevention, 4202, app II
1. All laboratories located in Delaware and laboratories that have specimen collection sites in Delaware, including those laboratories with testing or processing facilities located out of state, are required to submit suspected and confirmed isolates and clinical materials of proposed agents from Delaware residents to the DPHL.
2. All clinical or hospital laboratories, or other facilities, located in Delaware that presumptively identify or are unable to rule out biothreat organisms shall notify immediately and send an isolate, clinical material, or specimen to the DPHL for testing as soon as possible. Those located outside the State, should contact their nearest State Laboratory or Laboratory Response Network laboratory.
3. All other isolates and clinical specimens of microorganism listed in item four below shall be sent to the DPHL.
4. List of microorganisms to send to the DPHL:
4.1 Select Agent organisms (notify DPHL immediately, by secure email or telephone, prior to sending for confirmation within 24 hours of suspicion of clinical presentation for the following agents:
Bacillus anthracis/Bacillus cereus biovar anthracis
Brucella species
Burkholderia mallei
Burkholderia pseudomallei
Clostridium botulinum
Coxiella burnetii
Francisella tularensis
Ebola and other viral hemorrhagic viruses
Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV)
Mpox virus
SARS-Coronavirus (CoV)/SARS-CoV-2 Chimeric viruses
Vaccinia virus
Variola (smallpox) virus
Yersinia pestis
4.2 Emerging Infectious Organisms of Public Health Concern - (notify DPHL immediately, by secure email or telephone, prior to sending for confirmation within 24 hours of suspicion of clinical presentation for the following agents:
Measles and Mumps virus
Mycobacterium tuberculosis complex
Haemophilus influenzae and Neisseria meningitidis from sterile body sites
Any agent suspected of displaying cluster/outbreak potential
Any individual cases displaying unusual patterns of antimicrobial resistance (including non-susceptibility to all tested antimicrobials), atypical virulence/resistance genetic mechanisms, or emerging infectious pathogen or pathogens.
4.3 Surveillance (Foodborne/Respiratory) (send within 3 - 5 business days, prior notification to lab not required)
Campylobacter species (minimum two samples per month per submitter)
Cronobacter species
COVID-19 (minimum two samples per week per submitter)
Influenza (minimum two samples per day per submitter during outbreak season)
Listeria monocytogenes
Norovirus (two samples per month per submitter)
Salmonella species
Shiga toxin producing Escherichia coli (STEC)
Shigella species
Vibrio species
Yersinia enterocolitica
4.4 Antimicrobial resistance (send within 3 - 5 business days, prior notification of lab not re-quired).
Candida auris
Neisseria gonorrhoeae, (cases suspected of antimicrobial resistance/treatment failure)
Staphylococcus aureus, Vancomycin resistant (VRSA)
Carbapenem resistant organisms (CRO) including Enterobacteriaceae (CRE) Acineto-bacter baumannii (CRAB), and Pseudomonas aeruginosa (CRPA)
5. Any environmental sample deemed as credible threats for harboring a toxin or a biological agent of terrorism shall be sent to the DPHL for testing immediately upon identification. Organizations must noti-fy DPHL, by secure email/phone, prior to submitting for testing.
6. Clinical specimens from patients potentially exposed to a chemical agent of terrorism shall be sent to the DPHL for testing immediately upon identification.
Del. Admin. Code tit. 16, Department of Health and Social Services, Division of Public Health, Health Promotion and Disease Prevention, 4202, app II
12 DE Reg. 1418 (05/01/09)
15 DE Reg. 1163 (02/01/12)
17 DE Reg. 320 (9/1/2013)
22 DE Reg. 1012 (6/1/2019)
23 DE Reg. 665 (2/1/2020)
24 DE Reg. 791 (2/1/2021)
27 DE Reg. 863 (5/1/2024) (Final)