0920-1335 Attachment H_Enhanced Data Collection During COVID

OMB Approved

Control No. 0920–1335

Exp. 04/30/2022

Enhanced Data Collection (EDC) During COVID-19 Pandemic

**Please submit to [email protected] daily by 1200 ET**

Directions: Please enter all data for:

1) Case counts and traveler test results identified for the previous day

(i.e., report submitted by 1200 ET today will include information from yesterday [0000 hrs. to 2359 hrs. ET]), and

2) Traveler test results received since last submission for the following:

• Symptomatic Case Counts with Viral testing

• Asymptomatic Case Counts with Viral testing for

  • Identified close contacts

  • Embarkation day screening

  • During or end of quarantine screening of newly embarking crew

  • Routine screening

  • Disembarkation screening

Completion of this form is required by foreign-flagged cruise ships operating or intending to operate in U.S. waters under CDC’s COVID-19 Program for Cruise Ships. For additional guidance, see Technical Instructions for Mitigation of COVID-19 Among Cruise Ship Crew and COVID-19 Operations Manual for CDC’s COVID-19 Program for Cruise Ships

Ship:
Voyage number:			Voyage start date (mm/dd/yyyy):		Voyage end date (mm/dd/yyyy):
Date Submitted (mm/dd/yyyy):
Closest seaport at time of submission (City and Country):
GPS coordinates of ship at time of submission (in decimal degrees):						Crew*	Passengers
Latitude: (in decimal degrees [DD], e.g., 45.34)		Longitude: (in decimal degrees [DD], e.g., -78.0)		Total # of travelers onboard:
Important Reminders About COVID-19, Influenza, and Other Respiratory Pathogens Testing for COVID-19 using viral tests (i.e., Nucleic Acid Amplification [NAAT] or antigen test) CDC considers all positive viral test (NAAT or antigen) results as new cases, unless laboratory documentation is provided of a previous SARS-CoV-2 viral test result within the past 90 days and the individual is asymptomatic. Cruise ship operators must have a protocol for evaluating documentation of recovery, including reviewing previous laboratory results. Cruise ship clinicians should diagnose but do not need to report any persistent positive results via EDC. A febrile person in the presence of a more likely diagnosis (e.g., cellulitis, urinary tract infection, tooth abscess) does not represent CLI and should not be reported via EDC. If separate respiratory specimens are collected for multiple tests (e.g., COVID-19 viral and influenza rapid antigen test) among symptomatic persons, these specimens should be collected from alternating nostrils of the patient with the first collected specimen designated for COVID-19 testing. To ensure the integrity of testing, persons with positive NAAT results for COVID-19 must not be retested. The original positive result must be reported; subsequent negative results do not negate an initial positive NAAT result and should not be reported. FOR ASYMPTOMATIC TESTING ONLY (i.e., not testing for symptomatic persons): confirmatory testing for a positive antigen test (i.e., presumptive positives) should take place as soon as possible after the antigen test, and not longer than 48 hours after the initial antigen testing. If more than 48 hours separate the two specimen collections, or if there have been opportunities for new exposures, a NAAT should be considered a separate test—not a confirmation of the earlier test. Ships that choose to use antigen tests should follow CDC Interim Guidance for Antigen Testing for SARS-CoV-2 Prior receipt of a COVID-19 vaccine will not affect the results of COVID-19 viral tests. Isolation Practices Symptomatic persons with confirmed COVID-19, defined as laboratory confirmation of SARS-CoV-2 by viral test: should be isolated for COVID-19 per CDC guidelines, and isolation may be discontinued under conditions outlined at: Technical Instructions for Mitigation of COVID-19 Among Cruise Ship Crew | Quarantine | CDC Symptomatic persons with CLI that initially test negative via NAAT for COVID-19 and no alternative etiology is identified (e.g., influenza, Legionella, Streptococcal pharyngitis, infectious mononucleosis, and respiratory syncytial virus (RSV)): should be isolated for COVID-19 per CDC guidelines, and isolation may be discontinued if a repeat NAAT result—collected at least 24 hours from the initial COVID-19 test—is negative Identifying Vaccine Adverse Events for COVID-19 and Influenza COVID-19 vaccine side effects can include: fever, chills, rigors, muscle or body aches (myalgias), headache, fatigue, vomiting, or diarrhea. Please refer to this CDC website appendix. COVID-19 vaccine side effects do not include: cough, sore throat, nasal congestion, runny nose (rhinorrhea), new olfactory disorder, new taste disorder, shortness of breath, or difficulty breathing. Inactivated Influenza vaccine side effects can include: fever, chills, fatigue, muscle or body aches (myalgias). Please refer to influenza vaccination side effects. Allergic reactions to vaccines (which typically occur immediately post-vaccination) can include: shortness of breath (i.e., anaphylaxis), vomiting, or diarrhea. Please report any vaccine adverse events (i.e., side effects or allergic reactions) to CDC’s Vaccine Adverse Event Reporting System (VAERS). Influenza Management Until further notice, cumulative influenza-like-illness (ILI) reporting via the Maritime Conveyance Cumulative Influenza/Influenza-like Illness (ILI) Form is suspended due to the COVID-19 pandemic. If needed, please refer to CDC’s website for Guidance for Cruise Ships on Influenza Management. Reporting Cruise Ship Fatalities or Other Illnesses of Public Health Concern Acute gastroenteritis or diarrhea: should be reported to CDC’s Vessel Sanitation Program (VSP) via the Maritime Illness Database and Reporting System (MIDRS). For more information, visit CDC Vessel Sanitation Program (VSP) Legionnaires’ disease: should be reported to CDC’s Respiratory Diseases Branch at [email protected]. For more information about Legionnaires’ disease, visit CDC’s Respiratory Diseases Branch (RDB). Fatalities and all other illnesses of public health concern (e.g., TB, varicella, measles, pertussis) should be reported via the Maritime Conveyance Illness or Death Investigation Form to the appropriate CDC Quarantine Station. Check to acknowledge that you have reviewed these Important Reminders ☐
Do you have ANY new testing, results, or other information to report via EDC today? Yes No
Today, are you entering new (not previously reported) results for the following test categories (check all that apply)? Testing of crew with CLI Testing of passengers with CLI Testing of close contacts among crew Testing of close contacts among passengers Embarkation day screening testing During or end of quarantine screening of newly embarking crew Routine screening testing (applies to crew only) Disembarkation testing
Symptomatic Case Counts with Viral Testing (i.e., NAAT§ or antigen test): (Please report final diagnostic test results only [e.g., if a symptomatic person is antigen-negative then tests NAAT-positive on the same day, do not report the initial antigen-negative result to EDC]‖ or if a symptomatic person is NAAT-negative then tests NAAT-positive on the next day, do not report the initial NAAT-negative result to EDC]) Ships that choose to use antigen tests should follow CDC Interim Guidance for Antigen Testing for SARS-CoV-2						Enter Numbers Below (Unless Otherwise Specified)
						Crew*	Passengers
Row	What is your COVID-19-like Illness (CLI) case count for the previous day? CLI clinical criteria: Persons with at least one or more of the following symptoms: fever‡, cough, difficulty breathing, shortness of breath, new olfactory disorder, or new taste disorder in the absence of a non-infectious diagnosis as determined by the ship’s physician (e.g., heart failure) or Persons with at least two or more of the following symptoms: sore throat, nasal congestion, runny nose (rhinorrhea), chills, rigors, muscle or body aches (myalgias), headache, fatigue, vomiting, or diarrhea in the absence of a non-infectious diagnosis as determined by the ship’s physician (e.g., allergies) or Persons with severe respiratory illness with at least one of the following: Clinical or radiographic evidence of pneumonia, Acute respiratory distress syndrome (ARDS).
1
2	Of those persons with CLI, how many were tested for COVID-19 using a viral test?
3	Of those persons with CLI tested for COVID-19 using a viral test, how many tested positive?
4	Of those persons with CLI that tested positive for COVID-19 using a viral test, how many were newly embarking crew members in quarantine?
5	Of those persons with CLI tested for COVID-19 using a viral test, how many tested negative?
6	Of those persons with CLI that tested negative for COVID-19 using a viral test, how many were newly embarking crew members in quarantine?
7	Of those persons with CLI that tested negative for COVID-19 using a viral test, how many tested positive for influenza? ¶¶
8	Of those persons with CLI that tested negative for COVID-19 using a viral test, how many tested positive for another respiratory pathogen (e.g., Legionella, Streptococcal pharyngitis, infectious mononucleosis, respiratory syncytial virus [RSV])? ¶¶
9	Of those persons with CLI tested for COVID-19 using a viral test, how many never registered a positive or negative result (e.g., inconclusive or invalid result)?
10	Of those persons with CLI for this reporting day, how many were not tested for COVID-19 because they had already tested positive as an identified close contact (and asymptomatic) in the past 14 days (i.e., on a previous reporting day)?
11	Were there any additional CLI cases that were not accounted for by the questions above? Please explain:
HOSPITALIZATIONS (Note: Travelers with CLI who test negative for COVID-19 twice, with samples taken 24 hours apart, OR have a confirmed alternative etiology (e.g., influenza) should not be included in reported hospitalizations, ventilations, and medical evacuations.)
12	How many symptomatic persons needed hospitalization (onboard or ashore) due to CLI or COVID-19?
13	Of those hospitalized due to CLI or COVID-19, how many required mechanical ventilation?
14	Of those hospitalized due to CLI or COVID-19, how many were medically evacuated from the ship?
Asymptomatic Case Counts with Viral Testing (i.e., NAAT§ or antigen test): (Please report final screening test results only [e.g., if an asymptomatic person is antigen-positive (i.e., presumptive positives) then tests NAAT-negative, do not report the initial antigen-positive result to EDC]).‖ Ships that choose to use antigen tests should follow CDC Interim Guidance for Antigen Testing for SARS-CoV-2. Persistent Positive Results Cruise ship clinicians should diagnose but do not need to report any persistent positive results via EDC. CDC considers all positive viral test (NAAT or antigen) results as new cases, unless laboratory documentation is provided of a previous SARS-CoV-2 viral test result within the past 90 days and the individual is asymptomatic. Cruise ship operators must have a protocol for evaluating documentation of recovery, including reviewing previous laboratory results.						Enter Numbers Below (Unless Otherwise Specified)
						Crew*	Passengers
IDENTIFIED CLOSE CONTACT TESTING (please see this table in CDC’s Technical Instructions for close contact testing requirements) (Please report final screening test results only [i.e., if an asymptomatic person is antigen-positive (i.e., presumptive positive) then tests NAAT-negative on the same day, do not report the initial antigen-positive result to EDC]).‖ Ships that choose to use antigen tests should follow CDC Interim Guidance for Antigen Testing for SARS-CoV-2
15	How many asymptomatic persons were tested for COVID-19 using a viral test after being identified as a close contact of a: Symptomatic person with CLI and a positive viral test, or Symptomatic person with CLI and a negative viral test result, or Asymptomatic person with a positive viral test result?
16	Of the asymptomatic persons tested for COVID-19 using a viral test after being identified as a close contact, how many tested positive?
17	Of the asymptomatic persons tested for COVID-19 using a viral test after being identified as a close contact, how many tested negative?
18	Of the asymptomatic persons tested for COVID-19 using a viral test after being identified as a close contact, how many were never able to register a positive or negative result (e.g., inconclusive or invalid result)?
EMBARKATION DAY SCREENING TESTING¶¶ (Please report final screening test results only [e.g., if an asymptomatic person is antigen-positive (i.e., presumptive positive) then tests NAAT-negative, do not report the initial antigen-positive result to EDC]).‖ Ships that choose to use antigen tests should follow CDC Interim Guidance for Antigen Testing for SARS-CoV-2.
19	How many asymptomatic persons were tested for COVID-19 using a viral test on the day of embarkation?
20	Of the asymptomatic persons tested for COVID-19 using a viral test on the day of embarkation, how many tested positive?
21	Of the asymptomatic persons tested for COVID-19 using a viral test on the day of embarkation, how many tested negative?
22	Of the asymptomatic persons tested for COVID-19 using a viral test on the day of embarkation, how many were never able to register a positive or negative result (e.g., inconclusive or invalid result)?
DURING OR END OF QUARANTINE SCREENING TESTING OF NEWLY EMBARKING CREW (Please report final screening test results only [e.g., if an asymptomatic person is antigen-positive (i.e., presumptive positive) then tests NAAT-negative, do not report the initial antigen-positive result to EDC]).‖
23	How many asymptomatic newly embarking crew members were tested for COVID-19 using a viral test at the end of quarantine (i.e., prior to leaving quarantine)?
24	Of the asymptomatic newly embarking crew members tested for COVID-19 using a viral test at the end of quarantine, how many tested positive?
25	Of the asymptomatic newly embarking crew members tested for COVID-19 using a viral test at the end of quarantine, how many tested negative?
26	Of the asymptomatic newly embarking crew members tested for COVID-19 using a viral test at the end of quarantine, how many were never able to register a positive or negative result (e.g., inconclusive or invalid result)?
ROUTINE SCREENING TESTING (Please report final screening test results only [e.g., if an asymptomatic person is antigen-positive (i.e., presumptive positive) then tests NAAT-negative, do not report the initial antigen-positive result to EDC]).‖ Ships that choose to use antigen tests should follow CDC Interim Guidance for Antigen Testing for SARS-CoV-2.
27	How many asymptomatic persons were tested for COVID-19 using a viral test for routine crew screening or passenger voyage testing?
28	Of the asymptomatic persons tested for COVID-19 using a viral test for routine crew screening or passenger voyage testing, how many tested positive?
29	Of the asymptomatic persons tested for COVID-19 using a viral test for routine crew screening or passenger voyage testing, how many tested negative?
30	Of the asymptomatic persons tested for COVID-19 using a viral test for routine crew screening or passenger voyage testing, how many were never able to register a positive or negative result (e.g., inconclusive or invalid result)?
DISEMBARKATION SCREENING TESTING OF TRAVELERS (Please report final screening test results only [e.g., if an asymptomatic person is antigen-positive then tests NAAT-negative, do not report the initial antigen-positive result to EDC]).‖ Ships that choose to use antigen tests should follow CDC Interim Guidance for Antigen Testing for SARS-CoV-2.
31	How many asymptomatic persons were tested for COVID-19 using a viral test collected within 24 hours before disembarkation?
32	Of the asymptomatic persons tested for COVID-19 using a viral test collected within 24 hours before disembarkation, how many tested positive?
33	Of the asymptomatic persons tested for COVID-19 using a viral test collected within 24 hours before disembarkation, how many tested negative?
34	Of the asymptomatic persons tested for COVID-19 using a viral test collected within 24 hours before disembarkation, how many were never able to register a positive or negative result (e.g., inconclusive or invalid result)?
35	Were there any additional asymptomatic cases testing positive that were not accounted for by the questions above? Please explain:
Isolation Practices: Were persons with the following isolated for COVID-19 per CDC guidelines? Confirmed cases of COVID-19 defined as laboratory confirmation of SARS-CoV-2 by viral test, or CLI with negative test results for another respiratory pathogen (e.g., influenza, Legionella, Streptococcal pharyngitis, infectious mononucleosis, and respiratory syncytial virus (RSV)) prior to repeat negative NAAT results (see more in note below)¶? Note: For symptomatic persons with confirmed COVID-19, isolation may be discontinued under conditions outlined at: Technical Instructions for Mitigation of COVID-19 Among Cruise Ship Crew | Quarantine | CDC For symptomatic persons with CLI that initially test negative via NAAT for COVID-19 and no alternative etiology is identified, isolation may be discontinued if a repeat NAAT result—collected at least 24 hours from the initial COVID-19 test—is negative.

* All overnight contractors/visitors/vendors should be identified as crew for all CDC reporting requirements (i.e., day contractor/visitors/vendors can be excluded)

‡ A febrile person in the presence of a more likely diagnosis (e.g., cellulitis, urinary tract infection, tooth abscess) does not represent CLI and should not be reported via EDC.

§ Examples of available NAATs for SARS-CoV-2 include but are not restricted to: reverse transcription polymerase chain reaction (RT-PCR), reverse transcription loop-mediated isothermal amplification (RT-LAMP), transcription-mediated amplification (TMA), nicking enzyme amplification reaction (NEAR), and helicase-dependent amplification (HDA).

‖ Please refer to CDC’s antigen testing guidance.

^¶ If an alternate infectious etiology is identified through laboratory testing, routine infection control precautions recommended for the diagnosis should be followed.

^¶¶ Embarkation day testing applies to all passengers on back-to-back sailings prior to the ship sailing on the next voyage, regardless of vaccination status.  

Public reporting burden of this collection of information is estimated to average 20 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB Control Number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA 0920-1335.