0920-1335 Enhanced Data Collection During COVID-19 Pandemic 21MAY2

Phased Approach to the Resumption of Cruise Ship Passenger Operations

Enhanced Data Collection During COVID-19_Daily_2021 05 20_for OMB

Enhanced data collection during COVID-19 Pandemic (daily)

OMB: 0920-1335

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OMB Approved

Control No. 0920–1335

Exp. 10/31/2021

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 (previously entered as “pending”) for the following:

  • Symptomatic Case Counts with Viral testing

  • Asymptomatic Case Counts with Viral testing for

    • Identified close contacts

    • Embarkation day screening

    • End of quarantine screening of newly embarking crew

    • Routine screening

    • Disembarkation screening

Completion of this form is required by cruise ships operating or intending to operate in U.S. waters during the period of CDC’s Framework for Conditional Sailing Order (CSO). For additional guidance, see Technical Instructions for Mitigation of COVID-19 Among Cruise Ship Crew and COVID-19 Operations Manual for Simulated and Restricted Voyages under the Framework for Conditional Sailing Order | Quarantine | CDC

Ship:

Date Submitted (mm/dd/yy):

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])

Longitude:

(in decimal degrees [DD])

Total # of travelers onboard:





Percentage of travelers fully vaccinated† for COVID-19:



Important Reminders About COVID-19 and Influenza

Testing for COVID-19 using viral tests (i.e., Nucleic Acid Amplification [NAAT] or antigen test)

  • 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 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. 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 Appendix D of this CDC website.

  • 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

Check to acknowledge that you have reviewed these Important Reminders ☐

Today, are you reporting traveler test results that were previously entered as “pending” for the following (check all that apply)?

  • COVID-19-like illness (CLI) testing of crew

  • CLI testing of passengers

  • Close contacts testing of crew

  • Close contacts testing of passengers

  • Embarkation day screening testing

  • End of newly embarking quarantine screening testing (applies to not fully vaccinated crew)

  • Routine screening testing (applies to crew only)

  • Disembarkation testing (applies to not fully vaccinated crew and passengers)


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])‖

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

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 CLI cases, how many were tested for COVID-19 using a viral test?



3

Of those CLI cases tested for COVID-19 using a viral test, how many tested positive?



4

Of those CLI cases that tested positive for COVID-19 using a viral test, how many were newly embarking crew members in quarantine?



5

Of those CLI cases tested for COVID-19 using a viral test, how many tested negative?



6

Of those CLI cases that tested negative for COVID-19 using a viral test, how many tested positive for influenza?



7

Of those CLI cases that tested negative for COVID-19 using a viral test, how many tested positive for another respiratory pathogen (e.g., RSV or Legionella)?



8

Of those CLI cases tested for COVID-19 using a viral test, how many never registered a positive or negative result (e.g., inconclusive or invalid result)?



9

Of those CLI cases tested for COVID-19 using a viral test, how many results are pending?



10

If pending, please choose why (please circle all that apply): a) onboard testing capability for this ship is pending b) ran out of supplies (e.g., cartridges) c) technical/mechanical problems



11

Of those CLI cases tested for COVID-19 using a viral test with pending results on a previous EDC submission day, how many tested positive?



12

Of those CLI cases that tested positive for COVID-19 using a viral test from pending results on a previous EDC submission day, how many were newly embarking crew members in quarantine?



13

Of those CLI cases tested for COVID-19 using a viral test with pending results on a previous EDC submission day, how many tested negative?



14

Of those CLI cases tested for COVID-19 using a viral test with pending results on a previous EDC submission day, how many never registered a positive or negative result (e.g., inconclusive or invalid result)?



15

Of those CLI cases with previously pending results that tested negative for COVID-19 using a viral test, how many tested positive for influenza?



16

Of those CLI cases with previously pending results that tested negative for COVID-19 using a viral test, how many tested positive for another respiratory pathogen (e.g., RSV or Legionella)?



17

Of those persons symptomatic 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)?



18

Were there any additional symptomatic cases that were not accounted for by the questions above?

Please explain:



HOSPITALIZATIONS



19

How many symptomatic persons needed hospitalization (onboard or ashore) due to CLI or COVID-19?



20

Of those hospitalized due to CLI or COVID-19, how many required mechanical ventilation?



21

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 then tests NAAT-negative on the same day, do not report the initial antigen-positive result to EDC])‖

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 then tests NAAT-negative on the same day, do not report the initial antigen-positive result to EDC])‖

22

How many asymptomatic persons were tested for COVID-19 using a viral test after being identified as a close contact of a:

  1. Symptomatic person with CLI and a positive viral test , or

  2. Symptomatic person with CLI and a negative viral test result, or

  3. Asymptomatic person with a positive viral test result?



23

Of the asymptomatic persons tested for COVID-19 using a viral test after being identified as a close contact, how many tested positive?



24

Of the asymptomatic persons tested for COVID-19 using a viral test after being identified as a close contact, how many tested negative?



25

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)?



26

Of the asymptomatic persons tested for COVID-19 using a viral test after being identified as a close contact, how many results are pending?



27

If pending, please choose why (please circle all that apply): a) onboard testing capability for this ship is pending b) ran out of supplies (e.g., cartridges) c) technical/mechanical problems



28

Of the asymptomatic persons tested for COVID-19 using a viral test after being identified as a close contact with pending results on a previous EDC submission day, how many tested positive?



29

Of the asymptomatic persons tested for COVID-19 using a viral test after being identified as a close contact with pending results on a previous EDC submission day, how many tested negative?



30

Of the asymptomatic persons tested for COVID-19 using a viral test after being identified as a close contact with pending results on a previous EDC submission day, 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 then tests NAAT-negative on the same day, do not report the initial antigen-positive result to EDC])‖

31

How many asymptomatic persons were tested for COVID-19 using a viral test on the day of embarkation?



32

Of the asymptomatic persons tested for COVID-19 using a viral test on the day of embarkation, how many tested positive?



33

Of the asymptomatic persons tested for COVID-19 using a viral test on the day of embarkation, how many tested negative?



34

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)?



35

Of the asymptomatic persons tested for COVID-19 using a viral test on the day of embarkation, how many have pending results (Note: this applies to crew only)?



36

Of the asymptomatic crew members tested for COVID-19 using a viral test on the day of embarkation with pending results on a previous EDC submission day, how many tested positive?



37

Of the asymptomatic crew members tested for COVID-19 using a viral test on the day of embarkation with pending results on a previous EDC submission day, how many tested negative?



38

Of the asymptomatic crew members tested for COVID-19 using a viral test on the day of embarkation with pending results on a previous EDC submission day, how many were never able to register a positive or negative result (e.g., inconclusive or invalid result)?



END OF QUARANTINE SCREENING TESTING OF NEWLY EMBARKING NOT FULLY VACCINATED CREW

(Please report final screening test results only [e.g., if an asymptomatic person is antigen-positive then tests NAAT-negative on the same day, do not report the initial antigen-positive result to EDC])‖

39

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)?



40

Of the asymptomatic newly embarking crew members tested for COVID-19 using a viral test at the end of quarantine, how many tested positive?



41

Of the asymptomatic newly embarking crew members tested for COVID-19 using a viral test at the end of quarantine, how many tested negative?



42

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)?



43

Of the asymptomatic newly embarking crew members tested for COVID-19 using a viral test at the end of quarantine, how many have pending results?



44

Of the asymptomatic newly embarking crew members tested for COVID-19 using a viral test at the end of quarantine with pending results on a previous EDC submission day, how many tested positive?



45

Of the asymptomatic newly embarking crew members tested for COVID-19 using a viral test at the end of quarantine with pending results on a previous EDC submission day, how many tested negative?



46

Of the asymptomatic newly embarking crew members tested for COVID-19 using a viral test at the end of quarantine with pending results on a previous EDC submission day, 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 then tests NAAT-negative on the same day, do not report the initial antigen-positive result to EDC])‖

47

How many asymptomatic persons were tested for COVID-19 using a viral test for routine crew screening or passenger voyage testing?



48

Of the asymptomatic persons tested for COVID-19 using a viral test for routine crew screening or passenger voyage testing, how many tested positive?



49

Of the asymptomatic persons tested for COVID-19 using a viral test for routine crew screening or passenger voyage testing, how many tested negative?



50

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)?



51

Of the asymptomatic persons tested for COVID-19 using a viral test for routine crew screening, how many have pending results (Note: this applies to crew only)?



52

Of the asymptomatic persons tested for COVID-19 using a viral test for routine crew screening with pending results on a previous EDC submission day, how many tested positive?



53

Of the asymptomatic persons tested for COVID-19 using a viral test for routine crew screening with pending results on a previous EDC submission day, how many tested negative?



54

Of the asymptomatic persons tested for COVID-19 using a viral test for routine crew screening with pending results on a previous EDC submission day, how many were never able to register a positive or negative result (e.g., inconclusive or invalid result)?



DISEMBARKATION SCREENING TESTING OF NOT FULLY VACCINATED TRAVELERS

(Please report final screening test results only [e.g., if an asymptomatic person is antigen-positive then tests NAAT-negative on the same day, do not report the initial antigen-positive result to EDC])‖

55

How many asymptomatic persons were tested for COVID-19 using a viral test collected within 24 hours before disembarkation?



56

Of the asymptomatic persons tested for COVID-19 using a viral test collected within 24 hours before disembarkation, how many tested positive?



57

Of the asymptomatic persons tested for COVID-19 using a viral test collected within 24 hours before disembarkation, how many tested negative?



58

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)?



59

Of the asymptomatic persons tested for COVID-19 using a viral test collected within 24 hours before disembarkation, how many have pending results (Note: this applies to crew only)?



60

Of the asymptomatic crew members tested for COVID-19 using a viral test collected within 24 hours before disembarkation with pending results on a previous EDC submission day, how many tested positive?



61

Of the asymptomatic crew members tested for COVID-19 using a viral test collected within 24 hours before disembarkation with pending results on a previous EDC submission day, how many tested negative?



62

Of the asymptomatic crew members tested for COVID-19 using a viral test collected within 24 hours before disembarkation with pending results on a previous EDC submission day, how many were never able to register a positive or negative result (e.g., inconclusive or invalid result)?



63

Were there any additional asymptomatic cases that were not accounted for by the questions above?

Please explain:



Isolation Practices:

Were the following persons 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 influenza, Legionella, and respiratory syncytial virus (RSV)?

Note: Isolation may be discontinued for symptomatic persons with CLI or confirmed COVID-19 under conditions outlined at: www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html



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

† People are considered fully vaccinated: 

  • 2 weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or

  • 2 weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine

This definition applies to COVID-19 vaccines currently authorized for emergency use by the Food and Drug Administration: Pfizer-BioNTech, Moderna, and Johnson and Johnson (J&J)/Janssen COVID-19 vaccines. This definition can also be applied to COVID-19 vaccines that have been authorized for emergency use by the World Health Organization (e.g., AstraZeneca/Oxford).

‡ 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 0920-0900.

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