Enhanced Data Collection during COVID-19 Pandemic

Phased Approach to the Resumption of Cruise Ship Passenger Operations

Attachment H. Enhanced Data Collection (EDC) During COVID-19 Pandemic Form

Enhanced data collection during COVID-19 Pandemic (daily)

OMB: 0920-1335

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OMB Approved

Control No. XXXX-XXX

Exp. XX/XX/XXXX

Enhanced Data Collection (EDC) During COVID-19 Pandemic

**Please submit to [email protected] daily by 0900 ET**

Directions: Please enter all data for;

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

(i.e., report submitted by 0900 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

    • Quarantine day 14 screening of newly embarking crew

    • Routine screening

    • Disembarkation day 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.

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):

Total # of travelers onboard:

Crew

Passengers

Latitude:

Longitude:



Important Reminders About COVID-19 and Influenza

Testing for COVID-19 via Nucleic Acid Amplification Test (NAAT)

  • If separate nasopharyngeal specimens are collected for multiple tests (e.g., COVID-19 NAAT and influenza rapid antigen test) among symptomatic persons, these specimens should be collected from alternating nostrils of the case-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 result and should not be reported.

  • 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 C 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 testing (applies to crew only)

  • Quarantine day 14 testing (applies to crew only)

  • Routine testing (applies to crew only)

  • Disembarkation testing (applies to crew only)


Symptomatic Case Counts with Viral Testing:

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 via a nucleic acid amplification test (NAAT), such as:

  • reverse transcription polymerase chain reaction PCR (RT–PCR), or

  • transcription-mediated amplification (TMA), or

  • reverse transcription loop-mediated isothermal amplification (RT-LAMP)?



3

Of those CLI cases tested for COVID-19 via a NAAT, how many tested positive?



4

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



5

Of those CLI cases tested for COVID-19 via a NAAT, how many tested negative?



6

Of those CLI cases that tested negative for COVID-19 via a NAAT, how many tested positive for influenza?



7

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



8

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



9

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



12

Of those CLI cases that tested positive for COVID-19 via a NAAT 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 via a NAAT with pending results on a previous EDC submission day, how many tested negative?



14

Of those CLI cases tested for COVID-19 via a NAAT 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 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)?



16

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

Please explain:



HOSPITALIZATIONS



17

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



18

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



19

Of those hospitalized due to CLI or COVID-19, how many were medically evacuated from the ship?



Asymptomatic Case Counts with Viral Testing:

Enter Numbers Below

(Unless Otherwise Specified)

Crew

Passengers

IDENTIFIED CLOSE CONTACT TESTING

20

How many asymptomatic persons were tested for COVID-19 via a NAAT after being identified as a close contact of a:

  1. Symptomatic person with CLI and a positive NAAT result, or

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

  3. Asymptomatic person with a positive NAAT result?



21

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



22

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



23

Of the asymptomatic persons tested for COVID-19 via a NAAT 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)?



24

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



25

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



26

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



27

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



28

Of the asymptomatic persons tested for COVID-19 via a NAAT 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 TESTING

29

How many asymptomatic persons were tested for COVID-19 via a NAAT on the day of embarkation?



30

Of the asymptomatic persons tested for COVID-19 via a NAAT on the day of embarkation, how many tested positive?



31

Of the asymptomatic persons tested for COVID-19 via a NAAT on the day of embarkation who tested positive, how many cases were persistent positives (i.e., viral debris/dead bugs)?

Note: CDC cannot make a persistent positive determination without submission of a previously positive NAAT result within the specified time period.



32

Were the previously positive NAAT results sent to CDC Maritime Unit: [email protected]? (please circle one) Yes/No



33

Of the asymptomatic persons tested for COVID-19 via a NAAT on the day of embarkation, how many tested negative?



34

Of the asymptomatic persons tested for COVID-19 via a NAAT 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 via a NAAT 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 via a NAAT 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 via a NAAT 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 via a NAAT 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)?



QUARANTINE DAY #14 TESTING OF NEWLY EMBARKING CREW

39

How many asymptomatic newly embarking crew members were tested for COVID-19 via a NAAT on day #14 of quarantine (i.e., prior to leaving quarantine)?



40

Of the asymptomatic newly embarking crew members tested for COVID-19 via a NAAT on day #14 of quarantine, how many tested positive?



41

Of the asymptomatic newly embarking crew members tested for COVID-19 via a NAAT on day #14 of quarantine, how many tested negative?



42

Of the asymptomatic newly embarking crew members tested for COVID-19 via a NAAT on day #14 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 via a NAAT on day #14 of quarantine, how many have pending results?



44

Of the asymptomatic newly embarking crew members tested for COVID-19 via a NAAT on day #14 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 via a NAAT on day #14 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 via a NAAT on day #14 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 TESTING

47

How many asymptomatic persons were tested for COVID-19 via a NAAT for routine crew screening or passenger voyage testing?



48

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



49

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



50

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



52

Of the asymptomatic persons tested for COVID-19 via a NAAT 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 via a NAAT 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 via a NAAT 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 DAY TESTING

55

How many asymptomatic persons were tested for COVID-19 via a NAAT on the day of disembarkation?



56

Of the asymptomatic persons tested for COVID-19 via a NAAT on the day of disembarkation, how many tested positive?



57

Of the asymptomatic persons tested for COVID-19 via a NAAT on the day of disembarkation, how many tested negative?



58

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



60

Of the asymptomatic crew members tested for COVID-19 via a NAAT on the day of disembarkation with pending results on a previous EDC submission day, how many tested positive?



61

Of the asymptomatic crew members tested for COVID-19 via a NAAT on the day of disembarkation with pending results on a previous EDC submission day, how many tested negative?



62

Of the asymptomatic crew members tested for COVID-19 via a NAAT on the day of 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:

  • NAAT-positive for COVID-19 (i.e., confirmed COVID-19), 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



Public reporting burden of this collection of information is estimated to average 15 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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