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Attachment J.1 - Data Reporting Requirements
Testing data enumerated in sections A through C below shall be reported daily to the HHS Protect system or other system designated by the Government. Test result and patient data shall be reported in HHS Protect within 24 hours of receipt of result interpretation.
A. Test-Related Fields
| Field Name |
| Format |
| Description/Options |
| Example |
| Resulted Date |
| MM/DD/YYYY |
| The date the sample is resulted. |
| 11/01/2021 |
| Facility ID |
| Defined by Contractor or Government |
| Unique identifier for each site. Contractor shall obtain approval from the Government for the Facility ID. |
| P2000 |
| Collected Date |
| MM/DD/YYYY |
| The date the sample was collected |
| 11/01/2021 |
| Test Results |
| String |
| Positive, Negative, Indeterminate |
| Positive |
| Test Type |
| String |
| Options to be defined by the Government |
| Swab and Send |
| Test ID |
| String |
| Unique identifier for each test to prevent duplicate result submission |
| Budgetary Test Type |
| String |
| Options to be defined by the Government to aid in reconciling invoices submitted by the Contractor |
| Point-of-Care Test - Pharmacy |
B. Patient-Related Fields
| Field Name |
| Format |
| Description/Options |
| Example |
| Patient Residence County |
| County name |
| The county (not the city) where the patient resides. |
| Harris |
| Patient Residence State |
| 2-letter state abbreviation |
| The state where the patient resides. |
| TX |
| Age |
| Single year age 0-120 |
| The age of the patient at the time of the test. Ages 85+ will be aggregated upon ingestion to the data system. |
| 32 |
| Patient Gender |
| String |
| Male, Female, Other, Not Reported |
| Female |
| Patient Race |
| String |
| American Indian or Alaska Native; Asian; Black or African American; Native Hawaiian or Other Pacific Islander; White; Other; Not Reported |
| Asian |
| Patient Ethnicity |
| String |
| Hispanic/Latino; Non-Hispanic/Latino; Not Reported |
| Hispanic/Latino |
| Patient ID |
| String |
| Unique identifier for the patient, if available, subject to the condition that the identifier cannot be linked back to the patient |
C. Screening Questions Fields
| Field Name |
| Format |
| Description/Options |
| Example |
| Patient Symptom Status |
| String |
| Result of patient screening question that enumerates a set of COVID-19-related symptoms. If the patient selects one or more symptoms, they are deemed Symptomatic. If not, they are deemed Asymptomatic. |
| Asymptomatic |
| Patient Exposure |
| Yes/No |
| Result of patient screening question that seeks to identify if a patient is a close contact of a confirmed case of COVID-19. |
| Yes |
| Patient Travel |
| Yes/No |
| Result of patient screening question that seeks to identify if a patient has recently traveled or will travel in the near future. |
| No |
| Patient Underlying Conditions |
| Yes/No |
| Result of patient screening question that enumerates a set of underlying conditions that are thought to increase risk for severe COVID-19 infection. If the patient selects one or more conditions, the result is Yes. If not, the result is No. |
| No |
| Patient Immunocompromised Status |
| Yes/No |
| Result of patient screening question that enumerates a set of underlying conditions that are thought to indicate immunocompromised status. If the patient selects one or more conditions, the result is Yes. If not, the result is No. |
| Yes |
| Patient Pregnancy Status |
| Yes/No |
| Result of patient screening question that seeks to identify if the patient is pregnant. |
| Yes |
| Patient Vaccination Status |
| Yes/No |
| Result of patient screening question that seeks to identify if the patient has received one or more COVID-19 vaccination doses. |
| Yes |
| Patient Doses Received |
| 1, 2, 3 |
| Result of patient screening question that seeks to identify number of COVID-19 vaccination doses received. If patient is not vaccinated, field is left blank. The Government reserves the right to change the number of doses captured in this question subject to FDA and CDC guidance on booster doses. |
| 2 |
| First vaccine type |
| Pfizer-BioNTech, Moderna, J&J, Other |
| Result of patient screening question that seeks to identify the manufacturer of each vaccination dose. If patient is not vaccinated, field is left blank. The Government reserves the right to change the number of doses captured in this question subject to FDA and CDC guidance on approved vaccines. |
| Pfizer-BioNTech |
| Second vaccine type |
| Pfizer-BioNTech, Moderna, J&J, Other |
| Result of patient screening question that seeks to identify the manufacturer of each vaccination dose. If patient is not vaccinated, field is left blank. The Government reserves the right to change the manufacturers in this question subject to FDA and CDC guidance on approved vaccines. |
| Pfizer-BioNTech |
| Third vaccine type |
| Pfizer-BioNTech, Moderna, J&J, Other |
| Result of patient screening question that seeks to identify the manufacturer of each vaccination dose. If patient is not vaccinated, field is left blank. The Government reserves the right to change the manufacturers in this question subject to FDA and CDC guidance on approved vaccines. |
| Pfizer-BioNTech |
| Fourth vaccine type |
| Pfizer-BioNTech, Moderna, J&J, Other |
| Result of patient screening question that seeks to identify the manufacturer of each vaccination dose. If patient is not vaccinated, field is left blank. The Government reserves the right to change the manufacturers in this question subject to FDA and CDC guidance on approved vaccines. |
| Pfizer-BioNTech |
| First vaccination date |
| Month and year of vaccination |
| Result of patient screening question that seeks to identify the time of each vaccine dose. If patient is not vaccinated, field is left blank. The Contractor shall report this to the Government in the form of MM/01/YYYY. |
| 10/01/2021 |
| Second vaccination date |
| Month and year of vaccination |
| Result of patient screening question that seeks to identify the time of each vaccine dose. If patient is not vaccinated, field is left blank. The Contractor shall report this to the Government in the form of MM/01/YYYY. |
| 10/01/2021 |
| Third vaccination date |
| Month and year of vaccination |
| Result of patient screening question that seeks to identify the time of each vaccine dose. If patient is not vaccinated, field is left blank. The Contractor shall report this to the Government in the form of MM/01/YYYY. |
| 10/01/2021 |
| Fourth vaccination date |
| Month and year of vaccination |
| Result of patient screening question that seeks to identify the time of each vaccine dose. If patient is not vaccinated, field is left blank. The Contractor shall report this to the Government in the form of MM/01/YYYY. |
| 10/01/2021 |
| Two weeks since last dose? |
| Yes/No |
| Result of patient screening question that seeks to identify, when final dose of vaccination was received in the current or previous month, if the dose was at least two weeks in the past. If patient was vaccinated prior to the previous month or is unvaccinated, field is left blank. |
| Yes |
| Patient past positive test |
| Yes/No |
| Result of patient screening question that seeks to identify if the patient has tested positive for COVID-19 in the past. |
| No |
| Patient positive test within 90 days |
| Yes/No |
| Result of patient screening question that seeks to identify if the patient has tested positive for COVID-19 in the past 90 days. If patient has never tested positive for COVID-19, field is left blank. |
| Yes |
| Patient positive test prior to 90 days |
| Yes/No |
| Result of patient screening question that seeks to identify if the patient has tested positive for COVID-19 prior to the past 90 days. If patient has never tested positive for COVID-19, field is left blank. |
| Yes |
A draft of the screening questions provided by the Government is included in this Statement of Work under Exhibit A, ICATT Pharmacy Screening Questions. The Contractor shall use these screening questions in the wording provided by the Government. However, the Contractor may consult with the Government on modifying question wording or response options to suit its testing circumstances.
The Contractor may ask additional screening questions subject to the following conditions:
· The Government-provided screening questions are the first screening questions asked.
· Additional questions are approved by the Government.
The Contractor may report additional fields upon Government approval. The Contractor is not required to report the results of additional questions that it may ask.
D. Testing Site Data Testing site data shall be reported by the Contractor to the Government in advance of the site beginning testing. Testing at any site is subject to Government approval. Testing site data shall be reported by the Contractor to the HHS Protect system or other system designated by the Government.
| Field Name |
| Format |
| Description/Options |
| Example |
| Facility ID |
| Defined by Contractor or Government |
| Unique identifier for each site. Contractor shall obtain approval from the Government for the Facility ID. |
| P2000 |
| Subcontractor |
| String |
| If Contractor has a Subcontractor arrangement, the Contractor will identify their Subcontractor to the Government. |
| Topco-eTN |
| Site Description |
| String |
| Description of testing site to include relevant details at discretion of Government and Contractor. |
| Store #10000 |
| Address |
| Address |
| Address of testing site |
| 100 S Main St |
| City |
| City |
| City of testing site |
| Houston |
| State |
| Two-letter state abbreviation |
| State of testing site |
| AK |
| ZIP Code |
| ZIP |
| 5-digit ZIP code of testing site |
| 10000 |
| Go Live Date |
| MM/DD/YYYY |
| Date site will begin testing. |
| 11/01/2021 |
E. Over-the-Counter Test Sales Under an executed data use agreement, the Contractor shall provide to the Government aggregate sales data related to over-the-counter COVID-19 tests. The Contractor shall provide at least aggregated national sales data on a weekly basis by count of item(s) sold. If available, the Contractor shall provide sales data at the state and/or distribution center level. If available, the Contractor shall provide data on inventory in stock. Over-the-counter sales data shall be reported via email to the Government or its designee, to the HHS Protect system, or to another system designated by the Government.
F. Site Metadata The Contractor shall provide the Government with the operating hours of its testing sites. The Contractor shall provide the Government information on the testing capacity available at its sites, including, if available, information on the number or percentage of appointments dedicated to ICATT-funded tests. The Contractor shall provide the Government information on the tests available for patients at each of its testing sites (e.g. POC, lab-based PCR).
Exhibit A: ICATT Pharmacy Screening Questions
| Question |
| Response Options |
| Reporting Field Name |
| Reporting Field Options |
| 1. |
| In the last 14 days, have you experienced any of these symptoms? Select all that apply. |
| fever |
cough shortness of breath recent loss of sense of smell or taste muscle pain fatigue chill headache, sore throat congestion/runny nose vomiting diarrhea (checkbox, select all that apply)
| symptom_status |
| Asymptomatic |
Symptomatic Not Reported
| 2. |
| In the last 14 days, have you had contact with someone who has a suspected or confirmed case of COVID-19? Count any contact that lasted longer than 15 minutes, closer than 6 feet away. |
| Yes/No |
| recent_contact |
| Yes |
No Not Reported
| 3. |
| Are you seeking a COVID-19 test because you have either recently returned from travel or are planning on traveling soon? |
| Yes/No |
| traveling |
| Yes |
No Not Reported
| 4. |
| Has a healthcare worker ever diagnosed you with any of the following? Select all that apply. |
| Heart conditions |
High blood pressure Overweight or obesity Diabetes Current or former smoker Kidney failure or end stage renal disease Cirrhosis of the liver Chronic lung disease, such as COPD, moderate to severe asthma, cystic fibrosis, or pulmonary embolism Immunocompromised state, such as from immunocompromising medications, solid organ or blood stem cell transplant, HIV, or other immunocompromising conditions (checkbox, select all that apply) underlying_conditions (If any box other than immunocompromised state checked) Yes No Not Reported immunocompromised (If immunocompromised checked) Yes No Not Reported
| 5. |
| Are you pregnant? |
| Yes/No |
| pregnant |
| Yes |
No Not Reported
| 6. |
| Have you had a COVID-19 vaccine? |
| Yes/No |
| has_received_vaccine |
| Yes |
If yes:
| 6a. |
| How many doses have you received? |
| 1 / 2 / 3 / 4 (bubbles) |
| received_doses |
| 1 |
For each dose:
| 6b. |
| Which vaccine have you had? |
| Pfizer-BioNTech, Moderna, Johnson & Johnson / Janssen, Other (bubbles) |
| first_vaccine_type |
second_vaccine_type third_vaccine_type fourth_vaccine_type Pfizer-BioNTech, Moderna, J&J, Other Not Reported
| 6c. |
| Time of shot |
| Month and year (drop downs) |
| first_vaccination_date |
second_vaccination_date third_vaccination_date fourth_vaccination_date First of the month
If final shot received in current or previous month:
| 6d. |
| Has it been two weeks since your most recent dose? |
| Yes/No |
| two_weeks_since_dose |
| Yes |
No Not Reported
| 7. |
| Have you tested positive for COVID-19 in the past? |
| Yes/No |
| past_positive_test |
| Yes |
If yes:
| 7a. |
| Did you receive this positive test… |
| Within the last 90 days, Prior to the last 90 days (checkbox, can select both) |
| past_positive_test_ |
within_90_days past_positive_test_ prior_to_90_days Yes
Notes:
· Please continue to ask any other questions necessary for CARES Act reporting requirements or other state-mandated requirements.
· ICATT requests any data pharmacies have on completion rates of the existing screeners. ICATT will conduct an analysis of this data before and after implementation of the revised questions in partnership with each pharmacy partner if desired.
· ICATT requests that this screener be implemented as soon as possible and that the timeline of implementation be communicated to ICATT.