Version 1.0.6 (Release July 2, 2019)

Demographics Form

  • Added answer option to Race list, ‘Caribbean’
  • Added answer option to Race list, ‘Mixed race’
  • Modified answer option on Race list, ‘Pacific Islander (Native Hawaiian)’ to remove (Native Hawaiian)

Diagnosis (Appendix B)

Diagnoses are reported on the Tier 1 and Tier 2 Surgery Forms in question 3
  • Added answer option of ‘Cardiac trauma’

Pre-operative Risk Factors (Appendix F)

Pre-operative risk factors are reported on the Tier 1 Surgery Form in question 6
  • Added answer option of ‘Greater than 2 hospital admission for non-cardiac infections in the last 3 months’.
  • Added answer option of ‘Malnutrition: as noted by the clinician in the History & Physical’

Version 1.0.4 (Release April 20, 2018)

Site Dashboard

  • The ‘Pending and In Progress’ Grid will now indicate forms that are past due by highlighting them in red. Forms are due within 30 days of the event that is being reported.

Reporting

  • Added ability to download, view, and sign off on reports. Centers will begin to receive monthly Data Quality Reports. Centers will review these reports, make any corrections as necessary in the database, and then sign off on the reports in the data entry system. Additional details and the first Data Quality Reports will be coming soon.

Tier 1 Surgery Form

  • Added answer option of ‘Pericardial Disease (Non Specific)’ under question 3, ‘Primary Cardiac Diagnosis’ (added April 24, 2018)
  • Added answer option of ‘Pericardial Disease (Non Specific)’ under question 4a, ‘Additional Cardiac Diagnosis’ (added April 24, 2018)

Tier 2 Surgery Form

  • Added answer option of ‘Pericardial Disease (Non Specific)’ under question 3, ‘Primary Cardiac Diagnosis’ (added April 24, 2018)
  • Added answer option of ‘Pericardial Disease (Non Specific)’ under question 4a, ‘Additional Cardiac Diagnosis’ (added April 24, 2018)

Post Op Events Form

  • Added answer option of ‘Pneumonia’ to question 1a, complications. (added April 24, 2018)

Version 1.0.3 (Release January 17, 2018)

Add Surgery Form

  • Previously this form collected the date of birth in the form of month/year. This field will now be collected as day/month/year.

Tier 2 Surgery Form (New Form)

  • A new form has been added to collect patient status at discharge for Tier 2 surgeries. This form will automatically generate for Tier 2 surgery patients and cannot manually be entered.

Death Form

  • Validations have been added to the death date to so that if intra-op mortality is reported as ‘yes’, the date of death on the death form will be required to be within one day of the Tier 1 Surgery date.
  • Additional validations within forms have been added so that if a death is reported on Tier 1 patients within another form a death form will automatically generate.

Version 1.0.2 (Release September 29, 2017)

Tier 1 Surgery form

  • A new question has been added (question 16) that asks, “Was sternum left open at the end of operation”.

Post Operative Events Form:

  • Question 2 (Non-Cardiac Operations within this admission) was previously a radio button where only one option could be selected. This question is now a ‘repeating section’ so the user can enter more than one operation and date.
  • Question 3 (Catheter-based Interventions within this admission) was previously a radio button where only one option could be selected. This question is now a ‘repeating section’ so the user can enter more than one intervention and date.

One Year Follow-up Form

  • Question 2 (Readmission for a Non-Cardiac Operations since completion of the post operative events form)was previously a radio button where only one option could be selected. This question is now a ‘repeating section’ so the user can enter more than one operation and date.
  • Question 3 (Catheter based Interventions since completion of the post operative events form) was previously a radio button where only one option could be selected. This question is now a ‘repeating section’ so the user can enter the more than one intervention and date.

Complications (Appendix H)

Complications are reported on the post operative events form in question 1.
  • Added answer option of Spinal cord injury, Neurological deficit persisting at discharge
  • Added answer option of Wound dehiscence-Median Sternotomy

Version 1.0.1 (Release March 22, 2017)

Tier 1 Surgery Form

Question 3 (Primary Cardiac Diagnosis)
  • If Hypoplastic Left Heart Syndrome (HLHS) is selected, two additional questions will drop down. New questions are:
    • Aortic Arch Coarctation (yes/no/unknown)?
    • Aortic Arch Hypoplasia (yes/no/unknown)?

Question 4a (Additional Cardiac Diagnoses)
  • If Hypoplastic Left Heart Syndrome (HLHS) is selected, two additional questions will drop down. New questions are:
    • i. Aortic Arch Coarctation (yes/no/unknown)?
    • ii. Aortic Arch Hypoplasia (yes/no/unknown)?

Tier 2 Surgery Form

Question 1 (Primary Cardiac Procedure)
  • “Other, specify” option added under the Miscellaneous Procedures category.

Question 2a (Additional Cardiac Procedures During the same OR Visit)
  • “Other, specify” option added under the Miscellaneous Procedures category.

Question 3 (Primary Cardiac Diagnosis)
  • If Hypoplastic Left Heart Syndrome (HLHS) is selected, two additional questions will drop down. New questions are:
    • i. Aortic Arch Coarctation (yes/no/unknown)?
    • i. Aortic Arch Hypoplasia (yes/no/unknown)?

Question 4a (Additional Cardiac Diagnoses)
  • If Hypoplastic Left Heart Syndrome (HLHS) is selected, two additional questions will drop down. New questions are:
    • i. Aortic Arch Coarctation (yes/no/unknown)?
    • ii. Aortic Arch Hypoplasia (yes/no/unknown)?
Security of Data Storage
The application database is hosted on servers that reside in the Assured Computing Platform (ACP), a FISMA compliant data center, located in the RUST Data Center Facility on campus at the University of Alabama at Birmingham (UAB). Location of the building is 815 18th Street South. Birmingham, Alabama 35233 (on the UAB Campus).

For more information on FISMA and its standards, please check these links: https://www.dhs.gov/fisma

The ACP is classified as FISMA moderate, based on the NIST 800-53 revision 4 publication, found here: http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf

The databases are hosted on Microsoft SQL Server 2012 instances, and use TDE for data encryption, which ensures at-rest security of all data, including backups.

For more information on TDE, please check this Knowledge Base article: https://msdn.microsoft.com/en-us/library/bb934049(v=sql.110).aspx

Data Transfer encryption (such as between a user's computer and the servers, or between the Application and the database) adheres to up-to-date, industry-standard TLS protocols with valid certificates. (TLS ECDHE RSA with AES 256 CBC SHA 265bit TLS 1.2)


Backups
Full data backups are taken nightly, and incremental backups are taken hourly. All backups are encrypted via TDE at the database level (SQL Server 2012). Full backups are replicated off site for Disaster Recovery purposes.


Administrative Responsibility of Servers
All servers involved with the World Database application are monitored by the ACP System Administrators, who are employees of the IT organization at UAB.