FAQs: Antimicrobial Use (AU) Synthetic Data Set (SDS)
General
Q1: When was the Antimicrobial Use (AU) Synthetic Data Set (SDS) Validation initially released and what is required now?
The initial AU SDS validation requirement began in January 2021, requiring all production AU Summary Clinical Document Architecture (CDA) files to contain an AU SDS Validation ID, provided by the NHSN AUR Team after successful validation, and a Vendor (Application) Object Identifier (OID). The NHSN application began rejecting AU Summary CDA files without this information for files dated January 2021 and forward.
In the fall of 2024, the NHSN SDS Team released v5.0 of the AU SDS. All vendors creating AU CDA files are required to re-validate their software against AU SDS v5.0 prior to March 2025. AU CDA files for March 2025 and forward will be rejected by the NHSN application if they do not contain an updated AU SDS Validation ID.
Q2: Where can I find the AU Synthetic Data Set?
The NHSN SDS Team provides the AU Synthetic Data Set and detailed instructions for its use for download on the AU Synthetic Data Set Validation webpage.
Q3: Are any vendors grandfathered in?
No. NHSN will require all vendors, regardless if they’ve been preparing and submitting AU CDA files for their facilities for years, to complete the AU SDS Validation process. This includes “homegrown” internal facility information technology (IT) or informatics groups/vendors.
Q4: I’m a “homegrown” vendor. Do I still need to participate in the SDS process?
Yes. NHSN requires facilities that create their AU CDA files in-house using their own “homegrown” IT or informatics resources to go through the AU SDS Validation process. Please note that “homegrown” vendors also need to obtain a Vendor OID, which is separate from the Facility OID. See question 8 below regarding Vendor OID.
Q5: Will NHSN require SDS Validation for other types of data?
Currently, NHSN requires vendors to complete the SDS Validation process for both AU and AR files to be able to successfully submit AU/AR data in production.
Q6: I work at a facility that reports AU data to NHSN. How does this initiative affect me?
It’s important for facilities to be aware of the AU SDS Validation requirements and the validation status of their vendor. However, NHSN does not require any direct actions from facilities using a vendor to submit AU data to NHSN. If you are searching for an AU CDA vendor for your facility, please review the list of vendors that have successfully passed AU SDS Validation.
Vendor OID
Q7: I already include the Facility OID in my AU CDA files. Do I still need a Vendor OID?
The Vendor (Application) OID is different from the Facility OID. The NHSN application uses the Facility OID to identify the facility in each CDA file so the data can be uploaded into the appropriate NHSN facility. NHSN uses the Vendor OID to track the SDS Validation status of vendors and their software.
Q8: How do I obtain a Vendor OID?
CDC’s Public Health Information Network Helpdesk assigns the Vendor (Application) OID. The Vendor OID is unique for each Vendor. You can find instructions for obtaining a Vendor OID on the Vendor OID webpage.
Q9: Will I use a single Vendor OID on all AU files created by my software?
Yes. The Vendor (Application) OID is specific to the vendor software. All AU CDAs produced by your software will include the same Vendor (Application) OID.
Using the AU Synthetic Data Set
Q10: Why is the Synthetic Data Set in Comma Separated Values (CSV) and My Structured Query Language (MySQL) format?
We chose the two source data formats, CSV and MySQL database export, because these are common formats and most vendors can import these formats with minimal effort compared to other formats.
Q11: I’ve processed the Synthetic Data Set through my software application and created the AU Summary SDS Excel file of the aggregated AU data. What do I do next?
Upload that AU Summary SDS Excel file to the NHSN SDS Validation Web Service to validate the aggregated AU data against the answer key. You can complete this step as many times as needed to obtain an error-free file.
Q12: I’ve received errors after uploading my AU Summary SDS Excel file into the web service tool. Where do I go for help interpreting them?
Email questions about the NHSN AU SDS Validation Process to NHSNCDA@cdc.gov.
Q13: I’ve internally tested my AU Summary SDS Excel file using the NHSN AU Data web service tool and received no errors. What do I do next?
Send that same AU Summary SDS Excel file and the following information to NHSNCDA@cdc.gov:
- Vendor (Application) OID (instructions for obtaining OID)
- Vendor Name
- Vendor Software Name
- Vendor Software Version/Release
- Technical Point of Contact (one primary person but you may cc others on file submission emails)
- SDS Validation Web Service URL used for testing
- Vendor Website (optional)
If any of the information above is missing, the NHSN AU SDS Team will not process your request.
AU CDA Author Section
Q14: How should the author section of the AU CDA be set up?
Once the vendor receives notification from the NHSN AU SDS Team that the AU Summary SDS Excel file passed validation, the SDS Validation ID and vendor information can be included in the author section of AU CDA files. Below is an example of the Extensible Markup Language (XML) coding of the author field.
Q15: Which author fields does the NHSN application require in the AU CDA file?
The NHSN application requires vendors to populate the assigned author ID root and extension in the AU CDA file per the Implementation Guide. Vendor name, vendor software name, software version, and release are currently optional fields. The NHSN AU SDS Team encourages vendors to include these additional fields to assist with troubleshooting. The table below contains the XML Path (XPath) Language for the author section within the AU Summary CDA files.
Re-Validation Requirements
Q16: How often do I need to re-validate?
The NHSN AU SDS Team expects vendors to complete the AU SDS Validation process once per software version. All client facilities using the same software version will have the same information in the author fields of their AU Summary CDA files. The NHSN Team expects to have vendors re-validate only when NHSN makes major changes to the AU Option Protocol. When these changes occur and re-validation is necessary, NHSN will inform the vendor community via email, NHSN Newsletter and NHSN Vendor webinar of need to re-validate.
Q17: Do I have to re-validate if NHSN adds or removes antimicrobials from the AU Option protocol?
No. The NHSN AU SDS Team does not require vendors to re-validate following addition or deletion of antimicrobials from the NHSN AU value set, as this should not impact the process of aggregating AU data.
Q18: If I change my software, do I need to re-validate?
Vendors should re-validate only when they make major changes to their software that affect AU Summary data aggregation.
Q19: I have three different versions of the same software in production across multiple client facilities. Do I need to validate all of them?
Yes. Vendors should validate each version of their software. NHSN will post vendor information, including software name and software version/release, on the NHSN AU SDS website.
Posting of Successful Vendors
Q20: How will my clients know if I’ve passed AU SDS Validation?
NHSN posts a list of vendors that have passed AU SDS Validation on the NHSN AU SDS website.
Q21: How long will it take to post vendor information on the NHSN website?
Once the NHSN AU SDS Team receives a file, they will record the vendor information, test the file, document the findings, and then submit passing vendor information for website posting. The NHSN AU SDS Team anticipates it could take up to one month from the time a vendor sends a successful AU Summary SDS Excel file to the time NHSN AU SDS Team posts their information on the website.