FAQs: Antimicrobial Use (AU) Synthetic Data Set (SDS)
Q1: When does Antimicrobial Use (AU) Synthetic Data Set (SDS) Validation start?
Vendors may send the NHSN SDS Team a passing AU Summary SDS Excel file to receive confirmation of successful AU SDS Validation beginning in January 2020.
Beginning in January 2021, NHSN will require all production AU Summary Clinical Document Architecture (CDA) files contain an SDS Validation ID, provided by the NHSN SDS Team after successful validation, and Vendor (Application) Object Identifier (OID). The NHSN application will reject AU Summary CDA files without this information.
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 will even require 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 9 below regarding Vendor OID.
Q5: The Office of the National Coordinator for Health Information Technology (ONC) already certified my software. Why do I need to go through the AU SDS Validation process?
The AU SDS process is specifically for testing whether your software properly aggregates AU data following the Antimicrobial Use and Resistance (AUR) Module Protocol definitions. This is separate and distinct from obtaining ONC Certificationexternal icon for the Centers for Medicare and Medicaid Services Promoting Interoperability Program, which simply tests whether the software can produce AU and Antimicrobial Resistance (AR) CDA files that pass basic schema validation. For additional information on Promoting Interoperability (formerly called Meaningful Use) as it relates to NHSN Antimicrobial Use and Antimicrobial Resistance (AUR) reporting please see the NHSN Meaningful Use Stage 3 webpage.
Q6: Will NHSN require SDS Validation for other types of data?
Currently, NHSN only requires vendors to complete the SDS Validation process for AU Summary files. The NHSN SDS Team plans to pilot AR Option SDS Validation in the future.
Q7: 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. NHSN encourages facilities to ask their vendor about their AU SDS Validation timeline to ensure it meets the 2021 requirement (see question 1). If you are searching for an AU CDA vendor for your facility, please review the guidance in question 23.
Q8: 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.
Q9: 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.
Q10: 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.
Q11: 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.
Q12: 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.
The NHSN SDS Team realizes that vendor systems have varying capabilities for capturing all drugs and all routes.
- If your system is not capable of reporting blank (or null) values for some of the routes of administration while reporting values for other routes (for example, reporting null for Penicillin V respiratory route while reporting numeric values for the remaining routes), please use the below NHSN SDS Validation Web Service link to validate your SDS file: https://nhsnpilot.ng.philab.cdc.gov/AUValidation-Zero/home.html.
- If your system can report blank (or null) values for some of the routes and while reporting numerical values for others, please use the below NHSN SDS Validation Web Service link to validate your SDS file: https://nhsnpilot.ng.philab.cdc.gov/AUValidation-Production/home.html.
Q13: 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.
Q14: 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.
Q15: 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.
Q16: 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.
Q17: 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.
Q18: 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.
Q19: 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.
Q20: 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.
Q21: 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.
Q22: 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 two months 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.
Q23: What is the difference between the vendors shown on the NHSN AU SDS website and the vendors shown on the Society of Infectious Diseases Pharmacists website?
The Society of Infectious Diseases Pharmacists websiteexternal icon lists vendors that self-identify as providing services and software that allow NHSN AUR Module participation. The NHSN AU SDS website lists vendors that completed the NHSN AU SDS validation process for their AU reporting solution. The validation process involves vendors using the AU Synthetic Data Set to demonstrate that their system can properly aggregate AU data following the AUR Module Protocol definitions. The NHSN application will require AU SDS Validation for all AU CDA vendors beginning in 2021.