FAQs: Antimicrobial Use (AU) Synthetic Data Set (SDS)

General

Q1: When does Antimicrobial Use (AU) Synthetic Data Set (SDS) Validation start?

Beginning in January 2020, vendors may send the NHSN Team a passing SDS Excel file in order to receive confirmation of successful AU SDS Validation.

Beginning in January 2021, NHSN will require that all production AU Summary Clinical Document Architecture (CDA) files contain the SDS Validation ID, provided by the NHSN Team after confirmation of successful validation, and Vendor (Application) Object Identifier (OID). AU Summary CDA files that do not contain this information will be rejected.

 

Q2: Are any vendors grandfathered in?

All vendors, regardless if they’ve been preparing and submitting AU CDA files for their facilities for years, will be required to complete the AU SDS Validation process. This includes “homegrown” internal facility IT or Informatics groups/vendors.

 

Q3: I’m a “homegrown” vendor. Do I still need to participate in the SDS process?

Yes. Even facilities that create their AU CDA files in-house using their own IT or Informatics resources will need to go through the AU SDS Validation process. Please note that “homegrown” vendors will also need to obtain a Vendor OID which is separate from the Facility OID. See FAQ question 8 below regarding Vendor OID.

 

Q4: My software has already been certified by The Office of the National Coordinator for Health Information Technology (ONC). Why do I need to go through the AU SDS Validation process?

The AU SDS process is specifically for testing whether the AU data have been aggregated properly 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 vendor 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 reporting please see the NHSN Meaningful Use Stage 3 webpage.

 

Q5: Will I be required to validate other NHSN data using this process?

At this time, only AU Summary files are required to complete the SDS Validation process. The NHSN Team plans to pilot AR Option SDS data in the future.

 

Q6: I’m at an AU reporting healthcare facility. How does this initiative affect me?

It’s important for AU reporters at facilities to be aware of the requirement and the validation status of their vendor. However, for facilities using an AU CDA vendor, there is no direct action needed from the facility. NHSN encourages facilities to ask their AU CDA vendor about their SDS Validation timeline to ensure it meets the 2021 requirement (see Q1). If you are searching for an AU CDA vendor, please review our webpage listing successful vendors (see Q21).

Vendor OID

Q7: I already include Facility OID in my AU CDA files. Do I still need a Vendor OID?

The Vendor (Application) OID is not the same as the Facility OID. The Facility OID is used to indicate the hospital/healthcare facility whose data are included in the CDA file so that the data can be uploaded into the appropriate NHSN facility. The Vendor OID is needed as part of the AU SDS Validation initiative so that NHSN can track the SDS Validation status of vendors and their software.

 

Q8: How do I obtain a Vendor OID?

The Vendor (Application) OID is assigned by the CDC’s Public Health Information Network Helpdesk and is unique for each Vendor. The instructions for obtaining a Vendor OID are available 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 that software will therefore include the same Vendor (Application) OID.

AU Synthetic Data Set

Q10: Where can I find the AU Synthetic Data Set?

The data set and detailed instructions are available for download on our AU Synthetic Data Set Validation webpage.

 

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, since these are common formats and most vendors could consume the synthetic data into their system with minimal effort compared to other formats.

Using the AU Synthetic Data Set

Q12: I’ve processed the Synthetic Data Set through my software application and created an Excel file of the aggregated AU data. What do I do next?

The vendor should upload that Excel file to the NHSN AU Data web service tool to validate the aggregated AU data against the answer key. This step can be completed as many times as needed to obtain an error-free file.

 

Q13: I’ve received errors after uploading my Excel file into the web service tool. Where do I go for help interpreting them?

Email questions to NHSNCDA@cdc.gov.

 

Q14: I’ve internally tested my Excel file using the NHSN AU Data web service tool and received no errors. What do I do next?

The vendor should 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
  • Technical Point of Contact (one primary person but you may cc others on file submission)

If any of the information above is missing, the NHSN Team will not process your request.

AU CDA Author Section

Q15: How should the author section of the AU CDA be set up?

Once the vendor has received notification back from the NHSN 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 the AU CDA. Below is an example of the Extensible Markup Language (XML) coding of the author field.

An example of the XML coding of the author field for AU CDA files

 

Q16: Which author fields are required in the AU CDA file?

The assigned author ID root and extension are required to be populated in the AU CDA file per the Implementation Guide. Vendor name, vendor software name, software version and release are currently optional fields. Vendors are highly encouraged to include these additional fields to assist with troubleshooting. The below table contains the XML Path (XPath) Language for the author section within the AU Summary CDA files:

table contains the XML Path (XPath) Language for the author section within the AU Summary CDA files

Re-validation Requirements

Q17: How often do I need to validate?

This process is expected to be completed once per vendor per software version. All client facilities using the same software version will have the exact same information in the author fields of the AU Summary CDA files. The NHSN Team expects to have vendors recomplete the AU SDS Validation process only when major changes have been made to the AU Option Protocol.

 

Q18: If new drugs are added or removed from the AU Option protocol, does that mean I need to undergo AU SDS Validation again?

No. We do not anticipate a change to an NHSN value set such as the addition or deletion of drugs will require a vendor to re-validate as the process of aggregating AU data should not be impacted.

 

Q19: If my software changes, do I need to revalidate?

Vendors should complete the re-validation process when major changes are made to their software that affect the AU Summary data aggregation.

 

Q20: I have 3 different versions of the same software in production across multiple facilities. Do I need to validate all of them?

Yes. Vendors should validate each software version. Vendor information including software name and software version will be posted on the NHSN website.

Posting of Successful Vendors

Q21: How will my customers know if I’ve passed AU SDS?

A list of vendors that have passed AU SDS Validation will be posted on the NHSN website starting in 2020.

 

Q22: How long will it take to post vendor information on the NHSN website?

Once a file is received, the NHSN Team will record the vendor information, test the file, document the findings, and then submit the passing vendor information for website posting. We anticipate it could take up to two months from the time a vendor sends a successful AU SDS Excel file to the time vendor information is posted on the website.