FAQs About NHSN Agreement to Participate and Consent
- What is the National Healthcare Safety Network (NHSN) Agreement to Participate and Consent, sometimes called the NHSN 308(d) document?
- Why do facilities have to accept the Agreement to Participate and Consent?
- When will facilities be able to review and accept the updated Agreement to Participate and Consent?
- What happens if a component has not agreed to the consent by April 14th, 2018?
- As a corporate health system group user, can I view the consent status of the facilities and components in my NHSN group?
- What does the agreement say?
- This is different than the previous agreement. Why?
- Do the new purposes include all data in NHSN, or just HAI data?
- What if other organizations want access to data from my facility?
- Will infection preventionists’ identity be protected?
- Will a facility user have access to a printable Agreement to Participate and Consent once it has been accepted?
- Will it be possible for a user to sign the new Agreement to Participate and Consent for multiple facilities at once?
- What else should I know?
Q: What is the National Healthcare Safety Network (NHSN) Agreement to Participate and Consent, sometimes called the NHSN 308(d) document?
A: The NHSN Agreement to Participate and Consent is a user agreement and data consent form required to use NHSN, the surveillance system for healthcare-associated adverse events, adherence to prevention practices, and antimicrobial use and resistance. The document details the purposes of NHSN and data access and protection provisions. Facilities that request NHSN access must have a facility administrator or primary contact review and accept the electronic form after informing a healthcare or residential facility executive of the terms of the agreement. Included in the NHSN Agreement to Participate and Consent is the Assurance of Confidentiality, which is a formal confidentiality protection authorized under Section 308(d) of the Public Health Service Act. This assurance covers those data that are voluntarily provided by healthcare facilities through NHSN that would permit identification of any individual or institution and guarantees the data will not otherwise be disclosed or released without the consent of the individual or the institution.
Q: Why do facilities have to accept the Agreement to Participate and Consent?
A: NHSN collects valuable information, some of which can be shared with territorial, local, state, and federal health authorities. Therefore, it is important for every healthcare facility to know exactly which entities have access to their data and for what purposes, and also which entities cannot have access to the data. Of course, individual facilities can share their data with other organizations as they deem fit. All newly enrolling facilities must accept the Agreement to Participate and Consent upon enrollment, and all currently participating facilities must accept or “re-consent” to the Agreement because the NHSN purposes have been recently updated with new provisions for sharing data with local and territorial health departments and with the Centers for Medicare and Medicaid Services (CMS).
Q: When will facilities be able to review and accept the updated Agreement to Participate and Consent?
A: Beginning in late January 2018, with the NHSN application release 8.8.1, all facility administrators and primary contacts will receive an e-mail notification that the new consent form is available. All facility administrators and primary contacts will then be able to electronically view and accept the Agreement to Participate and Consent, and all components are encouraged to agree to its terms by the deadline of April 14th, 2018 at 11:59 PST. Newly enrolling NHSN users have 60 days from enrollment to accept the Agreement to Participate and Consent.
NHSN Agreement to Participate and Consent [Video – 5 min]
Q: What happens if a component has not agreed to the consent by April 14th, 2018?
A: If a component has not agreed to the new consent form by the April 14th deadline, its NHSN functionality will be disabled until the consent form is accepted by the facility administrator or the primary contact.
Q: As a corporate health system group user, can I view the consent status of the facilities and components in my NHSN group?
A: During the re-consent process, NHSN will provide reports to corporate health system group users that will provide the consent status for the facilities in the NHSN group. Reports will be provided about one month before the deadline, one week before the deadline, and the day after the consent deadline. These reports will enable group users to know if any of the group facilities are close to missing the consent deadline and will facilitate outreach in hopes of mitigating barriers to NHSN reporting.
Q: What does the agreement say?
A: The agreement provides information about data confidentiality and data access. The updated data access provisions allow healthcare facility users to work closely with their respective health departments and to comply with Medicare reporting requirements.
With respect to health department collaboration, the new provisions enable CDC to provide state, local, and territorial health departments, at their request, with access to NHSN data via a data use agreement for surveillance and prevention purposes only (not for regulatory purposes). This will enable CDC to bring healthcare-associated infection (HAI) prevention efforts into the traditional public health model, working closely with state, local, and territorial health departments and healthcare facilities in their particular jurisdictions to reduce HAIs.
State, local, and territorial health departments requesting data access beyond a state, local, or territorial mandate will be required to enter into a signed data use agreement with CDC. When a request is accepted by CDC, the facilities involved will be notified and given the option to opt out of NHSN either partially or completely. Therefore, it will be important to know exactly what your facility reporting requirements are for territorial, local, state, and federal levels.
As part of CMS’ elective pay-for-reporting program, CDC will share with CMS HAI data for healthcare facilities that elect to participate in CMS’ Quality Reporting Programs. View the CMS quality reporting requirements for NHSN. As with all CMS healthcare quality measures, these statistics will be publicly reported on the CMS Compare websites.
In addition, the updated agreement grants CDC permission to share with CMS patient-level data and facility survey data as deemed required data in CMS rule-making and that are used by CMS for its program administration, monitoring and evaluation activities, including validation, appeals review, program impact evaluation, and development of quality measure specifications. The agreement also permits CDC to provide patient- and healthcare facility-level data, including annual facility survey data, to CMS for use by CMS programs in the design, operations, and evaluation of quality improvement programs in which healthcare facilities participate voluntarily. The NHSN purposes are also updated to provide facility-level information to state, local, or territorial health departments to facilitate HAI prevention efforts, and to provide patient- and facility-level data to health departments during an outbreak investigation to assist case-finding or outbreak control. Other than the purposes stated in the Agreement to Participate and Consent, CDC cannot release facility-level data to any person or organization. View the full text of the NHSN purposes as stated in the Agreement to Participate and Consent.
Q: This is different than the previous agreement. Why?
A: As HAI prevention continues to be recognized as a critical element of quality healthcare, the purpose of NHSN is expanding, and the impact of NHSN data is being greatly amplified. There are several drivers for this change.
First, CDC is striving to bring HAI prevention efforts in line with traditional public health response. In that effort, state, local, and territorial health departments are playing a strong role in monitoring and preventing HAIs; to further strengthen efforts, state, local, and territorial health authorities need more access to data. Regardless of mandate coverage, the new agreement grants data access to health departments for prevention and surveillance purposes only. (See previous question for details.)
In addition, the updated agreement grants CDC permission to share patient- and facility-level data CMS so that facilities can comply with the evolving requirements of CMS’ Quality Reporting, Value-Based Purchasing, and Hospital-Acquired Condition Reduction Programs.
(See previous question for details.)
Q: Do the new purposes include all data in NHSN, or just HAI data?
A: Some Component data are not included in the new purpose regarding data access for state, local, and territorial agencies. Please contact NHSN@cdc.gov to receive the list of data that are permitted and are not permitted as part of state, local and territorial health department data use agreements.
Q: What if other organizations want access to data from my facility?
A: Other than to state, local, and territorial health departments and CMS, CDC cannot grant data access to any organization. If other organizations request data access, CDC will direct them to contact individual facilities, which can grant data access privileges as they see fit through the NHSN Group Function.
Q: Will infection preventionists’ identity be protected?
A: CDC will not share the name of any individual infection preventionist or patient with any organization.
Q: Will a facility user have access to a printable Agreement to Participate and Consent once it has been accepted?
A: Yes. On the NHSN Facility Information page, the Components Followed table will include link to a printable consent form for each component that has accepted the form. The printable consent form will display the name of the facility administrator or primary contact and the date the form was electronically signed.
Q: Will it be possible for a user to sign the new Agreement to Participate and Consent for multiple facilities at once?
A: Yes. A facility administrator or primary contact will be able to accept the consent form for all facilities that are active and have an active component that matches the component that the facility administrator or primary contact is logged into. The facility administrator or primary contact will be able to select all facilities or individual facilities for which to accept the consent form.
A: CDC recognizes that this change presents a shift in the way HAI prevention has been traditionally addressed. We have been working with partners from across the healthcare spectrum to garner input and ensure smooth transition.
During the transition, it is important to remember that this new culture of HAI prevention highlights the importance of supporting a strong infection prevention program and enhances the role of healthcare epidemiologists and infection preventionists in overall facility performance. It is important for facility-based infection preventionists and state epidemiology staff to work closely together to maximize prevention efforts and to take advantage of mutually beneficial support and advocacy for resources, as well as technical implementation.
Extending the scope of HAI reporting means more data with which to target prevention, improve patient outcomes and reduce healthcare costs. Ultimately we want to eliminate all HAIs. We look forward to working with you along the way.
