[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3452-3453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01915]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2019-0007]


The National Healthcare Safety Network's Outpatient Procedure 
Component (OPC) Surveillance Protocol and the Bloodstream Infection 
(BSI) Surveillance Protocol; Request for Information

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Request for information.

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SUMMARY: The Centers for Disease Control and Prevention, in the 
Department of Health and Human Services, seeks information related to 
the surveillance protocols for the National Healthcare Safety Network's 
(NHSN) Outpatient Procedure Component (OPC) and Bloodstream Infection 
(BSI) Module of the Patient Safety Component. CDC is opening this 
docket to provide the opportunity to identify issues and areas for 
potential improvement for consideration as CDC updates and maintains 
the NHSN surveillance protocols beginning in 2020.

DATES: Written comments will be accepted beginning February 14, 2019 
and must be received on or before April 15, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
xxxx, by either of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Katherine Allen-Bridson, National Center for 
Emerging and

[[Page 3453]]

Infectious Zoonotic Disease, Centers for Disease Control and 
Prevention, 1600 Clifton Road NE, Mail Stop H16-3, Atlanta, GA 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to http://regulations.gov, including any personal 
information provided. For access to the docket to read background 
documents or comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Katherine Allen-Bridson, RN, BSN, 
MScPH, CIC, National Center for Emerging and Infectious Zoonotic 
Disease, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, Mail Stop H16-3, Atlanta, GA 30329. Phone: 404-639-4000; 
Email:[email protected].

SUPPLEMENTARY INFORMATION: 
    Purpose of the Notice: The purpose of this notice is to request 
input and information from individuals and organizations on issues and 
areas for potential improvement for consideration as CDC updates and 
maintains the NHSN surveillance protocols for 2020. CDC will carefully 
consider all comments with an intent to improve on and maintain the 
requirements for a successful surveillance program: Acceptable data 
collection burden, consistency, sensitivity, specificity, 
representativeness, and timeliness. The CDC reserves the right to 
respond to time-sensitive issues outside of this RFI as needed to 
maintain the reliability of the NHSN data.
    Scope of Issue: The mission of CDC's Division of Healthcare Quality 
Promotion (DHQP) is to protect patients and healthcare personnel and 
promote safety, quality, and value in national and international 
healthcare delivery systems. In accordance with this mission, DHQP 
seeks to identify effective prevention methods, foster their 
implementation, and measure their impact on the incidence of 
healthcare-associated infections (HAIs). Over 21,000 healthcare 
facilities report data on HAIs to CDC's NHSN. This includes data that 
CDC reports to the Centers for Medicare and Medicaid Services (CMS) on 
behalf of healthcare facilities. CMS uses the data in its public 
reporting and payment programs.
    Approach: CDC seeks information from NHSN users and stakeholders 
regarding the NHSN surveillance protocols, including comments that 
describe specific concerns about and recommendations for specific 
changes regarding the following topics: Protocol scope, definitions, 
criteria, data collection requirements, and other surveillance 
specifications for the OPC and BSI module.
    Also, CDC is exploring the possibility of adding a new HAI event to 
its surveillance protocols, hospital onset bacteremia (HOB). The scope 
of HOB's surveillance would be all bloodstream infections that develop 
in patients following hospital admission, i.e., those bloodstream 
infections that are not present on admission. Although this scope would 
be wider than Central Line-associated Bloodstream Infection (CLABSI) 
surveillance, CLABSI surveillance could be incorporated as a subset of 
HOB surveillance. CDC seeks input on NHSN's current CLABSI surveillance 
protocol and potential work on HOB surveillance.
    Potential Areas of Focus: CDC is interested in receiving 
information on issues and areas for potential improvement for 
consideration for the following:
    1. Outpatient Procedure Component surveillance protocol.
    2. Patient Safety Component Bloodstream Infection Module 
surveillance protocol.
    3. Possible addition of hospital onset bacteremia (HOB) to NHSN's 
surveillance protocols.
    Examples of the types of information valuable to CDC include:
    1. How could the CLABSI and OPC surveillance protocols and/or 
surveillance definitions be improved?
    2. What challenges are faced when applying these definitions? What 
could be added to the definitions to address these challenges?
    3. What protocol or data analysis changes could make the CLABSI or 
OPC data more useful?

    Dated: February 6, 2019.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2019-01915 Filed 2-11-19; 8:45 am]
 BILLING CODE 4163-18-P