Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

# AGENCY:

Department of Health and Human Services, Office of the Assistant Secretary for Health, Office of Healthcare Quality.

# ACTION:

Notice.

# SUMMARY:

The Office of Healthcare Quality is soliciting public comment on three new strategies or modules of the “HHS Action Plan to Prevent Healthcare-Associated Infections.” To further the HHS mission to protect the health and well-being of the nation, the HHS Steering Committee for the Prevention of Healthcare-Associated Infections has developed draft comprehensive strategies for preventing and reducing healthcare-associated infections in ambulatory surgical centers and end-stage renal disease facilities, as well as a strategy to increase influenza vaccination coverage among healthcare personnel. These Tier 2 modules build upon and are to be included in the existing “HHS Action Plan to Prevent Healthcare-Associated Infections” that focuses on reducing hospital-acquired infections (Tier 1).

# DATES:

Comments on the draft Tier 2 modules should be received no later than 5 p.m. on October 11, 2010.

# ADDRESSES:

                        The draft Tier 2 modules can be found at                         *http://www.hhs.gov/​ophs/​initiatives/​hai/​actionplan/​index.html#tier2*. Comments are preferred electronically and may be addressed to                         *OHQ@hhs.gov*. Written responses should be addressed to the Department of Health and Human Services, 200 Independence Ave, SW., Room 719B, Washington, DC 20201, Attention: Draft Tier 2 Modules.                    

# FOR FURTHER INFORMATION CONTACT:

                        Danielle Doughman, (202) 690-6476 or                         *OHQ@hhs.gov*.                    

# SUPPLEMENTARY INFORMATION

## I. Background

Healthcare-associated infections are among the leading causes of morbidity and mortality in the United States and the most common type of adverse event in the field of healthcare today. They are defined as localized or systemic adverse events, resulting from the presence of an infectious agent or toxin, occurring to a patient in a healthcare setting. An epidemiologic study by the Centers for Disease Control and Prevention (CDC) revealed that the subset of HAIs with hospital-onset accounted for 1.7 million infections annually and were associated with 99,000 deaths in 2002. The fiscal cost is steep as well. Healthcare-associated infections contribute to an additional $28 to $33 billion dollars in healthcare expenditures annually.

For these reasons, the prevention and reduction of healthcare-associated infections is a top priority for the U.S. Department of Health and Human Services (HHS). Multiple agencies within HHS have been working to reduce the incidence and prevalence of healthcare-associated infections for decades. To further efforts, the HHS Steering Committee for the Prevention of Healthcare-Associated Infections was established in July 2008 and charged with developing a comprehensive strategy to progress toward the elimination of healthcare-associated infections.

In 2009, the Steering Committee issued the initial version of the “HHS Action Plan to Prevent Healthcare-Associated Infections.” The initial strategy (Tier 1) focused on the prevention of infections in the acute care hospital setting and includes a prioritized research agenda; an integrated information systems strategy; policy options for linking payment incentives or disincentives to quality of care and enhancing regulatory oversight of hospitals; and a national messaging plan to raise awareness of HAIs among the general public, providers, and other stakeholder groups. The Action Plan also delineates specific measures and five-year goals to focus efforts and track national progress in reducing the most prevalent infections. In addition, the plan intended to enhance collaboration with non-government stakeholders and partners at the national, regional, state, and local levels to strengthen coordination and impact of efforts.

                    Recognizing the need to coordinate prevention efforts across healthcare facilities, HHS began to transition into the second phase (Tier 2) of the Action Plan in late 2009. Tier 2 expands efforts outside of the acute care setting into outpatient facilities (e.g., ambulatory surgical centers, end-stage renal disease facilities). The healthcare and public health communities are increasingly challenged to identify, respond to, and prevent healthcare-associated infections across the continuum of settings where                           ( print page 57959)                        healthcare is delivered. The public health model's population-based perspective can be deployed to enhance healthcare-associated infection prevention, particularly given the shifts in healthcare delivery from the acute care (Tier 1) to ambulatory (Tier 2) and other settings.                 

Also, influenza transmission to patients by healthcare personnel is well documented. Healthcare personnel can acquire and transmit influenza from patients or transmit influenza to patients and other staff. Higher vaccination coverage among healthcare personnel has been associated with a lower incidence of healthcare-associated influenza cases. In addition, the proportion of healthcare-associated cases among hospitalized patients decreases as well, suggesting that increased staff vaccination can contribute to the decline in the number of healthcare-associated influenza cases. 

The Steering Committee has drafted two strategies or modules that address healthcare-associated infection prevention in ambulatory surgical centers and end-stage renal disease facilities. An additional module addresses influenza vaccination of healthcare personnel. Similar to its Tier 1 efforts, Tier 2 healthcare-associated infection reduction strategies expect to be executed through research and guideline development, implementation of national quality improvement initiatives at the provider level, and creation of payment policies that promote infection control and reduction in healthcare facilities. 

                    To assist the Steering Committee in obtaining broad input in the development of the three draft modules, HHS, through this request for information (RFI), is seeking comments from stakeholders and the general public on the draft Tier 2 modules. The modules can be found at                     *http://www.hhs.gov/​ophs/​initiatives/​hai/​actionplan/​index.html#tier2.*

## II. Information Request 

The Office of Healthcare Quality, on behalf of the HHS Steering Committee for the Prevention of Healthcare-Associated Infections, requests input on three drafts: “Section A: Ambulatory Surgical Centers,” “Section B: End-Stage Renal Disease Facilities,” and “Section C: Influenza Vaccination of Healthcare Personnel.” In addition to general comments, the Steering Committee is seeking input on any additional gaps not addressed in the draft strategies. 

## III. Potential Responders 

HHS invites input from a broad range of individuals and organizations that have interests in preventing and reducing healthcare-associated infections. Some examples of these organizations include, but are not limited to the following:

—General public 

—Healthcare, professional, and educational organizations/societies 

—Caregivers or health system providers (e.g., physicians, physician assistants, nurses, infection preventionists) 

—State and local public health agencies 

—Public health organizations 

—Foundations 

—Medicaid- and Medicare-related organizations 

—Insurers and business groups 

—Collaboratives and consortia

When responding, please self-identify with any of the above or other categories (include all that apply) and your name. Anonymous submissions will not be considered. The submission of written materials in response to the RFI should not exceed 10 pages, not including appendices and supplemental documents. Responders may submit other forms of electronic materials to demonstrate or exhibit concepts of their written responses. All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. 

Dated: September 16, 2010. 

Don Wright, 

Deputy Assistant Secretary for Healthcare Quality.

[FR Doc. 2010-23762 Filed 9-22-10; 8:45 am] 

BILLING CODE 4150-28-P