```

[Federal Register: March 31, 2010 (Volume 75, Number 61)]
[Notices]               
[Page 16132-16134]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr10-88]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

 
Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces the intention of the Agency for 
Healthcare Research and Quality (AHRQ) to request that the Office of 
Management and Budget (OMB) approve the proposed information collection 
project: ``Reductions of Infection Caused by Carbapenem Resistant 
Enterobacteriaceae (KPC) Producing Organisms through the Application of 
Recently Developed CDC/HICPAC Recommendations.'' In accordance with the 
Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public 
to comment on this proposed information collection.

DATES: Comments on this notice must be received by June 1, 2010.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by e-mail at 
doris.lefkowitz@AHRQ.hhs.gov.
    Copies of the proposed collection plans, data collection 
instruments, and specific details on the estimated burden can be 
obtained from the AHRQ Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by e-mail at 
doris.lefkowitz@AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION:

Proposed Project

Reductions of Infection Caused by Carbapenem Resistant 
Enterobacteriaceae (KPC) Producing Organisms Through the Application of 
Recently Developed CDC/HICPAC Recommendations

    Healthcare Acquired Infections (HAIs) caused almost 100,000 deaths 
among the 2.1 million people who acquired infections while hospitalized 
in 2000, and HAI rates have risen relentlessly since then. On March 20, 
2009, the Centers for Disease Control (CDC) and the Healthcare 
Infections Control Practices Advisory Committee (HICPAC) developed 
infection control (IC) guidance for Klebsiella pneumonia carbapenemase-
producing (KPC) isolates, as they have been rapidly emerging as a 
significant challenge in healthcare settings. The danger of these 
bacteria is that they are resistant to carbapenem (a class of beta-
lactam antibiotics with a broad spectrum of antibacterial activity) and 
cannot be treated by the most commonly prescribed antibiotics. Limited 
treatment options mean that infections caused by carbapenem resistant 
bacteria result in substantial mortality and morbidity.
    The CDC and HICPAC recommendations draw on infection control 
strategies which have been applied to these pathogens in other 
settings, and other evidence based strategies in infection control. 
There has been little research, however, on the implementation of 
control strategies to prevent the spread of these KPC infections. The 
goal of this project is to understand how these recommendations can 
best be implemented and how effective these recommendations will be in 
practice. This research will advance private and public efforts to 
improve health care quality by improving measures to control the spread 
of a dangerous organism. This research will also provide data for the 
development of an implementation toolkit that hospitals can use to 
prevent the spread of carbapenem resistant bacteria. The toolkit may 
include the following types of resources: General information about the 
implementation of evidenced-based clinical practices, resource 
materials, and tools and methods that users can adopt to conduct point 
prevalence surveys, protocols and tools that users can adopt to specify 
when active KPC surveillance is needed, and resources for approaching 
the problem as a team-based quality-improvement effort.
    OMB clearance will be sought for this toolkit once it is developed.
    This study is being conducted by AHRQ through its contractor, 
Boston University, pursuant to AHRQ's statutory authority to conduct 
and support research on healthcare and on systems for the delivery of 
such care, including activities with respect to the quality, 
effectiveness, efficiency, appropriateness and value of healthcare 
services and with respect to quality measurement and improvement. 42 
U.S.C. 299a(a)(1) and (2).

Method of Collection

    This project will include the following data collections from the 
intensive care unit (ICU) staff within each of three participating 
hospitals:
    (1) Pre-intervention focus groups will be conducted separately with 
managers and staff. The purpose of these focus groups is to identify 
potential problems in the implementation that can be addressed through 
various means (e.g., additional education, other changes in process). 
Another purpose is to understand the existing approach to quality 
improvement, the connection(s) between overall approach to quality 
improvement and to KPC infection control practices, current practices 
at the hospital of quality reporting and accountability, and 
constraints and obstacles to quality improvement as seen in their 
roles. Staff members identified for the focus groups will be those with 
the most first-hand knowledge of existing quality improvement efforts, 
and KPC infection control practices.
    (2) Clinical staff survey. Factors identified in the pre-
intervention focus groups will be used to inform the development of a 
self-administered survey of staff knowledge of and attitudes toward KPC 
surveillance and infection control procedures. Respondents will be 
health care workers on the units where these new guidelines have been 
implemented. Findings from the survey will be used to assess barriers 
perceived by the staff, potential differences across units, and 
potential differences by employee/occupational group.
    (3) Post-intervention focus groups (6 months after implementation 
of new KPC IC guidelines) will be conducted separately with managers 
and staff. The purpose of these focus groups is to identify actual 
problems experienced in the initial implementation and possible 
measures to address, and to identify successful practices to include in 
a toolkit that hospitals can use to implement the CDC and HICPAC 
recommendations.
    In addition to developing a toolkit, AHRQ plans to disseminate the 
lessons

[[Page 16133]]

learned from this project about how hospitals can best implement the 
CDC guidance for KPC screening and infection control, in order to 
inform efforts to change practice in this area.

Estimated Annual Respondent Burden

    The estimated annualized burden hours for respondents to 
participate in this two year research project are presented in Exhibit 
1. Pre-intervention focus groups with clinical staff will be conducted 
with 18 staff members (an average of 9 per year for 2 years) from each 
of the 3 participating hospitals and will take about 1 hour. Pre-
intervention focus groups with also be conducted with 2 managers (an 
average of 1 per year for 2 years) from each hospital and will take 
about an hour to complete.
    The clinical staff survey will be administered to 20 clinical staff 
(an average of 10 per year for 2 years) from each hospital and will 
take 15 minutes to complete.
    Finally, respondents from the pre-intervention focus groups will 
participate in post-intervention focus groups approximately four months 
after the initiation of the intervention. They will not last more than 
an hour each. The total annualized burden hours are estimated to be 68 
hours.
    Exhibit 2 shows the estimated annualized cost burden associated 
with the respondents' time to participate in this research. The total 
annualized cost burden is estimated to be $3,108.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                 Data collection                     Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Pre-intervention focus groups with clinical                    3               9               1              27
 staff *........................................
Pre-intervention focus groups with managers *...               3               1               1               3
Clinical staff survey...........................               3              10           15/60               8
Post-intervention focus groups with clinical                   3               9               1              27
 staff *........................................
Post-intervention focus groups with managers *..               3               1               1               3
                                                 ---------------------------------------------------------------
    Total.......................................              15             n/a             n/a              68
----------------------------------------------------------------------------------------------------------------
* Individuals that cannot attend the focus groups will be interviewed one-on-one. Clinical staff includes IC
  leaders, QI team members and unit staff. Managers include the chief nursing officer and chief medical officer.


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly    Total cost
                 Data collection                    respondents        hours         wage rate        burden
----------------------------------------------------------------------------------------------------------------
Pre-intervention focus groups with clinical                    3              27        * $36.73            $992
 staff..........................................
Pre-intervention focus groups with managers.....               3               3       ** 138.38             415
Clinical staff survey...........................               3               8         * 36.73             294
Post-intervention focus groups with clinical                   3              27         * 36.73             992
 staff..........................................
Post-intervention focus groups with managers....               3               3       ** 138.38             415
                                                 ---------------------------------------------------------------
    Total.......................................              15              68              na           3,108
----------------------------------------------------------------------------------------------------------------
* Based upon the mean hourly wage for Registered Nurses in Nassau and Suffolk County, NY as reported by the
  Bureau of Labor Statistics in May 2008.
** Based on report of a private survey of HR departments conducted in November 2009 in New York, NY published by
  http://www.salary.com; 3 chief nursing officers at $101.14/hr and 3 chief medical officers at $175.61/hour.

Estimated Annual Costs to the Federal Government

    Exhibit 3 shows the annualized and total cost to the federal 
government for this two year research project. Project development 
covers steps taken to revise the research plan and begin 
implementation. The total cost is estimated to be $500,001.

     Exhibit 3--Annualized and Total Cost to the Federal Government
------------------------------------------------------------------------
          Cost component             Annualized cost       Total cost
------------------------------------------------------------------------
Project Management................           $125,526           $251,052
Project Development...............             54,622            109,244
Data Collection Activities........             41,864             83,728
Travel............................              4,000              8,000
Overhead..........................             23,754             47,507
                                   -------------------------------------
    Total.........................            250,001            500,001
------------------------------------------------------------------------

Request for Comments

    In accordance with the above-cited Paperwork Reduction Act 
legislation, comments on AHRQ's information collection are requested 
with regard to any of the following: (a) Whether the proposed 
collection of information is necessary for the proper performance of 
AHRQ healthcare research and healthcare information dissemination 
functions, including whether the information will have practical 
utility; (b) the accuracy of AHRQ's estimate of burden (including hours 
and costs) of the proposed collection(s) of

[[Page 16134]]

information; (c) ways to enhance the quality, utility, and clarity of 
the information to be collected; and (d) ways to minimize the burden of 
the collection of information upon the respondents, including the use 
of automated collection techniques or other forms of information 
technology.
    Comments submitted in response to this notice will be summarized 
and included in the Agency's subsequent request for OMB approval of the 
proposed information collection. All comments will become a matter of 
public record.

    Dated: March 19, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-6778 Filed 3-30-10; 8:45 am]
BILLING CODE 4160-90-M
```