Supporting Statement and Justification for Change

Methicillin-Resistant Staphylococcus aureus (MRSA)

Infection Control Practices Survey

(OMB Control Number 0920-0772)

Request for Change

March, 2009

Contact:

Anne O’Connor

Office of Policy and Planning

National Center for Preparedness, Detection, and Control of Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, N.E., MS C-12

Atlanta, Georgia 30333

Phone: (404) 639-1042

Fax: (404) 639-3039

Email: [email protected]

Methicillin-Resistant Staphylococcus aureus (MRSA)

Infection Control Practices Survey

(OMB Control Number 0920-0772)

Request for Change

A. Justification

1. Circumstances Making the Collection of Information Necessary

This information collection request was originally approved on April 28, 2008 to collect information on the implementation of recommended infection control practices to control the transmission of methicillin-resistant Staphylococcus aureus (MRSA) in healthcare settings. MRSA is a significant cause of difficult to treat healthcare-associated MRSA infections and controlling its transmission has become a national priority. The first release of the survey has provided valuable information on the impact of these guidelines and the extent of efforts used to control MRSA in hospitals. A copy of the currently approved survey is found in Attachment 3.

The survey is sent electronically to one infection control practitioner at each healthcare facility that is part of the Centers for Disease Control and Prevention’s (CDC), Emerging Infections Program (EIP)/Active Bacterial Core Surveillance (ABCs) MRSA project. This surveillance system collects information on the rate of invasive MRSA infections in 9 sites throughout the United States and provides an excellent platform for conducting the survey. The original project was approved for three rounds of surveys; each round will allow for a widespread assessment of changes in MRSA prevention over time. The survey is collected under authority granted to CDC under Section 301 of the Public Health Service Act (42 U.S.C. 241) (Attachment 1).

With this submission, CDC is requesting OMB approval to modify certain questions on the original survey (Attachment 3) and to add new respondents from the state of Illinois. Since obtaining OMB approval, three issues have come up that make modification of the original survey of MRSA Control Practices necessary:

1. Due to the rapidly evolving use of techniques in acute and chronic healthcare settings to prevent infections caused by methicillin-resistant Staphylococcus aureus (MRSA), some of the questions in the original MRSA Infection Control Practices Survey no longer provide valuable information.

2. The increasing use of new MRSA control practices, such as decolonization, has made the inclusion of additional questions targeting these areas important.

3. Respondents have identified problems with the wording of several question stems and/or response choices. CDC feels that this issue should be addressed to improve the survey for future proposed deployments.

A list of the proposed changes to the currently approved information collection request is found in Attachment 4.

In addition, the State of Illinois passed legislation requiring that high-risk patients and patients admitted to intensive care units be screened for MRSA (called active surveillance testing or AST). In light of this requirement, the Illinois Department of Public Health has asked CDC to help evaluate the impact of this legislation in Illinois. One important aspect of this assessment would be to evaluate changes in MRSA control practices following the legislation. Since baseline data on practices prior to the legislation exist, CDC is requesting OMB approval to add acute care hospitals in Illinois to the facilities from which survey data are being collected. This would add 188 respondents to this data collection and 94 burden hours.

The proposed surveys are found in Attachments 5 and 6. Two versions of the survey are necessary because of different requirements for the cover page in Illinois. The survey questions are identical except for numbering and Question #2 (which asks for the state that the facility is located in) is not included on the Illinois specific survey (since all these facilities will be in Illinois).

2. Purpose and Use of Information Collection

The information provided from the first Methicillin-Resistant Staphylococcus aureus (MRSA) Infection Control Practices Survey has already been used by CDC to review and understand how currently recommended infection control guidelines are used and to better understand how prevention efforts may be affecting rates of MRSA infections. State specific information has also been provided to two individual ABCs sites to allow them to better understand MRSA control practices in their area. The two additional planned surveys (approved in the original application) and the proposed changes will provide further context to these efforts as they evolve over time. The additional information acquired in the proposed Illinois survey will both add to the data being collected from the EIP/ABCs sites and will be used by CDC and the Illinois Department of Public Health to better understand the impact of the AST legislation on healthcare facilities in Illinois.

3. Use of Improved Information Technology and Burden Reduction

The data described in this change request will be collected in the same manner as the original information collection request. Data is collected via an electronic survey submitted to one infection control practitioner (ICP) at each eligible facility. Paper copies of the survey will be available if requested. The electronic collection of data using mrInterview worked very well with the initial survey deployment with response rates of over 80%.

4. Efforts to Identify Duplication and Use of Similar Information

To our knowledge, this data is not being collected in any other form by other organizations. In Illinois, the additional data collection was requested by the State Department of Public Health and they are not aware of any similar information being collected from facilities in that state.

5. Impact on Small Businesses or Other Small Entities

No small businesses are involved in the additional data collection. All facilities in Illinois are acute care hospitals and not individual providers (physicians or dentists).

6. Consequences of Collecting the Information Less Frequently

CDC plans to collect data twice more under the current approval. Data collections are tentatively planned for mid-2009 and mid-2010. Collecting these data over time will allow for a more complete view of MRSA control practices as they evolve over time as well as the short-term sustainability of these interventions. Performing fewer surveys would not allow for this complete of an assessment; however, there are no legal obstacles to reduce the burden.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

The request fully complies with the regulation.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A. CDC published a 60 day Federal Register Notice on April 5, 2007 (Vol. 72, No., 65, page 16791). A 30 day Federal Register Notice was published on November 15, 2007 (Vol. 72, No. 65, page 64228). Both Federal Register Notices are found in Attachment 2. No comments were received from the original Federal Register Notices.

B. CDC has consulted with the following individuals on the proposed changes to the survey:

Tom Talbot, MD MPH

Assistant Professor of Medicine and Preventive Medicine

Chief Hospital Epidemiologist

Vanderbilt University School of Medicine

Phone: (615) 322-2789

Craig Conover, MD

Medical Director

Illinois Department of Public Health

Phone (312) 814-4846

Michael Lin, MD

Assistant Professor

Rush Univ. School of Medicine,

Phone (312) 942-4811

Stephen Weber, MD, MPH

Healthcare Epidemiologist and Assistant Professor

University of Chicago

Phone (773) 702-1365

9. Explanation of Any Payment or Gift to Respondents

No payment or gifts will be provided to respondents

10. Assurance of Confidentiality Provided to Respondents

There are no changes from the original information collection request. The submission was reviewed by CDC/ICRO who determined that the Privacy Act did not apply. Respondents are speaking from their roles as infection control professionals employed by healthcare facilities. Although respondents’ names will be collected when the survey is administered, an unique hospital identifier will be created and transmitted to CDC. CDC will not hold the link between the facility name and the unique identifier. Respondents’ names will not be transmitted to CDC. While the local EIP/ABC site contacts will know who completed the survey, survey responses will not be linked to the respondent.

Data will be treated in a secure manner by the EIP contacts. All data collected is completely voluntary as stated in the introductory forward of the survey (Attachment E). We will be collecting information at the hospital level only; no patient specific information will be collected (Attachment E). The only information that will be collected is the state where the facility is located. Respondent’s name and hospital name will be kept in a secure manner by the local EIP/ABCs site and not transmitted to CDC. Only the unique hospital identifier will be transmitted to CDC and CDC will not know the link between this id and the actual facility name.

All information provided though CDC’s web based system will be kept confidential and housed on a secure CDC server. State specific data will be provided to each EIP/ABCs site. Local state authorities may use data to improve their understanding of infection control practices in their hospitals.

The information provided though this survey will neither be used to influence funding nor to scrutinize the hospital in any way. CDC does not hold a regulatory role and will not share data with any regulatory agencies. CDC provides guidance in public health practice. The information is provided specifically to assess the degree of implementation of the national guidelines.

11. Justification of Sensitive Questions

No questions of a sensitive nature are included in this survey. The unique identifier will be created by the EIP/ABCs site. CDC will not have access to hospital names. No infection rates are being reported as part of this survey.

12. Estimates of Annualized Burden Hours and Costs

A. As in the original request, it is estimated that respondents will require no more than 30 minutes to complete the new facility survey on line; this time includes logging on to the website. Use of the previous survey supports this time estimate. Respondents will be asked to complete a total of 42 questions about their facility; questions will ask either about the respondent’s opinion or for information that should already be well known to the Infection Control Practitioners and should not require additional research. Table A12A shows the additional burden associated with the additional survey sites in Illinois. The changes in the current survey at the EIP/ABCs site should not add any additional burden for respondents.

Table A12A: Estimated total response burden, in hours

Respondent	Number of Respondents	Responses per Respondent	Average burden per response (in hours)	Total Burden Hours
Illinois Infection Control Practitioners	188	1	30/60	94
Total				94

B. To calculate the annualized cost to respondents, we have used the average hourly wage for a Registered Nurse (median hourly wage $28.85) obtained from the Bureau of Labor Statistics, Occupational and Employment Statistics Section May 2007 data (access February 19, 2009 at http://www.bls.gov/oes/2007/may/oes_nat.htm#b29-0000).

Table A12B: Annualized cost to respondents

Respondent	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Illinois Infection Control Practitioners	94	$28.85	$2,711.90
Total			$2,711.90

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

None

14. Annualized Cost to the Government

The original cost to the government for the three years of the survey was estimated to be $25,811.00. This cost estimate included costs for a web-based survey developer, time for surveillance officers to disseminate the surveys and follow-up on any unreturned surveys, and cost for m.r.Interview software.

Adding Illinois as a site to the survey, as described in this addendum request, will results in an estimated $453.00 per year to administer the survey.

15. Explanation for Program Changes or Adjustments

CDC is requesting OMB approval for two changes to this previously approved information collection request.

1. Due to the rapid evolution of MRSA control measures in U.S. healthcare facilities, several of the original questions are no longer germane enough to capture useful information. Therefore, CDC is proposing to delete or modify these questions and/or add additional, more relevant, questions. Also, the first round of the survey identified some issues with the original phrasing of the questions or the response choices that were not identified in the original pilot testing. CDC is requesting OMB approval to correct these problems. The number of questions (42) on the survey would remain the same and CDC does not believe the overall burden to respondents has changed between the two versions. Attachment 3 is the currently approved survey. Attachment 4 includes a list of added and deleted questions. Attachment 5 is the proposed survey for the EIP/ABCs sites and Attachment 6 is the proposed survey for Illinois. Two versions of the survey are necessary because of different requirements for the cover page in Illinois. The survey questions are identical except for numbering and Question #2 (which asks for the state that the facility is located in) is not included on the Illinois specific survey (since all these facilities will be in Illinois).

2. With the institution of a legislated requirement to screen high-risk patients in Illinois for MRSA, the state of Illinois requested CDC assistance to assess the impact of the requirement to employ specific MRSA control measures. Because the first deployment of the Methicillin-Resistant Staphylococcus aureus (MRSA) Infection Control Practices Survey has already taken place, CDC and the Illinois Department of Public Health request the addition of acute-care hospitals in Illinois (approximately 188) to the next two survey deployments. This will increase the survey sample size by 188 respondents and allow for a closer look at changes that may have resulted from the implementation of MRSA screening legislation in Illinois. This change will increase the total burden of the information collection request by 94 hours.

16. Plans for Tabulation and Publication and Project Time Schedule

We anticipate no major changes to plans for tabulation, publication, and the data project timeline. Following OMB approval, the second survey will be distributed in mid-2009 and the third survey will be distributed in mid-2010.

17. Reason Display of OMB Expiration Date is Inappropriate

Not applicable

18. Exceptions to Certification for Paperwork Reduction Act Submissions

None

B. Collections of Information Employing Statistical Methods

CDC is requesting approval to survey all acute care hospitals in Illinois (n = 188). No sampling techniques will be employed. As described in the original information collection request, data collection will occur two more times using the proposed new version of the survey and with the proposed addition of acute care hospitals in Illinois to the original set of facilities from the ABCs MRSA project. The surveys as described in the original request are sent to one Infection Control Practitioner (ICP) at each facility. A Surveillance Officer at each site (including Illinois) will distribute links for the survey to each ICP via email.

Participation in this survey is voluntary. An introductory forward will appear before the survey that stresses that the participation is voluntary and that respondent’s information will be kept completely confidential. Furthermore, any report of these data will not link survey responses specifically to hospital name. Based on the first round of surveys, we estimate approximately 80% participation overall. These facilities are not a sample but represent all acute care facilities in the respective catchment areas.

The proposed changes to the survey will not affect the previous distribution plan at the EIP/ABCs sites. In order to maximize response rates in Illinois, we are collaborating with the Illinois Department of Public Health, who has existing relationships with facilities in their state. Contacts at Illinois hospitals have already been identified. At all sites reminder emails will be sent to facilities who do not responded to initial requests for survey completion. In addition, we have worked with local chapters of the Association of Professionals in Infection Control and with the Illinois Critical Access Hospital Network (ICAHN) to promote the project.

No changes to the analysis of the data are anticipated.

Statistician consulted for data analysis:

Jonathan R. Edwards, MS, Statistician

Centers for Disease Control and Prevention

Division of Healthcare Quality Promotion/NCPDCID/CCID

1600 Clifton Rd NE, MSA-24

Atlanta, GA 30333

(404) 639-4177

Email: [email protected]

Behavioral Scientist consulted on survey methodology and measurement

Ronda Sinkowitz-Cochran, MPH

Centers for Disease Control and Prevention

Division of Healthcare Quality Promotion/NCPDCID/CCID

1600 Clifton Road NE, MS A-31

Atlanta, Georgia 30333

(404) 639-4244

List of Attachments

Attachment 1 – Section 301 of the Public Health Service Act (42 USC 241)

Attachment 2 – Federal Register Notices

Attachment 3 – Copy of the currently approved survey

Attachment 4 – List of major changes to the approved survey

Attachment 5 – Proposed survey – EIP/ABCs version

Attachment 6 – Proposed survey – Illinois version

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