E8-12768. Agency Information Collection Activities: Proposed Collection; Comment Request

AGENCY:

Agency for Healthcare Research and Quality, Department of Health and Human Services.

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) allow the proposed information collection project, “Reducing Healthcare Associated Infections (HAI): Improving patient safety through implementing multidisciplinary training.” In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.

This proposed information collection was previously published in the Federal Register on April 3rd, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

DATES:

Comments on this notice must be received by July 10, 2008.

ADDRESSES:

Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at [phone] (attention: AHRQ's desk officer) or by e-mail at [e-mail] (attention: AHRQ's desk officer).

Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from AHRQ's Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT:

Doris Lefkowitz, AHRQ Reports Clearance Officer, [phone], or by e-mail at [e-mail].

SUPPLEMENTARY INFORMATION:

Proposed Project

“Reducing Healthcare Associated Infections (HAI): Improving patient safety through implementing multi-disciplinary training”

The goal of the HAI project is to identify factors associated with the implementation of training that can assist hospitals in successfully reducing and sustaining the reduction of infections associated with the process of care. The project is being carried out pursuant to AHRQ's statutory mandates under 42 U.S.C. 299b(b) and 299(b)(1)(G) to disseminate research findings to community settings for practice improvement and to support research on determinants of practitioner use and development of best practices. The findings from the HAI project will be shared publicly to assist other healthcare organizations in their efforts to improve infection safety.

For the HAI project, AHRQ will use the Accelerating Change and Transformation in Organizations and Networks (ACTION) which is a program of task order contracts to support field-based partnerships for conducting applied research. In order to understand the challenges of infection prevention and patient safety at the point of care, AHRQ has funded five ACTION partnerships, each of which has experience with implementing interventions and tools to improve the processes of care and the safety and quality of healthcare delivery. These ACTION partnerships will be working collaboratively with 34 hospitals, ranging from large academic teaching hospitals to community hospitals, in 11 states. At each of these hospitals, multi-disciplinary teams will implement clinician training that uses AHRQ-supported evidence-based tools to improve infection safety. Through the HAI project, these hospitals will focus on barriers and challenges to implementing infection prevention training and how to sustain lessons learned in order to help other hospitals achieve success.

The project involves six activities: (1) Implement training focused on mitigating infections, particularly with respect to blood stream infections (BSI), central line insertions, ventilator associated pneumonia (VAP) and chest tube insertions; (2) catalogue infection rates before and after the training; (3) analyze the opinions of hospital staff about their hospital's infection prevention and patient safety activities; (4) analyze the trainees' evaluation of the infection prevention and patient safety training and materials; (5) determine the impact of the implementation of infection prevention training and the hospitals' participation in the HAI project on their ability to mitigate and sustain infection safety improvements; and, (6) make publicly available case studies focusing on the hospitals' experiences of the training and their success with infection reduction and sustainability.

In order to support the healthcare organizations and hospitals, AHRQ will be issuing a contract to coordinate the assessment aspects of the HAI program. The objective of the HAI assessment contract is to facilitate the collection of infection information across the HAI project hospitals including providing technical assistance and support for the administration of the common data collection instruments. In addition, the assessment contractor will assist AHRQ in sharing the lessons learned about the successes, barriers, and challenges in implementing and sustaining infection safety interventions and tools. Each of the 34 participating hospitals will be responsible for securing clearance from their own Institutional Review Boards for their activities as part of the HAI project, including administration of the proposed data collection instruments. The data collection will be conducted in accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, 45 CFR Parts 160 and 164, and with the Protection of Human Subjects regulations, 45 CFR Part 46. Identifiable data for provider organizations and individuals will only be used for the above-stated purposes and will be kept confidential.

Methods of Collection

The infection prevention training will be implemented at 34 hospitals over a 6 month period at the end of 2008 through 2009. The data collection instruments will be administered at each hospital before, during and after the training. Respondents include both medical and administrative personnel. These instruments will be a key input to AHRQ understanding the challenges and barriers to implementing training and improving infection safety. The proposed paper-based data collection instruments are:

Pre-Training Infection Prevention and Safety Assessment;

Post-Training Infection Prevention and Safety Assessment;

Baseline Infection Rates Summary; Follow-up Infection Rates Summary; Infection Prevention and Patient Safety Activities Catalogue; Training Evaluation.

In addition to the 34 hospitals which will implement the training and fully participate in the HAI project, there will be a control group consisting of 102 rural hospitals. At each of the control group hospitals, an infection prevention staff member will complete the Post-Training Infection Prevention and Safety Assessment, Follow-up Infection Rate Summary, and the Infection Prevention and Patient Safety Activities Catalogue. In addition to providing a baseline measure, the control group hospitals will provide additional insights on the challenges of and barriers to infection prevention and patient safety at rural hospitals.

Estimated Annual Respondent Burden

Exhibit 1 shows the estimated burden hours to the respondents for providing all of the data needed to meet the study's objectives. For both the Pre-Training and Post-Training Infection Prevention and Safety Assessment instruments, the number of respondents is based on an estimate of 20 respondents at each of the 34 implementation hospitals. In addition, one respondent at each of the 102 hospitals in the control group will complete the Post-Training instrument. For both the Baseline and Follow-up Infection Rate Summary instrument, the number of respondents is based on an estimate of one respondent at each of the 34 implementation hospitals. In addition, one respondent at each of the 102 control group hospitals will complete the Follow-Up instrument. For the Infection Prevention and Patient Safety Activity Catalogue, the number of respondents is based on an estimate of 1 respondent at each of the 34 implementation hospitals and the 102 control group hospitals. Finally, the number of respondents for the Training Evaluation instrument is based on an estimate of 25 respondents at each of the 34 implementation hospitals.

Exhibit 2 shows the estimated annualized cost burden for the respondents' time to participate in this project. There will be no cost burden to the respondent other than that associated with their time to provide the required data. There will be no additional costs for capital equipment, software, computer services, etc.

Exhibit 1.—Estimated Annualized Burden Hours

Data collection instrument	Number of respondents	Number of responses per respondent	Hours per response	Total burden hours
Pre-Training Infection Prevention and Safety Assessment	34	20	30/60	340
Post-Training Infection Prevention and Safety Assessment	136	5.75	45/60	587
Baseline Infection Rate Summary	34	1	30/60	17
Follow-up Infection Rate Summary	136	1	40/60	91
Infection Prevention and Patient Safety Activity Catalogue	136	1	1.00	136
Training Evaluation	34	25	10/60	141
Total	136	na	na	1,312

Exhibit 2.—Estimated Annualized Cost Burden

Data collection instrument	Number of respondents (hours)	Total burden rate*	Average hourly wage burden	Total cost
Pre-Training Infection Prevention and Safety Assessment	34	340	$41.75	$14,195
Post-Training Infection Prevention and Safety Assessment	136	587	41.75	24,507
Baseline Infection Rate Summary	34	17	28.99	493
Follow-up Infection Rate Summary	136	91	28.99	2,638
Infection Prevention and Patient Safety Activity Catalogue	136	136	39.02	5,307
Training Evaluation	34	141	49.04	6,915
Total	136	1,312	na	54,055
* Based on the planned respondents, the average hourly rates are the average of the mean hourly wage estimates for the following occupational groups: epidemiologists, healthcare support aides, medical and health services managers, pharmacists, physicians, physician assistants, registered nurses, and respiratory therapists. The wage estimates are derived from the National Occupational Employment and Wage Estimates, Bureau of Labor Statistics, May 2006.

Estimated Annual Costs to the Federal Government

This data collection effort is one aspect of a larger effort focused on reducing healthcare associated infections, The cost of developing the data collection instruments by a one-time statistical support task order is $25,000. The costs of implementing the data collection instruments and analyzing and publishing the results are $108,650 annually. Finally, the estimated costs for federal staff time for supporting the common data collection efforts are $24,000 annually. Thus, the estimated annual cost to the federal government is $145,150.

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 health care research, quality improvement and 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 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: May 30, 2008.

Carolyn M. Clancy,

Director.