Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 16783 

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: March 15, 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–6857 Filed 3–24–11; 8:45 am] 

BILLING CODE 4160–90–M 

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: ‘‘Using 

Nursing Home Antibiograms to Improve 

Antibiotic Prescribing and Delivery.’’ In 

accordance with the Paperwork 

Reduction Act, 44 U.S.C. 3501–3521, 

AHRQ invites the public to comment on 

this proposed information collection. 

DATES: Comments on this notice must be 

received by May 24, 2011. 

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 

Using Nursing Home Antibiograms To 

Improve Antibiotic Prescribing and 

Delivery 

Overuse and inappropriate use of 

antibiotics, particularly broad-spectrum 

antibiotics, is recognized as a serious 

problem in nursing homes (NHs). The 

adverse consequences of inappropriate 

prescribing practices including drug 

reactions/interactions, secondary 

complications, and the emergence of 

multi-drug resistant organisms, have 

become more common. For example, in 

one point-prevalence survey of 117 NH 

residents, 43 percent were culturepositive for one or more antimicrobialresistant pathogens, including 

methicillin-resistant staphylococcus 

aureas (24 percent), extended-spectrum 

+-lactamase-producing klebsiella 

pneumoniae (18 percent) or Escherichia 

coli (15 percent), and vancomycinresistant enterococci. Inappropriate 

overprescribing and overuse of broadspectrum antibiotics, when narrower 

spectrum drugs would suffice, are 

believed to be important contributors to 

this problem. 

Physicians typically begin antibiotics 

for suspected infections in NH residents 

without waiting for bacteriology 

laboratory culture results. If there is a 

clinical failure (e.g., patient does not 

improve), the physician may request a 

bacteriology laboratory test, but will 

often try a second antibiotic without 

waiting for culture confirmation. If a NH 

resident is deteriorating, many NHs do 

not try a second antibiotic but will 

instead transfer the patient to a hospital 

emergency department (ED). In the ED, 

physicians must make quick decisions 

about whether to continue the first 

antibiotic prescribed in the NH or start 

another, again often without culture 

results. 

NH patients are transferred to EDs for 

all sorts of medical reasons, including 

but not limited to infections. When NH 

patients arrive at an ED, physicians may 

identify a urinary tract, respiratory, or 

other infection that was not the primary 

reason for the ED visit. Thus, patients 

may not leave the NH with a suspected 

bacterial infection or taking any 

antibiotics, but an infection is suspected 

in the ED and the first antibiotic is 

prescribed there. 

As a result of the above complexities, 

NHs are increasingly recognized as 

reservoirs of antibiotic-resistant 

bacteria. Antibiograms aggregate 

information for an entire institution 

over a period of several months or a 

year. They display the organisms 

present in clinical specimens sent for 

laboratory testing, and the susceptibility 

of each organisms to an array of 

antibiotics. Antibiograms are routinely 

prepared by hospital laboratories but are 

not routine in the NH setting. The 

culmination of this project will be a NH 

Antibiogram toolkit so that NHs can 

create facility-specific antibiograms that 

are cost-effective and helpful to 

physicians who must make antibiotic 

prescription decisions without 

bacteriology laboratory test results, for 

patients in NHs, and for patients who 

are transferred from the NH to the ED. 

Outcomes of interest for antibiograms 

include reduced reliance on broadspectrum antibiotics as initial therapy, 

and fewer clinical failures of antibiotics 

that are first prescribed. The 

development of a toolkit will be the first 

step in this process; future studies are 

required to test the toolkit and, 

subsequently, the effectiveness of NH 

antibiograms. 

The objectives of the study are to: 

1. Develop a standardized method for 

determining antibiotic susceptibility 

patterns and developing NH-specific 

antibiograms; 

2. Extract preliminary data from NH 

facilities of various sizes and types to 

guide the development of the draft 

toolkit; and 

3. Develop a draft toolkit to guide a 

wide variety of sizes and types of NHs 

in developing and sharing antibiogram 

information with prescribing providers 

(i.e., physicians and physician 

extenders) and EDs. 

Three NHs and one ED will 

participate in this study, which will be 

conducted in two phases. The first 

phase will include one small NH and 

one ED and is intended to test the data 

collection instruments and to draft the 

initial toolkit, including the creation of 

a NH specific antibiogram. The second 

phase will expand the study by adding 

two larger NHs, while retaining the 

same NH and ED as in the first phase 

and is intended to further test the data 

collection instruments and refine the 

draft toolkit. Each phase will use the 

same methods and data collections. 

This study is being conducted by the 

Agency for Healthcare Research and 

Quality through its contractors, Abt 

Associates and the Brigham and 

Women’s Hospital ED, pursuant to the 

Agency for Healthcare Research and 

Quality’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 


erowe on DSK5CLS3C1PROD with NOTICES
16784 Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 

services and with respect to quality 

measurement and improvement. 42 

U.S.C. 299a(a)(1) and (2). 

Method of Collection 

The following data collection 

activities will be implemented to 

achieve the objectives of this project: 

(1) Medical Records Extraction. 

Medical record data related to antibiotic 

use will be extracted by the research 

team at the three participating NHs and 

one ED. The team will extract the 

necessary data from the infection 

control log and request access to 

additional records (e.g., medication log 

and/or patient medical record) as 

needed to collect relevant data. Two 

months of retrospective NH and ED 

medical records will be reviewed prior 

to the implementation period, on a 

monthly basis during implementation, 

and for one month post-implementation. 

In the ED medical records will be 

extracted for only those NH residents 

who have been transferred to the ED 

from one of the participating NHs. The 

pre-implementation data will be 

compared to the data collected during 

implementation and postimplementation to see if the use of the 

antibiogram report had an effect on 

antibiotic use at the participating 

facilities. It is unlikely, but possible, 

that NH staff may be asked to assist the 

research team with this task in the two 

larger, Expansion Phase Two sites; 

however, ED staff will not. Medical 

record extraction during Phase One will 

occur prior to OMB clearance and will 

be limited to 9 or fewer records. 

(2) Provider Pre-Implementation and 

Post-Implementation Questionnaires. 

These questionnaires will be completed 

by providers at both the NHs and ED 

one month prior to implementation and 

again in the final month of 

implementation. NH and ED questions 

differ somewhat, as do pre- and postimplementation surveys. In addition to 

basic background questions such as the 

providers’ title, type of residency and 

length of practice, questions related to 

their use and opinion of antibiograms 

are included. The post-implementation 

questionnaire contains three additional 

questions related to the use of 

antibiograms as well as a series of 

vignettes administered before and after 

the presentation of an antibiogram 

report. These questionnaires will assess 

change in the providers’ use and 

opinion of antibiograms. 

(3) Nurse Pre/Post-Implementation 

Questionnaire. This questionnaire will 

be administered one month prior to 

implementation and again in the final 

month of implementation. In addition to 

basic background questions such as the 

nurses’ title, position at the NH and 

length of employment, questions related 

to their use and opinion of antibiograms 

are included. The same set of questions 

is asked at each time period. This 

questionnaire will measure any change 

in the nurses’ use and opinion of 

antibiograms. 

(4) NH Leadership PostImplementation Questionnaire. This 

questionnaire will be completed by the 

NH administrator or the director of 

nursing in the final month of the 

implementation. In addition to basic 

background questions such as their title, 

position at the NH and length of 

employment, questions are asked about 

the impact the antibiograms had in 

terms of antibiotic use, the cost 

associated with their use and whether 

they intend to continue using them once 

the study has been completed. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondents’ time to participate in this 

research. Although medical records 

extraction using the NH and ED Data 

Extraction Tools will occur at the NHs 

and ED, the potential information 

collection burden will be limited to staff 

at each of the Expansion Phase 2 NHs. 

Medical record data extraction will 

occur monthly for 7 months at the two 

Expansion Phase Two NHs and may 

require 15 minutes assistance from the 

NH staff. 

The NH Provider Pre-Implementation 

Questionnaire will be completed by 10 

providers at each of the two Expansion 

Phase Two NHs and will take about 10 

minutes to complete. The NH Provider 

Post-Implementation Questionnaire will 

be completed by three providers in the 

Initial Phase One NH and 10 providers 

at each of the two Expansion Phase Two 

NHs (23 total or an average of 7.67 

providers per NH as shown in Exhibit 

1) and takes 15 minutes to complete. 

The ED Provider Post-Implementation 

Questionnaire will be completed by 30 

providers in the ED and requires 15 

minutes to complete. The Nurse Pre/ 

Post Implementation Questionnaire will 

be completed pre-implementation by 

approximately 25 nurses at each of the 

two Expansion Phase Two NHs and 

again post-implementation by 25 nurses 

at each of the 3 participating NHs (125 

total or an average of 41.67 nurses per 

NH as shown in Exhibit 1). The Nurse 

Pre/Post-Implementation Questionnaire 

is estimated to take 5 minutes to 

complete. The NH Leadership PostImplementation Questionnaire will be 

completed by one NH administrator or 

director of nursing at each of the three 

participating NHs and will require 10 

minutes to complete. 

The total annualized burden hours are 

estimated to be 32 hours. 

Exhibit 2 shows the estimated annual 

cost burden to the respondent, based on 

their time to participate in this research. 

The annual cost burden is estimated to 

be $1,921. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

facilities 

Number of 

responses per 

facility 

Hours per 

response 

Total burden 

hours 

Medical Records Extraction ............................................................................. 2 7 15/60 4 

NH Provider Pre-Implementation Questionnaire ............................................. 2 10 10/60 3 

NH Provider Post-Implementation Questionnaire ............................................ 3 7.67 15/60 6 

ED Physician Post-implementation Questionnaire .......................................... 1 30 15/60 8 

Nurse Pre/Post Implementation Questionnaire ............................................... 3 41.67 5/60 10 

NH Leadership Post-Implementation Questionnaire ....................................... 3 1 10/60 1 

Total .......................................................................................................... 14 n/a n/a 32 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 16785 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

facilities 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total cost 

burden 

Medical Records Extraction ............................................................................. 2 4 $31.99 $128 

NH Provider Pre-Implementation Questionnaire ............................................. 2 3 83.59 251 

NH Provider Post-Implementation Questionnaire ............................................ 3 6 83.59 502 

ED Physician Post-implementation Questionnaire .......................................... 1 8 83.59 669 

Nurse Pre/Post Implementation Questionnaire ............................................... 5 10 31.99 320 

NH Leadership Post-Implementation Questionnaire ....................................... 3 1 51.45 511 

Total .......................................................................................................... 14 32 n/a 1,921 

* Based upon the mean of the average wages, National Occupational Employment and Wage Estimates, U.S. Department of Labor, Bureau of 

Labor Statistics. May 2009. Hourly mean wage for registered nurse ($31.99), physician ($83.59), and NH administrator ($51.45). 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the total and 

annualized cost for conducting this 

research. The total budget for this two 

year study is $458,812. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

Cost component Total Annualized 

cost 

Project Administration .............................................................................................................................................. $60, 511 $30,256 

Initial Antibiogram Development and Implementation ............................................................................................. 47,618 23,809 

Expansion of Antibiogram Development and Implementation ................................................................................ 36,948 18,474 

Toolkit—Development and Refinement ................................................................................................................... 92,688 46,344 

Evaluation ................................................................................................................................................................ 153,978 76,989 

Final Report and Dissemination .............................................................................................................................. 67,071 33,536 

Total .................................................................................................................................................................. 458,812 229,406 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, 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 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 15, 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–6848 Filed 3–24–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Meeting for Software Developers on 

the Technical Specifications for 

Common Formats for Patient Safety 

Data Collection and Event Reporting 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Patient Safety and 

Quality Improvement Act of 2005, 42 

U.S.C. 299b–21 to b–26, (Patient Safety 

Act) provides for the formation of 

Patient Safety Organizations (PSOs), 

which collect, aggregate, and analyze 

confidential information regarding the 

quality and safety of healthcare 

delivery. The Patient Safety Act (at 42 

U.S.C. 299b–23) authorizes the 

collection of this information in a 

standardized manner, as explained in 

the related Patient Safety and Quality 

Improvement Final Rule, 42 CFR part 3 

(Patient Safety Rule), published in the 

Federal Register on November 21, 2008: 

73 FR 70731–70814. AHRQ coordinates 

the development of a set of common 

definitions and reporting formats 

(Common Formats) that allow 

healthcare providers to voluntarily 

collect and submit standardized 

information regarding patient safety 

events. In order to support the Common 

Formats, AHRQ has provided technical 

specifications to promote 

standardization by ensuring that data 

collected by PSOs and other entities are 

clinically and electronically 

comparable. More information on the 

Common Formats, including the 

technical specifications, can be obtained 

through AHRQ’s PSO Web site: http:// 

www.PSO.AHRQ.GOV/index.html. 

The purpose of this notice is to 

announce a meeting to discuss the 

technical specifications, including the 

Hospital Common Formats technical 

specifications and the Skilled Nursing 

Facility Common Formats. This meeting 

is designed as an interactive forum 

where PSOs and software developers 

can provide input on these technical 


erowe on DSK5CLS3C1PROD with NOTICES