59034 Federal Register / Vol. 78, No. 186 / Wednesday, September 25, 2013 / Notices 

If you file your comment on paper, 

write ‘‘Used Car Rule, PRA Comment, 

P137606,’’ on your comment and on the 

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Room H–113 (Annex J), 600 

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Visit the Commission Web site at 

www.ftc.gov to read this Notice. The 

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Commission administers permit the 

collection of public comments to 

consider and use in this proceeding as 

appropriate. The Commission will 

consider all timely and responsive 

public comments that it receives on or 

before November 25, 2013. You can find 

more information, including routine 

uses permitted by the Privacy Act, in 

the Commission’s privacy policy, at 

http://www.ftc.gov/ftc/privacy.htm. 

David C. Shonka, 

Principal Deputy General Counsel. 

[FR Doc. 2013–23353 Filed 9–24–13; 8:45 am] 

BILLING CODE 6750–01–P 

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: ‘‘Pretest 

of the Ambulatory Surgery/Procedure 

Survey on Patient Safety Culture 

Questionnaire (Ambulatory Surgery 

SOPS).’’ In accordance with the 

Paperwork Reduction Act, 44 U.S.C. 

3501–3521, AHRQ invites the public to 

comment on this proposed information 

collection. 

This proposed information collection 

was previously published in the Federal 

Register on July 8th, 2013 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 October 25, 2013. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s desk officer) or by 

email at OIRA_submission@

omb.eop.gov (attention: AHRQ’s desk 

officer). 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Pretest of the Ambulatory Surgery/

Procedure Survey on Patient Safety 

Culture Questionnaire (Ambulatory 

Surgery SOPS) 

One setting which has demonstrated 

tremendous growth both in the volume 

and complexity of procedures being 

performed is ambulatory surgical and 

procedure centers (ASCs). ASCs are 

defined by the Centers for Medicare & 

Medicaid Services (CMS) as distinct 

entities that operate exclusively to 

provide surgical services to patients 

who do not require hospitalization and 

are not expected to need to stay in a 

surgical facility longer than 24 hours (42 

CFR 416.2). Many of the services 

performed in these facilities extend 

beyond procedures traditionally thought 

of as surgery, including endoscopy, and 

injections to treat chronic pain. 

Currently, there are over 5,300 

Medicare-certified ASCs in the U.S., 

which represents a greater than 54% 

increase since 2001. In 2007, Medicare 

paid for more than 6 million surgeries 

performed in these facilities at a cost of 

nearly $3 billion. Recent CMS audits 

suggest infection control deficiencies in 

these facilities are widespread. For 

example, preliminary data from 2011 

found that 51 percent of ASCs surveyed 

had an infection control deficiency; 11 

percent were considered very serious 

deficiencies. These findings are only 

slightly lower than 2010 audits and a 

2008 sample of ASCs in three states. 

Given the widespread impact of ASCs 

on patient safety, the new Ambulatory 

Surgery/Procedure Survey on Patient 

Safety Culture (Ambulatory Surgery 

SOPS) will measure ASC staff 

perceptions about what is important in 

their organization and what attitudes 

and behaviors related to patient safety 

culture are supported, rewarded, and 

expected. The survey will help ASCs to 

identify and discuss strengths and 

weaknesses of patient safety culture 

within their individual facilities. They 

can then use that knowledge to develop 

appropriate action plans to improve 

their practices and their culture of 

patient safety. This survey is designed 

for use in ASCs that practice all types 

of surgical procedures including those 

that require incisions and less invasive 

or non-surgical procedures such as 

gastrointestinal procedures or pain 

management injections. 

This research has the following goals: 

(1) Develop, cognitively test and 

modify as necessary the Ambulatory 

Surgery/Procedure Survey on Patient 

Safety Culture Questionnaire 

(Ambulatory Surgery SOPS); 

(2) Pretest and modify the 

questionnaire as necessary, and 

(3) Make the final questionnaire 

publicly available. 

This study is being conducted by 

AHRQ through its contractor, Health 

Research & Educational Trust (HRET), 

and subcontractor, Westat, 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 

To achieve the projects’ goals the 

following activities and data collections 

will be implemented: 

(1) Cognitive interviews. One round of 

cognitive interviews on the Ambulatory 

Surgery SOPS will be conducted by 

telephone with 15 respondents from 

ASCs. The purpose of these interviews 

is to understand the cognitive processes 

the respondent engages in when 

answering a question on the survey and 

to refine the survey’s items and 

composites. These interviews will be 

conducted with a mix of physicians, 

management, nurses, surgical 

technicians, and administrative staff 

throughout the U.S. from ASCs with 

varying characteristics (e.g., size, 

geographic location, and type of 

ownership). 

(2) Pretest for the Ambulatory Surgery 

SOPS. The draft questionnaire will be 

pretested with physicians and staff from 

40 ASCs. The purpose of the pretest is 

to collect data for an assessment of the 

reliability and construct validity of the 

survey items and composites, allowing 

for their further refinement. A site-level 

point of contact (POC) will be recruited 

in each ASC to manage the data 

collection at that organization (compile 

sample information, distribute surveys, 

promote survey response, etc.). 

(3) Dissemination activities. The final 

questionnaire will be made publicly 

available through the AHRQ Web site. 

This activity does not impose a burden 

on the public and is therefore not 

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Federal Register / Vol. 78, No. 186 / Wednesday, September 25, 2013 / Notices 59035 

included in the burden estimates in 

Exhibit 1. 

The information collected will be 

used to test and improve the draft 

survey items in the Ambulatory Surgery 

SOPS. Psychometric analysis will be 

conducted on the pretest data to 

examine item nonresponse, item 

response variability, factor structure, 

reliability, and construct validity of the 

items included in the survey. Because 

the survey items are being developed to 

measure specific aspects of patient 

safety culture in the ambulatory surgery 

setting, the factor structure of the survey 

items will be evaluated through 

multilevel confirmatory factor analysis. 

On the basis of the data analyses, items 

or factors may be dropped. 

The final survey instrument will be 

made available to the public for use in 

ASCs to assess their safety culture from 

the perspectives of their staff. The 

survey can be used by ASCs to identify 

areas for patient safety culture 

improvement. Researchers are also 

likely to use the survey to assess the 

impact of ASC’s patient safety culture 

improvement initiatives such as the 

implementation of a surgical safety 

checklist. This survey is an expansion of 

AHRQ’s suite of surveys on patient 

safety culture, which are available on 

the AHRQ Web site at (http://

www.ahrq.gov/professionals/qualitypatient-safety/surveys/index.html). 

Those surveys have been used by 

thousands of hospitals, nursing homes, 

medical offices, and pharmacies across 

the U.S. to assess patient safety culture. 

The Ambulatory Surgery SOPS contains 

new and revised questions and 

composites that more accurately apply 

to the ambulatory surgery setting. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondents’ time to participate in this 

research. Cognitive interviews will be 

conducted with 15 ASC staff 

(approximately three physicians, six 

nurses, two medical technicians, two 

administrative managers, and two 

administrative assistants) and will take 

about one hour and 30 minutes to 

complete. The Ambulatory Surgery 

SOPS will be completed by 529 ASC 

staff from 40 facilities (about 13 per 

facility). Each survey will require 

approximately 15 minutes to complete. 

A site-level POC will spend 

approximately 6 hours administering 

the Ambulatory Surgery SOPS. The total 

burden is estimated to be 395 hours 

annually. 

Exhibit 2 shows the estimated 

annualized cost burden associated with 

the respondents’ time to participate in 

this research. The total cost burden is 

estimated to be $16,173 annually. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Cognitive interviews ................................................................. 15 1 1.5 23 

Pretest for the Ambulatory Surgery SOPS .............................. 529 1 15/60 132 

POC Administration of the survey ........................................... 40 1 6 240 

Total .................................................................................. 584 na na 395 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average hourly 

wage rate * Total cost burden 

Cognitive interviews ................................................................. 15 23 $46.52 a $1,070 

Pretest for the Ambulatory Surgery SOPS .............................. 529 132 $46.04 b $6,077 

POC Administration of the survey ........................................... 40 240 $37.61 c $9,026 

Total .................................................................................. 584 395 na $16,173 

aBased on the weighted average wages for 1 Anesthesiologist (29–1061, $108.35), 2 Surgeons (29–1067, $106.48), 2 Administrative Services 

Managers (11–3011, $37.61), 6 Registered Nurses (29–1141, $34.23), 2 Medical and Clinical Laboratory Technicians (29–2030, $28.90), 1 Licensed Practical or Licensed Vocational Nurse (29–2061, $21.17), and 1 Office and Administrative Support Workers, All Other (43–9199, 

$16.92). bBased on the weighted average wages for 150 Registered Nurses, 85 Office and Administrative Support Workers, 85 Medical and Clinical 

Laboratory Technicians, 70 Surgeons, 50 Licensed Practical/Vocational Nurses, 49 Anesthesiologists, and 40 Administrative Services Managers. cBased on the on the average wages for 1 Administrative Services Managers. 

* National Occupational Employment and Wage Estimates in the United States, May 2012, ‘‘U.S. Department of Labor, Bureau of Labor Statistics’’ (available at http://www.bls.gov/oes/current/naics4_621400.htm [for outpatient care setting] 

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 health care 

research and health care 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: September 17, 2013. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2013–23299 Filed 9–24–13; 8:45 am] 

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