```

[Federal Register Volume 78, Number 186 (Wednesday, September 25, 2013)]
[Notices]
[Pages 59034-59035]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23299]

=======================================================================
-----------------------------------------------------------------------

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

[[Page 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/quality-patient-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
----------------------------------------------------------------------------------------------------------------
                                                             Number of
              Form name                   Number of        responses per        Hours per         Total burden
                                         respondents         respondent          response            hours
----------------------------------------------------------------------------------------------------------------
Cognitive interviews................                 15                  1                1.5                 23
Pretest for the Ambulatory Surgery                  529                  1              15/60                132
 SOPS...............................
POC Administration of the survey....                 40                  1                  6                240
                                     ---------------------------------------------------------------------------
    Total...........................                584                 na                 na                395
----------------------------------------------------------------------------------------------------------------

                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                          Number of         Total burden      Average hourly
              Form name                  respondents           hours           wage rate *     Total cost burden
----------------------------------------------------------------------------------------------------------------
Cognitive interviews................                 15                 23         $46.52 \a\             $1,070
Pretest for the Ambulatory Surgery                  529                132         $46.04 \b\             $6,077
 SOPS...............................
POC Administration of the survey....                 40                240         $37.61 \c\             $9,026
                                     ---------------------------------------------------------------------------
    Total...........................                584                395                 na           $16,173
----------------------------------------------------------------------------------------------------------------
\a\ Based 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).
\b\ Based 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.
\c\ Based 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]
BILLING CODE 4160-90-P
```