80 FR 26258 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 80, Issue 88 (May 7, 2015)

Page Range		26258-26261
FR Document		2015-10982
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: ``Pilot Test of the Proposed Hospital Survey on Patient Safety Culture Version 2.0.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Federal Register, Volume 80 Issue 88 (Thursday, May 7, 2015)
[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26258-26261]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10982]


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 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: ``Pilot Test of the Proposed Hospital Survey on Patient Safety 
Culture Version 2.0.'' 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 July 6, 2015.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
[email protected].
    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 email at 
[email protected].

SUPPLEMENTARY INFORMATION:

Pilot Test of the Proposed Hospital Survey on Patient Safety Culture 
Version 2.0

Proposed Project

    In 2004, AHRQ developed and published a measurement tool to assess 
the culture of patient safety in hospitals (OMB control no. 0935-0115). 
The Hospital Survey on Patient Safety Culture (HSOPS) is a survey of 
providers and staff that can be implemented by hospitals to identify 
strengths and areas for patient safety culture improvement as well as 
raise awareness about patient safety. When

[[Page 26259]]

conducted routinely, the survey can be used to examine trends in 
patient safety culture over time and evaluate the cultural impact of 
patient safety initiatives and interventions. The data can also be used 
to make comparisons across hospital units. AHRQ also produced a survey 
user's guide to assist hospitals in conducting the survey successfully. 
The guide addresses issues such as which providers and staff should 
complete the survey, how to select a sample of hospital providers and 
staff, how to administer the questionnaire, and how to analyze and 
report on the resulting data.
    Since 2004, thousands of hospitals within the U.S. and 
internationally have implemented the survey. In response to requests 
for comparative data from other hospitals, AHRQ funded the development 
of a comparative database on the survey in 2006 (OMB control no. 0935-
0162). The database is currently compiled every two years, using the 
latest data provided by participating hospitals (and retaining 
submitted data for no more than 2 years). Reports describing the 
findings from analysis of the database are made available on the AHRQ 
Web site to assist hospitals in comparing their results. The 2014 
database contains data from 405,281 hospital provider and staff 
respondents within 653 participating hospitals. The 2014 User 
Comparative Database Report presents results by hospital 
characteristics (e.g., number of beds, teaching status, geographic 
location) and respondent characteristics (e.g., position type, work 
area/unit).
    The survey constructed in 2004 remains in use today, more than 10 
years after its initial launch. Since the launch of HSOPS, AHRQ has 
funded development of patient safety culture surveys for other 
settings. In 2008, surveys were published for outpatient medical 
offices (OMB control no. 0935-0131) and nursing homes (OMB control no. 
0935-0132). In 2012, a survey for community pharmacies (OMB control no. 
0935-0183) was released. Surveys for each setting built upon the 
strengths of HSOPS but improved and updated items where appropriate.
    Users of HSOPS have provided feedback over the years suggesting 
that changes to the instrument would be valuable and welcomed. The 
comparative database registrants provided feedback about potential 
changes in 2013, and telephone interviews were conducted with 8 current 
survey users and vendors to gain an in-depth understanding of their 
thoughts on the current survey and possible changes. As a result of 
this feedback, the Hospital Survey on Patient Safety Culture Version 
2.0 (HSOPS 2.0) is being constructed with the following 8 objectives in 
mind.
    (1) Shift to a Just Culture framework for understanding responses 
to errors. In the original HSOPS, questions around responses to errors 
were negatively worded to detect a ``culture of blame'' in 
organizations. For example, respondents evaluated the extent to which 
errors were held against them and whether it felt as though the person 
was being written up rather than the problem. In contrast, a Just 
Culture framework emphasizes learning from mistakes, providing a safe 
environment for reporting errors, and utilizing a balanced approach to 
errors that considers both system and individual behavioral reasons as 
causes for errors. New items will be constructed in HSOPS 2.0 to 
capture the extent to which positive responses to error consistent with 
a Just Culture framework are present in an organization. For example, 
respondents will be asked to evaluate the extent to which the 
organization tries to understand the factors that lead to patient 
safety errors.
    (2) Reduce the number of negatively worded items. The original 
HSOPS has negatively worded items. For example, respondents are asked 
whether there are ``patient safety problems in this unit'' (negatively 
worded). Using some negatively worded items was intended to reduce 
social desirability and acquiescence biases and identify individuals 
not giving the survey their full attention (e.g., ``straight-lining,'' 
or providing the same answer for every item, regardless of positive or 
negative wording). However, many users have indicated that respondents 
sometimes had difficultly correctly interpreting and responding to the 
negatively worded items. Therefore, many survey users recommended that 
the number of negatively worded items should be reduced, but they did 
not recommend removing all of these items as they felt a mixture of 
items helps keep respondents engaged.
    (3) Add a ``Does not apply/Don't know'' response option. Analysis 
of the Comparative Database data found that a percentage of respondents 
selects ``neither agree nor disagree'' on many items when they really 
should have answered ``Does not apply/Don't know''. While some portion 
of respondents will always have neutral feelings about a statement, in 
some cases a respondent will select a neutral response to an item 
because they do not have experience in that area or the item does not 
apply to their position. Addition of a ``does not apply/don't know'' 
response option should reduce neutral responses to an item in cases 
where the item is not relevant for a respondent, providing more 
statistical variability in responses. Recognizing these issues, the 
other AHRQ Surveys on Patient Safety Culture all have a 5th ``Does not 
apply/Don't know'' response option.
    (4) Reword unclear or difficult-to-translate items. HSOPS was 
originally designed for use in U.S. hospitals, but it has since been 
translated into languages other than English. Some HSOPS items use 
idiomatic expressions that do not translate well, such as ``things fall 
between the cracks'' and ``the person is being written up.'' Other 
items have words that are complex or may mean different things to 
different people, such as ``sacrifice'' and ``overlook.'' HSOPS 2.0 
uses more universal phrases which can be accurately translated and have 
more consistent meaning across respondents, some of whom are non-
clinical staff. A related change across many items is use of the word 
``we'' rather than ``staff.'' It may be unclear to respondents whether 
providers such as physicians, residents, and interns qualify as 
``staff,'' while ``we'' invites a more inclusive view of those in the 
hospital or unit.
    (5) Reword items to be more applicable to physicians and non-
clinical staff. Users have indicated that the wording of some of the 
items makes it awkward for physicians to answer. For example, the 
section that asks about ``Your Supervisor/Manager'' does not apply well 
to physicians who report to a clinical leader but not to a manager per 
se. In addition, some items were difficult for non-clinical staff to 
answer. For example, the item ``We have patient safety problems in this 
unit'' may not be relevant for staff who do not have direct interaction 
with patients (e.g., IT staff).
    (6) Align the HSOPS survey with AHRQ patient safety culture surveys 
for other settings. The development of patient safety culture surveys 
for other settings provided opportunities to test new items and 
refinements of original HSOPS items. Many of these items have performed 
well for other settings and are relevant to the hospital setting. In 
addition, standardizing items across the patient safety culture surveys 
would allow cross-setting comparisons that are not currently possible.
    (7) Reduce survey length. To increase response rates and reduce the 
survey administration burden for hospitals, the revised survey is 
intended to be shorter than the original instrument. Some of the 
original items have relatively low variability and therefore contribute 
little to discrimination between positive and negative assessment of 
patient safety

[[Page 26260]]

culture. However, the need for careful testing of alternative questions 
means that the initial draft of the revised or 2.0 survey is slightly 
longer than the original. Through cognitive interviewing, pilot 
testing, and expert review, we will identify items that can be deleted, 
resulting in a shorter final instrument.
    (8) Investigate supplemental items/composites. Develop a set of 
supplemental items for the HSOPS 2.0 survey pertaining to Health 
Information Technology (Health IT).
    Further details about the specific changes by composite and at the 
item level can be found on the AHRQ Web site at: http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/hospital/update/index.html.
    The draft 2.0 version of the instrument has undergone preliminary 
cognitive testing with 9 hospital physicians and staff members as well 
as review by a Technical Expert Panel (TEP).
    This research has the following goals:
    (1) Cognitively test with individual respondents the items in a) 
the draft HSOPS 2.0 survey and b) HSOPS 2.0 supplemental item set 
assessing Health IT Patient Safety. Cognitive testing will be conducted 
in English and Spanish.
    (2) Conduct data collection as follows:
    a. A combined pilot test and bridge study for the draft HSOPS 2.0 
in 40 hospitals and modify the questionnaire as necessary. The pilot 
test component will entail administering the draft 2.0 version to 
determine which items to retain. The bridge study component will entail 
administering the original HSOPS in addition to the draft HSOPS 2.0 
version to provide guidance to hospitals in understanding changes in 
their scores resulting from the new instrument versus changes resulting 
from true changes in culture.
    b. The pilot testing of the supplemental item set will be conducted 
with the same hospitals and respondents as the pilot test for the draft 
HSOPS 2.0. These supplemental items will be added to the draft HSOPS 
2.0 survey for pilot testing.
    (3) Engage a TEP in review of pilot results and finalize the 
questionnaire and supplemental item set.
    (4) Make the final HSOPS 2.0 survey and the supplemental items 
publicly available.
    This work is being conducted by AHRQ through its contractor, 
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

    Cognitive interviews--The purpose of these interviews is to 
understand the cognitive processes respondents engage in when answering 
each item on the survey, which will aid in refining the survey 
instrument. These interviews will be conducted with a mix of hospital 
personnel, including physicians, nurses, and other types of staff (from 
dietitians to housekeepers).
    Draft HSOPS 2.0--Cognitive interviews have already been conducted 
with 9 respondents to inform development of the current draft HSOPS 
2.0. Up to three additional rounds of interviews will be conducted by 
telephone with a total of 27 respondents (nine respondents each round). 
The instrument will be translated into Spanish and another round of 
cognitive interviews will be conducted with nine Spanish-speaking 
respondents for a total of up to 36 respondents across all four rounds. 
A cognitive interview guide will be used for all rounds.
    Supplemental Items--Up to three rounds of interviews will be 
conducted by telephone for a total of 27 respondents (nine respondents 
each round). The supplemental items will be translated into Spanish and 
another round of cognitive interviews will be conducted with nine 
Spanish-speaking respondents for a total of up to 36 respondents across 
all four rounds. A cognitive interview guide will be used for all 
rounds.
    Feedback obtained from the first round of interviews for the draft 
HSOPS 2.0 and the supplemental items will be used to refine the items. 
The results of Round 1 testing, along with the proposed revisions, will 
be reviewed with a TEP prior to commencing with Rounds 2 and/or 3 
testing. In total, up to 72 cognitive interviews will be conducted to 
refine the draft HSOPS 2.0 and supplemental items for pilot testing.
    (2) Pilot test and bridge study--There will be one data collection 
effort which will provide data for the pilot test and the bridge study. 
The pilot test of the draft HSOPS 2.0 and supplemental items will allow 
the assessment of the psychometric properties of the items and 
composites. We will assess the variability, reliability, factor 
structure and construct validity of the draft HSOPS 2.0 and 
supplemental items and composites, allowing for their further 
refinement. The draft HSOPS 2.0 survey and supplemental items will be 
pilot tested with hospital personnel in approximately 40 hospitals to 
facilitate multilevel analysis of the data. Approximately 500 providers 
and staff will be sampled from each hospital, with 250 receiving HSOPS 
2.0 with supplemental items for the pilot test and 250 receiving the 
original HSOPS for the bridge study comparisons. A hospital point of 
contact will be recruited in each hospital to publicize the survey and 
assemble a list of sampled providers and staff. Providers and staff 
will receive notification of the survey and reminders via email and the 
web-based survey will be fielded entirely online.
    The goal of the bridge study will be to provide users with guidance 
on how their new results will compare with results from the original 
HSOPS survey. Although users have requested that the HSOPS survey be 
revised, they are also concerned about their ability to trend results 
with data from prior years. A similar bridge study was conducted during 
the 1994 redesign of the Census Bureau's Current Population Survey 
(CPS). In the CPS bridge study, an additional 12,000 households were 
added to the survey's monthly rotation schedule between July 1992 and 
December 1993. The added households received the redesigned version of 
the instrument. Thus, the CPS fielded both the revised and the original 
versions of the instrument simultaneously. One of the most important 
results of the CPS bridge study was the development of metrics that 
allowed estimates of change that were due to the changes in the 
instrument. These metrics were used to adjust the estimates produced by 
the revised CPS instrument. As a result of the study, key labor force 
metrics such as the unemployment rate could be trended accurately after 
the instrument's redesign.
    We propose to conduct a similarly constructed bridge study in which 
sampled providers and staff take either the draft HSOPS 2.0 or original 
versions of HSOPS. As noted above, a split ballot design will be used 
in which half of sampled providers and staff in each hospital receive 
the original HSOPS (N=250) and the other half receive the draft HSOPS 
2.0 (N=250). This bridge study is designed to produce metrics of change 
that are attributable to the changed survey instrument. The number of 
hospitals and sampled providers and staff for this data collection 
effort was calculated to ensure the statistical power needed to detect 
relatively small differences in scores (3 percentage points).
    (3) TEP feedback--A TEP has been assembled to provide input to 
guide patient safety culture survey product

[[Page 26261]]

development and has been convened to discuss the proposed changes to 
the HSOPS survey and supplemental items. Upon completion of the pilot 
test, results will be reviewed with the TEP and the survey will be 
finalized. This TEP activity does not impose a burden on the public and 
is therefore not included in the burden estimates in Exhibits 1 and 2.
    (4) Dissemination activities--The final HSOPS 2.0 instrument and 
supplemental items will be made publicly available through the AHRQ Web 
site. A report from the bridge study will also be made public as a 
resource to hospitals making the transition to the new survey. This 
dissemination activity does not impose a burden on the public and is 
therefore not included in the burden estimates in Exhibits 1 and 2.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
participants' time to take part in this research. Cognitive interviews 
for the draft HSOPS 2.0 will be conducted with 36 individuals and will 
take about one hour and 30 minutes to complete. Cognitive interviews 
for the supplemental items will be conducted with 36 individuals and 
take about one hour to complete. We will recruit 40 hospitals for the 
pilot test and bridge study, sampling approximately 500 staff members 
in each (250 taking the original survey and 250 taking the HSOPS 2.0 
and supplemental item set). Because we require such a large sample 
within each hospital, we will target only hospitals with 49 or more 
beds. For hospitals with fewer than 500 providers and staff, we will 
conduct a census in the hospital (assuming on average 375 providers and 
staff in these hospitals this will yield a total of 18,375 sample 
members assuming all 40 hospitals participate. Assuming a response rate 
of 50 percent, this will yield a total of 9,188 completed 
questionnaires. The total annualized burden is estimated to be 2,387 
hours.
    Exhibit 2 shows the estimated annualized cost burden associated 
with the participants' time to take part in this research. The total 
cost burden is estimated to be $83,533.26.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of       Hours per     Total burden
                       Form name/activity                           respondents      response          hours
----------------------------------------------------------------------------------------------------------------
Cognitive interviews--HSOPS 2.0.................................              36             1.5              54
Cognitive interviews--Supplemental Items........................              36             1.0              36
Pilot test and bridge study.....................................           9,188            0.25           2,297
                                                                 -----------------------------------------------
    Total.......................................................           9,260              na           2,387
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                                   Total burden   Average hourly    Total cost
                       Form name/activity                              hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
Cognitive interviews (HSOPS 2.0 and supplemental items).........              90      \a\ $35.38       $3,184.20
Pilot test and bridge study.....................................           2,297       \b\ 34.98       80,349.06
                                                                 -----------------------------------------------
    Total.......................................................           2,387              na       83,533.26
----------------------------------------------------------------------------------------------------------------
\a\ Based on the weighted average hourly wage in hospitals for one physician (29-1060; $101.53), one registered
  nurse (29-1141; $30.22), one general and operations manager (11-1021; $52.64), and six clinical lab techs (29-
  2010; $22.34) whose hourly wage is meant to represent wages for other hospital employees who may participate
  in cognitive interviews.
\b\ Based on the weighted average hourly wage in hospitals for 1,981 registered nurses, 209 clinical lab techs,
  176 physicians and surgeons, and 21 general and operations managers.
* National Industry-Specific Occupational Employment and Wage Estimates, May 2013, from the Bureau of Labor
  Statistics (available at http://www.bls.gov/oes/current/naics4_621100.htm [for general medical and surgical
  hospitals, NAICS 622100]).

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: April 27, 2015.
Sharon B. Arnold,
Deputy Director, AHRQ.
[FR Doc. 2015-10982 Filed 5-6-15; 8:45 am]
 BILLING CODE 4160-90-P
26258 Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices

that corresponds with ‘‘Information Obtaining Copies of Proposals: Bulletins can be found at www.gsa.gov/
Collection 9000–0076, Novation/Change Requesters may obtain a copy of the ftrbulletin.
of Name Requirements.’’ Follow the information collection documents from Dated: May 1, 2015.
instructions provided at the ‘‘Submit a the General Services Administration, Giancarlo Brizzi,
Comment’’ screen. Please include your Regulatory Secretariat Division (MVCB),
Acting Associate Administrator, Office of
name, company name (if any), and 1800 F Street NW., Washington, DC Government-wide Policy.
‘‘Information Collection 9000–0076, 20405, telephone 202–501–4755. Please
[FR Doc. 2015–10631 Filed 5–6–15; 8:45 am]
Novation/Change of Name cite OMB Control No. 9000–0076,
BILLING CODE 6820–14–P
Requirements’’ on your attached Novation/Change of Name
document. Requirements, in all correspondence.
• Mail: General Services Dated: May 4, 2015.
Administration, Regulatory Secretariat DEPARTMENT OF HEALTH AND
Edward Loeb, HUMAN SERVICES
Division (MVCB), 1800 F Street NW.,
Acting Director, Federal Acquisition Policy
Washington, DC 20405. ATTN: Ms.
Division, Office of Governmentwide Agency for Healthcare Research and
Flowers/IC 9000–0076, Novation/ Acquisition Policy, Office of Acquisition Quality
Change of Name Requirements. Policy, Office of Governmentwide Policy.
Instructions: Please submit comments [FR Doc. 2015–11074 Filed 5–6–15; 8:45 am] Agency Information Collection
only and cite Information Collection Activities: Proposed Collection;
BILLING CODE 6820–EP–P
9000–0076, Novation/Change of Name Comment Request
Requirements, in all correspondence
related to this collection. All comments AGENCY: Agency for Healthcare Research
received will be posted without change GENERAL SERVICES and Quality, HHS.
to http://www.regulations.gov, including ADMINISTRATION ACTION: Notice.
any personal and/or business [Notice–MA–2015–02; Docket No. 2015–
confidential information provided. 0002, Sequence No. 10] SUMMARY: This notice announces the
intention of the Agency for Healthcare
FOR FURTHER INFORMATION CONTACT: Mr.
Federal Travel Regulation (FTR); Research and Quality (AHRQ) to request
Curtis E. Glover, Sr., Procurement
Relocation Allowances—Requirement that the Office of Management and
Analyst, Office of Governmentwide
To Report Agency Payments for Budget (OMB) approve the proposed
Acquisition Policy, GSA, 202–208–4949
Relocation information collection project: ‘‘Pilot
or via email curtis.glover@gsa.gov.
Test of the Proposed Hospital Survey on
SUPPLEMENTARY INFORMATION: AGENCY: Office of Government-Wide Patient Safety Culture Version 2.0.’’ In
Policy, General Services Administration accordance with the Paperwork
A. Purpose
(GSA). Reduction Act, 44 U.S.C. 3501–3521,
Federal Acquisition Regulation ACTION: Notice of a bulletin.
42.1203 and 42.1204 provide AHRQ invites the public to comment on
requirements for contractors to request SUMMARY: The purpose of this notice is this proposed information collection.
novation/change of name agreements to inform agencies that FTR Bulletin 15– DATES: Comments on this notice must be
and supporting documents when a firm 04, pertaining to the Requirement to received by July 6, 2015.
performing under Government contracts Report Agency Payments for Relocation, ADDRESSES: Written comments should
wishes the Government to recognize (1) is now available online at www.gsa.gov/ be submitted to: Doris Lefkowitz,
a successor in interest to these contracts, ftrbulletin. Reports Clearance Officer, AHRQ, by
or (2) a name change, it must submit DATES: Effective: May 7, 2015. email at doris.lefkowitz@AHRQ.hhs.gov.
certain documentation to the FOR FURTHER INFORMATION CONTACT: Mr.
Copies of the proposed collection
Government. Rick Miller, Office of Asset and plans, data collection instruments, and
Transportation Management (MA), specific details on the estimated burden
B. Annual Reporting Burden can be obtained from the AHRQ Reports
Office of Government-wide Policy, GSA,
Respondents: 1,178. at 202–501–3822 or via email at Clearance Officer.
Responses per Respondent: 1. FOR FURTHER INFORMATION CONTACT:
rodney.miller@gsa.gov. Please cite FTR
Annual Responses: 1,178. Doris Lefkowitz, AHRQ Reports
Hours per Response: 2.0. Bulletin 15–04.
SUPPLEMENTARY INFORMATION: Under 5
Clearance Officer, (301) 427–1477, or by
Total Burden Hours: 2,356. email at doris.lefkowitz@AHRQ.hhs.gov.
U.S.C. 5707(c), as implemented in the
C. Public Comments Federal Travel Regulation, Part 300–70, SUPPLEMENTARY INFORMATION:
Public comments are particularly Subpart A—Requirement To Report Pilot Test of the Proposed Hospital
invited on: Whether this collection of Agency Payments for Employee Travel Survey on Patient Safety Culture
information is necessary; whether it will and Relocation, and Part 302–1, Subpart Version 2.0
have practical utility; whether our B—Requirement to Report Agency Data
estimate of the public burden of this for Employee Relocation, the Proposed Project
collection of information is accurate, Administrator of General Services is In 2004, AHRQ developed and
and based on valid assumptions and required to collect data on total agency published a measurement tool to assess
methodology; ways to enhance the payments for travel, transportation, and the culture of patient safety in hospitals
mstockstill on DSK4VPTVN1PROD with NOTICES

quality, utility, and clarity of the relocation expenses every year. This (OMB control no. 0935–0115). The
information to be collected; and ways in bulletin provides guidance to agencies Hospital Survey on Patient Safety
which we can minimize the burden of that spent more than $5 million on Culture (HSOPS) is a survey of
the collection of information on those travel and transportation payments, providers and staff that can be
who are to respond, through the use of including relocation costs, and the implemented by hospitals to identify
appropriate technological collection requirement procedures to report the strengths and areas for patient safety
techniques or other forms of information data to GSA. Federal Travel Regulation culture improvement as well as raise
technology. Bulletin 15–04 and all other FTR awareness about patient safety. When

VerDate Sep<11>2014 18:07 May 06, 2015 Jkt 235001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\07MYN1.SGM 07MYN1
26260 Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices

culture. However, the need for careful effectiveness, efficiency, tested with hospital personnel in
testing of alternative questions means appropriateness and value of healthcare approximately 40 hospitals to facilitate
that the initial draft of the revised or 2.0 services and with respect to quality multilevel analysis of the data.
survey is slightly longer than the measurement and improvement. 42 Approximately 500 providers and staff
original. Through cognitive U.S.C. 299a(a)(1) and (2). will be sampled from each hospital,
interviewing, pilot testing, and expert with 250 receiving HSOPS 2.0 with
Method of Collection
review, we will identify items that can supplemental items for the pilot test and
be deleted, resulting in a shorter final Cognitive interviews—The purpose of 250 receiving the original HSOPS for the
instrument. these interviews is to understand the bridge study comparisons. A hospital
(8) Investigate supplemental items/ cognitive processes respondents engage point of contact will be recruited in
composites. Develop a set of in when answering each item on the each hospital to publicize the survey
supplemental items for the HSOPS 2.0 survey, which will aid in refining the and assemble a list of sampled providers
survey pertaining to Health Information survey instrument. These interviews and staff. Providers and staff will
Technology (Health IT). will be conducted with a mix of hospital receive notification of the survey and
Further details about the specific personnel, including physicians, nurses, reminders via email and the web-based
changes by composite and at the item and other types of staff (from dietitians survey will be fielded entirely online.
level can be found on the AHRQ Web to housekeepers). The goal of the bridge study will be
site at: http://www.ahrq.gov/ Draft HSOPS 2.0—Cognitive to provide users with guidance on how
professionals/quality-patient-safety/ interviews have already been conducted their new results will compare with
patientsafetyculture/hospital/update/ with 9 respondents to inform results from the original HSOPS survey.
index.html. development of the current draft HSOPS Although users have requested that the
The draft 2.0 version of the 2.0. Up to three additional rounds of HSOPS survey be revised, they are also
instrument has undergone preliminary interviews will be conducted by concerned about their ability to trend
cognitive testing with 9 hospital telephone with a total of 27 respondents results with data from prior years. A
physicians and staff members as well as (nine respondents each round). The similar bridge study was conducted
review by a Technical Expert Panel instrument will be translated into during the 1994 redesign of the Census
(TEP). Spanish and another round of cognitive Bureau’s Current Population Survey
This research has the following goals: interviews will be conducted with nine (CPS). In the CPS bridge study, an
(1) Cognitively test with individual Spanish-speaking respondents for a total additional 12,000 households were
respondents the items in a) the draft of up to 36 respondents across all four added to the survey’s monthly rotation
HSOPS 2.0 survey and b) HSOPS 2.0 rounds. A cognitive interview guide will schedule between July 1992 and
supplemental item set assessing Health be used for all rounds. December 1993. The added households
IT Patient Safety. Cognitive testing will Supplemental Items—Up to three received the redesigned version of the
be conducted in English and Spanish. rounds of interviews will be conducted instrument. Thus, the CPS fielded both
(2) Conduct data collection as follows: by telephone for a total of 27 the revised and the original versions of
a. A combined pilot test and bridge respondents (nine respondents each the instrument simultaneously. One of
study for the draft HSOPS 2.0 in 40 round). The supplemental items will be the most important results of the CPS
hospitals and modify the questionnaire translated into Spanish and another bridge study was the development of
as necessary. The pilot test component round of cognitive interviews will be metrics that allowed estimates of change
will entail administering the draft 2.0 conducted with nine Spanish-speaking that were due to the changes in the
version to determine which items to respondents for a total of up to 36 instrument. These metrics were used to
retain. The bridge study component will respondents across all four rounds. A adjust the estimates produced by the
entail administering the original HSOPS cognitive interview guide will be used revised CPS instrument. As a result of
in addition to the draft HSOPS 2.0 for all rounds. the study, key labor force metrics such
version to provide guidance to hospitals Feedback obtained from the first as the unemployment rate could be
in understanding changes in their scores round of interviews for the draft HSOPS trended accurately after the instrument’s
resulting from the new instrument 2.0 and the supplemental items will be redesign.
versus changes resulting from true used to refine the items. The results of We propose to conduct a similarly
changes in culture. Round 1 testing, along with the constructed bridge study in which
b. The pilot testing of the proposed revisions, will be reviewed sampled providers and staff take either
supplemental item set will be with a TEP prior to commencing with the draft HSOPS 2.0 or original versions
conducted with the same hospitals and Rounds 2 and/or 3 testing. In total, up of HSOPS. As noted above, a split ballot
respondents as the pilot test for the draft to 72 cognitive interviews will be design will be used in which half of
HSOPS 2.0. These supplemental items conducted to refine the draft HSOPS 2.0 sampled providers and staff in each
will be added to the draft HSOPS 2.0 and supplemental items for pilot testing. hospital receive the original HSOPS
survey for pilot testing. (2) Pilot test and bridge study—There (N=250) and the other half receive the
(3) Engage a TEP in review of pilot will be one data collection effort which draft HSOPS 2.0 (N=250). This bridge
results and finalize the questionnaire will provide data for the pilot test and study is designed to produce metrics of
and supplemental item set. the bridge study. The pilot test of the change that are attributable to the
(4) Make the final HSOPS 2.0 survey draft HSOPS 2.0 and supplemental changed survey instrument. The number
and the supplemental items publicly items will allow the assessment of the of hospitals and sampled providers and
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available. psychometric properties of the items staff for this data collection effort was
This work is being conducted by and composites. We will assess the calculated to ensure the statistical
AHRQ through its contractor, Westat, variability, reliability, factor structure power needed to detect relatively small
pursuant to AHRQ’s statutory authority and construct validity of the draft differences in scores (3 percentage
to conduct and support research on HSOPS 2.0 and supplemental items and points).
healthcare and on systems for the composites, allowing for their further (3) TEP feedback—A TEP has been
delivery of such care, including refinement. The draft HSOPS 2.0 survey assembled to provide input to guide
activities with respect to the quality, and supplemental items will be pilot patient safety culture survey product

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Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices 26261

development and has been convened to and is therefore not included in the Because we require such a large sample
discuss the proposed changes to the burden estimates in Exhibits 1 and 2. within each hospital, we will target only
HSOPS survey and supplemental items. Estimated Annual Respondent Burden hospitals with 49 or more beds. For
Upon completion of the pilot test, hospitals with fewer than 500 providers
results will be reviewed with the TEP Exhibit 1 shows the estimated and staff, we will conduct a census in
and the survey will be finalized. This annualized burden hours for the the hospital (assuming on average 375
TEP activity does not impose a burden participants’ time to take part in this providers and staff in these hospitals
on the public and is therefore not research. Cognitive interviews for the this will yield a total of 18,375 sample
included in the burden estimates in draft HSOPS 2.0 will be conducted with members assuming all 40 hospitals
Exhibits 1 and 2. 36 individuals and will take about one participate. Assuming a response rate of
hour and 30 minutes to complete.
(4) Dissemination activities—The 50 percent, this will yield a total of
Cognitive interviews for the
final HSOPS 2.0 instrument and 9,188 completed questionnaires. The
supplemental items will be conducted
supplemental items will be made total annualized burden is estimated to
with 36 individuals and take about one
publicly available through the AHRQ hour to complete. We will recruit 40 be 2,387 hours.
Web site. A report from the bridge study hospitals for the pilot test and bridge Exhibit 2 shows the estimated
will also be made public as a resource study, sampling approximately 500 staff annualized cost burden associated with
to hospitals making the transition to the members in each (250 taking the the participants’ time to take part in this
new survey. This dissemination activity original survey and 250 taking the research. The total cost burden is
does not impose a burden on the public HSOPS 2.0 and supplemental item set). estimated to be $83,533.26.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of Hours per Total burden
Form name/activity respondents response hours

Cognitive interviews—HSOPS 2.0 .............................................................................................. 36 1.5 54
Cognitive interviews—Supplemental Items ................................................................................. 36 1.0 36
Pilot test and bridge study ........................................................................................................... 9,188 0.25 2,297

Total ...................................................................................................................................... 9,260 na 2,387

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Average
Total burden Total cost
Form name/activity hourly wage
hours burden
rate *

Cognitive interviews (HSOPS 2.0 and supplemental items) ....................................................... 90 a $35.38 $3,184.20
Pilot test and bridge study ........................................................................................................... 2,297 b 34.98 80,349.06

Total ...................................................................................................................................... 2,387 na 83,533.26
a Based on the weighted average hourly wage in hospitals for one physician (29–1060; $101.53), one registered nurse (29–1141; $30.22), one
general and operations manager (11–1021; $52.64), and six clinical lab techs (29–2010; $22.34) whose hourly wage is meant to represent
wages for other hospital employees who may participate in cognitive interviews.
b Based on the weighted average hourly wage in hospitals for 1,981 registered nurses, 209 clinical lab techs, 176 physicians and surgeons,
and 21 general and operations managers.
* National Industry-Specific Occupational Employment and Wage Estimates, May 2013, from the Bureau of Labor Statistics (available at http://
www.bls.gov/oes/current/naics4_621100.htm [for general medical and surgical hospitals, NAICS 622100]).

Request for Comments automated collection techniques or DEPARTMENT OF HEALTH AND
In accordance with the Paperwork other forms of information technology. HUMAN SERVICES
Reduction Act, comments on AHRQ’s Comments submitted in response to
information collection are requested Agency for Healthcare Research and
this notice will be summarized and
with regard to any of the following: (a) Quality
included in the Agency’s subsequent
Whether the proposed collection of request for OMB approval of the National Advisory Council for
information is necessary for the proper proposed information collection. All Healthcare Research and Quality:
performance of AHRQ health care comments will become a matter of Request for Nominations for Public
research and health care information public record. Members
dissemination functions, including
whether the information will have Dated: April 27, 2015. AGENCY: Agency for Healthcare Research
practical utility; (b) the accuracy of Sharon B. Arnold, and Quality (AHRQ), HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES

AHRQ’s estimate of burden (including Deputy Director, AHRQ. ACTION: Notice of request for
hours and costs) of the proposed [FR Doc. 2015–10982 Filed 5–6–15; 8:45 am] nominations for public members.
collection(s) of information; (c) ways to BILLING CODE 4160–90–P
enhance the quality, utility, and clarity SUMMARY: 42 U.S.C. 299c establishes a
of the information to be collected; and National Advisory Council for
(d) ways to minimize the burden of the Healthcare Research and Quality (the
collection of information upon the Council). The Council is to advise the
respondents, including the use of Secretary of HHS (Secretary) and the

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Document Created: 2015-12-16 07:49:57
Document Modified: 2015-12-16 07:49:57
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments on this notice must be received by July 6, 2015.
Contact		Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]
FR Citation		80 FR 26258
80 FR 26258 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESAgency for Healthcare Research and Quality

Federal Register Volume 80, Issue 88 (May 7, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
