80 FR 50005 - 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 159 (August 18, 2015)

Page Range		50005-50008
FR Document		2015-20359
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. This proposed information collection was previously published in the Federal Register on May 7, 2015 and allowed 60 days for public comment. AHRQ received one comment of substance. The purpose of this notice is to allow an additional 30 days for public comment.
Federal Register, Volume 80 Issue 159 (Tuesday, August 18, 2015)
[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Notices]
[Pages 50005-50008]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20359]


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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.

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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.
    This proposed information collection was previously published in 
the Federal Register on May 7, 2015 and allowed 60 days for public 
comment. AHRQ received one comment of substance. The purpose of this 
notice is to allow an additional 30 days for public comment.

DATES: Comments on this notice must be received by September 17, 2015.

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 [email protected] (attention: AHRQ's desk 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 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 had 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

[[Page 50006]]

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 fifth ``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 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) Test cognitively 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 health care and on systems for the delivery of such care, 
including activities with respect to the quality, effectiveness, 
efficiency, appropriateness and value of health care 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

[[Page 50007]]

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.
    (1) 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. Fielding a bridge study is not 
unprecedented. For example, 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 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
----------------------------------------------------------------------------------------------------------------


[[Page 50008]]


                                   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.

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2015-20359 Filed 8-17-15; 8:45 am]
 BILLING CODE 4160-90-P
Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices 50005

Request for Comments DATES: Comments on this notice must be characteristics (e.g., number of beds,
In accordance with the Paperwork received by September 17, 2015. teaching status, geographic location)
Reduction Act, comments on AHRQ’s ADDRESSES: Written comments should and respondent characteristics (e.g.,
information collection are requested be submitted to: AHRQ’s OMB Desk position type, work area/unit).
Officer by fax at (202) 395–6974 The survey constructed in 2004
with regard to any of the following: (a)
(attention: AHRQ’s desk officer) or by remains in use today, more than 10
Whether the proposed collection of
email at OIRA_submission@ years after its initial launch. Since the
information is necessary for the proper launch of HSOPS, AHRQ has funded
performance of AHRQ health care omb.eop.gov (attention: AHRQ’s desk
officer). development of patient safety culture
research and health care information surveys for other settings. In 2008,
dissemination functions, including FOR FURTHER INFORMATION CONTACT: surveys were published for outpatient
whether the information will have Doris Lefkowitz, AHRQ Reports medical offices (OMB control no. 0935–
practical utility; (b) the accuracy of Clearance Officer, (301) 427–1477, or by 0131) and nursing homes (OMB control
AHRQ’s estimate of burden (including email at doris.lefkowitz@AHRQ.hhs.gov. no. 0935–0132). In 2012, a survey for
hours and costs) of the proposed SUPPLEMENTARY INFORMATION: community pharmacies (OMB control
collection(s) of information; (c) ways to no. 0935–0183) was released. Surveys
enhance the quality, utility, and clarity Pilot Test of the Proposed Hospital
for each setting built upon the strengths
of the information to be collected; and Survey on Patient Safety Culture
of HSOPS but improved and updated
(d) ways to minimize the burden of the Version 2.0 items where appropriate.
collection of information upon the Proposed Project Users of HSOPS have provided
respondents, including the use of feedback over the years suggesting that
automated collection techniques or In 2004, AHRQ developed and changes to the instrument would be
other forms of information technology. published a measurement tool to assess valuable and welcomed. The
Comments submitted in response to the culture of patient safety in hospitals comparative database registrants
this notice will be summarized and (OMB control no. 0935–0115). The provided feedback about potential
included in the Agency’s subsequent Hospital Survey on Patient Safety changes in 2013, and telephone
request for OMB approval of the Culture (HSOPS) is a survey of interviews were conducted with 8
proposed information collection. All providers and staff that can be current survey users and vendors to gain
comments will become a matter of implemented by hospitals to identify an in-depth understanding of their
public record. strengths and areas for patient safety thoughts on the current survey and
culture improvement as well as raise possible changes. As a result of this
Sharon B. Arnold, awareness about patient safety. When feedback, the Hospital Survey on Patient
Deputy Director. conducted routinely, the survey can be Safety Culture Version 2.0 (HSOPS 2.0)
[FR Doc. 2015–20358 Filed 8–17–15; 8:45 am] used to examine trends in patient safety is being constructed with the following
BILLING CODE 4160–90–P culture over time and evaluate the 8 objectives in mind.
cultural impact of patient safety (1) Shift to a Just Culture framework
initiatives and interventions. The data for understanding responses to errors. In
DEPARTMENT OF HEALTH AND can also be used to make comparisons the original HSOPS, questions around
HUMAN SERVICES across hospital units. AHRQ also responses to errors were negatively
produced a survey user’s guide to assist worded to detect a ‘‘culture of blame’’
Agency for Healthcare Research and hospitals in conducting the survey in organizations. For example,
Quality successfully. The guide addresses issues respondents evaluated the extent to
such as which providers and staff which errors were held against them
Agency Information Collection
should complete the survey, how to and whether it felt as though the person
Activities: Proposed Collection;
select a sample of hospital providers was being written up rather than the
Comment Request
and staff, how to administer the problem. In contrast, a Just Culture
AGENCY: Agency for Healthcare Research questionnaire, and how to analyze and framework emphasizes learning from
and Quality, HHS. report on the resulting data. mistakes, providing a safe environment
ACTION: Notice. Since 2004, thousands of hospitals for reporting errors, and utilizing a
within the U.S. and internationally have balanced approach to errors that
SUMMARY: This notice announces the implemented the survey. In response to considers both system and individual
intention of the Agency for Healthcare requests for comparative data from other behavioral reasons as causes for errors.
Research and Quality (AHRQ) to request hospitals, AHRQ funded the New items will be constructed in
that the Office of Management and development of a comparative database HSOPS 2.0 to capture the extent to
Budget (OMB) approve the proposed on the survey in 2006 (OMB control no. which positive responses to error
information collection project: ‘‘Pilot 0935–0162). The database is currently consistent with a Just Culture
Test of the Proposed Hospital Survey on compiled every two years, using the framework are present in an
Patient Safety Culture Version 2.0.’’ In latest data provided by participating organization. For example, respondents
accordance with the Paperwork hospitals (and retaining submitted data will be asked to evaluate the extent to
Reduction Act, 44 U.S.C. 3501–3521, for no more than 2 years). Reports which the organization tries to
AHRQ invites the public to comment on describing the findings from analysis of understand the factors that lead to
asabaliauskas on DSK5VPTVN1PROD with NOTICES

this proposed information collection. the database are made available on the patient safety errors.
This proposed information collection AHRQ Web site to assist hospitals in (2) Reduce the number of negatively
was previously published in the Federal comparing their results. The 2014 worded items. The original HSOPS had
Register on May 7, 2015 and allowed 60 database contains data from 405,281 negatively worded items. For example,
days for public comment. AHRQ hospital provider and staff respondents respondents are asked whether there are
received one comment of substance. The within 653 participating hospitals. The ‘‘patient safety problems in this unit’’
purpose of this notice is to allow an 2014 User Comparative Database Report (negatively worded). Using some
additional 30 days for public comment. presents results by hospital negatively worded items was intended

VerDate Sep<11>2014 17:02 Aug 17, 2015 Jkt 235001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\FR\FM\18AUN1.SGM 18AUN1
Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices 50007

translated into Spanish and another concerned about their ability to trend and the survey will be finalized. This
round of cognitive interviews will be results with data from prior years. TEP activity does not impose a burden
conducted with nine Spanish-speaking Fielding a bridge study is not on the public and is therefore not
respondents for a total of up to 36 unprecedented. For example, a similar included in the burden estimates in
respondents across all four rounds. A bridge study was conducted during the Exhibits 1 and 2.
cognitive interview guide will be used 1994 redesign of the Census Bureau’s (4) Dissemination activities—The
for all rounds. Current Population Survey (CPS). In the final HSOPS 2.0 instrument and
(1) Feedback obtained from the first CPS bridge study, an additional 12,000 supplemental items will be made
round of interviews for the draft HSOPS households were added to the survey’s publicly available through the AHRQ
2.0 and the supplemental items will be monthly rotation schedule between July Web site. A report from the bridge study
used to refine the items. The results of 1992 and December 1993. The added will also be made public as a resource
Round 1 testing, along with the households received the redesigned to hospitals making the transition to the
proposed revisions, will be reviewed version of the instrument. Thus, the CPS new survey. This dissemination activity
with a TEP prior to commencing with fielded both the revised and the original does not impose a burden on the public
Rounds 2 and/or 3 testing. In total, up versions of the instrument and is therefore not included in the
to 72 cognitive interviews will be simultaneously. One of the most burden estimates in Exhibits 1 and 2.
conducted to refine the draft HSOPS 2.0 important results of the CPS bridge
Estimated Annual Respondent Burden
and supplemental items for pilot testing. study was the development of metrics
(2) Pilot test and bridge study—There that allowed estimates of change that Exhibit 1 shows the estimated
will be one data collection effort which were due to the changes in the annualized burden hours for the
will provide data for the pilot test and instrument. These metrics were used to participants’ time to take part in this
the bridge study. The pilot test of the adjust the estimates produced by the research. Cognitive interviews for the
draft HSOPS 2.0 and supplemental revised CPS instrument. As a result of draft HSOPS 2.0 will be conducted with
items will allow the assessment of the the study, key labor force metrics such 36 individuals and will take about one
psychometric properties of the items as the unemployment rate could be hour and 30 minutes to complete.
and composites. We will assess the trended accurately after the instrument’s Cognitive interviews for the
variability, reliability, factor structure redesign. supplemental items will be conducted
and construct validity of the draft We propose to conduct a similarly with 36 individuals and take about one
HSOPS 2.0 and supplemental items and constructed bridge study in which hour to complete. We will recruit 40
composites, allowing for their further sampled providers and staff take either hospitals for the pilot test and bridge
refinement. The draft HSOPS 2.0 survey the draft HSOPS 2.0 or original versions study, sampling approximately 500 staff
and supplemental items will be pilot of HSOPS. As noted above, a split ballot members in each (250 taking the
tested with hospital personnel in design will be used in which half of original survey and 250 taking the
approximately 40 hospitals to facilitate sampled providers and staff in each HSOPS 2.0 and supplemental item set).
multilevel analysis of the data. hospital receive the original HSOPS Because we require such a large sample
Approximately 500 providers and staff (N=250) and the other half receive the within each hospital, we will target only
will be sampled from each hospital, draft HSOPS 2.0 (N=250). This bridge hospitals with 49 or more beds. For
with 250 receiving HSOPS 2.0 with study is designed to produce metrics of hospitals with fewer than 500 providers
supplemental items for the pilot test and change that are attributable to the and staff, we will conduct a census in
250 receiving the original HSOPS for the changed survey instrument. The number the hospital (assuming on average 375
bridge study comparisons. A hospital of hospitals and sampled providers and providers and staff in these hospitals
point of contact will be recruited in staff for this data collection effort was this will yield a total of 18,375 sample
each hospital to publicize the survey calculated to ensure the statistical members assuming all 40 hospitals
and assemble a list of sampled providers power needed to detect relatively small participate. Assuming a response rate of
and staff. Providers and staff will differences in scores (3 percentage 50 percent, this will yield a total of
receive notification of the survey and points). 9,188 completed questionnaires. The
reminders via email and the web-based (3) TEP feedback—A TEP has been total annualized burden is estimated to
survey will be fielded entirely online. assembled to provide input to guide be 2,387 hours.
The goal of the bridge study will be patient safety culture survey product Exhibit 2 shows the estimated
to provide users with guidance on how development and has been convened to annualized cost burden associated with
their new results will compare with discuss the proposed changes to the the participants’ time to take part in this
results from the original HSOPS survey. HSOPS survey and supplemental items. research. The total cost burden is
Although users have requested that the Upon completion of the pilot test, estimated to be $83,533.26.
HSOPS survey be revised, they are also results will be reviewed with the TEP

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Total
Number of Hours per
Form name/activity burden
respondents response hours
asabaliauskas on DSK5VPTVN1PROD with NOTICES

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

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50008 Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices

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 SUMMARY: The Food and Drug Division of Dockets Management (HFA–
In accordance with the Paperwork Administration (FDA) is announcing the 305), Food and Drug Administration,
Reduction Act, comments on AHRQ’s availability of the guidance entitled 5630 Fishers Lane, Rm. 1061, Rockville,
information collection are requested ‘‘Select Updates for Non-Clinical MD 20852. Identify comments with the
with regard to any of the following: (a) Engineering Tests and Recommended docket number found in brackets in the
Whether the proposed collection of Labeling for Intravascular Stents and heading of this document.
information is necessary for the proper Associated Delivery Systems.’’ FDA has FOR FURTHER INFORMATION CONTACT:
performance of AHRQ health care developed this guidance to inform the Katharine Chowdhury, Center for
research and health care information coronary and peripheral stent industry Devices and Radiological Health, Food
dissemination functions, including about selected updates to FDA’s and Drug Administration, 10903 New
whether the information will have thinking regarding certain non-clinical Hampshire Ave. Bldg. 66, Rm. 1222,
practical utility; (b) the accuracy of testing for these devices. While FDA is Silver Spring, MD 20993–0002, 301–
AHRQ’s estimate of burden (including considering more substantial updates to 796–6344, or Erica Takai, Center for
hours and costs) of the proposed the ‘‘Non-Clinical Engineering Tests and Devices and Radiological Health, Food
Recommended Labeling for and Drug Administration, 10903 New
collection(s) of information; (c) ways to
Intravascular Stents and Associated Hampshire Ave. Bldg. 62, Rm. 3226,
enhance the quality, utility, and clarity
Delivery Systems’’ guidance (http:// Silver Spring, MD 20993–0002, 301–
of the information to be collected; and
www.fda.gov/medicaldevices/ 796–6353.
(d) ways to minimize the burden of the
deviceregulationandguidance/ SUPPLEMENTARY INFORMATION:
collection of information upon the
guidancedocuments/ucm071863.htm),
respondents, including the use of I. Background
we are issuing this update on select
automated collection techniques or
sections in order to notify the industry FDA held a public workshop entitled
other forms of information technology.
in a timely manner of our revised ‘‘Cardiovascular Metallic Implants:
Comments submitted in response to
recommendations. Corrosion, Surface Characterization, and
this notice will be summarized and
included in the Agency’s subsequent DATES: Submit either electronic or Nickel Leaching’’ on March 8 and 9,
request for OMB approval of the written comments on this guidance at 2012, that provided information on
proposed information collection. All any time. General comments on Agency current practices for performing these
comments will become a matter of guidance documents are welcome at any tests (see http://www.fda.gov/
public record. time. MedicalDevices/NewsEvents/
ADDRESSES: An electronic copy of the WorkshopsConferences/
Sharon B. Arnold, ucm287535.htm). A group of
guidance document is available for
Deputy Director. download from the Internet. See the participants from industry, test
[FR Doc. 2015–20359 Filed 8–17–15; 8:45 am] SUPPLEMENTARY INFORMATION section for facilities, and academia provided
BILLING CODE 4160–90–P information on electronic access to the comments on practices for corrosion
guidance. Submit written requests for a testing and nickel ion release testing.
single hard copy of the guidance Based on the discussion at the
DEPARTMENT OF HEALTH AND document entitled ‘‘Select Updates for workshop, this guidance updates a key
HUMAN SERVICES Non-Clinical Engineering Tests and aspect of sample conditioning for pitting
Recommended Labeling for corrosion testing that is less
Food and Drug Administration burdensome, and includes additional
Intravascular Stents and Associated
[Docket No. FDA–2013–D–0920] Delivery Systems’’ to the Office of the information on when galvanic corrosion
Center Director, Guidance and Policy testing may be omitted with
Select Updates for Non-Clinical Development, Center for Devices and justification, based on information
Engineering Tests and Recommended Radiological Health, Food and Drug gained from the workshop. This
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Labeling for Intravascular Stents and Administration, 10903 New Hampshire guidance provides updates only for the
Associated Delivery Systems; Ave. Bldg. 66, Rm. 5431, Silver Spring, following topics:
Guidance for Industry and Food and MD 20993–0002. Send one self- • Pitting corrosion potential
Drug Administration Staff; Availability addressed adhesive label to assist that • Galvanic corrosion
AGENCY: Food and Drug Administration, office in processing your request. • Surface characterization
Submit electronic comments on the • Nickel ion release
HHS.
guidance to http://www.regulations.gov. This guidance provides cross-
ACTION: Notice.
Submit written comments to the references and updates to the related

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Document Created: 2015-12-15 12:05:21
Document Modified: 2015-12-15 12:05:21
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 September 17, 2015.
Contact		Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]
FR Citation		80 FR 50005
80 FR 50005 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESAgency for Healthcare Research and Quality

Federal Register Volume 80, Issue 159 (August 18, 2015)

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