82_FR_22923 82 FR 22828 - Agency Information Collection Activities: Proposed Collection; Comment Request

82 FR 22828 - Agency Information Collection Activities: Proposed Collection; Comment Request

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

Federal Register Volume 82, Issue 95 (May 18, 2017)

Page Range22828-22830
FR Document2017-10066

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: ``TeamSTEPPS 2.0 Online Master Trainer Course.''

Federal Register, Volume 82 Issue 95 (Thursday, May 18, 2017)
[Federal Register Volume 82, Number 95 (Thursday, May 18, 2017)]
[Notices]
[Pages 22828-22830]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-10066]


-----------------------------------------------------------------------

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: ``TeamSTEPPS 2.0 Online Master Trainer Course.''

DATES: Comments on this notice must be received by July 17, 2017.

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:

Proposed Project

TeamSTEPPS 2.0 Online Master Trainer Course

    In accordance with the Paperwork Reduction Act of 1995, Public Law 
104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on 
this proposed information collection. As part of its effort to fulfill 
its mission goals, AHRQ, in collaboration with the U.S. Department of 
Defense's TRICARE Management Activity, developed TeamSTEPPS[supreg] 
(Team Strategies and Tools for Enhancing Performance and Patient 
Safety) to provide an evidence-based suite of tools and strategies for 
training teamwork-based patient safety to health care professionals. 
TeamSTEPPS includes multiple toolkits, which are all tied to, or are 
variants of, the core curriculum. TeamSTEPPS resources have been 
developed for primary care, rapid response systems, long-term care, and 
patients with limited English proficiency.
    The main objective of the TeamSTEPPS program is to improve patient 
safety by training health care staff in various teamwork, 
communication, and patient safety concepts, tools, and techniques and 
ultimately helping to build national capacity for supporting teamwork-
based patient safety efforts in health care organizations.
    Created in 2007, AHRQ's National Implementation Program trains 
Master Trainers who have stimulated the use and adoption of TeamSTEPPS 
in health care delivery systems. These individuals were trained during 
two-day, in-person classes using the TeamSTEPPS core curriculum at 
regional training centers across the U.S. AHRQ has also provided 
technical assistance and consultation on implementing TeamSTEPPS and 
has developed user networks, various educational venues, and other 
channel of learning for continued support and the improvement of 
teamwork in health care. Since the inception of the National 
Implementation Program, AHRQ has trained more than 6,000 participants 
to serve as TeamSTEPPS Master Trainers.
    Due to the success of the National Implementation Program, which 
resulted in increased requests for in-person training, AHRQ had been 
unable to match the demand for TeamSTEPPS Master Training, and wait 
lists for training at times exceeded 500 individuals.
    To address this prevailing need, AHRQ developed TeamSTEPPS 2.0 
Online Master Trainer course, which mirrors the TeamSTEPPS 2.0 core 
curriculum and provides equivalent training to the in-person classes 
offered through the National Implementation Program.
    As part of this initiative, AHRQ seeks to continue to conduct an 
evaluation of the TeamSTEPPS 2.0 Online Master

[[Page 22829]]

Trainer program. This evaluation seeks to understand the effectiveness 
of TeamSTEPPS 2.0 Online Master Training and what revisions might be 
required to improve the training program.
    This research has the following goals:
    (1) Conduct a formative assessment of the TeamSTEPPS 2.0 Online 
Master Trainer program to determine what improvements should be made to 
the training and how it is delivered, and
    (2) Identify how trained participants use and implement the 
TeamSTEPPS tools and resources.
    The TeamSTEPPS 2.0 Online Master Trainer program is led by 
Reingold, Inc. This study is being conducted by Reingold's 
subcontractor, IMPAQ International (IMPAQ). This study is being 
conducted 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

    To achieve this project's goals, AHRQ will train participants using 
the TeamSTEPPS 2.0 Online Master Trainer program and then survey these 
participants six months post-training. Each activity is briefly 
described below.
    1. TeamSTEPPS 2.0 Online Master Trainer Course. This training 
program, which includes 13 accredited hours of training, is based on 
the TeamSTEPPS 2.0 instructional materials and will be delivered online 
to 3,000 participants. The training will cover the core TeamSTEPPS 
tools and strategies, coaching, organizational change, and 
implementation science.
    2. TeamSTEPPS 2.0 Online Post-Training Survey. This online 
instrument will be administered to all participants who complete the 
TeamSTEPPS 2.0 Online Master Training. The survey will be administered 
six months after participants complete the training program.
    This data collection is for the purpose of conducting an evaluation 
of the TeamSTEPPS 2.0 Online Master Trainer program which was last 
approved by OMB on November 14th 2014 (OMB Control Number is 0935-
0224), and will expire November 30th, 2017. The evaluation is primarily 
formative in nature as AHRQ seeks information to improve the delivery 
of the training.
    This is a new data collection for the purpose of conducting an 
evaluation of TeamSTEPPS 2.0 Online Master Trainer program. The 
evaluation will be primarily formative in nature as AHRQ seeks 
information to improve the delivery of the training.
    The OMB Control Number for the MEPS-HC and MPC is 0935-0118, which 
was last approved by OMB on December 20th, 2012, and will expire on 
December 31st, 2015.
    To conduct the evaluation, the TeamSTEPPS 2.0 Online Post-Training 
Survey will be administered to all individuals who completed the 
TeamSTEPPS 2.0 Online Master Trainer program, six months after 
completing training. The purpose of the survey is to assess the degree 
to which participants felt prepared by the training and what they did 
to implement TeamSTEPPS. Specifically, participants will be asked about 
their reasons for participating in the program; the degree to which 
they feel the training prepared them to train others in and use 
TeamSTEPPS; what tools they have implemented in their organizations; 
and resulting changes they have observed in the delivery of care.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondent's time to participate in the study. The TeamSTEPPS 2.0 
Online Post-Training Survey will be completed by approximately 3,000 
individuals. We estimate that each respondent will require 20 minutes 
to complete the survey. The total annualized burden is estimated to be 
1,000 hours.
    Exhibit 2 shows the estimated annualized cost burden based on the 
respondents' time to participate in the study. The total cost burden is 
estimated to be $45,320.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Training participant questionnaire..............           3,000               1           20/60           1,000
                                                 ---------------------------------------------------------------
    Total.......................................           3,000             N/A             N/A           1,000
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                    Form name                        Number of     Total burden     hourly wage     Total cost
                                                    respondents        hours          rate *          burden
----------------------------------------------------------------------------------------------------------------
Training participant questionnaire..............           3,000           1,000          $45.32         $45,320
                                                 ---------------------------------------------------------------
    Total.......................................           3,000           1,000             N/A         $45,320
----------------------------------------------------------------------------------------------------------------
* Based on the mean of the average wages for all health professionals (29-0000) and wages for medical and health
  services managers (11-9111) for the training participant questionnaire presented in the National Compensation
  Survey: Occupational Wages in the United States, May 2016, U.S. Department of Labor, Bureau of Labor
  Statistics (https://www.bls.gov/oes/current/oes_nat.htm).

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

[[Page 22830]]

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. 2017-10066 Filed 5-17-17; 8:45 am]
 BILLING CODE 4160-90-P



                                                  22828                          Federal Register / Vol. 82, No. 95 / Thursday, May 18, 2017 / Notices

                                                  PICOTS (Populations, Interventions,                       C. Opioid use                                       13 (44 U.S.C. 3506(c)(2)(A)), AHRQ
                                                  Comparators, Outcomes, Timing,                            D. Sleep quality, sleep disturbance                 invites the public to comment on this
                                                  Settings)                                                 E. Health care utilization                          proposed information collection. As
                                                  Population(s): Adults with the following                Timing                                                part of its effort to fulfill its mission
                                                  chronic pain (defined as pain lasting 12                                                                      goals, AHRQ, in collaboration with the
                                                                                                          I. Duration of followup: Short term (up               U.S. Department of Defense’s TRICARE
                                                  weeks or longer or pain persisting past                       to 6 months), intermediate term (6–             Management Activity, developed
                                                  the time for normal tissue healing)                           12 months) and long term (at least              TeamSTEPPS® (Team Strategies and
                                                  conditions specified in the Key                               1 year); we will focus on longer-               Tools for Enhancing Performance and
                                                  Questions:                                                    term (>1 year) effects where                    Patient Safety) to provide an evidence-
                                                  Key Question 1: Nonradicular chronic                          possible                                        based suite of tools and strategies for
                                                    low back pain                                         II. Studies with <1 month followup after              training teamwork-based patient safety
                                                  Key Question 2: Chronic neck pain                             treatment will be excluded                      to health care professionals.
                                                    without radiculopathy or myelopathy                   Settings                                              TeamSTEPPS includes multiple
                                                  Key Question 3: Pain related to primary                                                                       toolkits, which are all tied to, or are
                                                    or secondary osteoarthritis                           I. Any nonhospital setting or setting of
                                                                                                               self-directed care                               variants of, the core curriculum.
                                                  Key Question 4: Fibromyalgia                                                                                  TeamSTEPPS resources have been
                                                  Key Question 5: Primary chronic                         II. Exclusions: Hospital care, hospice
                                                                                                               care, emergency department care                  developed for primary care, rapid
                                                    tension headache (defined as 15 or                                                                          response systems, long-term care, and
                                                    more headache days per month for at                   Sharon B. Arnold,                                     patients with limited English
                                                    least 3 months)                                       Deputy Director.                                      proficiency.
                                                  Key Question 6: Patients with any of the                [FR Doc. 2017–10067 Filed 5–17–17; 8:45 am]              The main objective of the
                                                    five chronic pain conditions                          BILLING CODE 4160–90–P                                TeamSTEPPS program is to improve
                                                  Interventions (All Key Questions)                                                                             patient safety by training health care
                                                                                                                                                                staff in various teamwork,
                                                  I. Exercise                                             DEPARTMENT OF HEALTH AND                              communication, and patient safety
                                                  II. Psychological therapies                             HUMAN SERVICES                                        concepts, tools, and techniques and
                                                  III. Physical modalities                                                                                      ultimately helping to build national
                                                  IV. Manual therapies                                    Agency for Healthcare Research and                    capacity for supporting teamwork-based
                                                  V. Mindfulness practices                                Quality                                               patient safety efforts in health care
                                                  VI. Mind-body practices                                                                                       organizations.
                                                  VII. Acupuncture                                        Agency Information Collection                            Created in 2007, AHRQ’s National
                                                  VIII. Functional restoration training                   Activities: Proposed Collection;                      Implementation Program trains Master
                                                  IX. Multidisciplinary/interdisciplinary                 Comment Request                                       Trainers who have stimulated the use
                                                        rehabilitation                                    AGENCY: Agency for Healthcare Research                and adoption of TeamSTEPPS in health
                                                  Comparators                                             and Quality, HHS.                                     care delivery systems. These individuals
                                                                                                          ACTION: Notice.
                                                                                                                                                                were trained during two-day, in-person
                                                  I. For all Key Questions, subquestion                                                                         classes using the TeamSTEPPS core
                                                        ‘‘a’’                                             SUMMARY:   This notice announces the                  curriculum at regional training centers
                                                     A. Sham treatment                                    intention of the Agency for Healthcare                across the U.S. AHRQ has also provided
                                                     B. Waitlist                                          Research and Quality (AHRQ) to request                technical assistance and consultation on
                                                     C. Usual care                                        that the Office of Management and                     implementing TeamSTEPPS and has
                                                     D. Attention control                                 Budget (OMB) approve the proposed                     developed user networks, various
                                                     E. No treatment                                      information collection project:                       educational venues, and other channel
                                                  II. For all Key Questions, subquestion                  ‘‘TeamSTEPPS 2.0 Online Master                        of learning for continued support and
                                                        ‘‘b’’                                             Trainer Course.’’                                     the improvement of teamwork in health
                                                     A. Non-opioid pharmacological                        DATES: Comments on this notice must be                care. Since the inception of the National
                                                        therapy (nonsteroidal anti-                       received by July 17, 2017.                            Implementation Program, AHRQ has
                                                        inflammatory drugs,                                                                                     trained more than 6,000 participants to
                                                                                                          ADDRESSES: Written comments should
                                                        acetaminophen, antiseizure                                                                              serve as TeamSTEPPS Master Trainers.
                                                                                                          be submitted to: Doris Lefkowitz,
                                                        medications, antidepressants)                                                                              Due to the success of the National
                                                                                                          Reports Clearance Officer, AHRQ, by
                                                     B. Opioid analgesics                                                                                       Implementation Program, which
                                                                                                          email at doris.lefkowitz@ahrq.hhs.gov.
                                                  III. Key Questions 1–4, 6, subquestion                     Copies of the proposed collection                  resulted in increased requests for in-
                                                        ‘‘c’’: Exercise                                   plans, data collection instruments, and               person training, AHRQ had been unable
                                                  IV. Key Question 5, 6, subquestion ‘‘c’’:               specific details on the estimated burden              to match the demand for TeamSTEPPS
                                                        Biofeedback                                       can be obtained from the AHRQ Reports                 Master Training, and wait lists for
                                                  Outcomes                                                Clearance Officer.                                    training at times exceeded 500
                                                                                                          FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                individuals.
                                                  I. Primary efficacy outcomes (in priority                                                                        To address this prevailing need,
                                                        order); we will focus on outcomes                 Doris Lefkowitz, AHRQ Reports
                                                                                                                                                                AHRQ developed TeamSTEPPS 2.0
                                                        from validated measures                           Clearance Officer, (301) 427–1477, or by
                                                                                                                                                                Online Master Trainer course, which
                                                     A. Function/disability/pain                          email at doris.lefkowitz@ahrq.hhs.gov.
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                                                                                                                                mirrors the TeamSTEPPS 2.0 core
                                                        interference                                      SUPPLEMENTARY INFORMATION:                            curriculum and provides equivalent
                                                     B. Pain                                              Proposed Project                                      training to the in-person classes offered
                                                  II. Harms and adverse effects                                                                                 through the National Implementation
                                                  III. Secondary outcomes                                 TeamSTEPPS 2.0 Online Master Trainer                  Program.
                                                     A. Psychological distress (including                 Course                                                   As part of this initiative, AHRQ seeks
                                                        depression and anxiety)                             In accordance with the Paperwork                    to continue to conduct an evaluation of
                                                     B. Quality of life                                   Reduction Act of 1995, Public Law 104–                the TeamSTEPPS 2.0 Online Master


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                                                                                           Federal Register / Vol. 82, No. 95 / Thursday, May 18, 2017 / Notices                                                                    22829

                                                  Trainer program. This evaluation seeks                                        1. TeamSTEPPS 2.0 Online Master                              December 20th, 2012, and will expire on
                                                  to understand the effectiveness of                                         Trainer Course. This training program,                          December 31st, 2015.
                                                  TeamSTEPPS 2.0 Online Master                                               which includes 13 accredited hours of                              To conduct the evaluation, the
                                                  Training and what revisions might be                                       training, is based on the TeamSTEPPS                            TeamSTEPPS 2.0 Online Post-Training
                                                  required to improve the training                                           2.0 instructional materials and will be                         Survey will be administered to all
                                                  program.                                                                   delivered online to 3,000 participants.                         individuals who completed the
                                                     This research has the following goals:                                  The training will cover the core                                TeamSTEPPS 2.0 Online Master Trainer
                                                     (1) Conduct a formative assessment of                                   TeamSTEPPS tools and strategies,                                program, six months after completing
                                                  the TeamSTEPPS 2.0 Online Master                                           coaching, organizational change, and                            training. The purpose of the survey is to
                                                  Trainer program to determine what                                          implementation science.                                         assess the degree to which participants
                                                  improvements should be made to the                                            2. TeamSTEPPS 2.0 Online Post-                               felt prepared by the training and what
                                                  training and how it is delivered, and                                      Training Survey. This online instrument                         they did to implement TeamSTEPPS.
                                                     (2) Identify how trained participants                                   will be administered to all participants                        Specifically, participants will be asked
                                                  use and implement the TeamSTEPPS                                           who complete the TeamSTEPPS 2.0                                 about their reasons for participating in
                                                  tools and resources.                                                       Online Master Training. The survey will                         the program; the degree to which they
                                                     The TeamSTEPPS 2.0 Online Master                                        be administered six months after                                feel the training prepared them to train
                                                  Trainer program is led by Reingold, Inc.                                   participants complete the training                              others in and use TeamSTEPPS; what
                                                  This study is being conducted by                                           program.                                                        tools they have implemented in their
                                                  Reingold’s subcontractor, IMPAQ                                               This data collection is for the purpose                      organizations; and resulting changes
                                                  International (IMPAQ). This study is                                       of conducting an evaluation of the                              they have observed in the delivery of
                                                  being conducted pursuant to AHRQ’s                                         TeamSTEPPS 2.0 Online Master Trainer                            care.
                                                  statutory authority to conduct and                                         program which was last approved by
                                                                                                                                                                                             Estimated Annual Respondent Burden
                                                  support research on health care and on                                     OMB on November 14th 2014 (OMB
                                                  systems for the delivery of such care,                                     Control Number is 0935–0224), and will                            Exhibit 1 shows the estimated
                                                  including activities with respect to the                                   expire November 30th, 2017. The                                 annualized burden hours for the
                                                  quality, effectiveness, efficiency,                                        evaluation is primarily formative in                            respondent’s time to participate in the
                                                  appropriateness, and value of health                                       nature as AHRQ seeks information to                             study. The TeamSTEPPS 2.0 Online
                                                  care services and with respect to quality                                  improve the delivery of the training.                           Post-Training Survey will be completed
                                                  measurement and improvement, 42                                               This is a new data collection for the                        by approximately 3,000 individuals. We
                                                  U.S.C. 299a(a)(1) and (2).                                                 purpose of conducting an evaluation of                          estimate that each respondent will
                                                                                                                             TeamSTEPPS 2.0 Online Master Trainer                            require 20 minutes to complete the
                                                  Method of Collection                                                       program. The evaluation will be                                 survey. The total annualized burden is
                                                    To achieve this project’s goals, AHRQ                                    primarily formative in nature as AHRQ                           estimated to be 1,000 hours.
                                                  will train participants using the                                          seeks information to improve the                                  Exhibit 2 shows the estimated
                                                  TeamSTEPPS 2.0 Online Master Trainer                                       delivery of the training.                                       annualized cost burden based on the
                                                  program and then survey these                                                 The OMB Control Number for the                               respondents’ time to participate in the
                                                  participants six months post-training.                                     MEPS–HC and MPC is 0935–0118,                                   study. The total cost burden is estimated
                                                  Each activity is briefly described below.                                  which was last approved by OMB on                               to be $45,320.

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

                                                  Training participant questionnaire ...................................................................                          3,000                  1             20/60          1,000

                                                       Total ..........................................................................................................           3,000                N/A              N/A           1,000


                                                                                                                 EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
                                                                                                                                                                                                                  Average
                                                                                                                                                                           Number of       Total burden                         Total cost
                                                                                                  Form name                                                                                                     hourly wage
                                                                                                                                                                          respondents         hours                              burden
                                                                                                                                                                                                                   rate *

                                                  Training participant questionnaire ...................................................................                          3,000               1,000           $45.32        $45,320

                                                       Total ..........................................................................................................           3,000               1,000             N/A         $45,320
                                                    * Based on the mean of the average wages for all health professionals (29–0000) and wages for medical and health services managers (11–
                                                  9111) for the training participant questionnaire presented in the National Compensation Survey: Occupational Wages in the United States, May
                                                  2016, U.S. Department of Labor, Bureau of Labor Statistics (https://www.bls.gov/oes/current/oes_nat.htm).
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  Request for Comments                                                       information is necessary for the proper                         hours and costs) of the proposed
                                                                                                                             performance of AHRQ health care                                 collection(s) of information; (c) ways to
                                                    In accordance with the Paperwork                                         research and health care information                            enhance the quality, utility, and clarity
                                                  Reduction Act, comments on AHRQ’s                                          dissemination functions, including                              of the information to be collected; and
                                                  information collection are requested                                       whether the information will have                               (d) ways to minimize the burden of the
                                                  with regard to any of the following: (a)                                   practical utility; (b) the accuracy of                          collection of information upon the
                                                  Whether the proposed collection of                                         AHRQ’s estimate of burden (including                            respondents, including the use of


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                                                  22830                          Federal Register / Vol. 82, No. 95 / Thursday, May 18, 2017 / Notices

                                                  automated collection techniques or                      Patient Safety Organizations (PSOs),                  applies to all patient safety concerns
                                                  other forms of information technology.                  which collect, aggregate, and analyze                 including: incidents—patient safety
                                                    Comments submitted in response to                     confidential information regarding the                events that reached the patient, whether
                                                  this notice will be summarized and                      quality and safety of health care                     or not there was harm; near misses or
                                                  included in the Agency’s subsequent                     delivery. Information that is assembled               close calls—patient safety events that
                                                  request for OMB approval of the                         and developed by providers for                        did not reach the patient; and unsafe
                                                  proposed information collection. All                    reporting to PSOs and the information                 conditions—circumstances that increase
                                                  comments will become a matter of                        received and analyzed by PSOs—called                  the probability of a patient safety event.
                                                  public record.                                          ‘‘patient safety work product’’—allows                  AHRQ’s Common Formats for patient
                                                                                                          for the aggregation of data that help to              safety event reporting include:
                                                  Sharon B. Arnold,
                                                                                                          identify and address underlying causal                  • Event descriptions (definitions of
                                                  Deputy Director.                                        factors of patient safety and quality                 patient safety events, near misses, and
                                                  [FR Doc. 2017–10066 Filed 5–17–17; 8:45 am]             issues.                                               unsafe conditions to be reported);
                                                  BILLING CODE 4160–90–P                                     The Patient Safety Act and Patient                   • Delineation of data elements and
                                                                                                          Safety Rule establish a framework by                  algorithms to be used for collection of
                                                                                                          which doctors, hospitals, skilled                     adverse event data to populate the
                                                  DEPARTMENT OF HEALTH AND                                nursing facilities, and other health care             reports; and
                                                  HUMAN SERVICES                                          providers may assemble information                      • Technical specifications for
                                                                                                          regarding patient safety events and                   electronic data collection and reporting.
                                                  Agency for Healthcare Research and                      quality of care. Information that is                    The technical specifications promote
                                                  Quality                                                 assembled and developed by providers                  standardization of collected patient
                                                                                                          for reporting to PSOs and the                         safety concerns by specifying rules for
                                                  Common Formats for Reporting on                                                                               data collection and submission, as well
                                                                                                          information received and analyzed by
                                                  Health Care Quality and Patient Safety                                                                        as by providing guidance for how and
                                                                                                          PSOs is privileged and confidential.
                                                  AGENCY: Agency for Healthcare Research                  Patient safety work product is used to                when to create data elements, their valid
                                                  and Quality (AHRQ), Department of                       conduct patient safety activities, which              values, conditional and go-to logic, and
                                                  Health and Human Services (HHS).                        may include identifying events, patterns              reports. These specifications will ensure
                                                                                                          of care, and unsafe conditions that                   that data collected by PSOs and other
                                                  ACTION: Notice of availability—new
                                                                                                          increase risks and hazards to patients.               entities have comparable clinical
                                                  common formats.
                                                                                                          Definitions and other details about PSOs              meaning. They also provide direction to
                                                  SUMMARY:   As authorized by the                         and patient safety work product are                   software developers, so that the
                                                  Secretary of HHS, AHRQ coordinates                      included in the Patient Safety Act and                Common Formats can be implemented
                                                  the development of sets of common                       Patient Safety Rule which can be                      electronically, and to PSOs, so that the
                                                  definitions and reporting formats                       accessed electronically at: http://                   Common Formats can be submitted
                                                  (Common Formats) for reporting on                       www.pso.ahrq.gov/legislation/.                        electronically to the PSO Privacy
                                                  health care quality and patient safety.                                                                       Protection Center (PSOPPC) for non-
                                                                                                          Definition of Common Formats                          identification and data transmission to
                                                  The purpose of this notice is to
                                                  announce the release of the Common                         The term ‘‘Common Formats’’ refers                 the Network of Patient Safety Databases.
                                                  Formats for Event Reporting—Hospital                    to the standardized reporting formats—
                                                                                                          using common language and                             Common Formats Development
                                                  Version 2.0.
                                                                                                          definitions—that AHRQ has developed                      In anticipation of the need for
                                                  DATES: Ongoing public input.
                                                                                                          for reporting safety concerns from a                  Common Formats, AHRQ began its
                                                  ADDRESSES: The Common Formats for                       variety of health care settings and                   development by creating an inventory of
                                                  Event Reporting—Hospital Version 2.0                    throughout the quality improvement                    functioning private and public sector
                                                  and the remaining Common Formats                        cycle. The Common Formats allow                       patient safety reporting systems. This
                                                  can be accessed electronically at the                   health care providers to collect and                  inventory provided an evidence base to
                                                  following Web site: https://                            submit standardized information and                   inform construction of the Common
                                                  www.psoppc.org/psoppc_web/.                             facilitate aggregation of comparable data             Formats. The inventory included many
                                                  FOR FURTHER INFORMATION CONTACT: Dr.                    at local, PSO, regional, and national                 systems from the private sector,
                                                  Barbara Choo, Center for Quality                        levels. The formats are not intended to               including prominent academic settings,
                                                  Improvement and Patient Safety, AHRQ,                   replace any current mandatory reporting               hospital systems, and international
                                                  5600 Fishers Lane, Room 06N100B,                        system, collaborative/voluntary                       reporting systems (e.g., from the United
                                                  Rockville, MD 20857; Telephone (toll                    reporting system, research-related                    Kingdom and the Commonwealth of
                                                  free): (866) 403–3697; Telephone (local):               reporting system, or other reporting/                 Australia). In addition, virtually all
                                                  (301) 427–1111; TTY (toll free): (866)                  recording system; rather, the Common                  major Federal patient safety reporting
                                                  438–7231; TTY (local): (301) 427–1130;                  Formats are intended to enhance the                   systems were included, such as those
                                                  Email: pso@ahrq.hhs.gov.                                ability of health care providers to report            from the Centers for Disease Control and
                                                  SUPPLEMENTARY INFORMATION:                              information that is standardized both                 Prevention (CDC), the Food and Drug
                                                                                                          clinically and electronically.                        Administration (FDA), the Department
                                                  Background                                                 In collaboration with the interagency              of Defense (DoD), and the Department of
                                                    The Patient Safety and Quality                        Federal Patient Safety Workgroup                      Veterans Affairs (VA).
                                                  Improvement Act of 2005, 42 U.S.C.                      (PSWG), the National Quality Forum                       Since February 2005, AHRQ has
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  299b–21 to b–26, (Patient Safety Act)                   (NQF), and the public, AHRQ has                       convened the PSWG to assist AHRQ
                                                  and the related Patient Safety and                      developed Common Formats for three                    with developing and maintaining the
                                                  Quality Improvement Final Rule, 42                      settings of care—acute care hospitals,                Common Formats. The PSWG includes
                                                  CFR part 3 (Patient Safety Rule),                       skilled nursing facilities, and                       major health agencies within HHS—
                                                  published in the Federal Register on                    community pharmacies—in order to                      CDC, Centers for Medicare & Medicaid
                                                  November 21, 2008, 73 FR 70732–                         facilitate standardized data collection               Services, FDA, Health Resources and
                                                  70814, provide for the formation of                     and analysis. The scope of the formats                Services Administration, Indian Health


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Document Created: 2017-05-18 01:20:27
Document Modified: 2017-05-18 01:20:27
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on this notice must be received by July 17, 2017.
ContactDoris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]
FR Citation82 FR 22828 

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