9212 Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total 

burden hours 

Data entry into GRS ........................................................................................ 500 4 10/60 333 

Total .......................................................................................................... 500 na na 333 

EXHIBIT 2. ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total 

burden hours 

Average 

hourly wage 

rate * 

Total cost 

burden 

Data entry into GRS ........................................................................................ 500 333 $35.35 $11,772 

Total .......................................................................................................... 500 333 na $11,772 

* Based upon the average wages for Healthcare Practitioner and Technical Occupations (29–0000), ‘‘National Compensation Survey: Occupational Wages in the United States, May 2012,’’ U.S. Department of Labor, Bureau of Labor Statistics. 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

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 healthcare research and 

healthcare information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: February 6, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–03487 Filed 2–14–14; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Health care Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Health care 

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: 

‘‘Assessing the Impact of the National 

Implementation of TeamSTEPPS Master 

Training Program.’’ 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 August 27th, 2013 and 

allowed 60 days for public comment. No 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. 

DATES: Comments on this notice must be 

received by March 20, 2014. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s desk officer) or by 

email at OIRA_submission@

omb.eop.gov (attention: AHRQ’s desk 

officer). 

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 doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Assessing the Impact of the National 

Implementation of TeamSTEPPS Master 

Training Program 

As part of their effort to fulfill their 

mission goals, AHRQ, in collaboration 

with the Department of Defense’s (DoD) 

Tricare Management Activity (TMA), 

developed TeamSTEPPS® (aka Team 

Strategies and Tools for Enhancing 

Performance and Patient Safety) to 

provide an evidence-based suite of tools 

and strategies for training teamworkbased patient safety to health care 

professionals. In 2007, AHRQ and DoD 

coordinated the national 

implementation of the TeamSTEPPS 

program. The main objective of this 

program is to improve patient safety by 

training a select group of stakeholders 

such as Quality Improvement 

Organization (QIO) personnel, High 

Reliability Organization (HRO) staff, and 

health care system 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 and at the state level. The 

implementation includes the 

availability of voluntary training of 

Master Trainers in various health care 

systems capable of stimulating the 

utilization and adoption of 

TeamSTEPPS in their health care 

delivery systems, providing technical 

assistance and consultation on 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices 9213 

implementing TeamSTEPPS, and 

developing various channels of learning 

(e.g., user networks, various educational 

venues) for continuation support and 

improvement of teamwork in health 

care. During this effort, AHRQ has 

trained more than 2400 participants to 

serve as the Master Trainer 

infrastructure supporting national 

adoption of TeamSTEPPS. Participants 

in training become Master Trainers in 

TeamSTEPPS and are afforded the 

opportunity to observe the tools and 

strategies provided in the program in 

action. In addition to developing Master 

Trainers, AHRQ has also developed a 

series of support mechanisms for this 

effort including a data collection Web 

tool, a TeamSTEPPS call support center, 

and a monthly consortium to address 

any challenges encountered by 

implementers of TeamSTEPPS. 

To understand the extent to which 

this expanded patient safety knowledge 

and skills have been created, AHRQ will 

conduct an evaluation of the National 

Implementation of TeamSTEPPS Master 

Training program. The goals of this 

evaluation are to examine the extent to 

which training participants have been 

able to: 

(1) Implement the TeamSTEPPS 

products, concepts, tools, and 

techniques in their home organizations 

and, 

(2) spread that training, knowledge, 

and skills to their organizations, local 

areas, regions, and states. 

This study is being conducted by 

AHRQ through its contractor, Health 

Research & Educational Trust (HRET), 

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 the goals of this 

assessment the following two data 

collections will be implemented: 

(1) Web-based questionnaire to 

examine post-training activities and 

teamwork outcomes as a result of 

training from multiple perspectives. The 

questionnaire is directed to all master 

training participants. Items will cover 

post-training activities, implementation 

experiences, facilitators and barriers to 

implementation encountered, and 

perceived outcomes as a result of these 

activities. 

(2) Semi-structured interviews will be 

conducted with members from 

organizations who participated in the 

TeamSTEPPS Master Training program. 

Information gathered from these 

interviews will be analyzed and used to 

draft a ‘‘lessons learned’’ document that 

will capture additional detail on the 

issues related to participants’ and 

organizations’ abilities to implement 

and disseminate the TeamSTEPPS posttraining. The organizations will vary in 

terms of type of organization (e.g., QIO 

or hospital associations versus health 

care systems) and region (i.e., Northeast, 

Midwest, Southwest, Southeast, MidAtlantic, and West Coast). In addition, 

we will strive to ensure 

representativeness of the sites by 

ensuring that the distribution of 

organizations mirrors the distribution of 

organizations in the master training 

population. For example, if the 

distribution of organizations is such that 

only one out of every five organizations 

is a QIO, we will ensure that a 

maximum of two organizations in the 

sample are QIOs. The interviews will 

more accurately reveal the degree of 

training spread for the organizations 

included. Interviewees will be drawn 

from qualified individuals serving in 

one of two roles (i.e., implementers or 

facilitators). The interview protocol will 

be adapted for each role based on the 

respondent group and to some degree, 

for each individual, based on their 

training and patient safety experience. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondent’s time to participate in the 

study. Semi-structured interviews will 

be conducted with a maximum of 9 

individuals from each of 9 participating 

organizations and will last about one 

hour each. The training participant 

questionnaire will be completed by 

approximately 10 individuals from each 

of about 240 organizations and is 

estimated to require 20 minutes to 

complete. The total annualized burden 

is estimated to be 881 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 $38,923. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of respondents 

Number of responses per 

respondent 

Hours per response Total burden 

hours 

Semi-structured interview ................................................................................ 9 9 60/60 81 

Training participant questionnaire ................................................................... 240 10 20/60 800 

Total .......................................................................................................... 249 NA NA 881 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of respondents 

Total burden 

hours 

Average hourly wage rate* Total cost burden 

Semi-structured interview ................................................................................ 9 81 $44.18 $3,579 

Training participant questionnaire ................................................................... 240 800 44.18 35,344 

Total .......................................................................................................... 249 881 NA 38,923 

* Based upon the mean of the average wages for all health professionals (29–0000) for the training participant questionnaire and for executives, administrators, and managers for the organizational leader questionnaire presented in the National Compensation Survey: Occupational 

Wages in the United States, May, 2012, U.S. Department of Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/oes_nat.htm#37– 

0000. 


tkelley on DSK3SPTVN1PROD with NOTICES
9214 Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: January 29, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–03482 Filed 2–14–14; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Common Formats for Patient Safety 

Data Collection and Event Reporting 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), Department of 

Health and Human Services (HHS). 

ACTION: Notice of Availability—New 

Common Formats 

SUMMARY: As authorized by the 

Secretary of HHS, AHRQ coordinates 

the development of common definitions 

and reporting formats (Common 

Formats) for reporting patient safety 

events to Patient Safety Organizations 

(PSOs) and other entities. The purpose 

of this notice is to announce the 

availability of a new type of Common 

Formats for public review and 

comment—Common Formats for 

Surveillance—Hospital. 

DATES: Ongoing public input. 

ADDRESSES: The newly released 

Common Formats for Surveillance— 

Hospital—which includes modules 

entitled Generic Adverse Event 

Information, Blood or Blood Product, 

Delivery-Maternal, Delivery-Neonatal, 

Device or Medical/Surgical Supply 

Including Health Information 

Technology (HIT), Fall, Medications, 

Pressure Ulcer, Readmissions, Surgery 

or Anesthesia, Venous 

Thromboembolism, and Other 

Outcomes of Interest—can be accessed 

electronically at the following HHS Web 

site: http://www.PSO.AHRQ.gov/

index.html 

FOR FURTHER INFORMATION CONTACT: 

Glenn Egelman, M.D., Center for Quality 

Improvement and Patient Safety, AHRQ, 

540 Gaither Road, Rockville, MD 20850; 

Telephone (toll free): (866) 403–3697; 

Telephone (local): (301) 427–1111; TTY 

(toll free): (866) 438–7231; TTY (local): 

(301) 427–1130; Email: PSO@

AHRQ.HHS.GOV. 

SUPPLEMENTARY INFORMATION: 

Background 

The Patient Safety and Quality 

Improvement Act of 2005, 42 U.S.C. 

299b-21 to b-26, (Patient Safety Act) and 

the related Patient Safety and Quality 

Improvement Final Rule, 42 CFR Part 3 

(Patient Safety Rule), published in the 

Federal Register on November 21, 2008: 

73 FR 70731–70814, provide for the 

formation of PSOs, which collect, 

aggregate, and analyze confidential 

information regarding the quality and 

safety of healthcare delivery. The 

Patient Safety Act (at 42 U.S.C. 299b24(b)(1)(F)) requires PSOs to collect 

information from providers in a 

standardized manner that permits valid 

comparisons of similar cases among 

similar providers, to the extent practical 

and appropriate. As explained in 42 

CFR 3.102(b)(1)(iii)(A)(1), one option for 

a PSO to satisfy this requirement is by 

certifying that it is using the Secretary’s 

published guidance for common formats 

and definitions in its collection of 

information from healthcare providers. 

The Patient Safety Act and Patient 

Safety Rule establish a framework by 

which doctors, hospitals, skilled 

nursing facilities, and other healthcare 

providers may assemble information 

regarding patient safety events and 

quality of care. Information that is 

assembled and developed by providers 

for reporting to PSOs and the 

information received and analyzed by 

PSOs—called patient safety work 

product—is privileged and confidential. 

Patient safety work product is used to 

conduct patient safety activities, which 

may include identifying events, patterns 

of care, and unsafe conditions that 

increase risks and hazards to patients. 

Definitions and other details about PSOs 

and patient safety work product are 

included in the Patient Safety Act and 

Patient Safety Rule which can be 

accessed electronically at: http://

www.PSO.AHRQ.gov/REGULATIONS/

REGULATIONS.htm. 

Definition of Common Formats 

The term Common Formats refers to 

the common definitions and reporting 

formats, specified by AHRQ, that allow 

healthcare providers to collect and 

submit standardized information 

regarding patient safety events. The 

Common Formats are not intended to 

replace any current mandatory reporting 

system, collaborative/voluntary 

reporting system, research-related 

reporting system, or other reporting/

recording system; rather the formats are 

intended to enhance the ability of 

healthcare providers to report 

information that is standardized both 

clinically and electronically. 

In collaboration with the interagency 

Federal Patient Safety Workgroup 

(PSWG), the National Quality Forum 

(NQF) and the public, AHRQ has 

developed Common Formats for two 

settings of care—acute care hospitals 

and skilled nursing facilities—in order 

to facilitate standardized data 

collection. The scope of Common 

Formats applies to all patient safety 

concerns including: Incidents—patient 

safety events that reached the patient, 

whether or not there was harm; near 

misses or close calls—patient safety 

events that did not reach the patient; 

and unsafe conditions—circumstances 

that increase the probability of a patient 

safety event. 

Until now, Common Formats have 

been designed to support only 

traditional event reporting. Common 

Formats for Surveillance—Hospital are 

designed to provide, through 

retrospective review of medical records, 

information that is complementary to 

that derived from event reporting 

systems. These formats will facilitate 

improved detection of events and 

calculation of adverse event rates in 

populations reviewed. 

Common Formats Development 

In anticipation of the need for 

Common Formats, AHRQ began their 

development by creating an inventory of 

functioning private and public sector 

patient safety reporting systems. This 

inventory provides an evidence base 

that informed construction of the 

Common Formats. The inventory 

includes many systems from the private 

sector, including academic settings, 

hospital systems, and international 

reporting systems (e.g., from the United 

Kingdom and the Commonwealth of 


tkelley on DSK3SPTVN1PROD with NOTICES