67456 Federal Register / Vol. 76, No. 211 / Tuesday, November 1, 2011 / Notices 

ESTIMATED ANNUALIZED BURDEN TABLE

Forms Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

(in hours) 

per response 

Total burden 

hours 

Focus Group ..................................... General Public .................................. 621 1 1.5 932 

Focus Group screening .................... General Public .................................. 5544 1 10/60 924 

Web usability testing ......................... General Public .................................. 144 1 1.5 216 

Web usability screening .................... General Public .................................. 2160 1 10/60 360 

Self-Administered Surveys ................ General Public .................................. 2000 1 15/60 500 

Self-Administered survey screening General Public .................................. 8000 1 10/60 1333 

Omnibus Surveys .............................. General Public .................................. 2000 1 10/60 333 

Cognitive testing ............................... General Public .................................. 25 1 2 50 

Focus Group ..................................... Health Professional .......................... 288 1 1.5 432 

Screening .......................................... Health Professional .......................... 4320 1 10/60 720 

Web usability testing ......................... Health Professional .......................... 144 1 1.5 216 

Screening .......................................... Health Professional .......................... 2160 1 10/60 360 

Self-Administered Surveys ................ Health Professional .......................... 2000 1 15/60 500 

Screening .......................................... Health Professional .......................... 8000 1 10/60 1333 

Omnibus Surveys .............................. Health Professional .......................... 2000 1 10/60 333 

In-Depth Interviews ........................... Health Professional .......................... 100 1 45/60 75 

Screening .......................................... Health Professional .......................... 1000 1 10/60 167 

Total (Overall) ............................ ........................................................... 40,506 ........................ ........................ 8,784 

Keith A. Tucker, 

Office of the Secretary, Paperwork Reduction 

Act Clearance Officer. 

[FR Doc. 2011–28284 Filed 10–31–11; 8:45 am] 

BILLING CODE 4150–45–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), HHS. 

ACTION: Notice of Availability—New 

Common Format. 

SUMMARY: The Patient Safety and 

Quality Improvement Act of 2005, 42 

U.S.C. 299b–21 to b–26, (Patient Safety 

Act) provides for the formation of 

Patient Safety Organizations (PSOs), 

which collect, aggregate, and analyze 

confidential information regarding the 

quality and safety of health care 

delivery. The Patient Safety Act (at 42 

U.S.C. 299b–23) authorizes the 

collection of this information in a 

standardized manner, as explained in 

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. AHRQ coordinates 

the development of a set of common 

definitions and reporting formats 

(Common Formats) that allow health 

care providers to voluntarily collect and 

submit standardized information 

regarding patient safety events. The 

purpose of this notice is to announce 

the availability of a new beta version 

Common Format for Venous 

Thromboembolism (VTE) for public 

review and comment. 

DATES: Ongoing public input. 

ADDRESSES: The new beta version of the 

Common Format for Venous 

Thromboembolism (VTE), version dated 

October 2011, and the remaining 

Common Formats, can be accessed 

electronically at the following HHS Web 

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

index.html. 

FOR FURTHER INFORMATION CONTACT: 

Susan Grinder, 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 Act and Patient 

Safety Rule establish a framework by 

which doctors, hospitals, skilled 

nursing facilities, and other health care 

providers may voluntarily report 

information regarding patient safety 

events and quality of care. Both the 

Patient Safety Act and Patient Safety 

Rule, including any relevant guidance, 

can be accessed electronically at: http:// 

www.PSO.AHRQ.gov/regulations/

regulations.htm. 

AHRQ develops and maintains the 

Common Formats in order to facilitate 

standardized data collection and 

improve the safety and quality of health 

care delivery. Since the initial release of 

the Common Formats in August 2008, 

AHRQ regularly revises the formats 

based upon public comment. Earlier this 

year, AHRQ released the beta version of 

the Skilled Nursing Facilities format, as 

announced in the Federal Register on 

March 7, 2011: 76 FR 12358–12359. 

With this release, AHRQ had made 

available Common Formats for two 

settings of care—acute care hospitals 

and skilled nursing facilities. The new 

beta version of the Common Format for 

Venous Thromboembolism (VTE), 

which includes Deep Vein Thrombosis 

(DVT) and Pulmonary Embolism (PE), 

will apply to both settings of care. 

Definition of Common Formats 

The term ‘‘Common Formats’’ refers 

to the common definitions and reporting 

formats that allow health care 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 health care 

providers to report information that is 

standardized both clinically and 

electronically. 

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, 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 211 / Tuesday, November 1, 2011 / Notices 67457 

• 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. 

The Common Formats include two 

general types of formats, generic and 

event-specific. The generic Common 

Formats pertain to all patient safety 

concerns. The three generic formats are: 

Healthcare Event Reporting Form, 

Patient Information Form, and Summary 

of Initial Report. The event-specific 

Common Formats pertain to frequentlyoccurring and/or serious patient safety 

events. When used as designed, the 

Common Formats allow collection of 

information on all harms to patients: 

‘‘All-cause harm.’’ 

The VTE format includes a 

description of the patient safety events 

to be reported (event description), and 

a sample patient safety aggregate report. 

The Venous Thromboembolism (VTE) 

Common Format is available at the PSO 

Privacy Protection Center (PPC) Web 

site: https://www.psoppc.org/web/ 

patientsafety. 

Commenting on Venous 

Thromboembolism (VTE) Common 

Format 

To allow for greater participation by 

the private sector in the subsequent 

development of the Common Formats, 

AHRQ engaged the National Quality 

Forum (NQF), a non-profit organization 

focused on health care quality, to solicit 

comments and advice to guide the 

further refinement of the Common 

Formats. The NQF began this process 

with feedback on AHRQ’s 0.1 Beta 

release of the Common Formats in 2008. 

Based upon the expert panel’s feedback, 

AHRQ, in conjunction with an 

interagency Federal Patient Safety Work 

Group (PSWG), revises and refines the 

Common Formats. 

The Agency is specifically interested 

in obtaining feedback from both the 

private and public sectors on this new 

beta VTE format to guide their 

improvement. Information on how to 

comment and provide feedback on the 

Common Formats, including the Venous 

Thromboembolism (VTE) beta version, 

is available at the National Quality 

Forum (NQF) Web site for Common 

Formats: http://www.Quality.forum.org/

projects/commonformats.aspx. 

Common Formats Development 

In anticipation of the need for 

Common Formats, AHRQ began their 

development in 2005 by creating an 

inventory of functioning private and 

public sector patient safety reporting 

systems. This inventory provides an 

evidence base that informs construction 

of the Common Formats. The inventory 

includes systems from the private 

sector, including prominent academic 

settings, hospital systems, and 

international reporting systems (e.g., the 

United Kingdom and the 

Commonwealth of Australia). In 

addition, virtually all major Federal 

patient safety reporting systems are 

included, such as those from the Centers 

for Disease Control and Prevention 

(CDC), the Food and Drug 

Administration (FDA), the Department 

of Defense (DoD), and the Department of 

Veterans Affairs (VA). 

Since February 2005, AHRQ has 

coordinated the PSWG to assist AHRQ 

with developing and maintaining the 

Common Formats. The PSWG includes 

major health agencies and offices within 

the HHS—CDC, Centers for Medicare & 

Medicaid Services, FDA, Health 

Resources and Services Administration, 

the Indian Health Service, the National 

Institutes of Health, the National Library 

of Medicine, Office of Healthcare 

Quality, Office of the National 

Coordinator for Health Information 

Technology (ONC), the Office of Public 

Health and Science, the Substance 

Abuse and Mental Health Services 

Administration—as well as the DoD and 

the VA. 

The PSWG assists AHRQ with 

assuring the consistency of definitions/ 

formats with those of relevant 

government agencies as refinement of 

the Common Formats continues. When 

developing Common Formats, AHRQ 

first reviews existing patient safety 

event reporting systems from a variety 

of health care organizations. Working 

with the PSWG and Federal subject 

matter experts, AHRQ drafts and 

releases beta versions of the Common 

Formats for public review and 

comment. To the extent practicable, the 

Common Formats are also aligned with 

World Health Organization (WHO) 

concepts, framework, and definitions 

contained in their draft International 

Classification for Patient Safety (ICPS). 

The process for updating and refining 

the formats will continue to be an 

iterative one. Future versions of the 

Common Formats will be developed for 

ambulatory settings, such as ambulatory 

surgery centers and physician and 

practitioner offices. More information 

on the Common Formats can be 

obtained through AHRQ’s PSO Web site: 

http://www.PSO.AHRQ.gov/index.html. 

Dated: October 20, 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–27892 Filed 10–31–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–12–12AL] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call the CDC Reports 

Clearance Officer at (404) 639–5960 or 

send comments to Daniel Holcomb, CDC 

Reports Clearance Officer, 1600 Clifton 

Road, MS–D74, Atlanta, GA 30333 or 

send an email to omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection 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 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

The National Hospital Care Survey 

(NHCS): Ambulatory Care Pretest— 

New—National Center for Health 

Statistics (NCHS), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

Section 306 of the Public Health 

Service (PHS) Act (42 U.S.C. 242k), as 

amended, authorizes that the Secretary 

of Health and Human Services (DHHS), 

acting through NCHS, shall collect 

statistics on the extent and nature of 

illness and disability of the population 

of the United States. This one-year 

clearance request seeks approval to pretest: (1) Data collection from hospital 

ambulatory departments including 

emergency departments (ED), outpatient 

departments (OPD), and ambulatory 

surgery locations (ASLs) through the 


srobinson on DSK4SPTVN1PROD with NOTICES