12358 Federal Register / Vol. 76, No. 44 / Monday, March 7, 2011 / Notices 

helium requirement forecasts, discovers 

apparent serious discrepancies. 

The information is used in 

administration of certain Federal 

contracts to ensure contractor 

compliance with contract clauses. 

Without the information, the required 

use of Government helium cannot be 

monitored and enforced effectively. 

B. Annual Reporting Burden 

Respondents: 26. 

Responses per Respondent: 1. 

Total Responses: 26. 

Hours Per Response: 1. 

Total Burden Hours: 26. 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the General Services Administration, 

Regulatory Secretariat (MVCB), 1275 1st 

Street, NE., Washington, DC 20417, 

telephone (202) 501–4755. Please cite 

OMB Control No. 9000–0113, 

Acquisition of Helium, in all 

correspondence. 

Dated: February 24, 2011. 

Millisa Gary, 

Acting Director, Office of Governmentwide 

Acquisition Policy. 

[FR Doc. 2011–4770 Filed 3–4–11; 8:45 am] 

BILLING CODE 6820–EP–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 healthcare 

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. As authorized by 

the Secretary of HHS, AHRQ 

coordinates the development of a set of 

common definitions and reporting 

formats (Common Formats) that allow 

healthcare 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 of the Common Format for 

Skilled Nursing Facilities for public 

review and comment. 

DATES: Ongoing public input. 

ADDRESSES: The new beta version of the 

Ski/led Nursing Facilities format 

(version dated February 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: 

Deborah Perfetto, 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; ITY (local): 

(301) 427–1130; E-mail: 

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 healthcare 

providers may voluntarily report 

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 identify 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 Rule. 

The Patient Safety Act and Patient 

Safety Rule require PSOs, to the extent 

practical and appropriate, to collect 

patient safety work product from 

providers in a standardized manner in 

order to permit valid comparisons of 

similar cases among similar providers. 

The collection of patient safety work 

product allows the aggregation of 

sufficient data to identify and address 

underlying causal factors of patient 

safety problems. 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. 

In order to facilitate standardized data 

collection, the Secretary of HHS 

authorized AHRQ to develop and 

maintain the Common Formats to 

improve the safety and quality of 

healthcare delivery. In August 2008, 

AHRQ issued the initial release of the 

formats, Version 0.1 Beta, developed for 

acute care hospitals. The second release 

of the Common Formats, Version 1.0, 

was announced in the Federal Register 

on September 2, 2009: 74 FR 45457– 

45458. This release was later replaced 

by Version 1.1, as announced in the 

Federal Register on March 31, 2010: 75 

FR 16140–16142. Version 1.1 includes 

updated event descriptions, forms, and 

technical specifications for software 

developers. As an update to this release, 

AHRQ developed the beta version of an 

event-specific format—Device or 

Supply, including Health Information 

Technology—to capture information 

about patient safety events that are 

related to health information 

technology. This update was announced 

in the Federal Register on October 22, 

2010: 75 FR 65359–65360. With the 

release of the beta version of the Skilled 

Nursing Facilities format, AHRQ has 

made available Common Formats for 

two settings of care—acute care 

hospitals and skilled nursing facilities. 

Definition of Common Formats 

The term ‘‘Common Formats’’ refers to 

the common definitions and reporting 

formats, specified by AHRQ, 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, 

• 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 frequentlyVerDate Mar<15>2010 17:54 Mar 04, 2011 Jkt 223001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\07MRN1.SGM 07MRN1

srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 44 / Monday, March 7, 2011 / Notices 12359 

occurring and/or serious patient safety 

events. The skilled nursing facilities 

event-specific formats are: Device or 

Supply, including Health Information 

Technology; Fall; Healthcare-Associated 

Infection; Medication or Other 

Substance; and Pressure Ulcer. 

This new format includes a 

description of patient safety events and 

unsafe conditions to be reported (event 

description) and a sample patient safety 

aggregate report and individual event 

summary in skilled nursing facilities. 

The Skilled Nursing Facilities Common 

Format is available at the PSO Privacy 

Protection Center (PPC) Web site: 

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

patientsafety. 

Commenting on Skilled Nursing 

Facilities 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. Based 

upon the expert panel’s feedback, 

AHRQ, in conjunction with the PSWG, 

further revised and refined the Common 

Formats and released Version 1.0. 

The review process above was 

repeated again from September 2009 

through February 2010 to further refine 

Common Formats Version 1.0 and 

incorporate public comments prior to 

finalization of the technical 

specifications for electronic 

implementation. The latest version of 

the formats is Version 1.1. 

The Agency is specifically interested 

in obtaining feedback from both the 

private and public sectors on this new 

format for skilled nursing facilities to 

guide their improvement. Information 

on how to comment and provide 

feedback on the Common Formats, the 

Skilled Nursing Facilities 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 

now numbers 69 and includes many 

systems from the private sector, 

including prominent academic settings, 

hospital systems, and international 

reporting systems (e.g., from 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 an interagency Federal 

Patient Safety Work Group (PSWG) to 

assist AHRQ with developing and 

maintaining the Common Formats. The 

PSWG includes major health agencies 

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 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: February 23, 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–4813 Filed 3–4–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–11–0770] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

National HIV Behavioral Surveillance 

System (NHBS)—0920–0770 exp. 03/31/ 

2011)—Revision-National Center for 

HIV, Hepatitis, STD, and TB Prevention 

(NCHHSTP), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The purpose of this data collection is 

to monitor behaviors related to human 

immunodeficiency virus (HIV) infection 

among persons at high risk for infection 

in the United States. The primary 

objectives of NHBS are to obtain data 

from samples of persons at risk to: (a) 

Describe the prevalence and trends in 

risk behaviors; (b) describe the 

prevalence of and trends in HIV testing 

and HIV infection; (c) describe the 

prevalence of and trends in use of HIV 

prevention services; (d) identify met and 

unmet needs for HIV prevention 

services in order to inform health 

departments, community-based 

organizations, community planning 

groups and other stakeholders. This 

project addresses the goals of CDC’s HIV 

prevention strategic plan, specifically 

the goal of strengthening the national 

capacity to monitor the HIV epidemic to 

better direct and evaluate prevention 

efforts. 

For the proposed data collection, CDC 

has revised the interview data collection 

instruments. A few questions were 

added (related to health care access and 

utilization, use of pre-exposure 

prophylaxis, homophobia, HIV stigma, 

and discrimination), some were 

removed, and others were revised from 

the previously approved instrument to 

make them easier for respondents to 


srobinson on DSKHWCL6B1PROD with NOTICES