9252 Federal Register / Vol. 77, No. 32 / Thursday, February 16, 2012 / Notices 

OHRP and other offices or agencies 

within HHS responsible for human 

subjects protection. These evaluations 

may include, but are not limited to, a 

review of assurance systems, the 

application of minimal research risk 

standards, the granting of waivers, 

education programs sponsored by 

OHRP, and the ongoing monitoring and 

oversight of institutional review boards 

and the institutions that sponsor 

research. 

Nominations: OHRP is requesting 

nominations to fill four positions for 

voting members of SACHRP. Two 

positions will become vacant in July 

and two in October, 2012. Nominations 

of potential candidates for consideration 

are being sought from a wide array of 

fields, including, but not limited to: 

public health and medicine, behavioral 

and social sciences, health 

administration, and biomedical ethics. 

To qualify for consideration of 

appointment to the Committee, an 

individual must possess demonstrated 

experience and expertise in any of the 

several disciplines and fields pertinent 

to human subjects protection or clinical 

research. 

The individuals selected for 

appointment to the Committee can be 

invited to serve a term of up to four 

years. Committee members receive a 

stipend and reimbursement for per diem 

and any travel expenses incurred for 

attending Committee meetings or 

conducting other business in the 

interest of the Committee. Interested 

applicants may self-nominate. 

Nominations should be typewritten. 

The following information should be 

included in the package of material 

submitted for each individual being 

nominated for consideration: (1) A letter 

of nomination that clearly states the 

name and affiliation of the nominee, the 

basis for the nomination (i.e., specific 

attributes which qualify the nominee for 

service in this capacity), and a statement 

that the nominee is willing to serve as 

a member of the Committee; (2) the 

nominator’s name, address, daytime 

telephone number, and the home or 

work address, telephone number, and 

email address of the individual being 

nominated; and (3) a current copy of the 

nominee’s curriculum vitae. Federal 

employees should not be nominated for 

consideration of appointment to this 

Committee. 

The Department makes every effort to 

ensure that the membership of HHS 

Federal advisory committees is fairly 

balanced in terms of points of view 

represented and the committee’s 

function. Every effort is made to ensure 

that individuals from a broad 

representation of geographic areas, 

women and men, ethnic and minority 

groups, and the disabled are given 

consideration for membership on HHS 

Federal advisory committees. 

Appointment to this Committee shall be 

made without discrimination on the 

basis of age, race, ethnicity, gender, 

sexual orientation, disability, and 

cultural, religious, or socioeconomic 

status. 

Individuals who are selected to be 

considered for appointment will be 

required to provide detailed information 

regarding their financial holdings, 

consultancies, and research grants or 

contracts. Disclosure of this information 

is necessary in order to determine if the 

selected candidate is involved in any 

activity that may pose a potential 

conflict with the official duties to be 

performed as a member of SACHRP. 

Dated: February 10, 2012. 

Jerry Menikoff, 

Director, Office for Human Research 

Protections Executive Secretary, Secretary’s 

Advisory Committee on Human Research 

Protections. 

[FR Doc. 2012–3625 Filed 2–15–12; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Meeting for Software Developers on 

the Technical Specifications for 

Common Formats for Patient Safety 

Data Collection and Event Reporting 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of public meeting. 

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. In order 

to support the Common Formats, AHRQ 

has provided technical specifications to 

promote standardization by ensuring 

that data collected by PSOs and other 

entities are clinically and electronically 

comparable. More information on the 

Common Formats, including the 

technical specifications, can be obtained 

through AHRQ’s PSO Web site: http:// 

www.PSO.AHRQ.GOV/index.html. 

The purpose of this notice is to 

announce a meeting to discuss the 

Common Formats technical 

specifications. This meeting is designed 

as an interactive forum where PSOs and 

software developers can provide input 

on these technical specifications. AHRQ 

especially requests input from those 

entities which have used AHRQ’s 

technical specifications and 

implemented, or plan to implement, the 

formats electronically. 

DATES: The meeting will be held from 10 

a.m. to 3:30 p.m. on April 12, 2012. 

ADDRESSES: The meeting will be held at 

the Hyatt Regency Bethesda, 7400 

Wisconsin Avenue, Bethesda, MD 

20814. 

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. 

If sign language interpretation or other 

reasonable accommodation for a 

disability is needed, please contact the 

Food and Drug Administration (FDA) 

Office of Equal Employment 

Opportunity and Disability Management 

at (301) 827–4840, no later than March 

28, 2012. 

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. 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. 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 32 / Thursday, February 16, 2012 / Notices 9253 

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 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 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. AHRQ’s 

Common Formats include: 

• Event descriptions (descriptions of 

patient safety events and unsafe 

conditions to be reported), 

• Specifications for patient safety 

aggregate reports and individual event 

summaries, 

• Delineation of data elements to be 

collected for different types of events to 

populate the reports, 

• A user’s guide and quick guide, and 

• Technical specifications for 

electronic data collection and reporting. 

AHRQ convenes the PSWG to assist 

AHRQ with developing and maintaining 

the Common Formats. The PSWG 

includes major health agencies within 

the Department of Health and Human 

Services (HHS)—the Centers for Disease 

Control and Prevention, Centers for 

Medicare & Medicaid Services, Food 

and Drug Administration, Health 

Resources and Services Administration, 

Indian Health Service, National 

Institutes of Health, National Library of 

Medicine, Office of the National 

Coordinator for Health Information 

Technology, Office of Public Health and 

Science, and Substance Abuse and 

Mental Health Services 

Administration—as well as the 

Department of Defense and Department 

of Veterans Affairs. 

When developing Common Formats, 

AHRQ first reviews existing patient 

safety event reporting systems from a 

variety of health care organizations. In 

collaboration with the PSWG and 

Federal subject matter experts, AHRQ 

drafts and releases beta versions of the 

Common Formats for public review and 

comment. 

Through a contract with AHRQ, NQF 

solicits feedback on the beta (and 

subsequent) versions of the Common 

Formats from private sector 

organizations and individuals. The 

NQF, a nonprofit organization that 

focuses on health care quality, then 

convenes an expert panel to review the 

comments received and provide 

feedback to AHRQ. Based upon the 

expert panel’s feedback, AHRQ, in 

conjunction with the PSWG, further 

revises the Common Formats. 

The technical specifications promote 

standardization of collected patient 

safety event information by specifying 

rules for data collection and submission, 

as well as by providing guidance for 

how and when to create data elements, 

their valid values, conditional and go-to 

logic, and reports. These specifications 

will ensure that data collected by PSOs 

and other entities have comparable 

clinical meaning. 

The technical specifications also 

provide direction to software 

developers, so that the Common 

Formats can be implemented 

electronically, and to PSOs, so that the 

Common Formats can be submitted 

electronically to the PSO Privacy 

Protection Center (PSO PPC) for data deidentification and transmission to the 

Network of Patient Safety Databases 

(NPSD). 

Most recently, AHRQ and the PSWG 

released the beta version of the Venous 

Thromboembolism (VTE) format for 

reporting of VTE-related patient safety 

events as announced in the Federal 

Register on November 1, 2011: 76 FR 

67456–67457. 

The Software Developer’s meeting 

will focus on discussion of an 

anticipated Spring release—Hospital 

Common Formats 1.2—and the 

technical specifications, which provide 

direction to software developers that 

plan to implement the Common Formats 

electronically. The technical 

specifications are a critical component 

that allow for the aggregation of patient 

safety event data. 

The technical specifications consist of 

the following: 

• Data dictionary—defines data 

elements and their attributes (data 

element name, answer values, field 

length, guide for use, etc.) included in 

Common Formats; 

• Clinical document architecture 

(CDA) implementation guide—provides 

instructions for developing a file to 

transmit the Common Formats Patient 

Safety data from the PSO to the PSO 

PPC using the Common Formats; 

• Validation rules and errors 

document—specifies and defines the 

validation rules that will be applied to 

the Common Formats data elements 

submitted to the PSO PPC; 

• Common Formats flow charts— 

diagrams the valid paths to complete 

generic and event specific formats (a 

complete event report); 

• Local specifications—provides 

specifications for processing, linking 

and reporting on events and details 

specifications for reports; and 

• Metadata registry—includes 

descriptive facts about information 

contained in the data dictionary to 

illustrate how such data corresponds 

with similar data elements used by 

other Federal agencies and standards 

development organizations [e.g., HL—7, 

International Standards Organization 

(ISO)]. 

Agenda, Registration and Other 

Information About the Meeting 

On Thursday, April 12, 2012, the 

meeting will convene at 10 a.m. with an 

overview of the Common Formats, 

including the Hospital Common 

Formats Version 1.2 technical 

specifications, and next steps for 

upcoming Common Formats releases. 

AHRQ staff and contractors will review 

database functionality, which is 

available through the PSO PPC, for 

PSOs to generate aggregate reports with 

technical specifications. Finally, the 

meeting will review data submission 

both by PSOs and by vendors on behalf 

of a PSO. Throughout the meeting there 

will be interactive discussion to allow 

meeting participants not only to provide 

input, but also to respond to the input 

provided by others. A more specific 

proposed agenda will be posted before 

the meeting at http://www.cvent.com/d/ 

0cQkQx. 

AHRQ requests that interested 

persons register with the PSO PPC on 

the Internet at http://www.cvent.com/d/ 

0cQkQx/4W to participate in the 

meeting. The contact at the PSO PPC is 

Rhonda Davis who can be reached by 

telephone at (866) 571–7712 and by 

email at supportpsoppc.ORG. 

Additional logistical information for the 

meeting is also available from the PSO 

PPC. The meeting space will 

accommodate approximately 150 

participants. Interested persons are 

encouraged to register as soon as 

possible for the meeting. Non-registered 

individuals will be able to attend the 

meeting in person if space is available. 

Prior to the meeting, AHRQ invites 

review of the technical specifications for 

Common Formats. The formats can be 


srobinson on DSK4SPTVN1PROD with NOTICES
9254 Federal Register / Vol. 77, No. 32 / Thursday, February 16, 2012 / Notices 

accessed through AHRQ’s PSO Web site 

at http://www.pso.AHRQ.GOV/formats/ 

commonfmt.htm. AHRQ is committed to 

continuing refinement of the Common 

Formats, and welcomes questions from 

prospective meeting participants and 

interested individuals on the technical 

specifications. These questions should 

be emailed to support@psoppc.ORG no 

later than March 21, 2012. AHRQ will 

use the input received at this meeting to 

further update and refine the Common 

Formats. 

A summary of the meeting will be 

provided upon request. If you are 

unable to participate in the meeting and 

would like a copy of the summary, 

please send an email to 

supportpsoppc.ORG and it will be sent 

as soon as it is available after the 

meeting. 

Dated: January 25, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–2937 Filed 2–15–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Board on Radiation and 

Worker Health (ABRWH or Advisory 

Board), National Institute for 

Occupational Safety and Health 

(NIOSH) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), and pursuant to the 

requirements of 42 CFR 83.15(a), the 

Centers for Disease Control and 

Prevention (CDC), announces the 

following meeting of the 

aforementioned committee: 

Board Public Meeting Times and 

Dates (All times are Pacific Time): 9:45 

a.m.–5 p.m., February 28, 2012. 8:15 

a.m.–6 p.m., February 29, 2012. 

Public Comment Times and Dates (All 

times are Pacific Time): 5 p.m.–6:30 

p.m.,* February 28, 2012. 

* Please note that the public comment 

periods may end before the times 

indicated, following the last call for 

comments. Members of the public who 

wish to provide public comments 

should plan to attend public comment 

sessions at the start times listed. 

Place: Waterfront Hotel, 10 

Washington Street, Oakland, California 

94607, Telephone: (510) 836–3800, Fax: 

(510) 832–5695, Audio Conference Call 

via FTS Conferencing, the USA toll-free 

number is 1–866–659–0537 with a pass 

code of 9933701. 

Status: Open to the public, limited 

only by the space available. The meeting 

space accommodates approximately 150 

people. 

Background: The Advisory Board was 

established under the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000 to advise the 

President on a variety of policy and 

technical functions required to 

implement and effectively manage the 

new compensation program. Key 

functions of the Advisory Board include 

providing advice on the development of 

probability of causation guidelines 

which have been promulgated by the 

Department of Health and Human 

Services (HHS) as a final rule, advice on 

methods of dose reconstruction which 

have also been promulgated by HHS as 

a final rule, advice on the scientific 

validity and quality of dose estimation 

and reconstruction efforts being 

performed for purposes of the 

compensation program, and advice on 

petitions to add classes of workers to the 

Special Exposure Cohort (SEC). 

In December 2000, the President 

delegated responsibility for funding, 

staffing, and operating the Advisory 

Board to HHS, which subsequently 

delegated this authority to the CDC. 

NIOSH implements this responsibility 

for CDC. The charter was issued on 

August 3, 2001, renewed at appropriate 

intervals, and will expire on August 3, 

2013. 

Purpose: This Advisory Board is 

charged with (a) providing advice to the 

Secretary, HHS, on the development of 

guidelines under Executive Order 

13179; (b) providing advice to the 

Secretary, HHS, on the scientific 

validity and quality of dose 

reconstruction efforts performed for this 

program; and (c) upon request by the 

Secretary, HHS, advise the Secretary on 

whether there is a class of employees at 

any Department of Energy facility who 

were exposed to radiation but for whom 

it is not feasible to estimate their 

radiation dose, and on whether there is 

reasonable likelihood that such 

radiation doses may have endangered 

the health of members of this class. 

Matters To Be Discussed: The agenda 

for the Advisory Board meeting 

includes: NIOSH Program Update; 

Department of Labor (DOL) Program 

Update; Department of Energy (DOE) 

Program Update; NIOSH 10-Year 

Program Review Implementation; Status 

of Activities for Lawrence Berkeley 

National Laboratory and Stanford Linear 

Accelerator; SEC petitions for: Electro 

Metallurgical (Niagara Falls, NY), 

Hangar 481 (Kirtland Air Force Base); 

Weldon Spring Plant (Weldon Spring, 

MO), Sandia National Laboratories, 

Clinton Engineering Works (Oak Ridge, 

TN), Feed Materials Production Center 

(Fernald, Ohio), and Brookhaven 

National Laboratory; SEC Petition Status 

Updates; and Board Work Sessions. 

The agenda is subject to change as 

priorities dictate. 

In the event an individual cannot 

attend, written comments may be 

submitted in accordance with the 

redaction policy provided below. Any 

written comments received will be 

provided at the meeting and should be 

submitted to the contact person below 

well in advance of the meeting. 

Policy on Redaction of Board Meeting 

Transcripts (Public Comment): (1) If a 

person making a comment gives his or 

her name, no attempt will be made to 

redact that name. (2) NIOSH will take 

reasonable steps to ensure that 

individuals making public comment are 

aware of the fact that their comments 

(including their name, if provided) will 

appear in a transcript of the meeting 

posted on a public Web site. Such 

reasonable steps include: (a) A 

statement read at the start of each public 

comment period stating that transcripts 

will be posted and names of speakers 

will not be redacted; (b) A printed copy 

of the statement mentioned in (a) above 

will be displayed on the table where 

individuals sign up to make public 

comments; (c) A statement such as 

outlined in (a) above will also appear 

with the agenda for a Board Meeting 

when it is posted on the NIOSH Web 

site; (d) A statement such as in (a) above 

will appear in the Federal Register 

Notice that announces Board and 

Subcommittee meetings. (3) If an 

individual in making a statement 

reveals personal information (e.g., 

medical information) about themselves 

that information will not usually be 

redacted. The NIOSH FOIA coordinator 

will, however, review such revelations 

in accordance with the Freedom of 

Information Act and the Federal 

Advisory Committee Act and if deemed 

appropriate, will redact such 

information. (4) All disclosures of 

information concerning third parties 

will be redacted. (5) If it comes to the 

attention of the DFO that an individual 

wishes to share information with the 

Board but objects to doing so in a public 

forum, the Designated Federal Officer 

will work with that individual, in 

accordance with the Federal Advisory 

Committee Act, to find a way that the 

Board can hear such comments. 

Contact Person for More Information: 

Theodore Katz, M.P.A., Executive 

Secretary, NIOSH, CDC, 1600 Clifton 

Road NE., MS E–20, Atlanta, Georgia 

30333, Telephone: (513) 533–6800, toll 


srobinson on DSK4SPTVN1PROD with NOTICES