16140 Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Notices 

maintained at all health care facilities in 

the United States that are verified for 

completeness and accuracy varied 

greatly across the Nation. 

The application process has been 

streamlined and is using information 

technology to make the application 

electronically available on the Internet. 

Affected Public: Individuals and 

households. 

Type of Respondents: Individuals. 

The table below provides: Types of 

data collection instruments, Estimated 

number of respondents, Number of 

annual number of responses, Average 

burden per response, and Total annual 

burden hours. 

Data collection instrument(s) 

Estimated number of respondents 

Responses per 

respondent 

Average burden 

hour per 

response* 

Total annual burden hours 

Application to Medical Staff .............................................................. 570 1 1.00 (60 mins) .. 570 

Reference Letter ............................................................................... 1710 1 0.33 (20 mins) .. 570 

Reappointment Request ................................................................... 190 1 1.00 (60 mins) .. 190 

Ob-Gyn Privileges ............................................................................. 20 1 1.00 (60 mins) .. 20 

Internal Medicine .............................................................................. 325 1 1.00 (60 mins) .. 325 

Surgery Privileges ............................................................................. 20 1 1.00 (60 mins) .. 20 

Psychiatry Privileges ......................................................................... 13 1 1.00 (60 mins) .. 13 

Anesthesia Privileges ....................................................................... 15 1 1.00 (60 mins) .. 15 

Dental Privileges ............................................................................... 150 1 0.33 (20 mins) .. 50 

Optometry Privileges ........................................................................ 21 1 0.33 (20 mins) .. 7 

Psychology Privileges ....................................................................... 30 1 0.17 (10 mins) .. 5 

Audiology Privileges ......................................................................... 7 1 0.08 (5 mins) .... 1 

Podiatry Privileges ............................................................................ 7 1 0.08 (5 mins) .... 1 

Radiology Privileges ......................................................................... 8 1 0.33 (20 mins) .. 3 

Pathology Privileges ......................................................................... 3 1 0.33 (20 mins) .. 1 

Total ........................................................................................... 3,089 ............................ ........................... 1,791 

* For ease of understanding, burden hours are provided in actual minutes. There are no capital costs, operating costs and/or maintenance 

costs to respondents. 

Request For Comments: Your written 

comments and/or suggestions are 

invited on one or more of the following 

points: (a) Whether the information 

collection activity is necessary to carry 

out an agency function; (b) whether the 

agency processes the information 

collected in a useful and timely fashion; 

(c) the accuracy of public burden 

estimate (the estimated amount of time 

needed for individual respondents to 

provide the requested information); (d) 

whether the methodology and 

assumptions used to determine the 

estimate is logical; (e) ways to enhance 

the quality, utility, and clarity of the 

information being collected; and (f) 

ways to minimize the public burden 

through the use of automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Direct Comments to OMB: Send your 

written comments and suggestions 

regarding the proposed information 

collection contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time to: Office of Management and 

Budget, Office of Regulatory Affairs, 

Attention: Desk Officer for IHS, New 

Executive Office Building, Room 10235, 

Washington, DC 20503. 

Send Comments and Requests for 

Further Information: To request more 

information on the proposed collection 

or to obtain a copy of the data collection 

instrument(s) and/or instruction(s) 

contact: Mr. Hershel Gorham, Reports 

Clearance Officer, 801 Thompson 

Avenue, TMP, Suite 450, Rockville, MD 

20852–1627; call non-toll free (301) 

443–5932; send via facsimile to (301) 

443–9879; or send your e-mail requests, 

comments, and return address to: 

Hershel.Gorham@ihs.gov. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having full effect if 

received within 30 days of the date of 

this publication. 

Dated: March 19, 2010. 

Yvette Roubideaux, 

Director, Indian Health Service. 

[FR Doc. 2010–7253 Filed 3–30–10; 8:45 am] 

BILLING CODE 4165–16–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— 

Common Formats Version 1.1. 

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 the 

expanded and enhanced Common 

Formats Version 1.1—including 

updated event descriptions, reports, 

data elements, and technical 

specifications for software developers— 

and the process for their continued 

refinement. 

DATES: Ongoing public input. 

ADDRESSES: The Common Formats 

Version 1.1 can be accessed 

electronically at the following HHS Web 

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

index.html. 

FOR FURTHER INFORMATION CONTACT: 

Marcy Opstal, Center for Quality 

Improvement and Patient Safety, AHRQ, 

540 Gaither Road, Rockville, MD 20850; 

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


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Notices 16141 

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

(toll free): (866) 438–7231; TTY (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, 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 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. The second 

release of the Common Formats, Version 

1.0, was announced in the Federal 

Register on September 2, 2009: 74 FR 

45457–45458. 

Definition of Common Formats 

The term ‘‘Common Formats’’ is used 

to describe clinical definitions and 

technical requirements developed for 

the uniform collection and reporting of 

patient safety data, including all 

supporting material. 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. 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. 

Common Formats Version 1.1 is 

currently limited to patient safety 

reporting for acute care hospitals and is 

designed to support the first stage in the 

improvement cycle. Version 1.1 

includes 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 eventspecific Common Formats pertain to 

frequently-occurring and/or serious 

patient safety events. The eight eventspecific formats are: Blood or Blood 

Product, Device or Medical/surgical 

Supply, Fall, Healthcare-Associated 

Infection, Medication or Other 

Substance, Perinatal, Pressure Ulcer, 

and Surgery or Anesthesia. 

The Common Formats Version 1.1 has 

a defined focus on patient safety 

reporting for acute care hospitals. It 

should be noted, however, that the 

privilege and confidentiality protections 

of the Patient Safety Act and Patient 

Safety Rule apply to patient safety work 

product developed under the aegis of a 

PSO with respect to healthcare in any 

setting. Future versions of the Common 

Formats are being developed for other 

settings such as: Skilled nursing 

facilities (SNFs), ambulatory surgery 

centers, and physician and practitioner 

offices. 

AHRQ’s Common Formats Version 1.1 

includes: 

• Descriptions of patient safety events 

and unsafe conditions to be reported 

(event descriptions), 

• Specifications for patient safety 

aggregate reports and individual event 

summaries, 

• Delineation of data elements to be 

collected for specific types of events, 

• A user’s guide and quick guide, and 

• Technical specifications for 

electronic data collection and reporting. 

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, the Office of the National 

Coordinator for Health Information 

Technology, 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. 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). 

Common Formats Version 1.1— 

Technical Specifications Enhancements 

The technical specifications promote 

standardization by ensuring that data 

collected by PSOs and other entities are 

clinically and electronically 

comparable. The specifications also 

provide direction to software 

developers, so the Common Formats can 

be implemented electronically, and to 

PSOs, so the Common Formats can be 

submitted electronically to the PSO 

Privacy Protection Center (PPC) for data 

de-identification and transmission to 

the Network of Patient Safety Databases 

(NPSD). 

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 Version 1.1; 


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16142 Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Notices 

• Clinical document architecture 

(CDA) implementation guide—provides 

instructions for developing a Health 

Level Seven (HL7) CDA Extensible 

Markup Language (XML) file to transmit 

the Common Formats patient safety data 

from the PSO to the 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 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)]. 

Commenting on Common Formats 

Version 1.1 

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 healthcare 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. The 

NQF also convened an expert panel to 

review the comments received on 

Common Formats Version 1.0 and 

provide feedback to AHRQ. Based upon 

the expert panel’s feedback, AHRQ, in 

conjunction with the PSWG, has further 

revised and refined the Common 

Formats that are now available as 

Version 1.1. 

AHRQ is committed to continuing 

refinement of the Common Formats. The 

Agency is specifically interested in 

obtaining feedback from both the private 

and public sectors, particularly from 

those who use the Common Formats, to 

guide their improvement. Although 

AHRQ’s Version 1.1 has been developed 

based on evidence, consensus of the 

PSWG, public comments and input, and 

feedback from the NQF expert panel, the 

formats do not fully reflect the 

refinement that comes from large-scale 

use and repeated revision. The process 

for updating and refining the formats 

will be an iterative one. 

More information on the Common 

Formats Version 1.1, including the 

feedback process, can be obtained 

through AHRQ’s PSO Web site: http:// 

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

Dated: March 19, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–6781 Filed 3–30–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

FY 2010 Special Diabetes Program for 

Indians Community-Directed Grant 

Program 

Announcement Type: New/Competing 

Continuation. 

Funding Opportunity Number: HHS– 

2010–IHS–SDPI–0004. 

Catalog of Federal Domestic Assistance 

Number: 93.237 

Key Dates: 

Application Deadline: April 30, 2010. 

Review Date: June 21–24, 2010. 

Earliest Anticipated Start Date: July 15, 

2010. 

Other information: This 

announcement will be open throughout 

Fiscal Year (FY) 2010 based on existing 

budget cycles. Refer to application 

instructions for additional details. This 

current announcement targets grantees 

that currently operate under a budget 

cycle that begins on June 1. 

I. Funding Opportunity Description 

Statutory Authority 

The Indian Health Service (IHS) is 

accepting grant applications for the FY 

2010 Special Diabetes Program for 

Indians (SDPI) Community-Directed 

grant program. This competitive grant 

announcement is open to all existing 

SDPI grantees that have an active grant 

in place and are in compliance with the 

previous terms and conditions of the 

grant. This program is authorized under 

H.R. 6331 ‘‘Medicare Improvement for 

Patients and Providers Act of 2008’’ 

(Section 303 of Pub. L. 110–275) and the 

Snyder Act, 25 U.S.C. 13. The program 

is described in the Catalog of Federal 

Domestic Assistance (CDFA) under 

93.237. 

Overview 

The SDPI seeks to support diabetes 

treatment and prevention activities for 

American Indian/Alaska Native (AI/AN) 

communities. Grantees will implement 

programs based on identified diabetesrelated community needs. Activities 

will be targeted to reduce the risk of 

diabetes in at-risk individuals, provide 

services that target those with new onset 

diabetes, provide high quality care to 

those with diagnosed diabetes, and/or 

reduce the complications of diabetes. 

The purpose of the FY 2010 SDPI 

Community-Directed grant program is to 

support diabetes treatment and 

prevention programs that have a 

program plan which integrates at least 

one IHS Diabetes Best Practice and that 

have a program evaluation plan in place 

which includes tracking outcome 

measures. 

This is not an application for 

continued funding as was previously 

available for Community-Directed grant 

programs. 

Background 

Diabetes Among American Indian/ 

Alaska Native Communities 

During the past 50 years, type 2 

diabetes has become a major public 

health issue in many AI/AN 

communities, and it is increasingly 

recognized that AI/AN populations have 

a disproportionate burden of diabetes 

(Ghodes, 1995). In 2006, 16.1% of AI/ 

ANs age 20 years or older had diagnosed 

diabetes (unpublished IHS Diabetes 

Program Statistics, 2006) compared to 

7.8% for the non-Hispanic white 

population (CDC, 2007). In addition, AI/ 

AN people have higher rates of diabetesrelated morbidity and mortality than the 

general U.S. population (Carter, 1996; 

Harris, 1995; Gilliland, 1997). Strategies 

to address the prevention and treatment 

of diabetes in AI/AN communities are 

urgently needed. 

Under the Balanced Budget Act of 

1997, Congress authorized the IHS to 

administer the SDPI grant program. 

SDPI grants are programmatically 

directed by the IHS Division of Diabetes 

Treatment and Prevention (DDTP). 

Special Diabetes Program for Indians 

The SDPI is a $150 million per year 

grant program. Over 330 programs have 

received SDPI Community-Directed 

grants annually since 1998. In addition, 

66 demonstration projects have been 

funded annually since 2004 to address 

prevention of type 2 diabetes or 

cardiovascular disease risk reduction. A 

Congressional re-authorization in 2008 

extended the SDPI through FY 2011. 

II. Award Information 

Type of Awards 

Grants. 

Estimated Funds Available 

The total amount of funding 

identified for FY 2010 SDPI 


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