Federal Register / Vol. 74, No. 169 / Wednesday, September 2, 2009 / Notices 45457 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued 

Form name 

Number of 

respondents/ 

POCs 

Total burden 

hours 

Average 

hourly wage 

rate* 

Total cost 

burden 

Data Use Agreement ....................................................................................... 250 13 45.22 588 

Patient Safety Improvement Initiatives Form (for trending hospitals only) ..... 125 32 45.22 1,447 

Hospital Information Form ............................................................................... 250 63 45.22 2,849 

Total .......................................................................................................... 875 1,508 NA 69,438 

* Wage rates were calculated using the mean hourly wage based on occupational employment and wage estimates from the Dept of Labor, 

Bureau of Labor Statistics’ May 2008 National Industry-Specific Occupational Employment and Wage Estimates NAICS 622000—Hospitals, located at http://www.bls.gov/oes/2008/may/naics3_622000.htm. Wage rate of $46.22 is based on the mean hourly wages for Medical and Health 

Services Managers. Wage rate of $46.11 is the weighted mean hourly wage for: Medical and Health Services Managers ($45.22 × 2.6 hours = 

$117.57), Lawyers ($62.95 × .5 hours = $31.48), Chief Executives ($89.16 × .5 hours = $44.58), and Database Administrators ($32.30 × 2 hours 

= $64.60) [Weighted mean ($117.57 + 31.48 + 44.58 + 64.60)/5.6 hours = $258.23/5.6 hours = $46.11/hour]. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the estimated 

annualized cost to the government for 

developing, maintaining, and managing 

the database and analyzing the data and 

producing reports. The cost is estimated 

to be $250,000 annually. 

EXHIBIT 3—ESTIMATED ANNUALIZED

COST

Cost component Annualized 

cost 

Database Development and 

Maintenance ...................... $50,000 

Data Submission .................. 75,000 

Data Analysis & Reports ...... 125,000 

Total ............................... 250,000 

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, quality 

improvement and 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: August 26, 2009. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E9–21079 Filed 9–1–09; 8:45 am] 

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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 1.0. 

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 initial release of the formats, 

Version 0.1 Beta, was announced in the 

Federal Register on August 29, 2008: 73 

FR 50974–50976. The purpose of this 

notice is to announce the availability of 

the expanded and enhanced Common 

Formats Version 1.0 and the process for 

their continued development and 

refinement. 

DATES: Ongoing public input. 

ADDRESSES: The 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; 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 


jlentini on DSKJ8SOYB1PROD with NOTICES
45458 Federal Register / Vol. 74, No. 169 / Wednesday, September 2, 2009 / Notices 

underlying causal factors of patient 

safety problems. 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. 

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. AHRQ’s Common 

Formats include: 

• Descriptions of patient safety events 

and unsafe conditions to be reported, 

• Delineation of data elements to be 

collected for specific types of events, 

• Specifications for patient safety 

population reports, 

• Technical specifications for 

electronic data collection and reporting, 

and 

• A user’s guide. 

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. 

Score of Common Formats 

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. 

Version 1.0 includes two general 

types of formats, generic and eventspecific. 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. The eight event-specific 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 1.0 has 

a defined focus on patient safety 

reporting for acute care hospitals. It 

should be noted, however, that the 

Patient Safety Act and Patient Safety 

Rule confer both privilege and 

confidentiality on all patient safety 

work product developed under the aegis 

of a PSO with respect to healthcare in 

any setting. AHRQ anticipates 

expanding future versions of the 

Common Formats to include other 

settings such as: Nursing homes and 

other bedded facilities; ambulatory 

surgery centers; other ambulatory care 

settings, including community health 

centers, rehabilitation centers, and 

hemodialysis centers; physician and 

practitioner offices; and retail 

establishments such as pharmacies. 

Common Formats Development 

AHRQ established a process to 

develop Common Formats that: (1) Is 

evidence based; (2) harmonizes across 

governmental health agencies; (3) 

incorporates feedback from the private 

sector, including professional 

associations/organizations, those who 

use the formats, and the public; and (4) 

permits timely updating of these 

clinically-sensitive formats. 

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 66 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). 

In addition, AHRQ convened 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 

Department—CDC, Centers for Medicare 

and 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. 

Subsequently, AHRQ, in conjunction 

with the PSWG, developed and released 

Common Formats Version 0.1 Beta. To 

the extent practicable, the Common 

Formats were aligned with World 

Health Organization (WHO) concepts, 

framework, and definitions contained in 

their draft International Classification 

for Patient Safety (ICPS). 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 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 convened an expert 

panel to review the comments received 

on Version 0.1 Beta and provide 

feedback to AHRQ. Based upon the 

expert panel’s feedback, AHRQ, in 

conjunction with the PSWG, further 

revised and refined the Common 

Formats that are now available as 

Version 1.0. 

Commenting on Common Formats 

Version 1.0 

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 1.0 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 yet reflect the refinement 

that will come from large-scale use and 

repeated revision. The process for 

updating and refining the formats will 

be an iterative one. AHRQ anticipates 

that it will receive helpful guidance 

from early users of the Common 

Formats. 

The NQF will continue to assist 

AHRQ in updating future versions of the 

formats by soliciting public comments 

from providers, professional 

organizations, the general public, PSOs, 

and other users of Common Formats. 

More information on the Common 

Formats Version 1.0, including the 

feedback process, can be obtained 

through AHRQ’s PSO Web site: http:// 

www.pso.ahrq.gov/index.html. 

Dated: August 26, 2009. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E9–21080 Filed 9–1–09; 8:45 am] 

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