Federal Register / Vol. 74, No. 169 / Wednesday, September 2, 2009 / Notices 45455 

maintained should registrations exceed 

room capacity. Individuals on the 

waiting list will be contacted as 

additional space for the meeting 

becomes available. On September 17 

and 18, 2009, registered meeting 

attendees should arrive 45 minutes prior 

to the start of the meeting for the 

necessary security procedures to be 

conducted. Security procedures require 

that all registered public attendees must 

present a valid photo identification (i.e., 

driver’s license) and be escorted by 

appropriate Federal staff to the 

designated meeting site. 

Registration questions may be 

directed to Hillary Scherer at the 

following e-mail address: 

HP2020@norc.org, by phone on (301) 

634–9374 or by fax at (301) 634–9301. 

Dated: August 28, 2009. 

Penelope Slade-Sawyer, 

P.T., M.S.W., RADM, USPHS, Deputy 

Assistant Secretary for Health (Disease 

Prevention and Health Promotion), Office of 

Disease Prevention and Health Promotion. 

[FR Doc. E9–21217 Filed 9–1–09; 8:45 am] 

BILLING CODE 4150–32–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; HIT 

Standards Committee Advisory 

Meeting; Notice of Meeting 

AGENCY: Office of the National 

Coordinator for Health Information 

Technology, HHS. 

ACTION: Notice of meeting. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Office of the National Coordinator 

for Health Information Technology 

(ONC). The meeting will be open to the 

public. 

Name of Committee: HIT Standards 

Committee. 

General Function of the Committee: 

To provide recommendations to the 

National Coordinator on standards, 

implementation specifications, and 

certification criteria for the electronic 

exchange and use of health information 

for purposes of adoption, consistent 

with the implementation of the Federal 

Health IT Strategic Plan, and in 

accordance with policies developed by 

the HIT Policy Committee. 

Date and Time: The meeting will be 

held on September 15, 2009, from 9:00 

a.m. to 3 p.m./Eastern Time. 

Location: The Omni Shoreham Hotel, 

2500 Calvert Street, NW., Washington, 

DC. The hotel telephone number is 202– 

234–0700. 

Contact Person: Judy Sparrow, Office 

of the National Coordinator, HHS, 330 C 

Street, SW., Washington, DC 20201, 

202–205–4528, Fax: 202–690–6079, email: judy.sparrow@hhs.gov Please call 

the contact person for up-to-date 

information on this meeting. A notice in 

the Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Agenda: The Committee will discuss 

a report from its Privacy and Security 

Workgroup, and a discussion on 

implementation guidance. ONC intends 

to make background material available 

to the public no later than two (2) 

business days prior to the meeting. If 

ONC is unable to post the background 

material on its Web site prior to the 

meeting, it will be made publicly 

available at the location of the advisory 

committee meeting, and the background 

material will be posted on ONC’s Web 

site after the meeting, at http:// 

healthit.hhs.gov 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before September 4, 2009. 

Oral comments from the public will be 

scheduled between approximately 2:30 

p.m. to 3 p.m. Time allotted for each 

presentation may be limited. If the 

number of speakers requesting to 

comment is greater than can be 

reasonably accommodated during the 

scheduled open public hearing session, 

ONC will take written comments after 

the meeting until close of business. 

Persons attending ONC’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

ONC welcomes the attendance of the 

public at its advisory committee 

meetings. Seating is limited at the 

location, and ONC will make every 

effort to accommodate persons with 

physical disabilities or special needs. If 

you require special accommodations 

due to a disability, please contact Judy 

Sparrow at least seven (7) days in 

advance of the meeting. 

ONC is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://healthit.hhs.gov for procedures 

on public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act 

(Pub. L. No. 92–463, 5 U.S.C., App. 2). 

Dated: August 28, 2009. 

Judith Sparrow, 

Office of Programs and Coordination, Office 

of the National Coordinator for Health 

Information Technology. 

[FR Doc. E9–21204 Filed 9–1–09; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: 

‘‘Collection of Information for Agency 

for Healthcare Research and Quality’s 

(AHRQ) Hospital Survey on Patient 

Safety Culture Comparative Database.’’ 

In accordance with the Paperwork 

Reduction Act of 1995, 44 U.S.C. 

3506(c)(2)(A), AHRQ invites the public 

to comment on this proposed 

information collection. 

DATES: Comments on this notice must be 

received by November 2, 2009. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@ahrg.hhs.gov. 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

e-mail at doris.1efkowitz@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Collection of Information for Agency for 

Healthcare Research and Quality’s 

(AHRQ) Hospital Survey on Patient 

Safety Culture Comparative Database 

The Agency for Healthcare Research 

and Quality (AHRQ) requests that the 

Office of Management and Budget 

(OMB) approve, under the Paperwork 

Reduction Act of 1995, AHRQ’s 

collection of information for the AHRQ 

Hospital Survey on Patient Safety 

Culture (Hospital SOPS) Comparative 


jlentini on DSKJ8SOYB1PROD with NOTICES
45456 Federal Register / Vol. 74, No. 169 / Wednesday, September 2, 2009 / Notices 

Database. The Hospital SOPS 

Comparative Database consists of data 

from the AHRQ Hospital Survey on 

Patient Safety Culture. Hospitals in the 

U.S. are asked to voluntarily submit 

data from the survey to AHRQ, through 

its contractor, Westat. The database was 

developed by AHRQ in 2006 in 

response to requests from hospitals 

interested in knowing how their patient 

safety culture survey results compare to 

those of other hospitals in their efforts 

to improve patient safety. 

In 1999, the Institute of Medicine 

called for health care organizations to 

develop a ‘‘culture of safety’’ in which 

their workforces and processes focus on 

improving the reliability and safety of 

care for patients (IOM, 1999; To Err is 

Human: Building a Safer Health 

System). To respond to the need for 

tools to assess patient safety culture in 

health care, AHRQ developed and pilot 

tested the Hospital Survey on Patient 

Safety Culture with OMB approval 

(OMB No. 0935–01 15; Approved 2/4/ 

2003). The survey was designed to 

enable hospitals to assess staff opinions 

about patient safety issues, medical 

error, and error reporting and includes 

42 items that measure 12 dimensions of 

patient safety culture. AHRQ released 

the survey in the public domain along 

with a Survey User’s Guide and other 

toolkit materials in November 2004 on 

the AHRQ Web site. Since its release, 

the survey has been voluntarily used by 

hundreds of hospitals in the U.S. 

The Hospital SOPS survey and the 

Hospital SOPS Comparative Database 

are supported by AHRQ to meet its goals 

of promoting improvements in the 

quality and safety of health care in 

hospital settings. This project is 

conducted pursuant to AHRQ’s 

statutory authority to conduct and 

support research on health care and on 

systems for the delivery of such care, 

including activities with respect to the 

quality, effectiveness, efficiency, 

appropriateness and value of health care 

services and with respect to health 

statistics, surveys, and database 

development. See 42 U.S.C. 299a(a)(l) 

and (8). The surveys, toolkit materials, 

and comparative database results are all 

made available in the public domain 

along with technical assistance, 

provided by AHRQ through its 

contractor at no charge to hospitals, to 

facilitate the use of these materials for 

hospital patient safety and quality 

improvement. 

Method of Collection 

Information for the Hospital SOPS 

database has been collected by AHRQ 

on an annual basis since 2006. Hospitals 

are asked to voluntarily submit their 

Hospital SOPS survey data to the 

comparative database between May 1 

and June 30. The data are then cleaned 

and aggregated and used to produce a 

comparative Database Report that 

displays averages, standard deviations, 

and percentile scores on the survey’s 42 

items and 12 patient safety culture 

dimensions, as well as displaying these 

results by hospital characteristics (bed 

size, teaching status, ownership) and 

respondent characteristics (hospital 

work area, staff position, and those with 

direct interaction with patients). In 

addition, trend data, showing changes 

in scores over time, are presented from 

hospitals that have submitted to the 

database more than once. 

Estimated Annual Respondent Burden 

Hospitals administer the AHRQ 

Hospital Survey on Patient Safety 

Culture every 16 months on average. 

Therefore, the number of hospital 

submissions to the database varies each 

year because hospitals do not submit 

data every year. The 250 respondents/ 

point-of-contacts (POCs) shown in 

Exhibit 1 are based on an estimated 

increase in the number of submissions 

in 2010 and 2011 (above the 180 

respondents from 2009). Data 

submission is typically handled by one 

POC who is either a hospital patient 

safety manager or a survey vendor. The 

POC completes a number of data 

submission steps and forms, beginning 

with completion of an online Eligibility 

and Registration Form. The POCs 

typically submit data on behalf of 3 

hospitals, on average, because many 

hospitals are part of a multi-hospital 

system that is submitting data, or the 

POC is a vendor that is submitting data 

for multiple hospitals. In 2009, 180 

POCs submitted data on behalf of a total 

of 535 hospitals (an average of 3 

hospital submissions per POC). Exhibits 

1 and 2 are based on the estimated 

number of individual POCs who will 

complete the database submission steps 

and forms in the coming years, not 

based on the number of hospitals. 

The Patient Safety Improvement 

Initiatives Form is completed only by 

POCs from trending hospitals that have 

submitted data more than once, so only 

about half of the POCs each year will be 

asked to complete the form for each of 

the 3 hospitals (on average) they are 

submitting data for. The Hospital 

Information Form is completed by all 

POCs for each of their hospitals. The 

total annual burden hours are estimated 

to be 1,508. 

Exhibit 2 shows the estimated 

annualized cost burden based on the 

respondents’ time to submit their data. 

The cost burden is estimated to be 

$69,438 annually. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name 

Number of 

respondents/ 

POCs 

Number of 

responses per 

POC 

Hours per 

response 

Total burden 

hours 

Eligibility/Registration Form and Data Submission* ........................................ 250 1 5.6 1,400 

Data Use Agreement ....................................................................................... 250 1 3/60 13 

Patient Safety Improvement Initiatives Form (for trending hospitals only) ..... 125 3 5/60 32 

Hospital Information Form ............................................................................... 250 3 5/60 63 

Total .......................................................................................................... 875 NA NA 1,508 

* The Eligibility and Registration Form requires 3 minutes to complete; however, about 5.5 hours is required to prepare/plan for the data submission. This includes the amount of time POCs and other hospital staff (CEO, lawyer, database administrator) typically spend deciding whether 

to participate in the database and preparing their materials and data set for submission to the database, and performing the submission. 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name 

Number of 

respondents/ 

POCs 

Total burden 

hours 

Average 

hourly wage 

rate* 

Total cost 

burden 

Eligibility/Registration Form and Data Submission .......................................... 250 1,400 $46.11 $64,554 


jlentini on DSKJ8SOYB1PROD with NOTICES
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] 

BILLING CODE 4160–90–M 

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