Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices 65359 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

Administrative Subpoena ................................................................. 35,286 1 0.50 17,643 

Estimated Total Annual Burden 

Hours: 17,643 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7285, 

E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: October 19, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–26693 Filed 10–21–10; 8:45 am] 

BILLING CODE 4184–01–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—revised 

and enhanced event-specific 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 

significant revision of a previously 

released Common Format for public 

review and comment. 

DATES: Ongoing public input. 

ADDRESSES: The revised Device or 

Medical/Surgical Supply including 

Health Information Technology (HIT) 

Device format and the remaining 

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: 

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; 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/requlations/ 

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. 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. 

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: 

Æ Incidents—patient safety events 

that reached the patient, whether or not 

there was harm, 

Æ Near misses or close calls—patient 

safety events that did not reach the 

patient, and 


emcdonald on DSK2BSOYB1PROD with NOTICES
65360 Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices 

Æ 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. 

As part of the Agency’s efforts to 

continually refine and update the 

formats, AHRQ has issued a significant 

revision of the previously released 

Common Format—Device or Medical/ 

Surgical Supply. In conjunction with 

the Food and Drug Administration 

(FDA) and the Office of the National 

Coordinator for Health Information 

Technology (ONC), AHRQ developed 

the beta version of this event-specific 

format to capture information about 

patient safety events that are related to 

HIT. Subsequently, the format was 

reviewed and revised by an interagency 

Federal Patient Safety Work Group 

(PSWG). The enhanced format, Device 

or Medical/Surgical Supply including 

HIT Device, will be incorporated into 

the next version of the Common 

Formats (Version 1.2). 

This revised 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. The Device or Medical/ 

Surgical Supply including HIT Device 

Common Format is available at the 

Patient Safety Organization (PSO) 

Privacy Protection Center (PPC) Web 

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

patientsafety. 

Commenting on Device or Medical/ 

Surgical Supply Including HIT Device 

Common Format, 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 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. These revised formats 

are now available as Version 1.1. 

As evidenced by the release of this 

Device or Medical/Surgical Supply 

including HIT Device format, 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. Information on how 

to comment and provide feedback on 

the Common Formats, Version 1.1 and 

the Device or Medical/Surgical Supply 

including HIT Device 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), FDA, the Department 

of Defense (DOD), and the Department 

of Veterans Affairs (VA). 

Since February 2005, AHRQ has 

coordinated the 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, 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. 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. More information on the 

Common Formats Version 1.1 can be 

obtained through AHRQ’s PSO Web site: 

http://www.PSO.AHRQ.qov/index.html. 

Dated: October 12, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–26667 Filed 10–21–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2326–PN] 

Medicare and Medicaid Programs; 

Application by the Joint Commission 

for Deeming Authority for Psychiatric 

Hospitals 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed notice. 

SUMMARY This proposed notice with 

comment period acknowledges the 

receipt of an application from the Joint 

Commission for recognition as a 

national accrediting organization for 

psychiatric hospitals that wish to 

participate in the Medicare or Medicaid 

programs. Section 1865(a)(3)(A) of the 

Social Security Act requires that within 

60 days of receipt of an organization’s 

complete application, we publish a 

notice that identifies the national 

accrediting body making the request, 

describes the nature of the request, and 

provides at least a 30-day public 

comment period. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on November 22, 2010. 

ADDRESSES: In commenting, please refer 

to file code CMS–2326–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 


emcdonald on DSK2BSOYB1PROD with NOTICES