42736 Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Notices 

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—New 

Common Format. 

SUMMARY: As authorized by the 

Secretary of HHS, AHRQ coordinates 

the development of a set of common 

definitions and reporting formats 

(Common Formats) for reporting patient 

safety events to Patient Safety 

Organizations (PSOs). The purpose of 

this notice is to announce the 

availability of a new Common Format— 

Readmissions Version 0.1 Beta for 

public review and comment. 

DATES: Ongoing public input. 

ADDRESSES: The new Common Format— 

Readmissions Version 0.1 Beta, version 

dated July 2012—and the remaining 

Common Formats can be accessed 

electronically at the following HHS Web 

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

index.html. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Niane, 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. 

SUPPLEMENTARY INFORMATION: 

Background 

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 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 healthcare 

providers to voluntarily collect and 

submit 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. This collection allows the 

aggregation of sufficient data to identify 

and address underlying causal factors of 

patient safety problems. 

The Patient Safety Act and Patient 

Safety Rule establish a framework by 

which doctors, hospitals, skilled 

nursing facilities, and other healthcare 

providers may assemble 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 Act and Patient Safety Rule 

which can be accessed electronically at: 

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

REGULATIONS/REGULATIONS.htm. 

Definition of Common Formats 

The term ‘‘Common Formats’’ refers 

to the common definitions and reporting 

formats, specified by AHRQ, that allow 

health care providers to collect and 

submit standardized information 

regarding patient safety events. 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; rather the formats are 

intended to enhance the ability of health 

care providers to report information that 

is standardized both clinically and 

electronically. 

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 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. 

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. 

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. They 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 (PPC) for data 

de-identification and transmission to 

the Network of Patient Safety Databases 

(NPSD). 

Since the initial release of the 

Common Formats in August 2008, 

AHRQ has regularly revised the formats 

based upon public comment. Most 

recently, AHRQ and the PSWG 

developed Common Format— 

Readmissions Version 0.1 Beta to allow 

hospitals to aggregate data that describe 

circumstances associated with the 

readmission of patients. These factors 

include actions taken at the index 

hospitalization to prevent a 

readmission, risk factors for 

readmission, length of stay, presence of 

an adverse event, location of discharge 

setting, as well as other attributes. Using 

this standardized method of review, 

hospitals can identify factors associated 

with unnecessary readmissions. In 

addition, hospitals can compare their 

data to others and analyze trends on a 

community, regional, and national level. 

The Common Format—Readmissions 

Version 0.1 Beta, dated July 2012, is 

available at the PSO PPC Web site: 

https://www.PSOPPC.ORG/web/ 

patientsafety. 

Common Formats Development 

In anticipation of the need for 

Common Formats, AHRQ began their 

development 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 

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 

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of Defense (DoD), and the Department of 

Veterans Affairs (VA). 

Since February 2005, AHRQ has 

convened the PSWG to assist AHRQ 

with developing and maintaining the 

Common Formats. The PSWG includes 

major health agencies within HHS— 

CDC, Centers for Medicare & Medicaid 

Services, FDA, 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 

DoD and VA. 

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. 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). 

Commenting on Common Format— 

Readmissions Version 0.1 Beta 

To allow for greater participation by 

the private sector in the subsequent 

development of the Common Formats, 

AHRQ engaged the 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 then 

convenes an expert panel to review the 

comments received and provide 

feedback. The NQF began this process 

with feedback on AHRQ’s 0.1 Beta 

release of the Common Formats in 2008. 

Based upon the expert panel’s feedback, 

AHRQ, in conjunction with the PSWG, 

revises and refines the Common 

Formats. 

The Agency is specifically interested 

in obtaining feedback from both the 

private and public sectors on the new 

Common Format—Readmissions 

Version 0.1 Beta to guide the 

improvement of the formats. 

Information on how to comment and 

provide feedback on the Common 

Format—Readmissions Version 0.1 Beta 

is available at the NQF Web site for 

Common Formats: http:// 

www.Quality.forum.ORG/projects/ 

commonformats.aspx. 

The process for updating and refining 

the formats will continue to be an 

iterative one. Future versions of the 

Common Formats will be developed for 

ambulatory settings, such as ambulatory 

surgery centers and physician and 

practitioner offices. More information 

on the Common Formats can be 

obtained through AHRQ’s PSO Web site: 

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

Dated: July 13, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–17529 Filed 7–19–12; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Patient Safety Organizations: Delisting 

for Cause for The Steward Group PSO 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of delisting. 

SUMMARY: AHRQ has delisted The 

Steward Group PSO as a Patient Safety 

Organization (PSO) due to its failure to 

correct a deficiency. The Patient Safety 

and Quality Improvement Act of 2005 

(Patient Safety Act) authorizes the 

listing of PSOs, which are entities or 

component organizations whose 

mission and primary activity is to 

conduct activities to improve patient 

safety and the quality of health care 

delivery. HHS issued the Patient Safety 

and Quality Improvement Final Rule 

(Patient Safety Rule) to implement the 

Patient Safety Act. AHRQ administers 

the provisions of the Patient Safety Act 

and Patient Safety Rule relating to the 

listing and operation of PSOs. 

DATES: The directories for both listed 

and delisted PSOs are ongoing and 

reviewed weekly by AHRQ. The 

delisting was effective at 12:00 Midnight 

ET (2400) on June 19, 2012. 

ADDRESSES: Both directories can be 

accessed electronically at the following 

HHS Web site: http:// 

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

FOR FURTHER INFORMATION CONTACT: 

Eileen Hogan, 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. 

SUPPLEMENTARY INFORMATION: 

Background 

The Patient Safety Act, Public Law 

109–41, 42 U.S.C. 299b–21—b–26, 

provides for the formation of PSOs, 

which collect, aggregate, and analyze 

confidential information regarding the 

quality and safety of health care 

delivery. The Patient Safety Rule, 42 

CFR part 3, authorizes AHRQ, on behalf 

of the Secretary of HHS, to list as a PSO 

an entity that attests that it meets the 

statutory and regulatory requirements 

for listing. A PSO can be ‘‘delisted’’ by 

the Secretary if it is found no longer to 

meet the requirements of the Patient 

Safety Act and Patient Safety Rule. 

Section 3.108(d) of the Patient Safety 

Rule requires AHRQ to provide public 

notice when it removes an organization 

from the list of federally approved 

PSOs. 

The Steward Group PSO failed to 

respond to a Notice of Preliminary 

Finding of Deficiency sent by AHRQ 

pursuant to 42 CFR 3.108(a)(2) and a 

Notice of Proposed Revocation and 

Delisting sent by AHRQ pursuant to 42 

CFR 3.108(a)(3)(iii)(C) which found that 

The Steward Group PSO failed to have, 

within every 24-month period following 

the PSO’s date of initial listing, at least 

two bona fide contracts with different 

providers for the purpose of receiving 

and reviewing patient safety work 

product, and to notify AHRQ no later 

than 45 calendar days prior to the last 

day of the pertinent 24-month period 

that the PSO has met this requirement. 

The Steward Group PSO did not 

exercise its opportunity to be heard in 

writing to respond to the deficiencies 

specified in the notices, and has not 

provided any evidence of a good faith 

effort to correct the deficiency. 

Accordingly, AHRQ has revoked the 

listing of The Steward Group PSO, PSO 

number P0088, a component entity of 

The Steward Group, Inc., effective at 

12:00 Midnight ET (2400) on June 19, 

2012. 

More information on PSOs can be 

obtained through AHRQ’s PSO Web site 

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

index.html. 

Dated: July 3, 2012. 

Carolyn M. Clancy, 

Director. 

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