Common Formats for Patient Safety Data Collection, 65628-65629 [2024-17927]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES 65628 Federal Register / Vol. 89, No. 155 / Monday, August 12, 2024 / Notices Action Alternatives for the Sumas LPOE are described below. Sumas Alternative 2 (Feasibility Study Preferred Alternative) would involve potential acquisition of land south and east of the LPOE, site preparation, and construction to modernize and expand the LPOE. The maximum proposed limits of disturbance for Sumas Alternative 2 would be approximately 12.9 acres. Sumas Alternative 3 (Commercial Inspection West) would include the same action and maximum proposed limits of disturbance as Alternative 2, with a difference of a ‘‘flipped’’ alignment of the commercial inspection facility. Sumas Alternative 4 (Multi-Story Construction LPOE Expansion) would include the same action and maximum proposed limits of disturbance as Sumas Alternative 2, with a difference of multistory Main Building being constructed. Construction sequencing options are described below. Under the Concurrent Construction option, both ports would remain open during construction. Pedestrian access would be maintained through the ports by utilizing and resetting, as necessary, various access and safety controls. POV access would also be maintained through both ports using various controls, which may require limits on the number of open processing lanes and shifting of POVs to commercial owned vehicle (COV) lanes for limited times. COVs may need to be detoured at times to other ports to permit adequate space for continued POV processing. Under the Sequential Construction Option, GSA and CBP are considering the potential for closure of the Lynden LPOE. All traffic, pedestrians, POVs, and COVs would be detoured from the Lynden LPOE during the majority of its construction. Once the modernized and expanded Lynden LPOE is reopened, construction that impacts traffic would begin on the Sumas LPOE. The Sumas LPOE would remain open to pedestrians and POVs during construction to the greatest extent possible. COVs would be detoured from the Sumas LPOE to other LPOEs during portions of the construction period. The Draft EIS addresses the potential environmental impacts of the proposed alternatives on environmental resources including land use; water resources; biological resources; geology, topography, and soils; air quality, climate change, and greenhouse gases; human health and safety; infrastructure and utilities; traffic and transportation; noise and vibration; socioeconomics; and environmental justice and protection of children’s health and VerDate Sep<11>2014 17:30 Aug 09, 2024 Jkt 262001 safety. Based on the analysis presented in the Draft EIS, impacts to all resource areas would be less-than-significant (i.e., negligible, minor, or moderate) adverse or beneficial. Impact reduction measures are presented in the Draft EIS to reduce potential adverse effects. GSA is currently undergoing formal consultation with the State Historic Preservation Officer (SHPO) and consulting parties to follow coordination procedures as required under section 106 of the NHPA to determine impacts to historic properties. Mitigation measures may be determined in consultation between GSA, SHPO, and applicable consulting parties. GSA is in the process of conducting informal consultation with the U.S. Fish and Wildlife Service (USFWS) under section 7 of the Endangered Species Act to determine potential effects to federally protected species and migratory birds. GSA initiated consultation with the USFWS regarding the Lynden LPOE and Sumas LPOE and is awaiting USFWS responses and findings. Once received, USFWS responses and findings would be included in the Final EIS. GSA coordinated with the Natural Resources Conservation Service (NRCS) via email concerning the Federal Farmland Protection Policy Act conversion impact rating forms completed for both the Lynden and Sumas LPOEs and is awaiting NRCS responses and findings. Once received, the NRCS responses and findings would be included in the Final EIS. The Sumas LPOE project area is located within the 1-percent-annualchance floodplain (also referred to as the base flood or 100-year flood) and 0.2-percent-annual-chance floodplain (also referred to as the 500-year flood). In compliance with Executive Order 11988 (Floodplain Management), GSA prepared a Floodplain Assessment and Statement of Findings addressing potential impacts on floodplains, which is included in the Draft EIS for public review and comment. As described in the Draft EIS, GSA would follow Federal, state, and local regulatory compliance requirements and incorporate design standards at the Sumas LPOE to minimize impacts to floodplains. Anamarie Crawley, Director, R10 Facilities Management Division Northwest/Arctic Region 10, U.S. General Services Administration. [FR Doc. 2024–17864 Filed 8–9–24; 8:45 am] BILLING CODE 6820–DL–P PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Common Formats for Patient Safety Data Collection Agency for Healthcare Research and Quality (AHRQ), Department of Health and Human Services (HHS). ACTION: Notice of availability—new common formats. AGENCY: As authorized by the Secretary of HHS, AHRQ coordinates the development of common definitions and reporting formats (Common Formats or formats) for reporting on health care quality and patient safety. The purpose of this notice is to announce the availability of Common Formats for Surveillance—Hospital (CFS–H) Version 1.0. DATES: Ongoing public input. ADDRESSES: The Common Formats for Surveillance—Hospital Version 1.0 can be accessed electronically at the following website: https:// www.psoppc.org/psoppc_web/ publicpages/surveillance commonformats. FOR FURTHER INFORMATION CONTACT: Dr. Hamid Jalal, Center for Quality Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, Rockville, MD 20857; 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: SUMMARY: Background on Common Formats Development The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to 299b-26, (Patient Safety Act) and 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, provide for the formation of Patient Safety Organizations (PSOs), which collect and analyze confidential and privileged information regarding the quality and safety of health care delivery that meets the definition of PSWP. Aggregation of these data enables PSOs and others to identify and address underlying causal factors of patient safety and quality issues. The Patient Safety Act provides for the development of standardized reporting formats using common language and definitions to ensure that health care quality and patient safety E:\FR\FM\12AUN1.SGM 12AUN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 89, No. 155 / Monday, August 12, 2024 / Notices data collected by PSOs and other entities are comparable. The Common Formats facilitate aggregation of comparable data at local, PSO, regional and national levels. Since February 2005, AHRQ has convened the Federal Patient Safety Work Group (PSWG) to assist AHRQ in developing and maintaining the Common Formats. The PSWG includes major health agencies within HHS as well as the Departments of Defense and Veterans Affairs. The PSWG helps assure the consistency of definitions/ formats with those of relevant government agencies. In addition, AHRQ solicits comments from the private and public sectors regarding proposed versions of the Common Formats through the Patient Safety Organization Privacy Protection Center (PSOPPC). After receiving comments, the PSOPPC solicits review of the formats by its Common Formats Expert Panel. Subsequently, PSOPPC will provide this input to AHRQ who then uses it to refine the Common Formats. At AHRQ, the Common Formats for Surveillance—Hospitals (CFS–H) are applied in the Quality and Safety Review System (QSRS), a surveillance system designed to detect and calculate patient safety event rates through retrospective in-patient record review. QSRS uses the CFS–H Event Descriptions to create standardized specifications to ensure adverse events are reliability identified across all hospitals and records. For the Common Formats, it should be noted that AHRQ uses the term ‘‘surveillance’’ in this context to refer to the improved detection of events and calculation of adverse event rates in populations reviewed that will allow for collection of comparable performance data over time and across populations of patients. These formats are designed to provide, through retrospective review of medical records, information that is complementary to that derived from event reporting systems. The Common Formats for Surveillance—Hospital Version 1.0 are categorized into the following topic areas (modules): • Birth—Maternal • Birth—Neonatal • Blood or Blood Product • Device • Fall • Hospital-Acquired Infection (HAI) • Medication • Other • Pressure Injury • Surgery or Anesthesia • Venous Thromboembolism At this time, AHRQ is releasing the CFS–H Version 1.0 Event Descriptions VerDate Sep<11>2014 17:30 Aug 09, 2024 Jkt 262001 and supporting materials, including an overview and user guide, tabular accounting, and technical release notes. Comments can be provided on the Common Formats for Surveillance— Hospital Version 1.0 using the commenting tool at: https:// www.psoppc.org/psoppc_web/ publicpages/openforcomment. Additional information about the Common Formats can be obtained through AHRQ’s PSO website: https:// pso.ahrq.gov/common-formats. Dated: August 7, 2024. Marquita Cullom, Associate Director. [FR Doc. 2024–17927 Filed 8–9–24; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. AGENCY: ACTION: Notice. 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 a revision of the currently approved information collection project: ‘‘Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats.’’ In accordance with the Paperwork Reduction Act of 1995, AHRQ invites the public to comment on this proposed information collection. SUMMARY: Comments on this notice must be received by October 11, 2024. DATES: Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at REPORTSCLEARANCEOFFICER@ ahrq.hhs.gov. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427–1477, or by email at REPORTSCLEARANCEOFFICER@ ahrq.hhs.gov. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 65629 Proposed Project Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats AHRQ requests that OMB approve a revision to AHRQ’s collection of information for the Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats: OMB Control number 0935–0143, expiration September 30th, 2024. The Patient Safety and Quality Improvement Act of 2005 (the Patient Safety Act), signed into law on July 29, 2005, was enacted in response to growing concern about patient safety in the United States and the Institute of Medicine’s 1999 report, To Err is Human: Building a Safer Health System. The Patient Safety Act signifies the Federal Government’s commitment to fostering a culture of patient safety among health care providers; it offers a mechanism for creating an environment in which the causes of risks and hazards to patient safety can be thoroughly and honestly examined and discussed without fear of penalties and liabilities. It provides for the voluntary formation of Patient Safety Organizations (PSOs) that can collect, aggregate, and analyze confidential information reported voluntarily by health care providers. By analyzing substantial amounts of patient safety event information across multiple institutions, PSOs are able to identify patterns of failures and propose measures to eliminate or reduce risks and hazards. In order to implement the Patient Safety Act, the Department of Health and Human Services (HHS) issued the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule, 42 CFR part 3), which became effective on January 19, 2009. The Patient Safety Rule outlines the requirements that entities must meet to become and remain listed as PSOs, the process by which the Secretary of HHS (Secretary) will accept certifications and list PSOs, and provisions pertaining to the confidentiality and privilege protections for patient safety work product (PSWP). When specific statutory requirements are met, the information collected and the analyses and deliberations regarding the information receive confidentiality and privilege protections under this legislation. The Secretary delegated authority to the Director of the Office for Civil Rights (OCR) to interpret and enforce the confidentiality protections of the Patient Safety Act (Federal E:\FR\FM\12AUN1.SGM 12AUN1

Agencies

[Federal Register Volume 89, Number 155 (Monday, August 12, 2024)]
[Notices]
[Pages 65628-65629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17927]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Common Formats for Patient Safety Data Collection

AGENCY: Agency for Healthcare Research and Quality (AHRQ), Department 
of Health and Human Services (HHS).

ACTION: Notice of availability--new common formats.

-----------------------------------------------------------------------

SUMMARY: As authorized by the Secretary of HHS, AHRQ coordinates the 
development of common definitions and reporting formats (Common Formats 
or formats) for reporting on health care quality and patient safety. 
The purpose of this notice is to announce the availability of Common 
Formats for Surveillance--Hospital (CFS-H) Version 1.0.

DATES: Ongoing public input.

ADDRESSES: The Common Formats for Surveillance--Hospital Version 1.0 
can be accessed electronically at the following website: https://www.psoppc.org/psoppc_web/publicpages/surveillancecommonformats.

FOR FURTHER INFORMATION CONTACT: Dr. Hamid Jalal, Center for Quality 
Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, Rockville, MD 
20857; Telephone (toll free): (866) 403-3697; Telephone (local): (301) 
427-1111; TTY (toll free): (866) 438-7231; TTY (local): (301) 427-1130; 
Email: [email protected].

SUPPLEMENTARY INFORMATION:

Background on Common Formats Development

    The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 
299b-21 to 299b-26, (Patient Safety Act) and 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, provide for the formation of Patient Safety Organizations 
(PSOs), which collect and analyze confidential and privileged 
information regarding the quality and safety of health care delivery 
that meets the definition of PSWP. Aggregation of these data enables 
PSOs and others to identify and address underlying causal factors of 
patient safety and quality issues.
    The Patient Safety Act provides for the development of standardized 
reporting formats using common language and definitions to ensure that 
health care quality and patient safety

[[Page 65629]]

data collected by PSOs and other entities are comparable. The Common 
Formats facilitate aggregation of comparable data at local, PSO, 
regional and national levels.
    Since February 2005, AHRQ has convened the Federal Patient Safety 
Work Group (PSWG) to assist AHRQ in developing and maintaining the 
Common Formats. The PSWG includes major health agencies within HHS as 
well as the Departments of Defense and Veterans Affairs. The PSWG helps 
assure the consistency of definitions/formats with those of relevant 
government agencies. In addition, AHRQ solicits comments from the 
private and public sectors regarding proposed versions of the Common 
Formats through the Patient Safety Organization Privacy Protection 
Center (PSOPPC). After receiving comments, the PSOPPC solicits review 
of the formats by its Common Formats Expert Panel. Subsequently, PSOPPC 
will provide this input to AHRQ who then uses it to refine the Common 
Formats.
    At AHRQ, the Common Formats for Surveillance--Hospitals (CFS-H) are 
applied in the Quality and Safety Review System (QSRS), a surveillance 
system designed to detect and calculate patient safety event rates 
through retrospective in-patient record review. QSRS uses the CFS-H 
Event Descriptions to create standardized specifications to ensure 
adverse events are reliability identified across all hospitals and 
records. For the Common Formats, it should be noted that AHRQ uses the 
term ``surveillance'' in this context to refer to the improved 
detection of events and calculation of adverse event rates in 
populations reviewed that will allow for collection of comparable 
performance data over time and across populations of patients. These 
formats are designed to provide, through retrospective review of 
medical records, information that is complementary to that derived from 
event reporting systems.
    The Common Formats for Surveillance--Hospital Version 1.0 are 
categorized into the following topic areas (modules):

 Birth--Maternal
 Birth--Neonatal
 Blood or Blood Product
 Device
 Fall
 Hospital-Acquired Infection (HAI)
 Medication
 Other
 Pressure Injury
 Surgery or Anesthesia
 Venous Thromboembolism

    At this time, AHRQ is releasing the CFS-H Version 1.0 Event 
Descriptions and supporting materials, including an overview and user 
guide, tabular accounting, and technical release notes.
    Comments can be provided on the Common Formats for Surveillance--
Hospital Version 1.0 using the commenting tool at: https://www.psoppc.org/psoppc_web/publicpages/openforcomment.
    Additional information about the Common Formats can be obtained 
through AHRQ's PSO website: https://pso.ahrq.gov/common-formats.

    Dated: August 7, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-17927 Filed 8-9-24; 8:45 am]
BILLING CODE 4160-90-P


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