[Federal Register Volume 85, Number 242 (Wednesday, December 16, 2020)]
[Notices]
[Pages 81478-81479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27589]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Notice of Opportunity To Comment on Strategies To Improve Patient 
Safety: Draft Report to Congress for Public Comment and Review by the 
National Academy of Medicine

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

ACTION: Notice of opportunity to comment.

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SUMMARY: As required by the Patient Safety and Quality Improvement Act 
of 2005 (Patient Safety Act), the Secretary of HHS (the Secretary) is 
making this draft report on effective strategies for reducing medical 
errors and increasing patient safety available to the public for review 
and comment. The draft report includes measures determined appropriate 
by the Secretary to encourage the appropriate use of such strategies.

DATES: Send comments on or before February 16, 2021.

ADDRESSES: The draft report, Strategies to Improve Patient Safety: 
Draft Report to Congress for Public Comment and Review by the National 
Academy of Medicine, can be accessed electronically at the following 
HHS website: https://pso.ahrq.gov/legislation/act. Comments on the 
draft report must be submitted by email to [email protected].

FOR FURTHER INFORMATION CONTACT: Paula DiStabile, Patient Safety 
Organization Division, Center for Quality Improvement and Patient 
Safety, AHRQ, 5600 Fishers Lane, Mailstop 06N100B, 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

    The Secretary, in consultation with the Director of AHRQ, has 
prepared a draft report on effective strategies for reducing medical 
errors and increasing patient safety as required by the Patient Safety 
Act. The report includes measures determined appropriate by the 
Secretary to encourage the appropriate use of such strategies, 
including use in any federally funded programs. The draft report is now 
available for public comment and will be (or has been) submitted to the 
National Academy of Medicine for review. The final report is required 
to be submitted to Congress no later than December 21, 2021. The 
specific provision describing these requirements can be found at 42 
U.S.C. 299b-22(j).
    The Patient Safety Act created a framework for the development of a 
voluntary patient safety event reporting system to advance patient 
safety and quality of care across the Nation. Without limiting 
patients' rights to their medical information, the law created Federal 
legal privilege and confidentiality protections for patient safety work 
product; that is, information exchanged between healthcare providers 
and organizations listed by the Secretary that specialize in patient 
safety and quality improvement, called patient safety organizations 
(PSOs). The law charged PSOs with analyzing and using this information 
to provide feedback and assistance to help providers minimize patient 
risk and improve the safety and quality of their care. More information 
about the Patient Safety Act, its implementing regulation, and PSOs can 
be found at https://pso.ahrq.gov/.
    In addition to creating a protected legal environment where 
healthcare providers can share information and learning for improvement 
purposes beyond organizational and State boundaries, Congress also 
envisioned and created the potential for aggregating and analyzing 
patient safety data on a national scale. This part of the Patient 
Safety Act, the network of patient safety databases (NPSD), is a 
mechanism that can leverage data contributed by individual healthcare 
providers and PSOs across the United States into a valuable national 
resource for improving patient safety. Congress required the draft 
report that is the subject of this Notice to be made available for 
public comment and submitted to the Institute of Medicine (now the 
National Academy of Medicine) no later than 18 months after the NPSD 
became operational. The NPSD became operational on June 21, 2019. More 
information about the NPSD can be found at https://www.ahrq.gov/npsd/index.html.

Overview of the Draft Report

    The draft report contains three chapters. It begins with an 
overview of the impetus for and objectives of the Patient Safety Act, 
its key provisions, and some milestones in its implementation. Chapter 
2 reviews some of the principles and concepts underlying effective 
patient safety improvement, provides an overview of research and 
measurement in patient safety, and presents the strategies and 
practices for reducing medical errors and increasing patient safety 
reviewed in AHRQ's Making Healthcare Safer reports, published in 2001, 
2013, and 2020. Together, these reports reviewed the existing evidence 
for the effectiveness of more than 100 patient safety strategies and 
practices used in hospitals, primary care practices, long-term care 
facilities, and other healthcare settings. They include cross-cutting 
strategies and topics such as patient and family engagement and 
teamwork training; safety topics specific to particular clinical 
interventions, such as medications and surgery; a variety of tools and 
processes, such as rapid response teams and antimicrobial stewardship; 
and practices that target prevention of specific harms, such as 
healthcare-associated infections and pressure injuries. Hyperlinks in 
the draft report lead to the full text of the evidence review and to 
later updates regarding the assessment of evidence for the 
effectiveness for each strategy and practice. The final chapter in the 
draft report begins with an overview of learning health systems and 
concepts underlying effective implementation of patient safety 
strategies. It provides examples of resources Federal agencies make 
available to encourage healthcare providers to use effective patient 
safety strategies and describes ``Safer Together: A National Action 
Plan to Advance Patient Safety,'' recently released by the National 
Steering Committee for Patient Safety that was convened by the 
Institute for Healthcare Improvement. The draft report concludes by 
describing an approach that has a track record of success in 
encouraging providers to use effective practices to improve patient 
safety and outlines measures that could accelerate progress in 
improving patient safety and encouraging the use of effective patient 
safety improvement strategies.

Where To View the Draft Report and How To Submit Comments

    The draft report is posted on the AHRQ PSO Program website at 
https://pso.ahrq.gov/legislation/act. The website contains a link to 
the email address for submitting comments on the draft report, which is 
[email protected].


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    Dated: December 10, 2020.
Marquita Cullom,
Associate Director.
[FR Doc. 2020-27589 Filed 12-15-20; 8:45 am]
BILLING CODE 4160-90-P