The PSNet Collection

Examining the Status of VA’s Electronic Health Record Modernization Program.

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US Senate Committee on Veterans Affairs. 117th Cong (2021-2022). (July 20, 2022).

Large-scale electronic health record (EHR) implementation projects encompass a myriad of problems to navigate to arrive at success. This Congressional panel explores challenges experienced during EHR implementation in the VA Health system. Panelists from the Veterans Administration, the investigator and the technology vendor involved in the program shared insights and next steps to direct improvement.

Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors: Guidance for Industry.

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Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; May 18, 2022.

This guidance outlines design elements that reduce errors associated with medication labels. Improvements suggested include tall-man lettering use, look-alike / sound alike avoidance and abbreviation minimization.

COVID-19 Focused Inspection Initiative in Healthcare.

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Occupational Safety and Health Administration. March 2, 2022.

The impact of nursing home inspections to ensure the quality and safety of the service environment is lacking. Weaknesses in the process became more explicit as poor long-term care infection control was determined to be a contributor to the early spread of COVID amongst nursing home residents. This announcement outlines a targeted inspection initiative to assess whether organizations previously sited have made progress toward improving workforce safety.

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Medication/Drug Errors

Lessons Learned? Building a Culture of Patient Safety Within the Veterans Health Administration.

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US House of Representatives Committee on Veterans' Affairs Subcommittee on Health. 117th Cong. 1^st Sess (2021).

The Veterans Health Administration is a large complex system that faces various challenges to safe care provision. At this hearing, government administrators testified on current gaps that detract from safe care in the Veteran’s health system. The experts discussed several high-profile misconduct and systemic failure incidents, suggested that the culture and leadership within the system overall enables latency of issues, and outlined actions being taken to address weaknesses.

National Patient Safety Goals.

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The Joint Commission.

The National Patient Safety Goals (NPSGs) are one of the major methods by which The Joint Commission establishes standards for ensuring patient safety in all health care settings. In order to ensure health care facilities focus on preventing major sources of patient harm, The Joint Commission regularly revises the NPSGs based on their impact, cost, and effectiveness. Major focus areas include promoting surgical safety and preventing hospital-acquired infections, medication errors, inpatient suicide, and specific clinical harms such as falls and pressure ulcers.

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Maternal Safety

Medical malpractice claims by members of the uniformed services.

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Department of Defense Office of General Counsel. 32 CFR Part 45. Fed Register. 86(115); June 17, 2021:32194-32215.

Organizations with safety cultures facilitate the ability for an injured patient to seek an effective response to untoward incidents. This United States rule outlines the standards that enable members of the armed forces to file claims should they be harmed while in the military health care system.

Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products.

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Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; December 7, 2020.

Nonprescription drugs are commonly associated with medication errors. This draft guidance seeks to provide a structure for industry to reduce instances of drug name confusion in nonprescription formulas of prescription medications. It describes the US Food and Drug Administration (FDA) vetting process for drug names to improve naming actions prior to submission to the agency. The timeline for submitting comments is early February 2021.

Best Practices in Developing Proprietary Names for Human Prescription Drug Products Guidance for Industry.

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Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; December 2020.

Look-alike and sound-alike names weaken the safety of medication use. This guidance provides a structure for industry to reduce instances of drug name similarities and describes the US Food and Drug Administration (FDA) vetting process for drug names to improve naming actions prior to submission to the agency.

Improving Diagnosis in Medicine Act of 2020.

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116^th Congress 2d session. December 10, 2020.

The strengthening of diagnostic error research and processes can strategically ensure lasting diagnostic improvement. The ‘‘Improving Diagnosis in Medicine Act of 2020’’ outlines characteristics of a proposed Federal program to enhance agency cooperation and coordination to improve diagnosis in health care by addressing systemic weaknesses, knowledge gaps, and training issues in the workforce.

Patient Safety Improvement Act of 2020.

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SB 3380. 116th Congress (2020).

This bill submits amendments to existing US federal law to strengthen state-organized efforts to improve health care-associated infection control efforts, pediatric safety initiatives, care transitions, reporting systems and antimicrobial stewardship programs.

The NHS Patient Safety Strategy.

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NHS Improvement.

The United Kingdom National Health Service (NHS) has been at the forefront of patient safety innovation. This strategy seeks to further implement approaches that explore and optimize the intersection of systems and human behaviors to support safe care at the NHS. The framework builds upon the perspectives of patients, staff, and organizations to achieve whole system improvement and sustain those changes through effective intervention and program design.

Communication and Resolution After an Adverse Health Care Incident.

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Pettersen B, Tate J, Tipper K, McKean H. Colorado Senate Bill 19-201.

Communication-and-resolution mechanisms are seen as important approaches to improving transparency and healing after an adverse event. This state bill, referred to as the "Colorado Candor Act," protects conversations between organizations, clinicians, patient, and families from legal discoverability and outlines criteria to guarantee that protection.

ONC Health IT Certification Program: Enhanced Oversight and Accountability.

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Office of the National Coordinator for Health Information Technology; ONC; Health and Human Services; HHS.

Requirements are needed to manage risks associated with health information technology systems. This final rule provides a framework for government review of technologies certified by the ONC Health IT Certification Program. The rule also covers certification guidance for testing laboratories. The regulations were put into effect December 19, 2016.

Summary of Proposed Changes to ACGME Common Program Requirements Section VI.

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Accreditation Council for Graduate Medical Education; ACGME.

Implementation of resident duty hours, meant to address fatigue in health care, has long been a subject of patient safety discussions. This website provides a summary of proposed changes to the current ACGME residency Common Program Requirements that shape working hours, offers rationale for the revisions.

Medical gas containers and closures; current good manufacturing practice requirements.

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Fed Regist. 2016 Nov 18;81(223):81685-81697.

This U.S. Food and Drug Administration (FDA) guideline supports good manufacturing practices by suggesting several strategies for minimizing medical gas-related patient safety incidents.

Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care; Proposed Rule.

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Centers for Medicare & Medicaid Services; CMS.

This proposed rule suggests updates to the government requirements hospitals must comply with to participate in Medicare and Medicaid. Changes include emphasis on the role of leadership engagement and safety culture as ways to generate improvements in areas such as reducing hospital-acquired infections and readmissions. Comments on the proposed rule are due August 15, 2016.

Patient Safety and Quality Improvement Act of 2005--HHS guidance regarding patient safety work product and providers' external obligations.

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Agency for Healthcare Research and Quality. Fed Regist. 2016;81(100);32655-32660.

Patient Safety Organizations (PSOs) were formed with provisions to protect voluntarily submitted incident data to enhance transparency and learning from medical error. Despite those expectations, PSOs still have obligations to report certain situations to external organizations. This guidance aims to clarify what and when external reporting should take place for PSOs to remain in compliance with federal requirements while appropriately protecting incident data.

National Safety Standards for Invasive Procedures (NatSSIPs).

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NHS England Patient Safety Domain, National Safety Standards for Invasive Procedures Group. London, UK: National Health Service; 2015.

Patients face risks when undergoing invasive procedures. This report provides recommendations developed by multidisciplinary consensus and outlines how organizations can implement the standards to improve safety of invasive procedures.

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