Legal/Regulatory Issues

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October 2025
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Navigating challenges of connecting recalls to patients, inventory

Healthcare facilities face challenges in the recall process of tissue, non-biologic implants, and medical devices because of their time-sensitive nature and inherent risks to patient safety and compliance. Hospitals often use secondary sources for recall notifications. These lists, however, do not include two critical pieces—the identification of affected patient cases…

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By: Tracey Berkowitz
July 20, 2023
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Keeping it sterile: Fundamentals of sterile storage

Using sterile items in surgery is a fundamental practice, not a rudimentary one that can or should be taken for granted. Put simply, using unsterile items can result in a patient infection. If sterile storage conditions are not appropriate, the items can become contaminated. Such contamination may go undetected, rendering…

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By: Susan Klacik, BS, FCS, ACE, CHL, CIS, CRCST, AAMIF
July 20, 2023
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ASC joint ventures: 'To be, or not to be'

With healthcare costs continuing to rise, hospitals, payers, and patients are looking for different venues for care and ways to cut costs while maintaining quality and safety. As more surgical procedures are safely performed in outpatient settings, more ambulatory surgery centers (ASCs) are being built or restructured. Partnerships between hospitals…

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By: Uyen Vo, BSN, MBA
June 21, 2023
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AAMI releases updated protective barriers standard

The Association for the Advancement of Medical Instrumentation (AAMI) has revised the ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. This revised standard provides healthcare professionals with a better understanding of the barrier protection properties of available protective apparel. The…

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By: Susan Klacik, BS, FCS, ACE, CHL, CIS, CRCST, AAMIF
May 23, 2023
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Training and retaining skilled PACU nurses

When Ayumi Fielden, MSN, RN, CCRN-K, CPAN, worked as a preceptor in a PACU nurse residency program for new graduate nurses, she realized quickly that something was missing. “The graduate nurses struggled because they were not yet comfortable with basic nursing skills, such as assessments and giving medications. They also…

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By: Catherine Spader, RN
February 22, 2023
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Prepare for DEA inspections, controlled substances oversight

The headlines are attention grabbing: hospitals forced to pay millions of dollars after employees were found to have stolen opioids and other controlled substances. After being discovered and investigated by the Drug Enforcement Agency (DEA), the agents uncovered a number of issues: poor record-keeping, inventory, tracking, and other failures that…

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By: Brita Belli
February 22, 2023
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Making real change: How nurse leaders can collaborate with legislators

Nurses and legislation

Takeaways • OR nurse leaders are becoming a force in healthcare legislation. • Legislators value nursing expertise and want to collaborate with nurses on healthcare legislation. • It is easier than expected to get involved with legislation to improve patient safety, support staff, and optimize the workplace. Tracy Hoeft-Hoffman, MSN,…

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By: Catherine Spader, RN
January 19, 2023
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Strategies for preparing and surviving a CMS survey

The Centers for Medicare and Medicaid Services (CMS) develops conditions of participation (CoPs) and Conditions for Coverage (CfCs) that healthcare organizations must meet in order to participate in Medicare and Medicaid programs. Payers, including government payers, require facility certification or accreditation for reimbursement. “Reimbursement is the critical piece,” says Becky…

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By: Judith M. Mathias, MA, BS, RN
January 19, 2023
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Accreditation updates from The Joint Commission, CMS

Takeaways Many OR managers said they were overdue for a survey by The Joint Commission because of the pandemic. The Joint Commission is said to be 3,000 surveys behind. More checklists are being used by surveyors, which are available in The Joint Commission’s Perspectives and EC News newsletters. New in…

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By: Judith M. Mathias, MA, BS, RN
December 15, 2022
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Legal ABCs of drafting contracts with anesthesia

Navigating contracts with anesthesia when anesthesiology services are suffering from workforce shortages and high costs is often tricky and complex. The biggest mistake ambulatory surgery centers (ASCs) make is that they do not know what they want when entering a contract negotiation with an anesthesia provider. As a result, ASCs…

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By: Jennifer Lubell
December 15, 2022
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