Get your regulatory kicks in 2026! As this year comes to a close, the consulting team at Courtemanche & Associates developed the list below to help with your patient safety priorities and regulatory survey readiness for 2026.
Staffing will be one of the areas regulatory agencies will look at in 2026. You need to ensure that your organization has a staffing plan, that all staff have training and competencies documented in their education files, that staffing levels are adequate, and that staffing is evaluated. You will need to assess current staffing models. Develop robust, evidence-based staffing plans. Develop and implement reliable measurement tools to accurately evaluate staffing needs. Establish clear accountability structures and ensure leaders have the authority and resources to meet these new requirements.
The informed consent process is frequently cited during surveys for incomplete or missing documentation, failure to obtain or appropriately document informed consent, and non-compliance with the organization’s informed consent policy. Review your current policy and practice to identify gaps. Ask staff and providers for input on roadblocks to compliance. Streamline processes while ensuring alignment with regulations. Ensure that translation services are used when needed and documented as part of the informed consent process. Optimize the use of templates that can be customized to the patient’s needs. Train staff and providers on the process. Routinely audit documentation practice and report to leadership.
We observe organizations where the use of their cleaning and disinfection products is not aligned with acceptable practice or the Instructions for Use for the equipment being cleaned. This includes not using appropriate PPE, using spray when the IFU indicates wipes, and staff still struggling with the concept of dwell/contact time. We also observe unapproved products being used on equipment. Additionally, environmental services staff are often unaware of the products they use for cleaning or the dwell/contact time on surfaces. Round for contraband chemicals brought in by staff, as these may not be approved for use on equipment and may cause damage.
The use of Artificial Intelligence (AI) is exploding in the healthcare industry. This will be a growing focus for regulatory agencies, and most healthcare organizations are ill-prepared, lacking training, management practices, and policies to ensure safe and responsible use. Failure to develop system-wide governance to evaluate, implement, oversee, and monitor new and current AI applications may increase healthcare organizations’ liability risks. Organizations should conduct an inventory of current AI use and determine which policies, practices, and training should be established to manage this growing industry and protect patient privacy and data security. See The Joint Commission and Coalition for Health AI’s guidance “Responsible Use of AI in Healthcare” for recommended approaches to addressing AI in your organization.
Our teams are starting to observe increasing numbers of expired biomedical check labels on medical equipment. Additionally, we are observing medical equipment that has been placed into use without evidence of safety and functionality checks. These practices can result in unsafe equipment being used in patient care. Ensure that environmental rounding includes biomedical checks for equipment. Have a process in place to identify missing equipment during annual checks so managers can locate it. Ensure that new equipment is routed through a safety/functionality check process before use.
Our team continues to see issues with sterile instrument storage. Organizations should round on areas where sterile instruments are kept (storage room, cabinets, carts, and drawers). Ensure that temperature and humidity measurements are aligned with building code requirements (see ASHRAE), local codes, and your accrediting organization’s regulations (often referencing the CMS Infection Control Worksheet for the Hospital and Ambulatory Surgical Center). Look for stacked heavy instrument trays that may compromise packaging sterility. Look for peel packs that are stuffed in confined spaces that lead to instruments poking through the packaging. Round on your sterile storage area for heavy instrument cases (must not weigh more than 25lbs).
There are increasing observations of staff attire in surgical and procedural areas that are not aligned with organization policy and infection control practices. Long fingernails, artificial nails, loose hair, exposed jewelry/rings/earbuds, etc., can contribute to surgical/procedural site infections and possibly retained foreign objects. Leaders must set expectations for surgical/procedural attire and be consistent with enforcement. They should also set the example and model expected attire practices. Conduct rounds with your team members and empower them to inform other non-compliant staff so they can correct themselves. Ensure that expectations are patient safety-centered.
The American Heart Association (AHA) has updated its resuscitation protocols and algorithms for neonate, pediatric, and adult patients. Organizations should ensure that all crash carts, emergency carts, and other locations with existing protocols are updated. Information on the updated algorithms can be found on the American Heart Association.
Although counterfeit medications are often associated with illicit drug use, these medications represent an emerging threat to all, from young people seeking help with attention-deficit/ hyperactivity disorder to elderly patients looking for the lowest price for their prescriptions. Although regulatory practices protect inpatient medications from this issue, the risk is growing as more patients obtain medications online to save on pharmaceutical costs. Pharmacy and medical staff leaders should foster situational awareness to help identify patients who may present with adverse reactions to counterfeit medications. Leaders should engage clinical staff in monitoring patients for unexpected outcomes and consider whether counterfeit medications could be the cause. Provide patients with resources to help them procure affordable medications. Share warning signs with patients that an online pharmacy could be selling counterfeit medications. Educate patients about how to validate legitimate online pharmacies. Inform patients on how to review medication packages and labeling for spelling errors and other signs of counterfeit products. Educate patients on how to scrutinize medications and how to address concerns.
Each year in the United States, approximately 12 million adults experience diagnostic errors—about half of which may cause serious patient harm, and an estimated 795,000 Americans die or are permanently disabled due to misdiagnosis of dangerous diseases, predominantly those associated with cancer, vascular events, and infection. As these errors continue to pose a growing threat, expect accrediting organizations to address them during surveys. Healthcare organizations and clinicians should focus their resources and interventions on improving the specific process and system vulnerabilities that contribute to these diagnostic errors. Organizations should assemble a multidisciplinary team to promote diagnostic safety and quality. Enhance Providers’ access to diagnostic testing and specialist services. Ensure that providers adhere to current cancer screening and diagnostic guidelines. Review diagnostic uncertainty or discrepancies at all handoffs and transitions in care, especially for complex cases.
The Centers for Medicare & Medicaid Services (CMS) released revisions to Appendix A of the SOM in September, including new interpretive guidelines and survey processes. Organizations should review these changes, especially in light of the new interpretive guidelines, which can provide details on achieving compliance with regulations. The update also incorporates guidance from QSO memos S&C-16-29, 19-13 (revised), QSO-20-04, 22-20, 23-09, and QSO-23-19 into the SOM. These previously published memos include life safety code updates, co-location, electronic reporting for deaths in restraint and seclusion, infection prevention and control, Quality Assessment and Performance Improvement (QAPI), and ligature risk and assessments. See QSO-25-24-Hospitals for details
Our teams often find that clinical protocols referenced in orders (such as ventilator weaning, oxygen titration, medication titration, and various treatments) are missing from the patient’s medical record. This includes protocols for blood transfusion, dialysis, and medication administration. Additionally, protocols are found with documented review dates years in the past. Protocols must be kept up to date, with evidence of periodic review, consistent with nationally recognized, evidence-based guidelines, and be dated/timed/authenticated promptly in the patient’s medical record. Organizations should inventory their protocols, ensure they are updated, and review whether they are executed in accordance with policy and regulation.
For questions or to learn more, contact the C&A team at 704-573-4535 or email us at info@courtemanche-assocs.com.
