OSHA, FDA and Joint Commission top regulatory issues

OSHA/NIOSH releases respiratory program toolkit

Safety // The Occupational Safety and Health Administration (OSHA) and National Institute for Occupational Safety and Health recently released a toolkit to help hospitals protect staff from respiratory hazards. OSHA’s Respiratory Protection Standard requires that health care employers establish and maintain a respiratory protection program in workplaces where workers may be exposed to respiratory hazards. The toolkit covers respirator use, hazard assessment and the development of a hospital respiratory protection program, among other information.

FDA issues proposed rule for health care antiseptics

Infection prevention // The Food and Drug Administration issued a proposed rule that would require manufacturers to provide additional scientific data to support the safety and effectiveness of certain active ingredients in over-the-counter health care antiseptic products. These include hand washes and rubs for health care personnel, surgical hand scrubs and rubs, and patient preoperative skin preparations. The proposal “does not mean that we believe that health care antiseptic products containing these ingredients are ineffective or unsafe, or that their use should be discontinued,” the rule states. Consumer antiseptics such as antibacterial soaps and hand sanitizer rubs are not part of the proposed rule.

Facilities alerted to infusion pump vulnerability

Biomedical // The Food and Drug Administration (FDA) recently issued recommendations for health care facilities to reduce the risk of security vulnerabilities identified in two computerized infusion pumps made by Hospira. The Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems are computerized infusion pumps designed for the continuous delivery of anesthetic or therapeutic drugs. The systems can be programmed remotely through a health care facility’s Ethernet or wireless network. The FDA states it is not aware of any adverse events or unauthorized device access related to the vulnerabilities.

Joint Commission releases sentinel event statistics

Safety // The Joint Commission recently updated its sentinel event statistics for 2014 and published them in its Joint Commission Online newsletter. The Joint Commission reviewed a total of 764 sentinel events during 2014. While the majority of the events were clinical in nature, some, such as falls, suicides and criminal events, had facilities-related components. The Joint Commission office of quality and patient safety collaborates with organizations to identify a sentinel event’s root causes and create an action plan to reduce the risk that similar events might occur in the future.

Report details regulatory challenges for telehealth

Technology // A new American Hospital Association TrendWatch report highlights the challenges to realizing the promise of telehealth. “Telehealth is changing the way health care is provided — both expanding patient access to routine and specialty care while improving patient satisfaction and outcomes,” the report notes. But as use expands, “myriad significant federal and state legal and regulatory issues will determine whether and how hospitals, health systems and other providers can offer specific telehealth services,” the report adds. It describes challenges ranging from coverage and payment issues to a lack of portability of health professional licenses and a patchwork of inconsistent state laws with respect to online prescribing.