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FDA bans 24 ingredients in healthcare antiseptics

The FDA has banned two dozen active ingredients used in healthcare products because they weren’t generally recognized as safe and effective for use in over-the-counter (OTC) products. The ban is specifically aimed at OTC products used primarily in medical settings like hospitals, clinics, and doctors’ offices. The ingredients had been used in antiseptic hand washes and rubs, surgical hand scrubs, and patient antiseptic skin preps.

“Ensuring the safety and effectiveness of over-the-counter health care antiseptics has been a priority for the FDA, not only because these products are an important component of infection control strategies in health care settings, but also because of the role these products may play in contributing to antimicrobial resistance if they’re not manufactured or used appropriately,” said FDA Commissioner Scott Gottlieb, MD. “Health care providers are on the front lines of care. They need and deserve to have safe and effective means for preventing the spread of infection.”

With the exception of triclosan, none of the ingredients are currently being used in any marketed health care antiseptic products. And at industry urging, the FDA is deferring their final rulemaking for a year for six ingredients to give manufacturers more time to complete the scientific studies on their safety: alcohol (ethanol), isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX).

 

2018 version of “Patient Safety Systems” Chapter available

The Joint Commission has released the most recent versions of it’s PS Chapter for hospitals, nursing care centers, critical access hospitals, behavioral healthcare centers, laboratories, and more.

Main manual for CMS’ hospital Interpretive Guidelines updated

For the first time in two years, the online version of CMS’ State Operations Manual, Appendix A — also known as SOMA by some — is showing it has been revised!

The date on the appendix, which offers CMS surveyors Interpretive Guidelines to follow when implementing the hospital Conditions of Participation (CoP), is now Nov. 17, 2017. The last revision had been in November 2015.

The most recent update appears to mainly reflect changes to how CMS defines a hospital for survey. Those changes were announced in S&C memo 17-44-ALL-Hospitals.

And more changes should be on the way, especially in light of the recent publication of a new S&C memo on ligature risk. Among other things, S&C 18-06-Hospitals memo notes changes under Tag A-0701 that appear to delete references to emergency preparedness — now under their own set of CoP outlined in Appendix Z— and adds guidelines for checking out other physical safety concerns along with ligature risk within the environment of care.

Study: Concurrent surgeries are safe

A review of more than 2,000 neurosurgical cases published in the Journal of the American Medical Association, found no greater risk of postoperative complications for patients operated on by surgeons conducting overlapping surgeries. This casts a new light on the controversial practice, which is routine at many facilities nationwide.

The study, published earlier this month, examined patients who underwent neurosurgical procedures at Emory University Hospital in Atlanta from 2014 to 2015. Of the 2,275 cases reviewed, about 43% had the surgeon remain with the patient through the entire procedure. In the other 57% of cases, the primary surgeon performed two procedures in different operating rooms.

In the 90 days following their operations, no difference was found in morbidity, mortality, or worsened outcome measures between the two groups of patients. The researchers concluded that this data suggests overlapping neurosurgeries are safe and may benefit patients by allowing sought-after specialists to see more patients.

That said, researchers did note that overlapping surgeries were notably longer than when one surgery was done at a time. And guidelines from the American College of Surgeons require that patients be informed that they’ll be undergoing a concurrent surgery.

“Surgeons must use their experience, keen intuition and respect for their own ability and limitations to carefully select patients” for overlapping surgery, the authors wrote.

Workplace violence prevention resources

More than 70% of significant WPV injuries occur in healthcare and social service settings. That number has been on the rise, and the victims are primarily healthcare workers. Here are some other free resources and training on workplace violence prevention in your healthcare organization:

1.    The Center for Health Design’s Safety Risk Assessment Toolkit
2.    The CDC’s Workplace Violence Prevention for Nurses  
3.    OSHA’s Guidelines for Preventing Workplace Violence in Healthcare and Social Services    
4.    OSHA’s Preventing Workplace Violence: A Road Map for Healthcare Facilities
5.   The Emergency Nurses Association’s Workplace Violence Page
6.    ASIS International’s Managing Disruptive Behavior and Workplace Violence in Healthcare

Know the medical gas cylinder storage requirements

Editor’s note: This update was provided by Brad Keyes, CHSP, owner and senior consultant for Keyes Life Safety Compliance, LLC, and a consulting editor for Healthcare Life Safety Compliance.

 The following medical gas cylinder storage requirements are relative to the National Fire Protection Association (NFPA) Standards 99 Health Care Facilities (2005 edition) and are updated for 2017. In January 2007, CMS issued Survey and Certification memo 07-10, which clarified how oxygen cylinders should be stored, based on the 2005 edition of NFPA 99. The Joint Commission and the other accreditation organizations (AO) have adopted these clarifications and established clear requirements concerning medical gas cylinder storage. These AOs will assess your facility for compliance based on the following standards.

Medical gas cylinder storage

  • An aggregate total of compressed medical gases (e.g., oxygen, nitrogen, nitrous oxide) up to 300 cubic feet may be stored per smoke compartment in any room or alcove without special requirements for that room. Compressed gas cylinders must be secured in racks or by chains.
  • Quantities of compressed medical gases of more than 300 cubic feet but less than 3,000 cubic feet must be stored in specially designated rooms that meet the following requirements:
    • Rooms must be of noncombustible or limited-combustible construction (gypsum wallboard, tiled walls, etc.) with a door that can be secured from unauthorized entry (e.g., locked).
    • Oxygen may not be stored with other flammable gases or liquids.
    • Oxygen cylinders must maintain a minimum distance of 20 feet from combustibles (5 feet if room is sprinklered) or be placed within an enclosed cabinet having a fire rating of at least a half hour.
    • Cylinders must be secured in racks or by chains.
  • Quantities of compressed medical gases more than 3,000 cubic feet must be stored in specially designated rooms that meet the following requirements:
    • The room must have sufficient room to maneuver cylinders.
    • The room is able to be secured with lockable doors.
    • The room is constructed with noncombustible or limited-combustible construction, with a minimum fire rating of one hour (no allowances for fully sprinklered rooms). The entrance door to this room must also be fire rated for one hour, and not ¾ hour as allowed for other one-hour rated barriers.
    • The room is compliant with NFPA 70 National Electric Code, with electrical devices located at or above 5 feet from the finished floor.
    • The room is heated by indirect means, if heat is required. “Indirect” means gas-fired unit heaters and electric unit heaters are not permitted. Steam or hot water heating systems are permitted.
    • The room contains adequate racks constructed of noncombustible or limited-combustible materials and chains to secure all cylinders, full or empty.
    • The room contains a dedicated, continuously operating mechanical ventilation system that draws air from within 12 inches of the floor, with a means of make-up air provided.
    • In lieu of a mechanical ventilation system, and where natural ventilation is permitted, the room includes a natural ventilation system consisting of two louvered openings, each having a minimum free area of 72 square inches with one opening located 12 inches from the floor and the other located 12 inches from the ceiling. NOTE: Louvered natural ventilation openings are not permitted in an exit access corridor.

Definitions

  • One E-size cylinder = 24.96 ft.³
  • Twelve E-size cylinders = 299.52 ft.³
  • Therefore, up to 12 E-size cylinders may be stored in any smoke compartment without special requirements for the room.
  • One H-size cylinder = 250 ft.³
  • Therefore, one H-size and two E-size cylinders may be stored in any smoke compartment without special requirements for the room.
  • Cylinders on gurneys, crash carts, wheelchairs, etc., are considered “in use” and not subject to the total count for “in storage.”
  • Cylinders in a rack are “in storage.”
  • Empty cylinders are not considered part of “in use” or “in storage.”
  • A cylinder is considered “full” provided it still has its seal from the supplier. Once the seal has been removed, the cylinder is no longer considered full and cannot be stored with full cylinders.
  • NFPA 99 requires empty cylinders to be stored separately from full cylinders. This means partially full cylinders must be stored with the empty cylinders or stored separately from full or empty cylinders.
  • For the purpose of calculation of aggregate quantities of stored medical gas cylinders, empty cylinders must be considered as full cylinders since residual gas will remain in the cylinders.

Door alarms limit OR foot traffic and infection risks

A new study published in Orthopedics has found the best way to cut the number of unnecessary foot traffic in the operating room (OR) is by installing a door alarm. About a third of door openings during surgery are for unessential reasons, like future planning and social visits.

The opening and closing of doors during surgery increases the risk of infection to the patient, particularly in rooms where air pressure is controlled to prevent the airborne bacteria from infecting immune-compromised patients. One study has found that any increase in the number of door openings during surgery increases the risk of infection by 70%.

During the study, opening the OR door would trigger a double chime that would repeat every three seconds until the door was shut again. Using this method, they were able to reduce the average “open door” time from 14 minutes to 10. Other methods aren’t nearly as effective, according to the study’s authors. Rules restricting OR access are often ignored, and locking the door can impede patient care.

That said, the researchers noted that once alarm fatigue sets in, the door alarms would lose their effectiveness.

“Despite the limited long-term effect of this alarm, it should bring further attention to excessive operating room traffic,” they write. “Continuing education and awareness may be necessary to maintain the results found in this study.”

CMS Emergency Prep rule is now enforceable by surveyors

It’s finally here.

CMS’ new Emergency Preparedness rule went into effect on Wednesday, November 15, which means surveyors can now cite facilities who aren’t compliant with the rule’s requirements.

The rule closes gaps in CMS’ previous regulations, such as requiring facilities to have contingency planning in place, emergency response training for staff, and communicate and coordinate their emergency plans with other hospitals and government agencies at the tribal, local, regional, state, and federal levels. Facilities have had over two years to prepare for this rule, and the agency has already said it won’t be accepting excuses for noncompliance.

While the rule itself is new, Steve MacArthur, a safety consultant at The Greeley Company in Danvers, Massachusetts, says that a lot of the new requirements are things that hospitals should have already been doing.

“I suppose I should stop and say that while this rule is new to the ‘marketplace,’ there are really no new concepts contained therein,” he says. “This may provide some guidance for CMS surveyors as they drill down on organizational preparedness activities. But none of this is groundbreaking or in any way representative of a change in how hospitals have done, and will continue to do, business. [It’s] just another set of official ‘eyes’ looking through the compliance microscope.”

Resources

BOAQ

Webinar: Suicide Prevention in Hospitals: Reduce Risk and Comply With Joint Commission Requirements

Presented on: Tuesday, November 21, 2017, 1:00-2:30 p.m. EST
Speaker: Ernest E. Allen, ARM, CSP, CPHRM, CHFM
Program Level: Intermediate 
Registration: http://hcmarketplace.com/suicide-prevention-in-hospitals

Summary:  Hospitals are continually working to reduce the risk of patient suicide in their facilities, but the problem persists. The Joint Commission has placed particular emphasis on reducing suicide risk, including a National Patient Safety Goal and a recent Sentinel Event Alert.

In this webinar, former Joint Commission surveyor Ernest E. Allen, ARM, CSP, CPHRM, CHFM, will explain how hospitals can identify and reduce suicide risks and improve compliance with Joint Commission requirements.

At the conclusion of this program, participants will be able to:

  • Identify suicide risks in hospitals
  • Be able to reference applicable Joint Commission standards and Sentinel Event Alerts
  •  Learn prevention methods to help lower suicide risk

USP deadline on hazardous drug handling postponed until 2019

The U.S. Pharmacopeial Convention (USP) has announced it intends to push back the compliance deadline for USP Chapter <800> “Hazardous Drugs; Handling in Healthcare Settings” from July 1, 2018, to December 1, 2019.

USP <800> applies from the moment a hazardous drug is received at the loading dock all the way through to the medicine’s disposal. Its standards apply to anyone who comes into contact with hazardous drugs: nurses, physicians, pharmacists, pharmacy technicians, loading dock personnel, etc.

“USP encourages early adoption and implementation of General Chapter <800> to help ensure a safe environment and protection of healthcare practitioners and others when handling hazardous drugs. We will continue to support our stake-holders through education and outreach,” the organization wrote in a press release.