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Brian Ward

Brian Ward is an Associate Editor at HCPro working on accreditation news.

Featured Webcast- “CMS Surveys: Preparing With Confidence”

When: 1:00–2:30 p.m. EST, Wednesday, February 24, 2016

What: CMS has increased the frequency of its hospital surveys, and many healthcare facilities are finding themselves unprepared for the bump in federal scrutiny. This webcast will arm attendees with the preparatory steps and strategies needed to survive a CMS survey.  Attendees will also examine a real-life case study for specific examples of survey citations and how to respond to them. 

Why: This webinar will teach you how to:

  • Utilize a compliance plan to develop an organization-specific, comprehensive approach to accreditation and compliance readiness
  • Identify at least three sources of information to review changes in the Conditions of Participation/survey process
  • Implement a gap analysis of your organization’s compliance readiness

Who: Victoria Fennel, PhD, RN-BC, CPHQ, is the director of accreditation and clinical compliance for Compass Clinical Consulting and has 20 years of healthcare leadership experience. She has spent the majority of her career in nursing leadership roles and brings expertise in evidence-based practice, nursing education, quality management, performance improvement, accreditation, risk management, patient safety, and patient-centered care.

Julie Campbell, MHA, BSN, NE-BC, HACP, is the Baylor Scott & White Health North Texas Division vice president and has than 25 years of nursing leadership experience. Campbell assists in survey preparation, development of corporate policies and procedures, communications on revisions to regulations/standards, and recommendations of regulatory changes to various system councils to maintain continuous readiness. 

For more details on how to join the webcast, please visit our website.  



All Olympus duodenoscopes recalled, replaced with approved FDA model

Olympus Corp., the biggest seller of duodenoscopes in the nation, announced a recall of all its scopes on January 15. The recall was issued a day after a Senate committee report linked Olympus products to 142 antibiotic-resistant infection (ARI) cases.

Duodenoscopes are flexible cameras that are inserted into a patient’s mouth or digestive tract to diagnose cancers, and are used in over 500,000 procedures a year. Recent investigations found that a flaw in the scope’s design made it near impossible to fully disinfect, exposing patients to ARIs and resulting in 25 outbreaks in three years and four countries.

Olympus is the largest of the three companies listed in the Senate Committee on Health, Education, Labor, and Pensions report, controlling 85% of the American duodenoscope market. Olympus voluntarily issued the recall after the Food and Drug Administration (FDA) cleared the company’s new safety modifications to its TJF-Q180V model duodenoscope. 

“We have made it a top priority to improve the safety of duodenoscopes and help protect patients from bacterial infections associated with these medical devices,” said William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, in a press release. “The Olympus TJF-Q180V’s new design, as well as the new annual inspection program, is intended to reduce the risk of fluid leakage into the elevator channel, which in turn can reduce patient exposure to bacteria and other potential infections.”

Olympus says it will call every facility using the scopes and provide them with a free replacement for their recalled devices. There are around 4,400 TJF-Q180V models currently in use in America and Olympus hopes to have them all replaced or modified by August 2016. In the short term, healthcare facilities may continue to use unmodified TJF-Q180Vs, but are urged to meticulously follow the manufacturer’s reprocessing instructions.


Senate panel: 250 confirmed antibiotic-resistant infections now linked to duodenoscopes

In December, the FDA linked 45 antibiotic-resistant infections (ARI) cases to Olympus brand duodenoscopes since 2012, with the infections causing 24 illnesses and 21 deaths.

Now, a new Senate committee report has tripled the number of confirmed Olympus duodenoscopes infections to 142. Industrywide, there have been 250 patients since 2012 who’ve contracted ARIs from duodenoscopes made by various companies. Dirty scopes have been responsible for 25 patient outbreaks in 10 states and four countries. Several of the outbreaks involved Carbapenem-resistant Enterobacteriaceae infections, which can kill up to 50% of those it infects and can sometimes share its drug resistance with other bacteria. 

The three companies singled out in the report were Pentax Medical, Fujifilm Medical Systems, and Olympus Corp. The Senate Health, Education, Labor, and Pensions Committee also placed blame on the FDA, saying the agency’s safety reporting system was too slow and cumbersome.

You can read the full report here. 


Joint Commission and CDC team up on ambulatory infection prevention project

In November, The Joint Commission and the Centers for Disease Control and Prevention (CDC) joined forces to create model infection control plans for outpatient settings. The initiative seeks to enhance the CDC’s existing guidance on infection control and prevention in ambulatory care centers.

For the initiative, The Joint Commission will be working with 12 outpatient-focused professional organizations and 10 ambulatory healthcare systems. The Joint Commission and CDC also will engage with local chapters of the professional organizations and state health departments that have an interest in enhancing infection prevention and control in their areas.

The goal of this effort, which is supported through a CDC Safety and Healthcare Epidemiology Prevention Research Development contract, is to create model infection control plans and expand the dissemination and adoption of these and other materials to prevent infections in outpatient settings.
The project will focus on a variety of free-standing ambulatory settings and services. The Joint Commission and CDC will select and work with 12 outpatient-focused professional organizations (e.g., medical specialties that primarily serve ambulatory patient populations), and 10 ambulatory health care systems. They also will engage with local chapters of the professional organizations and state health departments interested in improving infection prevention and control.

Joint Commission approves new behavioral standards for eating disorders and housing support services

The Joint Commission recently posted new behavioral facility standards for both outpatient and residential eating disorder programs as well as permanent housing support services standards.

The permanent housing support services standards are aimed at helping people with major mental illnesses, substance abuse issues, and other behavioral health issues get steady housing and care. The requirements for eating disorders address issues such as assessments, transitions of care and supervision of patients in eating disorder programs. Both sets of requirements will appear in the Comprehensive Accreditation Manual for Behavioral Health Care Organizations (CAMBHC) and will go into effect on July 2016.

The Joint Commission also approved program requirements for total hip and total knee replacement advanced certification which will go into effect in March 2016. 

Joint Commission releases revisions to Patient Safety Systems chapter

The Joint Commission this week released revisions to its Patient Safety Systems (PS) chapter for 2016. The chapter, which first went into effect in January 2015, highlights the accreditor’s patient safety requirements.

The PS chapter explains how to become a learning organization, the role of hospital leaders in patient safety, use of data and reporting systems, conducting proactive risk assessments, and patient involvement.

In other news, The Joint Commission is creating a new set of measures for its advanced certification program for palliative care. Volunteer hospitals will be testing the measures until the end of January, with the finalized measures to be released mid-2016.


Joint Commission seeks comment on total hip and total knee replacement measures

The Joint Commission is still working on six measures for its new advanced certification for total hip and total knee replacement and is seeking public comment up through January 2016.

The Joint Commission began accepting applications for its new program in December and on-site reviews for the program will being in early 2016. The certification is available for hospitals, critical access hospitals, and ambulatory surgery centers already accredited by The Joint Commission.

Update: Program requirements for total hip and total knee replacement advanced certification will go into effect in March 2016

FDA to provide more frequent info on medical device injuries and deaths

In 2016, the Food and Drug Administration (FDA) will be taking a stronger stance on reporting medical device complications and deaths. The agency’s newly published draft guidance will allow it to report early warnings signs associated with medical devices before the reports have been fully analyzed.

The FDA currently releases safety warnings and recalls on its website. That said, prior to this guidance the agency was unable to release any information on possible complications and injuries related to said warnings until after the all reports had been fully analyzed. The issue was that the agency receives hundreds of thousands of device safety reports in need of vetting each year.

Device manufacturers and other interested parties have until February 29 to comment on the draft.

Where’s my sponge? AORN updates guidelines for preventing retained surgical objects

Despite being labeled a “never event,” surgical items are accidentally left inside a patient 4,500 to 6,000 times every year. In response, the Association of periOperative Registered Nurses (AORN) updated its Guidelines for Prevention of Retained Surgical Items. The guidelines recommend standardizing count and reconciliation procedures to prevent items being left inside a patient. Some of the recommendations include:

1. Doing the initial count before the patient arrives in the operating room.
2. Having both the RN circulator and scrub person conduct the counts. The same two individuals should perform all the following counts throughout the procedure.
3. Establishing a standardized protocol for recording the counts during surgery on a count sheet or count board.
4. Establishing a no-interruption zone in the operating room, where non-essential conversation and activities are restricted. This prevents the team from becoming distracted and losing track of items.
5. Checking instruments and devices immediately after removal from the surgical wound to see if any parts or fragments came off inside the patient.

You can read the rest of the AORN Guidelines here.

Video gives sanitation advice for ambulatory care centers

The Joint Commission recently posted a new video Cleaning, High-Level Disinfection and Sterilization in Ambulatory Care Settings. The video covers infection control specialist Lisa Waldowski’s presentation on the benefits of infection prevention and the Joint Commission’s tracer program during their 2015 Annual Ambulatory Conference. The video is a prelude to The Joint Commission’s 2016 webinar Cleaning, High-Level Disinfection, and Sterilization for Ambulatory Care Organizations.