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Joint Commission issues another warning about improperly cleaned medical devices

For the second time in three years, The Joint Commission has released a Quick Safety issue on the topic of improperly sterilized or high-level disinfection (HLD) equipment and devices. The accreditor writes that despite bringing the problem to light in 2014, there’s an increase in cases of medical devices not being cleaned properly.

“Immediate threat to life (ITL) declarations related to improperly sterilized or high-level disinfected (HLD) equipment have increased significantly from 2013-2016,” wrote Lisa Waldowski, DNP, PNP, CIC, Joint Commission infection control specialist, in a blog post. “In 2016, 74% of all ITL declarations from The Joint Commission were related to improperly sterilized or HLD equipment. As reports of sterilization and HLD-related issues continue to be received by our Office of Quality and Patient Safety, our surveyors also are seeing it firsthand in hospitals, ambulatory care sites and other healthcare settings across the country.”

According to Quick Safety Issue 33, noncompliance with standard IC.02.02.01 (which deals with sterilization) has been on the rise since 2009 in Joint Commission-accredited hospitals, critical access hospitals, ambulatory centers, and office-based surgery facilities.

There are several risks tied to improper reprocessing such as infection and outbreaks, loss of accreditation, litigation, negative publicity, and lost revenue. A prime example of this occurred during the 2015-2016 outbreaks, when it was discovered that the design of the duodenoscopes could prevent them from being properly sterilized.

There are several factors that are causing this rise in noncompliance, according to The Joint Commission. These include:

•    The incorrect assumption that the risk of infection to patients is low or nonexistent
•    Staff either don’t know how to properly sterilize or HLD equipment or they knowingly chose not to follow proper procedures
•    Lack of leadership oversight and the belief that sterilization or HLD is a low priority
•    A culture that discourages the reporting of safety risks
•    No dedicated staff person to oversee the proper sterilization or HLD of equipment
•    Facility design or space issues prevent proper sterilization or HLD of equipment
•    Lack of monitoring or documentation of sterilization or HLD of equipment

“Healthcare organizations need to prioritize improving sterilization and HLD efforts year-round and well before a survey occurs to best protect patients,” says Waldowski. “Together, we can work to change news headlines from reporting on sterilization or HLD-related outbreaks to touting reductions in outbreaks through quality improvement efforts.”

Joint Commission comments on proposed CMS transparency rule

The Joint Commission has made a public comment regarding CMS’ proposed rule to require accrediting organizations (AO) to make their survey reports publicly available. The Joint Commission is opposed to sharing private survey reports and thinks making the reports public will harm patient care.

Currently, AOs like The Joint Commission and DNV aren’t required to make their survey reports or plans of corrections (PoC) available to the public. Under the proposed rule, AOs would have to post these on their websites. 

“Access to survey reports and PoCs will enable health care consumers, in addition to Medicare beneficiaries, to make a more informed decision regarding where to receive health care thus encouraging health care providers to improve the quality of care and services they provide,” CMS wrote in the proposal memo. If you want to read and comment on the proposed rule, you can find a copy of the memo and commenting instructions here. CMS will accept comments until June 13.

In an open letter to CMS, Joint Commission President and CEO Mark R. Chassin, MD, FACP, MPP, MPH, wrote that while the accreditor is a strong supporter of transparency, it believes revealing all accreditation survey reports to the public is a bad idea. The crux of the issue is that the contents of those survey reports are meant as tools for hospitals to improve. It’s not the same as healthcare quality data, a distinction that may be lost on the public.

“As an organization whose mission is to support quality improvement and patient safety and inspire excellence, we believe the proposal will have significant detrimental consequences on our nation’s ability to continually improve the delivery of health care services,” he writes. “To be clear, this opposition is not one against transparency, but one of creating the right balance between useful, publicly available information and improving the quality and safety of healthcare.”

Some of the Joint Commission’s concerns are:

  • It’ll be harder to get AOs and healthcare organizations to collaborate on patient safety and continuous quality improvement.Having AOs release collected information would make providers less candid about their weaknesses and create an adverse dynamic that will ultimately, there will be increased patient harm and lower quality.
  • It will stunt AO’s efforts to create new standards or raise compliance standards for existing requirements.
  • Healthcare organizations will be incentivized to use AOs that report on the least number of Medicare-comparable standards. This will spur a race to the bottom on quality and may also cause a growth in the number of non-accredited facilities that’ll be surveyed at taxpayer expense and with fewer oversight visits.
  • The proposal will diminish the value of accreditation as a way to motivate healthcare organizations to excel.
  • The proposal will increase costs for AOs and healthcare organizations.

Joint Commission clarifies four LSC-related requirements

The Joint Commission issued clarifications on some of its 2012 Life Safety Code®-related (LSC) requirements. In particular, the clarifications are aimed at the standards for fire doors, fire drills, and emergency department occupancy.

 

  1. Emergency department (ED) occupancy classification: Some EDs meet the qualifications to be considered healthcare or ambulatory healthcare occupancies. The clarification explains how to tell the difference.
  2. Annual door inspection: Fire and smoke doors must receive their annual inspection and testing before July 5, 2017. Corridor doors that aren’t required to be fire doors or smoke door assemblies aren’t subject to the National Fire Protection Association annual inspection and testing requirements. However, they should be routinely inspected as part of facility maintenance.
  3. Rated fire door assembly installed in lesser rated or non-rated assembly: If a fire-rated door is used in a nonrated barrier assembly, the fire door must be maintained as a fire door unless any markers identifying it as a fire door have been removed.
  4. Fire drills and varying times: There can’t be a pattern for conducting fire drills. But drills conducted no closer than one hour apart would be acceptable.

First set of SAFER Matrix data is online

The Joint Commission released the first set of data collected from its new Survey Analysis for Evaluating Risk™ (SAFER™) scoring methodology this May. The SAFER matrix was first rolled out to psychiatric hospitals as part of their accreditation surveys. It has been since implemented for all Joint Commission-accredited programs.

The accreditor made a chart of the most frequently cited compliance challenges for deemed psychiatric hospitals between Aug. 1, 2016 to Feb. 17, 2017.

The Joint Commission writes that it plans to keep analyzing aggregate SAFER data going forward to:

  • Continuously improve consistency
  • Identify potential EPs for revision
  • Assist in identifying areas of high risk noted within each program

Joint Commission: Facilities now to receive email notifications about upcoming surveys/reviews

Starting March 6, The Joint Commission will send email notifications to organizations about upcoming surveys/review events. For each event, The Joint Commission will post the letter of introduction, the survey/review agenda, and surveyor/reviewer biographies and photos on organizations’ Joint Commission Connect extranet site. Afterwards, an email will be sent to the CEO and contact person for the accreditation team, letting them know this information is now up on the extranet to view. The main difference is how far in advance notifications are sent:

  • Announced events—30 days in advance, plus a second email the day of the event
  • Short-notice Events—7 business days in advance, plus a second email the day of event
  • Unannounced events (including all Medicare certification events)—Same day as the event

Additional information about the different types of events can be found in “The Accreditation Process” (ACC) chapter or “The Joint Commission Certification Process” chapter.

Joint Commission issues new Sentinel Event Alert about culture of safety

The Joint Commission today published its newest Sentinel Event Alert (SEA), which addresses the role of leadership in creating a culture of safety, namely that leaders’ first priority is being held accountable for the safety of patients and staff. Leaders are expected to find flaws and gaps in the care process and ensure that they are resolved.

The SEA comes with an infographic on the “11 Tenets of a Safety Culture.” 

Joint Commission to check for FDA powdered glove compliance

The Joint Commission surveyors will now check to see if hospitals are compliant with the Food and Drug Administration’s (FDA) ban on powdered medical gloves. The ban went into effect in January, with the administration citing the powder’s potential to cause severe airway and wound inflammation, granulomas, and post-surgical adhesions in the tissue between internal organs. Powdered latex gloves also carry the risk of allergic reaction in patients. The Joint Commission will now issue citations on the powdered glove ban under LD 04.01.01, element of performance 2.

“This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health, in a press release. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”

To learn more about the FDA’s decision, read our previous coverage on the ban.

Workplace violence prevention resources added to Sentinel Event Alert 45

The Joint Commission has updated Sentinel Event Alert, Issue 45: Preventing Violence in the Health Care Setting with new resources:

In related news, The American Society for Healthcare Risk Management (ASHRM) has released multiple toolkits on how to assess workplace violence risks in healthcare settings. The toolkits also provide guidance and checklists on what to do if violence breaks out and how to protect staff. The toolkits cover five main areas:

  • Staff-to-staff violence/harassment
  • Physician- or third-party professional-to-staff violence/harassment
  • Patient-to-staff violence
  • Visitor/family-to-staff violence
  • Stranger/nonemployee-to-staff violence

Read Briefings on Accreditation and Quality for more on workplace violence protection.

Joint Commission clarifies “observer” standards

The Joint Commission announced an update of its “observer” definition in its accreditation and certification manuals. The new definition is meant to clarify the roles of surveyors and reviewer management staff during on-site surveys and reviews.

The new definition can be found under Accreditation Participation Requirement APR.07.01.01 and Certification Participation Requirement (CPR) 10, and goes into effect on July 1, 2017.

According to the new definition, observers will only participate in the survey/review process if they notice a potential finding or observation that they think the surveyor, reviewer, or organization needs to know about. Field directors are not included in this new definition and are still allowed to take part in the survey process.

Joint Commission makes more revisions to EC, LS standards

The Joint Commission has announced additional revisions to its Environment of Care (EC) and Life Safety (LS) chapters. The revisions are meant to bring the accreditor in closer alignment with the National Fire Protection Association’s 2012 Life Safety Code® (LSC). The LSC was adopted by CMS and The Joint Commission last year. The revisions go into effect July 1, 2017 and apply to hospitals, critical access hospitals, ambulatory healthcare centers, home care, and nursing care centers.