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Keep current with regulatory changes from more than a dozen federal regulatory bodies, including TJC & NIAHO

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MCN Healthcare: StayAlert! - Immediate Regulatory Updates Icon

StayAlert! Headlines

Sep 15 2014
CDC Issues Health Advisory about Severe Respiratory Illness Associated with Enterovirus D68

The Centers for Disease Control and Prevention (CDC) has issued a Health Advisory to inform health care providers, emergency departments and microbiology laboratories of recent increases in hospitalizations of patients with severe respiratory illness, provide awareness of Enterovirus D68 (EV-D68) as the possible cause of the illnesses and provide infection control guidance. 
In August 2014, a children's hospital in Kansas City, Missouri, and one in Chicago, Illinois, notified CDC of increases in pediatric patients examined and hospitalized with severe respiratory illness, including some admitted to pediatric intensive care units. Nasopharyngeal specimens from patients with recent onset of severe symptoms from both facilities were sequenced by the CDC Picornavirus Laboratory. EV-D68 was identified a majority of specimens. Admissions for severe respiratory illness have continued at both facilities at rates higher than expected for this time of year. CDC has been notified by various states of similar clusters of respiratory illness, though confirmation of EV-D68 in these potential clusters is still under way.

Of these severely ill patients who were confirmed positive for EV-D68 from both hospitals, all presented with difficulty breathing and hypoxemia, and some with wheezing. Notably, most patients were afebrile at presentation and throughout the hospital course. Approximately two thirds of cases had a previous medical history of asthma or wheezing, but both hospitals reported some patients with no known underlying respiratory illness. Ages ranged from 6 weeks through 16 years, with median ages of 4 and 5 years in Kansas City and Chicago, respectively.

Most patients were admitted to the pediatric intensive care unit. Of the 30 patients who were positive for EV-D68, two required mechanical ventilation (one of whom also received extracorporeal membrane oxygenation) and six required bilevel positive airway pressure ventilation. It should be noted that specimens from only the most severe cases have been typed at this time, and so these findings may not reflect the full spectrum of disease. 

In response to an increase in EV-D68 infections, the CDC recommends the following:

  • Health care providers should consider EV-D68 as a possible cause of acute, unexplained severe respiratory illness, even in the absence of fever.
  • Although the findings to date have been in children, EV-D68 may also affect adults.
  • Providers should consider laboratory testing of respiratory specimens for enteroviruses when the cause of respiratory infection in severely ill patients is unclear.
  • Confirmation of the presence of EV-D68 requires typing by molecular sequencing.
  • Providers should contact state or local health departments for further enterovirus typing.
  • Health departments may contact CDC for further enterovirus typing.
  • Providers should report suspected clusters of severe respiratory illness to local and state health departments.
  • EV-D68 is not nationally notifiable, but state and local health departments may have additional guidance on reporting.

The CDC is currently prioritizing respiratory specimens from patients with severe respiratory illness who are known to be positive for rhinovirus/enterovirus from initial screening assays.

Infection Control:

  • Routes of transmission for EV-D68 are not fully understood.
  • Infection control guidelines for hospitalized patients with EV-D68 infection should include standard precautions, and contact precautions in certain situations, as is recommended for all enteroviruses.
  • As EV-D68 is a cause of clusters of respiratory illness, similar to rhinoviruses, droplet precautions also should be considered as an interim recommendation until there is more definitive information available on appropriate infection control.
  • As EV-D68 is a non-enveloped virus, environmental disinfection of surfaces in healthcare settings should be performed using a hospital-grade disinfectant with an EPA label claim for any of several non-enveloped viruses (e.g. norovirus, poliovirus, rhinovirus). Disinfectant products should be used in accordance with the manufacturer's instructions for the specific label claim and in a manner consistent with environmental infection control recommendations.

Included with today's notice are polices that reflect infection control recommendations within this Health Advisory.

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Sep 13 2014
TJC Seeks Comments on Proposed Revised Diagnostic Imaging Requirements

The Joint Commission (TJC) is conducting a field review for proposed revised diagnostic imaging requirements.  As you may recall, earlier this year TJC postponed implementation of new and revised diagnostic imaging requirements because they decided additional research was needed. 

TJC is now seeking input on standard revisions for the following areas:

  • Minimum qualifications for radiologic and nuclear medicine technologists that perform computed tomography (CT) exams.
  • Orientation of technologists on safe practices related to the provision of diagnostic imaging.
  • Documentation of CT radiation dose.

TJC is asking that staff and clinicians with expertise in diagnostic imaging provide feedback by October 24, 2014.  To review the proposed revisions and for comment submission instructions please follow the link below.

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Sep 12 2014
Hospira Issues a Voluntary Nationwide Recall of One Lot of Heparin

Hospira, Inc. has initiated a voluntary nationwide user-level recall of one lot of Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with expiration date of 01NOV 2015. This action is due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair, sealed between the tube and the film at the round seal of the unused Administrative Port on the non-print side of the container.

In the unlikely event that the particulate breaks and pieces are able to pass through the intravenous catheter, injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response. Capillaries may become occluded. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk.

Heparin Sodium Injection in 0.9% Sodium Chloride at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. The root cause has not been determined and is under investigation.

The affected lot was distributed nationwide between June 2014 and August 2014 to wholesalers/distributors, hospitals and pharmacies.

Anyone with an existing inventory should stop use and distribution and quarantine the product immediately. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle. For additional assistance, call Stericycle at 1-855-201-4337 between the hours of 8am to 5pm ET, Monday through Friday.

See the firm's press release, link below, for additional information.

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MCN Healthcare: Policy Library - Customizable Policy Documents Icon

Featured Policy Library Manuals

Policy Library Manuals: Ambulatory Surgical Center and Outpatient Surgery Department Policy and Procedure Manual Icon
Ambulatory Surgical Center and Outpatient Surgery Department Policy and Procedure Manual

MCN's NEW Ambulatory Surgical Center/Outpatient Surgery Department Policy and Procedure Manual is cross referenced to TJC standards, AAAHC standards and CMS regulations. Policies and procedures meet AORN and CDC recommendations and guidelines. This comprehensive reference guide has over 290 policies and procedures that are ready to customize to your organization. See also the Administrative Manual for Ambulatory Care Facilities and the Ambulatory Services EOC Manual.

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Policy Library Manuals: Central Service Policy and Procedure Manual Icon
Central Service Policy and Procedure Manual

MCN's Central Service Policy and Procedure Manual provides over 200 proven, up-to-date policies and procedures in a ready-to-customize format. This manual is cross referenced to federal regulations, as well as Joint Commission and NIAHO standards. References used include AAMI Recommended Practices, IAHCSMM Central Service Technical Manual, ASHCSP Training Manual for Health Care Central Service Technicians and AORN Recommended Practices.

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Policy Library Manuals: Post Anesthesia Care Policy and Procedure Manual Icon
Post Anesthesia Care Policy and Procedure Manual

MCN's Post Anesthesia Care Policy and Procedure Manual is a comprehensive resource that covers the latest "hot topic" regulatory and patient safety issues that are relevant to PACU! This manual includes administrative, operational, functional and patient-centered policies and procedures. Policies and procedures are cross-referenced to CMS regulations, Joint Commission standards and NIAHO standards.

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