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MCN Healthcare: StayAlert! - Immediate Regulatory Updates Icon

StayAlert! Headlines

Jul 23 2014
Updated Guidance from SHEA on Central-Line Associated Blood Stream Infections

The Society for Healthcare Epidemiology of America has issued updated guidance for preventing central line-associated blood stream infections in hospitals.  Published in the July Issue of Infection Control and Hospital Epidemiology, the guidance updates the 2008 "Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals."

The purpose of the guidance document is to provide hospitals with practical recommendations for implementing and prioritizing central line-associated bloodstream infection (CLABSI) prevention efforts.  The recommendations in the guidance focus on central venous catheters (CVCs) and therefore the recommendations may not be effective for preventing bloodstream infections related to other intravascular devices. The guidance reviews both basic recommendations that should be adopted by all acute care hospitals and also specific practices that can be considered when CLABSIs are not controlled by the basic recommendations. 

Today's StayAlert! Notice reviews the basic recommendations. Please review the article for the Special Approaches for preventing CLABSI recommendations.  Basic recommendations include:

Before Insertion:

  • Have an evidence-based list of indications for CVC's readily available
  • Require education for healthcare personnel involved in the insertion, care and maintenance of CVCs.  Education should include CLABSI prevention strategies.
  • Ensure that any healthcare professional who inserts a CVC undergoes a credentialing process (as established by the individual healthcare organization) to ensure their competency before independently inserting a CVC.
  • Bathe all ICU patients over two (2) months of age with a  chlorhexidine preparation on a daily basis

During Insertion:

  • Processes should be in place to ensure infection prevention strategies are adhered to at the time of CVC insertion, i.e., a checklist
  • Hand hygiene must be performed prior to catheter insertion
  • When possible do not use the femoral vein for CVC access in obese adult patients
  • When possible utilize an all-inclusive catheter kit/cart
  • Utilize ultrasound guidance for the insertion of internal jugular catheters
  • Use maximum sterile barrier precautions during CVC insertion
  • Use an alcoholic chlorhexidine antiseptic for skin preparation

After Insertion:

  • Ensure appropriate staffing and limit use of float nurses in ICUs
  • Disinfect catheter hubs, needleless connectors, and injection ports before accessing the CVC
  • Remove all non- essential catheters as soon as possible
  • For non-tunneled CVCs in adults and children, change transparent dressings and perform site care with a chlorhexidine-based antiseptic every 5-7 days or immediately if the dressing is soiled, loose, or damp; change gauze dressings every 2 days or earlier if the dressing is soiled, loose, or damp
  • Replace administration sets not used for blood, blood products, or lipids at intervals not longer than 96 hours
  • Use antimicrobial ointments for hemodialysis catheter-insertion sites
  • Perform surveillance for CLABSI in ICU and non-ICU settings

The Guidance also addresses approaches that should not be considered routine for the prevention of CLABS i.e., systemic antimicrobial prophylaxis and routine catheter replacement are not recommended

Joint Commission National Patient Safety Goal (NPSG.07.04.01) requires hospitals to implement strategies to reduce central line associated blood stream infections.  Guidance such as this update from SHEA is a valuable tool for hospitals as they seek to prevent and decrease CLABSI and meet JTC requirements.

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Jul 23 2014
TJC Announces Standards Revisions for the ASC Deemed Program

As reviewed by StayAlert! on June 10, 2014, the Centers for Medicare & Medicaid Services (CMS) revised the Conditions for Coverage (CfC) for Ambulatory Surgical Centers (ASCs) regarding radiological services [§416.49(b)(2)] effective July 2014.

  • Radiologic services may only be provided when integral to procedures offered by the ASC and must meet the requirements specified in §482.26(b), (c)(2), and (d)(2). 
    • §482.26(b) Standard: Safety for Patients and Personnel- The radiologic services, particularly ionizing radiology procedures, must be free from hazards for patients and personnel.
    • §482.26(c)(2) - Only personnel designated as qualified by the medical staff may use the radiologic equipment and administer procedures.
    • §482.26(d)(2) - The hospital must maintain the following for at least 5 years:(i) Copies of reports and printouts; (ii) Films, scans, and other image records, as appropriate.
  • If radiologic services are utilized by an Ambulatory Surgical Center, the governing body shall appoint an individual qualified in accordance with State law and ASC policies who is responsible for assuring that all radiologic services are provided in accordance with the requirements of section §416.49(b)

In response to CMS changes, The Joint Commission has revised its requirements for ASCs that elect to use The Joint Commission deemed status option, effective immediately.  Please see the Prepublication Requirements at the link below.

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Jul 21 2014
American Health Packaging Announces the Voluntary Nationwide Recall of Ibuprofen Tablets, USP, 600 mg, 100 Hospital Unit Dose and Oxcarbazepine Tablets, 300 mg, 100 Hospital Unit Dose

American Health Packaging (Columbus, OH) has voluntarily recalled Lot #142588, Expiration Date, 01/2016 of Ibuprofen Tablets, USP, 600 mg, in a hospital unit dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300 mg, lot #142544.

In addition, American Health Packaging (AHP) has voluntarily recalled Oxcarbazepine Tablets, 300 mg, lot #142544, Expiration Date, 02/2016. This voluntary recall is the result of mislabeled inner unit dose blister packaging which could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine.

Affected products as follows:

  • Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Ibuprofen Tablets, USP, 600 mg, with outer carton NDC#: 68084-703-01 and individual dose NDC#: 68084-703-11, Lot #142588, Expiration Date, 01/2016. The drug product can be identified by physical description: white, oval-shaped, film-coated tablets, with "IP 465" printed on one side.
  • Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Oxcarbazepine Tablets, 300 mg, with outer carton NDC#: 62584-143-0 and individual dose NDC#: 62584-143-11, Lot #142544, Expiration Date, 02/2016. The drug product can be identified by physical description: yellow color, capsule shaped, film-coated tablets scored and debossed with '184' on one side and scored on other side.

These hospital unit dose products were distributed nationwide beginning June 20, 2014. No other products or lots were affected by this incident.

To date, AHP has received one (1) customer complaint which resulted in the investigation and recall of these drug products. AHP has not received any adverse event reports attributable to the mislabeled drug.

American Health Packaging initiated a voluntary product recall on July 1, 2014 as a safety precaution, and will continue to closely monitor for reports of adverse drug reactions and product complaints. Notification of the recall has been sent to distributors who received the affected product with instructions on how to notify their customers.

Consumers who have received the recalled product should immediately discontinue use and contact GENCO Pharmaceutical Services at 855-419-4608 from 7am to 5pm CST for instructions on returning the recalled product.

For medical information questions or product complaints related to Oxcarbazepine Tablets, 300 mg or Ibuprofen Tablets, USP, 600 mg please contact American Health Packaging customer service at 1-800-707-4621 from 8am to 4pm EST.

Any adverse events that may be related to the use of these products should be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or on the MedWatch website at

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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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