Your Complete Policy Management Partner
Everything your healthcare organization needs to confidently maintain accreditation compliance.
Robust document control and workflow management software solution
Simplify & automate policy access, review and approval across your organization
Web-based library of more than 18,000 customizable policy documents
Instantly access up-to-date policies, procedures & forms authored by MCN experts
Automated regulatory notification system of daily email or mobile alerts
Keep current with regulatory changes from more than a dozen federal regulatory bodies, including TJC & NIAHO
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MCN Healthcare has been indispensable to our accreditation compliance efforts. With Policy Manager, Policy Library and StayAlert!, we have peace of mind that our policies will always be up-to-date and easy to locate.
Beverly McKenzie, Compliance Programs Director, IASIS Healthcare
Helpful MCN Healthcare Resources
The Clinical Standards Group (CSG) in the U.S. Centers for Medicare and Medicaid Services (CMS) Center for Clinical Standards and Quality (CCSQ) is responsible for developing, updating and overseeing the CMS regulations on the Conditions for Coverage (CfCs) for end stage renal disease (ESRD) facilities.
According to CSG, the current ESRD regulations were last revised in 2008; therefore, CSG is asking the ESRD community to review the current Conditions for Coverage (CfCs) and provide suggestions for additions/changes/obsoletions that may be useful in a future update to the current regulations.
At this time there is no deadline for this comment period. Follow the link below to access the current ESRD CfC's. CSG is requesting that suggestions for future updates to the CMS regulations on the Conditions for Coverage (CfCs) for ESRD facilities be emailed to ESRDCSG@cms.hhs.gov.
Heritage Pharmaceuticals Recalls Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg Vial
Heritage Pharmaceuticals Inc. is informing health care professionals of their voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Heritage. Heritage has initiated this voluntary recall to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer's site potentially impacting product sterility. See the Press Release, link provided below for a listing of affected lot numbers.
Intravenous administration of non-sterile injection products to a normally sterile site may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity (permanent organ damage), or fatal outcome. To date, Heritage is not aware of any adverse patient events resulting from the use of the subject product lots.
The products were distributed to hospitals, wholesalers and distributors nationwide from December 2012 through January 2015 (Colistimethate) and from October 2014 through January 2015 (Rifampin). Colistimethate is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacteria. Rifampin is indicated for the treatment of all forms of tuberculosis. Customers are being notified by fax, email, UPS, and/or certified mail that includes arrangements for return of all recalled product.
Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of, and return the recalled lots of product. Customers who may have further distributed these products have been requested to identify their customers and notify them at once of this product recall. Any questions about returning unused product should be directed to the customer call center at (866) 901-1230 M-F 9am-5pm EST. Healthcare workers who have medical questions about Colistimethate for Injection, USP, 150 mg base/vial and Rifampin for Injection USP, 600 mg/vial may contact Heritage Medical Affairs(732-429-1000, Ext. 101) M-F 9am-5pm EST.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Read the MedWatch Safety Alert and the firm press release by following the links below.
Class I Recall of MAQUET Servo Humidifier 163 by Teleflex Medical - Cracks in Connector Tubes May Lead to Leak Failures
Two recalls have been issued for the Teleflex Medical, MAQUET Servo Humidifier 163 for connector cracks and cracks in connector tubes. Some connector cracks were found when preparing patients for support with a ventilator. These cracks may lead to oxygen and other gases leaking from the ventilator and not delivering sufficient treatment to patients, potentially causing serious injury or death. Also, cracks were found in the connector tubes during the manufacturing process and some devices were distributed before the problem was identified.
Affected lot numbers are listed in the Recall Notices.
The MAQUET Servo Humidifier is a heat and moisture condenser that is placed over a surgically-created opening in the throat (tracheotomy) or a tube inserted into the trachea to warm and moisten gases breathed in by a patient. The primary users of this device are nurses and respiratory therapists.
INMED sent customers an Urgent - Field Safety Notice dated December 4, 2014, and January 12, 2015. The notice identified the product, problem, and action to be taken.
- Immediately check inventory.
- Quarantine and discontinue use of the device.
- Return the acknowledgement form sent with the notice back to Maquet within five days of receipt.
- Request a return authorization form from Maquet for the recalled devices.
- Immediately stop distributing the recalled device.
- Send the Urgent Field Safety Notice to customers.
- Request customers to complete the acknowledgement form sent with the notice within five days of receipt and return to you.
- Forward the completed acknowledgement forms back to Maquet.
Featured Policy Library Manuals
MCN’s Utilities and Equipment Management Policy and procedure Manual is a reference guide that is compliant with Joint Commission, NIAHO and CIHQ standards and CMS regulations. MCN provides easy-to-use policies and procedures that are field tested and proven - you need only to customize them to your healthcare organization. Policies and procedures include Utility Systems Management Plan, Alternative Equipment Maintenance Program, Clinical Alarms, Emergency Power and much more!Read more »
MCN Healthcare’s Administrative Manual for Critical Access Hospitals is specifically designed to assist critical access hospitals meet CMS, TJC and NIAHO standards for CAHs. This manual provides over 275 ready-to-implement policies, procedures and forms in an easy-to-customize Word format, and is designed to demonstrate compliance with CAH regulations. Transplant Safety polices are also included in this manual.Read more »
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.Read more »