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Everything your healthcare organization needs to confidently maintain accreditation compliance.
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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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Helpful MCN Healthcare Resources
Recall of Effexor XR 150 Mg Extended-Release Capsules (Pfizer) and Venlafaxine HCl 150 Mg Extended-Release Capsules (Greenstone) - Possible Presence of Tikosyn Capsules
Pfizer Inc. has issued a voluntary recall of one lot of 30-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules, and one lot of 90-count Greenstone LLC-branded Venlafaxine HC1 150 mg extended-release capsules. This action is being taken because of a pharmacist report that one bottle of Pfizer's Effexor XR contained one capsule of Tikosyn (dofetilide) 0.25mg in addition to the Effexor XR capsules.
The use of Tikosyn by an Effexor XR/Venlafaxine HCl patient, where the contraindications and drug-drug interactions with Tikosyn have not been considered by the prescribing physician, could cause serious adverse health consequences that could be fatal.
This recall is to the patient level and involves Pfizer lot numbers V130142 and V130140, which both expire in October 2015, and Greenstone lot number V130014, which expires in August 2015.
These products were distributed nationally to wholesalers, distributors, certain government agencies, patient assistance programs and retailers, such as pharmacies and hospitals. These direct customers are being notified by UPS next day mail, and Pfizer is arranging for the return of all recalled products.
Pharmacists should immediately quarantine, discontinue distribution of and return all recalled lots of these products, as well as notify any of their customers to whom they distributed the products. Patients with affected product should notify their physicians and/or return product to their pharmacies.
Patients with questions regarding the return of product should contact Stericycle at 1-888-345-0481 (Monday to Friday 8am to 5pm ET). Patients with questions regarding this recall can contact Pfizer Medical Information at1-800-438-1985 (Monday to Thursday 9am to 8pm ET or Friday, 9am to 5pm ET).
Read the MedWatch Safety Alert, including a link to the press release, at the link below.
The U.S. Food and Drug Administration is informing healthcare professionals of a Class I Recall of Philips Respironics, Trilogy Ventilator, Models 100, 200, and 202. According to the FDA, There is a potentially defective component on the Trilogy Ventilator power management board which could affect the function of the device. If this issue is not corrected it is possible that the ventilator may fail to deliver mechanical breaths and that the alarm functionality may be reduced to indicate ventilatory failure, resulting in serious adverse health consequences or death.
The affected models were manufactured and distributed from December 31, 2013 through January 30, 2014. See the recall notice for serial numbers and product photos.
On February 11, 2014 the firm initiated the recall by phoning their direct customers who are primarily wholesale dealers of home healthcare products. The firm followed up their phone calls by sending recall notification letters to their customers.
Philips Respironics is instructing customers to remove the affected devices from service and to return them to Philips for replacement. All distributors, providers, and customers with potentially affected Trilogy devices will have their units replaced.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
In honor of Patient Safety Awareness Week, the annual education and awareness campaign sponsored by the National Patient Safety Foundation, StayAlert is providing a review and resources for one of the most often cited sentinel event in the Joint Commission sentinel event database: unintended retention of a foreign body. Patient Safety Awareness Week is an excellent time to reflect on your organization's approach to preventing the unintended retention of a foreign body and perhaps consider new approaches for patient safety.
Leadership and human and communication factors have been identified as contributing to the unintended retention of a foreign body. Therefore, organizations should consider these factors when they review and implement best practices for the prevention of unintended retention of a foreign body: (not all inclusive)
- Creating a culture of safety within the organization that promotes a thoughtful approach to preventing adverse patient safety events
- Having the Circulating RN and scrub person perform all counts, both audibly and visibly
- If the count is incorrect, the surgeon should be notified, a recount should be performed, and a search should be made for the missing item(s). If the item is still not found, x-ray should be used to help locate the item
- Ensuring that patients do not leave the OR until missing items are accounted for
Featured Policy Library Manuals
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 »
The Administrative Manual for Ambulatory Care Facilities covers every topic your free-standing ambulatory care center will need, from Patient Assessment to Performance Improvement in one easy-to-use volume. This comprehensive manual includes over 340 comprehensive policies, procedures and forms to meet Joint Commission and AAAHC standards. MCN Healthcare cross-references the policies to the current TJC and AAAHC standards in the table of contents, so you don't have to!Read more »
For 26 years, MCN has been providing the most comprehensive Environment of Care policy and procedure manuals to the healthcare community. The Ambulatory Services Environment of Care Manual includes more than 475 comprehensive policies, procedures and forms that meet Joint Commission’s standards and the Accreditation Association for Ambulatory Health Care standards. The Ambulatory Services EOC Manual provides policies your organization needs to run your Environment of Care Program effectively.Read more »