Your Complete Policy Management Partner
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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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.
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Helpful MCN Healthcare Resources
The U.S. Centers for Medicare and Medicaid Services (CMS) has released a series of FAQs that were posed by course participants during the 2014 Community Mental Health basic surveyor training classs. According to CMS, the FAQs and associated responses as an adjunct to the recent basic courses, will ensure greater surveyor consistency nationally and clarify questions that have been raised regarding the implementation of the new CMHC Conditions of Participation (CoPs). The FAQs and responses are a great tool for Community Health Center's as they provide insight into the survey process and demonstrate how CMS surveyors might evaluate certain aspects of the new CMHC CoPs.
The FAQ responses will be incorporated into the Interpretive Guidance as indicated. Additionally, as implementation of the new CMHC CoPs during FY 2015 continues, CMS anticipates adding additional questions from the surveyors to the FAQ list.
Follow the link below to access the FAQs and associated answers.
The U.S. Food and Drug Administration (FDA) is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. The FDA is also requiring these manufacturers add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. The FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man's symptoms seem related to low testosterone.
Based on the available evidence from studies and expert input from an FDA Advisory Committee meeting, the FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not. See the Data Summary section of the FDA Drug Safety Communication for additional details.
Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause hypogonadism. However, the FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.
Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy. Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as chest pain, shortness of breath or trouble breathing, weakness in one part or one side of the body, or slurred speech.
This information is an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014. Read the MedWatch Safety Alert, including a link to the Drug Safety Communication, at the link below.
Class I Recall of HeartWare Ventricular Assist System â€“ Electrostatic Discharge May Cause Pump Failure
The U.S. Food and Drug Administration (FDA) is informing health care professionals of a Class I Recall of HeartWare Ventricular Assist Systems (VAS):
- Device Models: 1400, 1401XX
- Control Serial Number: CON000001 through CON005472
- Manufacturing Dates: March 2006 through October 2012
The devices were distributed from March 2006 to February 2014 during the ADVANCE (August 2008 - August 2013) and ENDURANCE (October 2013 - Present) clinical trials.
The HeartWare VAS helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant.
The recall was initiated because a buildup of static may cause a sudden electrostatic discharge in the device. When this happens, data in the motor controller that manages the pump's operation may be corrupted and the device may stop working. This problem occurs more often in older model controllers distributed during the clinical trials. If the pump stops working, it can lead to serious adverse health consequences, including death.
Patients with questions about this recall should be instructed to contact their health care provider or the VAD (Ventricular Assist Devices) Coordinator at their hospital center.
Health care providers who want to return affected devices or have questions about the recall should contact their HeartWare representative, or contact HeartWare 24-hour Clinical Support at 888-494-6365, or emailFSCA@heartware.com.
On February 20, 2015 HeartWare sent an "Urgent Medical Device Recall" letter to their customers advising health care providers to:
- Identify patients with the affected device
- Review the risks of electrostatic discharge with patients, including telling patients how to reduce the risk of electrostatic discharge by avoiding:
- Dry environments
- Certain fabrics and materials, such as silk clothing and carpeting
- Electronic devices prone to static electricity
- Activities, such as vacuuming and removing clothes from a dryer
- Exchange the recalled controller for a new controller, if medically advisable. The exchange should take place in a controlled setting under medical supervision. Controllers should be exchanged for a new controller with a serial number of CON005473 or higher.
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 »