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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Helpful MCN Healthcare Resources
The US Food and Drug Administration (FDA) recently issued a final guidance document, "Distinguishing Medical Device Recalls from Medical Device Enhancements." The guidance clarifies for manufacturers how to determine when changes to a device constitute a recall and when they are considered a product enhancement.
While primarily aimed at manufactures, the guidance contains clear definitions and practical examples of different types of recalls that can also help providers in distinguishing a recall from a product enhancement recommendation.
Hospitals should have a formal process in place for receiving and responding to medical device recalls. Included with today's notice is an example policy reflecting such a process.
The Joint Commission is conducting a field review seeking insight from hospitals about their experiences with the requirements of the new National Patient Safety Goal (NPSG) on clinical alarm management.
National Patient Safety Goal (NPSG.06.01.01), was effective January 1, 2014, and requires hospitals and critical access hospitals to improve the safety of clinical alarm systems. The NPSG, which is being implemented in two phases, addresses clinical alarms that can directly affect patient care, IV machines, ventilators, cardiac monitors, etc.
The goal of the first phase implementation is to increase awareness of the risks associated with clinical alarms. As of July 1, 2014 organizations should have established alarm system safety as a hospital priority. Throughout 2014 hospitals are to identify the most important alarm signals to manage based on the following:
- Input from the medical staff and clinical departments
- Risk to patients if the alarm signal is not attended to or if it malfunctions
- Whether specific alarm signals are needed or unnecessarily contribute to alarm noise and alarm fatigue
- Potential for patient harm based on internal incident history
- Published best practices and guidelines
According to TJC, information from this field review will be used to determine whether it is necessary to enhance the NPSG before the January 1, 2016 implementation date for the phase II requirements. Follow the link below to read more about this field review and for comment submission instructions. Comments will be accepted through October 29, 2014.
Included with today's notice are tools to assist with compliance with phase I implementation of NPSG.06.01.01.
The US Centers for Disease Control and Prevention (CDC) is reminding providers of their role in ensure pregnant women receive the influenza and other important vaccines. Pregnant women and their babies are at increased risk for influenza-related complications, including premature labor and preterm birth. Additionally, pertussis outbreaks continue to occur in the United States with infants at highest risk of severe illness, including hospitalization and death.
Influenza vaccination is recommended in any trimester for all women who are pregnant or who plan to become pregnant during the influenza season, and a pertussis vaccination (Tdap) is recommended between 27 and 36 weeks of each pregnancy.
The CDC is asking providers to recommend the influenza vaccine to pregnant patients throughout the current influenza season and also to ensure that the Tdap vaccination is recommended to pregnant patients as they enter their third trimester. According to the CDC, one study showed that patients who were offered influenza vaccination during an office visit were 7 times more likely to be vaccinated for influenza than patients who reported their provider did not recommend or offer vaccination. Patients who received a recommendation alone were twice as likely to be vaccinated as those that received no recommendation.
The CDC is recommending that providers adopt the National Adult Immunization Practice Standards to help ensure that patients receive influenza and Tdap vaccinations as well as all other indicated vaccinations. The following steps should be provided at each patient encounter:
- Assess the immunization status of each patient.
- Recommend the indicated vaccines to each patient.
- Administer any necessary vaccines or, if you do not stock the vaccine, refer the patient to a provider or location that can vaccinate the patient.
- Document the vaccinations that your patient is given, ideally in your state or local immunization registry.
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 »
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.Read more »
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.Read more »