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Keep current with regulatory changes from more than a dozen federal regulatory bodies, including TJC & NIAHO
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Helpful MCN Healthcare Resources
Class I Recall of Respironics California, Esprit V1000 and V200 Ventilators - Power Failure May Occur
Respironics California Inc. has initiated a recall of Esprit V1000 and V200 Ventilators, Model V1000 and V200, installed with 3rd Generation Power Supplies, and 3rd Generation Power Supply Repair Part Kits. These devices were manufactured and distributed from December 21, 2012 to July 9, 2014.
The 3rd Generation Power Supplies are installed in Esprit V1000 and V200 Ventilators and are also sold as 3rd Generation Power Supply Repair Kits. A part in the 3rd Generation Power Supply may prevent the ventilator from using AC power (electricity from a wall socket) or may fail and prevent the ventilator from switching back to AC power after using battery power. Additionally, if a battery is not present or is used up, the ventilator will not work.
Failure of the power supply may cause the ventilator to shut off, which may result in too much carbon dioxide in a patient's blood, not enough oxygen in the blood, or death. There have been no reports of death or serious injury related to this potential problem.
The Esprit V1000 and V200 ventilators provide constant or periodic breathing help for adults and children, including newborns. These devices are used in hospitals and other health care settings.
A Philips field service engineer, trained service provider, or distributor will contact customers to schedule a replacement of the recalled 3rd Generation Power Supply with a 3.1 Power Supply on all Esprit V1000 and V200 ventilators, and all 3rd Generation Power Supply Repair Part Kits. Philips Healthcare sent an URGENT Field Safety Notice dated September 17, 2014 to all customers who purchased the Esprit V1000 and V200 Ventilators.
The letter recommends that customers and users take these actions:
- Until the ventilator is replaced, it can still be used according to the directions for use.
- If the power supply fails during use and the ventilator loses standard electrical current, a different ventilator must be used.
- Be aware of the warnings from the Esprit V1000 and V200 operator's manual. When lights and sound alarms occur, including a flashing red light when the battery is low, the patient must be supported by a different ventilator.
Read the MedWatch safety alert, including a link to the recall notice, at the link below.
Class I Recall of Baxter Healthcare Corporation, INTRAVIA Empty Containers with PVC Ports â€“ Particles Found in Patient Solution
A Class I Recall has been initiated for of Baxter Healthcare Corporation's INTRAVIA Empty Containers with PVC Ports because of visible particles found in INTRAVIA Empty Containers. These particles might be found in the solution in the tube that leads from a container to a patient's vein. These particles may irritate the patient's veins, cause pain, worsen a previous infection, cause allergic reactions, block blood vessels, and cause death. To date, no injuries have been reported.
The device recalled is:
- INTRAVIA Empty Container with PVC Ports, (Sterile, fluid path), 150 mL, Product Code 2B8011, Lot No. UR13D15112, manufacturing date: April 18, 2013, distribution dates April 26, 2013 to June 20, 2013
Devices with lot numbers that are not part of this recall can be used.
An lNTRAVIA Empty Container is used to prepare liquid medicines given to patients through a tube attached to a needle that is inserted into a vein. The primary users of these devices are hospitals and clinics.
Baxter Healthcare sent customers an Urgent Product Recall letter on September 10, 2014. The letter included the following advice for customers:
- Locate and remove all recalled devices from your facility.
- Contact Baxter Healthcare Center for Service to arrange for return of the recalled devices.
- Call 1-888-229-0001, Monday through Friday, 7:00 am - 6:00 pm, Central Time.
- Provide Baxter's 8-digit ship-to-account number when calling.
- Complete the customer reply form enclosed with the Urgent Product Recall letter and return it to Baxter either by fax or scanned email.
- Notify customers who may have received the recalled devices through re-distribution.
Follow the link below for additional information.
The Office of Inspector General recently released its 2015 Work Plan; today's notice is a summary of high-interest areas of focus for Medicare Home Health Agencies. The 2015 Work Plan outlines compliance and enforcement projects and priorities OIG intends to pursue in the coming year. Both areas where OIG will concentrate their efforts this year are ongoing work from 2014.
Home Health Agencies:
- Home health prospective payment system requirements: OIG will review compliance with various aspects of the home health prospective payment system (PPS), including the documentation required in support of the claims paid by Medicare. They will determine whether home health claims were paid in accordance with Federal laws and regulations. A prior OIG report found that one in four HHAs had questionable billing. Further, CMS designated newly enrolling HHAs as high-risk providers, citing their record of fraud, waste, and abuse.
- Employment of individuals with criminal convictions: OIG will determine the extent to which home health agencies (HHAs) are complying with State requirements for conducting criminal background checks on HHA applicants and employees. A previous OIG review found that 92 percent of nursing homes employed at least one individual with at least one criminal conviction; however, that review could not determine whether the nursing home employees should have been disqualified from working in nursing homes because OIG did not have access to detailed information on the nature of the employees' crimes. Federal law requires that HHAs comply with all applicable State and local laws and regulations. (Social Security Act, §1891(a)(5), implemented at 42 CFR § 484.12(a).) Nearly all States have laws prohibiting certain health-care-related entities from employing individuals with prohibited criminal convictions.
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 »