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Everything your healthcare organization needs to confidently maintain accreditation compliance.
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Web-based library of more than 18,000 customizable policy documents
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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
Hospira, Inc. is recalling one lot of Lidocaine HCI Injection, USP, 2%, 20 mg per mL, 5 mL single-Dose Vial, Preservative-Free (NDC 0409-2066-05; Lot 25-550-DD, Expiry 1JAN2015) to the user level due to a confirmed customer report of discolored product with visible particles in the solution as well as particulate embedded in the molded glass container. Hospira has identified the particulate as iron oxide.
Risk factors associated with the particulate include the potential for particulate to be injected and/or a delay in therapy. If the particulate goes undetected and solution is administered - depending on the particle size and number - it could block administration of the drug to the patient, causing a delay in therapy. Particulates may be able to pass through the catheter and may result in local inflammation, mechanical disruption of tissue or immune response to the particulate. While extremely rare, particulate exposed to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue damage.
Lidocaine is packaged 10 units per carton / 180 units per case in single-dose glass fliptop vials. This lot was distributed nationwide to distributors/wholesalers, hospitals and clinics from June 2013 through July 2013.
Anyone with existing inventory should immediately stop use and quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira is notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle for return processing. For additional assistance, call Stericycle at1-855-827-6586 (M-F, 8 a.m. - 5 p.m. ET). See the Hospira press release instructions on medical inquiries and reporting adverse events to the manufacturer.
Read the MedWatch safety alert, including a link to the press release, by following the link below.
The Centers for Medicare & Medicaid Services (CMS) has announced its decision to recognize and approve The Compliance Team's (TCT's) Medicare Rural Health Clinic (RHC) accreditation program for RHCs seeking to participate in the Medicare program via deemed status.
Section 1865(a) of the Social Security Act (the Act) permits providers and suppliers accredited by an approved Medicare accreditation program of a national accrediting body to be "deemed" to meet the applicable Medicare Conditions for that provider or supplier type. To receive approval, a national accrediting organization (AO) must demonstrate to CMS that its Medicare accreditation program requirements meet or exceed the applicable Medicare Conditions. CMS reviewed TCT's application for approval of its RHC Medicare accreditation program in accordance with the requirements at 42 CFR 491. CMS' review included TCT's survey and accrediting processes as well as its health and safety standards. CMS' review found TCT's Medicare accreditation program for RHCs to meet or exceed the Medicare RHC Conditions for Certification. This is an initial four-year approval effective July 18, 2014.
Please note that approval of this Medicare accreditation program is limited to its use in assuring compliance with the Medicare RHC Conditions for Certification and does not apply to ownership, enrollment, or other Medicare requirements.
This approval provides RHCs with another Medicare accreditation option in addition to those available through the American Association for Accreditation of Ambulatory Surgery Facilities, Inc.
CDC Issues Health Advisory - Ebola Virus Disease Confirmed in a Traveler to Nigeria, Two U.S. Healthcare Workers in Liberia
The US Centers for Disease Control and Prevention (CDC) is working with the World Health Organization (WHO), the ministries of health of Guinea, Liberia, and Sierra Leone, and other international organizations in response to an outbreak of Ebola Virus Disease (EVD) in West Africa, which was first reported in late March 2014. As of July 23, 2014, according to WHO, a total of 1,201 cases and 672 deaths (case fatality 55-60%) had been reported in Guinea, Liberia, and Sierra Leone. This is the largest outbreak of EVD ever documented and the first recorded in West Africa.
EVD is characterized by sudden onset of fever and malaise, accompanied by other nonspecific signs and symptoms, such as myalgia, headache, vomiting, and diarrhea. Patients with severe forms of the disease may develop multi-organ dysfunction, including hepatic damage, renal failure, and central nervous system involvement, leading to shock and death.
In outbreak settings, Ebola virus is typically first spread to humans after contact with infected wildlife and is then spread person-to-person through direct contact with bodily fluids such as, but not limited to, blood, urine, sweat, semen, and breast milk. The incubation period is usually 8-10 days (rarely ranging from 2-21 days). Patients can transmit the virus while febrile and through later stages of disease, as well as postmortem, when persons contact the body during funeral preparations.
Health authorities have reported that two U.S. healthcare workers at ELWA hospital in Monrovia, Liberia, have confirmed Ebola virus infection. One of the healthcare workers, a physician who worked with Ebola patients in the hospital, is symptomatic and in isolation. The other healthcare worker, a hygienist, developed fever but is showing no other signs of illness.
The recent cases in a traveler and in healthcare workers demonstrate the risk for spread of EVD in these populations. While no EVD cases have been reported in the United States, a human case, caused by a related virus, Marburg virus, occurred in Denver, Colorado in 2008. Successful implementation of standard precautions was sufficient to limit onward transmission. Other imported cases of viral hemorrhagic fever disease were also successfully managed through effective barrier methods, including a recent Lassa fever case in Minnesota.
While the possibility of infected persons entering the U.S. remains low, the Centers for Disease Control and Prevention (CDC) advises that healthcare providers in the U.S. should consider EVD in the differential diagnosis of febrile illness, with compatible symptoms, in any person with recent (within 21 days) travel history in the affected countries and consider isolation of those patients meeting these criteria, pending diagnostic testing.
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 »