Your Complete Policy Management Partner
Everything your healthcare organization needs to confidently maintain accreditation compliance.
Robust document control and workflow management software solution
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.
Beverly McKenzie, Compliance Programs Director, IASIS Healthcare
Helpful MCN Healthcare Resources
Hospira, Inc. announced a voluntary nationwide recall to the user level for one lot of 0.25% Marcaine (Bupivacaine HCl Injection, USP), 10 mL, Single-dose Vial - Preservative Free (NDC 0409-1559-10), Lot 34-440-DD. The recall is due to a confirmed customer report of discolored solution with visible particles embedded in the glass as well as discolored solution. Hospira has attributed the embedded particulate to a supplier's glass defect.
If the particulate goes undetected and solution is administered, it could block administration of the drug to the patient, causing a delay in therapy. Other risks include local inflammation, mechanical disruption of tissue or immune response to the particulate.
Marcaine is packaged 10 units per carton/100 units per case in glass fliptop vials. The impacted lot of Marcaine was distributed December 2013 through January 2014 to wholesalers/distributors, hospitals and clinics nationwide.
Hospira is working with its supplier on implementing corrective and preventive actions.
Anyone with an 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 will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle for returns processing. For additional assistance, call Stericycle at 1-877-546-7642 (M-F, 8 a.m - 5 p.m. ET).
Read the MedWatch Safety Alert, including a link to the press release, at the link below.
Two entities have paid the U.S. Department of Health and Human Services Office for Civil Rights (OCR) $1,975,220 collectively to resolve potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules. Both entities' HIPAA violations resulted from unencrypted laptops being stolen from a facility and these major enforcement actions underscore the significant risk to the security of patient information posed by unencrypted laptop computers and other mobile devices.
According to OCR, mobile device (including laptops) security is the obligation of a covered entity or business associate. The message from these enforcement actions is clear - encryption is the best defense against these incidents.
A valuable lesson gleaned from the two resolution agreements is that having polices about encryption is not sufficient. Policies must always reflect what is happening in practice. In the investigation against Concentra Health Services (Concentra) OCR found that Concentra had previously recognized in multiple risk analyses that a lack of encryption on its laptops, desktop computers, medical equipment, tablets and other devices containing electronic protected health information (ePHI) was a critical risk. While steps were taken to begin encryption, Concentra's efforts were incomplete and inconsistent over time leaving patient PHI vulnerable throughout the organization. OCR's investigation further found Concentra had insufficient security management processes in place to safeguard patient information.
HIPAA compliance risk analysis and corresponding risk management plans should include specific security measures to reduce the risks to and vulnerabilities of its ePHI. And, of course, these plans must be implemented.
OCR has six educational programs for health care providers on compliance with various aspects of the HIPAA Privacy and Security Rules. Each of these programs is available with free Continuing Medical Education credits for physicians and Continuing Education credits for health care professionals, with one module focusing specifically on mobile device security. Follow the link below to access these educational programs.
The US Food and Drug Administration (FDA) in informing health care professionals, via a new Drug Safety Communication, that injection of corticosteroids (including methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone) into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The injections are given to treat neck and back pain, and radiating pain in the arms and legs. The effectiveness and safety of epidural administration of corticosteroids have not been established, and FDA has not approved corticosteroids for this use.
The FDA is requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.
To raise awareness of the risks of epidural corticosteroid injections in the medical community,the FDA's Safe Use Initiative convened a panel of experts, including pain management experts to help define the techniques for such injections which would reduce preventable harm. The expert panel's recommendations will be released when they are finalized. The FDA will convene an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections and to determine if further FDA actions are needed. StayAlert is monitoring this topic and will provide additional information as it becomes available.
Patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. See the Drug Safety Communication for a Data Summary and additional information for both patients and healthcare professionals.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communications, at the link below.
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 »