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: StayAlert! - Immediate Regulatory Updates Icon

StayAlert! Headlines

Jul 21 2014
American Health Packaging Announces the Voluntary Nationwide Recall of Ibuprofen Tablets, USP, 600 mg, 100 Hospital Unit Dose and Oxcarbazepine Tablets, 300 mg, 100 Hospital Unit Dose

American Health Packaging (Columbus, OH) has voluntarily recalled Lot #142588, Expiration Date, 01/2016 of Ibuprofen Tablets, USP, 600 mg, in a hospital unit dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300 mg, lot #142544.

In addition, American Health Packaging (AHP) has voluntarily recalled Oxcarbazepine Tablets, 300 mg, lot #142544, Expiration Date, 02/2016. This voluntary recall is the result of mislabeled inner unit dose blister packaging which could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine.

Affected products as follows:

  • Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Ibuprofen Tablets, USP, 600 mg, with outer carton NDC#: 68084-703-01 and individual dose NDC#: 68084-703-11, Lot #142588, Expiration Date, 01/2016. The drug product can be identified by physical description: white, oval-shaped, film-coated tablets, with "IP 465" printed on one side.
  • Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Oxcarbazepine Tablets, 300 mg, with outer carton NDC#: 62584-143-0 and individual dose NDC#: 62584-143-11, Lot #142544, Expiration Date, 02/2016. The drug product can be identified by physical description: yellow color, capsule shaped, film-coated tablets scored and debossed with '184' on one side and scored on other side.

These hospital unit dose products were distributed nationwide beginning June 20, 2014. No other products or lots were affected by this incident.

To date, AHP has received one (1) customer complaint which resulted in the investigation and recall of these drug products. AHP has not received any adverse event reports attributable to the mislabeled drug.

American Health Packaging initiated a voluntary product recall on July 1, 2014 as a safety precaution, and will continue to closely monitor for reports of adverse drug reactions and product complaints. Notification of the recall has been sent to distributors who received the affected product with instructions on how to notify their customers.

Consumers who have received the recalled product should immediately discontinue use and contact GENCO Pharmaceutical Services at 855-419-4608 from 7am to 5pm CST for instructions on returning the recalled product.

For medical information questions or product complaints related to Oxcarbazepine Tablets, 300 mg or Ibuprofen Tablets, USP, 600 mg please contact American Health Packaging customer service at 1-800-707-4621 from 8am to 4pm EST.

Any adverse events that may be related to the use of these products should be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or on the MedWatch website at http://www.fda.gov/safety/medwatch/default.htm.

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Jul 21 2014
Unique Pharmaceuticals, Ltd. Announces a Voluntary Nationwide Recall of all Sterile Compounded Preparations within Their Expiry Period Due to a Lack of Sterility Assurance

Unique Pharmaceuticals, Ltd., ("Unique" or "the Company") announced a voluntary nationwide recall of all sterile drug preparations compounded by the outsourcing facility that have not reached the expiration date listed on the products.

Unique is initiating the recall due to the FDA's concerns associated with Unique's compounding facilities and compounding processes that the FDA contends presents a lack of sterility assurance and were observed during recent FDA inspections.

To date, Unique has received no reports of injury or illness associated with the use of its sterile preparations.

The recall includes all sterile compounded preparations that Unique has supplied to its customers within expiry. Non-sterile preparations are not affected by this recall. The affected products were distributed in syringes, vials, and bags.

The preparations covered by this recall were distributed nationwide. Until further notice, health care providers should stop using all lots of sterile products prepared by Unique that are within their expiry period and return them to the Company.

Unique will be notifying customers by phone, fax, mail, or personal visits to return the products to the Company.

Consumers or health care providers with questions regarding this recall may contact Unique by phone at [888-339-0874] from the hours of 9 a.m to 5 p.m. CST Central Time, Monday through Friday, or at the following e-mail address:recall@upisolutions.com

Any adverse events that may be related to the use of these products should be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or on the MedWatch website at http://www.fda.gov/safety/medwatch/default.htm.

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Jul 21 2014
AHA Issues Antimicrobial Stewardship Toolkit for Hospitals

The American Hospital Association (AHA), along with six national partners, recently released a toolkit to help hospitals and health systems enhance their antimicrobial stewardship programs.

The AHA states that the toolkit includes resources for hospital leaders, clinicians and patients, starting with a tool developed by the Centers for Disease Control and Prevention to help hospitals assess their readiness for optimal antibiotic prescribing and use.

According to the Centers for Disease Control and Prevention (CDC),"Antibiotics have transformed the practice of medicine, making once lethal infections readily treatable and making other medical advances, like cancer chemotherapy and organ transplants, possible.  However, 20-50% of all antibiotics prescribed in U.S. acute care hospitals are either unnecessary or inappropriate."

"The misuse of antibiotics has also contributed to the growing problem of antibiotic resistance, which has become one of the most serious and growing threats to public health.  Unlike other medications, the potential for spread of resistant organisms means that the misuse of antibiotics can adversely impact the health of patients who are not even exposed to them."

The CDC estimates more than two million people are infected with antibiotic-resistant organisms, resulting in approximately 23,000 deaths annually.

Components of the toolkit include the CDC's Core Elements of Hospital Antibiotic Stewardship Programs and the Checklist for Core Elements of Hospital Antibiotic Stewardship Programs. 

  • The CDC's Core Elements of Hospital Antibiotic Stewardship Programs summarizes core elements of successful hospital Antibiotic Stewardship Programs.  It complements existing guidelines on ASPs from organizations including the Infectious Diseases Society of America in conjunction with the Society for Healthcare Epidemiology of America, American Society of Health System Pharmacists, and The Joint Commission. 
  • The Checklist for Core Elements of Hospital Antibiotic Stewardship Programs should be used to systematically assess key elements and actions to ensure optimal antibiotic prescribing and limit overuse and misuse of antibiotics in hospitals. 

The CDC recommends that all hospitals implement an Antibiotic Stewardship Program.

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MCN Healthcare: Policy Library - Customizable Policy Documents Icon

Featured Policy Library Manuals

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Ambulatory Surgical Center and Outpatient Surgery Department Policy and Procedure Manual

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.

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Policy Library Manuals: Central Service Policy and Procedure Manual Icon
Central Service Policy and Procedure Manual

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.

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Policy Library Manuals: Post Anesthesia Care Policy and Procedure Manual Icon
Post Anesthesia Care Policy and Procedure Manual

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.

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