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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

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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

MCN Healthcare: StayAlert! - Immediate Regulatory Updates Icon

StayAlert! Headlines

Jul 29 2014
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.

Recommendation:

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.

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Jul 28 2014
OASIS-C1 Implementation Update

The Centers for Medicare and Medicaid Services (CMS) informing Home Health Agency provides of an update for the OASIS-C1 implementation.  As StayAlert reviewed in May 7, 2014 the implementation date for OASIS-C, originally scheduled for October 1, 2014 has been postponed. 

The Protecting Access to Medicare Act of 2014 (PAMA) was enacted in April 2014.  PAMA delayed adoption of ICD-10 until at least October 1, 2015.  CMS has determined that the ICD-10 delay will have an impact on the Home Health Quality Reporting Program and more specifically on the implementation of OASIS-C1 because the 5 data items contained in OASIS-C1 require the use ICD-10 codes.

In light of the fact that ICD-10 has been delayed until at least October 1, 2015, CMS has determined that it is necessary to make interim changes to the OASIS-C1 data items set and also the process for the reporting of OASIS-C1 data. The following is a summary of the changes that CMS will be making in the Home Health Quality Reporting Program:

A. OASIS-C1 Implementation

1. A modified version of OASIS-C1 will be created, in which the 5 items that use ICD-10 codes (i.e. - M1011, M1017, M1021, M1023, M1025) will be replaced with the corresponding ICD-9 based items from OASIS-C (i.e. - M1010, M1016, M1020, M1022, M1024).   This modified version of OASIS-C1 that will be referred to as "OASIS-C1/ICD-9 Version."

2. The current version of the OASIS data set (OASIS-C) will remain in effect until 11:59:59 p.m. on 12/31/2014;

3. The OASIS-C1 / ICD-9 Version will go into effect at 12:00 a.m. on 01/01/2015 and shall remain in effect until ICD-10 is implemented or until otherwise determined by CMS. 

B. Conversion to Assessment Submission and Processing (ASAP) System

1. OASIS submissions to the State system will discontinue starting at 6:00 p.m. ET on 12/26/2014. The HHA State submission system will no longer be used for OASIS submissions. New, modification, or inactivation records in the current flat file format must be submitted prior to 6:00 p.m. ET on 12/26/2014.

2. Effective January 1, 2015, OASIS assessment data will be submitted to CMS via the Assessment Submission and Processing system. With the implementation of the OASIS ASAP system, Home Health Agencies will no longer submit OASIS assessment data to CMS via their State databases.

C. Payment Grouper Updates

1. An updated home health payment grouper will be provided to accommodate assessments submitted 10/01/2014 and later using OASIS-C and ICD-9-CM codes;

2. An updated home health payment grouper will be provided to accommodate assessments submitted 01/01/2015 and later using OASIS-C1 and ICD-9-CM codes;

3. At this time, a new home health payment grouper update is not planned until 10/01/2015.

Additionally, on September 3, 2014, CMS's Survey and Certification Group is sponsoring a webinar on "OASIS-C1/ICD-9". The topics of this 1 ½ hour webinar will include:

  • The new OASIS-C1/ICD-9 data set and its implementation, scheduled for January 1, 2015;
  • Types of changes made to the data set;
  • OASIS-C1/ICD-9 Guidance Manual changes; and
  • OASIS Q&As update.

Please see the attached memorandum form CMS for additional information and for webinar call-in instructions.

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Jul 25 2014
Class I Recall - GE Healthcare, LLC - Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC)

A recall has been issued for the GE Healthcare, LLC, Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC).  The affected CO2 detectors may fail or provide incorrect CO2 values for mechanically and spontaneous ventilated patients.

  • Manufacturing Dates: February 10, 2012 through October 2, 2012
  • Distribution Dates: February 2012 to April 2014
  • Affected Product Details:
    • Single-Width Airway Modules (E-miniC) -Serial Numbers 6818561 through 6898777.
    • The Extension Modules N-FC and N-FCREC - Serial Numbers 6799191 through 6905206.
    • The serial number can be found on the device plate attached to the module.

 There have no reports of injuries or deaths assocated with the malfunctioned devices to date.

On June 11, 2014, the firm sent an Urgent Medical Devise Correction Letter (see below under Resources) to their customers. The letter identified the affected products, problem and provided safety instructions.  Customers should read the letter and follow the instructions provided. 

For questions about this Recall, customers may contact GE Healthcare Technical Support at 1-800-558-7044, Monday - Friday, 8:00 am  - 5:00 pm, Central Time or the local service representative.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch:  The FDA Safety Informatin and Adverse Event Reporting Program either online, by regular mail or by FAX.

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MCN Healthcare: Policy Library - Customizable Policy Documents Icon

Featured Policy Library Manuals

Policy Library Manuals: Ambulatory Surgical Center and Outpatient Surgery Department Policy and Procedure Manual Icon
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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