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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

Dec 16 2014
Baxter Voluntarily Initiates U.S. Recall of Two Lots of Sodium Chloride Injection, USP Due to the Presence of Particulate Matter

Baxter International Inc. is informing the public of a voluntary recall in the United States of two lots of 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container to the hospital/user level. The recall is being initiated as a result of two complaints (one per lot) of particulate matter that was identified as a fragment of the frangible from the vial adapter. The issue was identified upon standard visual inspection prior to patient administration.

Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number, and composition of the foreign material, and the patient's underlying medical condition. In the absence of in-line filtration, particles may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization (blockage of blood vessels, which can result in stroke, heart attack, or damage to other organs such as the kidney or liver). There have been no reported adverse events for the affected lots.

0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container is a sterile, nonpyrogenic solution for intravenous administration after admixture with a single dose powdered drug. Please see the recall notice, link below, for the specific recalled lot numbers.  Unaffected lot numbers can continue to be used according to the instructions for use.

According to the 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container product labeling, the product should be inspected visually for particulate matter and discoloration whenever solution and container permit.

Baxter has notified customers, who are being directed not to use product from the recalled lots. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.

Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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Dec 16 2014
CMS Issues Memo Clarifying Terms Implicating the Spousal Relationship in Regulations and Guidance for Medicare- and Medicaid-certified Providers and Suppliers

The Centers for Medicare and Medicaid Services has issued a memorandum to state surveyors  clarifying that the terms "spouse", "marriage," "relative," and "family," as well as other terms that implicitly or explicitly implicate the spousal relationship, such as (but not limited to) "representative," "support person," "surrogate," and "next-of-kin," include all marriages lawful where entered into, including lawful same-sex marriages, regardless of the certified provider's or supplier's location or the jurisdiction in which the spouse lives.

Section 3 of the Defense of Marriage Act (DOMA), enacted in 1996 (codified at 1 U.S.C. §7), defined "marriage" and "spouse" as follows:

"The word ‘marriage' means only a legal union between one man and one woman as husband and wife, and the word ‘spouse' refers only to a person of the opposite sex who is a husband or a wife."

However, in June 2013, the United States Supreme Court ruled that Section 3 of DOMA is unconstitutional, because it violates equal protection (United States v. Windsor, 570 U.S. 12, 133 S. Ct. 2675 (2013) ("Windsor")). After the Supreme Court's opinion in Windsor, section 3 of DOMA is no longer a barrier to the Federal government recognizing same-sex marriages when administering Federal statutes and programs.

In their memorandum, CMS states that it is clarifying guidance for provider and supplier types subject to certification the following terms: "spouse," "marriage," "family and "relative" consistently with the Windsor decision. Specifically:

  • "Spouse" means an individual who is married to another individual as a result of marriage lawful where it was entered into, including a lawful same-sex marriage, regardless of whether the jurisdiction where the provider or supplier providing health care services to the individual is located, or in which the spouse lives, permits such marriages to occur or recognizes such marriages.
  • "Marriage" means a marriage lawful where it was entered into, including a lawful same-sex marriage, regardless of whether the jurisdiction where the provider or supplier providing health care services to the individual is located, or in which the spouse lives, permits such marriages to occur or recognizes such marriages;
  • "Family" includes, but is not limited to, an individual's "spouse" (see above); and
  • "Relative" when used as a noun, includes, but is not limited to, an individual's "spouse".

Further, CMS clarifies that, except where CMS regulations explicitly require an interpretation
in accordance with State law, wherever the text of a regulation or associated guidance uses the above terms or includes a reference to a patient's or resident's "representative," "surrogate," "support person," "next-of-kin," or similar term in such a manner as would normally implicitly or explicitly include a spouse, the terms are to be interpreted consistent with the guidance above.

Effectively immediately, CMS has revised interpretive guidance found in Appendices: A (Hospitals), AA (Psychiatric Hospitals), M (Hospice), PP (Long Term Care Facilities), W (Critical Access Hospitals), and Y (Organ Procurement Organizations) to incorporate these clarifications.

Follow the link below for an advance copy of the SOM revisions and a copy of the CMS memorandum.

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Dec 15 2014
CDC Releases Health Care Personnel and Flu Vaccination, Internet Panel Survey, United States, November 2014

The U.S. Centers for Disease Control and Prevention has just released its Health Care Personnel and Flu Vaccination, Internet Panel Survey, United States, November 2014.  According to the CDC, Influenza (flu) among health care personnel (HCP) can result in medical visits and lost work days for the HCP and has the potential to spread flu to patients and other HCP, including those with chronic medical conditions, pregnant women, young children, and older people at higher risk of serious flu complications.  Flu vaccination of HCP has been shown to reduce the risk of flu and absenteeism in vaccinated HCP and reduce the risk of respiratory illness and deaths in nursing home residents.  The Advisory Committee on Immunization Practices (ACIP) recommends that all HCP receive an annual flu vaccination.

The CDC analyzed data from an Internet Panel Survey conducted from October 29-November 12, 2014 among HCP.  The results of the CDC's survey shows that flu vaccination coverage among HCP has improved but remains below the national Healthy People 2020 target of 90%:

  • Vaccination coverage measured with the Internet Panel Surveys was 67% during the 2011-12 season, 72% during the 2012-13 season, and 75% during the 2013-14 season.
  • Early season 2014-15 flu vaccination coverage among HCP was 64.3%, similar to early season coverage during the 2013-14 season (62.9%).
  • During the previous two seasons, flu vaccination coverage increased by 9-12 percentage points from early season to the end of the season.
  • By occupation, early season flu vaccination coverage was highest among pharmacists (86.7%), nurse practitioners/physician assistants (85.8%), physicians (82.2%), nurses (81.4%), and other clinical professionals (72.0%).
  • Flu vaccination coverage was lowest among administrative and non-clinical support staff (59.1%) and assistants or aides (46.6%).
  • By work setting, early season flu vaccination coverage was highest among HCP working in hospitals (78.7%).
  • Flu vaccination coverage was lowest among HCP working in long-term care facilities (54.4%).
  • Early season flu vaccination coverage was higher among HCP whose employers required (85.8%) or recommended (68.4%) that they be vaccinated compared to those HCP whose employer did not have a policy or recommendation regarding flu vaccination (43.4%).
  • Among unvaccinated HCP who did not intend to get the flu vaccination during this flu season, the most common reason reported for not getting vaccinated was that they don't think that flu vaccines work. The second most common reason was that they don't need the vaccine.

While overall HCP flu vaccination improved in the last several years, vaccination continued to be low among of assistants, aides, non-clinical support staff, and HCP working in long-term care.  The CDC recommends targeted efforts to improve coverage among these HCP groups, including ensuring convenient access to flu vaccine at the workplace at no cost to the HCP.

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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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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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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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