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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StayAlert! Headlines

Feb 27 2015
CMS Issues Memorandum on the Potential Adverse Impact of Lower Relative Humidity (RH) in Operating Rooms (ORs)

The U.S. Centers for Medicare and Medicaid Services (CMS) has issued a memorandum on the potential adverse impact of lower relative humidity (RH) in operating rooms (ORs).  According to CMS, regulations governing hospitals and CAHs require compliance with the 2000 Edition of the National Fire Protection Association (NFPA) 101: LSC, including the mandatory references of the LSC, such as the 1999 Edition of NFPA 99: Health Care Facilities. The NFPA 99 requires that mechanical ventilation systems supplying hospital anesthetizing locations, as defined by NFPA 99, have the capability of controlling RH at a level of 35 % or greater.

In April 2013 CMS issued a categorical waiver (S&C 13-25-LSC & ASC) to the above regulations which permits hospitals and CAHs with new and existing ventilation systems supplying anesthetizing locations to operate with a RH level of 20 % or greater in accordance with American Society for Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE) Standard 170, Ventilation of Health Care Facilities. Lowering the required minimum RH level to 20 % was intended to provide adequate humidity levels for patient health and safety, while alleviating unreasonable hardship on healthcare facilities. Note that Ambulatory Surgical Centers (ASCs) are not subject to all of the same LSC provisions as hospitals and CAHs, and thus the categorical waiver is not needed in an ASC that chooses to use lower RH in its ORs.

It has subsequently come to light that an RH level <30% is not compatible with the instructions for use (IFUs) for some sterile supplies and electro-medical equipment used in operating rooms. Multiple health-care related organizations convened by AAMI in 2014 to discuss this topic came to a consensus and released a Joint Communication on January 5, 2015; a link to that communication is below.

Among other things, the Joint Communication notes that:

  • While manufacturers of supplies and equipment will be expanding the lower level of the RH range in which their products may function to 20%, the pace of this change is likely to take time.
  • For facilities that continue to use older equipment it could be many years before this older equipment is replaced and all of the equipment they use will function appropriately at lower RH levels.

The Joint Communication offers a number of useful questions health care facility leadership should ask when assessing the risk of reducing RH in their ORs in light of the potential impact on equipment and supplies.

At this time CMS expects hospitals, CAHs and ASCs to follow the current IFUs for supplies and equipment used in their ORs. Failure to adhere to the IFUs must be cited, even if the facility has opted to use the categorical waiver of the LSC RH requirements. Citations would fall under §482.41(c)(2) for hospitals, §485.623(b)(1), for CAHs, and §415.44(a)(1) for ASCs.

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Feb 26 2015
CMS Seeks Input on Current Conditions for Coverage for ESRD Facilities

The Clinical Standards Group (CSG) in the U.S. Centers for Medicare and Medicaid Services (CMS) Center for Clinical Standards and Quality (CCSQ) is responsible for developing, updating and overseeing the CMS regulations on the Conditions for Coverage (CfCs) for end stage renal disease (ESRD) facilities.

According to CSG, the current ESRD regulations were last revised in 2008; therefore, CSG is asking the ESRD community to review the current Conditions for Coverage (CfCs) and provide suggestions for additions/changes/obsoletions that may be useful in a future update to the current regulations.

At this time there is no deadline for this comment period.  Follow the link below to access the current ESRD CfC's.  CSG is requesting that suggestions for future updates to the CMS regulations on the Conditions for Coverage (CfCs) for ESRD facilities be emailed to ESRDCSG@cms.hhs.gov.

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Feb 26 2015
Heritage Pharmaceuticals Recalls Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg Vial

Heritage Pharmaceuticals Inc. is informing health care professionals of their voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Heritage. Heritage has initiated this voluntary recall to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer's site potentially impacting product sterility. See the Press Release, link provided below for a listing of affected lot numbers.

Intravenous administration of non-sterile injection products to a normally sterile site may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity (permanent organ damage), or fatal outcome. To date, Heritage is not aware of any adverse patient events resulting from the use of the subject product lots.

The products were distributed to hospitals, wholesalers and distributors nationwide from December 2012 through January 2015 (Colistimethate) and from October 2014 through January 2015 (Rifampin). Colistimethate is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacteria. Rifampin is indicated for the treatment of all forms of tuberculosis. Customers are being notified by fax, email, UPS, and/or certified mail that includes arrangements for return of all recalled product.

Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of, and return the recalled lots of product. Customers who may have further distributed these products have been requested to identify their customers and notify them at once of this product recall. Any questions about returning unused product should be directed to the customer call center at (866) 901-1230 M-F 9am-5pm EST. Healthcare workers who have medical questions about Colistimethate for Injection, USP, 150 mg base/vial and Rifampin for Injection USP, 600 mg/vial may contact Heritage Medical Affairs(732-429-1000, Ext. 101) M-F 9am-5pm EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.


Read the MedWatch Safety Alert and the firm press release by following the links below.

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MCN Healthcare: Policy Library - Customizable Policy Documents Icon

Featured Policy Library Manuals

Policy Library Manuals: Utilities and Equipment Management Policy and Procedure Manual Icon
Utilities and Equipment Management Policy and Procedure Manual

MCN’s Utilities and Equipment Management Policy and procedure Manual is a reference guide that is compliant with Joint Commission, NIAHO and CIHQ standards and CMS regulations. MCN provides easy-to-use policies and procedures that are field tested and proven - you need only to customize them to your healthcare organization. Policies and procedures include Utility Systems Management Plan, Alternative Equipment Maintenance Program, Clinical Alarms, Emergency Power and much more!

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Policy Library Manuals: Administrative Manual for Critical Access Hospitals Icon
Administrative Manual for Critical Access Hospitals

MCN Healthcare’s Administrative Manual for Critical Access Hospitals is specifically designed to assist critical access hospitals meet CMS, TJC and NIAHO standards for CAHs. This manual provides over 275 ready-to-implement policies, procedures and forms in an easy-to-customize Word format, and is designed to demonstrate compliance with CAH regulations. Transplant Safety polices are also included in this manual.

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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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