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Helpful MCN Healthcare Resources
Baxter Voluntarily Initiates U.S. Recall of Two Lots of Peritoneal Dialysis Solution Due to Presence of Particulate Matter
Baxter International Inc. is informing healthcare professionals of a voluntary recall in the United States of two lots of DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II) to the hospital/user level. The recall is being initiated due to the presence of oxidized stainless steel, garment fiber, and PVC particulate matter identified during the manufacturing process. To date, no adverse events or related product complaints have been associated with the recalled products, which were distributed to dialysis centers, facilities, distributors, and patients in the United States.
DIANEAL is a peritoneal dialysis (PD) solution for use in chronic renal failure patients being maintained on peritoneal dialysis therapy. Intraperitoneal administration of a product with particulate matter may cause local inflammation with foreign body reaction or result in adhesion formation. The particulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to a fatal outcome.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. According to the DIANEAL PD Solution product labeling, the container should be inspected visually for signs of leakage prior to use. Solutions that are cloudy, discolored, contain visible particulate matter, or show evidence of leakage should not be used.
Baxter notified customers by recall letter to instruct them to locate and remove any affected product from their facility. All patients who received product from the affected lots also were contacted by recall letter and provided instructions to arrange for product return. Dialysis centers, facilities, distributors, and patients should stop use and return to place of purchase. The affected lots were distributed to customers between May 30, 2014 and July 9, 2014.
Healthcare providers who received affected product should return it 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 or requiring replacement product can call Baxter Home Care Services at 1-800-284-4060, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m. Central Time. Patients should be instructed to contact their physician or PD nurse if they have experienced any problems that may be related to taking or using this drug product.
Critical Access Hospitals (CAH) are required by 42 CFR 485.623(b)(1) to have preventive maintenance programs in place to ensure all essential mechanical and electrical equipment ("facility" equipment), and patient-care ("medical") related equipment is maintained in safe operating condition and in a manner that ensures the safety and well-being of patients. Facility equipment refers to devices intended to support the physical environment of the CAH; medical equipment refers to devices intended to be used for diagnostic, therapeutic, or monitoring care provided to a patient by a CAH. Compliance with this regulation is usually achieved when CAHs perform equipment maintenance in accordance with the manufacturer's recommendations and maintains documentation of the manufacturer's recommendations as well as of the CAH's actual maintenance activities.
A CAH may adjust its maintenance, inspection, and testing frequency and activities for facility and medical equipment from what is recommended by the manufacturer, based on a risk-based assessment, unless any of the following are applicable:
- Other Federal or state law, or CAH Conditions of Participation (CoPs) require adherence to manufacturers' recommendations and/or set specific requirements. For example, the National Fire Protection Association (NFPA) Life Safety Code (LSC) requirements incorporated by reference at 42 CFR 485.623(d) have some provisions pertinent to equipment maintenance, and compliance with these requirements is assessed on Federal surveys; or
- The equipment is imaging/radiologic equipment or a medical laser device; or
- Equipment is now and without a sufficient amount of maintenance history.
CAHs electing to adjust facility or medical equipment maintenance from manufacturer recommendations must develop policies and procedures outlining the adjusted maintenance procedures and maintain documentation supporting their Alternate Equipment Management (AEM) program. They must adhere strictly to the AEM activities and/or frequencies they establish. Further CAH's must be able to demonstrate that qualified personnel, whether employees or contractors, are making the decisions to place equipment in the AEM program, performing the risk-based assessments, establishing the alternate equipment maintenance requirements, managing the AEM program, and performing the maintenance in strict accordance with the AEM policies and procedures.
Included with today's notice is an example Alternate Equipment Management policy.
The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) has released guidance for submitting a contractor self-disclosure. The OIG's contractor self-disclosure program provides a means for contractors to self-disclose potential violations of the False Claims Act and various Federal criminal laws involving fraud, conflict of interest, bribery or gratuity.
The Federal False Claims Act (FCA) (31 USC § 3729-33) is designed to combat fraud and recover losses resulting from fraud in federal programs, such as Medicare and Medicaid. Violations of the False Claims Act can include "knowingly": Submitting a false claim for payment, making or using a false record or statement to obtain payment for a false claim, conspiring to make a false claim or get one paid, or making or using a false record to avoid payments owed to the US Government. Hospitals are required to educate their employees on the False Claims Act and to establish the expectation that employees, contractors or agents who suspect fraud should report it to the hospital. However, employees, contractors or agents who are not comfortable reporting to the hospital may report directly to the federal Department of Justice. Additionally, it is a violation of Federal law to retaliate against anyone who informs the hospital or the federal government of a possible false claims act violation.
The Federal Acquisition Regulation (FAR) requires certain Federal contractors (those with contracts valued over $5,000,000) to disclose when they have credible evidence of one of these violations. These contractors are required to make their disclosures to the Office of Inspector General. HHS OIG accepts contractor self-disclosures regarding contracts awarded by any HHS Operating or Staff Division.
Contractor self-disclosures are made with no advance agreement regarding possible OIG resolution of the matter and with no promises regarding potential civil or criminal actions by the U.S. Department of Justice. Prompt disclosure, full cooperation, completed access to necessary records, restitution, and adequate corrective actions are key indicators of an attitude of contractor integrity even in the wake of self-disclosures of potential criminal liability.
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 »