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| Washington State Passes Landmark Patient Lifting Law
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TENET HEALTHCARE, the Dallas-based hospital corporation, has agreed to pay 22 states and the federal government $820,000 in a settlement over concerns that some of its hospitals improperly billed Medicare and other insurers for outpatient lab services. The company itself alerted the U.S. Department of Justice in 1997, turning over evidence that hospitals had submitted claims for lab tests of questionable medical necessity and "unbundled" claims, which illegally reaped a higher reimbursement by billing related tests separately instead of grouping them into panels.
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| FDA Recalls Hernia Mesh, Issues Allograft Tissue Warning
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The FDA has issued a Class 1 recall on Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE and has updated a Public Health Notification on allograft tissue recovered by BioMedical Tissue Services.
Bard Composix Kugel Mesh. The mesh, used to repair ventral (incisional) hernias, is being recalled because the "memory recoil ring" that opens the Composix Kugel Mesh Patch after it has been inserted into the intra-abdominal space can break, according to the recall notice. This defect can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
Tissue recovered by BTS. This Public Health Notification is an update on the Oct. 26 information paper, which indicated that the human bone, skin and tendons recovered by BTS came from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases. According to the FDA, additional information regarding the reliability of blood donor samples has come to light and the agency therefore "strongly recommends that healthcare providers inform their patients who received tissue implants prepared from BTS donors that they may be at increased risk of communicable disease transmission and to offer them testing." The FDA "believes the risks from these tissues are low because the tissues were routinely processed using methods to help to reduce the risk of infectious disease," but the actual risk is unknown.
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| AAAASF Subsidiary Offers Accreditation Assistance
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The American Association for Accreditation of Ambulatory Surgery Facilities has launched a wholly-owned, for-profit subsidiary called Surgery Facilities Resources, Inc., to supply accreditation assistance products to office-based surgery practices.
The non-profit accreditation agency created the subsidiary in response to many surgery centers' inquiries about the availability of products to aid them In meeting accreditation standards and accomplishing successful surveys, says AAAASF executive director Jeff Pearcy.
"AAAASF has been aware for some time that facilities were identifying services from us that would be inappropriate for a regulatory body to provide," says James Yates, MD, AAAASF president. Dr. Yates notes that SFR, an organization not directly overseen by the AAAASF board, would have no potential conflicts of interest in providing those services.
SFR is presenting a Web-based product that will assist facilities in staying in compliance with a variety of regulatory bodies, says Mr. Pearcy. SFR is also exploring group purchasing arrangements and international accreditation, as well as a system for identifying qualified consultants to assist new facilities in the design, construction and accreditation of their offices.
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| News and Notes
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The American Association for Accreditation of Ambulatory Surgery Facilities has launched a wholly-owned, for-profit subsidiary called Surgery Facilities Resources, Inc., to supply accreditation assistance products to office-based surgery practices.
The non-profit accreditation agency created the subsidiary in response to many surgery centers' inquiries about the availability of products to aid them In meeting accreditation standards and accomplishing successful surveys, says AAAASF executive director Jeff Pearcy.
"AAAASF has been aware for some time that facilities were identifying services from us that would be inappropriate for a regulatory body to provide," says James Yates, MD, AAAASF president. Dr. Yates notes that SFR, an organization not directly overseen by the AAAASF board, would have no potential conflicts of interest in providing those services.
SFR is presenting a Web-based product that will assist facilities in staying in compliance with a variety of regulatory bodies, says Mr. Pearcy. SFR is also exploring group purchasing arrangements and international accreditation, as well as a system for identifying qualified consultants to assist new facilities in the design, construction and accreditation of their offices.
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