December 2004 Bulletin

Annual Meeting advance registration deadlines near

There’s still time to take advantage of the savings available with advance registration for the 2005 Annual Meeting in Washington, D.C. Advance registration forms with payment must be received by the Academy no later than Jan. 14, 2005. Registrations received after Jan. 14, 2005 will be returned to the sender. The deadline for advance housing reservations is Jan. 28, 2005. If you have questions about registration, please call (847) 384-4190.

FDA issues final rule on “Good Tissue Practice”

The Food and Drug Administration (FDA) has issued its long-awaited final rule on current good tissue practice, which covers the methods, facilities and controls used to manufacture these products. The new rule requires manufacturers to recover, process, store, label, package and distribute human cells, tissues and cellular and tissue-based products (HCT/Ps) in a way that prevents the introduction, transmission or spread of communicable diseases. The regulations apply to a broad range of products, including musculoskeletal tissue, corneas, human heart valves, dura mater and cellular therapies. The rule also requires manufacturers to report certain adverse reactions and HCT/P deviations, to have accurate and complete information on labels and to allow FDA inspections to ensure compliance with regulations. The new rule will go into effect on May 25, 2005 and will apply to HCT/P recovered on or after that date. The new rule is the last of three rules finalized as part of FDA’s overall plan to increase the safety of the U.S. tissue supply. Existing regulations will continue to apply to HCT/Ps recovered before May 25, 2005. Additional information can be found under “Guidances and Rules” at: http://www.fda.gov/cber/tissue/docs.htm

CMS issues guidance on requirements for hospital medical staff privileging

The Centers for Medicare and Medicaid Services (CMS) has issued a clarification on requirements for hospital medical staff privileging. The memo clarifies that a hospital’s governing body is responsible for ensuring that all practitioners who provide care in the hospital are individually evaluated by the hospital’s medical staff and that they have the appropriate qualifications and competencies. The hospital’s governing body can determine which categories of practitioners are eligible to be on its medical staff or have hospital privileges. Hospital staff must conduct individual review of practitioners at least once every two years to ensure they have the necessary qualifications and competencies for the privileges granted.

FDA approves surgical marker tag

The Food and Drug Administration (FDA) has approved an external surgical marker tag designed to minimize the likelihood of wrong-site, wrong-procedure, wrong-patient surgeries. The tag uses radio frequency identification technology to mark an anatomic site for surgery. The patient’s name and the surgical site are printed on the tag, and the inside of the tag is encoded with the type of surgery, date of surgery and surgeon’s name. The tag is scanned just before surgery to verify the information. A similar technology was approved to track drugs on their journey from manufacturing plants to pharmacists’ shelves.

Specialty physicians release 2005 legislative agenda

The Alliance of Specialty Medicine, a coalition of 14 national medical specialty societies including the AAOS, has issued its priorities for the new Congress. At the top of the list is “Fixing the nation’s broken medical liability system, by enacting reforms that will reduce frivolous lawsuits and stabilize professional liability insurance costs.” The second priority is reforming the Medicare sustainable growth rate formula used to set the yearly updates for Medicare physician reimbursements, followed by enacting and implementing patient safety legislation that protects the confidentiality of physicians and patients in reporting medical outcomes.

Orthopaedic community questions NIH open access proposal

The AAOS, the Orthopaedic Research Society and eight other orthopaedic specialty societies have expressed concerns about a National Institutes of Health (NIH) proposal to expand public access to NIH-funded research. The proposal would require researchers to submit their research to be included in a public electronic archive (PubMed Central) no later than six months after it appears in a peer-reviewed journal. In a letter to Elias Zerhouni, MD, Director of the NIH, the societies noted four specific concerns: The impact on current journal publishers; the possibility that the posted research would contain errors; the possibility that research not funded by the NIH would be considered as having “second-class” status, and the estimated yearly cost of the proposal.

JCAHO seeks nominations for 2005 Codman Award

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is accepting applications for the ninth annual Ernest A. Codman Award, which recognizes excellence in the use of outcomes measurement by organizations and individuals to achieve improvements in the quality and safety of health care. Applications are available at www.jcaho.org and must be submitted no later than February 14, 2005. Health care organizations may submit a description of any performance measurement and improvement initiative that reflects the accomplishment of a significant performance improvement. Applicant-organizations must demonstrate an organization-wide commitment and approach to data-driven improvement.


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