ASM Presentations to ClIAC and CLSI
The Centers for Medicare & Medicaid Services (CMS) recently issued a memo to State Survey Agency Directors to inform them of a revised policy regarding quality control (QC) for commercially available microbial identification systems allowable under the Clinical Laboratory Improvement Amendments (CLIA). The revised policy allows for streamlined QC for such systems as provided in the Clinical Laboratory Standards Institute (CLSI) document, M50-A, “Quality Control for Commercial Microbial Identification Systems, Approved Guideline.” The CMS memo outlines a four-step process with certain requirements to allow for streamlined QC.
Accredited laboratories must have appropriate documentation from their manufacturers before labs can initiate streamlined QC. Accreditation organizations must modify accreditation standards to allow for streamlined QC of commercial microbial identification systems in laboratories, and must notify CMS of the standards change. Interested laboratories should check with manufacturers and accrediting organization for more details.
In 2005, the ASM sent a survey to users of commercial microbial identification systems to assess QC failure rates. The ASM presented the survey data to the Clinical Laboratory Improvement Advisory Committee (CLIAC) and the CLSI in 2006; ASM recommended that the CLSI develop a guideline to allow for streamlined QC. The CLSI used ASM’s survey data as a basis for its M50-A guideline.
The ASM has contacted the College of American Pathology (CAP) and the Joint Commission accrediting programs to inform them of the CMS policy change, which is effective immediately. CAP informed the ASM that it is in the process of modifying accreditation standards; the Joint Commission informed the ASM that it is considering modifications to its standards. CMS will incorporate the policy change into the next revision of the CLIA Interpretive Guidelines for Laboratories and Laboratory Surveyors.
The Centers for Medicare & Medicaid Services posted the scheduled release of modifications to the Healthcare Common Procedure Coding System (HCPCS) code set to incorporate new changes.
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The Centers for Medicare & Medicaid Services (CMS) recently posted the transcript of its ICD-10-CM/PCS National Provider Conference Call for Other Part A and Part B Providers on its website. The conference call occurred on November 12, 2008.
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Importance of Influenza Vaccination for Health Care Personnel
National Influenza Vaccination Week
The Food and Drug Administration (FDA) is urging health care organizations to ensure that influenza vaccination programs are available for health care personnel (HCP). Because unvaccinated HCP can be a primary cause of outbreaks in health care settings, annual workplace immunization programs decrease the likelihood of contracting influenza and the chance of infecting others.
The Centers for Disease Control and Prevention (CDC) recently revised its guidance document for testing of suspected human cases of highly pathogenic avian influenza A (H5N1) virus infection in the United States. The guidance document revises the interim guidance issued in 2006, and reflects current knowledge regarding human infection with H5N1 viruses. The document, “Interim Guidance for Laboratory Testing of Persons with Suspected Infection with Highly Pathogenic Avian Influenza A (H5N1) Virus in the United States” is available on-line.
The Centers for Disease Control and Prevention (CDC) released its Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. The Guideline presents evidence-based recommendations on the preferred methods for cleaning, disinfection and sterilization of patient care medical devices. It also presents recommendations for cleaning and disinfecting the healthcare environment.
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On December 3, the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism released and presented its report, “World at Risk.” The report calls for the continuation of Administration policies to address the threat of terrorism and the proliferation of weapons of mass destruction.