PubMed · 8415110
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P Mangan. Home rules.. https://pubmed.ncbi.nlm.nih.gov/8415110/
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The Federal Register System is comprised primarily of two major publications, the Federal Register and the annually revised Code of Federal Regulations. These two publications work together to provide an up-to-date version of any agency regulation. To understand the system, one must understand each separate publication and the relationship between the two. Copies of home healthcare-proposed regulations are often made available to members through the National Association for Home Care and state home care associations. Other options include federal depository libraries, reprints of a specific issue for a fee, or a subscription for CD-ROM on a monthly basis.
Five-year retrospective review of negative or normal smears in patients with newly diagnosed high-grade squamous intraepithelial lesions or cancer is a federal regulation for all laboratories practicing gynecologic cytology under the Clinical Laboratory Improvement Amendments of 1988. Amended reports are required when significant discrepancies are found that would affect patient care. The focus of this regulation is current patient care. Two studies have found a retrospective discrepancy rate of about 10% when the threshold for discrepancy was at least dysplasia. Higher rates are reported when missed atypical cases are counted as discrepancies. Retrospective review highlights problem areas for laboratory education and quality improvement efforts, but liability concerns have been a detrimental consequence of this regulation. Clarification that amended reports be issued only when current patient care is affected should aid laboratories in complying with this regulation.
The Clinical Laboratory Improvement Amendments of 1988 requires a 5-year retrospective review of negative or normal smears in patients with diagnoses of high-grade squamous intraepithelial lesions or cancer, and amended reports are required when discrepancies that would affect current patient care are found. Notwithstanding the requirements of the Clinical Laboratory Improvement Amendments of 1988, one laboratory has been required by a State Department of Health to issue amended reports even when the discrepancy did not affect current patient care. The implications of notifying the patient and her physician of any discrepancy in a Papanicolaou smear may lead to media attention and litigation. This paper outlines how amended reports and/or correspondence to patients and physicians can be utilized to generate media attention and litigation and what laboratories can do to combat the litigation.