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House Passes Bills on Newborn Screening, Cytology Proficiency

On April 8, the House approved, by voice vote, two bills, the Newborn Screening Saves Lives Act (S. 1858) and the Cytology Proficiency Improvement Act of 2008 (H.R. 1237). The House Energy and Commerce Committee approved the bills on March 13 (see The Source, 3/14/08).

Newborn Screening Saves Lives Act

Sponsored by Sen. Chris Dodd (D-CT), the bill would authorize grants to support state and local public health agencies’ screening of newborns and children with, or at risk for, heritable disorders, fund training for health care professionals to conduct screenings, and establish “a system to assess and coordinate treatment relating to congenital, genetic, and metabolic disorders.” The bill provides $15 million for FY2008 and slightly increased amounts each year through FY2012.

Rep. Lois Capps (D-CA) said, “This legislation would facilitate the creation of federal guidelines on newborn screening and would assist state newborn screening programs in meeting these guidelines. Newborn screening is used for early identification of infants affected by certain genetic, metabolic, hormonal, and functional conditions for which there may be an effective treatment or intervention. If left untreated, these disorders can cause death, disability, mental retardation, and other serious conditions. Every year, more than 4 million infants are born and screened to detect conditions that could threaten their lives and their long-term health. S.1858 will educate parents and health care providers about newborn screening. It will improve follow-up care for infants when illness is detected, and it will help states expand and improve their newborn screening programs.”

Rep. Thomas Reynolds (R-NY) said, “Each year, over 4 million children are routinely tested at birth for genetic disorders. But what so many parents don’t realize is that the actual number of conditions that their child is screened for depends on the state they live in. A child’s life in one state should never mean more or less than a child’s life in another. Every child born with a disease, whether it is common or rare, should receive early diagnosis and treatment…In 2004, the American College of Medical Genetics completed a report…which recommended, at a minimum, every baby born in the United States be screened for a core set of 29 treatable disorders. Currently, only 19 states and the District of Columbia require infants to be screened for all 29 of the recommended disorders. It is my sincere hope through grants and research funding provided for in the Newborn Screening Saves Lives Act, every state will be able to coordinate their newborn screening tests in order to bring consistency across the country.”

Cytology Proficiency Improvement Act

Sponsored by Rep. Gordon Bart (D-TN), the bill would require that employees of clinical laboratories “involved in screening and interpreting cytological preparations at the laboratory participate annually in a continuing medical education program in gynecologic cytology” and that program results for each individual be submitted “to the laboratory’s accrediting organization for purposes of review and on-going monitoring by the accrediting organization.”

Rep. Lois Capps (D-CA) said, “I rise in support of H.R. 1237, the Cytology Proficiency Improvement Act of 2007. This legislation would modernize federal regulations under the Clinical Laboratory Improvement Amendments Act of 1988 (CLIA) [P.L. 100-578]  that subject those who screen and interpret Pap tests to annual proficiency testing. In 2005, CMS [the Centers for Medicare & Medicaid Services] launched a program to begin testing pathologists and other laboratory professionals who performed Pap tests for proficiency. However, the program was designed using regulations written in 1992. In the 13 years between the regulation and the program’s start, significant investments were made in the science and practice of Pap tests. Instead of relying on outdated practices, H.R. 1237 draws on the best that science and technology has to offer. H.R. 1237 has 175 bipartisan cosponsors, including myself and every other female member of the Energy and Commerce Committee.”

Rep. Sue Myrick (R-NC) said, “The current oversight model that CMS is using is intended to help ensure that Pap tests are being read accurately, to improve public health. However, the approach established more than a decade ago, and being used today, doesn’t necessarily protect women, improve quality, or further our fight against cervical cancer. H.R. 1237 provides an alternative. It redirects the current ‘testing’ scheme to require pathologists and other lab technicians who read Pap tests to participate in an annual continuing medical education (CME) program, where their skills would be assessed and where the latest advances in Pap test practice could be shared. It would complement extensive Pap test quality controls that labs must already meet under the Clinical Laboratory Improvement Act…I’ve talked to pathologists in my district to better understand what it would take to add value to their profession, rather than just more red tape…The laboratory and medical community support this bill, and I’m pleased to support it.”

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