The Honorable Pete Domenici
Hart Building, Room 328
Washington, DC 20510
Dear Senator Domenici:
The American Association for Clinical Chemistry (AACC), representing nearly 11,000 clinical laboratory professionals, supports your efforts, as outlined in S.422, the "Genetic Privacy and Nondiscrimination Act," to protect individuals from discrimination on the basis of their genetic data. We agree that such information must remain confidential, unless authorized by the patient, and that individuals intentionally violating patient privacy should be punished. AACC is concerned, however, that S.422 broadly defines new, additional patient rights that may hinder genetic research and the delivery of health care. Our specific concerns regarding S.422 follow:
The current definition of "genetic information" is too broad. The definition should be narrowed to information that can be used to predict disease in healthy people. DNA-based testing for infectious disease and tumor markers, which are used to characterize and manage disease in those who are already ill, should be specifically exempted from this or other genetic testing legislation. These medical data present no additional risks to patients, but may be invaluable in treating them.
In general, AACC agrees that health care providers should obtain written informed consent from the patient prior to performing a genetic analysis for predictive purposes. This information, although it can be used for beneficial purposes, such as identifying and reducing potential health risks, also can be used to deny individual’s health care insurance or employment. AACC believes that adequate legal protections should be instituted to ensure that sensitive genetic information is not casually disclosed. We are concerned, however, that S.422 goes beyond protecting genetic data to granting patients new, sweeping ownership rights over their specimens, which could adversely affect many kinds of research and the general practice of laboratory medicine.
Destruction of DNA Samples (Clinical Studies)
Further, sections 103(c)(3) & 301(a)(5) state that without the patient’s consent, the laboratory must destroy the patient sample once it has completed the analysis. We have strong reservations about these provisions. DNA samples play an important role in providing, as well as advancing of quality health care. These specimens serve many invaluable purposes, such as: (1) reagents for validating the accuracy of new tests; (2) proficiency survey samples for evaluating laboratory testing performance; and (3) test controls for ensuring testing process quality.
Clinical molecular biology laboratory directors, for example, have-long depended on the existence of DNA with known characteristics to validate new tests and to ensure that laboratories are performing these tests accurately. Laboratories should be permitted to maintain and use these samples (without patient authorization), unless the patient specifically requests that the sample be destroyed, as long as the patient identifiers are removed.
By way of background, AACC is the principal association of clinical chemists--professional laboratory scientists--including MDs, PhDs and medical technologists. AACC’s members develop and use chemical concepts, procedures, techniques and instrumentation in health-related investigations and work in hospitals, independent laboratories and the diagnostics industry nationwide. The AACC's objectives are to further the public interest and educational activities and help maintain high professional standards.
AACC looks forward to working with you on genetic testing issues. If we may be of any assistance, please call me at (708) 216-4725 or Vince Stine, Manager, Government Affairs at (202) 835-8721.
Stephen Kahn, PhD, DABCC