Genetic Identity's reference lab (GenQuest: DNA Analysis Laboratory) is accredited by the American Association of Blood Banks (AABB) and the Clinical Laboratory Improvements Amendment (CLIA) of the United States Department of Health and Human Services. There are only 42 AABB-accredited parentage testing laboratories; AABB provides a list of these accredited laboratories The Parentage Testing Accreditation Program is based on standards for the performance of tests for parentage, and provides for the assessment and accreditation of laboratories performing such tests. This accreditation helps laboratories achieve quality performance. Our laboratory participates in proficiency testing governed by the College of American Pathologists (CAP) in association with AABB. Participation in external and internal proficiency testing is part of the laboratory's quality assurance/quality control program, which assures that the highest standards and guidelines are used in the laboratory testing.
The AABB Accreditation Program strives to improve the quality and safety of all aspects of blood and parentage testing. The Accreditation Program assesses the quality and operational systems in place within the facility; the basis for assessment includes compliance with standards, codes of Federal regulations, and Federal guidance documents. This independent assessment of a facility's operations helps the facility to prepare for other inspections, and serves as a valuable tool for improving compliance and operations. Accreditation is granted for the collection, processing, testing, distribution, and administration of blood and blood components, hematopoietic progenitor cell activities, parentage testing activities, immunohematology reference laboratories, and SBB schools. For more information on the Parentage Testing program, contact Nicole Bass at or call (301) 215-6584.
Congress passed the Clinical Laboratory Improvement Amendment (CLIA) in 1988, establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results, regardless of where the test was performed. A laboratory is defined as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or the impairment or assessment of health.
In the United States, the American Association of Blood Banks (AABB) accredits private paternity laboratories. Every two years, the AABB obtains and reviews the procedures used by accredited laboratories, and also sends an inspector to each laboratory to perform an onsite inspection of equipment, laboratory procedures, paternity cases, and calculations, to make certain that everything is being performed according to proper scientific protocol.
Genetic testing to establish paternity was first acknowledged officially by the legal profession with the passage of a law in New York in 1935, which stated that ABO blood group test results could be introduced in court if performed by an individual of "acceptable expertise" (defined as a doctoral degree and training in blood banking, hematology or genetics). In 1937, the MN blood group system markers were added to the list of acceptable markers, and additional systems were added as reagents and the understanding of the genetics of blood groups improved. In the mid-1970s, with the addition of HLA serology, paternity laboratories routinely became able not only to exclude falsely accused men, but also to calculate probabilities of paternity for non-excluded men in a manner that was compelling to the courts. Such powerful and complex serological tests led both the American Bar Association and the American Medical Association to conclude that guidelines for performing tests and interpreting the results were needed. The first such fusion of law and science appeared in 1976 in the Family Law Quarterly (1). This collaborative work, prepared by physicians and legal experts, initiated a discussion on the qualifications needed for experts and for laboratories performing such tests, so the courts could accept test results without question. The discussion even extended to the proposal of an accreditation program based on generally agreed upon standards.
DEVELOPMENT OF PARENTAGE TESTING STANDARDS
The involvement of the American Association of Blood Banks (AABB) in parentage testing can be traced to the late 1970s, and grew out of a need to establish paternity as a result of the increasing number of requests to AFDC (Aid to Families with Dependent Children) for support of children living in single-parent households. The number of claims had been steadily rising since the end of World War II, not due to death or disability, but to the abandonment of families by fathers and the rise in illegitimacy in the postwar period. As one means to try to contain costs, the Federal government passed the Title IV-D legislation in 1975, which established a mechanism for identifying fathers in order to better enforce their responsibility for child support. Threshold levels of paternity establishment were set for states, which if met, resulted in financial support of their programs; if the thresholds were not met, penalties resulted.
Parentage testing relies on an expertise in serology usually found in blood bank laboratories, which are often associated with the AABB. Because of this, the AABB was a logical choice for involvement in the development of parentage testing standards. The first survey performed by the committee indicated that in 1978 there were 259 laboratories performing about 11,000 tests, with a mean caseload of about 42 cases per year. By comparison, the Annual Report on Parentage Testing for 1995, 1996 and 2000 (2-3), published by the AABB, indicated a total paternity test volume in the United States of approximately 170,000 cases in 1996 and 300,000 in 2000.
DEVELOPMENT OF ACCREDITATION GUIDELINES
The first step in the formulation of standards by the Parentage Testing Committee was the publication of the Guidelines for Reporting Estimates of Probability of Paternity (4). No procedure or policy in this first publication was mandatory; rather, the guidelines were simply recommendations. A publication of standards that included the words "must" and "shall" (i.e., requirements rather than recommendations) occurred with the implementation of an accreditation program in 1984. Accreditation and standard setting have undergone significant changes since that time; these changes have culminated in the present program, which includes an onsite inspection every two years, as outlined in the recently published Third Edition of Standards for Parentage Testing Laboratories (5). Other organizations engaged in genetic testing for identification have also established accreditation programs like that of the AABB, involving onsite inspection based on a set of mandated standards and recommended practices.
Technologies used in the dynamic field of parentage testing are changing rapidly, and any accreditation program must likewise evolve in order to remain effective at providing quality assurance to the end-user. In the coming year, the AABB Parentage Testing Committee will revisit the standards once again; with the goal of incorporating them into an ISO 9001-like format (ISO standards are internationally recognized). It is likely that other organizations that set standards for identity testing laboratories will move to this kind of format as well.
The accreditation program of the AABB has succeeded in ensuring a high level of quality in laboratory testing in cases of disputed parentage. This consistent level of overall quality has resulted in general acceptance of test results from AABB-accredited laboratories by the courts, without the need for expensive and time-consuming trials involving expert witnesses. It is likely that crime laboratories engaged in DNA typing will realize a similar benefit from a widespread accreditation program devoted to the forensic use of genetic testing.
1. Miale et al. (1976) Joint AMAA/ABA guidelines: Present status of serologic testing in problems of disputed parentage. Family Law Quarterly 10, 247.