provide expert consultants to CAP to establish laboratory certification in cytogenetics, biomedical genetics, and DNA-based diagnostics. In paternity testing, the American Association of Blood Banks (AABB) has developed laboratory-certification actions for protein typing methods and is establishing a set of standards for clinical DNA testing laboratories. AABB has also entered into discussions with CAP to codevelop proficiency testing for specialty laboratories. Additionally, the American Society for Histocompatibility and Immunogenetics has considered standards for histocompatibility testing, including DNA analysis.4
Mandatory government accreditation plays an essential role. Personnel certification and laboratory licensing are required in medicine, and formal requirements are set by state and federal regulatory bodies. Physicians, physician's assistants, medical technologists, laboratories, and others are licensed by states. Moreover, since 1967, a federal process of accreditation has been mandated for medical laboratories under the Clinical Laboratory Improvement Act (CLIA). In 1988, that process was expanded and restructured to enhance performance of laboratories involved in human DNA diagnostic programs. Officials responsible for implementing CLIA have recently initiated discussion with CAP for the purpose of codeveloping proficiency testing.
Medical accreditation programs have substantial force behind them. Government accreditation is mandated by law; private accreditation is often mandated as a component of government regulation; and both kinds of accreditation are required by third-party payers (e.g., insurance carriers) for payment.
Some initial efforts at developing accreditation and licensing standards for forensic DNA typing are already under way, as follows.
The American Society of Crime Laboratory Directors (ASCLD) is a professional organization of approximately 350 members that has represented forensic-science laboratory directors since 1975. Although most forensic laboratories in the United States are publicly funded and mandated by state or federal statutes to examine physical evidence and perform forensic testing, a voluntary laboratory-accreditation program has been in operation since 1985 through the auspices of the American Society of Crime Laboratory Directors-Laboratory Accreditation Board (ASCLD-LAB), which is an independently chartered organization affiliated with but separate from ASCLD. Some 77 forensic laboratories in the United States and in Australia are accredited by ASCLD-LAB. Such accreditation is available to all public and private forensic DNA laboratories, including ones that do not meet