Specifications include, but are not limited to: Personnel The laboratory shall be under the direction of an individual with a doctoral degree who is qualified by advanced training and/or experience in parentage testing. Tests shall be performed by personnel, or contracted personnel, of the Contractor who are qualified to perform such testing. The competency of the technical staff shall be the responsibility of the director of the laboratory. The laboratory director and technical staff shall participate in continuing education relative to the field of parentage testing. A qualified individual shall be available to act as an expert witness in the event that legal testimony related to the test results is required. General Operational Standards The Contractor’s laboratory shall have sufficient space, equipment, facilities and supplies to maintain safe and acceptable standards of performance. The staff of the Contractor’s laboratory shall be competent and adequate for performance of the required testing. The laboratory shall be in compliance with relevant safety codes including provisions for safe handling of blood and genetic samples, reagents and proper disposal of wastes. The Contractor’s laboratory shall utilize a program of quality control that is sufficiently comprehensive to ensure that reagents, equipment and personnel perform as expected. These shall be performed using appropriate sample and reagent controls. Reagents shall be stored and used appropriately. Samples shall be handled, processed and tested in a manner that ensures accuracy of test results. Tests shall be performed by standard methods or by methods independently verified by the laboratory. The Contractor’s laboratory shall participate in available external proficiency testing programs in all systems of phenotyping utilized by the laboratory. A manual detailing all procedures and policies shall be developed and maintained, and it shall be reviewed annually by the director of the laboratory. Identification, Specimen Collection and Documentation Individual and Specimen Identification There shall be a verifiable means for identification of all individuals who present themselves for testing. The donor’s identity must include a photograph identity (government issued picture id is preferred) and a fingerprint. A record shall be kept at the testing facility of all identifying information, including but not limited to, name, relationship, race, date of birth and place and date of collection of samples. The signature of the person or the guardian shall verify information about each individual. The date of birth of the child and a recent transfusion history (90-day history). Samples shall be identified with a firmly attached label bearing a unique identification for each individual and the date of collection. The name of the person collecting the test sample shall be a part of the permanent record. Storage and Handling Specimens shall be handled and stored in a manner that will preclude contamination, tampering or substitution.
