Section He-P 305.01 - Definitions(a) "Anatomical parts" mean "anatomical parts" as defined in RSA 291-A.I.V.(b) "Autologous donor" means an individual who provides a blood product or anatomical part for self-use.(c) "Blood transfusion centers" mean those facilities referenced in RSA 141-F:5, I which receive for distribution or use, donated whole blood or blood components.(d) "Blood components" mean whole blood constituents or derivatives.(e) "Clinical laboratory improvement amendments of 1988 (CLIA) " means the revision of Section 353 of the Public Health Service Act ( 42 U.S.C. 263(a) ) , compliance with which certifies that laboratories may accept human specimens for the purposes of performing laboratory examinations or procedures.(f) "Confirmatory test" means a test that utilizes a different methodology than the screening test and has equal or greater specificity than the screening test.(g) "Human immunodeficiency virus" or HIV means "human immunodeficiency virus" as defined in RSA 141-F:2, V.(h) "Indeterminate" test result means that a test result does not meet the criteria for either a reactive or nonreactive test. The term includes "equivocal".(i) "Initial test" means the first HIV test performed on the specimen.(j) "Laboratory" means any building or place for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body.(k) "Proficiency testing" means a form of external quality control in which specimens are received from outside the laboratory, analyzed as routine specimens, and the results returned to a central location for comparison with other participating laboratories.(l) "Reactive" means that a component of the patient's specimen has formed detectable complexes with the HIV antigen or antibody supplied by the laboratory scientist during the analysis as defined by the procedure used.(m) "Researcher" means an individual who conducts HIV tests, for the purpose of increasing the scientific knowledge of HIV, in accordance with RSA 141-F:5, III.(n) "Screening test" means any test which requires further testing by a different methodology in order to definitively report the presence of a condition.(o) "Specimen" means a portion of tissue or body fluid material from a human body.(p) "Test kit" means all components of a test procedure that are packaged together by the manufacturer.(q) "Tissue procurer" means a physician licensed or registered to practice in New Hampshire, or person authorized by such physician, who obtains, processes, distributes, or uses anatomical parts.N.H. Admin. Code § He-P 305.01
#4637, eff 6-19-89; EXPIRED 6-19-95
New. #6563, eff 8-21-97; ss by #8355, eff 5-24-05, EXPIRED: 5-24-13