Section He-P 305.06 - Standards for Performing HIV Testing(a) This section shall apply to any New Hampshire laboratory or other such business or organization which offers, or engages in, the performance of tests to detect or quantify antibody to, or antigen of, HIV in human body fluids or tissues.(b) A laboratory or other such business or organization which offers to test, or engages in testing, to detect or quantify antibody to, or antigen of, HIV shall comply with the provisions for consent in RSA 141-F:5 and the exceptions thereunder.(c) Any purposeful violation of the requirements set forth in these rules shall be subject to enforcement under RSA 141-F:11.(d) All laboratories, public or private, or other such businesses or organizations shall use only analytic procedures that are FDA approved and in compliance with CLIA, as found in 42CFR Part 493, and which include but are not limited to the following: (1) The manufacturer's testing insert kit for all initial and confirmatory testing; and(2) The performance of external controls.(e) No laboratories or other such businesses or organizations shall report any reactive or indeterminate screening test result prior to the performance of a confirmatory test as defined by the manufacturer's testing kit package insert, except: (1) When the test is being conducted by a blood transfusion center or tissue procurer for the purpose of determining the medical acceptability of a blood, organ or tissue donor;(2) When the physician who ordered the test specifically attests that he/she needs the initial test result to provide optimal emergency diagnosis and/or emergency treatment to the individual; or(3) When the reactive or indeterminate screening test result is obtained using a FDA-approved rapid testing technology and such test result is reported as a screening test result that must be subjected to a confirmatory test.(f) Reports of tests on all HIV specimens shall be kept confidential in accordance with RSA 141-F: 7 and RSA 141-F: 8;(g) Laboratories or other such businesses or organizations shall use the following record protocol: (1) A record of the number of tests performed on specimens received shall be maintained for at least 4 years;(2) A record of the number of tests that were positive or indeterminate shall be maintained for at least 4 years; and(3) Records of tests on all HIV specimens shall be kept confidential in accordance with RSA 141-F:7 and RSA 141-F:8.N.H. Admin. Code § He-P 305.06
#8355; eff 5-24-05 (from He-P 305.05 )