June 21, 2002 Twentieth Meeting Presidential Advisory Council on HIV AI!" #ouis "ullivan, M!

, Co$Chair To% Co&urn, M!, Co$Chair 'ashington, !C At todays meeting, the Presidential Advisory Council on HIV and AIDS (PACHA) will discuss a num er o! issues "ertaining to ra"id HIV testing# $ne o! the items !or review is whether such tests should receive waiver status under the Clinical %a oratory Im"rovement Amendments o! &'(( (C%IA(()# )he American Association !or Clinical Chemistry (AACC), re"resenting more than &*,*** "ro!essional scientists, has serious reservations a out granting waiver status to ra"id HIV tests# In recent years, technological advances have allowed manu!acturers to develo" new and sim"ler la oratory testing devices, which ma+e it easier !or individuals with less training to accurately "er!orm tests that "reviously could only e conducted in more so"histicated la oratories# Although AACC generally su""orts "lacing sim"le and highly accurate devices in the waiver category, we elieve that some tests, i! inaccurate, "resent a greater ,ris+ o! harm- to the "atient and the "u lic than others# AACC elieves that these tests re.uire a higher level o! oversight than the waiver category currently "rovides# It is our view that the HIV test is such a test, ecause an incorrect result, either a !alse/ "ositive or !alse/negative, could have devastating results !or the "atient, his or her !amily and, "otentially, society# I! a la oratory o tains a !alse/"ositive result, it means that the test inaccurately identi!ied the "erson as HIV "ositive when he or she is not# Such a result could have devastating conse.uences !or all concerned# )his mista+e could occur !or a variety o! reasons, such as iologic changes ta+ing "lace in the "atient, the +nown inherent technical limitation o! the method, or due to a "rocess error# AACC is also concerned a out the "otential harm associated with a !alse/negative result# In this instance, the la oratory re"orts that an individual is not HIV "ositive, when, in !act, he or she is in!ected# )his means that such "atients will not e started on treatment critical to delaying the onset o! AIDS and "rolonging their lives# 0rom a "u lic health

PACHA 1une 2&, 2**2 Page )wo "ers"ective, the la oratorys !ailure to detect the disease means that these "eo"le may not ta+e necessary measures to "revent the s"read o! the in!ectious viral agent, there y "ossi ly in!ecting other individuals with the deadly disease# Although AACC elieves that manu!acturers can develo" highly accurate HIV tests, we have serious concerns a out "ermitting tests with signi!icant "atient and "u lic health im"lications, such as HIV testing, in la oratories that are not su 3ect to "eriodic ins"ection4either "rivate or "u lic, are not re.uired to have trained health care "ersonnel "er!orm the tests and are not re.uired to "artici"ate in "ro!iciency testing (P)) to evaluate the accuracy o! their testing# Ironically, the only su stantive re.uirement "laced on waiver !acilities4that they !ollow the manu!acturers instructions4is not eing !ollowed# Although this may also e an issue !or some moderate and high com"le5ity la oratories, they have other re.uirements, such as "artici"ating in P), that may hel" identi!y testing errors4waiver la oratories do not# According to a recent C6S study, nearly one/hal! o! all waiver !acilities that were reviewed !ailed to "er!orm or a""ro"riately !ollow the manu!acturers instructions# 7e are concerned that these !indings, which indicate "ossi le 8C "ro lems in these !acilities, might result in mista+es that could harm the "atient and the "u lic# %ast 6ay, the Clinical %a oratory Im"rovement Advisory Committee (C%IAC), the !ederal advisory committee to the government on the C%IA(( regulations, discussed the issue o! waiving ra"id HIV tests and voted against this o"tion (see attachment)# Su se.uently, the 0ood and Drug Administrations (0DAs) 9lood Products Advisory Committee met to consider this issue in 1une 2**& and voted &:/* against waiving ra"id HIV tests# AACC recogni;es the di!!icult decision e!ore the !ederal agencies4whether to waive HIV +its, so that more "eo"le may have access to such testing or continue to restrict such testing to moderate and high com"le5ity testing to ensure the .uality o! the results# At this time, we elieve the most "rudent course o! action !or the government, and PACHA, is to +ee" such tests as moderate and high com"le5ity# I! !ederal oversight o! waiver !acilities could e strengthened, then reo"ening this issue may e a""ro"riate# 9y way o! ac+ground, AACC is the "rinci"al association o! "ro!essional la oratory scientists//including 6Ds, PhDs and medical technologists# AACCs mem ers develo" and use chemical conce"ts, "rocedures, techni.ues and instrumentation in health/related investigations and wor+ in hos"itals, inde"endent la oratories and the diagnostics industry nationwide# )he AACC "rovides national leadershi" in advancing the "ractice and "ro!ession o! clinical la oratory science and its a""lication to health care# I! you have any .uestions or we may e o! any assistance, "lease call 6ary %ou <ant;er, PhD, President, AACC, at (=*2) >=&/>(?* or Vince Stine, Director, <overnment A!!airs, at (2*2) (=:/(?2&#