WPC$0 p0o6Hyd#RR7 0f @nX5$$T%fM1,Rrjh 1d'vK/xps8/^'ru}^vSh_3XJ܊[gCDr{+*M\*m~>pkUkǁy~gnKYw+y]?v!IFhѐgБ$P DwT+TQ#@bgc0iTeV~œKcӒ#O$U\s˲`5<"YJ >MFp*i? 0 rU)<|Um6 0 0 0  0_ 0_? 0 0Z 0 0 06 0 0 0% 0 0o 0 0 0U(* 05 0 " 0D"B$ 1k&?' 0C( 1mT(:( C)f*a* Br+*fH*aJ* ^* B*n* B* B**UN* %0+6+ 0(>+ 1mf+U:+ ,w@,4-UN3--U<-UN- .:.U:Y/UN/ / h/ h7/<jd:Default ParaXXXQ\  `$Times NewRomanQXXXK<6X9`(Courier NewK\  `$Times NewRoman<6X9`(Courier New&jd$1XXXQ\  `$Times NewRomanQXXXK<6X9`(Courier NewK&jd$2XXXQ\  `$Times NewRomanQXXXK<6X9`(Courier NewK<jd:_Equation CaXXXQ\  `$Times NewRomanQXXXK<6X9`(Courier NewK0.header    K<6X9`(Courier NewKG=` hp x (#%'0*,.GXXXK<6X9`(Courier NewK0.footer    K<6X9`(Courier NewKG=` hp x (#%'0*,.GXXXK<6X9`(Courier NewK&jd$_XXXQ\  `$Times NewRomanQXXXK<6X9`(Courier NewK.,toc 1   K<6X9`(Courier NewKG=` hp x (#%'0*,.GXXXK<6X9`(Courier NewK.,toc 2         K<6X9`(Courier NewK     G=` hp x (#%'0*,.GXXXK<6X9`(Courier NewK.,toc 3  M       K<6X9`(Courier NewK     G=` hp x (#%'0*,.GXXXK<6X9`(Courier NewK.,toc 4         K<6X9`(Courier NewK     G=` hp x (#%'0*,.GXXXK<6X9`(Courier NewK.,toc 5         K<6X9`(Courier NewK     G=` hp x (#%'0*,.GXXXK<6X9`(Courier NewK.,toc 6  A       K<6X9`(Courier NewK     G=` hp x (#%'0*,.GXXXK<6X9`(Courier NewK.,toc 7         K<6X9`(Courier NewK     G=` hp x (#%'0*,.GXXXK<6X9`(Courier NewK.,toc 8         K<6X9`(Courier NewK     G=` hp x (#%'0*,.GXXXK<6X9`(Courier NewK.,toc 9  5       K<6X9`(Courier NewK     G=` hp x (#%'0*,.GXXXK<6X9`(Courier NewK2 0index 1          Z K<6X9`(Courier NewK      G=` hp x (#%'0*,.GXXXK<6X9`(Courier NewK2 0index 2  M        Z K<6X9`(Courier NewK      G=` hp x (#%'0*,.GXXXK<6X9`(Courier NewK:sg8toa heading d   XXX?%2A`Arial? XXXK<6X9`(Courier NewK%2A`Arial2g0caption d   K<6X9`(Courier NewK  XXXK<6X9`(Courier NewK&jd$3XXXQ\  `$Times NewRomanQXXXK<6X9`(Courier NewK4k2Quick 1.  P     XXXK<6X9`(Courier NewK     G=` hp x (#%'0*,.G ' ELAB-PBMS - 05/29/97 2Kathy J. Dien Hillig 0 .   $35;AGOW_e41.a.i.(1)(a)(i)1.a. m)   (#X+zX+Xz+zQ=` hp x (#%'0*,.(#Q(2m$ .!  $35;AGMU]e5I.A.1.a)(1)(a)(i)(a) 0 m)  0XXX+X0<X0XELABPBMSSubcommittee@JJJ  1  ڀof5EndDoc4  Ո   (#May29,1997#+z0<##+X,X+z=# dTable_A  dTable_BBM_1_& d d+ +dX Xd3|PF(9 Z 6Times New Roman Regular+X($# e37=CIQYag1.a.i.(1)(a)(i)1)a),cAZ"Arial Regular m)   (#X4zX+X6z+zQ=` hp x (#%'0*,.(#Q =E>?@HADBCDeErFbJ" 4 Plus,\\CS(9 Z 6Times New Roman RegularEndDoc\  `$Times NewRoman(x-  Z 6Times New Roman RegularX 0 m)  :XXX+X:<X0XELABPBMSSubcommittee@JJ<  1  ڀof5EndDoc4  Ո  d(#May29,1997#;z0<##;X,X+z=#,cAZ"Arial Regular(9 Z 6Times New Roman RegularHV!$$$ @ .!  DDX  Q=X4` <hDpXQDDD1D X,XX+XSummaryofthe  ELABPBMSSubcommitteeTeleconferenceMay29,1997 YXX,6Y  DDD9D  X X6X,X XXThePerformanceBasedMeasurementSystems(PBMS)subcommitteeoftheEnvironmental $t LaboratoryAdvisoryBoard(ELAB)convenedbyteleconferenceonMay29,1997,at1pm.Themeetingwasledbyitschair,Dr.KathyHilligofBASFCorporation.Thepurposeofthismeeting  L wastocontinuetodiscuss(a)matrixandmatrixtype,(b)whatneedstohappentomakePBMSacceptabletoallstakeholders,=<and<=>and>(c)?needfor?@dowewanttohave@anopenforumduringNELACforpeopletodiscussmatrixissuesorPBMSingeneral?TheseitemswerecontinuedfromtheMay19,1997    teleconferenceofthissubcommittee.ItwasnotedbyDr.HilligthatELABhasaskedthesubcommitteetoraiseissuesthatitperceivesmayhinderthesuccessfulimplementationofthePBMS.WhileELABwouldbeverygladtoreceiverecommendationsonhowtosolvethoseissues,itismoreimportantforthissubcommitteetoidentifyissuesthatwouldhinderthePBMSimplementation.Followingintroductoryremarkstheminutesoftheprecedingmeeting,May19,1997,wereapprovedwithrevisionsandwillbepostedontheNELACBulletinBoard.ThelistofactionitemsisprovidedinAttachmentAandthelistofparticipantsisgiveninAttachmentB. ASSESSORTRAINING YXX,6Y   X X6X,X XXTheissueofassessortrainingforsuccessfulimplementationofthePBMSprogramwasraised.   Underthecurrentsystemofprescriptivemethodsanassessorisfreetocheckagainstpredefinedmethodcharacteristicsandperformance.UnderthePBMSparadigm,theassessorwillhaveotherissuestoaddresswhichmaynotbeimmediatelyapparent.Thequestionthenbecomeshowalaboratorycansuccessfullydemonstratetotheassessorthatthemethodofchoicewhichisbeingassessedworksasspecified.Forexample,wouldequivalencytoareferencemethodbesufficient,orwouldperformanceofthemethodonaspecifiedreferencematerialbesufficient? MATRIXDEFINITION YXX,6Y  l X X6X,X XXItwasnotedthatthereisnocurrentuniformagencywidedefinitionofsamplematrix.One !X possibilityisthatperformanceonamatrixspikeduplicatemaybeasufficientbasistodefinethematrix.However,untilsuchadefinitionisagreedupon,particularlybyassessors,thereisapotentialforseriousmisunderstandingbetweenlaboratories,assessors,andregulatorsintheimplementationofPBMS. APPROVEDMETHODS &!%  ItwaspointedoutthatPBMSisaregulatoryconstructthatisasystemandthatitreferstoan |'"& approachunderwhichlaboratoriescanoperate.PBMSincludesbothEPAapprovedmethodsandotherappropriatemethodswhichalaboratorymaychoosetoimplement.Clarificationofwhatconstitutesan"EPAapproved"method,inalegallydefensiblemanner,willbenecessary. METHODVALIDATION ,h'+  AnacceptabledefinitionofMethodValidationisneededintheformofachecklistorother -T(, specificationthatisunderstandabletoboththelaboratory(asitdesignsmethodvalidationschemes)andtoassessorsastheyreviewsuchdata.Aspectsofthisdefinitionshouldinclude .,*. whatconstitutesamajororminormodification,andhowtheyareidentified.Additionally,acceptancecriteriaforthevalidationprocessneedstobespecifiedtoensurethatthelaboratorydesignsthevalidationprocessadequately. COST YXX,6Y ` X X6X,X XXWhiletheexpectationsforPBMScurrentlyarethattherewillbesignificantcostsavingsdueto L  thepossibilityofusinginnovativeinexpensivenewtestmethods,thereisalsothepotentialforasignificantincreaseinthenumberofqualityassurancesamplesthatmayberequired.Forexample,ifamatrixspikeduplicateisrequiredforeachsample,thetestingcostwouldimmediatelybedoubledandpotentiallynegateanycostsavingsinotherareas. LABORATORYCLIENTRELATIONSHIPS $   Additionalconcernsdiscussedincludedthenecessarychangeintheroleofalaboratoryfrom   merelyanalyzingsamplesprovidedaccordingtocontractualspecificationstoparticipatingintheplanninganddesignofthesamplingactivity.Issuessuchasapplicabilityofspecifiedmethodstoparticularsampletypes,therequiredsamplevolume,andthedefinitionoftheadequacyofthedatapackagemustallbeaddressed.Similarlytheissuesoftheresponsibilityforthevariousqualityassurancesamplesthatwillbecomenecessaryshouldbeaddressed.Itwasnotedthatthereshouldbeamechanismbywhichthelaboratorycanpromptlyandeffectivelycommunicatetheirconcernsaboutdataqualityanddatausabilitytotheclientinatimelymannerthatallowsrapidcorrection. NEXTMEETING YXX,6Y H X X6X,X XXNofurthermeetingsofthesubcommitteehavebeenscheduled.However,Dr.Hilligrequested 4 thatmembersemailtoheranysignificantconcernstheyhaveandshewillensurethattheyareincludedinthereportofthissubcommitteetoELABduringtheJulymeeting.YXX,6YW=` hp x (#%'0*,.X,W   Xppd(# ;l..;;7Y6;7X,X7YAttachmentA ;XԺX XXn;#7YX7X,#;#67Y#; X   X X6X,X XXACTIONITEMS YXX,6Y D  X X6X,X XXELABPBMSubcommitteeTeleconference 0 May29,1997 YXX,6Y  *q!" ddd Xdd Xdd X(#(#q,d[,dd+  1##" ` 11 Q=` hp x (#%'0*,.XQ X X6X,X XXAction YXX,6Y =###*"## = X X6X,X XXDate  Completed YXX,6Y N###=%}" 1 ### 1 NX X6X,X XXEmailtoDr.Hilliganysignificantconcernsandshewillincludetheminthe   reportofthissubcommitteetoELABduringtheJulymeetingYXX,6Y 4####!  ### 4,"   1  #### ,Q=X4` <hDpXQ       X X6X,X XXAttachmentB YXX,6Y X   X X6X,X XXLISTOFPARTICIPANTS YXX,6Y D  X X6X,X XXELABPBMSubcommitteeTeleconference 0 May29,1997 YXX,6Y    *`$% ddd[dd!"(#(#`,d[,d[,/ dd+  1##" ` y11W=` hp x (#%'0*,.X,WX X6X,X XXNameYXX,6Y 9##*"## 9X X6X,X XXAffiliationYXX,6Y =###*"## =X X6X,X XXTelephonesYXX,6Y Q##B*" 1 y ### O1Q&n6KathyHillig,   Chair6&n 0##!n ## 0&n6BASFCorporation6&n 4###! ## 4&n6T:313/2466334   F:313/2465226E:hilligk@np01.southgate.basfEEF% < Fcorp.com6&n H##9! . 1 O ### O1H&n6AJimABMikeBFC% 8 CFConlon w  6&n 0##!7 ## 0&n6LabStrategyGroup6&n 4###!w ## 4&n6T:703/9131314 w  F:703/9131314E:6&n H##9!  1 O ### O1H&n6DavidFriedman   (invited)6&n 0##! P ## 0&n6USEPA6&n 4###! ## 4&n6T:202/2603535   F:202/2604346E:friedman.david@epamail.epa.gov6&n H##9!h  1 O ### O1H&n6JanGeiselmanPower Y  (absent)6&n 0##! ## 0&n6PowerAssociatesCorp.6&n 4###!Y ## 4&n6T:301/2617074 Y  F:301/2614232E:6&n H##9!  1 O ### O1H&n6LarryLaFleur6&n 0##!r!## 0&n6NCASI6&n 4###!r"## 4&n6T:541/7528801 r# F:541/7528806E:llafleur@wcrcncasi.org6&n H##9!J% 1 O ### O1H&n6CynthiaLee6&n 0##!;&## 0&n6SmallLaboratory ;' Representative6&n 4###!(## 4&n6T:502/4737874 ;) F:E:chlee0z2@ulkyvm.louisville.edu6&n H##9!c+ 1 O ### 1H&n6JeanneMourrain, T, NELACDirector6&n 0##!,.## 0&n6USEPA6&n 4###!T/## 4&n6Tel:9195411120 T0 Fax:9195414101Email:mourrain.jeanne@epamail.epa.gov6&n C##4,2 1 ### O1C&n6TonyPagliaro 3 6&n 0##!4## 0&n6ACIL6&n 4###!5## 4&n6T:202/8875872 6 F:202/8870021E:acil@ix.netcom.com6&n H##9!E8 1 O ### O1H&n6JerryParr 69 (absent)6&n 0##!N:## 0&n6QuanterraEnvironmental 6; Service6&n 4###!N<## 4&n6T:303/4216611 6= F:303/4679136E:jerryparr@msn.com6&n H##9!? 1 O ### O1H&n6JerrryThoma% & %&8 @ (absent)6&n 0##!gA## 0&n6EnvironmentalHealth B Laboratories6&n 4###!gC## 4&n6T:219/2334777 D F:219/2338207E:thoma@hastech.iag.net6&n H##9!'F 1 O ### O1H&n6MimiUhlfelder p G (absent)6&n 0##!0!H## 0&n6EALaboratories6&n 4###!p I## 4&n6T:301/7714920 p J F:301/7714407E:mmu@eaeng.mhs.compuserve.com6&n H##9!!L 1 O ### O1H&n6Verstuyft,Al6&n 0##!" 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