Viral Marker Standard

Transcription

1 Virl Mrkr Stndrd Pbli Rviw rft 1, Proosd Rvision to Vrsion 4.1 In ordn with th rodrs for dvloing PPT Volntry Stndrds, this domnt is hrby issd for bli rviw, from Otobr 24, 2013 nry 2, This is roosd rvision to th rrnt IQPP Stndrd. W norg yor rly rviw nd look forwrd to yor fdbk. Pls snd yor fdbk sing th ommnt form tthd nd ostd on th PPT wbsit to Soni Blboni t sblboni@tglobl.org by Thrsdy, nry 2, ftr th los of th ommnt riod, ll ommnts rivd in rltion to th drft will b onsidrd. If rsoltion to th ommnts rslts in sbstntiv hngs to th drft, nothr ommnt riod my b inititd. If rsoltion to th ommnts rslts in no or minor hngs, th drft will b imlmntd s rt of th IQPP Volntry Stndrds Progrm. dqt noti will b rovidd rior to th imlmnttion riod of ny PPT stndrd or sifition.

2 Pbli Rviw RFT 1 1. Introdtion Th ( Stndrd ) is bsd on th indstry wid Qlifid onor virl mrkr rts for HIV, HBV nd HCV nd on th lsm ntr nmbr of olltions. It inlds virl mrkr onfirmd ositiv dontions by srology or NT. This Stndrd is rt of sris of stndrds tht omris th PPT IQPP Volntry Stndrds Progrm. For mor informtion bot th rogrm, visit 2. Rqirmnts 2.1. ll IQPP rtifid lsm ntrs ( ntrs ) shll rtiit in th PPT virl mrkr dt olltion rogrm, sing th IQPP Instrtions for Virl Mrkr t Rorting. Monthly srology nd NT virl mrkr tst rslts nd othr informtion shll b sbmittd within thr months ftr th bld month. Ths dt shll b sbmittd to PPT by th 20th dy of h month If virl mrkr dt hv not bn rortd to PPT within 30 dys of th d dt, lttr shll b snt to th Corort Bord Mmbr or Comny Contt vi xditd mil informing thm tht IQPP rtifition old b rvokd if virl mrkr dt r not rortd within 48 hors Th nmbr of Qlifid onor onfirmd ositiv virl mrkr tst rslts by srology or NT for HIV, HCV, HBV, nd omosit of th thr mrkrs for h ntr shll b t or blow th PPT blishd Virl Mrkr lrt Limits (th VM lrt Limit, s ndix I) Tbl I dsribs th norml vnts in th dt olltion nd stndrd dministrtion ross. t r olltd on monthly bsis nd r vltd in six-month inrmnts. t vltions will tk l in ril nd Otobr of h yr. Th ril vltion will ovr th riod from ly 1 throgh mbr 31. Th Otobr vltion will ovr th riod from nry 1 throgh n PPT shll notify ntr, in writing, if it is fond tht th ntr xdd th VM lrt Limit dring six-month riod. This notifition shll or no ltr

3 thn th lst dy of th month dring whih th dt r vltd (on ril 30 or Otobr 31). Th ntr shll hv 30 dys from notifition to sbmit orrtiv nd rvntiv tion ln (CP) to PPT. Th ntr shll thn dmonstrt virl mrkr rt t or blow th VM lrt Limit dring th nxt six month vltion riod bginning ftr th dt on whih th ntr ws notifid by PPT tht it ws ot of omlin 2.6. ll ntrs shll hv mhnism for dvloing CPs shold th ntr xd th Virl Mrkr lrt Limits. This mhnism shll inld rovisions for invstigtion, rformn of root s nlysis, involvmnt of rorit stff nd rords. 3. Virl Mrkr lrt Limits Th virl mrkr lrt limits r bsd on Poisson distribtion robbility tbls. Ths tbls ssss th rltiv robbility of hving nmbr of onfirmd ositiv donors bsd on ny givn nmbr of totl dontions nd th indstry wid vrg virl mrkr ositivity rts for Qlifid onors. Ths, h ntr n b ssssd with th sm riodiity sing its own olltion volm. Th s of robbilitis s stndrd stting tool rmits fir omrisons of ll ntrs rgrdlss of th nmbr of totl olltions for givn riod. ndix I ontins th PPT virl mrkr lrt limits onfirmd ositiv by srology & NT for HCV, HIV nd HBV. It lso inlds omosit tbl of th thr mrkrs. 4. Probbility nd Rfrn Rts Th lrt Limits r st t robbility of 0.01 for th virl mrkr rt stndrd omosit nd robbility of for th individl virl mrkrs. This mns tht ntr wold fll otsid th Stndrd if it hd mor ositiv donors thn wold b xtd 99% or 99.5% of th tim for ntr bsd on thir nmbr of dontions for givn riod. Th tl nmbr of ositiv donors tht wold t ntr otsid th Stndrd will dnd on two ftors: th nmbr of dontions t ntr for givn riod nd th rfrn rt. Th rfrn rts r th ovrll indstry vrg virl mrkr ositivity rts tht srv s th bsis for stblishing th VM lrt Limit tbls. Th indstry virl mrkr rvln for Qlifid onors msrd dring th dt olltion yr of nry throgh mbr 2000 is th bsis for th stndrd for HCV nd HIV. Th indstry virl mrkr rvln for Qlifid onors msrd dring th dt olltion yr of nry throgh mbr 2001 is th bsis for th stndrd for HBV. Th omosit is drivd from th sm of th HIV, HCV nd HBV rfrn rts. 5. Loss of Crtifition

4 5.1. If th ot of omlin ntr dos not dmonstrt imrovmnt in ordn with sbls II.5, IQPP rtifition shll b immditly rvokd IQPP rtifition shll b immditly rvokd from ny ntr xding tbl limits mor thn thr tims in thr yr riod IQPP rtifition my b rvokd if dt r not rortd to PPT within thirty (30) dys of th d dt, in ordn with Stion II.2 of this Stndrd If rtifition is rvokd d to non-omlin with th rqirmnts of this Stndrd, omnis shll b informd of thir rights to dist th dision in ordn with Cls VII (Conflit Rsoltion) of th Intrntionl Qlity Plsm Progrm Crtifition Progrm srition. 6. R-rtifition following rvotion or volntry withdrwl ntr tht hs volntrily withdrwn its rtifition or lost its rtifition d to nonomlin with th Stndrd my not bom r-rtifid ntil six months ftr th dt on whih th rtifition ws rvokd or volntrily withdrwn. NOTE: ntr my volntrily withdrw its rtifition t ny tim. s rt of its lition for r-rtifition th ntr shll sbmit virl mrkr dt olltd for th six months rior to th dt on whih th lition for r-rtifition ws sbmittd to PPT. R-rtifition will only b grntd if ll virl mrkr dt sbmittd s rt of th lition r t or blow th VM lrt Limits nd following th omltion of sssfl dit. R-rtifition will not b grntd if ths dt r non-omlint. If r-rtifition is not grntd, th ntr my r-ly t ny tim. ny rrtifition grntd will bgin on th dt whn th rrnt lition for rrtifition ws rivd by PPT.

5 Pbli Rviw RFT 1 Timlin for Virl Mrkr Stndrd l g S O t N o v n F b M r r M y n l g S O t N o v n F b M r r M y n l g S O t N o v t Colltion Priod 1: ly 1 mbr 31 B C CP Imlmnttion: ly - mbr E t Colltion Priod 2: nry 1 n 30 B C CP Imlmnttion: nry - n t Colltion Priod 3: ly 1 mbr 31 B C CP Imlmnttion: ly - mbr Lgnd : dlin for omny to sbmit dt for olltion riod: Mrh 20 or Stmbr 20 B: dlin for PPT to inform omny if dt r ot of omlin for th olltion riod: ril 30 or Otobr 31 C: dlin for th omny to sbmit CP to PPT if ot of omlin for tht riod: My 31 or Novmbr 30 : t on whih IPP rtifition will b rvokd if dt r still ot of omlin: ril 30 or Otobr 31 E: t on whih th ntr my bom r-rtifid: six months ftr th rvotion / withdrwl dt

6 PPENIX I PPT Virl Mrkr lrt Limits Virs ty = Comosit Confirmd Positivs by Srology or NT (HBV, HCV nd HIV ombind) lrt limits r bsd on obsrvd qlifid donor rvln (rfrn rt) of 8 r 100,000 dontions nd will b lid for givn six-month riod. TOTL NUMBER OF ONTIONS FROM TO MXIMUM NUMBER OF CONFIRME POSITIVE ONORS Lst Rvision: nry 2003

7 PPT Virl Mrkr lrt Limits Virs ty = HCV Confirmd Positivs by Srology or NT lrt limits r bsd on obsrvd qlifid donor rvln (rfrn rt) of 4 r 100,000 dontions nd will b lid for givn six-month riod. TOTL NUMBER OF ONTIONS FROM TO MXIMUM NUMBER OF CONFIRME POSITIVE ONORS Lst Rvision: nry 2003

8 PPT Virl Mrkr lrt Limits Virs ty = HIV Confirmd Positivs by Srology or NT lrt limits r bsd on obsrvd qlifid donor rvln (rfrn rt) of 1 r 100,000 dontions nd will b lid for givn six-month riod. TOTL NUMBER OF ONTIONS FROM TO MXIMUM NUMBER OF CONFIRME POSITIVE ONORS , , , , Lst Rvision: nry 2003 PPT Virl Mrkr lrt Limits Virs ty = HBV Confirmd Positivs by Srology or NT lrt limits r bsd on obsrvd qlifid donor rvln (rfrn rt) of 3 r 100,000 dontions nd will b lid for givn six-month riod. TOTL NUMBER OF ONTIONS MXIMUM NUMBER OF CONFIRME POSITIVE ONORS FROM TO Lst Rvision: nry 2003