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Laboratory Hemostasis
Laboratory HemostasisA Practical Guide for Pathologists
Sterling T. Bennett, M.D., M.S.Medical Director, Intermountain Healthcare CentralLaboratory, and Volunteer Adjunct Associate Professorof Pathology, University of Utah Health Sciences CenterSalt Lake City, Utah
Christopher M. Lehman, M.D.Associate Professor of PathologyUniversity of Utah Health Sciences CenterandAssistant Director of Hospital Clinical LaboratoriesARUP LaboratoriesSalt Lake City, Utah
George M. Rodgers, M.D., Ph.D.Professor of Medicine and PathologyDivision of HematologyUniversity of Utah Health Sciences CenterandMedical Director, Coagulation LaboratoryARUP LaboratoriesSalt Lake City, Utah
Editors
With Contributions by Catherine Thompson, B.S.,MT (ASCP), and Robert C. Blaylock, M.D.
Sterling T. Bennett, M.D., M.S.Medical DirectorIntermountain Healthcare Central
LaboratoryVolunteer Adjunct Associate Professor
of PathologyUniversity of Utah Health
Sciences CenterSalt Lake City, UT 84143USA
George M. Rodgers, M.D., Ph.D.Professor of Medicine and PathologyDivision of HematologyUniversity of Utah Health
Sciences CenterSalt Lake City, UT 84132andMedical Director, Coagulation LaboratoryARUP LaboratoriesSalt Lake City, UT 84132USA
Christopher M. Lehman, M.D.Associate Professor of PathologyUniversity of Utah Health
Sciences CenterSalt Lake City, UT 84132andAssistant Director of Hospital
Clinical LaboratoriesARUP LaboratoriesSalt Lake City, UT 84132USA
Library of Congress Control Number: 2006931198
ISBN-10: 0-387-36838-8 e-ISBN-10: 0-387-36840-XISBN-13: 978-0387-36838-2 e-ISBN-13: 978-0387-36840-5
Printed on acid-free paper.
© 2007 Springer Science+Business Media, LLC
All rights reserved. This work may not be translated or copied without the writtenpermission of the publisher (Springer Science+Business Media, LLC, 233 Spring Street,New York, NY 10013, USA), except for brief excerpts in connection with reviews orscholarly analysis. Use in connection with any form of information storage and retrieval,electronic adaptation, computer software, or by similar or dissimilar methodology nowknown or hereafter developed is forbidden.The use in this publication of trade names, trademarks, service marks and similar terms,even if they are not identified as such, is not to be taken as an expression of opinion asto whether or not they are subject to proprietary rights.While the advice and information in this book are believed to be true and accurate at thedate of going to press, neither the authors nor the editors nor the publisher can accept anylegal responsibility for any errors or omissions that may be made. The publisher makesno warranty, express or implied, with respect to the material contained herein.
9 8 7 6 5 4 3 2 1
springer.com
To Elizabeth Bennett, Julie Monahan andother family and friends for their unfailing support,
and to the numerous residents and fellowsand our faculty colleagues who havestimulated our interest in coagulation
and inspired this book
Preface
In the course of our practice as coagulation laboratory directors, we haveacquired personal libraries of hemostasis and thrombosis texts that serve asexcellent references for the basic science and clinical aspects of hemostasis.What is missing, though, is a single reference text that provides practicalinformation and guidance on the topics relevant to directing a coagulationlaboratory. We are sure we are not alone in wishing for such a reference. Aftertalking about it for several years, we have now attempted to fill the void witha handbook containing the information we provide to the residents and fellowsthat we are helping train to become laboratory directors.
In writing this book we have tried to cite the consensus recommendationsof authoritative bodies whenever possible, and otherwise, have cited reviews,chapters, and research articles of experts in their respective fields. These refer-ences should act as a starting point for a more detailed study of the variousaspects of coagulation testing.
It is our intent that pathologists, clinical laboratory scientists, and otherphysicians serving as laboratory directors will find this book helpful to under-stand and carry out their responsibilities. Another intent is that residents andfellows will find this book to be a useful tool for learning the basics of coagu-lation testing and for studying for board examinations. We also hope thatcoagulation laboratory supervisors, technologists, and technicians find this tobe a helpful reference for the day-to-day operation of the laboratory. Finally,clinicians may find aspects of this book helpful in understanding the role of thecoagulation laboratory in patient evaluation and monitoring.
Sterling T. Bennett
Christopher M. Lehman
George M. Rodgers
Acknowledgments
The Editors would like to thank Stephen J. Kling for his assistance with prepa-ration of illustrations, Kathleen Gibbs and Ronda Crist for helpful commentson the manuscript and Deborah Hoffman for preparation of the manuscript.
Contents
Preface viiAcknowledgments ix
1. Role and Responsibilities of the Laboratory Director 1Sterling T. Bennett
2. Collection of Coagulation Specimens 27Sterling T. Bennett
3. Instrumentation for the Coagulation Laboratory 41Christopher M. Lehman and Catherine Thompson
4. Validation of Coagulation Assays, Instruments and Reagents 57Sterling T. Bennett
5. Hemostasis Screening Assays 85George M. Rodgers and Christopher M. Lehman
6. Testing for Inherited Bleeding Disorders 103George M. Rodgers
7. Testing for Acquired Platelet Disorders 121Christopher M. Lehman
8. Acquired Coagulation Disorders and TTP 137George M. Rodgers
9. Testing for Inherited and Acquired Thrombotic Disorders 143George M. Rodgers
10. Monitoring Anticoagulant Therapy 167Sterling T. Bennett
11. Coagulation Testing and Transfusion Medicine 207Robert C. Blaylock and Christopher M. Lehman
Index 227
1Role and Responsibilitiesof the Laboratory Director
Sterling T. Bennett
Role and Responsibilities of the LaboratoryDirector
Clinical laboratories provide essential services and information for thepractice of medicine. The majority of electronic medical data consistsof laboratory results and laboratory results are vital information formany clinical decisions. Accordingly, laboratories have the potentialof making great contributions to patient safety and medical outcomeswhen their services are timely and results are accurate.
Serving as a laboratory director is an interesting, challenging, andrewarding job, and one that carries great responsibility. The directoris accountable for all aspects of the laboratory service and is thekey bridge between laboratory operations and clinical practice. Assuch, the laboratory director needs to have a broad knowledge ofclinical medicine, pathology disciplines, basic medical sciences, clinicallaboratory sciences, laboratory operations, and quality managementsystems. Knowledge of and skills in informatics, data analysis, andbusiness management are also important assets. The breadth ofknowledge and skills required of a laboratory director is one aspect thatmakes the job so attractive.
In the midst of all this knowledge, it is vital for the successof the laboratory that the director clearly understands his or her roleand responsibilities. Definitions of the laboratory director’s respon-sibilities have been published by the College of American Pathol-ogists, American Association of Blood Banks, International Organi-zation for Standards (ISO), Clinical Pathology Accreditation (UK)Ltd., National Pathology Accreditation Advisory Council, EuropeanSociety of Pathology, and Canadian Association of Pathologists, to
2 Sterling T. Bennett
name a few1−8. In addition, the United States’ Code of FederalRegulations defines the laboratory director’s responsibilities under theClinical Laboratory Improvement Amendments of 1988 (CLIA-88)9.Table 1.1 provides a summary listing of the laboratory director’sresponsibilities.
For any given laboratory, the laboratory director’s responsibil-ities are defined in large measure by prevailing regulations and thestandards of accreditation bodies. Responsibilities may be furtherdefined by the organizational structure of the institution and contractualarrangements between the institution and laboratory director; however,organizational structure and contracts do not absolve the laboratorydirector of responsibilities defined by regulations and accreditationstandards.
Each set of regulations or accreditation standards is unique,with its own emphasis on the director’s responsibilities. Some definedetailed responsibilities while others provide few specifics. Tables 1.2–1.8 illustrate these differences by listing the duties specificallyattributed to the laboratory director in four sets of regulations orstandards.
These tables are not intended to be a comprehensive cross-reference between various standards and regulations, but to illustratethe commonalities and differences in the level of detail that differentorganizations give to the specific responsibilities of the director. Manyother regulations and standards exist beyond those listed. These tablesinclude only those items that are specifically identified as responsi-bilities of the “laboratory director” by the regulations of the ClinicalLaboratory Improvement Amendments of 1988 (US)9 and the Collegeof American Pathologists1, the “person providing supervision anddirection” by the National Pathology Accreditation Advisory Council(Australia)7, or “laboratory management” by Clinical Pathology Accred-itation (UK) Ltd.4. The one point on which all agree is that the laboratorydirector is responsible for assuring the laboratory complies with allprovisions of the regulations or standards. An abstraction from thevarious definitions suggests the laboratory director’s responsibilitiesmay be broadly categorized into general responsibilities, personnel,facilities and safety, test procedures, quality management, consul-tation and education, communication, and operational management.This chapter will discuss specific responsibilities within each of thesecategories.
1. Role and Responsibilities of the Laboratory Director 3T
able
1.1.
Lab
orat
ory
Dir
ecto
r’s
Res
pons
ibili
ties
Gen
eral
Res
pons
ibil-
itie
sP
erso
nnel
Fac
iliti
es&
Safe
tyT
est
Pro
cedu
res
Qua
lity
Man
agem
ent
Con
sult
atio
n&
Edu
cati
onC
omm
unic
atio
nO
pera
tion
alM
anag
emen
t
Ove
rall
oper
atio
n&
adm
inis
-tr
atio
nD
efin
ition
ofot
hers
’du
ties
Del
egat
ion
ofau
thor
ityR
eten
tion
ofre
spon
si-
bilit
yL
icen
sure
&ac
cred
i-ta
tion
Med
ical
staf
fpr
ivile
ges
Nee
dsas
sess
men
tJo
bde
scri
ptio
nsH
irin
gst
anda
rds
Staf
fse
lect
ion
Ass
ignm
ent
ofdu
ties
Del
egat
ion
Tra
inin
gst
anda
rds
Staf
ftr
aini
ngC
ompe
tenc
yst
anda
rds
Com
pete
ncy
asse
ssm
ent
Perf
orm
ance
stan
dard
sPe
rfor
man
cere
view
sR
emed
ial
actio
ns
Bio
safe
tyC
hem
ical
hygi
ene
Erg
onom
ics
Tes
tm
enu
sele
ctio
nM
etho
dse
lect
ion
Met
hod
valid
atio
nQ
ualit
yco
ntro
lpr
ogra
mH
arm
oniz
atio
nor
stan
dard
izat
ion
ofm
etho
dsR
equi
sitio
ns/
orde
ring
proc
esse
sSp
ecim
enac
cept
ance
&re
ject
ion
crite
ria
Spec
imen
colle
ctio
n&
hand
ling
Tra
nspo
rtat
ion
Res
ult
repo
rtin
gSt
anda
rdop
erat
ing
proc
edur
esR
efer
ence
labo
rato
ryse
lect
ion
&m
onito
ring
Qua
lity
prog
ram
Qua
lity
stan
dard
sQ
ualit
yas
sess
men
tPr
ofic
ienc
yte
stin
gIn
ter-
met
hod
com
pari
sons
Aud
itsSu
rvey
sIn
spec
tions
Prob
lem
repo
rts
Rem
edia
lac
tions
Qua
lity
impr
ovem
ent
Acc
essi
ble
tom
edic
alst
aff
&la
bora
tory
staf
fT
est
orde
ring
Res
ult
inte
rpre
tatio
nT
hera
peut
icre
com
men
datio
nsT
roub
lesh
ootin
gU
tiliz
atio
npa
ttern
sT
est
men
uch
ange
sSt
aff
cont
inui
nged
ucat
ion
Clin
icia
ned
ucat
ion
Inst
itutio
nal
educ
atio
npr
ogra
msu
ppor
tU
sers
’ne
eds
asse
ssm
ent
Clin
icia
nsPa
tient
sA
dmin
istr
atio
nL
abst
aff
Ris
km
anag
emen
tR
egul
ator
sA
ccre
dita
tion
orce
rtif
icat
ion
bodi
es
Stra
tegi
cpl
anni
ngC
apita
lbu
dget
sO
pera
tiona
lbu
dget
sR
esea
rch
and
deve
l-op
men
tC
ontr
actin
gM
arke
ting
Bill
ing
Org
aniz
atio
nal
goal
sM
etri
cs
4 Sterling T. Bennett
Tab
le1.
2.G
ener
alR
espo
nsib
ilitie
sof
the
Lab
orat
ory
Dir
ecto
r;E
xam
ples
ofR
egul
atio
nsan
dSt
anda
rdsa
Cat
egor
yC
LIA
CA
PN
PA
AC
CP
A
Ove
rall
Ope
ratio
n&
Adm
inis
trat
ion
Tak
ere
spon
sibi
lity
for
over
all
oper
atio
nan
dad
min
istr
atio
nof
lab,
incl
udin
gem
ploy
men
tof
pers
onne
lco
mpe
tent
tope
rfor
mte
stpr
oced
ures
,re
cord
and
repo
rtte
stre
sults
prom
ptly
,acc
urat
ely
and
prof
icie
ntly
.
Tak
ere
spon
sibi
lity
for
over
all
oper
atio
nan
dad
min
istr
atio
nof
lab.
Prov
ide
supe
rvis
ion.
Ass
ume
prof
essi
onal
,sc
ient
ific
,con
sulta
tive,
orga
niza
tiona
l,ad
min
istr
ativ
e,an
ded
ucat
iona
lre
spon
sibi
litie
s.
Tak
ere
spon
sibi
lity
for
prof
essi
onal
,sc
ient
ific
,co
nsul
tativ
e,or
gani
zatio
nal,
adm
inis
trat
ive
and
educ
atio
nal
requ
irem
ents
ofla
b.
N/A
Dut
ies
&D
eleg
atio
nIf
desi
red,
dele
gate
dutie
sof
tech
nica
lsu
perv
isor
,tec
hnic
alco
nsul
tant
,cl
inic
alco
nsul
tant
,ge
nera
lsu
perv
isor
,an
dte
stin
gpe
rson
nel
toqu
alif
ied
pers
onne
l.Sp
ecif
y,in
wri
ting,
resp
onsi
bilit
ies
and
Ifde
sire
d,de
lega
tead
min
istr
ativ
e,m
edic
alan
dte
chni
cal
resp
onsi
bilit
ies
toqu
alif
ied
indi
vidu
als.
Ret
ain
cons
ulta
tive
serv
ices
,as
need
ed,f
orea
chla
bora
tory
disc
iplin
e.
Ifde
sire
d,de
lega
teel
emen
tsof
resp
onsi
bilit
ies
toqu
alif
ied
and
expe
rien
ced
path
olog
ists
orsc
ient
ists
.
Def
ine
orga
niza
tion
and
man
agem
ent
ofla
ban
dits
plac
ein
pare
ntor
gani
zatio
n.Sp
ecif
yro
les,
resp
onsi
bilit
ies,
auth
ority
and
inte
rrel
atio
nshi
psof
all
pers
onne
l.
(Con
tinu
ed)
1. Role and Responsibilities of the Laboratory Director 5
Tab
le1.
2.(C
onti
nued
)
dutie
sof
each
cons
ulta
nt,
supe
rvis
or,
and
pers
onen
gage
din
any
phas
eof
test
ing.
Ret
entio
nof
Res
pons
ibili
tyIf
resp
onsi
bilit
ies
are
reap
port
ione
d,re
mai
nre
spon
sibl
efo
ren
suri
ngal
ldu
ties
are
prop
erly
perf
orm
ed.
Ifdu
ties
are
dele
gate
d,re
mai
nre
spon
sibl
eto
assu
requ
ality
patie
ntse
rvic
esar
epr
ovid
ed.
N/A
N/A
Lic
ensu
re&
Acc
redi
tatio
nA
ssur
eco
mpl
ianc
ew
ithap
plic
able
regu
latio
ns.
Impl
emen
tan
dm
aint
ain
CA
PSt
anda
rds.
Impl
emen
tan
dm
aint
ain
stan
dard
s.C
omm
itto
cont
inui
ngco
mpl
ianc
ew
ithac
cred
itatio
nst
anda
rds.
Med
ical
Staf
fPr
ivile
ges
N/A
As
appl
icab
le,s
erve
asan
activ
em
embe
rof
med
ical
staf
ffo
rfa
cilit
ies
serv
ed.
N/A
N/A
aA
bbre
viat
ions
:CL
IA–
Clin
ical
Lab
orat
ory
Impr
ovem
entA
men
dmen
tsof
1988
(US)
,CA
P–
Col
lege
ofA
mer
ican
Path
olog
ists
,NPA
AC
–N
atio
nal
Path
olog
yA
ccre
dita
tion
Adv
isor
yC
ounc
il(A
ustr
alia
),C
PA–
Clin
ical
Path
olog
yA
ccre
dita
tion
(UK
).
6 Sterling T. Bennett
Tab
le1.
3.Pe
rson
nel:
Res
pons
ibili
ties
ofth
eL
abor
ator
yD
irec
tor;
Exa
mpl
esof
Reg
ulat
ions
and
Stan
dard
sa
Cat
egor
yC
LIA
CA
PN
PA
AC
CP
A
Supe
rvis
ion
Ens
ure
on-s
itesu
perv
isio
nof
high
com
plex
ityte
stin
g.Id
entif
ysu
perv
isio
nre
quir
edfo
rsp
ecim
enpr
oces
sing
,te
stpe
rfor
man
ceor
resu
ltre
port
ing.
Iden
tify
supe
rvis
ory
ordi
rect
orre
view
requ
ired
prio
rto
repo
rtin
gpa
tient
test
resu
lts.
N/A
N/A
N/A
Ade
quat
eSt
affi
ngE
mpl
oysu
ffic
ient
pers
onne
lw
ithed
ucat
ion,
trai
ning
,and
expe
rien
ceto
prov
ide
cons
ulta
tion,
supe
rvis
ean
dpe
rfor
mte
sts,
and
repo
rtte
stre
sults
.
Ens
ure
suff
icie
ntqu
alif
ied
pers
onne
lw
ithdo
cum
ente
dtr
aini
ngan
dex
peri
ence
tom
eet
need
sof
lab.
N/A
Ens
ure
appr
opri
ate
staf
f,w
ithed
ucat
ion
and
trai
ning
tom
eet
serv
ice
dem
ands
and
regu
latio
ns.
Ens
ure
regi
stra
tion
ofst
aff
inac
cord
ance
with
appl
icab
lere
gula
tions
.E
nsur
est
affi
ngin
clud
esro
les
inqu
ality
man
agem
ent,
trai
ning
,ed
ucat
ion,
heal
than
dsa
fety
.
(Con
tinu
ed)
1. Role and Responsibilities of the Laboratory Director 7T
able
1.3.
(Con
tinu
ed)
Pers
onne
lM
anag
emen
t&
Aut
hori
zatio
n
Iden
tify
whi
chex
amin
atio
nsan
dpr
oced
ures
each
indi
vidu
alis
auth
oriz
edto
perf
orm
.
N/A
N/A
Ens
ure
pers
onne
lpr
oced
ures
incl
ude
recr
uitm
ent,
sele
ctio
n,or
ient
atio
n,jo
bde
scri
ptio
ns,
cont
ract
s,re
cord
s,re
view
s,m
eetin
gs,
com
mun
icat
ion,
trai
ning
,ed
ucat
ion,
grie
vanc
ean
ddi
scip
linar
yac
tion.
Ens
ure
conf
iden
tialit
yof
pers
onne
lre
cord
s.T
rain
ing
&C
ompe
tenc
yA
sses
smen
t
Ens
ure
all
pers
onne
lha
veap
prop
riat
eed
ucat
ion
and
expe
rien
ce,
appr
opri
ate
trai
ning
for
type
and
com
plex
ityof
serv
ices
,an
dde
mon
stra
ted
they
can
perf
orm
test
ing
relia
bly
and
repo
rtac
cura
tere
sults
.
N/A
N/A
App
oint
atr
aini
ngof
fice
r.E
nsur
eal
lst
aff
are
orie
nted
tola
b,pa
rent
orga
niza
tion,
cond
ition
sof
empl
oym
ent,
patie
ntco
nfid
entia
lity,
data
prot
ectio
n,he
alth
,sa
fety
,oc
cupa
tiona
lhe
alth
serv
ices
,job
desc
ript
ion,
orga
niza
tiona
lch
art,
sala
ries
and
wag
es,a
ndst
aff
faci
litie
s.M
onito
ring
Com
pete
ncy
Ens
ure
polic
ies
and
proc
edur
esfo
rm
onito
ring
indi
vidu
als
toas
sure
com
pete
ncy
and
toas
sure
iden
tific
atio
nof
need
sfo
rre
med
ial
trai
ning
orco
ntin
uing
educ
atio
n.
N/A
N/A
N/A
aA
bbre
viat
ions
:CL
IA–
Clin
ical
Lab
orat
ory
Impr
ovem
entA
men
dmen
tsof
1988
(US)
,CA
P–
Col
lege
ofA
mer
ican
Path
olog
ists
,NPA
AC
–N
atio
nal
Path
olog
yA
ccre
dita
tion
Adv
isor
yC
ounc
il(A
ustr
alia
),C
PA–
Clin
ical
Path
olog
yA
ccre
dita
tion
(UK
).
8 Sterling T. Bennett
Tab
le1.
4.Fa
cilit
ies
and
Safe
ty:
Res
pons
ibili
ties
ofth
eL
abor
ator
yD
irec
tor;
Exa
mpl
esof
Reg
ulat
ions
and
Stan
dard
sa
Cat
egor
yC
LIA
CA
PN
PA
AC
CP
A
Faci
litie
s&
Safe
tyE
nsur
eph
ysic
alpl
ant
and
envi
ronm
enta
lco
nditi
ons
are
appr
opri
ate
and
prov
ide
asa
feen
viro
nmen
tin
whi
chem
ploy
ees
are
prot
ecte
dfr
omph
ysic
al,
chem
ical
,an
dbi
olog
ical
haza
rds.
Impl
emen
ta
safe
lab
envi
ronm
ent
inco
mpl
ianc
ew
ithgo
odpr
actic
ean
dap
plic
able
regu
latio
ns.
N/A
Ens
ure
asa
few
orki
ngen
viro
nmen
t.Pr
ovid
epe
rson
alpr
otec
tive
equi
pmen
t.D
eleg
ate
day
toda
ym
anag
emen
tof
heal
than
dsa
fety
tohe
alth
and
safe
tyof
fice
r.Pr
ovid
em
odel
rule
sfo
rst
aff
and
visi
tors
.Pr
ovid
efo
rre
gula
rre
port
ing
ofco
mm
unic
able
dise
ases
togo
vern
men
tag
enci
es.
Def
ine
and
impl
emen
tpr
oced
ures
for
actio
nsin
the
even
tof
fire
,m
ajor
spill
ofda
nger
ous
chem
ical
sor
clin
ical
mat
eria
l,or
inoc
ulat
ion
acci
dent
;re
port
ing
and
mon
itori
ngof
acci
dent
san
din
cide
nts;
risk
asse
ssm
ents
;di
sinf
ectio
npr
oces
ses;
deco
ntam
inat
ion
ofeq
uipm
ent;
chem
ical
hand
ling;
and
stor
age
and
disp
osal
ofw
aste
.
aA
bbre
viat
ions
:CL
IA–
Clin
ical
Lab
orat
ory
Impr
ovem
entA
men
dmen
tsof
1988
(US)
,CA
P–
Col
lege
ofA
mer
ican
Path
olog
ists
,NPA
AC
–N
atio
nal
Path
olog
yA
ccre
dita
tion
Adv
isor
yC
ounc
il(A
ustr
alia
),C
PA–
Clin
ical
Path
olog
yA
ccre
dita
tion
(UK
).
1. Role and Responsibilities of the Laboratory Director 9T
able
1.5.
Tes
tPr
oced
ures
:R
espo
nsib
ilitie
sof
the
Lab
orat
ory
Dir
ecto
r;E
xam
ples
ofR
egul
atio
nsan
dSt
anda
rdsa
Cat
egor
yC
LIA
CA
PN
PA
AC
CP
A
Qua
lity
inPr
eana
lytic
,A
naly
tic&
Post
anal
ytic
Phas
es
Ens
ure
test
ing
syst
ems
prov
ide
qual
ityse
rvic
esfo
ral
las
pect
sof
test
ing.
N/A
N/A
Def
ine
and
impl
emen
tpr
oced
ures
for
spec
imen
colle
ctio
n,ha
ndlin
g,re
cept
ion,
tran
spor
tatio
n,an
dre
ject
ion.
Tes
tM
etho
dsE
nsur
ete
stm
etho
dolo
gies
can
prov
ide
qual
ityre
quir
edfo
rpa
tient
care
.
N/A
N/A
Est
ablis
hpr
oced
ures
for
proc
urem
ent
and
man
agem
ent
ofeq
uipm
ent.
Ver
ific
atio
nof
Perf
orm
ance
Cha
ract
eris
tics
Ens
ure
veri
fica
tion
proc
edur
esde
term
ine
accu
racy
,pr
ecis
ion,
and
othe
rpe
rtin
ent
perf
orm
ance
char
acte
rist
ics
ofte
stm
etho
ds.
N/A
N/A
N/A
Qua
lity
Con
trol
Ens
ure
qual
ityco
ntro
lpr
ogra
mis
esta
blis
hed
and
mai
ntai
ned
toas
sure
qual
ityan
did
entif
yfa
ilure
sin
qual
ityas
they
occu
r.
Def
ine
over
all
qual
ityco
ntro
lpr
ogra
m,
incl
udin
ggo
als,
polic
ies,
proc
edur
es,d
eleg
atio
nof
resp
onsi
bilit
ies,
and
regu
lar
revi
ew.
Def
ine,
impl
emen
t,an
dm
onito
rst
anda
rds
ofpe
rfor
man
cein
qual
ityco
ntro
l.
N/A
Ens
ure
avai
labi
lity
ofqu
ality
cont
rol
mat
eria
l.E
stab
lish
proc
edur
esfo
rm
anag
emen
tof
qual
ityco
ntro
lm
ater
ial.
(Con
tinu
ed)
10 Sterling T. Bennett
Tab
le1.
5.(C
onti
nued
)
Cat
egor
yC
LIA
CA
PN
PA
AC
CP
A
Ana
lytic
alPe
rfor
man
ceL
evel
s
Ens
ure
pers
onne
lpe
rfor
mte
stm
etho
dsas
requ
ired
for
accu
rate
and
relia
ble
resu
lts.
Ens
ure
esta
blis
hmen
tan
dm
aint
enan
ceof
acce
ptab
lele
vels
ofan
alyt
ical
perf
orm
ance
for
each
test
syst
em.
Ens
ure
patie
ntte
stre
sults
are
repo
rted
only
whe
nth
esy
stem
isfu
nctio
ning
prop
erly
.
Def
ine
prog
ram
that
mon
itors
and
dem
onst
rate
sth
epr
oper
calib
ratio
n,fu
nctio
n,an
dpr
even
tive
mai
nten
ance
ofin
stru
men
tsan
deq
uipm
ent.
N/A
Ens
ure
avai
labi
lity
ofre
quir
edre
agen
ts,
calib
ratio
nan
dqu
ality
cont
rol
mat
eria
l.E
stab
lish
proc
edur
esfo
rm
anag
emen
tof
reag
ents
,ca
libra
tion
and
qual
ityco
ntro
lm
ater
ial,
incl
udin
gse
lect
ion,
purc
hasi
ng,
orde
ring
,su
pplie
ras
sess
men
t,re
ceip
t,ve
rifi
catio
nof
iden
tity
and
cond
ition
,in
vent
ory
man
agem
ent,
risk
asse
ssm
ent,
assi
gnm
ent
ofha
ndlin
gpr
ecau
tions
,an
dsa
fedi
spos
al.
Rem
edia
lA
ctio
nsE
nsur
ere
med
ial
actio
nsw
hene
ver
sign
ific
ant
devi
atio
nsfr
omes
tabl
ishe
dpe
rfor
man
cech
arac
teri
stic
sar
eid
entif
ied.
N/A
N/A
N/A
(Con
tinu
ed)
1. Role and Responsibilities of the Laboratory Director 11
Tab
le1.
5.(C
onti
nued
)
Rep
orts
Ens
ure
repo
rts
ofte
stre
sults
incl
ude
pert
inen
tin
form
atio
nre
quir
edfo
rin
terp
reta
tion.
N/A
N/A
Est
ablis
hpr
oced
ures
for
repo
rtin
gre
sults
,gi
ving
repo
rts
byte
leph
one,
and
issu
ing
amen
ded
repo
rts.
Dat
aM
anag
emen
tN
/AN
/AN
/AE
nsur
eav
aila
bilit
yof
data
and
info
rmat
ion
tom
eet
user
need
s.E
stab
lish
proc
edur
esfo
rm
anag
emen
tof
data
and
info
rmat
ion,
incl
udin
gse
curi
ty,a
cces
s,co
nfid
entia
lity,
data
prot
ectio
n,ba
ckup
syst
ems,
stor
age,
arch
ive,
retr
ieva
lan
dse
cure
disp
osal
.E
nsur
eco
mpl
ianc
ew
ithre
gula
tions
for
data
prot
ectio
n.Pr
oced
ure
Man
ual
Ens
ure
appr
oved
proc
edur
em
anua
lis
avai
labl
eto
all
pers
onne
l.
N/A
N/A
N/A
Ana
tom
icPa
thol
ogy
N/A
Perf
orm
anat
omic
path
olog
ypr
oced
ures
asap
prop
riat
e.
N/A
N/A
Ref
eren
ceL
abor
ator
ies
N/A
Sele
ctan
dm
onito
rre
fere
nce
labs
.N
/AD
efin
ean
dim
plem
ent
proc
edur
esfo
rre
ferr
alto
othe
rla
bs.
aA
bbre
viat
ions
:CL
IA–
Clin
ical
Lab
orat
ory
Impr
ovem
entA
men
dmen
tsof
1988
(US)
,CA
P–
Col
lege
ofA
mer
ican
Path
olog
ists
,NPA
AC
–N
atio
nal
Path
olog
yA
ccre
dita
tion
Adv
isor
yC
ounc
il(A
ustr
alia
),C
PA–
Clin
ical
Path
olog
yA
ccre
dita
tion
(UK
).
12 Sterling T. Bennett
Tab
le1.
6.Q
ualit
yM
anag
emen
t:R
espo
nsib
ilitie
sof
the
Lab
orat
ory
Dir
ecto
r;E
xam
ples
ofR
egul
atio
nsan
dSt
anda
rdsa
Cat
egor
yC
LIA
CA
PN
PA
AC
CP
A
Prof
icie
ncy
Tes
ting
Ens
ure
enro
llmen
tin
appr
oved
prof
icie
ncy
test
ing
prog
ram
.E
nsur
epr
ofic
ienc
yte
stin
gsa
mpl
esar
ete
sted
insa
me
man
ner
aspa
tient
s’sp
ecim
ens.
Ens
ure
resu
ltsar
ere
turn
edw
ithin
timef
ram
eses
tabl
ishe
dby
prof
icie
ncy
test
ing
prog
ram
.E
nsur
epr
ofic
ienc
yte
stin
gre
port
sar
ere
view
edto
eval
uate
perf
orm
ance
and
iden
tify
prob
lem
sth
atre
quir
eco
rrec
tive
actio
n.E
nsur
eap
prov
edco
rrec
tive
actio
npl
anis
follo
wed
whe
nan
ypr
ofic
ienc
yte
stin
gre
sult
isun
acce
ptab
leor
unsa
tisfa
ctor
y.
Mon
itor
resu
ltsof
prof
icie
ncy
test
ing
and
part
icip
ate
indo
cum
enta
tion
ofco
rrec
tive
actio
ns.
Dev
elop
am
echa
nism
for
dete
rmin
ing
accu
racy
and
relia
bilit
yof
proc
edur
esfo
rw
hich
afo
rmal
exte
rnal
audi
tpr
ogra
mis
not
avai
labl
e.
N/A
N/A
(Con
tinu
ed)
1. Role and Responsibilities of the Laboratory Director 13T
able
1.6.
(Con
tinu
ed)
Qua
lity
Prog
ram
Ens
ure
qual
ityas
sura
nce
prog
ram
ises
tabl
ishe
dan
dm
aint
aine
dto
assu
requ
ality
ofla
bse
rvic
esan
did
entif
yfa
ilure
sin
qual
ityas
they
occu
r.
Syst
emat
ical
lym
onito
ran
dev
alua
tequ
ality
and
appr
opri
aten
ess
ofth
ela
bora
tory
’sco
ntri
butio
nto
patie
ntca
re.
Ens
ure
apr
oces
sto
addr
ess
any
syst
emat
icpr
oble
mor
any
prob
lem
sof
indi
vidu
alco
mpe
tenc
eth
atha
vebe
enid
entif
ied.
N/A
Est
ablis
hqu
ality
man
agem
ent
syst
em.
Est
ablis
hqu
ality
polic
yth
atin
clud
esco
mm
itmen
tsto
full
impl
emen
tatio
nof
qual
itym
anag
emen
tsy
stem
.E
nsur
equ
ality
polic
yis
sign
edby
ape
rson
with
auth
ority
,un
ders
tood
and
impl
emen
ted
thro
ugho
utth
ela
bora
tory
,re
view
edan
nual
ly,
and
cons
iste
ntw
ithot
her
polic
ies
inth
eor
gani
zatio
n.Se
tqu
ality
obje
ctiv
esan
dun
dert
ake
qual
itypl
anni
ng.
Prep
are
qual
itym
anua
l.A
ppoi
ntqu
ality
man
ager
.E
stab
lish
proc
edur
esfo
rdo
cum
ent
cont
rol,
cont
rol
ofpr
oces
san
dqu
ality
reco
rds,
and
cont
rol
ofcl
inic
alm
ater
ial.
Con
duct
man
agem
ent
revi
ews
ofqu
ality
prog
ram
. (Con
tinu
ed)
14 Sterling T. Bennett
Tab
le1.
6.(C
onti
nued
)
Cat
egor
yC
LIA
CA
PN
PA
AC
CP
A
Qua
lity
Impr
ovem
ent
N/A
Ass
ume
resp
onsi
bilit
yfo
rim
plem
enta
tion
ofqu
ality
impr
ovem
ent
plan
.D
efin
e,im
plem
ent,
and
mon
itor
stan
dard
sof
perf
orm
ance
inqu
ality
impr
ovem
ent.
Ens
ure
depa
rtm
ent
part
icip
ates
fully
inin
stitu
tiona
lqu
ality
impr
ovem
ent
plan
sth
atde
alw
ithre
leva
ntar
eas
and
outc
omes
ofpa
tient
care
.Pa
rtic
ipat
eas
mem
bers
ofva
riou
squ
ality
impr
ovem
ent
com
mitt
ees
ofth
ein
stitu
tion.
N/A
Est
ablis
hpr
oced
ures
for
asse
ssm
ent
ofus
ersa
tisfa
ctio
nan
dco
mpl
aint
s,in
tern
alau
dit
ofqu
ality
man
agem
ent
syst
em,i
nter
nal
audi
tof
exam
inat
ion
proc
esse
s,ex
tern
alqu
ality
asse
ssm
ent,
repo
rts
from
exte
rnal
asse
ssm
ent
bodi
es,
and
qual
ityim
prov
emen
t.A
sses
scl
inic
alre
leva
nce
ofla
bin
vest
igat
ions
and
relia
bilit
yof
inte
rpre
tive
repo
rts
inco
njun
ctio
nw
ithus
ers.
Part
icip
ate
inev
alua
tion
ofcl
inic
alef
fect
iven
ess,
audi
tan
dri
skm
anag
emen
tac
tiviti
esof
the
pare
ntor
gani
zatio
nor
exte
rnal
bodi
es.
aA
bbre
viat
ions
:CL
IA–
Clin
ical
Lab
orat
ory
Impr
ovem
entA
men
dmen
tsof
1988
(US)
,CA
P–
Col
lege
ofA
mer
ican
Path
olog
ists
,NPA
AC
–N
atio
nal
Path
olog
yA
ccre
dita
tion
Adv
isor
yC
ounc
il(A
ustr
alia
),C
PA–
Clin
ical
Path
olog
yA
ccre
dita
tion
(UK
).
1. Role and Responsibilities of the Laboratory Director 15T
able
1.7.
Com
mun
icat
ion,
Con
sulta
tion
&E
duca
tion:
Res
pons
ibili
ties
ofth
eL
abor
ator
yD
irec
tor;
Exa
mpl
esof
Reg
ulat
ions
and
Stan
dard
sa
Cat
egor
yC
LIA
CA
PN
PA
AC
CP
A
Inte
ract
ion
with
Oth
ers
N/A
Rel
ate
and
func
tion
effe
ctiv
ely
with
accr
editi
ngre
gula
tory
agen
cies
,adm
inis
trat
ive
offi
cial
s,m
edic
alco
mm
unity
,m
edic
alde
vice
indu
stry
,an
dpa
tient
popu
latio
n.
N/A
N/A
Acc
essi
ble
toL
abor
ator
yB
eac
cess
ible
tola
bto
prov
ide
onsi
te,
tele
phon
eor
elec
tron
icco
nsul
tatio
nas
need
ed.
N/A
N/A
N/A
Med
ical
Sign
ifi-
canc
e,In
terp
re-
tatio
n&
Cor
rela
tion
ofD
ata
Ens
ure
cons
ulta
tion
isav
aila
ble
tola
b’s
clie
nts
onm
atte
rsre
latin
gto
qual
ityof
test
resu
ltsre
port
edan
din
terp
reta
tion
conc
erni
ngsp
ecif
icpa
tient
cond
ition
s.
Prov
ide
cons
ulta
tions
abou
tm
edic
alsi
gnif
ican
ceof
clin
ical
lab
data
.In
terp
ret,
corr
elat
e,an
dco
mm
unic
ate
lab
data
tocl
inic
alre
ques
tors
.
Prov
ide
advi
ceon
clin
ical
sign
ific
ance
ofre
sults
,in
terp
reta
tion
and
corr
elat
ion
ofla
bda
ta,
suita
bilit
yof
test
san
dpr
oced
ures
inva
riou
scl
inic
alsi
tuat
ions
,an
dap
prop
riat
efu
rthe
rte
sts
and
proc
edur
es.
Ens
ure
that
advi
ceon
exam
inat
ions
and
inte
rpre
tatio
nof
resu
ltsis
avai
labl
eto
mee
tth
ene
eds
and
requ
irem
ents
ofus
ers.
(Con
tinu
ed)
16 Sterling T. Bennett
Tab
le1.
7.(C
onti
nued
)
Cat
egor
yC
LIA
CA
PN
PA
AC
CP
A
Edu
catio
nN
/APr
ovid
eed
ucat
iona
lpr
ogra
ms
for
med
ical
and
lab
staf
f,an
dpa
rtic
ipat
ein
educ
atio
nal
prog
ram
sof
the
inst
itutio
n.
N/A
N/A
aA
bbre
viat
ions
:CL
IA–
Clin
ical
Lab
orat
ory
Impr
ovem
entA
men
dmen
tsof
1988
(US)
,CA
P–
Col
lege
ofA
mer
ican
Path
olog
ists
,NPA
AC
–N
atio
nal
Path
olog
yA
ccre
dita
tion
Adv
isor
yC
ounc
il(A
ustr
alia
),C
PA–
Clin
ical
Path
olog
yA
ccre
dita
tion
(UK
).
1. Role and Responsibilities of the Laboratory Director 17T
able
1.8.
Ope
ratio
nal
Man
agem
ent
Res
pons
ibili
ties
ofth
eL
abor
ator
yD
irec
tor:
Exa
mpl
esof
Reg
ulat
ions
and
Stan
dard
sa
Cat
egor
yC
LIA
CA
PN
PA
AC
CP
A
Stra
tegi
cPl
anni
ngN
/APe
rfor
mpl
anni
ngfo
rse
tting
goal
san
dde
velo
ping
and
allo
catin
gre
sour
ces
appr
opri
ate
tom
edic
alen
viro
nmen
t.
N/A
N/A
Adm
inis
trat
ion
& Man
agem
ent
N/A
Prov
ide
effe
ctiv
ean
def
fici
ent
adm
inis
trat
ion,
incl
udin
gbu
dget
plan
ning
and
cont
rol
with
resp
onsi
ble
fina
ncia
lm
anag
emen
t.D
efin
e,im
plem
ent,
and
mon
itor
stan
dard
sof
perf
orm
ance
inco
st-e
ffec
tiven
ess
ofla
bse
rvic
es.
N/A
Hav
ere
gula
rm
eetin
gs,w
ithre
cord
sof
agre
edac
tion
poin
ts,
and
ensu
reac
tions
are
disc
harg
edw
ithin
anap
prop
riat
ean
dag
reed
times
cale
.Pe
rfor
mm
anag
emen
tre
view
s.E
nsur
eav
aila
bilit
yof
nece
ssar
yre
sour
ces.
Res
earc
h&
Dev
elop
men
tN
/APl
anan
ddi
rect
rese
arch
and
deve
lopm
ent
appr
opri
ate
toth
efa
cilit
y.
N/A
N/A
Use
rs’
Nee
dsN
/AN
/AN
/AD
eter
min
eus
ers’
need
san
dre
quir
emen
tsw
ithus
ers.
Spec
ify
user
s’ne
eds
and
requ
irem
ents
asob
ject
ives
for
the
orga
niza
tion
and
man
agem
ent
ofth
ela
b.
aA
bbre
viat
ions
:CL
IA–
Clin
ical
Lab
orat
ory
Impr
ovem
entA
men
dmen
tsof
1988
(US)
,CA
P–
Col
lege
ofA
mer
ican
Path
olog
ists
,NPA
AC
–N
atio
nal
Path
olog
yA
ccre
dita
tion
Adv
isor
yC
ounc
il(A
ustr
alia
),C
PA–
Clin
ical
Path
olog
yA
ccre
dita
tion
(UK
).