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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&

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cati

onC

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unic

atio

nO

pera

tion

alM

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emen

t

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rall

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atio

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adm

inis

-tr

atio

nD

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ition

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egat

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ityR

eten

tion

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spon

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sure

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ical

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ignm

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ties

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egat

ion

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inin

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Com

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ent

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ns

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ualit

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dard

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proc

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ject

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crite

ria

Spec

imen

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ctio

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ult

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edia

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essi

ble

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&la

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tory

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ring

Res

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uch

ange

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aff

cont

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Clin

icia

ned

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ion

Inst

itutio

nal

educ

atio

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eds

asse

ssm

ent

Clin

icia

nsPa

tient

sA

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abst

aff

Ris

km

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icat

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tegi

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ngC

apita

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ing

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aniz

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goal

sM

etri

cs


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

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ies

&D

eleg

atio

nIf

desi

red,

dele

gate

dutie

sof

tech

nica

lsu

perv

isor

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alco

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tant

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inic

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nera

lsu

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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

).


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)


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

).


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

).


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)


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

).


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)


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)


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

).


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)


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

).


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

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es.

N/A

Hav

ere

gula

rm

eetin

gs,w

ithre

cord

sof

agre

edac

tion

poin

ts,

and

ensu

reac

tions

are

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ithin

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prop

riat

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dag

reed

times

cale

.Pe

rfor

mm

anag

emen

tre

view

s.E

nsur

eav

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nece

ssar

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sour

ces.

Res

earc

h&

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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

).

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