CLSI Documents Referenced to The Joint Commission … · 3 CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters CLSI Reference Documents QSA

CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards ChaptersUpdated July 2013

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* Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges; sources of error; reagent handling. Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ID, identification; LIS, laboratory information system; PT, proficiency testing; QC, quality control. 2

CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters

QSA(Quality System Assessment for Nonwaived Testing) Chapter*

DC

(Doc

umen

t and

Pro

cess

Con

trol

) Te

st O

rder

ing

and

Repo

rtin

g; P

atie

nt

Iden

tifica

tion;

Spe

cim

en C

olle

ctio

n,

Han

dlin

g, a

nd S

tora

ge; D

ocum

ent R

eten

tion

and

Writ

ten

Polic

ies/

Proc

edur

es

EC (E

nviro

nmen

t of C

are)

Sa

fety

; Fac

ilitie

s; Ha

zard

ous M

ater

ials;

La

bora

tory

Equi

pmen

t/In

stru

men

tatio

n

EM (E

mer

genc

y M

anag

emen

t)Em

erge

ncy R

espo

nse a

nd D

isast

er P

repa

redn

ess

HR

(Hum

an R

esou

rces

) Pe

rson

nel Q

ualifi

catio

ns; O

rient

atio

n an

d Tr

aini

ng; C

ompe

tenc

y

IC (I

nfec

tion

Pre

vent

ion

and

Cont

rol)

Prot

ectio

n, P

reve

ntio

n, C

omm

unica

tion,

and

Be

nch

Prec

autio

ns

IM (I

nfor

mat

ion

Man

agem

ent)

LIS R

equi

rem

ents

; Inte

rrupt

ions

and

Bac

kup

Plan

; Info

rmat

ion

Secu

rity;

Dat

a St

orag

e an

d Re

trie

val

LD (L

eade

rshi

p)

Gove

rnan

ce; E

thics

; Lice

nsur

e an

d Ac

cred

itatio

n;

Org

aniza

tiona

l Str

uctu

re a

nd S

ervi

ces;

Labo

rato

ry Pe

rform

ance

; Dat

a an

d In

form

atio

n Re

view

and

Res

pons

ivene

ss; C

ompl

aint

s, Re

solu

tions

, and

Com

mun

icatio

ns

NPS

G (N

atio

nal P

atie

nt S

afet

y G

oals

) Pa

tient

ID; C

ritica

l Res

ults

Rep

ortin

g; H

and

Hygi

ene

PI (P

erfo

rman

ce Im

prov

emen

t)

Data

Col

lect

ion;

Ana

lysi

s; Pe

rfor

man

ce

Revi

ew; C

orre

ctiv

e Ac

tions

WT

(Wai

ved

Test

ing)

CL

IA; O

vers

ight

and

Res

pons

ibili

ty fo

r Te

stin

g; Te

st P

erfo

rman

ce

I. Pro

ficie

ncy T

estin

g

II. Q

ualit

y Co

ntro

l

III. –

XXI

. Tec

hnica

l Sp

ecia

litie

s

CLSI Reference Documents

Automation and Informatics

AUTO01-A

AUTO02-A2

AUTO03-A2

AUTO04-A

AUTO05-A

AUTO07-A

AUTO08-A

AUTO09-A

AUTO10-A

AUTO11-A

AUTO12-A

AUTO13-A2 (formerly GP19-A2)

LIS01-A2

LIS02-A2

LIS03-A

LIS04-A

LIS05-A

3




DC

(Doc

umen

t and

Pro

cess

Con

trol

) Te

st O

rder

ing

and

Repo

rtin

g; P

atie

nt

Iden

tifica

tion;

Spe

cim

en C

olle

ctio

n,

Han

dlin

g, a

nd S

tora

ge; D

ocum

ent R

eten

tion

and

Writ

ten

Polic

ies/

Proc

edur

es

EC (E

nviro

nmen

t of C

are)

Sa

fety

; Fac

ilitie

s; Ha

zard

ous M

ater

ials;

La

bora

tory

Equi

pmen

t/In

stru

men

tatio

n

EM (E

mer

genc

y M

anag

emen

t)Em

erge

ncy R

espo

nse a

nd D

isast

er P

repa

redn

ess

HR

(Hum

an R

esou

rces

) Pe

rson

nel Q

ualifi

catio

ns; O

rient

atio

n an

d Tr

aini

ng; C

ompe

tenc

y

IC (I

nfec

tion

Pre

vent

ion

and

Cont

rol)

Prot

ectio

n, P

reve

ntio

n, C

omm

unica

tion,

and

Be

nch

Prec

autio

ns

IM (I

nfor

mat

ion

Man

agem

ent)

LIS R

equi

rem

ents

; Inte

rrupt

ions

and

Bac

kup

Plan

; Info

rmat

ion

Secu

rity;

Dat

a St

orag

e an

d Re

trie

val

LD (L

eade

rshi

p)

Gove

rnan

ce; E

thics

; Lice

nsur

e an

d Ac

cred

itatio

n;

Org

aniza

tiona

l Str

uctu

re a

nd S

ervi

ces;

Labo

rato

ry Pe

rform

ance

; Dat

a an

d In

form

atio

n Re

view

and

Res

pons

ivene

ss; C

ompl

aint

s, Re

solu

tions

, and

Com

mun

icatio

ns

NPS

G (N

atio

nal P

atie

nt S

afet

y G

oals

) Pa

tient

ID; C

ritica

l Res

ults

Rep

ortin

g; H

and

Hygi

ene

PI (P

erfo

rman

ce Im

prov

emen

t)

Data

Col

lect

ion;

Ana

lysi

s; Pe

rfor

man

ce

Revi

ew; C

orre

ctiv

e Ac

tions

WT

(Wai

ved

Test

ing)

CL

IA; O

vers

ight

and

Res

pons

ibili

ty fo

r Te

stin

g; Te

st P

erfo

rman

ce

I. Pro

ficie

ncy T

estin

g

II. Q

ualit

y Co

ntro

l

III. –

XXI

. Tec

hnica

l Sp

ecia

litie

s

Automation and Informatics (continued)

LIS06-A

LIS07-A

LIS08-A

LIS09-A

Clinical Chemistry and Toxicology

C24-A3

C29-A2

C31-A2

C34-A3

C37-A

C38-A

C39-A

C40-A

C42-A

C43-A2

C44-A

C45-A

* Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges; sources of error; reagent handling. Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ID, identification; LIS, laboratory information system; PT, proficiency testing; QC, quality control.

4




DC

(Doc

umen

t and

Pro

cess

Con

trol

) Te

st O

rder

ing

and

Repo

rtin

g; P

atie

nt

Iden

tifica

tion;

Spe

cim

en C

olle

ctio

n,

Han

dlin

g, a

nd S

tora

ge; D

ocum

ent R

eten

tion

and

Writ

ten

Polic

ies/

Proc

edur

es

EC (E

nviro

nmen

t of C

are)

Sa

fety

; Fac

ilitie

s; Ha

zard

ous M

ater

ials;

La

bora

tory

Equi

pmen

t/In

stru

men

tatio

n

EM (E

mer

genc

y M

anag

emen

t)Em

erge

ncy R

espo

nse a

nd D

isast

er P

repa

redn

ess

HR

(Hum

an R

esou

rces

) Pe

rson

nel Q

ualifi

catio

ns; O

rient

atio

n an

d Tr

aini

ng; C

ompe

tenc

y

IC (I

nfec

tion

Pre

vent

ion

and

Cont

rol)

Prot

ectio

n, P

reve

ntio

n, C

omm

unica

tion,

and

Be

nch

Prec

autio

ns

IM (I

nfor

mat

ion

Man

agem

ent)

LIS R

equi

rem

ents

; Inte

rrupt

ions

and

Bac

kup

Plan

; Info

rmat

ion

Secu

rity;

Dat

a St

orag

e an

d Re

trie

val

LD (L

eade

rshi

p)

Gove

rnan

ce; E

thics

; Lice

nsur

e an

d Ac

cred

itatio

n;

Org

aniza

tiona

l Str

uctu

re a

nd S

ervi

ces;

Labo

rato

ry Pe

rform

ance

; Dat

a an

d In

form

atio

n Re

view

and

Res

pons

ivene

ss; C

ompl

aint

s, Re

solu

tions

, and

Com

mun

icatio

ns

NPS

G (N

atio

nal P

atie

nt S

afet

y G

oals

) Pa

tient

ID; C

ritica

l Res

ults

Rep

ortin

g; H

and

Hygi

ene

PI (P

erfo

rman

ce Im

prov

emen

t)

Data

Col

lect

ion;

Ana

lysi

s; Pe

rfor

man

ce

Revi

ew; C

orre

ctiv

e Ac

tions

WT

(Wai

ved

Test

ing)

CL

IA; O

vers

ight

and

Res

pons

ibili

ty fo

r Te

stin

g; Te

st P

erfo

rman

ce

I. Pro

ficie

ncy T

estin

g

II. Q

ualit

y Co

ntro

l

III. –

XXI

. Tec

hnica

l Sp

ecia

litie

s

Clinical Chemistry and Toxicology (continued)

C46-A2

C48-A

C49-A

C50-A

C52-A2

C56-A

C58-A

C59-A (formerly I/LA15-A)

C60-A (formerly T/DM06-A)

C61-A (formerly H17-A)

General Laboratory

GP05-A3

GP11-A

GP15-A3

GP16-A3

GP17-A3

GP20-A2


5




DC

(Doc

umen

t and

Pro

cess

Con

trol

) Te

st O

rder

ing

and

Repo

rtin

g; P

atie

nt

Iden

tifica

tion;

Spe

cim

en C

olle

ctio

n,

Han

dlin

g, a

nd S

tora

ge; D

ocum

ent R

eten

tion

and

Writ

ten

Polic

ies/

Proc

edur

es

EC (E

nviro

nmen

t of C

are)

Sa

fety

; Fac

ilitie

s; Ha

zard

ous M

ater

ials;

La

bora

tory

Equi

pmen

t/In

stru

men

tatio

n

EM (E

mer

genc

y M

anag

emen

t)Em

erge

ncy R

espo

nse a

nd D

isast

er P

repa

redn

ess

HR

(Hum

an R

esou

rces

) Pe

rson

nel Q

ualifi

catio

ns; O

rient

atio

n an

d Tr

aini

ng; C

ompe

tenc

y

IC (I

nfec

tion

Pre

vent

ion

and

Cont

rol)

Prot

ectio

n, P

reve

ntio

n, C

omm

unica

tion,

and

Be

nch

Prec

autio

ns

IM (I

nfor

mat

ion

Man

agem

ent)

LIS R

equi

rem

ents

; Inte

rrupt

ions

and

Bac

kup

Plan

; Info

rmat

ion

Secu

rity;

Dat

a St

orag

e an

d Re

trie

val

LD (L

eade

rshi

p)

Gove

rnan

ce; E

thics

; Lice

nsur

e an

d Ac

cred

itatio

n;

Org

aniza

tiona

l Str

uctu

re a

nd S

ervi

ces;

Labo

rato

ry Pe

rform

ance

; Dat

a an

d In

form

atio

n Re

view

and

Res

pons

ivene

ss; C

ompl

aint

s, Re

solu

tions

, and

Com

mun

icatio

ns

NPS

G (N

atio

nal P

atie

nt S

afet

y G

oals

) Pa

tient

ID; C

ritica

l Res

ults

Rep

ortin

g; H

and

Hygi

ene

PI (P

erfo

rman

ce Im

prov

emen

t)

Data

Col

lect

ion;

Ana

lysi

s; Pe

rfor

man

ce

Revi

ew; C

orre

ctiv

e Ac

tions

WT

(Wai

ved

Test

ing)

CL

IA; O

vers

ight

and

Res

pons

ibili

ty fo

r Te

stin

g; Te

st P

erfo

rman

ce

I. Pro

ficie

ncy T

estin

g

II. Q

ualit

y Co

ntro

l

III. –

XXI

. Tec

hnica

l Sp

ecia

litie

s

General Laboratory (continued)

GP23-A

GP27-A2

GP28-A

GP29-A2

GP31-A

GP33-A

GP34-A

GP39-A6 (formerly H01-A6)

GP40-A4-AMD (formerly C03-A4-AMD)





GP45-A (formerly HS06-A)

GP46-R (formerly X04-R)

I03-A

I08-P


6




DC

(Doc

umen

t and

Pro

cess

Con

trol

) Te

st O

rder

ing

and

Repo

rtin

g; P

atie

nt

Iden

tifica

tion;

Spe

cim

en C

olle

ctio

n,

Han

dlin

g, a

nd S

tora

ge; D

ocum

ent R

eten

tion

and

Writ

ten

Polic

ies/

Proc

edur

es

EC (E

nviro

nmen

t of C

are)

Sa

fety

; Fac

ilitie

s; Ha

zard

ous M

ater

ials;

La

bora

tory

Equi

pmen

t/In

stru

men

tatio

n

EM (E

mer

genc

y M

anag

emen

t)Em

erge

ncy R

espo

nse a

nd D

isast

er P

repa

redn

ess

HR

(Hum

an R

esou

rces

) Pe

rson

nel Q

ualifi

catio

ns; O

rient

atio

n an

d Tr

aini

ng; C

ompe

tenc

y

IC (I

nfec

tion

Pre

vent

ion

and

Cont

rol)

Prot

ectio

n, P

reve

ntio

n, C

omm

unica

tion,

and

Be

nch

Prec

autio

ns

IM (I

nfor

mat

ion

Man

agem

ent)

LIS R

equi

rem

ents

; Inte

rrupt

ions

and

Bac

kup

Plan

; Info

rmat

ion

Secu

rity;

Dat

a St

orag

e an

d Re

trie

val

LD (L

eade

rshi

p)

Gove

rnan

ce; E

thics

; Lice

nsur

e an

d Ac

cred

itatio

n;

Org

aniza

tiona

l Str

uctu

re a

nd S

ervi

ces;

Labo

rato

ry Pe

rform

ance

; Dat

a an

d In

form

atio

n Re

view

and

Res

pons

ivene

ss; C

ompl

aint

s, Re

solu

tions

, and

Com

mun

icatio

ns

NPS

G (N

atio

nal P

atie

nt S

afet

y G

oals

) Pa

tient

ID; C

ritica

l Res

ults

Rep

ortin

g; H

and

Hygi

ene

PI (P

erfo

rman

ce Im

prov

emen

t)

Data

Col

lect

ion;

Ana

lysi

s; Pe

rfor

man

ce

Revi

ew; C

orre

ctiv

e Ac

tions

WT

(Wai

ved

Test

ing)

CL

IA; O

vers

ight

and

Res

pons

ibili

ty fo

r Te

stin

g; Te

st P

erfo

rman

ce

I. Pro

ficie

ncy T

estin

g

II. Q

ualit

y Co

ntro

l

III. –

XXI

. Tec

hnica

l Sp

ecia

litie

s

General Laboratory (continued)

I16-T

Hematology

H02-A5

H07-A3

H15-A3

H20-A2

H21-A5

H26-A2

H30-A2

H42-A2

H43-A2

H44-A2

H47-A2

H48-A

H51-A

H52-A

H54-A


7




DC

(Doc

umen

t and

Pro

cess

Con

trol

) Te

st O

rder

ing

and

Repo

rtin

g; P

atie

nt

Iden

tifica

tion;

Spe

cim

en C

olle

ctio

n,

Han

dlin

g, a

nd S

tora

ge; D

ocum

ent R

eten

tion

and

Writ

ten

Polic

ies/

Proc

edur

es

EC (E

nviro

nmen

t of C

are)

Sa

fety

; Fac

ilitie

s; Ha

zard

ous M

ater

ials;

La

bora

tory

Equi

pmen

t/In

stru

men

tatio

n

EM (E

mer

genc

y M

anag

emen

t)Em

erge

ncy R

espo

nse a

nd D

isast

er P

repa

redn

ess

HR

(Hum

an R

esou

rces

) Pe

rson

nel Q

ualifi

catio

ns; O

rient

atio

n an

d Tr

aini

ng; C

ompe

tenc

y

IC (I

nfec

tion

Pre

vent

ion

and

Cont

rol)

Prot

ectio

n, P

reve

ntio

n, C

omm

unica

tion,

and

Be

nch

Prec

autio

ns

IM (I

nfor

mat

ion

Man

agem

ent)

LIS R

equi

rem

ents

; Inte

rrupt

ions

and

Bac

kup

Plan

; Info

rmat

ion

Secu

rity;

Dat

a St

orag

e an

d Re

trie

val

LD (L

eade

rshi

p)

Gove

rnan

ce; E

thics

; Lice

nsur

e an

d Ac

cred

itatio

n;

Org

aniza

tiona

l Str

uctu

re a

nd S

ervi

ces;

Labo

rato

ry Pe

rform

ance

; Dat

a an

d In

form

atio

n Re

view

and

Res

pons

ivene

ss; C

ompl

aint

s, Re

solu

tions

, and

Com

mun

icatio

ns

NPS

G (N

atio

nal P

atie

nt S

afet

y G

oals

) Pa

tient

ID; C

ritica

l Res

ults

Rep

ortin

g; H

and

Hygi

ene

PI (P

erfo

rman

ce Im

prov

emen

t)

Data

Col

lect

ion;

Ana

lysi

s; Pe

rfor

man

ce

Revi

ew; C

orre

ctiv

e Ac

tions

WT

(Wai

ved

Test

ing)

CL

IA; O

vers

ight

and

Res

pons

ibili

ty fo

r Te

stin

g; Te

st P

erfo

rman

ce

I. Pro

ficie

ncy T

estin

g

II. Q

ualit

y Co

ntro

l

III. –

XXI

. Tec

hnica

l Sp

ecia

litie

s

Hematology (continued)

H56-A

H57-A

H58-A

H59-A

Immunology and Ligand Assay

I/LA02-A2

I/LA18-A2

I/LA20-A2

I/LA21-A2

I/LA23-A

I/LA25-A2

I/LA26-A

I/LA28-A2

I/LA29-A

I/LA30-A

I/LA33-A

I/LA34-A


8




DC

(Doc

umen

t and

Pro

cess

Con

trol

) Te

st O

rder

ing

and

Repo

rtin

g; P

atie

nt

Iden

tifica

tion;

Spe

cim

en C

olle

ctio

n,

Han

dlin

g, a

nd S

tora

ge; D

ocum

ent R

eten

tion

and

Writ

ten

Polic

ies/

Proc

edur

es

EC (E

nviro

nmen

t of C

are)

Sa

fety

; Fac

ilitie

s; Ha

zard

ous M

ater

ials;

La

bora

tory

Equi

pmen

t/In

stru

men

tatio

n

EM (E

mer

genc

y M

anag

emen

t)Em

erge

ncy R

espo

nse a

nd D

isast

er P

repa

redn

ess

HR

(Hum

an R

esou

rces

) Pe

rson

nel Q

ualifi

catio

ns; O

rient

atio

n an

d Tr

aini

ng; C

ompe

tenc

y

IC (I

nfec

tion

Pre

vent

ion

and

Cont

rol)

Prot

ectio

n, P

reve

ntio

n, C

omm

unica

tion,

and

Be

nch

Prec

autio

ns

IM (I

nfor

mat

ion

Man

agem

ent)

LIS R

equi

rem

ents

; Inte

rrupt

ions

and

Bac

kup

Plan

; Info

rmat

ion

Secu

rity;

Dat

a St

orag

e an

d Re

trie

val

LD (L

eade

rshi

p)

Gove

rnan

ce; E

thics

; Lice

nsur

e an

d Ac

cred

itatio

n;

Org

aniza

tiona

l Str

uctu

re a

nd S

ervi

ces;

Labo

rato

ry Pe

rform

ance

; Dat

a an

d In

form

atio

n Re

view

and

Res

pons

ivene

ss; C

ompl

aint

s, Re

solu

tions

, and

Com

mun

icatio

ns

NPS

G (N

atio

nal P

atie

nt S

afet

y G

oals

) Pa

tient

ID; C

ritica

l Res

ults

Rep

ortin

g; H

and

Hygi

ene

PI (P

erfo

rman

ce Im

prov

emen

t)

Data

Col

lect

ion;

Ana

lysi

s; Pe

rfor

man

ce

Revi

ew; C

orre

ctiv

e Ac

tions

WT

(Wai

ved

Test

ing)

CL

IA; O

vers

ight

and

Res

pons

ibili

ty fo

r Te

stin

g; Te

st P

erfo

rman

ce

I. Pro

ficie

ncy T

estin

g

II. Q

ualit

y Co

ntro

l

III. –

XXI

. Tec

hnica

l Sp

ecia

litie

s

Method Evaluation

EP05-A2

EP06-A

EP07-A2

EP09-A2-IR

EP10-A3

EP12-A2

EP14-A2

EP15-A2

EP17-A2

EP18-A2

EP19-R

EP21-A

EP23-ATM

EP24-A2

EP25-A

EP27-A

EP28-A3c (formerly C28-A3c)


9




DC

(Doc

umen

t and

Pro

cess

Con

trol

) Te

st O

rder

ing

and

Repo

rtin

g; P

atie

nt

Iden

tifica

tion;

Spe

cim

en C

olle

ctio

n,

Han

dlin

g, a

nd S

tora

ge; D

ocum

ent R

eten

tion

and

Writ

ten

Polic

ies/

Proc

edur

es

EC (E

nviro

nmen

t of C

are)

Sa

fety

; Fac

ilitie

s; Ha

zard

ous M

ater

ials;

La

bora

tory

Equi

pmen

t/In

stru

men

tatio

n

EM (E

mer

genc

y M

anag

emen

t)Em

erge

ncy R

espo

nse a

nd D

isast

er P

repa

redn

ess

HR

(Hum

an R

esou

rces

) Pe

rson

nel Q

ualifi

catio

ns; O

rient

atio

n an

d Tr

aini

ng; C

ompe

tenc

y

IC (I

nfec

tion

Pre

vent

ion

and

Cont

rol)

Prot

ectio

n, P

reve

ntio

n, C

omm

unica

tion,

and

Be

nch

Prec

autio

ns

IM (I

nfor

mat

ion

Man

agem

ent)

LIS R

equi

rem

ents

; Inte

rrupt

ions

and

Bac

kup

Plan

; Info

rmat

ion

Secu

rity;

Dat

a St

orag

e an

d Re

trie

val

LD (L

eade

rshi

p)

Gove

rnan

ce; E

thics

; Lice

nsur

e an

d Ac

cred

itatio

n;

Org

aniza

tiona

l Str

uctu

re a

nd S

ervi

ces;

Labo

rato

ry Pe

rform

ance

; Dat

a an

d In

form

atio

n Re

view

and

Res

pons

ivene

ss; C

ompl

aint

s, Re

solu

tions

, and

Com

mun

icatio

ns

NPS

G (N

atio

nal P

atie

nt S

afet

y G

oals

) Pa

tient

ID; C

ritica

l Res

ults

Rep

ortin

g; H

and

Hygi

ene

PI (P

erfo

rman

ce Im

prov

emen

t)

Data

Col

lect

ion;

Ana

lysi

s; Pe

rfor

man

ce

Revi

ew; C

orre

ctiv

e Ac

tions

WT

(Wai

ved

Test

ing)

CL

IA; O

vers

ight

and

Res

pons

ibili

ty fo

r Te

stin

g; Te

st P

erfo

rman

ce

I. Pro

ficie

ncy T

estin

g

II. Q

ualit

y Co

ntro

l

III. –

XXI

. Tec

hnica

l Sp

ecia

litie

s

Method Evaluation (continued)

EP29-A (formerly C51-A)

EP30-A (formerly C53-A)

EP31-A-IR (formerly C54-A-IR)

EP32-R (formerly X05-R)

Microbiology

M02-A11

M06-A2

M07-A9

M11-A8

M15-A

M21-A

M22-A3

M23-A3

M24-A2

M26-A

M27-A3

M27-S4


10




DC

(Doc

umen

t and

Pro

cess

Con

trol

) Te

st O

rder

ing

and

Repo

rtin

g; P

atie

nt

Iden

tifica

tion;

Spe

cim

en C

olle

ctio

n,

Han

dlin

g, a

nd S

tora

ge; D

ocum

ent R

eten

tion

and

Writ

ten

Polic

ies/

Proc

edur

es

EC (E

nviro

nmen

t of C

are)

Sa

fety

; Fac

ilitie

s; Ha

zard

ous M

ater

ials;

La

bora

tory

Equi

pmen

t/In

stru

men

tatio

n

EM (E

mer

genc

y M

anag

emen

t)Em

erge

ncy R

espo

nse a

nd D

isast

er P

repa

redn

ess

HR

(Hum

an R

esou

rces

) Pe

rson

nel Q

ualifi

catio

ns; O

rient

atio

n an

d Tr

aini

ng; C

ompe

tenc

y

IC (I

nfec

tion

Pre

vent

ion

and

Cont

rol)

Prot

ectio

n, P

reve

ntio

n, C

omm

unica

tion,

and

Be

nch

Prec

autio

ns

IM (I

nfor

mat

ion

Man

agem

ent)

LIS R

equi

rem

ents

; Inte

rrupt

ions

and

Bac

kup

Plan

; Info

rmat

ion

Secu

rity;

Dat

a St

orag

e an

d Re

trie

val

LD (L

eade

rshi

p)

Gove

rnan

ce; E

thics

; Lice

nsur

e an

d Ac

cred

itatio

n;

Org

aniza

tiona

l Str

uctu

re a

nd S

ervi

ces;

Labo

rato

ry Pe

rform

ance

; Dat

a an

d In

form

atio

n Re

view

and

Res

pons

ivene

ss; C

ompl

aint

s, Re

solu

tions

, and

Com

mun

icatio

ns

NPS

G (N

atio

nal P

atie

nt S

afet

y G

oals

) Pa

tient

ID; C

ritica

l Res

ults

Rep

ortin

g; H

and

Hygi

ene

PI (P

erfo

rman

ce Im

prov

emen

t)

Data

Col

lect

ion;

Ana

lysi

s; Pe

rfor

man

ce

Revi

ew; C

orre

ctiv

e Ac

tions

WT

(Wai

ved

Test

ing)

CL

IA; O

vers

ight

and

Res

pons

ibili

ty fo

r Te

stin

g; Te

st P

erfo

rman

ce

I. Pro

ficie

ncy T

estin

g

II. Q

ualit

y Co

ntro

l

III. –

XXI

. Tec

hnica

l Sp

ecia

litie

s

Microbiology (continued)

M28-A2

M29-A3

M32-P

M33-A

M34-A

M35-A2

M36-A

M38-A2

M39-A3

M40-A

M41-A

M43-A

M44-A2

M44-S3

M45-A2

M47-A

M48-A


11




DC

(Doc

umen

t and

Pro

cess

Con

trol

) Te

st O

rder

ing

and

Repo

rtin

g; P

atie

nt

Iden

tifica

tion;

Spe

cim

en C

olle

ctio

n,

Han

dlin

g, a

nd S

tora

ge; D

ocum

ent R

eten

tion

and

Writ

ten

Polic

ies/

Proc

edur

es

EC (E

nviro

nmen

t of C

are)

Sa

fety

; Fac

ilitie

s; Ha

zard

ous M

ater

ials;

La

bora

tory

Equi

pmen

t/In

stru

men

tatio

n

EM (E

mer

genc

y M

anag

emen

t)Em

erge

ncy R

espo

nse a

nd D

isast

er P

repa

redn

ess

HR

(Hum

an R

esou

rces

) Pe

rson

nel Q

ualifi

catio

ns; O

rient

atio

n an

d Tr

aini

ng; C

ompe

tenc

y

IC (I

nfec

tion

Pre

vent

ion

and

Cont

rol)

Prot

ectio

n, P

reve

ntio

n, C

omm

unica

tion,

and

Be

nch

Prec

autio

ns

IM (I

nfor

mat

ion

Man

agem

ent)

LIS R

equi

rem

ents

; Inte

rrupt

ions

and

Bac

kup

Plan

; Info

rmat

ion

Secu

rity;

Dat

a St

orag

e an

d Re

trie

val

LD (L

eade

rshi

p)

Gove

rnan

ce; E

thics

; Lice

nsur

e an

d Ac

cred

itatio

n;

Org

aniza

tiona

l Str

uctu

re a

nd S

ervi

ces;

Labo

rato

ry Pe

rform

ance

; Dat

a an

d In

form

atio

n Re

view

and

Res

pons

ivene

ss; C

ompl

aint

s, Re

solu

tions

, and

Com

mun

icatio

ns

NPS

G (N

atio

nal P

atie

nt S

afet

y G

oals

) Pa

tient

ID; C

ritica

l Res

ults

Rep

ortin

g; H

and

Hygi

ene

PI (P

erfo

rman

ce Im

prov

emen

t)

Data

Col

lect

ion;

Ana

lysi

s; Pe

rfor

man

ce

Revi

ew; C

orre

ctiv

e Ac

tions

WT

(Wai

ved

Test

ing)

CL

IA; O

vers

ight

and

Res

pons

ibili

ty fo

r Te

stin

g; Te

st P

erfo

rman

ce

I. Pro

ficie

ncy T

estin

g

II. Q

ualit

y Co

ntro

l

III. –

XXI

. Tec

hnica

l Sp

ecia

litie

s

Microbiology (continued)

M50-A

M51-A

M51-S1

M53-A

M54-A

M55-R (formerly X07-R)

M100-S23

Molecular Methods

MM01-A3

MM03-A2

MM05-A2

MM06-A2

MM07-A

MM09-A

MM10-A

MM11-A

MM12-A


12




DC

(Doc

umen

t and

Pro

cess

Con

trol

) Te

st O

rder

ing

and

Repo

rtin

g; P

atie

nt

Iden

tifica

tion;

Spe

cim

en C

olle

ctio

n,

Han

dlin

g, a

nd S

tora

ge; D

ocum

ent R

eten

tion

and

Writ

ten

Polic

ies/

Proc

edur

es

EC (E

nviro

nmen

t of C

are)

Sa

fety

; Fac

ilitie

s; Ha

zard

ous M

ater

ials;

La

bora

tory

Equi

pmen

t/In

stru

men

tatio

n

EM (E

mer

genc

y M

anag

emen

t)Em

erge

ncy R

espo

nse a

nd D

isast

er P

repa

redn

ess

HR

(Hum

an R

esou

rces

) Pe

rson

nel Q

ualifi

catio

ns; O

rient

atio

n an

d Tr

aini

ng; C

ompe

tenc

y

IC (I

nfec

tion

Pre

vent

ion

and

Cont

rol)

Prot

ectio

n, P

reve

ntio

n, C

omm

unica

tion,

and

Be

nch

Prec

autio

ns

IM (I

nfor

mat

ion

Man

agem

ent)

LIS R

equi

rem

ents

; Inte

rrupt

ions

and

Bac

kup

Plan

; Info

rmat

ion

Secu

rity;

Dat

a St

orag

e an

d Re

trie

val

LD (L

eade

rshi

p)

Gove

rnan

ce; E

thics

; Lice

nsur

e an

d Ac

cred

itatio

n;

Org

aniza

tiona

l Str

uctu

re a

nd S

ervi

ces;

Labo

rato

ry Pe

rform

ance

; Dat

a an

d In

form

atio

n Re

view

and

Res

pons

ivene

ss; C

ompl

aint

s, Re

solu

tions

, and

Com

mun

icatio

ns

NPS

G (N

atio

nal P

atie

nt S

afet

y G

oals

) Pa

tient

ID; C

ritica

l Res

ults

Rep

ortin

g; H

and

Hygi

ene

PI (P

erfo

rman

ce Im

prov

emen

t)

Data

Col

lect

ion;

Ana

lysi

s; Pe

rfor

man

ce

Revi

ew; C

orre

ctiv

e Ac

tions

WT

(Wai

ved

Test

ing)

CL

IA; O

vers

ight

and

Res

pons

ibili

ty fo

r Te

stin

g; Te

st P

erfo

rman

ce

I. Pro

ficie

ncy T

estin

g

II. Q

ualit

y Co

ntro

l

III. –

XXI

. Tec

hnica

l Sp

ecia

litie

s

Molecular Methods (continued)

MM13-A

MM14-A2

MM16-A

MM17-A

MM18-A

MM19-A

MM20-A

Newborn Screening

NBS01-A6 (replaces LA04-A5)

NBS02-A2 (replaces I/LA27-A)

NBS03-A (formerly I/LA31-A)



NBS06-A

Point-of-Care Testing

POCT01-A2

POCT02-A


13




DC

(Doc

umen

t and

Pro

cess

Con

trol

) Te

st O

rder

ing

and

Repo

rtin

g; P

atie

nt

Iden

tifica

tion;

Spe

cim

en C

olle

ctio

n,

Han

dlin

g, a

nd S

tora

ge; D

ocum

ent R

eten

tion

and

Writ

ten

Polic

ies/

Proc

edur

es

EC (E

nviro

nmen

t of C

are)

Sa

fety

; Fac

ilitie

s; Ha

zard

ous M

ater

ials;

La

bora

tory

Equi

pmen

t/In

stru

men

tatio

n

EM (E

mer

genc

y M

anag

emen

t)Em

erge

ncy R

espo

nse a

nd D

isast

er P

repa

redn

ess

HR

(Hum

an R

esou

rces

) Pe

rson

nel Q

ualifi

catio

ns; O

rient

atio

n an

d Tr

aini

ng; C

ompe

tenc

y

IC (I

nfec

tion

Pre

vent

ion

and

Cont

rol)

Prot

ectio

n, P

reve

ntio

n, C

omm

unica

tion,

and

Be

nch

Prec

autio

ns

IM (I

nfor

mat

ion

Man

agem

ent)

LIS R

equi

rem

ents

; Inte

rrupt

ions

and

Bac

kup

Plan

; Info

rmat

ion

Secu

rity;

Dat

a St

orag

e an

d Re

trie

val

LD (L

eade

rshi

p)

Gove

rnan

ce; E

thics

; Lice

nsur

e an

d Ac

cred

itatio

n;

Org

aniza

tiona

l Str

uctu

re a

nd S

ervi

ces;

Labo

rato

ry Pe

rform

ance

; Dat

a an

d In

form

atio

n Re

view

and

Res

pons

ivene

ss; C

ompl

aint

s, Re

solu

tions

, and

Com

mun

icatio

ns

NPS

G (N

atio

nal P

atie

nt S

afet

y G

oals

) Pa

tient

ID; C

ritica

l Res

ults

Rep

ortin

g; H

and

Hygi

ene

PI (P

erfo

rman

ce Im

prov

emen

t)

Data

Col

lect

ion;

Ana

lysi

s; Pe

rfor

man

ce

Revi

ew; C

orre

ctiv

e Ac

tions

WT

(Wai

ved

Test

ing)

CL

IA; O

vers

ight

and

Res

pons

ibili

ty fo

r Te

stin

g; Te

st P

erfo

rman

ce

I. Pro

ficie

ncy T

estin

g

II. Q

ualit

y Co

ntro

l

III. –

XXI

. Tec

hnica

l Sp

ecia

litie

s

Point-of-Care Testing (continued)

POCT04-A2

POCT05-A

POCT07-A

POCT08-A

POCT09-A

POCT10-A2

POCT12-A3

POCT13-A2 (formerly AST04-A2)

POCT14-A (formerly H49-A)

Quality Management Systems

QMS01-A4 (formerly GP26-A4)

QMS02-A6 (replaces GP02-A5)





QMS07-A2 (formerly HS04-A2)


14




DC

(Doc

umen

t and

Pro

cess

Con

trol

) Te

st O

rder

ing

and

Repo

rtin

g; P

atie

nt

Iden

tifica

tion;

Spe

cim

en C

olle

ctio

n,

Han

dlin

g, a

nd S

tora

ge; D

ocum

ent R

eten

tion

and

Writ

ten

Polic

ies/

Proc

edur

es

EC (E

nviro

nmen

t of C

are)

Sa

fety

; Fac

ilitie

s; Ha

zard

ous M

ater

ials;

La

bora

tory

Equi

pmen

t/In

stru

men

tatio

n

EM (E

mer

genc

y M

anag

emen

t)Em

erge

ncy R

espo

nse a

nd D

isast

er P

repa

redn

ess

HR

(Hum

an R

esou

rces

) Pe

rson

nel Q

ualifi

catio

ns; O

rient

atio

n an

d Tr

aini

ng; C

ompe

tenc

y

IC (I

nfec

tion

Pre

vent

ion

and

Cont

rol)

Prot

ectio

n, P

reve

ntio

n, C

omm

unica

tion,

and

Be

nch

Prec

autio

ns

IM (I

nfor

mat

ion

Man

agem

ent)

LIS R

equi

rem

ents

; Inte

rrupt

ions

and

Bac

kup

Plan

; Info

rmat

ion

Secu

rity;

Dat

a St

orag

e an

d Re

trie

val

LD (L

eade

rshi

p)

Gove

rnan

ce; E

thics

; Lice

nsur

e an

d Ac

cred

itatio

n;

Org

aniza

tiona

l Str

uctu

re a

nd S

ervi

ces;

Labo

rato

ry Pe

rform

ance

; Dat

a an

d In

form

atio

n Re

view

and

Res

pons

ivene

ss; C

ompl

aint

s, Re

solu

tions

, and

Com

mun

icatio

ns

NPS

G (N

atio

nal P

atie

nt S

afet

y G

oals

) Pa

tient

ID; C

ritica

l Res

ults

Rep

ortin

g; H

and

Hygi

ene

PI (P

erfo

rman

ce Im

prov

emen

t)

Data

Col

lect

ion;

Ana

lysi

s; Pe

rfor

man

ce

Revi

ew; C

orre

ctiv

e Ac

tions

WT

(Wai

ved

Test

ing)

CL

IA; O

vers

ight

and

Res

pons

ibili

ty fo

r Te

stin

g; Te

st P

erfo

rman

ce

I. Pro

ficie

ncy T

estin

g

II. Q

ualit

y Co

ntro

l

III. –

XXI

. Tec

hnica

l Sp

ecia

litie

s

Quality Management Systems (continued)

QMS10-A (formerly HS11-A)

QMS11-A (formerly GP32-A)




QMS14-AES (formerly GP38-AES)
