clsi references in the cap accreditation checklists · checklists and serve as key resources in ......
TRANSCRIPT
950 West Valley Road, Suite 2500, Wayne, PA 19087 | P: +1.610.688.0100 | Toll Free (US): 877.447.1888 | F: +1.610.688.0700 | E: [email protected]
CLSI References in the CAP Accreditation ChecklistsA quick reference tool for those seeking information on CLSI documents referenced in the CAP Accreditation Checklists.
CLSI References in the CAP Accreditation Checklists
Many CLSI documents are referenced in the College of American Pathologists (CAP) Accreditation Checklists and serve as key resources in satisfying regulatory requirements. CAP Accreditation Checklists are updated regularly and reference CLSI’s standards, guidelines, and other documents.
Some CLSI documents were revised after the publication of the CAP Accreditation Checklists. Parenthetical text beginning with “formerly” next to the CLSI document codes denotes the revised document code.
To see the full titles of all CLSI document codes included in this crosswalk or to purchase those documents, visit clsi.org/standards.
Updated 2017
Based on the 2017 CAP Accreditation Checklists
CLSI References in the CAP Accreditation Checklists
1Based on the 2017 CAP Accreditation Checklists
Anat
omic
Pat
holo
gy (A
NP)
Bior
epos
itory
(BAP
)
Clin
ical
Bio
chem
ical
G
enet
ics (
CBG
)
Chem
istr
y an
d To
xico
logy
(C
HM
)
All C
omm
on (C
OM
)
Cyto
gene
tics (
CYG
)
Cyto
path
olog
y (C
YP)
Fore
nsic
Dru
g Te
stin
g(F
DT)
Flow
Cyt
omet
ry (F
LO)
Labo
rato
ry G
ener
al (G
EN)
Hem
atol
ogy
and
Coag
ulat
ion
(HEM
)
His
toco
mpa
tibili
ty (H
SC)
Imm
unol
ogy
(IMM
)
Lim
ited
Serv
ice
Labo
rato
ry
(LSV
)
Mic
robi
olog
y (M
IC)
Mol
ecul
ar P
atho
logy
(MO
L)
Poin
t-of
-Car
e-Te
stin
g (P
OC)
Repr
oduc
tive
Labo
rato
ry
(RLM
)
Team
Lead
er A
sses
smen
t of
Dire
ctor
& Q
ualit
y (T
LC)
Tran
sfus
ion
Med
icin
e (T
RM)
Urin
alys
is (U
RN)
CLSI Document Referenced
Automation and Informatics
AUTO02-A2
AUTO08-A
AUTO10-A
AUTO11-A2
AUTO12-A
Clinical Chemistry and Toxicology
C24-Ed4
C34-A3
C43-A2
C46-A2
C49-A
C50-A
C52-Ed3 (formerly C52-A2)
C62-A
CLSI References in the CAP Accreditation Checklists
2 Based on the 2017 CAP Accreditation Checklists
Anat
omic
Pat
holo
gy (A
NP)
Bior
epos
itory
(BAP
)
Clin
ical
Bio
chem
ical
G
enet
ics (
CBG
)
Chem
istr
y an
d To
xico
logy
(C
HM
)
All C
omm
on (C
OM
)
Cyto
gene
tics (
CYG
)
Cyto
path
olog
y (C
YP)
Fore
nsic
Dru
g Te
stin
g(F
DT)
Flow
Cyt
omet
ry (F
LO)
Labo
rato
ry G
ener
al (G
EN)
Hem
atol
ogy
and
Coag
ulat
ion
(HEM
)
His
toco
mpa
tibili
ty (H
SC)
Imm
unol
ogy
(IMM
)
Lim
ited
Serv
ice
Labo
rato
ry
(LSV
)
Mic
robi
olog
y (M
IC)
Mol
ecul
ar P
atho
logy
(MO
L)
Poin
t-of
-Car
e-Te
stin
g (P
OC)
Repr
oduc
tive
Labo
rato
ry
(RLM
)
Team
Lead
er A
sses
smen
t of
Dire
ctor
& Q
ualit
y (T
LC)
Tran
sfus
ion
Med
icin
e (T
RM)
Urin
alys
is (U
RN)
CLSI Document Referenced
General Laboratory
GP05-A3
GP15-A3
GP16-A3
GP17-A3
GP20-A2
GP23-A2
GP31-A
GP33-A
GP34-A
GP36-A
GP40-A4-AMD
GP41-Ed7
GP42-A6
GP43-A4
GP44-A4
CLSI References in the CAP Accreditation Checklists
3Based on the 2017 CAP Accreditation Checklists
Anat
omic
Pat
holo
gy (A
NP)
Bior
epos
itory
(BAP
)
Clin
ical
Bio
chem
ical
G
enet
ics (
CBG
)
Chem
istr
y an
d To
xico
logy
(C
HM
)
All C
omm
on (C
OM
)
Cyto
gene
tics (
CYG
)
Cyto
path
olog
y (C
YP)
Fore
nsic
Dru
g Te
stin
g(F
DT)
Flow
Cyt
omet
ry (F
LO)
Labo
rato
ry G
ener
al (G
EN)
Hem
atol
ogy
and
Coag
ulat
ion
(HEM
)
His
toco
mpa
tibili
ty (H
SC)
Imm
unol
ogy
(IMM
)
Lim
ited
Serv
ice
Labo
rato
ry
(LSV
)
Mic
robi
olog
y (M
IC)
Mol
ecul
ar P
atho
logy
(MO
L)
Poin
t-of
-Car
e-Te
stin
g (P
OC)
Repr
oduc
tive
Labo
rato
ry
(RLM
)
Team
Lead
er A
sses
smen
t of
Dire
ctor
& Q
ualit
y (T
LC)
Tran
sfus
ion
Med
icin
e (T
RM)
Urin
alys
is (U
RN)
CLSI Document Referenced
Hematology
H07-A3
H20-A2
H21-A5
H26-A2
H30-A2
H42-A2
H43-A2
H47-A2
H48-Ed2
H52-A2
H54-A
H56-A
H57-A
H58-A
H59-A
CLSI References in the CAP Accreditation Checklists
4 Based on the 2017 CAP Accreditation Checklists
Anat
omic
Pat
holo
gy (A
NP)
Bior
epos
itory
(BAP
)
Clin
ical
Bio
chem
ical
G
enet
ics (
CBG
)
Chem
istr
y an
d To
xico
logy
(C
HM
)
All C
omm
on (C
OM
)
Cyto
gene
tics (
CYG
)
Cyto
path
olog
y (C
YP)
Fore
nsic
Dru
g Te
stin
g(F
DT)
Flow
Cyt
omet
ry (F
LO)
Labo
rato
ry G
ener
al (G
EN)
Hem
atol
ogy
and
Coag
ulat
ion
(HEM
)
His
toco
mpa
tibili
ty (H
SC)
Imm
unol
ogy
(IMM
)
Lim
ited
Serv
ice
Labo
rato
ry
(LSV
)
Mic
robi
olog
y (M
IC)
Mol
ecul
ar P
atho
logy
(MO
L)
Poin
t-of
-Car
e-Te
stin
g (P
OC)
Repr
oduc
tive
Labo
rato
ry
(RLM
)
Team
Lead
er A
sses
smen
t of
Dire
ctor
& Q
ualit
y (T
LC)
Tran
sfus
ion
Med
icin
e (T
RM)
Urin
alys
is (U
RN)
CLSI Document Referenced
Immunology and Ligand Assay
I/LA23-A
I/LA25-A2
I/LA28-A2
Method Evaluation
EP05-A3
EP07-A2
EP09-A3
EP10-A3-AMD
EP12-A2
EP14-A3
EP15-A3
EP17-A2
EP18-A2
EP19-Ed2
EP23-A
EP26-A
CLSI References in the CAP Accreditation Checklists
5Based on the 2017 CAP Accreditation Checklists
Anat
omic
Pat
holo
gy (A
NP)
Bior
epos
itory
(BAP
)
Clin
ical
Bio
chem
ical
G
enet
ics (
CBG
)
Chem
istr
y an
d To
xico
logy
(C
HM
)
All C
omm
on (C
OM
)
Cyto
gene
tics (
CYG
)
Cyto
path
olog
y (C
YP)
Fore
nsic
Dru
g Te
stin
g(F
DT)
Flow
Cyt
omet
ry (F
LO)
Labo
rato
ry G
ener
al (G
EN)
Hem
atol
ogy
and
Coag
ulat
ion
(HEM
)
His
toco
mpa
tibili
ty (H
SC)
Imm
unol
ogy
(IMM
)
Lim
ited
Serv
ice
Labo
rato
ry
(LSV
)
Mic
robi
olog
y (M
IC)
Mol
ecul
ar P
atho
logy
(MO
L)
Poin
t-of
-Car
e-Te
stin
g (P
OC)
Repr
oduc
tive
Labo
rato
ry
(RLM
)
Team
Lead
er A
sses
smen
t of
Dire
ctor
& Q
ualit
y (T
LC)
Tran
sfus
ion
Med
icin
e (T
RM)
Urin
alys
is (U
RN)
CLSI Document Referenced
Method Evaluation (continued)
EP28-A3c
EP31-A-IR
EP33-Ed1
Microbiology
M02-A12
M07-A10
M11-A8
M15-A
M22-A3
M24-A2
M27-A3
M27-S4
M28-A2
M29-A4
M34-A
M38-A2
CLSI References in the CAP Accreditation Checklists
6 Based on the 2017 CAP Accreditation Checklists
Anat
omic
Pat
holo
gy (A
NP)
Bior
epos
itory
(BAP
)
Clin
ical
Bio
chem
ical
G
enet
ics (
CBG
)
Chem
istr
y an
d To
xico
logy
(C
HM
)
All C
omm
on (C
OM
)
Cyto
gene
tics (
CYG
)
Cyto
path
olog
y (C
YP)
Fore
nsic
Dru
g Te
stin
g(F
DT)
Flow
Cyt
omet
ry (F
LO)
Labo
rato
ry G
ener
al (G
EN)
Hem
atol
ogy
and
Coag
ulat
ion
(HEM
)
His
toco
mpa
tibili
ty (H
SC)
Imm
unol
ogy
(IMM
)
Lim
ited
Serv
ice
Labo
rato
ry
(LSV
)
Mic
robi
olog
y (M
IC)
Mol
ecul
ar P
atho
logy
(MO
L)
Poin
t-of
-Car
e-Te
stin
g (P
OC)
Repr
oduc
tive
Labo
rato
ry
(RLM
)
Team
Lead
er A
sses
smen
t of
Dire
ctor
& Q
ualit
y (T
LC)
Tran
sfus
ion
Med
icin
e (T
RM)
Urin
alys
is (U
RN)
CLSI Document Referenced
Microbiology (continued)
M39-A4
M40-A2
M41-A
M44-A2
M45-Ed3
M47-A
M48-A
M50-A
M52-Ed1
M53-A
M54-A
M56-A
M100-S27
CLSI References in the CAP Accreditation Checklists
7Based on the 2017 CAP Accreditation Checklists
Anat
omic
Pat
holo
gy (A
NP)
Bior
epos
itory
(BAP
)
Clin
ical
Bio
chem
ical
G
enet
ics (
CBG
)
Chem
istr
y an
d To
xico
logy
(C
HM
)
All C
omm
on (C
OM
)
Cyto
gene
tics (
CYG
)
Cyto
path
olog
y (C
YP)
Fore
nsic
Dru
g Te
stin
g(F
DT)
Flow
Cyt
omet
ry (F
LO)
Labo
rato
ry G
ener
al (G
EN)
Hem
atol
ogy
and
Coag
ulat
ion
(HEM
)
His
toco
mpa
tibili
ty (H
SC)
Imm
unol
ogy
(IMM
)
Lim
ited
Serv
ice
Labo
rato
ry
(LSV
)
Mic
robi
olog
y (M
IC)
Mol
ecul
ar P
atho
logy
(MO
L)
Poin
t-of
-Car
e-Te
stin
g (P
OC)
Repr
oduc
tive
Labo
rato
ry
(RLM
)
Team
Lead
er A
sses
smen
t of
Dire
ctor
& Q
ualit
y (T
LC)
Tran
sfus
ion
Med
icin
e (T
RM)
Urin
alys
is (U
RN)
CLSI Document Referenced
Molecular Methods
MM01-A3
MM03-Ed3
MM07-A2
MM09-A2
MM12-A
MM13-A
MM19-A
MM21-Ed1
Newborn Screening
NBS01-A6
NBS02-A2
Point-of-Care Testing
POCT01-A2
POCT04-Ed3
POCT10-A2
POCT12-A3
CLSI References in the CAP Accreditation Checklists
8 Based on the 2017 CAP Accreditation Checklists
Anat
omic
Pat
holo
gy (A
NP)
Bior
epos
itory
(BAP
)
Clin
ical
Bio
chem
ical
G
enet
ics (
CBG
)
Chem
istr
y an
d To
xico
logy
(C
HM
)
All C
omm
on (C
OM
)
Cyto
gene
tics (
CYG
)
Cyto
path
olog
y (C
YP)
Fore
nsic
Dru
g Te
stin
g(F
DT)
Flow
Cyt
omet
ry (F
LO)
Labo
rato
ry G
ener
al (G
EN)
Hem
atol
ogy
and
Coag
ulat
ion
(HEM
)
His
toco
mpa
tibili
ty (H
SC)
Imm
unol
ogy
(IMM
)
Lim
ited
Serv
ice
Labo
rato
ry
(LSV
)
Mic
robi
olog
y (M
IC)
Mol
ecul
ar P
atho
logy
(MO
L)
Poin
t-of
-Car
e-Te
stin
g (P
OC)
Repr
oduc
tive
Labo
rato
ry
(RLM
)
Team
Lead
er A
sses
smen
t of
Dire
ctor
& Q
ualit
y (T
LC)
Tran
sfus
ion
Med
icin
e (T
RM)
Urin
alys
is (U
RN)
CLSI Document Referenced
Quality Management Systems
QMS01-A4
QMS02-A6
QMS03-Ed4 (formerly QMS03-A3)
QMS04-Ed3
QMS05-A2
QMS11-Ed2
QMS12-A
QMS15-A
QMS16-Ed1
QMS24-Ed3
950 West Valley Road, Suite 2500, Wayne, PA 19087 | P: +1.610.688.0100 | Toll Free (US): 877.447.1888 | F: +1.610.688.0700 | E: [email protected]
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