Professional Documents
Culture Documents
Abbreviation EP19-R
Vol 22
No Replaces 10 EP19-P
Status STATUS Date JUNE 2002 Dec 2005 Nov 2004 SEP 2002 1993
Approved by Board of Directors MAY 2002 Report Published JUNE 2002
TITLE
A Framework for NCCLS evaluation protocols A Model for Managing Medical Device Alerts
(Hazards and Recalls) for Healthcare Organizations
25 24 22 13 25 27 29
30 37 18 15 28 14 9
Approved Guideline Approved Guideline nd 2 Edition Approved Guideline Approved Guideline Approved Guideline nd 2 Edition Approved Guideline Approved Guideline nd 2 Edition
A Quality Management System Model for Health Care Abbreviated Identification of Bacteria and Yeast Agglutination analyses; antibody characterists,
methodology, limitation and clinical validation
VOL 16 VOL 17
Analysis of Body Fluids in Clinical Chemistry Analytical Performance Characteristics and Clinical Utility of
Immunological Assays for Human Immunoglobulin E (IgE)Antibodies and Defined Allergen Specificities
21 24 24 26 26
9 7 36 17 16
Jun 2001 Approved Guideline FEB 2004 Nov 2004 May 2006 May 2006 Approved Guideline Approved Guideline rd 3 Edition Approved Guideline nd 2 Edition Approved Guideline nd 2 Edition
LOCATION
Abbreviation HS4-A2
Vol 26 24 24
Status STATUS Date May 2006 JUL 2004 5/04 Approved Guideline nd 2 Edition Approved Guideline Approved Guideline
TITLE
VOL 8 VOL 5
LA1-A2 GP-10A
14 15
17 19
LA1-A GP10-T
VOL 7
VOL 3
GP29-A
GP11-A
22
18
26
14
GPA29-P
GP11-T
Approved Guideline
Basic cost accounting for clinical services Blood Alcohol Testing in the Clinical Laboratory
17 23 29
26
14 21 8
20
Jul 2003 Approved Standard Blood Collection on Filter Paper for Newborn th 4 Edition Screening Programs Feb 2009
June 2006 Apr-99
Blood gas and pH analysis & related measurements Body Fluid Analysis for Cellular Composition Calibration and quality control of automated
hematology analyzers
VOL 3
H38-P
19
Proposed Standard
LOCATION
Abbreviation
Vol No Replaces
TITLE
VOL 9
H42-A
17
18
42-T
VOL 9
H43-A
17
18
43-P
Approved Guideline
VOL 2
I/LA 21-A
22
I/LA21-P
Approved Guideline
Clinical evaluation of immunoassays Clinical Laboratory Safety Clinical laboratory waste management Clinical Use and Interpretation of Serologic Tests for
Toxoplasma gondii
VOL 5
GP17-A2
24
13
GP17-A
APRIL Approved GuidelineND 2004 2 Edition March 2002 FEB 2004 DEC 2003 Dec 2005 Nov 2004
Oct-99
VOL 7
GP5-A2
22
GP5-A
VOL 10
M36-A
24
M36-P
VOL 7
H21-A4
23
35
H21-A3
VOL 12
MM13-A
25
31
MM13-P
VOL 4
GP22-A2
24
35
GP22-A
VOL 2
C 39-A
18
23
C39-P
VOL 5
I/LA22-P
20
10
2000
LOCATION
Abbreviation
Vol No Replaces
Status STATUS Date DEC 1998 Oct 2008 Feb 2008 May 2006 April 2003 Approved Standard
TITLE
VOL 8 VOL 17
H17-A M23-A3
18 28
19 27
H17-P M23-A2
Approved Guideline- Development of In Vitro Susceptibility Testing Criteria and rd 3 Edition Quality Control Parameters Approved Guideline nd 3 Edition Approved Guideline
VOL 1
M37-A3
28
M37-A2
VOL 14
MM12-A
26
20
MM12-P
Diagnostic Nucleic Acid Microarrays Estimation of Total Analytical Error for Clinical
Methods
VOL 9
EP21-A
23
20
EP21-P
Approved Guideline
VOL 5
EP14-A2
25
EP14-A
January Approved Guideline 2005 2nd Edition Aug 2004 April 2003 Dec 2001 Approved nd Guideline 2 Edition Approved Guideline Approved Guideline
VOL 1
EP5-A2
24
25
EP5-A
VOL 6
EP6-A
23
16
EP6-P2
VOL 5
H52-A
21
26
H52-P
Vol No Replaces
Status STATUS Date Oct 2003 Approved Guideline nd 2 Edition Aug 2004 JAN 2004 JAN 1997 Nov 2002 Feb 2006 May 2005 Dec 2002 Approved Guideline
TITLE
23
27
GP20-A
Fine Needle Aspiration Biopsy (FNAB) Techniques Fluorescence Calibration and Quantitative
Measurement of Fluorescence Intensity
VOL 11
I/LA24-A
24
26
I/LA24-P
VOL 9
MM7-A
24
MM7-P
Approved Guideline
VOL 6
C25-A
17
C25-T
Approved Guideline
22
22
C43-P
Approved Guideline
26
MM10-P
Approved Guideline
VOL 1
AST4-A2
25
12
AST4-A
VOL 8
C44-A
22
25
C44-P
VOL 4
C28-A2
20
13
C28-A
LOCATION
Abbreviation
Vol No
Replaces
TITLE
VOL 9
MM2-A2
22
12
MM2-A
Aug 2002
VOL 7
D12-A2
13
14
1993
Approved nd Guideline -2 Edition Approved Guideline Published Report Approved nd Guideline 2 edition Approved Guideline Approved nd Guideline 2 edition Approved nd Standard 2 edition
VOL 17
X3-R
22
Mar 2002
VOL 8
EP7-A2
25
27
EP7-A2
Interference Testing in Clinical Chemistry Interpretive Criteria for Identification of Bacteria and
Fungi by DNA Target Sequencing
VOL 16
MM18-A
28
12
MM18-P
VOL 4
C31-A2
15
20
C31-A
Jun 2001
VOL 1
AUTO2-A2
25
29
AUTO2-A
Dec 2005
Dec-98
VOL 2
AUTO3-P
18
18
VOL 2
AUTO5-P
19
23
Oct-99
VOL 2
AUTO4-P
19
22
Oct-99
VOL 4
M15-A
20
12
M15-T
Jun 00
Vol No 24 18 28 22 20 3 17 5
VOL 5
GP19-A2
23
GP19-A
VOL 16 VOL 13
27 15 27 27 24 24
VOL 16
C50-A
VOL 16
VOL 12 I/LA25-A C45-A
VOL 11
Status STATUS TITLE Date June Approved Standard Laboratory Automation: Data Content for Specimen 2004 Identification APR 98 Approved Laboratory Design Guideline May Approved Laboratory Detection and Identification of 2008 Guideline Mycobacteria March Approved Laboratory Documents: Development and Control th 2006 Guideline 5 Edition Feb Approved Laboratory Instruments and Data Management 2003 Guideline Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation and Monitoring June Proposed Laboratory Instrument Implementation, Verification, and 2007 Guideline Maintenance Aug Report Laboratory Statistics 1995 May Approved Management of Nonconforming Laboratory Events 2007 Guideline Oct Approved Mass Spectrometry in the Clinical Laboratory: 2007 Guideline General Principles and Guidance Dec Approved Standard Maternal serum screening 2004 Oct 2004 Approved Measurement of Free Thyroid Hormones Guideline
Vol No
Replaces
22
19
EP9-A
26 24 19
19 15 17
Status STATUS TITLE Date Jul 2003 Corrected Version Medical Laboratories Particular requirements for quality and competence Sept Approved Method comparison and bias estimation using patient nd 2002 Guideline 2 samples Edition May 2006 Approved Guideline Methods for Antimicrobial Dilution and Disk Susceptibility
Testing of Infrequently Isolated of Fastidious Bacteria
5/04
Approved Guideline
VOL 9 VOL 6
VOL 3
M42-A M11-A6
M7-A8
26 24
29
23 2
2
M42-R M11-A5
M7-A7
June Approved Methods for Antimicrobial Disk Susceptibility Testing 2006 Guideline of Bacteria Isolated from Aquatic Animals. Jan 2004 Approved Standard Methods for Antimicrobial Susceptibility Testing of th 6 Edition Anaerobic Bacteria Jan Approved Standard Methods for Dilution Antimicrobial Susceptibility Tests 2009 8th Edition for Bacteria That Grow Aerobically
June 2006
Approved Guideline
VOL 14 VOL 3
M49-A M26-A
26 19
24 18
M49-P M26-T
VOL 8
H44-A2
24
H44-A
FEB 2004
LOCATION
VOL 10
Abbreviation
GP28-A
Vol No
25 7
Replaces
GP28-P
TITLE
Microwave Device Used in the Clinical Laboratory Molecular diagnostic methods for genetic diseases Molecular Diagnostic Methods for Infectious Diseases Newborn Screen Follow-up Newborn Screening Guidelines for Premature and/or Sick
Newborns
VOL 5
MM1-A2
26
27
MM1-A
June 2006
26 26 28 19
8 18 34 14
MM3-A I/LA27-P
VOL 12
MM9-A
24
40
MM9-P
23 16 21
17 3 17
April 2003 Approved Guideline JUN 96 Approved Guideline Nov 2001 Approved nd Guideline 2 Edition DEC 96 Approved Standard Oct 2004 Approved Guideline
June 2005 Approved Guideline
2nd Edition
VOL 5
H26-A
16
12
H26-P
VOL 11
I/LA26-A
24
29
I/LA26-P
Performance of Single Cell Immune Response Assays Performance of the Bleeding Time Test
VOL 12
H45-A2
25
15
H45-A
LOCATION
VOL 17 VOL 3
Abbreviation
POCT5-A M31-A2
Vol No
28 22 33 6
Replaces
POCT05-P M31-A
VOL 5
M2-A10
29
M2-A9
VOL 3
M100-S12
22
M100-S11
Status STATUS Date Dec 2008 Approved Standard May 2002 Approved Standard nd 2 Edition Jan Approved 2009 Standard th 10 Edition th Jan 2002 12
INFORMATIONAL SUPPLEMENT
TITLE
15 25 26 29
14 1 3 3
VOL 8
C30-A2
22
17
C30-A
VOL 1
POCT4-A2
26
30
AST2-A
Dec 1995 6 Informational Supplement th JAN 2005 15 Informational Supplement th Jan 16 Informational 2006 Supplement th Jan 2009 19 Informational Supplement Approved nd Standard 2 Edition Aug Approved nd 2002 Guideline 2 Edition Aug Approved nd 2006 Guideline 2 Edition JUL 2004 Approved Guideline
th
Point of care connectivity On CD-ROM Point-of-Care Blood Glucose Testing in Acute and
Chronic Care Facilities
VOL 11
H49-A
24
23
H49-P
LOCATION
Abbreviation
Vol No
Replaces
Status STATUS Date Dec 2002 June 2006 Approved nd Guideline 2 Edition Approved th Guideline 4 Edition
TITLE
VOL 6
EP10-A2
18
EP10-A
VOL 5
C3-A4
26
22
C3-P4
VOL 3
C37-A
19
25
C37-P
M47-A
27
17
M47-P
VOL 16
VOL 5 H7-A3 20 18 H7-A2
May 2007
VOL 7 *
H3-A5
23
32
H3-A4
DEC 2003
Approved Standard Procedure for the Collection of Diagnostic Blood th 5 Edition Specimens by Venipuncture.
2nd Edition
VOL 7
H30-A2
21
18
H30-A
VOL 3 *
H4-A4
19
16
VOL 13
H54-A
25
23
LOCATION
Abbreviation
Vol No
Replaces
TITLE
VOL 3
H11-A4
24
28
H11-A3
VOL 2
H 18-A3
24
38
H18-A2
Guideline 2 Edition VOL 12 M28-A2 25 16 M28-A June 2005 June 2005 MM14-P Aug 2005 March 2005
nd
VOL 14
X6-R
25
14
VOL 11
MM14-A
25
24
Approved Guideline
VOL 6
M29-A3
25
10
M29-A2
VOL 11
EP17-A
24
34
EP17-P
Approved Guideline - 3rd Edition Oct 2004 Approved Guideline Jan 2006 Feb 2003
VOL 13
M6-A2
26
M6-A
Approved Standard Protocols for Evaluating Dehydrated Mueller-Hinton nd -2 Edition Agar Approved Guideline
VOL 6
HS2-A
23
HS2-P
VOL 12
HS3-A
25
HS3-P
LOCATION VOL 10
Abbreviation M22-A3
Vol No 24 19
Replaces M22-A2
VOL 4
I/LA2-A2
16
11
I/LA2-A
Status STATUS Date June Approved rd 2004 Standard-3 Edition Mar Approved nd 2006 Guideline- 2 Edition Dec 2003 Aug 2008
TITLE
23 28
34 23
M40-P M50-P
Autoantibodies to Nuclear Antigens (1)Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods Approved Standard Quality Control of Microbiological Transport Systems Approved Guideline Informational Supplement
22
17
16
10
M38-P
AUG Approved Standard Reference Method for Broth Dilution Antifungal 2002 Susceptibility Testing of Filamentous Fungi Dec 99 Approved Guideline Quality for immunocytochemistry Dec Approved 2002 Guideline Oct 2003 Approved Guideline AUG Approved Standard 2002 2nd Edition Dec00 Approved Standard 4th Edition Dec00 Approved Standard 3rd Edition March Approved Standard 2006 Aug Proposed nd 2007 Guideline 2 Edition
22 23 22 20 20 26 27
28 28 15 27 28 11 23
Quality management for unit-use testing Quantitative Molecular Methods for Infectious Diseases Reference Method for Broth Dilution Antifungal Susceptibility
Testing of Yeasts
Vol No 18 28 15 13
VOL 11
LIS2-A
24
33
VOL 6 VOL 18
I/LA18-A2 LIS3-A
21 23
15 9
VOL 5
C29-A2
20
17
VOL 1
C24-A3
26
25
VOL 11 VOL 4
HS6-A C34-A2
24 20
32 14
VOL 7
M24-A
23
18
Status STATUS TITLE Date GP9-T Nov-98 Approved Selecting and evaluating a referral laboratory Guideline LIS1-A April Approved Standard Specification for Low-Level Protocol to Transfer nd 2008 2 Edition Messages Between Clinical Laboratory Instruments and Computer Systems. LIS2-A Oct 2004 Approved Standard Specification for Transferring Information Between 2nd Edition Clinical Laboratory Instruments and Information Systems I/LA18-A Sep Approved Specifications for Immunological Testing for Infectious 2001 Guideline Diseases Formerly Publish Standard Guide for Selection of a Clinical Laboratory ASTM E792- Apr 2003 Information Management System 02 C29-A Approved Standard Standardization of Sodium & Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method C24-A2 June Approved Statistical Quality Control for quantitative rd 2006 Guideline- 3 measurement procedures: principles & definitions Edition HS6-P Oct 2004 Approved Studies to Evaluate Patient Outcomes Guideline C34-A Jun 00 Approved Sweat testing sample collection & quantitative analysis Guideline 2nd Edition M24-T2 April Approved Standard Susceptibility Testing of Mycobacteria, Nocardia, and 2003 Other Aerobic Actinomycetes Approved Guideline APR 2004
Approved Guideline-2nd Edition
Replaces
VOL 5
NRSCL13-A
20
21 NRSCL 13-P
VOL 5
GP21-A2
24
14
GP21-A
LOCATION
Abbreviation
Vol No
Replaces
TITLE
VOL 10
H1-A5
23
33
H1-A4
Approved Standard Tubes and Additives for Venous Blood Specimen th 5 Edition Collection Approved ND Guideline 2 EDITION
VOL 5
GP16-A2
15
15
GP16-A
VOL 1
T/DMB-A
19
T/DMB-P
Feb 99 Approved Guideline Aug 2006 Aug 2002 April 2006 Approved Guideline Approved Guideline Approved nd Guideline-2 nd Edition 2 Printing Approved nd Guideline-2 Edition Approved Guideline
VOL 14
MM16-A
26
29
MM16-P
VOL 7
EP12-A
22
14
EP12-P
VOL 7
EP15-A2
25
17
EP15-A
VOL 1
GP27-A2
27
GP22-A
Feb 2007
M34-A VOL 5
20
20
M34-P