INDUSTRY REFERENCE DOCUMENTS FOR LABORATORY ACCREDITATION
Introduction
These documents are provided for your reference and will not be considered as mandatory practices. They are industry publications
that may be of assistance in establishing your procedures and satisfying the Joint Commission standards for procedure validation.
The references are organized by topic/ technical areas. Links to the web sites of groups who author these documents are found at
the end.
Automation and Informatics
Document
ID
Document Title
Organization
AUTO01-A
AUTO02-A2
AUTO03-A2
Laboratory Automation: Specimen Container/Specimen Carrier Approved Standard
Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard - Second Edition
Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices,
and Information Systems; Approved Standard—Second Edition
Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements;
Approved Standard
Laboratory Automation: Electromechanical Interfaces; Approved Standard
Laboratory Automation: Data Content for Specimen Identification; Approved Standard
Managing and Validating Laboratory Information Systems; Approved Guideline
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard
Autoverification of Clinical Laboratory Test Results; Approved Guideline
IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard
Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User
Software Systems Validation, Operation, and Monitoring; Approved Guideline—Second Edition
Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and
Computer Systems; Approved Standard—Second Edition
Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems;
Approved Standard—Second Edition
Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification
Criteria for Electronic Health Record Technology; Final Rule
CLSI
CLSI
CLSI
AUTO04-A
AUTO05-A
AUTO07-A
AUTO08-A
AUTO09-A
AUTO10-A
AUTO11-A
AUTO12-A
GP19-A2
LIS01-A2
LIS02-A2
Web
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
FDA
http://edocket.access.gpo.gov/2010/pdf/2010-17210.pdf
12/06/11
Quality Systems and Laboratory Practices
Document ID
Document Title
GP02-A5
GP05-A3
ISO 15189:2007
Laboratory Documents: Development and Control; Approved Guideline—Fifth Edition
Clinical Laboratory Waste Management; Approved Guideline - Third Edition
GP09-A
GP10-A
Selecting and Evaluating a Referral Laboratory; Approved Guideline
Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC)
Plots; Approved Guideline
Urinalysis; Approved Guideline—Third Edition
Clinical Laboratory Safety; Approved Guideline—Second Edition
Laboratory Design; Approved Guideline—Second Edition
Training and Competence Assessment; Approved Guideline—Third Edition
GP16-A3
GP17-A2
GP18-A2
GP21-A3
GP22-A3
GP26-A4
GP27-A2
GP28-A
GP29-A2
GP31-A
GP32-A
GP33-A
HS02-A
EP5-A2
EP6-A
EP07-A2
EP09-A2IR
ISO 15189:2007. Medical laboratories -- Particular requirements for quality and competence
Quality Management System: Continual Improvement; Approved Guideline—Third Edition
Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth Edition
Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline—Second Edition
Microwave Device Use in the Histology Laboratory; Approved Guideline
Assessment of Laboratory Tests When Proficiency Testing Is Not Available; Approved Guideline—Second
Edition
Laboratory Instrument Implementation, Verification, and Maintenance; Approved Guideline
Management of Nonconforming Laboratory Events; Approved Guideline
Accuracy in Patient and Sample Identification; Approved Guideline
Provider-Performed Microscopy Testing; Approved Guideline
Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline—Second
Edition
Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved
Guideline
Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition
Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second Edition
(Interim Revision)
Organization
CLSI
CLSI
ISO
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CL SI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
12/06/11
Document ID
EP10-A3
EP12-A2
EP14-A2
EP15-A2
EP17-A
EP18-A2
EP21-A
EP25-A
X03-R
X04-R
X05-R
X07-R
EP24-A2
EP26-P
EP28-P
HS11-A
Web
Document Title
Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline—
Third Edition
User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline—Second Edition
Evaluation of Matrix Effects; Approved Guideline—Second Edition
User Verification of Performance for Precision and Trueness; Approved Guideline—Second Edition
Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline
Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Third
Edition
Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline
Evaluation of Stability of In Vitro Diagnostic Reagents; Proposed Guideline
Implementing a Needlestick and Sharps Injury Prevention Program in the Clinical Laboratory; A Report
Planning for Challenges to Clinical Laboratory Operations During a Disaster; A Report
Metrological Traceability and Its Implementation; A Report
Surveillance for Methicillin-Resistant Staphylococcus aureus: Principles, Practices, and Challenges; A Report
Assessment of the Clinical Accuracy of Laboratory Tests Using ROC Curves; Approved Guideline - Second
Edition
Evaluating Between Reagent Lot Variation; Proposed Guideline
Delta Checks to Detect Patient Sample Misidentification; Proposed Guideline
A Model for Managing Medical Device Alerts (Hazards and Recalls) for Healthcare Organizations; Approved
Guideline
Hospital eTool: Laboratory
Organization
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
OHSA
http://www.osha.gov/SLTC/etools/hospital/lab/lab.html#OSHA_Laboratory_Standard
ASCLS Career Ladder Task Force Model Career Ladder
ASCLS
http://www.ascls.org/position/MCL.asp
Practice Levels and Educational Needs for Clinical Laboratory Personnel
ASCLS
http://www.ascls.org/position/LevelsofPractice.asp http://www.ascls.org/position/LevelsofPractice.asp
3
S : Simple Six Sigma for Blood Banking, Transfusion, and Cellular Therapy Product Code 072170
AABB
Quality Toolkit and Case Studies: Solutions for Common Problems
AABB
Web
Web
978-1-56395249-4
978-1-56395317-0
978-1-56395282-1
th
Regulations A to Z for Blood and HCT/Ps, 9 edition
Product Code 112059
Product Code 092024
AABB
12/06/11
Guidelines for the Quality Assessment of Transfusion
1-56395-225-4
Product Code 063060
AABB
Download version Product Code 063060DB
978-1-56395353-8
Autopsy Services
Document ID
Document Title
Organization
Web
Autopsy Practice Resources.
CAP
cap.org/autopsy
Blood Transfusion Service and Donor Center
Document ID
Document Title
978-1-56395-289-0
978-1-56395-314-9
978-1-56395-2609978-1-56395-3156
978-1-56395-321-7
Standards for Blood Banks and Transfusion Services, 26th edition 27 edition
Product Code 113120
Technical Manual, 16th Edition 17th edition
Product Code 113013
th
Technical Manual and Standards for Blood Banks and Transfusion Services on CD-ROM
Organization
AABB
AABB
AABB
17th edition Technical Manual (also editions 12-16)+ 27th ed. BBTS Standards (also editions 1-26)
Product Code 113122
Guidelines for Patient Blood Management and Blood Utilization
Product Code 113410 Download Product Code 113410DB
AABB
978-1-56395-333-0
978-1-56395-282-1
Regulations A to Z for Blood and HCT/Ps, 9th edition
AABB
978-1-56395-329-3
Product Code 092024
CFR Mini-Handbook Product Code 113888
978-1-56395-319-4
978-1-56395-326-2
978-1-56395-333-0
Decision Making in Transfusion Medicine Product Code 112071
Guidelines for Patient Blood Management and Blood Utilization
Download Product Code 113410DB
978-1-56395-333-0
Product Code 113410
AABB
AABB
AABB
12/06/11
1-56395-223-8
1-56395-225-4
The Transfusion Committee: Putting Patient Safety First
Product Code 062075
Guidelines for the Quality Assessment of Transfusion Product Code 063060
AABB
AABB
Download Product Code 063060DB
978-1-56395-353-8
978-1-56395-253-1
978-1-56395-307-1
Blood Management: Options for Better Patient Care Product Code 082185
Transfusion Therapy: Clinical Principles and Practice, 3rd edition
Product Code 102005
AABB
AABB
978-1-56395-308-8
978-1-40517-588-3
978-1-56395-311-8
CD-ROM version Product Code 102004
Rossi’s Principles of Transfusion Medicine, 4th edition
Product Code 092100
Guidelines for Antibody Identification Product Code 103001
AABB
AABB
978-1-56395-390-3
978-1-56395-266-1
978-1-56395-243-2
978-1-56395-157-6
Download Code 1030012DB
Judd’s Methods in Immunohematology, 3rd edition Product Code 082190
Practical Guide to Transfusion Medicine, 2nd edition Product Code 072017
Guidelines for the Labeling of Specimens for Compatibility Testing Product Code 023025
AABB
AABB
AABB
978-1-56395-350-7
978-1-56395-324-8
1-56395-156-8
Download version Product Code 023025DB
Collected Questions and Answers, 10th edition Product code 113106
Guidelines for the Use of Blood Warming Devices
Product Code 023015
AABB
AABB
978-1-56395-354-5
1-56395-209-2
Download version Product Code 023015DB
Serologic Problem-Solving: A Systematic Approach for Improved Practice
1-56395-199-1
Guidelines for Massive Transfusion
978-1-56395-397-2
978-1-56395-300-2
Download version Product code 053055DB
Blood Component Visual Inspection Guide Product Code 092435
Circular of Information for the Use of Human Blood and Blood Components Product Code 083011
978-1-56395-320-0
978-1-56395-310-1
1-56395-228-9
978-1-56395-244-9
1-56395-201-7
Blood Transfusion Therapy: A Physician’s Handbook, 10th edition Product Code 113016
Blood Component Preparation: From Benchtop to Bedside Product Code 102121
Blood Transfusion Therapy: A Guide to Blood Component Administration Product Code 063109
Transfusion Reactions, 3rd edition Product Code 072160
Guidelines for the Laboratory Evaluation of Transfusion Reactions Product Code 033030
978-1-56395-351-4
Download version Product Code 033030DB
Product Code 052070
Product Code 053055
AABB
AABB
AABB
AABB
AABB
AABB
AABB
AABB
AABB
12/06/11
978-1-56395-255-5
1-56395-192-4
978-1-56395-398-9
1-56395-181-9
Transfusion Service Manual of Standard Operating Procedures, Training Guides, and Competence
Assessment Tools, 2nd edition Product Code 072180
Guidelines for Pneumatic Tube Delivery Systems: Validation and Use to Transport Blood Components
Product Code 053045
Download version Product Code 053045DB
Guidelines for Implementing an Electronic Crossmatch Product Code 033040
1-56395-238-6
Download version Product Code 033040DB
Informed Consent in Blood Transfusion and Cellular Therapies: Patients, Donors and Research Subjects
Product Code 072175
Guidelines for Informed Consent in Transfusion Medicine Product Code 063080
978-1-56395-395-8
Web
Download version Product Code 063080DB
Link to all Blood Guidance documents:
978-1-56395-394-1
978-1-56395-254-8
AABB
AABB
AABB
AABB
AABB
FDA
www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/B
lood/default.htm
Web
Link to Code of Federal Regulation
FDA
Web
www.gpoaccess.gov/cfr/index.html
Association Bulletins contain guidelines, recommendations and reports for transfusion and collection
organizations
AABB
I/LA33-A
Web
Web
www.aabb.org/resources/publications/bulletins/Pages/default.aspx
Validation of Automated Devices for Immunohematologic Testing Prior to Implementation; Approved
Guideline
Validation and Qualification, including Change Control, for Hospital Transfusion Laboratories. British
Committee for Standards in Hematology Guidelines
www.bcshguidelines.com/documents/Guidelines_for_validation_hcsh_130810.pdf
CDC- National Healthcare Safety Network, Biovigilance Component
CLSI
BCSH
CDC
http://www.cdc.gov/nhsn/bio.html
12/06/11
Clinical Chemistry
Document
ID
Document Title
Organization
C03-A4
C24-A3
Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline—Fourth Edition
Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved
Guideline—Third Edition
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third
Edition
Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Second
Edition
Sweat Testing: Sample Collection and Quantitative Analysis; Approved Guideline— Second Edition
Analytical Procedures for the Determination of Lead in Blood and Urine; Approved Guideline
Gas Chromatography/Mass Spectrometry (GC/MS) Confirmation of Drugs; Approved Guideline—Second
Edition
Measurement of Free Thyroid Hormones; Approved Guideline
Blood Gas and pH Analysis and Related Measurements; Approved Guideline—Second Edition
Application of Biochemical Markers of Bone Turnover in the Assessment and Monitoring of Bone Diseases;
Approved Guideline
Analysis of Body Fluids in Clinical Chemistry; Approved Guideline
Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guideline
Toxicology and Drug Testing in the Clinical Laboratory; Approved Guideline—Second Edition
Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Approved
Guideline
Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric
Reference Method; Approved Standard—Second Edition
Ionized Calcium Determinations: Pre-collection Variables, Specimen Choice, Collection, and Handling;
Approved Guideline—Second Edition
Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for
Cholesterol Measurement Procedures; Approved Guideline
Control of Preanalytical Variation in Trace Element Determinations; Approved Guideline
A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard
Erythrocyte Protoporphyrin Testing; Approved Guideline
Harmonization of Glycohemoglobin Measurements; Approved Guideline
Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved
CLSI
CLSI
C28-A3C
C30-A2
C34-A3
C40-A
C43-A2
C45-A
C46-A2
C48-A
C49-A
C50-A
C52-A2
C53-A
C29-A2
C31-A2
C37-A
C38-A
C39-A
C42-A
C44-A
H17-A
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
12/06/11
T/DM06-A
Standard
Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline
CLSI
Cytology
Document ID
Document Title
Organization
Web
Guidelines for Review of GYN Cytology Samples in the Context of Litigation or Potential Litigation
ASC
www.cytopathology.org
Web
Daily Workload Guidelines for Cytotechnologists Using Automated Assisted-Screening Devices
ASC
Web
www.cytolpathology.org
Residency Guidelines
ASC
Web
www.cytopathology.org
The Bethesda System for Reporting Cervical Cytology. D. Solomon, R. Nayer, editors. Springer 2004,
Second Edition.
NA
Web
www.springer.com/medicine/pathology/book/978-0-387-40358-8
The Bethesda System for Reporting Thyroid Cytopathology, S. Ali, E. Cibus, editors. Springer, 2010
NA
GP15-A3
GP23-A
GP20-A2
www.springer.com/medicine/pathology/book/978-0-387-87665-8
Cervicovaginal Cytology Based on the Papanicolaou Technique; Approved. Guideline—Third Edition
Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques; Approved Guideline
Fine-Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline-Second Edition
CLSI
CLSI
CLSI
Cytogenetics
Document ID
Document Title
Web
Standards and Guidelines For Clinical Genetics Laboratories, 2008 edition
Organization
ACMG
www.acmg.net
12/06/11
Embryology
Document ID
Web
Web
Document Title
Implementation of the Fertility Clinic Success Rate and Certification Act of 1992; Proposed Model
Program for the Certification of Embryo Laboratories; Notice
wwwn.cdc.gov/dls/pdf/art/fcsrca.pdf
Practice Committee Standards and Minimum Guidelines assorted
Organization
CDC
ASRM
www.asrm.org
Hematology and Coagulation
Document ID
Document Title
Organization
9780781775830
H01-A6
H02-A5
H03-A6
The Bethesda Handbook of Clinical Hematology, 2nd Edition
Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard - Sixth Edition
Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard - Fifth Edition
Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard—Sixth
Edition
Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard—
Sixth Edition
Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard—Third
Edition
Procedures for the Collection of Arterial Blood Specimens; Approved Standard—Fourth Edition
Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved
Standard—Third Edition
Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved
Standard
Procedures for the Handling and Processing of Blood Specimens; Approved Guideline— Fourth Edition
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods;
Approved Standard—Second Edition
Document Title
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays
and Molecular Hemostasis Assays; Approved Guideline—Fifth Edition
AACC
CLSI
CLSI
CLSI
H04-A6
H07-A3
H11-A4
H15-A3
H17-A
H18-A4
H20-A2
Document ID
H21-A5
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
Organization
CLSI
12/06/11
H26-A2
H30-A2
H42-A2
H43-A2
H44-A2
H45-A2
H47-A2
H48-A
H49-A
H51-A
H52-A
H54-A
H56-A
H57-A
Am J Clin
Pathol
2010;134:955963
Performance Goals for the Internal Quality Control of Multichannel Hematology Analyzers; Approved
Standard—Second Edition
Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline— Second Edition
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline—Second
Edition
Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline—Second Edition
Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry and Supravital Dyes);
Approved Guideline—Second Edition
One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved
Guideline—Second Edition
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline—Second
Edition
Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline
Assays of von Willebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline
Fetal Red Cell Detection; Approved Guideline
Procedures for Validation of INR and Local Calibration of PT/INR Systems; Approved Guideline
Body Fluid Analysis for Cellular Composition; Approved Guideline
Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Approved Guideline
Platelet Function Testing by Aggregometry; Approved Guideline
Development of North American Consensus Guidelines for Medical Laboratories That Perform and Interpret
Platelet
Function Testing Using Light Transmission Aggregometry. Catherine P.M. Hayward et al.
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
NA
Histocompatibility
Document ID
NA
Web
I/LA29-A
Document Title
ASHI Laboratory Manual
CFR 42, Chapter I, Subchapter K--Health Resources Development, Part 121--Organ Procurement and
Transplantation Network
optn.transplant.hrsa.gov/policiesAndBylaws/bylaws.asp
Detection of HLA-Specific Alloantibody by Flow Cytometry and Solid Phase Assays; Approved Guideline
Organization
ASHI
HRSA
CLSI
12/06/11
Immunology, Ligand Assay and Syphilis Serology
Document ID
Document Title
I/LA02-A
Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence
Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline—Second
Edition
Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human
Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved Guideline—Second Edition
Clinical Evaluation of Immunoassays; Approved Guideline—Second Edition
Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme, Fluorescence, and
Luminescence Immunoassays; Approved Guideline
Fluorescence Calibration and Quantitative Measurement of Fluorescence Intensity; Approved Guideline
Maternal Serum Screening; Approved Standard
Performance of Single Cell Immune Response Assays; Approved Guideline
Newborn Screening Follow-up; Approved Guideline
Immunoassay Interference by Endogenous Antibodies; Approved Guideline
Newborn Screening for Preterm, Low Birth Weight and Sick Newborns; Approved Guideline
Newborn Screening by Tandem Mass Spectrometry; Proposed Guideline
Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Fifth Edition
Quality Assurance for Immunocytochemistry; Approved Guideline
I/LA20-A2
I/LA21-A2
I/LA23-A
I/LA24-A
I/LA25-A2
I/LA26-A
I/LA27-A
I/LA30-A
I/LA31-A
I/LA32-A
LA4-A5
MM04-A
Organization
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
Microbiology
Document ID
Document Title
MMWR Vol. 52
/ No. RR-2
Web
Guidelines for Using the QuantiFERON®-TB Test for Diagnosing Latent Mycobacterium tuberculosis
Infection
Vancomycin-Intermediate/Resistant Staphylococcus aureus Laboratory Testing Algorithm
Organization
CDC
CDC
www.cdc.gov/ncidod/dhqp/pdf/ar/VRSA_testing_algo09v4.pdf
Document ID
Web
MMWR Vol. 52
/ No. RR-2
Document Title
Sentinel Level Clinical Microbiology Laboratory Guidelines, assorted:
www.asm.org/index.php/policy/sentinel-level-clinical-microbiology-laboratory-guidelines.html
Guidelines for Performing Single-Platform Absolute CD4+ T-Cell Determinations with CD45 Gating for
Persons Infected with Human Immunodeficiency Virus
Organization
ASM
CDC
12/06/11
Guidelines for Laboratory Test Result Reporting of Human Immunodeficiency Virus Type 1 Ribonucleic Acid
Determination
Guidelines for Performing Single-Platform Absolute CD4+ T-Cell Determinations with CD45 Gating for
Persons Infected with Human Immunodeficiency Virus
CDC
Document ID
Document Title
978-1-55581527-1
M02-A10
M06-A2
M07-A8
Clinical Microbiology Procedures Handbook, 3rd Edition
Organization
ASM
MMWR Vol. 50
/ No. RR-20
MMWR Vol. 52
/ No. RR-2
M11-A7
M15-A
M21-A
M22-A3
M23-A3
M24-A2
M26-A
M27-A3
M28-A2
M29-A3
M31-A3
M33-A
M35-A2
M38-A2
M39-A3
M40-A
Web
Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Tenth Edition
Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard—Second Edition
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved
Standard—Eighth Edition
Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard—Seventh Edition
Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline
Methodology for the Serum Bactericidal Test; Approved Guideline
Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline—
Third Edition
Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard
Methods for Determining Bacterial Activity of Antimicrobial Agents; Approved Guideline
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard—Third
Edition
Procedures for the Recovery and Identification of Parasites From the Intestinal Tract; Approved Guideline—
Second Edition
Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Third
Edition
Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacterial Isolated From
Animals; Approved Standard—Third Edition
Antiviral Susceptibility Testing: Herpes Simplex Virus by Plaque Reduction Assay; Approved Standard
Abbreviated Identification of Bacteria and Yeast; Approved Guideline—Second Edition
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved
Standard—Second Edition
Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline—Third
Edition
Quality Control of Microbiological Transport Systems; Approved Standard
MMWR; Feb 11, 2011/60(05);133-137
Discordant Results from Reverse Sequence Syphilis Screening –Five Laboratories, United States 2006-2010
CDC
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CDC
12/06/11
(algorithms for Syphilis serology tests and types of tests recommended for here)
Web
http://www.cdc.gov/mmwr/
MMWR; March 4, 2011/Vol 60/NoRR-3/pg 1-20
Updated Norovirus Outbreak Management and Disease Prevention Guidelines (includes testing
recommendations and specimen collection and transport)
CDC
Web
http://www.cdc.gov/mmwr/
MMWR; Nov 19, 2010/Vol. 59/No RR-10/pg 1-36
Prevention of Perinatal Group B Strep Disease, Revised guidelines from CDC 2010
(includes lab testing, specimen collection and transport guidelines)
CDC
Web
http://www.cdc.gov/mmwr/
MMWR; June 25, 2010/Vol 59/No RR-5/pg 1-26
Updated Guidelines for Using Interferon Gamma Release Assays to Detect MTB Infections
CDC
Web
http://www.cdc.gov/mmwr/
MMWR; Oct 16, 2009/Vol 58/No RR-12/pg 1-14
Recommendations for Diagnosis of Shiga Toxin-Producing E. coli Infections by Clinical Laboratories
CDC
M41-A
M44-A2
M45-A2
M47-A
M48-A
M50-A
M51-A
M100-S21
http://www.cdc.gov/mmwr/
Viral Culture; Approved Guideline
Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline—Second Edition
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious
Bacteria; Approved Guideline
Principles and Procedures for Blood Cultures; Approved Guideline
Laboratory Detection and Identification of Mycobacteria; Approved Guideline
Quality Control for Commercial Microbial Identification Systems; Approved Guideline
Method for Antifungal Disk Diffusion Susceptibility Testing of Filamentous Fungi; Approved Guideline
Performance Standards for Antimicrobial Susceptibility Testing; Twenty-First Informational Supplement
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
Molecular Testing
Document ID
Document Title
MM01-A2
Molecular Diagnostic Methods for Genetic Diseases; Approved Guideline—Second Edition
Organization
CLSI
12/06/11
MM02-A2
MM03-A2
MM05-A
MM06-A2
MM07-A
Immunoglobulin and T-Cell Receptor Gene Rearrangement Assays; Approved Guideline—Second Edition
Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline—Second Edition
Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline
Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition
Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline
CLSI
CLSI
CLSI
CLSI
CLSI
MM09-A
MM10-A
MM11-A
MM12-A
MM13-A
MM14-A
MM16-A
MM17-A
MM18-A
Monograph
Genotyping for Infectious Diseases: Identification and Characterization; Approved Guideline
Molecular Methods for Bacterial Strain Typing; Approved Guideline
Diagnostic Nucleic Acid Microarrays; Approved Guideline
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline
Proficiency Testing (External Quality Assessment) for Molecular Methods; Approved Guideline
Use of External RNA Controls in Gene Expression Assays; Approved Guideline
Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline
Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline
Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline
General Recommendations for Quality Assurance Programs for Laboratory Molecular Genetic Tests
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CDC
Document ID
Document Title
Organization
Web
Web
Web
Cancer Protocols and Checklists posted on CAP website
ER/ PgR Guideline
Her 2 Testing Guidelines
Publication
CONSENSUS GUIDELINES: 2006 Consensus Guidelines for the Management of Women with Abnormal
Cervical Cancer Screening Tests. Am J Obstet Gynecol. 2007; 197:346-55
CONSENSUS GUIDELINES: 2006 Consensus Guidelines for the Management of Women with Cervical
Intraepithelial Neoplasia or Adenocarcinoma in situ. Am J Obstet Gynecol. 2007; 197: 340-345
Microwave Device Use in the Histology Laboratory; CAP Approved Guideline
CAP
ASCO/ CAP
ASCO/CAP
ASCCP
Pathology
Publication
GP28-A
ASCCP
CLSI
12/06/11
Semen Analysis (Andrology)
Document ID
Document Title
978 92 4 154778 9
WHO laboratory manual for the examination and processing of human semen, 2010
Organization
WHO
Point-of Care Testing/ PPM/ Waived Testing
Document ID
Document Title
Organization
MMWR Vol. 54 /
No. RR-13
Web
Good Laboratory Practices for Waived Testing Sites
CDC
Free online training module for waived testing:
CDC
AST04-A2
POCT01-A2
POCT02-A
POCT04-A2
POCT05-A
POCT07-A
POCT08-P
POCT09-A
H58-A
http://wwwn.cdc.gov/dls/waivedtests/
Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline—Second Edition
Point-of-Care Connectivity; Approved Standard—Second Edition
Implementation Guide of POCT01 for Health Care Providers; Approved Guideline
Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline—Second Edition
Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline
Quality Management: Approaches to Reducing Errors at the Point of Care; Approved Guideline
Quality Practices in Non-instrumented Near-Patient Testing: An Instructional Manual and Resources for
Health Care Workers; Proposed Guideline
Selection Criteria for Point-of-Care Testing Devices; Proposed Guideline
Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
CLSI
12/06/11
Link to Organizations:
AABB
AABB
www.aabb.org
AACC
American Association of Clinical Chemistry
www.aacc.org
ACMG
American College of Medical Genetics
www.acmg.net
ACS
American College of Surgeons
www.facs.org
AMP
Association of Molecular Pathology
www.amp.org
ASCLS
American Society for Clinical Laboratory Science
www.ascls.org
ASCO
American Society for Clinical Oncology
www.asco.org
ASCCP
American Society for Colposcopy and Cervical Pathology www.asccp.org
ASCP
American Society for Clinical Pathology
www.ascp.org
ASHI
American Society for Histocompatibility and
Immunogenetics
www.ashi-hla.org
ASM
American Society for Microbiology
www.asm.org
ASRM
American Society for Reproductive Medicine
www.asrm.org
BCSH
British Committee for Standards in Hematology
www.bcshguidelines.co
CDC
Center for Disease Control
www.cdc.gov
CLSI
Clinical and Laboratory Standards Institute
www.clsi.org
CLIA
Clinical Laboratory Improvement Act
www.cms.gov/clia
12/06/11
FDA
Food and Drug Administration
www.fda.gov
HRSA
Health Resources and Services Administration
Optn.transplant.hrsa.gov
ISO
International Standards Organization
www.iso.org
OHSA
Occupational Health and Safety Administration
www.osha.gov
WHO
World Health Organization
www.who.int
12/06/11