101 Topics for Clinical Microbiology Laboratory Leaders: Accreditation, Verification, Quality Systems, and More by Rebekah M. Martin is your roadmap to achieving and maintaining excellence in clinical microbiology laboratory administration. This quick reference guide is designed to help laboratory professionals efficiently navigate the key aspects of accreditation, regulatory compliance, and quality management. This practical resource is perfect for both new and experienced laboratory leaders who need accessible, actionable information.
Inside, you’ll find: - Regulatory Overview: Information on the Clinical Laboratory Improvement Amendments, test complexity categories, and the roles of key agencies like the Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and the Food & Drug Administration in overseeing clinical laboratories.- Accreditation Basics: Guidance on how to obtain and maintain laboratory accreditation, including what to expect during inspections and how to respond to deficiencies.- Test Verification & Validation: Essential tips on conducting verification and validation studies to ensure your laboratory’s test systems are accurate, reliable, and compliant with regulatory standards.- Quality Management Essentials: Practical strategies for implementing and maintaining a quality management system, including process control, document management, and continuous improvement techniques that keep your lab running smoothly.
Presented in a user-friendly question-and-answer format, 101 Topics for Clinical Microbiology Laboratory Leaders is your go-to resource for quick, reliable guidance on leading a compliant and high-performing clinical microbiology laboratory.
Table of Contents
Foreword xv
Preface xvii
Acknowledgments xix
About the Author xxi
List of Abbreviations xxiii
Part I Getting Started: Regulatory Oversight and Laboratory Accreditation 1
1 Clinical Laboratory Improvement Amendments (CLIA) and Regulatory Oversight 3
How is “clinical laboratory” defined? 3
What is CLIA? 4
What is the Code of Federal Regulations (CFR)? 5
What roles do the Centers for Medicare and Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), and the U.S. Food and Drug Administration (FDA) play in regulating clinical laboratories? 5
What is an FDA-cleared or FDA-approved test? 6
What is a laboratory developed test (LDT)? 7
What does the FDA final rule mean for my laboratory? 8
What is Emergency Use Authorization (EUA)? 14
What is test complexity? 15
Is there a list of tests categorized by complexity? 17
References 17
2 Clinical Laboratory Improvement Amendments (CLIA) Certificates 21
Which laboratories need a CLIA certificate? 21
Which laboratories are NOT required to obtain a CLIA certificate? 21
What are the types of CLIA certificates? 21
What procedures are categorized as provider-performed microscopy (PPM) procedures? 22
How does a laboratory obtain a CLIA certificate? 23
How many laboratories can be on one CLIA certificate? 24
Can one location have multiple CLIA certificates? 24
How many CLIA certificates can one laboratory director have? 25
How long is a CLIA certificate effective, and how does a laboratory renew a CLIA certificate? 25
What are the laboratory specialties and subspecialties? 25
Which states have CLIA-exempt laboratory programs? 26
When can a laboratory begin testing? 26
Who should be notified if there are changes in the laboratory, and when? 26
What happens if a laboratory is out of compliance with CLIA requirements? 27
References 28
3 Waived Testing 29
What are waived tests? 29
Is there a list of tests that are waived? 30
Is my laboratory subject to inspection if we perform waived testing? 30
What are the personnel qualifications for performing waived testing in clinical laboratories? 30
Are there compliance exemptions for laboratories performing waived testing? 30
References 31
4 Laboratory Accreditation 33
What is laboratory accreditation? 33
What are the current CMS-approved accrediting agencies? 33
How can my laboratory become accredited? 34
How does my laboratory maintain accreditation? 35
What happens during a laboratory inspection? 35
How does a laboratory respond when cited for deficiencies? 36
How is laboratory noncompliance addressed by CMS? 36
Can I become a laboratory inspector? 36
What is “ISO certification/accreditation” and does my laboratory need it? 37
I need some help with terms! 38
References 39
Part II Going Live: Verification and Validation of Test Systems 41
5 Verification and Validation 43
What are verification and validation? 43
When should a laboratory perform a verification or validation study? 43
If our laboratory complies with the FDA final rule for LDTs, do we still need to perform a validation study for our LDTs? 44
What is a test system? 45
What counts as a modification to a test system? 45
Who is responsible for designing and implementing a verification or validation study? 46
Can the company who made the instrument perform the verification study? 46
What performance characteristics should be assessed for a verification study? 46
What performance characteristics should be assessed for a validation study? 47
Is verification/validation necessary for point of care and other CLIA-waived assays? 47
My laboratory is moving an instrument. Is a verification/validation necessary? 47
My laboratory has five of the same instruments running the same assay. Do we have to run a verification/validation on each instrument? 48
My laboratory has multiple high-complexity laboratories across the health system that run the same assays on the same platform. Does a verification/validation need to be performed at each location? 48
My laboratory stopped running a particular assay. Is verification/validation necessary to resume testing with this assay? 48
My laboratory is running a test under Emergency Use Authorization (EUA). Is verification/ validation required? 49
Which laboratory personnel are involved in a verification/validation study? 49
References 49
6 Performance Characteristic: Precision 51
What is precision? 51
How many and what types of samples should be used to assess precision? 52
How does a laboratory assess precision for qualitative assays? 52
How does a laboratory assess precision for quantitative assays? 53
What calculations should be used for precision? 54
How can precision be assessed for matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) identification systems? 55
How can precision be assessed for antimicrobial susceptibility test (AST) systems? 57
How can precision be assessed for multiplex molecular systems? 57
References 62
7 Performance Characteristic: Accuracy/Agreement 65
What is accuracy? 65
How many and what types of samples should be used to assess accuracy? 66
What calculations should be used for accuracy? 67
What calculations should be used for agreement? 68
How does disease prevalence affect test performance? 69
How can accuracy be assessed for matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) identification systems? 69
How can accuracy be assessed for antimicrobial susceptibility test (AST) systems? 70
How can accuracy be assessed for multiplex molecular systems? 73
References 77
8 Performance Characteristic: Reportable Range 79
What is reportable range? 79
How many and what types of samples should be used to assess reportable range? 80
How does a laboratory assess reportable range for quantitative assays? 81
How does a laboratory assess reportable range for qualitative assays? 81
How can reportable range be assessed for matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) identification systems? 84
How can reportable range be assessed for antimicrobial susceptibility test (AST) systems? 84
How can reportable range be assessed for multiplex molecular systems? 84
References 85
9 Performance Characteristic: Reference Interval 87
What is a reference interval? 87
How many and what types of samples should be used to assess the reference interval? 87
How does a laboratory assess the reference interval? 88
What calculations should be used for reference interval? 88
How can the reference interval be assessed for matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) identification systems? 89
How can the reference interval be assessed for antimicrobial susceptibility test (AST) systems? 89
How can the reference interval be assessed for multiplex molecular systems? 89
References 89
10 Performance Characteristic: Analytical Sensitivity 91
What is analytical sensitivity? 91
How many and what types of samples should be used to assess analytical sensitivity? 92
How does a laboratory assess analytical sensitivity? 92
What calculations should be used for analytical sensitivity? 93
How can analytical sensitivity be assessed for matrix-assisted laser desorption ionization- time of flight (MALDI-TOF) identification systems? 93
How can analytical sensitivity be assessed for antimicrobial susceptibility test (AST) systems? 93
How can analytical sensitivity be assessed for multiplex molecular systems? 94
References 94
11 Performance Characteristic: Analytical Specificity 95
What is analytical specificity? 95
How many and what types of samples should be used to assess analytical specificity? 95
How does a laboratory assess analytical specificity? 96
What should we do if cross-reactivity or interfering substances are identified? 97
How can analytical specificity be assessed for matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) identification systems? 97
How can analytical specificity be assessed for antimicrobial susceptibility test (AST) systems? 98
How can analytical specificity be assessed for multiplex molecular systems? 98
References 98
12 Additional Performance Characteristics 99
What additional performance characteristics could be considered, and how are they assessed? 99
References 100
13 Unacceptable Results and Resolution 101
What should we do if there are significant discrepancies between our new assay and the comparator assay? (Accuracy) 101
We are using a less sensitive method as our comparator method, and our new test is showing poor agreement and increased “false positives.” What should we do? (Accuracy) 101
Our assay shows significant cross-reactivity with a particular organism. What should we do? (Analytical specificity) 102
References 103
14 Documentation for Verification and Validation Studies 105
What documentation is necessary for a verification or validation study? 105
What should be included in a verification/validation plan? 105
What should be included in a verification/validation summary? 106
How long is the laboratory required to keep verification/validation documentation? 106
What do I do if my laboratory’s legacy assays do not have verification/validation documentation? 106
References 107
Part III Staying Live: Quality Management Systems 109
15 Quality Management Systems 111
What is a quality management system, and why is it essential for clinical microbiology laboratories? 111
What are the essentials of a quality management system? 111
What are some additional resources to help with developing a quality management system? 112
References 113
16 Essential: Organization 115
What is “organization” in a quality management system? 115
What are some key organization components to consider for a clinical microbiology laboratory? 115
What is a quality manual and how do I write one? 119
References 120
17 Essential: Laboratory Personnel 121
Who are the key clinical microbiology laboratory personnel? 121
What are the qualifications for laboratory personnel by test complexity? 123
Do testing personnel need to be licensed and/or certified? 129
How is personnel competency assessed? 130
What personnel records should be maintained, where, and for how long? 131
References 132
18 Essential: Customer Service 133
Who are the clinical microbiology laboratory’s customers? 133
How is customer satisfaction monitored? 134
How is customer dissatisfaction managed? 135
References 136
19 Essential: Facilities and Safety 137
How does the laboratory maintain safety? 137
How does the laboratory maintain security? 138
How does a laboratory perform a risk assessment? 139
What role does facilities design play in safety? 141
What is emergency/disaster preparedness and how can this be implemented in the laboratory? 142
References 144
20 Essential: Purchasing and Inventory 147
What is the purchasing and inventory quality essential? 147
What are key considerations for purchasing materials and services? 147
How is inventory managed? 149
What happens when there is a lack of inventory? 151
What are examples of external services that need to be tracked and managed? 152
What documents and records should be retained for purchasing and inventory? 152
References 152
21 Essential: Equipment 155
What is the equipment quality essential? 155
What are examples of equipment in the clinical microbiology laboratory? 160
If we use multiple instruments to perform the same test, do test results need to be compared? 161
What documents and records should be maintained for equipment? 161
How is return on investment calculated? 162
References 163
22 Essential: Process Control 165
What is process control? 165
How can the laboratory implement process control? 165
What is quality control (QC)? 168
What is an individualized quality control plan (IQCP)? 169
What is a Levey-Jennings control chart? 171
What are calibration and calibration verification? 172
What documents and records should be retained as part of process control? 173
References 174
23 Essential: Document and Records Management 175
What are documents and records? 175
What is document and records management? 176
What are controlled and uncontrolled documents? 177
What is a policy versus a procedure? 178
What should be included in an analytical testing standard operating procedure (SOP)? 178
How does the laboratory store documents and records? 180
How long does the clinical microbiology laboratory need to retain documents and records? 181
References 183
24 Essential: Information Management 185
What is information management? 185
What are some key considerations for information management? 185
What is the LIS? 187
References 188
25 Essential: Occurrence Management 189
What is occurrence management? 189
What are some common laboratory errors? 189
How should the laboratory respond when a nonconforming event (NCE) occurs? 190
When and how does the laboratory perform a root cause analysis (RCA)? 193
What are corrective and preventive actions (CAPAs)? 197
References 199
26 Essential: Assessment 201
What is assessment? 201
How does the laboratory monitor quality processes? 201
What are inspections, surveys, or audits? 203
What indicators should the laboratory use to monitor and assess quality? 204
How does the laboratory implement proficiency testing (PT)? 205
References 209
27 Essential: Process Improvement 211
What is process improvement? 211
What should be included in a process improvement plan? 213
What does it mean for a process to be efficient and effective? 214
What are some common improvement models and tools? 214
What is a process map? 216
References 218
Index 219
