Beyond CLIA
Written by Lisbeth Roy
Updated at April 6th, 2025
Table of Contents
Presentation Outline
- Overview of international QMS standards & guidelines
- CLSI
- ISO
- Comparison of CLSI, ISO and CLIA
- Questions to consider
Questions to Consider
- What international QMS standards/guidelines apply to clinical laboratories?
- How do these standards/guidelines differ from CLIA?
- How are they being used within and outside of the US?
- What are the advantages/facilitators and disadvantages/barriers for US laboratories to implementing international QMS standards?
- What incentives do US laboratories have/need to implement QMS?
Standards Organizations
-
Clinical and Laboratory Standards Institute (CLSI)
- Uses consensus process
- Focus on health care services, especially laboratory
-
International Organization for Standardization (ISO):
- Guidance for quality in manufacturing and service industries
- Broad applicability, many kinds of organizations can use
Quality Management System (QMS)
- A framework for managing and monitoring activities to address quality standards and achieve organizational goals (CLSI).
- Organizational structure, resources, policies, processes and procedures needed to implement quality management (ISO, CLSI).
ISO Documents - Laboratory
| Standard No. | Title |
| ISO 9001:2000 | Quality Management System Requirements Model for QA in design, development production, installation, and servicing |
| ISO/FDIS 15189: 2003 | Medical Laboratories – Particular requirements for quality and competence |
| ISO/IEC 17025 | General requirements for the competence of testing and calibration labs |
CLSI Quality Standards
| Standard No. | Title |
| HS1-A2 |
A Quality Management System Model for Health Care
|
| GP 26-A3 |
Application of Quality Management System Model for Laboratory Services
|
QMS Document Hierarchy
QMS Guidance - A Timeline
CLSI Quality System Essentials
Laboratory Path of Workflow
Medical Laboratories - Particular Requirements for Quality and Competence (ISO 15189:2003)
Management Requirements
- Organization and management
- QMS
- Document control
- Review of contracts
- Referral laboratories
- External services/supplies
- Advisory services
- Resolution of complaints
- Control of nonconformities
- Corrective action
- Preventive action
- Continual improvement
- Quality and technical records
- Internal audits
- Management review
ISO 15189:2003, continued
Technical Requirements
- Personnel
- Accommodation and environmental conditions
- Laboratory equipment
- Pre-examination procedures
- Examination procedures
- Assuring quality of examination procedures
- Post-examination procedures
- Reporting of results
Annex A: Correlation with ISO 9001:2000 and ISO/IEC 17025:1999
Annex B: Recommendations for protection of LIS
Annex C: Ethics in laboratory medicine
CLIA Regulations
- Subpart A: General Provisions
- Subpart H: Participation in PT
- Subpart J: Facilities
- Subpart K: Quality Systems
- Specialties/subspecialties
- General laboratory systems
- Pre-analytic
- Analytic
- Post-analytic
- Subpart M: Personnel
- Subpart Q: Inspection
Comparison: CLSI QMS Model to ISO 15189 and CLIA Regulations
| CLSI QMS | ISO 15189 | CLIA |
| QSE | Clauses | Sections |
| Organization |
4.1 Organization and Management 4.2 Quality management system 4.15 Management review |
§ 493.1200 – § 493.1299 Subpart K – Quality System for Non- Waived Testing |
| Personnel | 5.1 Personnel |
§ 493.1351 - § 493.1495 Subpart M – Personnel for Non- Waived Testing |
| Equipment | 5.3 Laboratory Equipment |
§ 493.1252 - § 493.1255 Equipment, performance verification, maintenance and function checks, calibration |
| Purchasing & Inventory |
4.4 Contract review 4.5 Referral Laboratories 4.6 External Services and Supplies |
§ 493.1242(8)(c) Specimen referral § 493.1252 Test systems, equipment, instruments, reagents, materials, and supplies |
| CLSI QMS | ISO 15189 | CLIA |
| QSE | Clauses | Sections |
| Process control |
5.4 Pre-examination procedures 5.5 Examination procedures 5.6 Assuring quality – examination 5.7 Post-examination procedures |
§ 493.1240 - § 493.1249 Pre-analytic systems § 493.1250 - § 493.1289 Analytic Systems § 493.1290 - § 493.1299 Post-analytic systems |
| Documents and records |
4..3 Document Control 4.13 Quality and Technical Records |
§ 493.1101(e) Standard: Facilities 493.1105 Standard: Retention Requirements |
| Information management |
5.8 Reporting of results Annex B: LIS Annex C: Ethics |
§ 493.1290 - § 493.1291 Post-analytic Systems |
| Occurrence management |
4.8 Resolution of complaints 4.9 Identification and control of nonconformities 4.10 Corrective action |
§ 493.1299 Post-analytic systems quality assessment § 493.1256 - § 493.1282 Control procedures |
| CLSI QMS | ISO 15189 | CLIA |
| QSE | Clauses | Sections |
| Assessments: Internal & External |
4.11 Preventive action 4.14 Internal audits 5.6.4 External quality assessment |
§ 493..1250 - § 493.1255 Analytic Systems § 493.801- § 493.865 Participation in Proficiency Testing Subpart Q - Inspection |
| Process improvement | 4.12 Continual improvement |
§ 493.1200, § 493.1239, § 493.1249, § 493.1289, § 493.1299 Quality Systems assessments |
| Customer service |
4.7 Advisory services 4.8 Resolution of complaints Annex C: ethics |
§ 493.1407, § 493.1419 Consultation § 493.1233 Complaint investigation § 493.1234 Communication |
| Facilities and Safety |
4.6 External services and supplies 5.2 Accommodation and environmental conditions 5.3 Laboratory equipment |
§ 493.1100 - § 493.1101 Facility Administration for Non-waived Testing § 493.1252 Standard: Test systems, equipment, etc., |
How do CLIA requirements differ from ISO and CLSI QMS standards/guidelines?
General Differences between CLIA and ISO/CLSI
- CLIA – more specific in some areas, g.
- Personnel
- Quality control
- PT
- Record retention
- ISO/CLSI – more comprehensive and general, g.
- Applies to all laboratories, regardless of test complexity
- Management system
- Internal and external assessment
CLIA Requirements not Included in CLSI/ISO
- Complexity model, waived testing
- Specialties and subspecialties
- Specific retention requirements
- Establishment/verification of certain method performance specifications
- Quality control & calibration materials/frequency
- PT participation and grading criteria
- Personnel categories beyond Lab Director
- Specific personnel qualifications/responsibilities
CLSI/ISO Elements not Specified in CLIA
- Quality manager
- Management review
- Process improvement
- Quality manual (policy)
- Quality indicators
- Contract review
- Evaluation of referral laboratories, suppliers
- Continuing education for all personnel
- Internal audits
- PT for all tests (ISO compliant programs)
- Reports using internationally recognized standards
- Recommendations for LIS
International Laboratory Accreditation Cooperation (ILAC)
- International cooperation of laboratory and inspection accreditation bodies
- 46 full member economies
- Some countries mandate adherence to ISO 15189, others recognize/endorse ISO
ILAC: U.S. Representatives
- American Association for Laboratory Accreditation (A2LA)
- Assured Calibration and Laboratory Accreditation Select Services (ACLASS)
- International Accreditation Service, (IAS)
- National Voluntary Laboratory Accreditation Program (NVLAP)
Questions to Consider
- What international QMS standards/guidelines apply to clinical laboratories?
- How do these standards/guidelines differ from CLIA?
- How are they being used within and outside of the US?
- What are the advantages/facilitators and disadvantages/barriers for US laboratories to implementing international QMS standards?
- What incentives do US laboratories have/need to implement QMS?