Understanding ISO 15189 & CLIA Requirements for Medical Laboratories (MS 170)
During this course, the participant will gain an understanding of the ISO 15189 and CLIA requirements as well as the benefits through discussion, interactive exercises, and lecture. The participant will also be introduced to a new risk-based initiative recently introduced by CMS: The IQCP, or Individualized Quality Control Plan.
- Course Introduction.
- Mutual Recognition Agreements.
- The A2LA Accreditation Process.
- ISO 15189-What the Standard Requires:
- Management requirements and responsibility;
- Quality management system;
- Document control;
- Service agreements;
- Examination by referral laboratories;
- External services and supplies;
- Advisory services;
- Resolution of complaints;
- Identification and control of nonconformities;
- Corrective and preventive action;
- Continual improvement;
- Control of records;
- Evaluation and audits;
- Management review;
- Technical requirements;
- Accommodation and environmental conditions;
- Laboratory equipment, reagents, and consumables;
- Pre-examination, examination and post-examination processes;
- Ensuring quality of examination results;
- Reporting and release of results; and
- Laboratory information management.
- A2LA Specific Requirements:
- Advertising accreditation and reporting accredited results;
- Traceability requirements for measurement equipment; and
- Participation in proficiency testing.
- Implementing IQCP:
- Risk and risk management;
- Risk estimation and evaluation; and
- Failure Mode and Effects Analysis (FMEA).
Target learners include Clinical Testing Laboratory Directors, Managers, Auditors, Scientists, or Technicians.
After successful completion of this course, the participant will be able to:
1. Identify Documents and Records required by the Standard and CLIA;
2. Implement actionable clauses
3. Design and apply a risk management system;
4. Recognize how and when to implement an IQCP; and
5. Describe the benefits of the standard in conjunction with CLIA requirements
1.4 CEUs Awarded*
This course will use lecture, discussion and interactive exercises.
A legal, authorized copy of the ISO 15189 standard and the CLIA Requirements Document will be provided to each participant.
*American Association for Laboratory Accreditation (A2LA) is accredited by the International Association for Continuing Education and Training (IACET) and is authorized to issue the IACET CEU.