ISO 15189 and CLIA Clinical Laboratory Accreditation
This two-day course will use lecture, discussion and interactive exercises to assist you in understanding the benefits of the ISO 15189 standard. The CLIA portion of the seminar will focus on 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).
There is no prerequisite for this course.
Clinical laboratory management personnel
There is no exam for this course.
After successful completion of this course, attendees will be able to:
- Identify documents and records required by ISO 15189 and CLIA;
- Design and apply a risk management system;
- Recognize how and when to implement IQCP;
- Describe the benefits of compliance with the ISO 15189 standard in conjunction with CLIA requirements; and
- List the steps in the A2LA accreditation process.
1.2 CEUs Awarded*
This course will use lecture, discussion and interactive exercises.
ISO 15189-Medical Laboratories-Requirements for Quality and Competence
CLIA Brochure #11: Individualized Quality Control Plan Introduction
CDC/CMS Developing an IQCP: A Step-By-Step Guide
*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.
PLEASE NOTE: A2LA can offer on-site training at your facility. For additional information about this option, please contact Tim Osborne, Senior Director of Training Services, at 301 644 3235 or Training@A2LA.org.