American Association for Laboratory Accreditation

ISO 15189 and CLIA Clinical Laboratory Accreditation

COURSE DESCRIPTION:

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 CONTENT:

  • 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;
    • Personnel;
    • 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).

PREREQUISITE:

There is no prerequisite for this course.

TARGET ATTENDEES:

Clinical laboratory management personnel

EXAMS:

There is no exam for this course.

LEARNING OUTCOMES:

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.
  •  

CEUs AWARDED:

1.2 CEUs Awarded*

PRESENTATION STYLE:

This course will use lecture, discussion and interactive exercises.

REFERENCE:

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 Julie Collins, A2LA Training Manager, at 301 644 3235 or jcollins@A2LA.org.