COURSE OVERVIEW

 This practical and highly-interactive course includes real-life case studies and exercises where participants will be engaged in a series of interactive small groups and class workshops.

Medical laboratory services are essential to patient care and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients. Such services include arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent validation, interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work. The “core business” of the clinical laboratory is the production of reliable test results.

The development of automation and the availability of ready-to-use test kits for most of the analytes may induce the wrong idea that high quality results can be easily produced. This is not true and a considerable effort must be dedicated to the control of the analytical aspects in order to provide to the clinicians results useful for the patient’s care.

Medical laboratories wishing to have some verification of their quality and performance have for years used ISO 17025. While this standard provides a generic framework for a laboratory quality management system, essential elements relative to clinical laboratories are missing.

ISO 15189 is the medical laboratory version of ISO 17025. ISO 15189 incorporates the essential elements of ISO 9001 and adds technical competency factors relevant to medical laboratories. Its primary application is to improve the structure and function of medical laboratories. The ISO 15189 accreditation includes both the certification of the QMS and the evaluation of the competency of the laboratory functions.

This course is a comprehensive look at the latest revision of the ISO 15189:2007 and its documentation and internal auditing requirements. You will gain critical insight on the interpretation of the requirements of this medical laboratory standard and you will also receive a detailed review of the accreditation process.

You will learn how to design and develop laboratory documents and quality manuals. The quality manual will be examined as to its impact on laboratory operations and what purpose it serves. You will learn what information it should contain, what writing style is most effective and how to keep your documents and quality manual up to date.

This course also gives attendees the knowledge needed to establish an internal quality audit program as required by ISO 15189:2007, and to initiate the sequence of activities involved in scheduling, planning, conducting, reporting on and closing out internal quality audits.

Participants will be able to employ effective techniques of auditing and the ability to develop the auditing procedures, scheduling and recording systems needed to sustain the program.

Further, participants will receive practical instructions on the development, implementation and long-term maintenance of an effective medical laboratory quality system. In addition to the updated knowledge provided to course participants during the course, each participant will go back to his/her laboratory equipped with an outstanding manual that includes typical SOPs that can be modified and used within participant’s laboratory.

Further, participants will be given 12 video tapes, compressed in one CD that can be used by the participant in training colleagues and subordinate on laboratory safety.