SZNS ISO/TS 22367:2008 Medical laboratories — Reduction of error through risk management and continual improvement

E146.03

Scope

This Technical Specification gives guidance on the application of SZNS ISO 15189 as a system for reducing laboratory error and improving patient safety by applying the principles of risk management, with reference to examination aspects, especially to pre- and post-examination aspects, of the cycle of laboratory medical care.

This Technical Specification proposes a methodology for finding and characterizing medical laboratory error that would be avoided with the application of SZNS ISO 15189

Description

Table of contents                                                                                                                                                                                       Page

Introduction……………………………………………………………………………………………………………………………………………….. v

1 Scope. ………………………………………………………………………………………………………………………………………………………1

2 Normative references. ………………………………………………………………………………………………………………………………..1

3 Terms and definitions. …………………………………………………………………………………………………………………………………1

4 Management responsibility in preventive and corrective actions, and continual improvement …………………………2

4.1 General ……………………………………………………………………………………………………………………………………………………2

4.2 Management responsibility in preventive actions. ………………………………………………………………………………………2

4.3 Management responsibility in corrective actions. ………………………………………………………………………………………3

4.4 Management responsibility in continuous improvement …………………………………………………………………………..3

5 Identification of potential and actual laboratory non-conformities, errors and incidents. ………………………………3

6 Classification of laboratory non-conformities, errors and incidents. …………………………………………………………….3

7 Preventive action and corrective actions. ……………………………………………………………………………………………………4

8 Assessment of risk arising from actual and potential laboratory non-conformities. ……………………………………….5

9 Review of collected laboratory non-conformities, errors and incidents. ……………………………………………………….6

10 Preventive action and corrective action plans. …………………………………………………………………………………………6

11 Preventive action and corrective action plan files. …………………………………………………………………………………..6

12 Continual improvement plan. ……………………………………………………………………………………………………………….6

Annex A (informative) Failure modes and effects analysis. ……………………………………………………………………………..7

Annex B (informative) Model for assessing risk of harm.. ………………………………………………………………………………8

Annex C (informative) Ranking of severity levels. ………………………………………………………………………………………….9

Bibliography. …………………………………………………………………………………………………………………………………………….10

 

Additional information

FORMAT

PAPER, PDF