Ambiguity in ISO 15189:2012

By : Dr.Manisha P. Kapadia

3rd Year Resident Biochemistry

GMC Surat

Guided by: Dr.S.M.PatelORAL PRESENTATION AT CME – NABL IMPACT ON LABORATORY MEDICINE ON

27/09/2014

Legal EntityISO 15189 2007 4.1.1

The medical laboratory or the organization of which the laboratory is a part shall be legally identifiable.

ISO 15189 :2012 4.1.1.2 Legal entity The laboratory or the organization of which the laboratory is a part shall be an entity that can be held legally responsible for its activities.

• There is a confusion regarding this term .

• What is difference?

• In last assessment, assessor have not asked any thing about it.

Quality indicators and objectives

Quality Indicator:

measure of the degree to which a set of inherent characteristics fulfils requirements

Quality Objectives:

something sought, or aimed for, related to quality.

What is the difference between

Quality indicators

and

Quality objectives???

Service Agreement

ISO 15189 2012 4.4

The laboratory shall have documented procedures for the establishment and review of agreements for providing medical laboratory services.

Each request accepted by the laboratory for examination(s) shall be considered an agreement..

• What is meant by such agreement ???

• What is the significance of using agreement instead of contract??

• How we can define it in relation to users of laboratory ???

• Reviewing service agreements???

• Our last assessment NC

–“With reference to service agreements the following have not been defined and documented

–i. Users of laboratory services.

–ii. Appropriate service agreements with the various users.

–iii.Review of service agreements.”

Risk Management

ISO 15189 : 2012 4.14.6 The laboratory shall evaluate the impact of work processes and potential failures on examination results as they affect patient safety, and shall modify processes to reduce or eliminate the identified risks and document decisions and actions taken.

• Risk management means to identify potential areas of errors or weak part of the process and then devise a procedure so as to strengthen it..

• Risk management activity???

• Risk management records??

Sample transportation• “A laboratory which is not involved in

primary sample collection and transportation is considered to have satisfied clause 5.4.5 c) above when, upon receipt of a sample whose integrity was compromised or which could have jeopardized the safety of the carrier or the general public, the sender is contacted immediately and informed about measures to be taken to eliminate recurrence.”

Is ward sample collection under NABL assessed activity?

• Why Yes?

• Why No?

• If yes: are nursing staff laboratory personnel?

• If no, do we have to train them?

Is signature necessary in report?

ISO 15189 2007 5.8.3 n) signature or authorization of the person checking or releasing the report, where possible.

ISO 15189 2012 5.8.3 n) identification of the person(s) reviewing the results and authorizing the release of the report .

• Automated release of report

How do we report Critical value for OPD samples?

• Mobile Number? Doctor? Patient?

• What is its use?