Tangible Quality in Action

Manky Badger asks for some tangibles that will illustrate the notion of “Quality” in action. 

These tangibles are derived from knowledge, study and experience dating back through the past 70-80 years and adopted by many business sectors.  They exist today in a variety of sources, most commonly from the International Organization for Standardization. 
Whether a laboratory adopts them because they have to (mandatory accreditation or regulation) or because they see opportunity and advantage (voluntary adoption or voluntary accreditation) depends on the situation and circumstance. 
Some laboratories do both.
Many organizations in manufacturing and service sectors have demonstrated the tangible advantages to implementing Quality practices. 

Most locales that have created requirements for mandatory accreditation adapt these same tenets into their own language, regulation or legislation

An active Laboratory Quality program includes:

Management should manage:

Laboratory Management should show leadership in the laboratory by establishing policies that are important to laboratory testing, and then ensure that everyone in the laboratory knows what they are and why they are set as policy. 
Laboratory Management should then ensure that laboratory decisions are consistent with those policies.

Laboratory suitability:

Laboratories should be fit for working in.  They should be safe and secure and have enough resources to perform the tests that they laboratory is required to perform.

In-laboratory communications:

To reduce confusion that leads to error testing, ensure that your laboratory staff know to whom they report and who reports to them. 

Ensure that laboratory users know who is responsible for laboratory decisions.

Documents:

Laboratory documents should be written in a way that can be understood. 
When there are documents that are written as different versions, people working in the laboratory  should be able to know which is the most current and active version.  
When documents are stored, they should be stored safely and in an appropriate way so that they can be retrieved when needed.

Training and competency of laboratory staff:

Employees should know what tasks they have been hired to fulfill.  They should be trained to perform those tasks and their training confirmed.  They should be checked on some sort of regular basis to ensure they have continued competency doing those tasks, especially if they have been away, or ill, or the task has changed over time.

Laboratory personnel should have access to the information and resources they need to perform their tests and tasks both efficiently and effectively.  This means there should be some form of written instructions.

Equipment, materials and reagents should be  as well as equipment and reagents should be in a condition that assures they are working properly.   

Employees should have regular access to continuing education to ensure that their knowledge and skills meet current needs. 

Employees should be aware that working in a medical laboratory creates obligations with respect to error prevention, timely testing, error reporting, and patient confidentiality. 

Error Prevention:

Laboratories have an obligation to reduce the risk of error through the programs mentioned above and also monitoring for systemic error through active programs of quality control, quality assessment, and quality indicators.  Signals of problems are investigated to determine if errors have potentially been caused, and if so ensure they are addressed.

Pre-examination error:

The laboratory should have policies and procedures that prevent poor quality samples (wrong patient, wrong test request, wrong conditions, wrong timing) from being tested in order to reduce the risk of producing results that are clinically misleading.

Post-examination error:

The laboratory should ensure that the right person gets the right report on the right sample from the right patient in a clinically relevant time.

Addressing error:

Laboratories are complex environments and to some extent some error is inevitable.  That being said, laboratorians have an obligation to monitor for error, to detected it early, to remediate it rapidly, to investigation why the error occurred and to the extent possible correct the possible causes, reducing the risk of similar errors. 

Customer satisfaction:

Laboratorians should accept all complaints as cause for investigation and action.  Where problems have lead to the complaints these should be addressed and corrected.

If a laboratory is able to say with confidence that they are working within a system that enacts these tenets, then they are doing the things that will reduce the risk of producing error, increase the possibility of detecting error, and when error is found fix it and learn from it, thereby reducing the risk of repeating the same problem again

If they are in place, we call that having a Quality program. 

To get more tangible, Manky Badger may want to consider a course such as the UBC Certificate Course in Laboratory Quality Management (www.polqm.ca)