Standards of working practice

Maintaining standards of working practice

Please read the following before you complete your pieces of evidence as you will need a broad understanding of the following quality terms:

Quality Management System
Audit
Internal Quality Control
External Quality Assurance
Documents control system

1. Quality Management System

A Quality Management System (QMS) is a collection of business processes and functions aimed at continuous improvement of quality to ensure customer expectations and requirements are met or exceeded.

Or put more simply:

A Quality Management System is made up of everything which has been put in place to ensure provision of a good service.

This ‘everything’ includes:

The Laboratory (e.g. Equipment, Facilities)
The Staff (e.g. Training, Competency, CPD)
The Procedures (e.g. SOPs, COSHH)
The Protocols (e.g. Policies, Risk Assessments)
Spotting errors / mistakes (e.g. Fault / Incident Reporting, Audits)
Learning from errors / mistakes (e.g. CAPA, Quality Improvements)

Q-Pulse is an electronic quality management system used in the laboratory that automates and helps us manage many of the above processes.

2. Audit

Auditing involves an inspection or examination, of a particular process to ensure compliance to requirements. For example, and audit could be carried on the number the request forms (process) filled in correctly (compliance) over a certain time period.

The auditor (the person carrying out the audit) must:

Carry out the audit independently
Base the audit of objective evidence (i.e. based on fact)
Use a check list of areas to audit to keep them on track
Ask open ended questions (rather than yes of no types)

Audits can be internal (e.g. departmental) or external (e.g. UKAS).

There are different types of audit such as vertical (e.g. following a single sample from start to finish and all the steps involved) or horizontal (e.g. Looking at a number of samples on analyser to see how they had all been treated in a particular process).

Audits provide insight into the overall performance of an area, department or procedure and identify any areas that need improvement.

3. Internal Quality Control and External Quality Assurance

Internal quality control (IQC) programmes and external quality (EQA) assurance schemes are important in enabling the maintenance of good service to patients.

ICQ: In practice, internal quality control is designed to check that a laboratory will produce the same result or outcome if the test or procedure is done on different occasions or by different staff.

It usually involves running a sample with known test values at regular intervals as you would a routine patient sample – this will quickly allow for any errors in the testing process to be detected prior to the release of patient results.

EQA: In practice, external quality assurance enables the laboratory to test the same samples or undertake the same procedure as other laboratories would in order to evaluate their performance against that of others. The ultimate principle being that it should not matter to a patient’s care wherever the sample was tested as all test results throughout the UK should be comparable.

It usually involves an external company sending a number of laboratories the same sample (that the company knows the results of) so that results can be compared between different laboratories.

4. Document control system

A documents control system refers to procedures for the approval, distribution and change of documentation (e.g. an SOP) and the designation of an individual or individuals authorised to implement (or be notified) those procedures.

Hint! Can you think or anything already discussed above that is used for the laboratory document control system?

Evidence 1: Using the information above complete the following table:

1. Quality terms and their relevance:

Evidence 2: List 3 quality documents (see QMS notes above) used within your scope of practice to complete the following table.

2. Quality documents:

You may use the examples shown above or you own

Evidence 3: You will need to write a personal statement that summarises how you maintain the quality of your own work - see below for some example statements that you could include within your statement:

I make sure I am up to date with my training (departmental and trust).
I read and acknowledge and updates of changes to SOPS
I understand my scope if practice and know who to ask for help and advice if I am unsure

3. Your personal responsibility for the quality of work

Try and personalise your piece with the following types of sentences:

I ensure I perform . . .

I make sure that . . .

I work in a . . .

I avoid . . .

I seek advice . . .

I am . . .

I check regularly . . .

The piece should be at least 3 paragraphs long - Speak to your mentor / line manage if you are unsure

Sign off: After you have collected each piece of evidence, hand them into your trainer / mentor who will then countersign them. Please note that they may ask for additional evidence or ask you follow up questions. Also ensure that:

You have date and signed your work
You only submit evidence for checking once it is completed (you may take individual evidence pieces out of your portfolio)
Ensure any countersigned checked work is returned back (in order) to your portfolio

Try not to hand in multiple pieces of evidence for marking at once - this will create too much work for your trainer / mentor, instead spread submissions out throughout your training.

Trainer notes: Ensure the candidates line manager completes the 'Line Manager's Comments' section as each module in the portfolio is completed - continuous assessment of the candidates work is required throughout the training period.