Laboratory Quality Stepwise Implementation tool

Title

Write a Laboratory Service Manual and start to follow the procedures formulated in this manual

Why

Informing the clients of what the laboratory does is paramount to the quality of laboratory services. By informing the clients of the laboratory about all the tests that are available, and in which clinical situation which tests should be requested, the laboratory helps the client to request the best combination of tests that provides the most optimal information for the patient. The laboratory moreover prevents that tests are requested that are not relevant for the clinical situation of the patient, hence decreasing work pressure and increasing cost efficiency.

Informing the clients on what sample is needed for each examination and how this sample should be packed and sent to the laboratory increases biosafety and the quality of samples. This in turn enables the laboratory to better assure quality.

What

Make a Laboratory Service Manual. This manual contains the details of the laboratory (address + contact details + operation hours + types of services offered by the laboratory) and it explains the clients of the laboratory all they need to know regarding the pre-analytical phase, the analytical phase and the post-analytical phase. The contact details can be used when clients have questions.

The service manual is an extract of the SOP for Sample Collection, SOP on Sample Reception and the SOP on Reporting of Results.

Regarding the pre-analytical phase the service manual explains:

How to obtain a Request Form of the laboratory (you can attach the Request Form as appendix to the Laboratory Service Manual so that clients can copy this)
Which tests are available at the laboratory, including information on which the clinical situations require this test to be performed
What sample is needed for each test, the volume/amount needed, the transportation requirements and, if applicable, special timing of collection. This section also shows the sample acceptation/rejection criteria made in phase 2
How this sample must be collected, including:
- Identification of the patient and verification that the patient meets the pre-examination requirements (e.g. for some examinations the patient must have an empty stomach; the sample collector must verify that the patient hasn't eaten anything preceding the sample collection
- How to prepare the patient
- The type of container in which the sample must be collected
- How to label the Request Form and patient sample container(s)
How and under which conditions it must be packed and sent to the laboratory, including:
- Time frame for sending the test to the laboratory
- Temperature interval in which it must be transported
- The method of packing the sample container to prevent leaks, which damages the sample integrity and poses a risk for the safety of the general public and the sample transporter
- Which documents should be included
If applicable, requirements regarding patient consent
The procedure for requesting routine laboratory testing, including how to complete the Request Form.
The procedure for requesting urgent laboratory testing.

Regarding the analytical phase the service manual explains:

The normal turnaround time for each test
The biological reference intervals and, if applicable, the critical/alert values for specific tests
A list of factors known to affect the performance of the examination or the interpretation of results of each examination

Regarding the post-analytical phase the service manual explains:

The routine method of reporting.
The procedure for reporting urgent testing results.
A guideline to interpreting the Result Report.
Requesting additional testing, including the time-frame in which this is possible.
The laboratory's policy on protection of patient information (describe what the laboratory does to protect patient information from unauthorized access, such as storing the information in an archive that can be locked and is only accessible by authorized personnel, that personnel must sign confidentiality agreements, etc. Most of these procedures were established in phase 2, under Information Management).
The laboratory's complaint procedure (to be developed in phase 4).

The Laboratory Service Manual must be sent to all the clients of the laboratory. It will be part of the document control system to ensure that the information contained in the manual stays up to date and correct. After each change the document must be printed again and sent to all the clients.

How & who

Quality Officer:

Select staff members who are most suited to write (parts of) the Laboratory Service Manual. These should be staff members that are closely involved in carrying out the procedures that must be included in the service manual.
Ask the laboratory manager to assign these staff members with the task to write the sections of the service manual in cooperation with you.
Guide the staff members in writing the service manual. Explain to them why the service manual must be written, which outline it will have and what they have to include in the description of procedures assigned to them.
When the first draft of the service manual is finished, ask one or two staff members to review the manual. Also ask a few of the regular clients of the laboratory to review the manual and ask what they think that should be added, changed or deleted.
Include the service manual in the document control system (also established in phase 2) to ensure that it is reviewed on a regular basis and thus stays up to date. Add a front page to the manual and ask the internal reviewers to sign the front page once review has taken place according to the procedure described in the SOP for Document Control.
Ask the laboratory manager to authorize the service manual once finalized.
Print as many copies of the service manual as needed and send the copies to all the clients included in the Client Database developed earlier in phase 2 (you can also choose to send the manual electronically if clients have access to a computer).
As the service manual is part of the document control system, it must be reviewed and, if necessary revised on a yearly basis. When the manual is adapted due to this scheduled review (but also when an error has been detected, an examination procedure has changed or new examinations have become available), the new version must be printed directly and sent to the clients with the note that they have to destroy the old version. As the manual contains a front-page the clients can see what has changed compared to the previous version.