Title

Develop an SOP for Sample Reception and Processing and start registering all samples received by the laboratory

Why

The sample reception and processing unit is one of the most important elements of the primary process. If this unit is not properly organized the integrity of the complete analytical process is at risk. Without precisely following the correct procedures in the sample reception and processing stage the traceability of the sample is not guaranteed, the quality of results is not assured, and the health of the patient is at risk.


It should be kept in mind that research has shown that most laboratory errors take place in the pre-analytical stage of which the sample reception is a central part. It is therefore crucial that all the procedures in this stage are followed meticulously, and that all the controls are performed thoroughly and at all times.

What

Write an SOP that includes all the procedures related to sample reception and processing. Make sure that it includes at least the following procedures:

  • Checking sample integrity and deciding if the sample is accepted or rejected. Sample acceptation/rejection criteria were formulated earlier in phase 2. Refer to these criteria.
  • Introduction into the laboratory register: when the sample is accepted a decision is made which tests need to be performed and the sample is introduced in the laboratory register.
  • Sample labeling: when the sample is introduced in the register the sample is labeled. This creates the traceability: sample portions are made traceable to the primary sample by using the same label on all the portions. Moreover, the sample is also connected through the label to the important forms and registers. This in turn ensures that all the sample information is properly recorded.
  • Sample processing: review of requests by authorized personnel to decide which examinations must be performed.
  • Procedure for processing urgent samples.
  • Procedure for dealing with verbal requests (ensuring that all the relevant information is collected by filling-out a Request Form by the laboratory based on the verbal request).
  • Periodical review of required sample volumes: sometimes tests change and more or less sample material is needed. It must be prevented that too much sample material is taken (as this unnecessarily increases discomfort for the patient). Therefore the required volumes of samples must be reviewed regularly (once per year).
  • Procedure for sample rejection (a Sample Rejection Form will be developed in the next activity).


To start registering the samples a proper sample register must be made. This register must record all the relevant patient information and results of laboratory testing. This enables the possibility to verify the results and perform other quality controls. Include at least the following details:

  • Patient name + unique identifier (e.g. social security number (if applicable)/date and place of birth/etc.)
  • Patient laboratory ID
  • Contact details of the requester
  • Type of primary sample
  • Date of sample collection
  • Date of sample reception
  • Date of sample acceptance
  • Examination(s) requested
  • Results of examinations + name of the laboratory technologists performing the examinations
  • Date of reporting
  • Identification of person sending the report


A patient register can be maintained either on paper or electronically. It is strongly recommended to use an electronic system. The simplest electronic form is an Excel sheet. There are also many Laboratory Information System (LIS) software packages on the market. The advantage of using these systems is that they can give you a lot more control and oversight of performance of the laboratory and are more error-proof. Be careful in chosing which LIS you procure. A LIS should at least be able to:

  • Show you the results of all tests requested per patient; a combination of results may pinpoint characteristics of a specific disease which you would miss if you only see single results on specific tests
  • Give you easy oversight in historic dossiers of specific patients (showing you not only what has been requested now but also in the past which may give you important information of disease development
  • Easily assess the percentage of events in which the TAT was exceeded
  • Investigate the positivity rate for specific tests (this is a parameter that is highly important for surveillance of disease development or requester behavior)


In the right-hand column background information from the WHO Laboratory Quality Management System (LQMS) handbook is provided on sample processing and the patient register (called laboratory handbook in the LQMS handbook). For laboratories that chose a paper-based system: the WHO has published a manual called “Definitions and Reporting Framework for Tuberculosis”. This manual contains a template for tuberculosis laboratory registers in which already the most frequently used TB tests are included. It also provides a lot amount of background information on TB recording and reporting.


The International Union against Tuberculosis and Lung Disease also has published a guideline for bacteriology services in tuberculosis control. This guideline also contains templates for laboratory registers and forms especially for TB laboratories.

How & who

Quality Officer:

  1. Install a team with staff members that work most often in the sample reception and processing unit. Include the Laboratory Manager in this team for mandate to procure LIS software.
  2. Explain to them that the unit needs to be streamlined and that the procedures need to be standardized. Explain the reasons behind this as described above.
  3. Decide on the desired LIS. Keep in mind the required contents and functions as described above. When an appropriate LIS package has been identify; procure and install this system.
  4. Make an outline of the SOP for Sample Reception and Processing: discuss which procedures must be included in the SOP. You will play a supportive role by providing guidance to the colleague on how to write the SOP. He/she will create the content, you must put everything in Procedure SOP-format in accordance with the Master SOP.
  5. If certain procedures have to be introduced for the first time in the sample reception and processing unit it is important to formulate the outline of these procedures in consensus: develop and discuss the procedures with the whole team. This prevents confusion and disagreement and consequently reluctance to implement the procedures in a later stage.
  6. When the SOP is ready determine at which locations copies of the SOP must be available and indicate this on the SOP (to facilitate efficient and correct replacement of all copies when a new version of the SOP is printed).
  7. Include the SOP in a Read and Understand List and identify persons for which the SOP is relevant and who have to read and understand the SOP.
  8. Present the SOP to all staff members in a weekly staff meeting and explain which staff members have to read the SOP and that they must sign the Read and Understand List after reading.


Laboratory Manager:

  1. Assist in identifying a suitable LIS software package (identify funding if this is needed)
  2. Update the Authorization Matrix and job descriptions for the staff members who have received specific tasks in this activity and/or who have been authorized to perform certain activities (e.g.: reviewing Request Forms and deciding which examinations must be performed).
  3. Monitor the Read and Understand List to see if all assigned staff members have read the SOP for Sample Reception and Processing.


NOTE: When the SOP is reviewed according to the annual reviewing process of the document control system (established later in phase 2), the sample acceptance criteria in the SOP must also be reviewed. If a change in the sample requirements has occurred for a specific test, this change needs to be processed in the sample acceptance criteria. If for example a lower volume is needed for a specific test, the volume criteria need to be adapted. It is important that everyone is aware of these changes, so it is good to highlight them during the weekly staff meeting.

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This activity belongs to the QSE Process Management
ISO15189:2012: 5.4.6
ISO15190:2003: