Instructions for Completion of the Oncology Request Form

1. Scope and Application

These guidelines provide information for the correct completion of the Oncology Request Form. This form is used by the pathologist requesting tests to be performed on diagnostic samples (paraffin blocks or paraffin slides) at HistoGeneX.

2. Abbreviations and definitions

  • FISH--Fluorescence in situ Hybridization
  • HER2--Human Epidermal Growth Factor Receptor 2
  • RIZIV--Rijksinstituut voor ziekte- en invaliditeitsverzekering
  • APPLICANT--The requesting pathologist

4. Responsibilities

It is the duty of the requesting pathologist to complete and sign the Oncology Request Form. A poor standard of completion of the form may represent a threat to the patient's treatment and health.

The sample reception team of HistoGeneX is responsible for reviewing whether or not the Oncology Request Form has been completed correctly. If data are lacking or whenever uncertainty exists on the identification of a sample, the sample reception team has the responsibility to contact the responsible HistoGeneX project manager who will subsequently contact the requesting pathologist (or pathology lab). The requested analyses will not be performed until all required information has been obtained. The sample reception team of HistoGeneX is responsible for correct entry of all data into the database.

5.1. Procedure: Minimum criteria

The minimum criteria for completion of the Oncology Request Form are:

  • Patient Family Name
  • Patient First Name
  • Patient Date of Birth
  • Applicant Family Name
  • Applicant First Name
  • Applicant Identification number (RIZIV Number)
  • Applicant Address
  • Date of Request
  • Applicant Signature
  • Applicant Fax Number
  • Local Sample Number
  • Local Block Number
  • Paraffin Block/Sections
  • Fixative used
  • Fixation time (when FISH testing is requested)
  • Date of tissue collection
  • Time of tissue collection
  • Tests Requested

Criteria described at (Infobox RIZIV. Wegwijzer voor degeneesheer-specialist, page 96 to 105.)

On the sample block and/or slides, at least one identifier (e.g. local block number) must be present matching the identifier(s) on the accompanying Oncology Request Form.

5.2. Completion of the Oncology Request Form

The Oncology Request Form must be completed using black or blue-black ink. A separate form must be used for each patient.

5.2.1. Patient Details - MANDATORY

If possible, the use of National Health Service patient labels is preferred. If not available, the following data must be provided: patient family name, patient first name and date of birth.

5.2.2. Applicant Details - MANDATORY

Family name, first name, identification number (RIZIV number) and address of the applicant must be provided. Alternatively, an identification stamp of the applicant can be used if the entry is signed to authenticate it. The contact coordinates (including e-mail address) of each applicant are included as drop-down menus in the database. This ensures that an e-mail will be sent to the applicant once the report becomes available on the customer portal of HistoGeneX. The applicant must date and sign the completed Oncology Request Form.

5.2.3. Tissue and Processing Information - MANDATORY

The local sample number is the block identifier assigned by the local pathology laboratory. The local block number is the subsample number (e.g. 1 to 20) assigned to the specific tissue subsample from that patient. The local sample number is identical for the different local block numbers of the samples procured from a single patient at a certain point in time. These identifiers are essential to link the tissue sample to the patient identifiers.

In addition, the sample type, being paraffin block(s) or paraffin section(s), the number of blocks and/or slides should be indicated to enable the HistoGeneX employees to check whether the shipment arrived in its entirety.

Information on fixation is mandatory and gives important information allowing for correct interpretation of test results: fixatives other than formalin (buffered neutral), such as those containing picric acid, may damage nucleic acids and may therefore cause invalid test results. Not only the type of fixation but also fixation time may influence test results. Ideally, samples should be fixed between 6 and 48 hours in neutral buffered formalin. It is important to inform HistoGeneX about over-fixed samples (e.g. weekend samples), because for some tests the slide pre-treatments are adapted accordingly.

Also information on date and time of tissue collection is mandatory and needs to be provided on the Oncology Request Form.

5.2.4. Tests Required - MANDATORY

The requested tests should be ticked off. Whenever HER2 FISH analysis is requested, the result of the HER2 IHC test should be ticked off.