Purpose: By this procedure, the laboratory can ensure that your laboratory's request form is effective, efficient, and compliant with regulatory requirements.

Responsibility: Laboratory director, Quality manager & Section Incharge

Procedure:

• Draft the requisition form as per ISO 15189:2022 requirements.
• Format for Request form should include following information:
  1. Unequivocal traceability of the patient to the request and sample
  2. Name, Age, Gender, MRD Number,
  3. Identity and contact information of requester
  4. Name or Signature of requester
  5. Ward / OPD
  6. Identification of the examination(s) requested
  7. Informed clinical and technical advice, and clinical interpretation can be provided.
  8. Name & identification of Laboratory & Section of laboratory
  9. Type of sample, Site of collection if required for specific examination
  10. Sample collection date & time
  11. Write all the examinations performed by the laboratory.
  12. If necessary make different requisition forms for routine & special investigations.
  13. If a laboratory is performing any examination by different method or instruments, mention both method or instrument in requisition form so that users can select the required method or instrument.

• Ensure the request form is compliant with relevant regulations and standards (e.g., ISO 15189:2022)
• Review the draft with staff & management personnel.
• Approve and implement the request form.

• Schedule regular reviews of the request form every month or whenever change in laboratory procedures, policies, or regulations.
• Review the request form for:
  1. Addition of any examination in the laboratory scope
  2. To make any change in examination method
  3. Clarity and ease of use
  4. Completeness and relevance of information
  5. Compliance with regulations and standards

• Revise the request form as necessary.
• Verify and validate the revised form.
• Approve and implement the revised request form.
• Document and record the changes made to the form.
• Train laboratory staff on the proper use and completion of the request form.
• Maintain a record of the approved request form and its effective date.

• Record:
  1. Format for Test Requisition Form
  2. Record of Review of service agreement