procedure_to_establish_and_periodically_review_agreements [LSSTH - Laboratory Services Sir T Hospital, Bhavnagar]

This page is read only. You can view the source, but not change it. Ask your administrator if you think this is wrong.
===== Laboratory Services Sir T Hospital, Bhavnagar =====

=====Procedure to establish and periodically review agreements ===== 
^Name^Unique ID^Edition^Date of Edition^
|Procedure to establish and periodically review agreements |LSSTH/B/Central/DP/6.7.1/28 1 | 01-03-2023|   
 
^Preparing authority^Approving authority^Review period^Review Date^
|All teaching staff|Quality Manager|2 year|10/09/2025|


|**Printed copy of this document is considered uncontrolled.** It should be compared with controlled electronic copy before use|

=====Amendment Log=====
^Sr. No^ Date of Amendment^ Page & Clause Number of Amendment^ Amendment detail^ Reason for Amendment^
|1 | |


**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:
    - Unequivocal traceability of the patient to the request and sample 
    - Name, Age, Gender,  MRD Number,
    - Identity and contact information of requester
    - Name or Signature of requester
    - Ward / OPD 
    - Identification of the examination(s) requested
    - Informed clinical and technical advice, and clinical interpretation can be provided.
    - Name & identification of Laboratory & Section of laboratory
    - Type of sample, Site of collection if required for specific examination
    - Sample collection date & time
    - Write all the examinations performed by the laboratory. 
    - If necessary  make different requisition forms for routine & special investigations.
    - 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:
      - Addition of any examination in the laboratory scope
      - To make any change in examination method
      - Clarity and ease of use
      - Completeness and relevance of information
      - 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:
    - Format for Test Requisition Form
    - Record of Review of service agreement