procedure_to_establish_and_periodically_review_agreements

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procedure_to_establish_and_periodically_review_agreements [2025/09/22 12:15]
admin created 		procedure_to_establish_and_periodically_review_agreements [2025/09/22 12:30] (current)
admin [Amendment Log]
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-By this procedure, the laboratory  can ensure that your laboratory's request form is effective, efficient, and compliant with regulatory requirements.+**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 **Responsibility:** Laboratory director, Quality manager & Section Incharge
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 **Procedure:** **Procedure:**
  
-Draft the requisition form as per ISO 15189:2022 requirements.+  * 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.
  
-Format for Request form should include following information:+  * 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.
  
-  * Unequivocal traceability of the patient to the request and sample  +  * Schedule regular reviews of the request form every month or whenever change in laboratory procedures, policies, or regulations. 
-  * Name, Age, Gender,  MRD Number, +  * Review the request form for: 
-  * Identity and contact information of requester +      - Addition of any examination in the laboratory scope 
-  * Name or Signature of requester +      - To make any change in examination method 
-  * Ward / OPD  +      - Clarity and ease of use 
-  * Identification of the examination(s) requested +      - Completeness and relevance of information 
-  * Informed clinical and technical advice, and clinical interpretation can be provided. +      - Compliance with regulations and standards 
-  * Name & identification of Laboratory & Section of laboratory +   
-  * Type of sample, Site of collection if required for specific examination +  
-  * Sample collection date & time +  * Revise the request form as necessary. 
-  * Write all the examinations performed by the laboratory. If necessary  make different requisition forms for routine & special investigations. +  * Verify and validate the revised form. 
-  * 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.+  * 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.
  
-Ensure the request form is compliant with relevant regulations and standards (e.g., ISO 15189:2022) +  * Record: 
- +    - Format for Test Requisition Form 
-Review the draft with staff & management personnel. +    - Record of Review of service agreement
- +
-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 +
- +
-  - PATIENT INFORMATION +
-  - TIME +
-  - CLINICAL HISTORY +
-  - PROVISIONAL DIAGNOSIS +
-  - SAMPLE TYPE +
-  - CAUSE OF URGENCY +
-  - NAME AND SIGN OF DOCTOR +
-  - TEST IS WRITTEN SEPARATELY THOUGH IN TRF +
-  - UNIT/WARD IS WRITTEN IN OPD +
-  - SELECTION OF ROUTINE/URGENT +
-  - TEST REQUESTED WHICH IS NOT DONE IN LAB(PROLACTIN ) +
-  - TEST-Method REQUESTED WHICH IS NOT DONE IN LAB +
-  - RECEIVED BY +
-FOR LAB USE +
-  - STATUS AND TYPE OF SAMPLE +
-  - SAMPLE RECEIVING DATE AND TIME +
-    +
-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+
  
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