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Specimen Rejection Record and Sop

The document outlines the Standard Operating Procedure (SOP) for maintaining specimen rejection records in clinical laboratories, emphasizing the importance of documenting rejected specimens and their reasons. It details the structure and content required for SOPs to ensure consistency and quality in laboratory practices. Additionally, it includes references to guidelines from ICMR, NIH, and WHO for good clinical laboratory practices.

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Tyagi Prashant
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2 views16 pages

Specimen Rejection Record and Sop

The document outlines the Standard Operating Procedure (SOP) for maintaining specimen rejection records in clinical laboratories, emphasizing the importance of documenting rejected specimens and their reasons. It details the structure and content required for SOPs to ensure consistency and quality in laboratory practices. Additionally, it includes references to guidelines from ICMR, NIH, and WHO for good clinical laboratory practices.

Uploaded by

Tyagi Prashant
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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School of Medical and Allied Sciences

Course Code : BML603 Course Name: Clinical Laboratory Practice

Module-II
SPECIMEN REJECTION
RECORD
STANDARD OPERATING
PROCEDURE

Name of the Faculty: P.Yashwanth Kumar


Program Name: B.Sc. MLT Mail: p.yashwanth@galgotiasuniversity.edu.in
• Practice how to setup the infrastructure of
laboratory and SOP needed in maintaining
laboratory personnel and equipments.

2
Learning Objectives
After completion of class student will be able to
• Explain infrastructure of Laboratory
• Maintenance of documents required for the
personnel working in the laboratory
• Explain documentation guidelines for the
maintenance of equipments .
• Demonstrate SOP practices
• Outline on laboratory formatts
SPECIMEN REJECTION RECORD

4
• Laboratories should maintain a record of
specimens which were rejected prior to
analysis. Rejection statistics (eg. number of
hemolyzed specimen etc.) along with reason
for rejection and person responsible for
rejection should be maintained
• Specimen rejection statistics can be used by
laboratories to identify the need and areas for
staff training.
5
Specimen Rejection record
• Refer Annexure-7 of ICMR(2008) guidelines for
good clinical laboratory practices.

6
STANDARD OPERATING
PROCEDURE (SOP)

7
• SOP is a document, which contains
detailed, written instructions describing the
stepwise process and technique of
performing a test or procedure in the
laboratory.
• Helps to ensure uniformity, consistency and
control over the processes carried out. It
ensures that the procedures are done in
exactly the same way each time
irrespective of the operator.

8
SOP should contain information on

• who can perform the test,


• their qualification and training,
• how to carry out the test including pre-analytical,
analytical and post-analytical stages of
test/procedure,
• laboratory conditions required for the test/
procedure,
• routine care and maintenance of equipment,
precautions
• safety instructions, trouble shooting measures,
• waste disposal and linkage with reference 9
• The procedure described in the SOP must be
followed exactly by all staff members to ensure
high quality results.
• It should be titled along with version number,
dated and signed by an authorized person and
updated regularly.
• It is important for the SOP document to be
readily available in the working area and is
therefore also referred to as 'laboratory bench
work manual'.
• SOPs are controlled documents and can be
changed only with approval of the laboratory10
Format of SOP

The header of SOP should display the following


information on all pages:
– • Title of SOP and Document number
– • Version number with dates of revision
– • Issue number and date of issue of the document
– • Page number/Number of pages

11
The text of SOP for test procedure should
contain information on:

• • Name of test
• • Author's name and approving authority
• • Scope of test
• • Principle of the test
• • Equipment and materials required
• • Detailed test procedure including type,
quantity and condition of specimen required;
sample processing and
preparation.Alternative procedure for test in
12
• Documentation of results including calculations
• • Limit of detection (Analytical sensitivity)
• • Analytical Measurement Range (AMR)
• • Reference range
• • Clinical significance, Inference and limitation of
the test
• • Critical alert values
• • References of test procedure
• • Precautions & Safety
• • Quality Control procedures
• • Specimen preservation and storage before
analysis and after analysis 13
Types of SOP include:
• Staff appointment, training, evaluation
• • Maintenance of laboratory conditions including
work space, lighting, ventilation, temperature
regulation, noise control, designated eating and
smoking area
• • Cleaning, sterilization & disinfecting procedures
• • Equipment care, operation, calibration,
validation and maintenance of equipment
• • Data Management
• • Precautions & Safety measures including 14
• Documentation of laboratory's reference
ranges
• Internal quality control procedures including
procedure for reporting abnormal test results
and corrective action procedure for quality
control outliers
• • Internal audit procedures
• • Participation in external quality assessment
programmes
15
References
• ICMR(2008) guidelines for good clinical
laboratory practices.
• NIH :DIADS guidelines for Good Clinical
Laboratory Practice Standerds,2011
• WHO : Good Clinical Laboratory Practice
(GCLP),2009

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