INTRODUCTION TO QUALITY MANAGEMENT SYSTEM IN HISTOPATHOLOGY LABORATORY- PART 4

DOCUMENTS AND RECORDS

Documents and records lay the foundation for information obtained in the laboratory therefore, information management and documents/records interwoven. 

Documents are written policies, processes and procedures which lay the foundation for all activities in the histopathology laboratory.  They include:

1.      Histopathology Laboratory Handbook

2.      SOP manual

3.      Safety manual

4.      Histopathology Laboratory policy manual

5.      Histopathology laboratory quality management system guidelines etc Documents could be updated/reviewed hence are subject to changes.

Records on the other hand are data generated in the laboratory in the course of performing histopathology laboratory activities.  Such records include:

1*   Histology day register

2* Cut –up register

3*   Decal register

4*   Post mortem register

5*     Processing register

6*  Sectioning register

7* Special stain register

8*     H&E register/Dispatch register

9*     Immuno register

1*.  Histology request form

11.  Special stain request form

12.  Immuno request form etc

Records are not subject to changes and are therefore permanent. 

Documents and records must be accessible to users at all times for consistent results and assessment

OCURRENCE MANAGEMENT

According to the WHO QMS guidelines, occurrence is ‘any event that has a negative impact on an organization, including its personnel, products of the organization, equipments or the environment in which it operates.

The occurrence management system detect errors, correct the errors and also put measures in place to prevent future occurrence.Errors are more likely and preponderant in the pre-analytic (41%) and post-analytic (55%) than in the analytic phase (4%) (CDC report).

Pre-examination errors include wrong/inadequate sample collection, unfixed/improperly fixed specimen, mislabeling/wrong/insufficient patient’s detail, improper storage or specimens and reagents. 

Analytical errors include, non usage of SOP, non usage of control blocks, mislabeling of blocks, sample mix-up, reagent mix-up, and expired reagents.

Post examination errors include, transcription error, illegible handwriting, wrong dispatch/loss of report and non availability of report.

Problems arise in the histopathology laboratory from time to time.  These errors should be investigated, corrected and prevented.

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