Quality Indicator of Histopathology

1) Pre-analytical Internal Quality Control (IQC)

• Staining quality for histopathology slides is validated daily and records are maintained.
• &Microtomy quality for thickness of histopathology section is validated 2 times in a month and records are maintained.
• Appropriate remarks are documented and records are monitored monthly.
• Lot validation of every reagent is done and records of which is maintained. Records are monitored annually.
• All Records are retained for a period of one year

2) External and Internal Audit:

• Records of external and internal audit are maintained in the laboratory with documents of the corrective actions taken.
• Audit records are evaluated annually and every attempt is made to prevent those non-conformities again.

3) External Quality Assessment:

• Four cycles of histopathology EQAS is received within a year. Cases of histopathology EQAS includes a tissue for processing and analysis and virtual slides images. Feedback report for each participant is evaluated with each cycle. A final report of tissue processing analysis is given as a preanalytic scoring.
• Out of 5 score, less than 3 score requires attention by the laboratory. Repeat training is given to the respective technician in the area of poor score in pre-analytic assessment. Which is followed by evaluation of section quality. To consider satisfactory performance of virtual slides, the diagnosis should fall into concordant diagnosis by majority of the participants.
• Inter-laboratory quality assurance is done for Reticulin, Pas and ZN Stain every 6 monthly under a memorandum of understanding with an external laboratory (Unipath).
• All EQAS records are maintained in File-EQAS records. Documents are retained for one year or till next assessment, whichever is later.

4) Internal Quality Control:

• Monthly one case, each from routine histopathology and frozen section is randomly selected for examination by another authorized faculty from other section of the department. Findings of examination by both faculties are recorded and records are monitored annually.
• 6 monthly inter-observer comparison is done for all special stains.
• More than 80% concordant diagnosis/findings are considered as satisfactory.

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5) Turnaround time (TAT):

• Turnaround time of the histopathology reports for indoor, outdoor cases has been established. In case of delayed report, appropriate remarks are made in TAT register.
• Percentage of out of TAT reports is counted month wise and records are maintained in TAT register. <15 % out of TAT records are acceptable.

6) Number of request received:

• Number of request by clinicians is recorded on daily, monthly and yearly basis. Details of sample/case details are mentioned in receiving register with appropriate remarks if any. All the data and receiving records including frozen section, review slides and IHC are monitored monthly and annually.

7) Competency evaluation of laboratory staff:

• Laboratory staff is properly trained for the work for which they are authorized. The monitoring of work performance and competency evaluation are done once in a year and records are maintained. Whenever required appropriate remarks are generated and staff is retrained for the same.

8) Feedback records:

• Laboratory has established policy of taking feedback by clinician, patient or laboratory staff. Appropriate corrective or protective actions are taken care of at the earliest. All the records are maintained in feedback records and monitored annually.

9) Incident/Accident records:

• Any incident or accident related to laboratory procedures when happened are recorded in the register with appropriate action taken report and data are monitored annually.