Quality Indicator of Cytopathology

1) 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.

2) External Quality Assessment:

Two cycles of cytopathology EQA is received within a year with minimum two participants of cytopathology section. Cases of Cytology EQAS include fine needle aspiration (FNA), fluid cytology and gynecology cytology. Feedback report for each participant is evaluated annually. More than 70% score indicate satisfactory performance. More than 80% (concordant diagnosis) are considered good and more than 90% are considered excellent score.

3) Internal Quality Control:

Monthly one case, each of FNA, Fluid cytology and gynecology cytology is randomly selected for examination by another authorized faculty of other section of the department. Findings of both are recorded and records are monitored annually. More than 90% concordant diagnosis/findings are considered as satisfactory.

Staining quality for cytopathology slides is validated daily and records are maintained annually. 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.

4) Cyto-histo Correlation:

Procedure for Cyto-histo correlation has been established by the laboratory. The records of same are monitored monthly and annually.

5) Turn around time(TAT):

Turn around time of the cytopathology reports for indoor, outdoor cases and gynecology cytology 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. Out of TAT if <5%, is considered satisfactory.

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 FNA, fluid cytology, gynecology cytology, intraoperative cytology, USG guided (or CT guided FNA) and special stains 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 occur are recorded in the register with appropriate action taken report and data are monitored annually.

10) ASCUS:SIL ratio

Ratio is calculated annually and record of which is documented.

11) Re-screening of previously reported slides on receiving fresh samples/smears from the same patient, during follow up.

Cytopathology Laboratory
QUALITY INDICATORS FOR CONTINUAL IMPROVEMENT
PRE ANALYTICAL
Any discrepancy in patient details mentioned on request form & on sample container	<1% of total sample received
Inadequate quantity of fluid samples
ANALYTICAL
EQAS	More than 70% score indicate satisfactory performance. More than 80% (concordant diagnosis) are considered good and more than 90% are considered excellent score.
IQC records	More than or equal to 80% concordant diagnosis/ findings are considered as satisfactory
ASCUS:SIL ratio for Gynecology PAP smear	Less than 3:1
POST ANALYTICAL
TAT records	Outliers should be <5% of total samples recieved
Others
External and Internal Audit	Audit records are evaluated annually and every attempt is made to prevent those non-conformities again
Feedback records	Appropriate corrective or protective actions are taken care of at the earliest.
Incident/Accident records	Appropriate action are taken care of at the earliest.