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Hematology & CP Laboratory Risk Analysis Checklist
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Risk Analysis Fishbone Diagram
Grading Key
Sample integrity and Presentation *
0
1
2
3
4
5
NA
Integrity of sample is monitored
Correctness of the sample tube is monitored
Volume in the tube is monitored
Sample type and request is counter checked
Sample Missing/damaged/lost is minimum
Operator Training and Capacity *
0
1
2
3
4
5
NA
All dept staff have induction training
Regular training is scheduled & conducted In the dept
All trainings are evaluated for efficacy
All staff are evaluated for performance once 6 months
All staffs competency is evaluated once in 6 months
Professional development programme for the faculty
Reagents *
0
1
2
3
4
5
NA
Reagents are transported to & received at appropriate temperatures
Sufficient storage for reagents and consumables
No expired reagents are being used.
Near expiry reagents are returned
Reagent /consumable inventory is proper
QC is properly stored, prepared and stored
Calibrators are properly stored, prepared and stored
Adequate inventory is maintained
Expired costly reagents are used only with appropriate authority and quality check
Environment *
0
1
2
3
4
5
NA
The testing area has access control
Testing is in a dust free environment
All testing area Room temperature and humidity is monitored
Fire related safety is maintained
Safety related training is regular to all dept staff
Water used is grade 1 with backup
Refrigerators & its compartments has proper temperature control
Reagent loss is minimum
All reagent loss has records
Measuring System *
0
1
2
3
4
5
NA
Earthing and power regularly monitored by company people
Software failure duration is minimum
Daily maintenance of equipments are up-to-date
Preventive maintenance are up-to-date
Equipment Calibrations are up-to-date
All equipment not under scope is marked
All equipment not under used is marked
All new additions of equipment has adequate documentation
IQ/OQ/PQ Available for all equipments
QC is verified after Equipment Calibrations and Preventive maintenance and Major breakdowns
Internal Quality Control - Department *
5 if Full Compliance; 4 if >80% Compliance; 3 if  >60% Compliance; 2 if >40% Compliance; 1if >20% Compliance; 0 if Non Compliance
0
1
2
3
4
5
NA
IQC processing and frequency
IQC Corrections
IQC RCA and CAPA
Split test processing
CV% of tests have a monthly evaluation
Proper documentation
External Quality Control - Department *
5 if Full Compliance; 4 if >80% Compliance; 3 if  >60% Compliance; 2 if >40% Compliance; 1if >20% Compliance; 0 if Non Compliance
0
1
2
3
4
5
NA
EQAS processing and frequency
EQAS pass scores
ILC Z score pass
Split test when EQA and ILC not available
All outliers has RCA & CAPA filed
EQAS Z score is recorded in NABL format and is monthly monitored
TAT *
5 if Full Compliance; 4 if >80% Compliance; 3 if  >60% Compliance; 2 if >40% Compliance; 1if >20% Compliance; 0 if Non Compliance
0
1
2
3
4
5
NA
TAT for the routine tests are monitored
TAT for outsourced tests are monitored
TAT for emergency tests are monitored
Critical test reports are reported as per protocol
Satisfaction score *
5 if  no issues, 1 if there are frequent issues
0
1
2
3
4
5
NA
Patients complaints and errors in OPD samples
Patients complaints and errors in IPD samples
Clinicians Complaints to department
Staff complaints to department
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