CRL Mol Laboratory Risk Analysis Checklist

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

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

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