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

Operator Training and Capacity *

0

1

2

3

4

5

NA

All staff have induction training

Regular training is scheduled & conducted

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 shipped & received at appropriate temperatures

Sufficient storage for reagents and consumables

No expired reagents are 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

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

Electricity is UPS with backup-monitored

Water used is grade 1 with backup

Refrigerators has proper temperature control

Reagent loss is minimum

Measuring System *

0

1

2

3

4

5

NA

Earthing and power regularly monitored

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

Internal Quality Control - Biochemistry *

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 monthly evaluation

Proper documentation

Internal Quality Control - Pathology, Hematology & Clin Path *

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 monthly evaluation

Proper documentation

Internal Quality Control - Microbiology *

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 monthly evaluation

Proper documentation

External Quality Control - Biochemistry *

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

External Quality Control - Pathology, hematology and clin path *

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 procesing and frequenncy

EQAS pass scores

ILC Z score pass

External Quality Control - Microbiology *

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 procesing and frequenncy

EQAS pass scores

ILC Z score pass

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 >95% ; 4 if >80% ; 3 if >60% ; 2 if >40% ; 1if >20% ; 0 if <10%

0

1

2

3

4

5

NA

Patients OPD

Patients IPD

Clinicians

Staff