MUTHUMEENAKSHI HOSPITALS

MOLECULAR BIOLOGY
RISK ASSESSMENT DATA SHEET MMH/SOP/MB/
Page 1 of 6
RATING CRITERIA
SEVERITY RATING (S): PROBABILITY RATING (P) DETECTABILITY RATING (D) RPN (S×PD)
Rating Description Rating Description Rating Description Rating Description
1 Low No possible impact on 1 Extremel Highly improbable 1 High Control system in place has a >216 Critical
- Patient, Work process. - y low to occur - high probability of detecting
2 2 2 the defect or its effects
3 Moderate Possible impact 3 Low Improbable to 3 Moderate Control system in place could 40 to 216 Major
- - occur - detect the defect or its effects
4 4 4
5 High Probable impact 5 Moderate Probable to occur 5 Low Control system in place has a <40 Minor
- - - low probability of detecting
6 6 6 the defect or its effects
7 Critical Probable serious harm or 7 High Highly probable to 7 Non There is no control system to
- death; impact on work - occur - existent detect the defect
8 process. 8 8

RISK ANALYSISEFFECTIVE DATE: NEXT REVIEW DUE DATE :

Who is RP Preventive Measures
Process Prospective Impact/Potential N
Process affected S P D &Monitoring System required Responsibility
Stage Risk Failures (S×
By P×D) to reduce the risk
PRE- Test ordering/ Wrong information of Patient Reporting errors, 5 4 2 40 Re-verification of request and Receptionist
ANALYTICAL Registration patient age & Sex Report interpretation registered entry in Information
errors on reference system
ranges
Specimen Patient preparation Patient Result interpretation is 5 6 6 180 Training given to phlebotomist Phlebotomist
collection instructions not given affected. for providing patient preparation
instructions.

Patient preparation instructions

slips are provided to patients.
Wrong site of vein Patient Hematoma, 7 4 2 56 Trained & Experienced Phlebotomist
Specimen puncture Inadequate blood phlebotomist is made available.
collection volume, Junior staff are monitored by
Patient discomfort senior staff

MMH/MB/RADS

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 MUTHUMEENAKSHI HOSPITALS

MOLECULAR BIOLOGY
RISK ASSESSMENT DATA SHEET MMH/SOP/MB/
Page 2 of 6
RISK ANALYSISEFFECTIVE DATE: NEXT REVIEW DUE DATE :
Who is RP Preventive Measures
Process Prospective Impact/Potential N
Process affected S P D &Monitoring System required Responsibility
Stage Risk Failures (S×
By P×D) to reduce the risk
Collecting the wrong Patient Invalid for testing. 8 4 6 192 Sample Rejection Criteria was Phlebotomist
sample/Transferred in Report not in accurate kept placed in the respective
wrong tubes. department toavoid testing of
invalid samples.
Order of blood draw Patient Cross contamination of 6 6 6 216 Oder of blood draw chart is Phlebotomist
not followed additives between placed in appropriate primary
tubes. sample collection areas. Staffs are
oriented regarding Oder of blood
Measurement Errors draw process.
Specimen Sample mixing not Patient Clotting, 6 6 6 216
collection adhered Periodically verify the adherence
Erroneous test results of order of blood draw practices.
may be obtained when
the blood is not
thoroughly mixed with
the additive
Mislabeling/ failing to Patient Wrong report 8 4 2 64 Review of patient history for Phlebotomist
label the sample detection of any changes.
Less volume sample Patient Inadequate for testing 4 8 2 64 Sample Rejection Criteria was Phlebotomist
analysis. kept placed in the respective
department to avoid testing of
inadequate samples.
Collected in expired Patient Improper 8 4 2 64 First in first out practices is Phlebotomist
tubes anticoagulation, followed to prevent inadvertent
Reporting errors, use of expired tubes.

Verification on each batch of

vacutainer prior to use.

MMH/MB/RADS

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 MUTHUMEENAKSHI HOSPITALS

MOLECULAR BIOLOGY
RISK ASSESSMENT DATA SHEET MMH/SOP/MB/
Page 3 of 6
RISK ANALYSISEFFECTIVE DATE: NEXT REVIEW DUE DATE :
Who is RP Preventive Measures
Process Prospective Impact/Potential N
Process affected S P D &Monitoring System required Responsibility
Stage Risk Failures (S×
By P×D) to reduce the risk
Specimen Temperature Patient Affect on sample 6 6 4 144 Instructions are provided to Phlebotomist
transport conditions not integrity. sample collection facilities to
maintained transport with adequate Ice packs.

Samples are rejected if Laboratory

transported with inadequate Technicians
temperature/provided warning to
particular concerned to prevent
re-occurrence.
Patient Not able to perform 8 4 2 64 Samples are immediately corked. Phlebotomist
test. Samples are transported in
Sample spilled vertical manner with appropriate
accidentally rack.
Specimen Accepting invalid Patient Inability to perform test 6 4 2 48 Laboratory staff is trained to Lab Technician
Receipt samples avoid accepting the samples if not
meets with examination
requirements.

Rejection criteria are place at

every department at accession
area.
ANALYTICAL Sample Pippeting errors Patient Measurement Errors, 6 6 4 144 Micropipettes/Dispensers are Laboratory
Preparation Result variations. calibrated with NABL accredited technician
calibration providers for every 6
months.

Annual PPM will be done by the

In-house BME department.

Pipette positioning will be

adhered by the technical staff.

MMH/MB/RADS

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 MUTHUMEENAKSHI HOSPITALS

MOLECULAR BIOLOGY
RISK ASSESSMENT DATA SHEET MMH/SOP/MB/
Page 4 of 6
RISK ANALYSISEFFECTIVE DATE: NEXT REVIEW DUE DATE :
Who is RP Preventive Measures
Process Prospective Impact/Potential N
Process affected S P D &Monitoring System required Responsibility
Stage Risk Failures (S×
By P×D) to reduce the risk
Wrong labeling of Patient Reporting Errors 8 4 4 128 After labeling will be ensured Laboratory
samples with the requisition form. technician
Reagents not stored in Patient Stability problem, 6 2 2 24 Temperature conditions of storage Laboratory
appropriate Measurement Errors. devices are monitored with technician
temperatures calibrated digital temperature
indicators.
Using expired Patient Measurement Errors 8 2 2 32 Reagents are used within expiry Laboratory
reagents dates. Reconstituted reagents are technician
identified with open vial stability
as per manufacturer instructions.
Testing Reporting the result Patient Reporting 8 6 2 96 Patient samples are tested only if Laboratory
without identifying errors/deviations. the QC results fall within defined technician
QC out of range limits.
Result Not reviewed the Patient Problem in 8 4 2 64 Test requisition forms are ensured Authorized
review& patient history ( Not abnormality detection for written provisional diagnosis. Signatory
Interpretation provided the
provisional diagnosis
in test requisition)
Chemical Chemical Hazard Staff Respiratory problem, 4 4 4 64 MSDS are made available, All Lab Staff
Handing Eye splashes, Spill Hazard signages and its
interpretation was displayed.
Appropriate PPE are worn
POST Result Transcription errors Patient Wrong report, 8 4 4 128 All typed reports are rechecked Laboratory
ANALYTICAL reporting when preparing the Wrong Treatment by by another technician. Technician
report the referring doctor.

Incorrect result Patient Diagnosis for patient 8 2 4 64 All typed reports are rechecked Laboratory
reported treatment will be by another technician. Technician/
affected. Authorized
Signatory
MMH/MB/RADS

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 MUTHUMEENAKSHI HOSPITALS

MOLECULAR BIOLOGY
RISK ASSESSMENT DATA SHEET MMH/SOP/MB/
Page 5 of 6
RISK ANALYSISEFFECTIVE DATE: NEXT REVIEW DUE DATE :
Who is RP Preventive Measures
Process Prospective Impact/Potential N
Process affected S P D &Monitoring System required Responsibility
Stage Risk Failures (S×
By P×D) to reduce the risk
Test reported to wrong Patient Patient distress for 8 2 2 32 Patient details are verified with Receptionist
provider. receiving correct report the bill and issued the report.

Not immediately Patient Immediate treatment 8 4 2 64 Critical alert values are defined Laboratory
reported the gets affected. and displayed in respective Technician
Critical/Panic values department for immediate
reporting.
Specimen Sample storage Patient Integrity of sample 8 6 4 192 Samples are stored in Laboratory
Storage conditions not adhered affected. Measurement refrigerator/Freezer as per NABL Technician
Errors. guideline requirements.

Retesting of samples is Temperature conditions of storage

affected upon patient device are monitored twice a day
request for retesting. with calibrated temperature
monitoring probe.

Laboratory Failure or downtime Patient Inability to provide 8 4 4 128 Lab uses validated laboratory IT Department
Information in laboratory service to users within information management system
management information systems. defined Turn Around to prevent failures.
Time interval.
Periodic preventive maintenance
Treatment is affected of LIS is done by the IT Admin.
due to reporting
communication. Laboratory hasdocumented
POST contingency plan to face any
ANALYTICAL failure/downtime in laboratory
information systems.

MMH/MB/RADS

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 MUTHUMEENAKSHI HOSPITALS

MOLECULAR BIOLOGY
RISK ASSESSMENT DATA SHEET MMH/SOP/MB/
Page 6 of 6
RISK ANALYSISEFFECTIVE DATE: NEXT REVIEW DUE DATE :
Who is RP Preventive Measures
Process Prospective Impact/Potential N
Process affected S P D &Monitoring System required Responsibility
Stage Risk Failures (S×
By P×D) to reduce the risk
Biomedical Cross Contamination, Staff & Spill, Potential 6 6 4 144 Biomedical waste management Lab Staff &
waste Infection Spreading, Environ infection spreading chart was followed. PPE are worn Housekeeping
disposal Health Problem, Not ment by house keeping staff. staff
POST Biomedical waste are disposing
safe to environment
ANALYTICAL with TNPCB licensed Biomedical
waste disposal agency
Staff Potential to get Laborato Infection to Serological 6 6 6 216 All staff are immunized with Quality
Immunization infected by Hepatitis ry diseases ( Hepatitis B) hepatitis B Vaccine. Manager
B Vaccine working
Staff & Titre Value will be periodically
Staff verified.
handling
biologic Any new staff introduced to the
al lab will get vaccinated.
samples

PREPARED BY: Quality Manager REVIEWED & APPROVED BY: Lab Director

MMH/MB/RADS

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