Risk Evaluation

Overview

The nPOC-BB was originally developed at GHL as the front-end of a prototype diagnostic test system called NAATOS. Therefore, the design inputs for the nPOC-BB are a subset of the design inputs for NAATOS, and the Risk Evaluation for the nPOC-BB is excerpted from the larger NAATOS Risk Evaluation.

You can also download a tabular version of this Risk Evaluation Table in the *.csv format.

Lookup Matrices

Probability

P1 (Probability of the Hazardous Situation Occurring) × P2 (Probability of the Hazardous Situation Leading to Harm) = Probability

P1 \ P2	1 - Improbable	2 - Remote	3 - Occasional	4 - Probable	5 - Frequent
1 - Improbable	1 - Improbable	1 - Improbable	2 - Remote	2 - Remote	3 - Occasional
2 - Remote	1 - Improbable	2 - Remote	2 - Remote	3 - Occasional	3 - Occasional
3 - Occasional	2 - Remote	2 - Remote	3 - Occasional	4 - Probable	4 - Probable
4 - Probable	2 - Remote	3 - Occasional	4 - Probable	4 - Probable	5 - Frequent
5 - Frequent	3 - Occasional	3 - Occasional	4 - Probable	5 - Frequent	5 - Frequent

Risk Level

S (Severity) × P (Probability) = Risk Level

P \ S	1 - Negligible	2 - Minor	3 - Serious	4 - Critical	5 - Catastrophic
1 - Improbable	Low	Low	Low	Low	Medium
2 - Remote	Low	Low	Medium	Medium	Medium
3 - Occasional	Low	Medium	Medium	Medium	High
4 - Probable	Low	Medium	Medium	High	High
5 - Frequent	Medium	Medium	High	High	High

Risk Evaluation Table

Name	Sequence of Events	Hazardous Situation	Harm	Severity	P1 (Probability of the Hazardous Situation Occurring)	P2 (Probability of the Hazardous Situation Leading to Harm)	Ptotal = P1 x P2	Initial Risk Level	Initial Risk Acceptability
SCC contaminates environment with sample	SCC collects sample from an infectious patient SCC touches objects in environment before transfer into STC or handle touches objects in environment after separation from head in STC	Person exposed to sample	Disease transmission	3 - Serious	2 - Remote	3 - Occasional	2 - Remote	Medium	Unacceptable
SCC is reused	SCC collects sample from an infectious patient SCC collects sample from a different patient	Person exposed to sample	Disease transmission	3 - Serious	1 - Improbable	5 - Frequent	3 - Occasional	Medium	Unacceptable
STC contaminates environment with sample	SCC collects sample from an infectious patient SCC transfers sample into STC STC spills sample onto workspace or person	Person exposed to sample	Disease transmission	3 - Serious	2 - Remote	3 - Occasional	2 - Remote	Medium	Unacceptable
STC is reused	STC with remnants of sample from an infectious patient is re-opened	Person exposed to sample	Disease transmission	3 - Serious	1 - Improbable	1 - Improbable	1 - Improbable	Low	Acceptable
SPM contaminates environment with sample	a. SPM containment fails during operation or b. STC containment fails inside SPM during operation SPM shakes infectious sample into the environment	Person exposed to sample	Disease transmission	3 - Serious	2 - Remote	4 - Probable	3 - Occasional	Medium	Unacceptable
SPM does not inactivate sample	a. SPM is mis-calibrated or b. SPM software fails or 1c. SPM electronics fail SPM appears to heat and shake but fails to inactivate sample in STC STC allows transfer of infectious sample to person	Person exposed to sample	Disease transmission	3 - Serious	1 - Improbable	2 - Remote	1 - Improbable	Low	Acceptable
SCC is contaminated with manufacturing chemicals	SCC is contaminated with chemicals during manufacture SCC is used to collect sample from person and transfers chemicals to sampling site on person	Patient exposed to chemicals	Toxicity	3 - Serious	1 - Improbable	2 - Remote	1 - Improbable	Low	Acceptable
SCC is contaminated by environment	SCC collects MTb from the environment SCC is used to collect a negative sample	Patient receives false positive result	Incorrect diagnosis	3 - Serious	1 - Improbable	4 - Probable	2 - Remote	Medium	Unacceptable
SCC is never added to STC	SCC is never added to STC	Patient receives false negative result	Incorrect diagnosis	4 - Critical	1 - Improbable	4 - Probable	2 - Remote	Medium	Unacceptable
STC is contaminated by environment	STC collects MTb from the environment STC is used to process a negative sample	Patient receives false positive result	Incorrect diagnosis	3 - Serious	1 - Improbable	4 - Probable	2 - Remote	Medium	Unacceptable
STC is opened and left exposed to environment	STC is left open until liquid reagents evaporate	Operator obtains invalid result	Delayed diagnosis	1 - Negligible	1 - Improbable	3 - Occasional	2 - Remote	Low	Acceptable
STC is removed from SPM during operation	STC with positive sample is removed early from SPM STC transfers insufficiently lysed sample to TC TC fails to amplify insufficiently lysed sample	Patient receives false negative result	Incorrect diagnosis	4 - Critical	1 - Improbable	3 - Occasional	2 - Remote	Medium	Unacceptable
STC sample transfer into TC introduces air bubbles	STC sample transfer introduces air bubbles into TC TC fails fluidically because of bubbles	Operator obtains invalid result	Delayed diagnosis	1 - Negligible	2 - Remote	2 - Remote	2 - Remote	Low	Acceptable
STC sample transfer into TC is delayed	STC sample transfer of a positive sample into TC is delayed STC sample degrades TC fails to amplify degraded positive sample	Patient receives false negative result	Incorrect diagnosis	4 - Critical	1 - Improbable	2 - Remote	1 - Improbable	Low	Acceptable
STC sample transfer into TC leaks	STC sample transfer into TC leaks TC fails fluidically because of insufficient fluid volume	Operator obtains invalid result	Delayed diagnosis	1 - Negligible	1 - Improbable	3 - Occasional	2 - Remote	Low	Acceptable
STC leaks fluid into SPM	STC leaks while in SPM SPM electronics are shorted by leaking fluid and catch fire	Operator exposed to fire	Burn	3 - Serious	1 - Improbable	2 - Remote	1 - Improbable	Low	Acceptable
SPM batteries overcharge	SPM batteries overcharge, heat up, and catch fire	Operator exposed to fire	Burn	3 - Serious	1 - Improbable	4 - Probable	2 - Remote	Medium	Unacceptable
SPM batteries over-discharge	SPM batteries over-discharge SPM can no longer hold a charge	Operator unable to use SPM	Delayed diagnosis	1 - Negligible	1 - Improbable	4 - Probable	2 - Remote	Low	Acceptable
SPM electrical components fail	SPM electrical component is of insufficient quality and fails	Operator unable to use SPM	Delayed diagnosis	1 - Negligible	1 - Improbable	5 - Frequent	3 - Occasional	Low	Acceptable
SPM experiences electrostatic discharge	SPM is touched by person carrying electrostatic charge SPM electronics are damaged by resulting discharge	Operator unable to use SPM	Delayed diagnosis	1 - Negligible	1 - Improbable	5 - Frequent	3 - Occasional	Low	Acceptable
SPM experiences electrical interference	SPM experiences hardware failure due to voltage and electrical noise caused by nearby EM waves	Operator unable to use SPM	Delayed diagnosis	1 - Negligible	1 - Improbable	5 - Frequent	3 - Occasional	Low	Acceptable
SPM is dropped and breakage exposes electrical circuits	SPM is dropped and breakage exposes electrical circuits	Operator exposed to electricity	Electrical shock	2 - Minor	2 - Remote	2 - Remote	2 - Remote	Low	Acceptable
SPM is plugged in to faulty power supply	SPM is plugged in to faulty power supply SPM electronics overdraw current and catch fire	Operator exposed to fire	Burn	3 - Serious	1 - Improbable	2 - Remote	1 - Improbable	Low	Acceptable
SPM is unplugged during operation on insufficient battery charge	SPM is unplugged during operation on insufficient battery charge SPM dies during STC operation STC contains a positive sample that is insufficiently lysed	Patient receives false negative result	Incorrect diagnosis	4 - Critical	1 - Improbable	5 - Frequent	3 - Occasional	Medium	Unacceptable
SPM placed near magnetic field	SPM is placed near magnetic field that triggers lid sensor while lid is open SPM shakes while exposed	Operator exposed to moving parts	Physical trauma	2 - Minor	1 - Improbable	3 - Occasional	2 - Remote	Low	Acceptable
SPM wires are exposed	SPM internal wiring or power cord insulation breaks down SPM exposed wiring energizes ungrounded enclosure SPM enclosure is touched	Operator exposed to electricity	Electrical shock	2 - Minor	1 - Improbable	2 - Remote	1 - Improbable	Low	Acceptable
PM is dropped on person	PM is dropped on person	Person hit by PM	Physical trauma	2 - Minor	1 - Improbable	3 - Occasional	2 - Remote	Low	Acceptable
PM magnetic closure pinches	PM lid is closed on fingers and magnetic closure causes pinch	Operator pinches fingers	Physical trauma	2 - Minor	2 - Remote	2 - Remote	2 - Remote	Low	Acceptable
SPM connector fails during shaking	SPM connecter fails mechanically SPM is unusable	Operator unable to use SPM	Delayed diagnosis	1 - Negligible	1 - Improbable	5 - Frequent	3 - Occasional	Low	Acceptable
SPM is dropped on person	SPM is dropped on person	Person hit by PM	Physical trauma	2 - Minor	1 - Improbable	3 - Occasional	2 - Remote	Low	Acceptable
SPM loses control of shaker	SPM shaker control fails SPM shakes even when lid is open	Operator exposed to moving parts	Physical trauma	2 - Minor	1 - Improbable	3 - Occasional	2 - Remote	Low	Acceptable
SPM observation window breaks	SPM observation window breaks	Operator exposed to moving/sharp parts	Physical trauma	2 - Minor	1 - Improbable	2 - Remote	1 - Improbable	Low	Acceptable
SPM magnetic closure pinches	SPM lid is closed on fingers and magnetic closure causes pinch	Operator pinches fingers	Physical trauma	2 - Minor	2 - Remote	2 - Remote	2 - Remote	Low	Acceptable
SPM shakes while open	SPM fails to stop shaking when lid is opened	Operator exposed to moving parts	Physical trauma	2 - Minor	1 - Improbable	2 - Remote	1 - Improbable	Low	Acceptable
SPM vibrates off of surface during shaking	SPM vibrates off surface during shaking and falls on a person	Person hit by PM	Physical trauma	2 - Minor	2 - Remote	3 - Occasional	2 - Remote	Low	Acceptable
System damaged by shipping	System is inadequately packed and is unusable at customer site	Operator unable to use system	Delayed diagnosis	1 - Negligible	1 - Improbable	5 - Frequent	3 - Occasional	Low	Acceptable
STC melts during heating in SPM	STC is operated in SPM STC melts onto electronics, and they catch fire	Operator exposed to fire	Burn	3 - Serious	1 - Improbable	2 - Remote	1 - Improbable	Low	Acceptable
SPM loses control of heater	SPM heater control fails SPM heats uncontrollably until it catches fire	Operator exposed to fire	Burn	3 - Serious	1 - Improbable	2 - Remote	1 - Improbable	Low	Acceptable