64 Apollo Medicine, Vol.1, September 2004

FMEA (Failure Mode and Effects Analysis) is a proactive tool,technique and quality method that enables the identificationand prevention of process or product failures before theyoccur. It is a systematic approach of addressing what could failin the process, why it might fail, how badly it might fail, howfrequently it might fail, and how it can be made safer.

FMEA VIS-A-VIS ROOT CAUSE ANALYSIS

Root Cause analysis is identifying the causes of failure andcorrecting it after the failure has happened. Root causeanalysis is reactive because it is conducted after the incidenthas occurred. While FMEA is proactive because it is designedto prevent an incident from happening.

HEALTHCARE AND FMEA

“To err is human”. Healthcare industry is human resourceintensive and the impact of errors within the healthcare systemon human life and organization is tremendous.

So the FMEA approach aims at the very first placeavoiding adverse events that could potentially cause harm topatients, families, employees or others in the healthcareset up.

THE FMEA ROADMAP

The steps- 4 A’s involved in implementation of FMEA are:• Step 1: Analyze the current process: Study the

current process and detail out each step of theprocess.

• Step 2: Anticipate the failure modes and the causes offailure at each step.

• Step 3: Assess priority that is high-risk areas: Evaluateseverity of the failure (how badly it might fail),probability of failure and probability of detectionof failure.Severity, probability of failure and probability ofdetection are rated on the scale of 1 to 10.

Quality in Health

FAILURE MODE EFFECT ANALYSIS IN HEALTHCARE - PREVENTING AN ERRORBEFORE ANY HARM IS DONE

Umesh Gupta, Manisha Chugh+, Anupama Sharma*, Anjula Bansal# and Neha Jain#

From the Consultant in Vascular Surgery, Team leader-JCI DICE+, DICE+ Executive, DICE* Residents,DICE, Indraprastha Apollo Hospitals, Sarita Vihar, New Delhi -110044, India.

Correspondence to: Dr. Umesh Gupta, Consultant in Vascular Surgery, Indraprastha Apollo Hospitals,Sarita Vihar, New Delhi -110044, India.

E-mail:uhgupta@hotmail.com

Key words: Failure mode effect analysis, Healthcare, Medication errors.

Severity-1 indicates no effect on the system; Severity -10indicates highly hazardous to the system. Probability ofFailure-1 indicates that failure is extremely unlikely; while10indicates that failure is bound to happen. Probability ofdetection-1 indicates that current control measures woulddetect the failure before it happens; while 10 indicates thatfailure with current control measures cannot be detected.Calculate priority (RPN: Risk priority no.) on the basis ofabove. RPN = severity* probability of likelihood of failure*probability of detection.

• Step 4: Action: Focus on high risk areas that is areas withhigh RPN. Make an action plan, formulateimprovement strategies to eliminate or reducerisk to the process. Assign responsibility andtime frame of implementation to the relevantstaff.

CHALLENGES IN IMPLEMENTATION OF FMEA

• Implementation of FMEA is time consuming: Cost of errorcan be very high in terms of image of the hospital, time andmoney. So the management should be sensitized to investtime at the outset of the process to avoid harm later to thepatients and organization. FMEA can be implemented oncritical and high-risk processes only.

• Reluctant Staff: FMEA team should insist that the conceptis totally blame free. Rewards and incentives shouldbe there to involve the staff. The FMEA team shouldnot let the concept become the month’s flavor and fizzleout.

Case Study

A proactive risk assessment of medication process atIndraprastha Apollo hospital. As a part of constant endeavorfor a safe environment of patients, Indraprastha ApolloHospital applied FMEA on the medication process to controlmedication errors.

65 Apollo Medicine, Vol.1, September 2004

Quality in Health

Start

Nurse ties Patient Id band having Unique Reg. no. on thept's wrist. Nurse ties Allergy band on the patient's wrist ifthe patient is allergic.

Resident writes history in the case file.

Dr. prescribes medication/gives verbal orders, which is transcribed by Resident. Drug is mentioned in the drug chart. Dose,Frequency, sp. instructions are written in separate columns against the drug.

Orders/Indent entered by nurse by selecting pre existing list in the system.

A pharmacist at the stores receives indents. The indents are distributed. among operators for billing & issuing. The operatorgets to know the QOH by the system. The bill is printed .It carries the batch and expiry date (Issued in FIFO manner)

The staff in the dispatch section rechecks the drug. The drug is sent to the ward through the helper. The nurse receives thedrug. Acknowledgement of receipt is mentioned on the dispatch register.

Nurse looks for medication at the administration time. Nurse marks the administration times in the drug chart. Nurse locatesmedication

Nurse assesses 5 R’s: Right Patient, Right Time, Right Route, Right Medicine, and Right Dose.Nurse prepares medication

Another nurse accompanies for administration. Nurse Rechecks 5 Rs at bedside.

• Step 1: Analyze current process.

Nurse documents medication administration. Monitors and documents for adverse reaction and effectiveness.

The bill and original indent is given to pharmacist for physically issuing the drug. The pharmacist withdraws drug from theshelf and further the container labeled with medicine name. The drug withdrawn is packed & a label of batch, expiry date andbed no. is stuck on the medicine

Apollo Medicine, Vol.1, September 2004 66

Quality in Health

Potential Failure Modes Potential effects of Severity Probability Probability RPNfailures of of

detection detection

PrescriptionNo history, No old record Adverse Drug Reaction 10 2 2 40No HIS support: Allergy, drug interaction alerts Allergy, 9 2 2 36non existent in the system Adverse Drug Reaction

Allergy not highlighted on the case sheet Allergy, 10 5 3 150Adverse Drug Reaction

Formulary not there Wrong Drug 9 2 1 18Dr. prescribes non-formulary drug, which isbanned by hospital drugs committee for clinicalreasons.

Formulary not there Delay 5 5 5 125Dr. prescribes non-formulary drug, pharmacyhas to procure the drug

Illegible Entry, Non Standard Abbreviation used Wrong Drug 10 3 7 210- clarification not done Wrong Dose

Frequency, RouteWrong Time

Illegible Entry Non Standard Abbreviation used Delay 4 3 7 84-clarification done.

Time-High patient load, No time to verify the Wrong Drugorders transcribed by Resident Wrong Time 10 2 6 120

Indent/Order Entry

HIS facilities-Availability of a particular Delay 5 3 7 126dug/brand not known at the ward, but stillindented leading to delay.

Time of Indent-No fixed time for sending Delay 5 7 8 280regular/ongoing indents. As a result there is avery irregular and unpredictable inflow ofworkload at pharmacy leading to delays whenthere are high volumes of indents.

Time of Indent-Drugs indented only for 24 hrs Delay 5 3 8 120leading to high number of transactions betweenward and stores and hence more chances of delay.

Time of Indent (As above 2 points) leading to Wrong Drug 10 2 5 100heavy volume of workload and hence issuing ofwrong drug

Education and Experience-Lack of knowledge, Wrong Drug 10 2 3 60new to specialty, new to system Wrong Patient

Wrong Time

• Step 2: Anticipate the failure modes and the causes of failure at each step.• Step 3: Assess priority - Evaluate severity of the failure (how badly it might fail), probability of failure and probability of

detection of failure. Calculate priority (Risk priority no.) on the basis of above. RPN= severity* probability oflikelihood of failure* probability of detection.

67 Apollo Medicine, Vol.1, September 2004

Quality in Health

Potential Failure Modes Potential effects of Severity Probability Probability RPNfailures of of

detection detection

Time-Patient Load, multiple priorities, volumes Wrong Drug 10 2 3 60of medicines, Physician inaccessibility Wrong Patient

Wrong Time

Supply of Drugs

Time-High volumes of indents, so the pharmacist Wrong Patient 10 3 2 60has no time to clinically evaluate the validity of WrongDrugdrug.

Containers not labeled with medicine name, Wrong Drug 10 1 1 10strength Wrong Strength

Look alike drugs not highlighted. Wrong Drug 10 2 5 100

Operator having less knowledge of substitutes Wrong Drug 10 5 2 100and drugs issuing the drug in the system

Medicines not issued in earliest expiry fashion. Expired Drug Issued 10 2 5 100

Containers not labeled expiry date. Expired Drug Issued 10 2 6 120

Administration of drug

Education-Lack of knowledge/new drug Wrong Drug Wrong Dose 10 4 5 200Experience-New grad/New to specialty, New to Wrong Mode Wrong Patientsystem Wrong Time

Time- Multiple Priorities Wrong Drug; Wrong Dose 10 2 6 80Volumes of medicines Wrong Mode; Wrong PatientPatient loads Wrong Time

Communication-Unclear Parameters and Wrong Drug; Wrong Dose 10 2 5Physician inaccessibility, Nurse to nurse, Wrong Mode; Wrong Timenurse to patient

No space for preparation of medication Contamination 9 3 6 162

Patient Id band not tied Wrong Patient

Patient allergy band not tied Administration of 10 4 2 80drug patient is allergic to

Failure of Lab System Adverse reaction; 10 1 5 50Wrong decision about care

• Step 4: Action: Focus on high-risk areas i.e., areas with high RPN. Action plan, improvement strategies.

Recommended Actions

Prescription

System should support drug allergy alerts, drug interaction alerts etc.

Report of patients prescribed antibiotics; narcotics beyond maximum range should be generated in the system and should beavailable to drugs committee.

Allergy and Adverse Drug reaction should be highlighted on the cover of case file to bring to attention of any Dr. prescribingthe drug.

Apollo Medicine, Vol.1, September 2004 68

Quality in Health

Formulary should be circulated to all Drs. and Drs. should try and prescribe drug from the formulary only.

Indent/Order Entry

To regulate the inflow, there should be a particular slot of the day when regular indents (non emergency) should be sent to thepharmacy from the wards. More staff in the shift can man that slot. And rest of the day, the emergency, new admissions andnew orders indents can be catered to.

Also, for the ongoing/regular indents, the drug should be indented for 48 hrs rather than 24 hrs. This is to decrease the numberof transactions between store and ward to increase efficiency and timely availability

System should support drug allergy alerts, drug interaction alerts etc while indenting the drug in the system.

Supply of Drug

Look alike drugs should be highlighted with separate label

The operator should be able to see only relevant substitutes against the drug indented.

System should support earliest expiry issuing. This is to make sure that medicine expired/’with wrong strength is notdispensed. Also medicine with earliest expiry is dispensed first.

Medicines having batches with different expiry dates and different strengths should be kept in separate containers labeledwith strengths and expiry dates.

Encouragement to store single strength of a particular drug in the hospital rather than multiple strengths.

Administration

Nurse/Patient ratio to be appropriate

Job responsibility of the nurses should be allocated/divided in a way that one of the two nurses administering the drug shouldbe experienced and preferably specialized in the given area.

Encouragement to store single strength of a particular drug in the hospital rather than multiple strengths.

Separate section for preparation of drug.

Ongoing educational sessions of medication desired effects, side effects, and adverse effects. Easy access of medicationrelated information. Adverse reactions to be highlighted on the case file.

SUMMARY

FMEA is mantra to risk assessment and management. It isa tool to identify, assess, prioritize and correct potentialfailures in the process before they occur. So in healthcare setup the FMEA approach aims at the very first place avoidingadverse events that could potentially cause harm to patients,families, employees or others in the healthcare set up. Thecomponents of FMEA are studying and analyzing the currentprocess, anticipating all possible failure modes, identifyingtheir causes, assessing the highest risk area, making actionplan and implementing on it.

ACKNOWLEDGEMENTS

We are grateful to Dr. Anupam Sibal for providing usguidance and support on quality and hospital managementissues

REFERENCES

1. Failure mode and effect analysis: an application in reducingrisk in blood transfusion. Bergmeier J.

2. www.gha.org/pha/resources/fmea/HFMEA_TELNET_Handout.pdf FMEA- By Dr. Deborah L. Smith