Hazard Identification & Risk analysis concerning to Medical Equipment in Hospital

The following are few examples of adverse events I have encountered in Hospitals due to faulty medical equipment.
“The patient gets burn injury due to malfunctioning of patient plate in electrosurgical unit in operating room.”
“The medication error to patient due to non-calibrated syringe pumps in ICU”.
I am sure you too might have faced similar issues at your hospital.
The goal of this blog is to facilitate hospital team especially medical administration, Biomedical engineer (also referred as clinical engineers), clinicians, nursing & paramedical team on safe usage of medical equipment.
The ever evolving role of technology in healthcare services now allows Hospital to diagnose faster, with greater accuracy than ever before and increasingly in a manner which is least invasive. It allows Hospital to treat better and helps patients recover faster. In most of clinical areas in hospital of high risk like Operating room, Intensive care area, the processes involve usage of medical equipment. But the faulty medical equipment or use of equipment in a manner other than the equipment intended to use may lead to serious disability or death of patient. The Indian National Accreditation Board for Hospitals and Healthcare providers (NABH) accreditation standard ROM 6a mandates top management of Hospital should ensure proactive risk management across the organization .As per Joint Commission International ( JCI) standard FMS 2 & NABH accreditation standard FMS 1a, the hazard identification and risk analysis (HIRA) exercise is to be conducted by hospital and should take all the necessary steps to eliminate or reduced such hazards and associated risks. It is mandatory to monitor adverse events, near misses, and sentinel events in hospital as per both NABH & JCI accreditation standard.
The failure mode and effect analysis (FMEA) is one of the tools that can be used for performing HIRA on processes involving medical equipment. The FMEA like any other process improvement methodology is a team activity wherein relevant members from different department will be involved. The goals of FMEA are as follows:
• To identify the failure modes in the process involving medical equipment
• Establish the risks and the consequences of these failure modes
• Identify and implement mitigation strategies for the effects
• Assess the success of the mitigation strategies
• Implement modifications to hospital procedures as appropriate
The roadmap for implementation of FMEA is as follows:
• Select a process or sub process involving medical equipment
• List the potential failure modes i.e. how it may fail.
• List the potential effects of the failure.
• Estimate the Severity number (S) i.e. a numerical measure as given in table 1 of how serious is the effect of the failure to the patient.
• List potential causes or mechanism of failure.
• Estimate the occurrences number (O) i.e. a numerical measure as given in table 1.It is a measure of probability that a particular failure mode will actually happen.
• Estimate the detection number ( D ) i.e. a numerical measure as given in table 1 .It is measure of probability that particular failure mode would be detected by process members.
• Compute the risk priority number ( RPN = S X O X D)
• Determining Corrective and Preventive Actions i.e. mitigation strategies for the effects including list of individual responsible for completing the action.
• Prioritizing Actions Based on the RPN.
• Recomputed RPN after corrective actions to hospital procedures as appropriate are computed.
The following FMEA case study was done on to eliminate the possible failure modes in the use of defibrillator in multispecialty Hospital in North India. Defibrillators apply an electric shock to establish a more normal cardiac rhythm in patients who are experiencing ventricular fibrillation or another shock able rhythm.The defibrillator is lifesaving equipment used in emergency situations and any failure /wrong use while applying electric shock can lead to first or second degree burns or death of the patient .
HIRA_v1
The process of using defibrillator using external paddle whenever code blue in Hospital initiated is shown below. The failure mode for each sub process is tabulated along with effect of each failure, its severity. Occurrence & detectability. The possible cause of failure & mitigating strategies is also filled. The rating for S, O & D are fixed based on detailed brainstorming session between nursing team, Clinicians, Head of Emergency Department & Clinical Engineering (also referred as Biomedical Engineering). The risk priority number for each failure is calculated to understand which sub process needs to be focused on priority.
As we can notice the following sub process needs improvements based on calculated RPN.
• Switching on defibrillator
• Positioning of paddles on patient chest & deliver shock
• Application of conductive gel on paddle
The team assigned responsibility to relevant member to work on mitigating strategy. The team decided to review the sub process again after three months based corrective action taken & revisit RPN.

HIRA2

There is plenty of scope for hospital to do HIRA studies on medical equipment like Ventilators, diathermy unit, syringe pump. I would encourage all my e-friends who are working on safety issues in hospital to take such activity in their hospitals. In case anyone is performing HIRA study using other tools instead of FEMA, kindly shares your methodology.

Defining your KPI’s – What is your Hospital Measuring ?

KPIs what are you measuring

Ill start with a  Cliche  – “What is not measured is not done”, but  i truly believe  in the power of measurement  and that’s why measuring all that you have envisioned for your hospital becomes critical.  But then how good are our hospitals at measuring?

Before we can really answer that question we need to identify what it is exactly that we our measuring.  I have come across a few discussions which were based entirely around what hospitals should measure and honestly every individual seems to have his / her own response.  Yes there are some basic KPIs such  as  ALOS , Occupancy, Revenue etc that keep cropping up from time to time however  I haven’t really come across a  really well defined KPI directory that you can choose from .  And sadly enough some  rare  managers and administrators that I have come across  are not  even aware of  the  entire  implication that a  particular KPI has  on the  functioning  of the  hospital.

My attempt here is not to define a directory for you but rather to set a direction to our way of thinking about KPIs

So what do hospitals measure?

Our entire KPI classification is based around

 Clinical Quality  – e.g. Medication errors, outcomes, mortality, hospital acquired infection , repeated surgeries, readmissions etc

Operational Quality – e.g. waiting times,  Going  above  estimates, Consultation quality, Discharge times, Admission times etc

Operational efficiency – e.g. ALOS, Volume growth, Cost per bed, Material cost  %, utilization rates, Your basic time motion studies regarding process efficiency etc

Financial health – eg. EBITA, Debtors outstanding, Case mix, Revenue source mix, Cash to debtor’s ratio, Cash flow etc.

This is definitely not all inclusive in terms of KPIs or categories but basically top of the head stuff. I have  also seen people merge Operational quality and efficiency but id rather keep them separated.

Wow that’s quite a lot of things to measure  if you think about it and  we haven’t even quite scratched the surface yet.  How will I keep an eye on the ball when I’m being bombarded with balls? The answer my friend is simple identify what’s important for you

So what is important for you? Prioritise

The KPI dashboard that you are most concerned about is directly related to the level / nature of involvement that you have with the organization.

If you are a C level executive your KPI dashboard might be entirely different from let’s say someone related solely to Operations which might be different from the individual heading Quality. When i say different it doesn’t mean there is no overlap there will be overlaps but functionalities are different.

So a CEO would have some of these things on his / her  mind  –  EBITA , Material Expenditure, Volumes for critical procedures , Case Mix , ALOS, Debtors , Utilization etc.

And then this further would percolate down to departmental levels.  Eg OPD would have different Performance indicators such as waiting times, doctor punctuality, material consumption, Staff attendance, Overtimes, Complains, average consultation times, volumes,  etc .Marketing would have measures  like – call volunmes, sector wise revenue, cost per  customer  acquisition ,  doctor wise  performance, activity vs conversion etc

I would say define your parameters well at the departmental levels to drive true quality and efficiency.

Ideally a C level manager should look at about 30 – 50 selected indicators on a daily basis and then selectively look at indicators from departmental levels which show huge discrepancy from the expected values or unusual results. Focus can also be shifted while working on specific projects. Please note it’s difficult to keep an eye  on 170 parameters so prioritise and reorganize your dashboard  on regular intervals

At the departmental level each department should be encouraged to develop their own KPI bout 20 – 30 against which they measure themselves. Please remember while defining your KPI it’s important to understand why you are measuring it and whether you need to include it, be specific and be selective.  Also VOC (voice of customer) must  be imbibed into your Dashboard structure. Lastly  identify the correct method to measure the KPI you are defining a lot of times time is wasted on goose  chases with either  the  wrong  data or  erroneous  data  collection.

Implementation 

This is the tough part here is where you record, review and correct and this is not only for a particular phenomenon that you  are  measuring  but also your dashboard structure add omit and refine the  dashboard as  you go along. But before  that  i can not stress on the  importance of getting the  message across to your entire hospital team. The  grass root level must understand the  importance of  an entry they make or the data they capture to ensure the quality of data and the  success of the system.

What would be the benefit?

The answer is simple consistent quality service provided with efficiency and accuracy.

HIS / BI Tools

I am certain there are quite a few HIS systems as well as Business Intelligence tools which integrate with your HIS systems to raise alarm and to bring things to your notice. However treat them as tools but don’t be over dependent on them. Because solutions which come in a tin are not necessarily the solutions we need.

Authors note:

My overall experience with KPI mapping in hospitals in India is that we are inept at measurement.  Most hospitals basically follow a basic set of indicators that are commonly predefined and taught in Hospital Management courses, however creative development of newer indicators seems rare.  A problem that is causing this is that management professionals are not necessarily keen at sharing their knowledge,  and the knowledge share which happens is mostly of data which is already out there in the  public domain.  Also as an industry there is a lot to learn from the Manufacturing sector and we must keep our minds open to newer possibilities through cross industrial / sector learning. In the end Collective Cognition is the need of the hour.

Disclaimer: The views expressed in this  post are my own and  are  not meant to be derogatory  to any institution or organisation. These are just my thoughts and  these are open for further  discussion and  development. Please do comment and  share and  let’s get some universal cognition into this. Thank you for your patience and  tolerance.

Going Cellular on healthcare – an exploration

According to mobile analytics firm Flurry India’s connected device installed (smart phones and tablets for the uninitiated) base grew by a whooping 160% from April 2012 to April 2013. According to the latest report of IAMAI and IMRB, till Oct. 2012there  are a total of  76 million mobile internet users  ie accessing internet from their  mobile devices  in India and this doesnt include  dongles and data cards.  This number is expected to reach 130.6 million by march 2014 and 164.8 million by march 2015.

Now those  are  crazy  stats but the  question here  is  are  you on the  smart phone  yet. Applicability for   smart devices in hospitals is just  at its infancy but the  possibillities are just enormous.

A Hospital Based  App  –  this is for marketers as well as for  operational convenience. Though i have thought of other  applicability ill leave that for another post.

Developing one  basic downloadable hospital application with various utility parameters set into it. So lets get my thoughts straight here these  are just some random ideas that  i have  worked  upon or come across which work or should work you can always add  more in the  comment section.

a) Pill Reminders  – once a  prescriptions been filled  out and dispatched from the pharmacy this application can be downloaded and it will remind you when you need to take your  medicines  could be used for both in and  outpatient. I think this application is already being used  by Wallgreen  (part of the wall mart enterprise)

b) Health check reminders once you have booked  a  health checkup this does a basic count down to the  health check reminding you from three days  prior to the HC . and  one day before it sends you details as to what is expected from you . Also allows  you to give an online feedback

c) Virtual consultant  feed your query get an answer and  tie in for fixing up an appointment

d) Appointment  scheduler no calls required like an online consultation allows you to choose a speciality a consultant and an available time slot maybe about a  month in advance again a  reminder system can be put in for when your consultation is due

e) Diet check – basic calorie / special need diets  includes interesting recipes as well as  a basic calorie calculator such apps already exist on  the  ios and  android markets and can be integrated they are  for free  usually.

f) im not to sure if this can be done but basically an emergency helpline number that  the  app can directly feed into your mobile and  which will be  accessible at the  touch one button

g) Promotions any new  promotion pass it on  to your existing customer , though this is a  bit of an issue but can be

h) Disease research  – if you need to know anything about a  particular disease  get the data here

i) Patient connect  – connecting with patients suffering from similar disorders successfully treated by the  hospital with contacts if required like mobile testimonials and brand ambassadors. also mention best times to contact.

Thats  just the  tip of the iceberg i am certain as we go ahead we can find more utility.

Whats important for a particular app to be successful is that its  patient centric and understands  what purpose in patient care or patient  information provision it serves.  The  App has to be utility focussed and  not just there because  everyone is moving onto the  mobile platform or because  you want  to push messages to your community  from your hospital. If thats the  approach you have  then even if people do  download your app  they will get  rid of it faster than you can say flu. So remember friends utility is king and thats the only way you can create a  successful app.

Disclaimer: The views expressed in this  post are my own and  are  not meant to be derogatory  to any institution or organisation. These are just my thoughts and  these are open for further  discussion and  development. Please do comment and  share and  let’s get some universal cognition into this. Thank you for your patience and  tolerance.