How did the HPV process get improved by Sample360.cloud?
The improvements are centred around the lack of a closed loop process that Sample360.cloud can supply rather than the first class Clinical testing. So let’s begin at the beginning and explain what is going on and how it can be improved.
What is HPV aka the Human papillomavirus?
Human papillomavirus (HPV) is the name of a very common group of viruses. They do not cause any problems in most people, but some types can cause genital warts or cancer.
HPV affects the skin. There are more than 100 different types.
The big problem of HPV is it does not usually cause any symptoms.
Most people who have it do not realise and do not have any problems.
But sometimes the virus can cause painless growths or lumps around your vagina, penis or anus (genital warts).
Conditions linked to HPV
Most of the time HPV does not cause any problems.
In some people, some types of HPV can cause:
- genital warts
- abnormal changes in the cells that can sometimes turn into cancer
- HPV types linked to cancer are called high-risk types.
Cancers linked to high-risk HPV include:
- cervical cancer
- anal cancer
- penile cancer
- vulval cancer
- vaginal cancer
- some types of head and neck cancer
- You can have HPV for many years without it causing problems.
You can have it even if you have not been sexually active or had a new partner for many years.
The big problem is the Cancer part caused by certain types of HPV in Women especially. This is why Women must be tested regularly for the virus.
Testing for HPV
HPV testing is part of cervical screening. There’s no blood test for HPV.
During cervical screening, a small sample of cells is taken from the cervix and tested for HPV.
It is this important Sample that Sample360.cloud can help with.
Screening is offered to all women and people with a cervix aged 25 to 64. It helps protect them against cervical cancer.
Some sexual health clinics may offer anal screening to men with a higher risk of developing anal cancer, such as men who have sex with men.
Is there something wrong with the Clinical Testing of HPV in the Lab?
Absolutely not – that is a big No. Testing is first class and performed by the best Hub Labs around the country.
So what is the problem?
The problem with HPV testing is it is not a closed loop process – this means one end of the process does not know what the other end is doing because there is no feedback or link.
Why is this a problem with HPV Testing?
HPV has a rather unique way of analysing the cervical screening samples. The Sample is not analysed the same way a Blood Sample is processed in the Community – in the case of a GP a Blood sample will be analysed by the local NHS Hospital Lab.
In the case of HPV this Sample is analysed by specialist HPV Labs in a Hub and Spoke system.
So why isn’t HPV Testing Closed Loop?
Because there are 5 different disprate unlinked organisations involved.
1. Department of Health
The first organisation is the Department of Health who writes to each Woman with a cervix of a certain age to come in for a Cervical Smear Test – they are urged to do this periodically. Their information is then entered onto a software system called OpenExeter.
At this stage the Lab is not aware that a Sample request has been ordered.
This produces an order form for the Smear to proceed. The form looks like this:
2. GP Practice
This OpenExeter form is then used by the GP to record the Cervical Smear Test Order. The Form is then placed into a special package containing a pot and bag (from a company like Hologic) destined for the specialist HPV Testing Lab. This form can be handwritten and it can also be printed from the GP Practice computer system. The Barcode on the form is not a patient identifier but instead it is a form identifier.
Please note the GP Practice computer system is unlikely to be linked to the Lab.
The Lab is still not aware an order has been raised or a Sample has been taken at this point.
3. Logistics
The process of collecting and delivering these packages is performed by either an in-house NHS team or an external specialist Logistics company. Once again their systems are not linked to the destination Lab.
The Lab is still not aware a Sample has been taken at this point.
4. Consolidation at an NHS Trust
Sometimes the GP Surgery sourced Samples are delivered to another local NHS Trust as part of the normal Blood Sample collections. The role of this intermediary Trust is to consolidate all the HPV Sample packages into one single cool-box to then be sent to the specialist HPV Lab.
Once again the specialist Lab is still not aware a Sample is on its way.
5. Specialist HPV Testing Lab
Finally the Samples arrive at the Lab for Testing. This is the first time the Lab has knowledge of the Samples taken.
However the first thing that needs to be done is to OCR (Optical Character Recognition) scan the OpenExeter form to create the necessary HL7 Electronic Order Messages for the Lab System. This is because neither the GP surgery computer system nor the OpenExeter system is linked to the Lab.
This HL7 Message contains all the information about the Patient and the Sample Order and must be generated before analysis can begin.
Once the analysis has been completed the Lab will then notify the Department of Health of a Positive result on the OpenExeter system so that a Letter can be sent to the Patient to book another appointment with their GP for a consultation.
No Letter is sent if there is a negative result – this is important.
Sometimes the GP is also notified of the Positive Result via a Letter via the Department of Health or Lab.
Conclusion and how Sample360 can help
Before we explain how Sample360 can help let’s explore all of the pitfalls of this current non-closed loop System.
- The Department of Health is inviting Patients to have an HPV Test without informing the GP or Lab.
- The Department of Health does not know it actually reached the Patient who needs the HPV Smear due to postal issues or wrong addresses.
- The GP may or may not know about the age groups of the Patients in its locality – people move or never register.
- The GP is only aware of the Test request when the Patient presents themselves at the Surgery.
- The Lab is not aware a Sample has been taken and it is on its way.
- Logistics are not aware of the contents of the Sample Boxes and handover of responsibility of the Samples is not performed.
- The intermediary Trust is not aware of the Samples when they arrive for consolidation and are certainly not aware of any losses en-route.
- The Lab is not aware of the Samples until they actually arrive at the Lab for analysis unaware of any losses or expiry.
- Data entry of the Sample Orders is performed using OCR and manual input with no knowledge of any losses.
- Analysis of the Samples are sent to the Department of Health to contact the Patient of a Positive result.
- A Letter is often sent to the GP of the positive result.
The conclusion to that process is there are large areas in which losses of these vital Samples can take place without the key members of the analysis team ever knowing something went wrong.
MSoft360.cloud are even aware of reported cases in which HPV Samples have gone missing between the GP and the Lab.
The problem is the Lab does not know the Samples went missing as they don’t know they have been taken. The GP is unaware of the loss as they are only notified if there is a positive result of the analysis of the HPV Sample. Negative results are not sent.
There is a complete breakdown of closed loop communication because of the fact not one of these pillars in the process are aware of the other pillars actions or failures in between.
This is were Sample360.cloud comes in.
Sample360.cloud will perform the following to close the loop:
- As soon as the OpenExeter order is started by the GP the order form is OCR scanned by the Sample360.cloud App – this immediately notifies the Lab an order has begun.
- The OCR Scan of the order form also generates the HL7 messages for the Lab system cutting out the Lab time to perform this manual task.
- The GP attaches a trackable 2D Sample360.cloud barcode to the HPV Sample tube linked to the OpenExeter form barcode.
- The GP follows protocol collecting the information on the mobile device screen and pacing it into a named and barcoded Cool-box.
- The Cool-box is environmentally monitored enuring the Sample arrives at the Lab in good condition.
- The Logistics company or organisation is notified of how many cool-boxes to collect and when.
- The GP Surgery hands over responsibility of the Samples to a named individual in the Logistics team.
- The Lab can see how many cool-boxes are on their way and when they are estimated to arrive using the Sample360.cloud dashboards. If the service of collection is inhouse the system can GPS track the Samples.
- Samples are now searchable as the Sample360.cloud 2D barcode is linked to the OpenExeter originating order number.
- Samples arrive and scanned into the Lab – marking them as arrived.
- Sample360.cloud notifies the Lab of any potential LOST samples or any that have past their expiry date or failed their environmental checks.
The system is now fully closed loop thanks to Sample360.cloud.
The Patient Samples are now secure and any losses are visible and traceable back to the Patient.
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