Doing More with Less: New Approaches to Gaining Lab Efficiency
For decades, forensic DNA labs around the world have employed the same tried-and-true processes, and while they work, they may not be able to support the ever-growing number of casework samples. Employing proven techniques, emerging technologies, and user training improve forensic laboratory workflow efficiency. During this webinar you will hear case studies that illustrate how forensic DNA laboratories have embraced new approaches to reduce backlog, improve turnaround times, and increase efficiency. In this webinar you’ll hear: •About the steps you can take to increase throughput and conquer your caseload •How to increase efficiency without taxing your already limited bandwidth •How to leverage automation, Y-screening and other technology to reduce hands-on time and enable more time for complex analyses •How to gain and maintain accreditation more efficiently •How comprehensive training is a road to long term success
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Hello, and welcome to Doing More with Less, New Approaches to Gaining Lab
Efficiency,
Brought to you by Forensic and Sponsored by Thermo Fisher Scientific.
My name is Michelle Taylor, Editor-in-Chief of Forensic, and I will be your
moderator
throughout.
For today's webinar, you can earn one hour of continuing education credit.
Following the conclusion of the webinar, you will receive an email on how to
obtain
CE Credit Documentation for your participation today.
We have a great lineup scheduled to present to you, but before we begin, I'd
like to
take just a moment to cover a few logistics.
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Now, with those logistics out of the way, we can get started.
I'm going to hand the reins over to Carne Pruitt, Senior HID Training
Specialist at Thermophisher
Scientific.
Carne is going to lead us on a tour around the world, speaking with multiple
forensic
laboratory leaders and hearing their stories on how they employed proven
techniques and
training to improve their laboratory workflow efficiency.
Carne, the floor is yours.
[Music]
Hello, I'm Carne Pruitt.
Let me tell you a little about myself.
I've spent four years as an infectious disease researcher, one year as a
biology professor,
and eight years as a forensic scientist, codis administrator, and crime scene
investigator
at the Washington State Patrol Crime Laboratory.
Most recently, I've worked for Thermophisher Scientific as a field application
scientist,
and now as an instructor, delivering customer training for the HID Professional
Services
team.
The HID Professional Services team, also known as HBS, has performed services
in over 300
customer labs across 39 countries.
We've developed proven processes to accelerate the validation process and
adoption of new
workflows.
We've performed validations in a shorter period of time compared to personnel
in most laboratories,
and our end-to-end expertise goes beyond validation to provide assistance with
SOP development,
documentation, troubleshooting, and comprehensive training programs to drive
consistency and
competency across your organization.
During today's webinar, we're going to talk to forensic laboratory leaders from
around
the globe and hear stories about how they have improved their efficiency.
Like many of you on the webinar, they're faced with an ever-growing number of
forensic
case work samples to process.
Their stories address how they have employed proven techniques, used technology
, and engaged
training to improve forensic laboratory workflow efficiency.
For our first story, we'll travel to a subcontinent of Asia located in the
Indian Ocean, the Maldives,
Dr. Itisham Ali is head of the DNA Laboratory Forensic Services for the Mald
ives Police Service.
He started the DNA Laboratory at Forensic Services in the Maldives and has
worked as
the technical lead in forensic DNA case work to the present day.
He advised at the policy and laboratory level to deploy real-time PCR testing
services across
the Maldives.
He also helps oversee the long-term development of forensic services.
Dr. Ali, thank you for joining us.
Will you please tell us a little bit about your laboratory?
Hello, and greetings from the Maldives.
My name is Ith Itisham Ali and I'm the head of the DNA lab here at Forensic
Services.
Forensic Services is an independent direct threat within Maldives Police
Service.
NPS is the primary law enforcement agency in the country with a mandate for
frontline
policing, criminal intelligence and criminal investigations.
So overall, we have a responsibility for both crime prevention and crime
detection.
From 2004, there was a major push from confession-based investigations to
evidence-based investigations.
Forensic Services led this transition using forensic science as the key crime
detection
tool.
In fact, I joined in 2007 to introduce forensic DNA testing.
The lab was opened in March 2008.
The main function of the lab is to use SGR profiling for human identification.
The crime problem in Maldives has become more expansive and very complex.
Traditional forensic evidence such as fingerprints are less available in crime
scenes now.
On the other hand, the use of DNA profiling has become more prevalent across
all case
types.
This can be volume crimes such as theft and arson and more serious crimes like
murder,
assault, sexual faces and terrorism.
Around 2010, we had just under 100 cases per year, but the number of cases on
average
submitted to our lab has increased to 350 per year.
Do you have the same number of people in your laboratory processing those cases
or did you
hire more individuals?
So when we started out, we had three staff.
Right now, we've been adding staff over the years and right now we have 12
analysts working
on case work.
So going from 100 cases per year to 350, you definitely needed more people to
process
that.
Yeah, and obviously, we're doing roughly about five months of work and trying
to treat all
that work into one month.
We processed more than 2,500 samples per year and additionally, we add
reference DNA profiles
to our database and we now have over 8,000 profiles in the database.
So I would say that we've been once months that we've had in the past few years
The real golden age of DNA profiling is really just beginning in this country.
Do you think as the golden age of DNA profiling kind of picks up speed,
especially after COVID,
that the number of cases that you're going to be receiving is going to go up?
Yes, the number of cases are going to increase and also the number of samples
we expect from
each evidence is going to increase because it's not just SDR profiling that we
do.
We do humans, biological stain identification and we're trying to introduce
more types of
serological and screening techniques to complement our SDR profiling work.
Do you use any kind of automation to help speed that process up?
Yes, for the bulk of our samples, we use automated DNA extraction.
But at the moment, everything from quantitative PCR to targeted SDR PCR and CE
is done manually.
I know that you partnered with our HPS team, the HID Professional Services
Group.
That was in 2018.
So our test services has always been built around the applied biosystems,
platforms and
chemistry and after using the 3-1-3-0 genetic analyzer for over 10 years, we
upgraded to
the 3500 platform.
And also we changed from the Identifyler and Byfiler kits to the Global Filer
and Byfiler
Plus Extended Target Lowside.
At the same time, we were looking into obtaining ISO 17025 accreditation.
The initial reason for conducting the internal validation was to conform to
that standard.
So the management team here decided that we needed professional support to
conduct the
validation.
That's when the HPS team stepped in.
We've had a great partnership with the Thermophicious Scientific Team over the
years and it was
only logical that the HPS team would be helping us conduct the internal
validation.
There was a second reason in hindsight that the internal validation was very
important
to us.
When we started generating these new data, we realized that our current profile
interpretation
and statistical testing matters were really needed to be modernized and
standardized.
And in a few short months, we were able to adopt the SOG-DAM interpretation
guideline
for SDR data.
But the key factor in allowing us to do that so quickly was because we already
had the
experimental data from the validation studies that were done by the HPS team.
And also the teach back sessions that gave our analysts some knowledge and
familiarity
with the data and the findings.
And also the study reading materials and reports that they gave us really
helped us to finalize
the analytical protocols that we have now today.
Do you think that having HPS partner with you enabled you to validate and
implement the
new technology faster than if you'd done it on your own?
Yes, obviously having a professional team with prior work in the area of
validation
and with their tried and proven experimental designs would really help any lab
to fasten
the process of getting the validation work done.
And it has been our experience that the HPS team helped us to do that much
quicker than
we could have done on our own.
Was the training itself helpful to the laboratory getting online?
Yes, so when I returned from my studies, the analysts who were working here
already had
some knowledge and familiarity with the validation reports and their findings.
And it was easy for me to kind of help them adopt the SOGDAM interpretation
guideline
because there already knew many of the parameters that we had to set.
Dr. Amit Gokle is with us right now as well.
And I just wanted to ask you, Dr. Gokle, what was your role in the Small Deafs
project?
During HPS, it was mainly to set up the experiments, perform the experiments
and then help them
understand what we are doing.
So sort of like the whole process also helped to develop an SOP, sort of a
parameters which
they could develop further based on their requirements.
Can you tell me, do you have any takeaways for other laboratories that might
help them
if they are looking for validations or to meet ISO requirements?
Yeah, definitely.
Means first of all, I would say maybe not work related, but my deep police lab
is a
great place to work.
That's the best thing I would say that is there.
But by having said that the takeaway, I would say from my deep police services
would be
that their meticulousness, the way their labs are set up, something that would
help basically
for labs to go quick up and running very quickly when they are working to
develop HPS
projects.
Another thing would be to involve maybe the HPS services early on.
I would say that would be the key takeaway because that would help to ensure
that the
labs get up and running pretty fast.
Back to Dr. Ali, you said that your laboratory was interested in accreditation
and ISO compliance.
Have you reached that yet?
Have you finished reaching your goals?
Yes, we were able to obtain accreditation in July 2019 and we currently are in
the process
of renewing that accreditation.
Do you have any takeaways for other laboratories that might be in your position
to help them
think about how they can be more efficient at obtaining accreditation?
As I've implied before, forensic DNA profiling has become very standardized.
So that means quality assurance is a major and integral part of our work.
So the best advice I can give you is to adopt international standards and seek
compatibility
with other labs around the world in the forensic DNA community.
And the HPS team is one of those professional teams that can help you do that
in a more
systematic way.
What is the best part about working with HPS or did you find that there were
any challenges
about it?
I think when you go to university or any type of higher education and study
theory
on genetics and human genetic variation, you can get a bit complicated and
additionally
in these days bio-formatics the math side of it can be very confusing and a bit
daunting
to be honest.
But having actually done internal validation in this lab and seeing how
everything works
really helps people understand at least my analysts understand what different,
how data
is really generated and processed and how you can do to really perfect DNA
profiles
when you initially get data.
So one of the things that we want to do in the future in terms of our DNA lab
is that
we want to work more with overseas labs, transnational crime including human
trafficking, drug trafficking
and terrorism cases.
So having the internal validation studies done, having an accreditation helps
us to connect
with other labs around the world.
So that's some of the ideas we have for the future.
Thank you so much for joining us here today.
I hope that everyone has enjoyed this discussion as much as I have.
For our second story, we'll travel to Western Europe.
David Gonzales, a senior product and validation application specialist at Ther
mo Fisher Scientific,
has been part of the HID team for the last eight years.
Previously, he spent close to a decade working for cell mark forensic services
in the United
Kingdom.
David has been involved in projects and validations in the HID space for over a
decade and often
travels to support customers globally to implement new technology into their
case working and
data-basing laboratories.
He'll share a story about a government agency for Renzik Lab located in Western
Europe.
David?
Hello everyone, my name is David Gonzales.
I'm a validation application specialist on the Human Intervocation Professional
Services
or HPS for short.
I'm going to share the story about a forensic laboratory customer from a
Western European
government agency.
Let's call them LabGA.
Thermo Fisher Scientific HID has been working with LabGA for about the past
four years, providing
services ranging from the validation of rapid-hit ID instruments, automated
platforms, training
and opening a brand new laboratory at one of their sites.
Technically, what we have here is a multi-site customer who was presented with
a change of
legislation that required all the forensic labs to move over to ISO 1702.5.
This was in a period of time when they did not have the spec capacity to
dedicate resources
to validation work in order to show accreditation standards across all their
sites so they wished
to discuss the possibility of using the HID professional services.
Validation standard operating procedures were very robust, broadly following SW
IG DAM and
NFS requirements, meaning it was not just a case of running a few samples but
truly investigating
whether their workflow was working correctly.
At the time, the best approach was simply to spend some time with the customer
understanding
what their needs were, what their SOP stated and how best to meet those demands
While we in HPS follow SWIG DAM guidelines, we can tailor the service to suit
the customer
needs, large and small.
And so this is what we did.
We spent the time needed to gain a complete understanding of their needs, how
best to
meet the additional demands of ISO standards.
What we came up with in the end was an experimental design that covered all the
customer requirements.
It was clear that HPS could provide real value to the customer by providing the
resources
needed to complete the work in a timely manner.
HPS has completed over 700 validations worldwide and so we are well versed in
all aspects of
the validation process.
We have the resources to turn around validations in a shorter period of time
compared to an
internal lab personnel since it's our focus.
As mentioned, a validation is performed to test the workflow and sometimes it
shows there
are issues.
An additional benefit of using HPS is that we have direct access to our
internal resources
here at Thermafisher Scientific.
We can resolve problems quickly.
We've now worked with this government lab ten times across different projects
and sites.
What we have built up over the years is a relationship with the customer by
being present, providing
services that they need but also create a level of trust.
That means that they know that we will do everything that we can to ensure we
meet their
needs.
This is in fact what we aim to do with all our customers.
So David, can you discuss how HPS assisted the customer in achieving acc
reditation or
increase their efficiency at achieving accreditation?
To achieve ISOS and Dnotify accreditation is not just a matter of running some
experiments
and completing a validation.
It includes a wide range of actions that include things like risk management,
training
specifications, maintenance of instrumentation and a lot of other things.
So by HPS running the validation portion of the ISOS 1705 accreditation, that
meant
that the customer could focus on what it was that they needed to do for all of
these
other parts of the accreditation and therefore increase their capacity to focus
on the other
things whilst we completed the validation piece.
Has this work with the validation that you've done helped the laboratory
position themselves
to have higher throughput?
So what ISOS allowed them to do is to make sure that they're achieving certain
standard.
By meeting that standard across all the different sites has meant that the work
that they're
doing is more robust by having validations in place has meant that they know
that their
processes are working to their full capacity and therefore their run rates,
their pass
rates, their failure rates at either higher or much higher or much lower level
than it
was previously.
And by meeting ISOS 1705 standards, it's meant that they can also show to the
world that
they're meeting that standard and level of work.
Is accreditation a requirement for this country?
Legislation changed.
It became mandatory.
They had a certain amount of time to at least initiate the processes.
They wanted to get in touch with us because they knew that we were experts
within the
matter, I would say.
They discussed it with us, realized the potential of working with us and that
meant that we
could get validations done quickly for them at different sites, meet the same
validation
standards across all the different sites and that has put them in a very good
position,
moving forward.
Were they able to meet the deadline?
They were able to meet the deadline.
They essentially showed progress to their auditors and that is very important
in itself,
even if they didn't necessarily meet accreditation standards across all sites
at the same time,
which was going to be a physical challenge and a logistical challenge is
nothing else.
Can you discuss a little bit how important the HPS involvement has been to the
customer?
I would say it's a worthy investment that they've made in working with us,
simply because
after the first couple of validations, they realized how quickly we could turn
around
all this work.
From their side, they were struggling to meet the demands simply because they
had other
things to do to meet the accreditation standard but also their day-to-day work.
They had limited resources, time and capacity to dedicate to do this piece of
work.
By engaging with us, they've managed to free up some resources to do other
things.
They've realized that the standard of work that we produce is exactly what they
need and they've continued to use us across multiple validations up to 10 and we're
going and working
on to our 11th and potentially our 12th coming up soon.
I understand that this customer has validated both automation and the RapidHit
ID system.
Do you think that those two things will affect the customer?
Customer runs traditional casework labs mainly.
By introducing automation and Rapid, you can then start to massage or change
your workflow
a little bit to be able to deal with an increase in capacity or urgency.
They introduced automation to increase their capacity.
Being able to do multiple samples at the same time on a walk away platform is
always a useful
solution to having a smaller budget for staff, for example.
We validated one of the platforms to run prep file.
They've been using, they initially used it.
We've gone back and helped them with some training on that platform as well.
We're hoping that they're going to have that up and running soon.
The Rapid on the other hand is a small bench top instrument that can be put
anywhere.
The fact that it can produce full profiles from samples in 90 minutes means
that they
could use them for urgent samples, for example.
Things that they need to turn around very quickly without essentially
disrupting their
day-to-day casework workflow.
It also means that they can do reference samples from a crime scene without
having to wait for
the crime scene samples to be run.
They could be run at the same time, they could be run at a different area in
the lab, and
that sometimes is important for reasons like contamination.
How was Rapid Hit ID validated?
We validated it for the customer.
We had a discussion with the customer because it is ever so slightly different
to a traditional
validation.
The instrument itself is a direct amp instrument and therefore doing some of
the studies within
SWIG-DAMN's fee, especially for example, the Sensitivity series is done
slightly different
because there is no quantitation.
To do a sensitivity series without knowing the quantitation of the samples is a
little
bit different.
You have to still perform it, but you have to interpret it in a slightly
different way
so that you glean the information that you should be gleaning from it.
Then also things like mixtures are a little bit harder to deconvolute from the
output
from a Rapid Hit ID.
You can still run some mixtures on the system to check that the flags are there
to let you
know that there is a mixture in the sample, but at the same time you need to
take the
readout in a slightly different way.
You can't deconvolute in a traditional format.
What kind of automation is the laboratory using now?
The lab was using Hamilton Starlet.
That was the initial platform that they used to run PrEPFiler.
Then the second lab, which is also running automation, has recently been
testing an ID
in Nimbus Presto, so it's one of the new instruments that some of Fisher has
brought
to the market for HID.
It's a Hamilton Nimbus platform with a King Fisher Presto on the deck and
together they
can run up to 96 samples in a very short period of time.
I believe extraction is around two hours if I remember correctly.
Once again, the ability and a platform that can be running whilst stuff can be
going and
doing some other work.
They're currently testing it for bones and they're comparing it back to an
automated
express and they're getting surprisingly good results from bones on this
platform.
It's good news.
Why are the results surprising?
Traditionally, bone has never been an easy sample to work with.
It requires an extra few steps.
It's not as easy as say a buckle swap.
To be able to process a high throughput of bones, I wouldn't say it's unheard
of, but
it's a challenge.
The fact that this platform with essentially no modifications to this specific
platform
is just a standard idea in the MSP and they're getting a good result from it.
The customer is happy with the results in comparison to the automated express,
which has traditionally been known to be very good for bones.
David, thanks so much for telling your story.
It's really helpful, I think, to everyone to understand what other laboratories
have
gone through.
Our final story brings us across the Atlantic Ocean to the eastern United
States.
I am pleased to introduce Dr. Jessica Esparsa.
I am the DNA technical leader for the North Louisiana Criminalistics Laboratory
And Jarrett Roth from ThermoFisher Scientific to talk about a validation
project that they
have done.
Could you go ahead and introduce yourself, Jessica?
Yes, my name is Jessica Esparsa.
I'm the DNA technical leader at the North Louisiana Crime Lab in Shreveport,
Louisiana.
Thanks.
And Jarrett, do you want to give yourself a little introduction too?
Sure, Ken.
My name is Jarrett Roth and I am an Applications Manager for North America.
I am Dean of the East Region and my primary focus is on HPS workflow.
Dr. Esparsa, will you please tell us a little bit about your lab?
So we are located in Shreveport, Louisiana.
There are seven qualified analysts and we have one technical support staff.
We serve 29 parishes in Northern Louisiana.
In 2019, we were using the Caiogen 24plex Investigator Kit Quant Trio on 3130s.
The 3130s were aging out and we had previously purchased 3500s on grant funding
And so an opportunity presented itself in which we had funding to utilize the H
PS team
to validate a new quant kit, two new amplification kits on the 3500.
And so given that opportunity, we went ahead and took it with the idea that
they would
do the wet work and then we would do the validation summaries or put those
together and submit
the validation summary for Verifiler Plus to end this.
We partnered with Thermo Fisher to work on the validation of Quant Trio along
with Verifiler
Plus and Wi-Fi-ler Plus and we also validated a new capillary electrophoresis
instrument,
the 3500.
I mean, that probably helps save you a lot of time for your analysts to be able
to do
casework by partnering with Thermo Fisher Scientific.
It did because we only have seven analysts and actually at the time we had six.
It did allow us to do casework instead of having to work on the validation
summary.
And so by having the team at the lab doing all of the wet work, we were able to
focus
our energy elsewhere.
And Jarrett, what was your role in this?
Hi, Karen.
So my role was primarily the support for Jessica and her analysts at the
Northern Louisiana
Crime Lab.
So they came to us with a request for some validation work to bring on some new
chemistry.
And so we partnered with her and her team.
We came in and did all of the lab work for them.
We were there for a little while because there was a lot to do, but they were
gracious
hosts.
Yeah, that was my real role was to support her and identify the studies that
she needed
in order to bring her new chemistries and new technology online.
So Dr. Esparza, can you tell us a little bit more about why you chose to
partner with
Thermo Fisher?
We partnered with Thermo Fisher so that way they could come in and do all of
the experiments
that are required by the FBI's quality assurance standards for the validation
of each of those
chemistries and the instrument.
It allowed us as a laboratory to be able to focus on other things such as
policies and
procedures that we would be implementing for our new workflow.
What was the most challenging part of the validation for you?
We had to, we shut down for COVID.
And so during COVID is when I wrote the validation summaries, all of the
experiments had been
performed prior to the shutdown.
And then we also had to get Verefiler Plus and disapproved before it could be
used in
case work.
So that was one hurdle that we had to do or to overcome.
And then after that it was the training of the new analysts or training of the
analysts
with the new technologies and get them competency trained before we were able
to put it online.
Have you ever submitted a validation study to end this before for approval?
We had not.
How did that process go?
It wasn't bad.
We were able to submit in September of 2020.
We received full approval in February of 2021.
And then we went online April 1st.
Do you have anything else that you want to talk about for the validation
process that
you might want to share with other laboratories?
It was extremely helpful to have Thorma Fisher come in and do the wet work, the
wet lab stuff.
It really allowed us to focus on the minutia of the process and get that down
pat.
I still had to go over the validation summaries that were supplied by Thorma
Fisher and write
those up accordingly and submit that to end this.
But with everything that we did, there were three different validation studies
that came
out of this project.
How long do you think the validation process would have taken your laboratory
if you had
done it on your own and not partnered with Thorma Fisher Scientific?
I think we got the final validation studies at the end of 2019.
And I had already started to work on putting everything together.
Had COVID not happened, I probably would have gotten everything done.
But we still had to get end this approval.
So that was something that was going to take a minute.
But if I was able to get everything done, it would have probably been by the
end of 2020
as opposed to probably been six months different.
So I would think.
Jared, do you have any things that you would like to add about specific
challenges for this
particular project?
The way that we break these down is that we ultimately want the service to
reflect what
the customer needs are.
As Jessica mentioned, we want to follow or we do follow QAS guidelines,
obviously, in
order for them to bring these systems or these chemistries online.
But just the sheer size of it was challenging, but we just break it down and we
just have
multiple conversations.
I lost count of how many conversations Jessica and I had for this validation.
But it's just all about communication.
That's the way to kind of get through it all and just make sure that all
expectations
are being met to make sure that the way that we're presenting the experiments
and the data
makes sense to the customer.
But yeah, it was big but doable because it just took a team effort all of a
sudden RN,
but the buy-in from Jessica and her team as well to be so accommodating to
allow us to
come in, hang out at their conference room or their conference table, kind of
talking
through it as we progress through the project.
You had thermofusular scientific employees coming into your laboratory.
Did that really break up your laboratory process, Dr. Sparsa, or was it pretty
smooth to work
that in?
It was pretty smooth because we hadn't validated the 3500s.
It was easy enough for us to accommodate the analysts if they needed to, if
they had case
work that they needed to work on.
We did only have 17500 real-time instrument at the time.
That was the only problem, but we had plenty of thermal cyclers.
At the time, we were also using a different kit.
We were using the 3130 genetic analyzers.
It was not a problem at all for them to come in.
Was it difficult to make that switch between the kit you were using previously
and the
new kit that you validated?
It wasn't.
One of the reasons we liked Verifiler Plus was because it had the quality
sensors, which
are old kit.
We were using the Kijian 24plex investigator QS kit.
Those also had the quality sensors in that as well.
That's one of the reasons why Verifiler Plus appealed to us so much.
Moving over, there were some differences just in the volumes used per sample,
but overall
it wasn't a difficult switch.
You've been online for about a year with the new workflow that you validated.
What benefits have you experienced from that?
We've actually been able to go paperless in part of our workflow.
From quantitation through CE, we have no paper.
This has brought up another project in which we are trying to implement LIMS
Plus DNA to
become paperless all the way through.
We are slowly making that journey piecemeal right now, but we have issued paper
less cases.
One of the first projects that came out of this was to implement a stop at
quantification
with both Verifiler Plus and YFiler Plus using the Y target in the quant trio
kit.
We are now currently looking at our serology procedures to determine whether or
not we
want to continue with and how much quant trio using the Y target and the male/
female ratio,
if there's any way that we can utilize that information to not perform ser
ological testing
on sexual assault kits.
That's what we're trying to determine.
We're trying to determine if we can use this information and if our serological
, our presumptive
tests that we currently use, if they're really giving us the results in autos
omal and in YSTRs
or Y testing, if they're really giving us what we think they should be giving
us.
That's where the quant trio comes in.
Jared, it sounds like this is a really large project with a couple of different
kits, a
lot of different instruments.
How did HPS approach this to be able to validate this project for the
laboratory?
You're right, it was a big project, Karn.
We approached it by just making sure that we're completely aligned with the
customer
and customer expectations.
When our account managers come to us saying our customers are looking for
assistance in
validating a new chemistry or new instrumentation, we then set up a
conversation with them to
understand what their needs are, what their potential gaps are in order to
formulate or
present a validation project to them that meets their needs.
From there, we can build out our pricing for those projects, our estimates for
them.
We work with them to make sure that that pricing and the project execution
align appropriately.
Then from there, we begin our what we call pre-validation stage.
With the experimental design, we partner with the customer.
We have them go through the experimental design as close as they want.
Obviously, everything that we've determined prior to the experimental design is
already
in there.
We want to make sure that there's everything in there that makes sense.
It's clear as to what we're trying to execute on.
Once there's agreement on the experimental design, we move into the wet work,
which is
where myself and a couple of other colleagues, which are our validation
application specialists
or VAS for short, will show up on their doorstep with our reagents and consum
ables.
We will attempt not to disrupt their workflows as much as we possibly can.
As Jessica mentioned, we were sharing a 7,500.
There wasn't really a complication or a difficulty with that one instrument
because what we try
to do in our validations is check in with a customer on a constant basis so
that they
know what we're working on, but then also to know what's on our schedule for
the next
day so that we can work around their schedules in case they do need the
instrumentation that
they need.
This was a large project, as we said, many a times.
We were there for a handful of weeks, generating a lot of data.
Once we have all of that data collated, we then take it with us and we pass it
along
to our global team who are responsible for the data analysis and report writing
Once report writing is concluded, it goes through an extensive technical review
and then the
reports are then delivered back to the customer.
That's when all of the information, all of our data that we've generated is all
put
into the report and put placed on Jessica's desk.
We give her time to review them, but we also emphasize that we are there to
answer any
questions about the conclusions, about the formatting, anything that might not
necessarily
make sense to them at the moment.
We are there to clarify and answer any questions throughout their report review
Once they're comfortable with reports, we then schedule what's called our teach
back.
This is where we go through all of the reports that we generated for the
customer.
We could go to the extent of if we also need to do an in-person training with
wet work.
We can show them the chemistry in-person in real time, set up some samples and
process
those through their workflow, their new workflow, and then review that data
with them in tandem.
Once the teachback is concluded, we are still there for them because obviously
they have
to get their SOPs online.
They have to do their competencies.
Even if our work is done in the lab and we're done presenting the data, we're
never done
supporting the customer throughout the entire process.
Even when they're online, they might still have questions that sometimes it can
take
up to a year to get online.
Jessica, in their example, it took them quite some time.
Thank you, COVID.
We're still there to answer any questions months, years after the project is
concluded
and they're online because we want to make sure that they're successful and we
want
to make sure that the work that we did is to their needs.
One suggestion that I would have is to listen to your analysts, the individuals
who are
in the lab day in and day out.
Listening to where their pain points are and identifying if something within
the physical
workflow could use an improvement or optimization.
Obviously, on the back end, when it comes to technical review and data analysis
, those
types of things could also be evaluated.
Automation, as Jessica mentioned, is another fantastic way of gaining
efficiency within
your laboratory.
You can break it down to individual sections of your workflow or you can look
at it at
a macro level and identify automation that can do all different stages of your
workflow.
Then you take them one by one and just break them out and say, "Okay, what can
we do to
make them better or how can we improve off of what we currently have?"
Obviously, we mentioned automation can help with efficiency.
Everything is on the table when it comes to identifying and optimizing your
workflow.
The good thing is, as someone like me who's been within HPS for almost 15 years
now, we've
seen a lot of different approaches to workflows.
I encourage anyone that has any gaps or any concerns within their workflow to
reach out
to us just for a conversation.
We love talking about validation.
We love talking about efficiency and optimization.
We don't have to come into your laboratory to do the work, but we do love
helping.
Again, it comes down to the success of the customer.
We want to make sure that everyone is capable to do the work that they're doing
for their
community.
That's all it really matters to us.
Well, thank you both.
I really appreciate you're talking to me today.
We can't end this portion of the webinar without recognizing the North
Louisiana Criminalistics
Laboratory for their recent award.
The American Society of Crime Laboratory Directors recently announced the
recipients of its 2022
Forsyte Maximus Award, a distinction that recognizes the top performing
forensic laboratories
in the world.
The award is presented annually to participant laboratories operating at 90% or
better of
peak efficiency and productivity.
Congratulations to Dr. Esparza and the rest of the team on winning this award.
Coming from the Forensic Lab, I can relate to many of the pain points we heard
today.
Where your lab is faced with a backlog, implementing and validating new
equipment, training your
workforce, or just optimizing what you already have.
I am thrilled to know that many of these challenges are growing increasingly
easier to address
and to be part of the solution.
The Thermo Fisher Scientific Human Identification Team is committed to
supporting our partners
and customers to help make the world a safer place.
We've listened to and collaborated with Forensic Labs to deliver products and
services to meet
their growing needs from new offerings to automated workflow processes like the
soon-to-be-released
HID Nimbus Presto.
The HID Nimbus Presto automates the extraction and purification process.
The robot combines the pipetting expertise of the Hamilton Nimbus with the high
-quality
yields of the King Fisher Presto.
That also includes the chemistry of the Applied Biosystems Prep Filer Forensic
DNA Extraction
Kits, which are specifically designed to improve the quantity and quality of
DNA isolated for
forensic samples.
The HID Nimbus Presto wraps this all into a 90-minute walk-away solution.
Thermo Fisher's Y-Screen Solution is another great example of a workflow
improvement that
we have helped many labs implement.
This involves utilizing a quantification kit with a sensitive Y marker like
Quantifiler
Trio to replace traditional serology for sexual assault samples.
This can save a great deal of time and money, as shown in this comparison.
And to bring it all together, our HID Professional Services is there to help
with any of your
challenges with its expertise, commitment to efficiency, and educational
services.
Thanks everybody for attending today, and thank you very much to all our
speakers.
I'm going to hand this over to Michelle now for a live Q&A, so send in all your
questions.
A special thank you to all our speakers for their interesting and informative
presentations
just now.
We do have time for Q&A, so if you have a question that you haven't already
submitted,
please go ahead and do that now through the Q&A panel on your screen.
And while we wait for everyone to do that, I have a few polling questions for
you.
So our first polling question, what area or areas are your greatest need for
automation?
Q&A Lysis, Automated Differential Lysis, DNA Purification, Quantification Setup
, Normalization
SGR Amp Setup, CE Setup, or even all of the above?
Go ahead and answer that, and then we'll see what everyone thinks.
All right, it looks like 19% almost 20% for DNA Purification.
How good that is Automated Differential Lysis.
That's super interesting.
All right, we will go to our next one.
Which area or areas do you think could benefit from the support of HID
Professional Services,
validation and performance checks, widescreen, consultancy and operational
efficiency programs,
implementing automation, lab relocations, flash renovations, accreditation
support, or
SOP development?
Go ahead and input your answer and let's see what everyone thinks.
All right, it looks like we got pretty even split here between implementing
automation
and validation and performance checks.
Not too far behind is consultancy and operational efficiency programs.
Our last poll for the day before we go ahead and get to our Q&A, would you like
to receive
more information on today's webinar topic?
All right, thank you so much for your participation in those polls.
I see there's a bunch of questions coming in now, so we're going to go ahead
and get
those started for you guys.
So I'm going to tap in town, meet air.
I am.
All right, we got a bunch of questions.
So our first one is how long does the validation process take?
That question is best directed to both either David or Jared.
I think both of them might have something to say.
David, can you give us an idea of how long the validation process takes?
Hi, everyone.
Sorry, the validation process.
It takes, on average, something between, say, from having an agreed work of
scope to a completion
from our side as in a delivery of, so a final report from a HPS service.
It's an average between 12 and 14 weeks, depending.
But it's highly dependent on the scope of work, how many things you wish to
implement,
whether there's automation involved in this as well.
And so there's a lot of bunch of variables.
But for a typical standard validation, it's around 12 weeks.
And just with Jared on the spot, do you have anything to add to that?
Does that sound about right to you?
I can't.
Now, I would agree with David.
It definitely is dependent on the scope of work and how much it is that you are
requesting
validated and performance checks.
So I think his range is accurate.
Yeah, it's just all about the size.
Perfect.
Thank you.
Well, our next question is, how many samples were used for validation of the
rapid hit ID?
And was it just reference samples or were they forensic samples?
I think David would be a good person to answer this question as well.
Also, something I had a con given exact number.
And I know that we went through several different sort of validation processes,
things like,
you know, making sure that the thresholds were validated.
And to do that, we would use hundreds of samples, literally hundreds of samples
And if I were to sort of return it back to a typical validation that we would
perform,
we wouldn't actually use that many samples, but we would use a mixture of
samples to the
obviously challenge system, depending on what is interesting and what the lab
wants to run
on these instruments.
And so it really depends again on the situation and how it's used, but it was
definitely a
thorough validation.
But like that.
So I know Jared has done a couple of validations of RHID here in North America.
Do you have an idea of the sample number and type for the validation you've
done, Jared?
The amount of validations we've done based off of either using a certain or a
combination
of both.
I mean, we varied drastically to how little to how many samples and the
different types
of samples that we process.
It's hard to give you a number to be honest, Karen, but what we do for these
validation
services is we absolutely consult with the customers to identify what sample
types they
want.
And then we just work with them to kind of build out that subset.
And then once agreed upon we execute on that on the services.
So it can range.
It definitely can range and it comes down to the comfort level of the customer
and how
they want to present that validation moving forward once we're done.
Thank you.
You're welcome.
All right, next question, we'll fly through some of these.
When it comes to bone DNA extraction for human identification, what kit manual
or automated
instrument is the best?
What do you recommend?
So I'm going to go to David because he talked about bone extraction and let him
take this
one as well.
Sure thing.
So when it comes to bone extraction, PrEPFIDRA BTA is our go-to kit.
BTA stands for bone teeth and adhesive.
So it's definitely the kit that we would recommend.
The automated express is also quite good for bone.
So that's another system that you could use and that's semi-automated, let's
say.
And we have the HID numbers presto that is right now forming quite well with
bone as
well.
So take a quick.
It depends on the sample, throughput, for example.
And having that discussion with us to understand what it is that you would need
to do is certainly
the best of just steps to go.
Would you say that the manual process versus the automated process, one of
those has advantages?
Potentially I think automation will give you a more standardized result, right?
Because there's less of a human interaction and that's one of the benefits from
having
an automated platform.
So I would say potentially, but in most labs I would also recommend that you do
some testing
to find out what it is that works better for you.
Sounds good.
All right, thank you.
All right now, Corinne, how about a question for you over there?
How are Thermo's educational/teachback trainings delivered?
Well, that's a good question.
Just like everyone else, during COVID we had to scramble to figure out how to
deliver
our trainings.
We'd always done them traditionally in person, visiting the laboratory and as a
big production,
which is their benefit to that, but there's also some drawbacks to it, which we
found
as we pivoted to virtual trainings during 2020, we found that offering a
virtual option
to laboratories gives them more flexibility and the ability to choose what they
want.
If they want an in-person training, they can get it.
If they want to be more flexible as far as scheduling and even budgeting, they
can choose
that as well.
So we have both virtual and in-person options available for people who are
looking for training
from us, whether it's teachbacks or other more in-depth training on kits or
instruments.
Perfect, thank you.
David, you're up again.
I'm interested in getting automation for my lab, but I don't know where to
start.
How do you work with vendors like Hamilton on these big projects?
Would I go to Thermo first or Hamilton?
David, could you help our user here?
Well, finding the right solution is important.
So at first, I'd just come to team your local summer fish team, right?
So they can manage the FAS and they'd be able to organize a discussion with the
correct
people that some are fisher to establish what is needed.
We have a good relationship with Hamilton, and so depending on what you need,
we can
build a list of requirements together.
In the case of the HOD members press, though, however, some are fisher will be
able to apply
that automated platform directly from September this year, making purchasing
easier, and it
will also be installed and supported by summer fisher.
So that's one of the confusing issues taken care of.
That platform will come validated already with PrpFila BTA extraction chem
istries, and
it has a simplified interface, making it really easy to implement and run.
And further to that, you will also be able to use that platform for quant and
amplification
setups from next year, which makes it quite easy to install, quite easy to use,
quite
easy to run, quite easy to validate.
So it's a really nice platform that's coming up.
Perfect.
Thank you.
All right, Dr. Ali, let's get you in here.
We've got a really interesting question for you.
All right.
All right.
So the benefit of doing work yourself is that you become familiar with the
material
and the data, right?
So are you concerned that your analysts may not be as familiar with the methods
since
they did not do the validation work themselves?
All right.
Not necessarily.
It doesn't have to be that way.
Even if they are not doing the hands-on work in the lab, the basic process
within the
work that the HPA team does is very similar to what my analysts would be doing
during
their case work.
So the workflow remains very similar.
And it's through the Teachback sessions and the detailed reports that will come
out at
the end of the validation study that will really help to get the analysts on
board and
informed about the results and finding findings of the data in those reports.
So I wouldn't say that it would be something that's detrimental or there would
be a lack
of understanding of the reports and their findings if they don't do the work
themselves.
The analysts obviously know a lot about how the experiments were done.
So I think through the Teachback sessions and the reports they can get meaning
out of
them and actually utilize them in their case work.
So that makes sense.
Okay.
Thank you for answering that.
Now Dr. Esparda, we have a couple questions for you here.
So we'll bring you into the combo.
How are you able to pay for HPS to come for such a big service?
I fear they're too expensive for our small lab, so they're one user.
What is your advice there?
We were able to use backlogs, grant money to help pay for it.
Oh, that's awesome.
Okay, so that's something to consider, audience.
Were there any surprises when you worked with HPS?
No, only one of the things that we had to do was with the new PCR amplification
kit,
Verifiler Plus, we did have to submit that to end for approval before we could
use the
case work.
So that was one of the biggest obstacles that we dealt with.
Well, and that and COVID.
So.
Yes, the ever present COVID obstacles.
Okay, perfect.
Thank you.
I gave it, we got a couple here for you again.
David, is it more difficult to validate automation than manual workflows?
What should labs be aware of that might cause problems that are unique to
automation?
I don't think that automation is that much harder to validate than manual
processes.
I think part of the issues that people have is that they, it's a bit of an
unknown, right?
And they have less experience with automation.
And one of the things that we really need to keep in mind is that the
instrument has to
be set up correctly from the beginning.
It, a lot of attention needs to be made in the initial setup to make sure that
when you
come to do the validation, what you're seeing as a result is not as a cause of
a problem
with the instrument.
But once you get your instrument up and running and you can get those samples
coming through,
then it tends to be just as easy as manual.
Perfect.
All right, so it's not harder, which is great.
But what would you say is the easiest automated workflow to validate?
I mean, is it better to validate a full workflow all at once or do it in stages
one step at
a time?
I'll answer the second part first.
One step at the time is probably a nicer way to do it, just so that you have
control
all over your workflow.
It also depends if you have a backup workflow.
You can then go and rely upon should something go wrong or something take
longer than expected.
So once the time is fully safer, and it depends on the expertise you'll have to
hand as well.
If you have a very experienced team who have been doing this a lot, then it
might go that
a little bit faster, a little bit easier.
And in terms of what the easiest way to make it work for to validate, I'm a
little bit
stumped here, I don't think there's any easy or hard systems really.
Like I said, I think it just comes down to the teams working on there.
If it's a very inexperienced team, it's all going to be difficult.
I think I wanted to pass this one over to Jarrat and C.V. has any further
thoughts.
You got it.
Yeah, it just depends on the scope of what it is that you are wanting to do.
As David said, you can break it down and kind of focus on each individual.
If you look at it from a total perspective, obviously, then you're starting
from start
to finish.
You can kind of capture any variation as you go along through the workflow.
But yeah, I would echo what you said, David.
I mean, it just comes down to the conversations with the customer, with the
specialists to
identify the best forward approach, because each step of the workflow has its
challenges.
And obviously, they're quite different between the different stages, but their
challenges
nonetheless.
So it's hard to really say which one's harder, or it's also difficult to say
what system
or what platform would work better.
It all comes down to identifying the need and ensuring that whatever solution
is out
there meets that need.
Perfect.
Thank you both of you.
Hi, Carne.
We have another question.
If you're using the trio kit for quant to replace serology testing in sexual
assault
cases, do you use the sample directly for DNA extraction?
And what is the sample selection criteria there?
So there's a couple of different options.
What you're talking about is what we're calling a "wise screening," so that
rather than doing
a serology test on a sample, you can screen a swab to determine whether male
DNA is present
using the quantifier trio kit.
Our wyestreen assay has you take a small portion of that swab, about a tenth of
the swab, and
test it using quantifier trio, and then only carry forward the swabs that had
male DNA
detected.
What we recommend you do at that point is take the remainder of the swab, the
portion
that was not tested for screening, and actually extract that using a
differential extraction
if you think semen is present or a normal standard extraction if you don't, and
evaluate
those.
There are some laboratories that have a slightly different approach, and they
will extract all
of the samples, quantify them, and then stop that quant for anything that doesn
't have
male DNA detected.
So both of those technically are the same process.
And it's very effective because serology is, in a lot of sense, is less
sensitive than
our QPCR kits.
And also serology only detects things that are body fluid based or enzyme based
and not
DNA.
So touch DNA that might be present would be missed by serology.
To determine which sample, when you're using sexual assault samples, I would
say you're
looking primarily at a lot of swabs in the kit.
So this is most useful to screen your swabs, and then you can also add in a
quick serology
test, maybe an AP screening for acid-bostages, to help you determine which sw
abs you want
to screen if you don't want to do all the swabs in the kit.
Hopefully that answers your question.
Absolutely.
Thank you.
And we have time for one more question.
So Dr. Ali, we're going to turn it to you.
It's an important question.
Why did your lab adopt SWIG DAM guidelines?
All right, so the simple answer is to adopt the binary method for proper
interpretation
and statistical testing.
So binary method involves setting thresholds, like analytical thresholds to
determine whether
it's a real allele or not, and then setting stochastic thresholds where we can
establish
whether it's the right genotype for the contributor that we are looking at.
And also because of the PCR tests that we are using right now, like RoboFiler,
there
is characteristic status that you can see at each locus.
And the statidator that we have enables us to distinguish between real alleles
and non-elibis
peaks.
So using the binary method, which is the self-damn guideline of 2017, the most
recent version
is the one that we've adopted because the workflow and the results that we have
in our
lab matches closely with what we can do with that data.
And that approaches what we are -- is the main reason why we adopted the SWIG
DAM guidelines.
Perfect.
Thank you so much.
Now that wraps up all the time we have for Q&A today, so I'd like to thank our
fantastic
presenters as well as their most vicious scientific sponsor for today's webinar
In 24 hours or less, this webinar will be available on demand if you'd like to
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Additionally, you will receive an email with a URL to obtain CE credit
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your participation today.
This webinar series will continue throughout the year, so please keep your eyes
open once
registration begins for the next one.
And until then, thank you so much for attending today, and we hope to see you
very soon.
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