WEBVTT

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So change control is important
because you want to make sure

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you know what you changed
when you changed it, why you changed it.

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It's not just documenting, okay,
I updated this procedure at this time.

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So change
control is really a theory or a process.

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So you go through and you say okay,
if I change this, what's going to happen?

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Does it in fact
does it affect anyone else in the company?

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So if I change how I'm testing platelets
or when the timing of when I do

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the bacterial testing on the platelets,

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that's
going to affect the courier service,

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because they're the ones that come

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and bring the blood
to the transfusion service.

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So you have to look at everything
as a whole.

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Do we need to change procedures? Do.

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If I change something we're probably going
to need to, train the staff.

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So you want to make sure that you have
time to get staff trained and everything.

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So it's kind of,
a process that you go through.

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It's not just a form or a log that
you would fill out for change control,

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because you want to make sure
that you're changing everything in a way

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that improves and doesn't
cause more problems, because if I reformat

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a form, for instance, or change
something in the computer system.

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So I build a new test
and the computer system

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and the analytes used to be

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in order
that they came off the instrument.

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So it was always matched one, two.

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And I'm asking the computer one to
if the I.T people switch that and techs

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are used to putting things in exactly
as they come off on the analyzer.

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I have a potential for switching result.

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So you want to make sure
everything is reviewed ahead of time

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and that you're making the best change
possible and don't change

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just for the sake of changing.

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So validation
all agencies, all the inspection

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agencies that we've talked
about have requirements for validation.

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So you have to make sure
that you validate your process

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and then it's working correctly.

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And equipment validation is pretty

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no brainer.

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Yes I get a new piece piece of equipment.

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I obviously have to validate that.

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But in transfusion service
you also have to validate procedures.

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So I changed that procedure.

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So I want to have someone or multiple
people go through and follow that

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procedure and make sure what I wrote
actually make sense is what was written.

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What you actually do
to complete this task.

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So you have, document validation.

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And then so these are just the different

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requirements under Cap for validation.

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And blood bank validations.

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So you do an initial validation.

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So I get this new piece of equipment,
I get this new analyzer in.

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So obviously I'm going to validate it.

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But when do you have to revalidate.

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So if you have something that is repaired,
so is there any kind of major

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repair on an instrument
that may affect that instruments.

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Output.

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Did I move it?

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How far did I move it?

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Are there anything with moving it
that would matter

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if I had it plugged into this socket,
and I plug it into that socket.

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Is that going to affect anything?

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Do I need to revalidate it?

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Maybe.

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Is the equipment designed to move.

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So we do, therapeutic plasma

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exchanges or regular exchanges?

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The blood services staff
do it here in the hospital.

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So they have equipment that is designed
to roll to the patient's bedside.

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So if I move that equipment,
I don't need to revalidate it.

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But if I move an analyzer
from one place to another,

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then I probably do need to validate it.

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So what is the validation process.

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So you have to write a plan.

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You have to know how you're

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going to validate it
and what is acceptable before you start.

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So I'm going to validate this.

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And I expect that the temperature must be

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in this refrigerator plus or minus
one to the standard thermometer.

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I have to know what is acceptable
before I start doing it.

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And then you

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have your plan approved,
and then you perform the validation.

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You compile and look at all your data,

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you resolve any discrepancies.

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Sometimes it fails and it's like,
this isn't going to work at all.

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We need to start over.

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So then you would start the process again.

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You would rewrite a new plan,
get the plan approved

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and go through that way.

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And then you would write a validation
summary.

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And the validation
summary has to go through and get approved

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with all the people above,
plus the medical director.

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And it has to be completely signed off

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before you can start using that equipment
or that process.

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And then you implement.

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So we do installation qualification.

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So I installed this instrument,
I installed whatever it is

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we do that we do operational qualification

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and performance qualification
and each validation that we do.

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And if we don't do one of these
we have to say why we didn't do it.

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So the instrument was repaired.

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It wasn't reinstalled.

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So if we're validating post repair
we may not do installation qualification.

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So we are going to document on the
validation plan why we're not doing that.

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So what do I validate

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validate
everything in transfusion service.

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So we have machines that make ice

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ice machines in the transfusion service
so that when they're sending blood,

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they put the ice with it
in the pneumatic tube so it stays

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at the correct temperature,
send it on its way.

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That's a pretty easy validation,
but you still have to validate it.

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Plug it in.

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Does it make ice does not pass fail.

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Other validations
are quite elaborate and long.

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But you have to have documentation
about why

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you're doing each validation
and what you're thinking is behind it.

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Before you start doing that.

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Okay.

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So standard operating procedures
we've talked a little bit about,

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but you want to make sure
that they are all,

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up to date and available.

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And they include every step
that you would need to know.

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And if there are any kind of downtime
procedures, you want to make sure

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that that's available.

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If there's a situation where I'm
not going to follow this procedure,

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what am I going to do?

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Where are you expecting
this person to look?

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You want to make sure that that's all well
defined and written down.

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All standard operating procedures
have to be reviewed

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by the medical director
before they're implemented.

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And every two years thereafter.

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So maybe just this year change
from annual review to by initial review.

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So they get reviewed with AP as well.

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Every two years.

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So the FDA doesn't say when you have to
review them or the frequency.

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They just tell you
they have to be reviewed.

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So we can go with the
AP standard there with biennial.

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So training, everybody must be trained

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and it must be documented,

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and it has to be approved
before you start doing anything.

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So if I do the module that says
I know how to issue

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blood, that's all I can do by myself.

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Until the training is documented
and approved by the supervisor.

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So competency assessments,

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once you're trained, we want to make sure
that you still know what you're doing.

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Once you learn
all the processes that you do.

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And this is required by clear.

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So competency assessment
must be done within six months,

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for a new employee
and then annually thereafter.

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So when you're a new employee you're going
to get two competency assessments.

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You're going to get one at six months.

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And it has to be six months,
not six months.

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And seven, you know,
six and a half months, six months.

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They're very strict about that.

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And then, at the year mark.

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So you're going to get to that first year

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and then every year
you're going to get it,

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competence
competency assessment each year.

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So if you were to switch, laboratory
say I was working in micro,

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now I'm going to go work in molecular

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or I was a generalist
and I'm going to only work in transfusion.

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You would be a new employee
for that laboratory.

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So you would be expected

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to have six months competency for that
first year after your transfer.

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And they want to make sure

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that you assess these five elements
when you're assessing competency.

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So can I review data.

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Can I problem solve.

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Make sure you have direct observation
that I'm watching this person

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perform this task.
And yes they're doing it appropriately.