Medical Technology is not always the lab bench, automation,
staining slides, or reviewing quality control data for testing
procedures, although these are some of the activities this Clinical
Laboratory Scientist enjoys doing in my line of work. Sometimes
there are other duties as assigned just like in all work activities,
professions, and positions held by productive citizens across this
great nation.
One of the most challenging activities I have had in my experience
as a laboratory manager has brought both vast enjoyment and disdain
although at different times. As a Laboratory Manager at a large
laboratory servicing the pharmaceutical industry, part of the job was
to tour the laboratories with auditing teams from pharmaceutical
companies then field the questions as they inspected procedures,
documents, and assorted lab data. The laboratory was a show
place and was on display for everyone and anyone who wanted to take a
look-see. During an audit of the laboratory, anything was game,
nothing was off limits, and no question was too stupid or complex to
answer. Sometimes auditors had great questions to ask, then
follow up questions, assertions, inquisitive speculation either
refuted or validated. Sometimes the questions were ridiculous
or off base. An audit is different from an inspection for a
laboratory. The most common type of inspection for a laboratory
is a CAP inspection; [College of American Pathologists].
This is where an inspection team is put together with clinical
laboratory experts and standardized established check lists are used
to inspect each section and department of a laboratory facility.
The CAP inspection team shows up on a random day within a 3-month
window. Department of Health inspections are even less fun.
A representative from a state run DOH like New York State, visit the
laboratory for 1-3 days and pour over everything and question
everything that is done as if it is incorrect and you have to prove
otherwise. Audits are neither inspections or certification
processes. They are wild games of show me this , show me that,
why did that happen...and also everything and anything the auditor
wishes to ask and see. Nothing is off the table. Audits
are done by customers at the facility of the vendor.
I have had the pleasure of sitting on each side of the table as an
auditor and as the one being audited. Both positions are
tedious hard work requiring exact attention to detail and exhaustive
attention to the matters at hand. There are no winners or
losers from an audit process. The amount of background data or
backup info required to satisfy the auditor can be minimal or
downright horrendously voluminous. The end result of a good
audit or inspection is the sharing of ideas, gained expertise and
possibly a better way to do something in your own lab. Give and
take of experience between auditor(s) and the vendor lab can be
rewarding. Sometimes it can be awful and just plain stupid!
One example of an audit from hell that I can give is a two person
female audit team from a well know old school pharma company which
visited for two days. One lady was pleasant, did not talk much
but assisted the other nasty one to help explain what the crazy one
was trying to get across. Anyway, I was called into the audit
room to field questions which I frequently did for many audits.
Outside the audit room was the Metrologist and his manager; unhappy
they looked after being grilled over nonsense and abstract
questioning. Next it was my turn, they both said "Good
Luck" before I opened the door. Entering the room I was
looked up and down by the crazy one like I was being matched up
against a suitable sized Lion just big enough to overtake me but
small enough that I could last a few minutes before being devoured.
Or something like that - I knew I was in for it. One thing of a
cardinal rule though; the auditor is always right and you must remain
calm and collected at all times.
They can smell blood and attack
when vulnerable
- Your boss will be after you for smart mouthing the auditor
and you will be in hot water as the amount of necessary
documentation to satisfy the auditor(s) grows exponentially when
they are on a mission to hurt you.
After being sized up and exchanging niceties, names, credentials,
and brief discussion of what I did at the lab, then the games began.
At first, the questions were general about procedures being followed,
equipment maintenance procedures, quality control and such.
Then a question or two from the quiet one. Good questions
following up on the QC and maintenance theme. Then crazy one
started rolling her eyes, a blank stare on her stone face, I thought
she was going to turn green and spit pea soup on the wall! "Tell
me about calibrations of your equipment" she quipped? I
proceeded to tell her about frequency and procedure to calibrate a
hematology analyzer and she started to smile. A strange smile.
It was weird. Finally after 15-20 minutes of banter she smiles
and out of her mouth comes the ridiculous. She says, "Tell
me, who does the calibrations or better yet who is qualified to do
the calibrations?". I tell her I have two techs who
regularly calibrate the equipment every 3 months and that I am also
experienced and qualified to perform the calibration procedure.
Next was the knock down drag out of all follow-ups. She interrupts me
mid sentence to ask, "So- suppose you are on your way to work
one day and it is the day the instruments are scheduled to be
calibrated, and you come up to a railroad crossing and BAM! a train
smashes into your car and your splattered all over the tracks...how
are you going to insure the equipment gets calibrated the right
way?" I look over at quiet one and she is holding her head
down with a grin on her face. I look at crazy and say, "If
I am splattered by a train I guess it doesn't really matter, but in
my absence there are still several very capable laboratory scientists
here that can perform without me". A couple more
scientific related questions and I was dismissed by the quiet one.
Later that day she called me back for some more "abuse" and
then again the next morning before their half-day exit. By God
that was the weirdest off base, asinine auditor question ever
asked of me.
Most audits were enjoyable though with our visitors asking good
questions with a flavor of respect and admiration. You don't
mind responding to those types of people all day long. Probably
one in six auditors thought they had something to prove - A "Hired
Gun" sort of attitude. Some of them gave the impression
that they were paid well and they had to bring back to their customer
lots of damage. The auditors that were actually employed by the
pharma companies were for the most part respectful and not on a
mission of seek and destroy. "Quiet one" and her
partner "Crazy Lady" were not hired guns. Crazy was
just a nasty B*otch.
On the other side of the table, a most memorable audit I conducted
at another lab was at a lab conducting esoteric testing. I had
three days with a manager from my own QA dept. to review this lab.
What fun I had. I did not go there with the idea of seek and
destroy but sometimes either at an audit or CAP inspection, you will
see something wrong and so you dig and dig and dig, follow the trail,
and dredge up everything wrong in its path. Well that is what
happened to this poor highly respected, well known specialized
testing laboratory in the mid-west. Some problems I observed
right at the start even during greetings and the tour of the
facility; eating in the specimen prep areas, CO2 tanks not secured,
and staff carrying specimens uncovered in the elevator with us as we
rode down to the lower level where specimen receiving was located.
Open plates of food like a party was going on just steps away from
open specimens on lab benches. That was just the first 20
minutes during introductions. My job was to look over SOP's for
the lab procedures, look over safety issues, analyzer maintenance and
testing, and anything related to such subject matter. The QA
manager was to review facility general, general SOP's, business
practices as it pertained to our contract and so forth. I
started with the analyzers performing the bulk of the work this lab
did for my organization. Record keeping was sloppy, maintenance
documents not identified with each unique instrument ID so I could
not tell what document belonged to which instrument nor what
maintenance and care was done to each instrument. Then onto the
DI water used for the assays. The water quality testing was
spotty at best and not completely up to CAP standards. Then the
pipettes which had not been calibrated/checked in over a year.
I reviewed documents for the last 5 years! Unlabeled reagent
bottles and undated open containers of reagent, water, and supplies
out in open visibility on lab benches. These are big No-No's.
Right then I had enough documentation to suspect that every lab
result this lab supplied for my organization was in doubt at best and
not to be trusted at worst. I had people very upset. A lab
supervisor retreated into the ladies room for a good cry. The
QA person hosting us tried to explain away the pipette calibration as
a mis-identification of the pipettes themselves like the analyzer
maintenance records. Then, I checked for software upgrades for
the analyzers and what was done post upgrade to validate the
equipment back into service? Nothing was done? I was questioned why
this was important. I then got a visit from the Lab Director.
All of this was before lunch the first day. During lunch in a
common break room I was introduced to various company principles and
got lots of stink-eye from employees. I guess I will never be
invited back. After lunch I ventured into more scrutiny of the
water quality procedures, analyzer maintenance, and training records
of the staff performing the testing. More insufficient data,
incomplete data, missing data which was promised by next day.
In all, I cataloged 67 issues requiring backup data or supporting
documentation to prove that this lab was not the shoddy appearance I
was getting in a two day visit. Yes, some issues were minor but
when you add water quality, pipette maintenance, and shoddy analyzer
records together that is very bad laboratory practice. My
laundry list of issues took almost 6 months for this lab to come up
with supporting documentation and some issues just could not be
satisfied. Responses addressing the issues consisted of staff
training, more detailed documentation, and timely adherence to
maintenance procedures. The most common explanation given in
response by this lab was "Absence of Supporting Documentation".
I have also participated as an inspector on a CAP inspection team
many times. Those types of inspections are tedious and
sometimes very sad. The Lab being inspected must respond to
each finding documented. Findings are items not meeting the
specification as per the checklist for each section of the lab
facility. It is rare but possible that a lab can lose CAP
Certification status because of egregious or numerous findings.
I have never had the displeasure of being inspected by the FDA and
wish never to be under that type of serious scrutiny. FDA can
shut down a lab on the spot or impose serious sanctions and severely
limit services a lab can provide. Not fun!
Anyway - Inspections are a great tool to maintain quality in lab
work for the industry as a whole.
If you are going to be inspected here are some tools to help you
get through a trying experience...
Plan ahead - Review all your
procedures months in advance of the open window for your inspection.
Get your documentation in order
and have it readily available. Being able to supply
documentation quickly and in presentable fashion raises the
confidence of the inspector/auditor that everything is mostly ok
instead of mostly in shambles.
Review checklists or frequently
asked questions and have that documentation ready such as
calibration data, temperature records, maintenance records, etc.
Frequently, inspectors will ask to see INR/Prothrombin calculation
data.
Get training records organized and
ready. The inspectors get to choose what/whose records they
want to see so they all better be in order.
In the weeks before you CAP window
opens, tour the lab yourself, ask your staff question like you are
the inspector...this will help prepare them for the event instead of
them running to the bathroom when the inspection team shows up.
Check, check, and double check
your documentation, your lab signage, and your reagents. Check
to make sure everything is labeled as appropriate per regulation.
Come up with an action plan before
the inspection happens. I would sit with my staff and assign
duties to each for when the inspectors showed up. I knew I
could count on them to quickly review maintenance and temperature
charting for that morning, reagent labeling, and general clean up
around the lab. Printouts of critical calibration data like
PT/INR would be printed and ready to show. Anything that could
frequently be asked for - have it ready or set to be ready when the
inspection team arrives.
Don't panic - stay calm - and be
friendly. More conversation = less time the inspectors have to
run through your stuff and be all up in your grill with issues.
Be assertive but don't offer "extra" information.
Answer questions like you are a witness on the stand. Answer
exact and to the point. Nothing extra. Don't be
responsible for leading an inspector into your hidden problems.
Don't cheap out on lunch.
These people are taking time to volunteer to do an inspection of
your lab. There is a great amount of required training and
prep work the inspectors must go through to prepare to inspect your
lab. Treat them well.
- Treat every workday like a potential inspection day.
Get your staff in the habit of being prepared for an inspection at
any time not just at that time of the year. This will help
your staff cope with the event and prepare them to be calm and
poised to answer questions confidently and interact with the
inspection in a positive way.
Good day my friends ~ take care ~ be prepared for success.
Scott Mayorga BS MT(ASCP)H
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