Saturday, June 15, 2013

Laboratory Inspections, Audits, Trains and Ridiculous Questions

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.
  1. They can smell blood and attack when vulnerable
  2. 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 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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