First inspection as chief tech. Am I going to be nervous for the next 3 months?

[Kathy]

I have been the chief tech at my current employer for 1 1/2 years. Prior to that I was a blood bank tech for 20 years. I know blood banking, but having only been a chief tech for a short time, I know that there is a lot that I don't know as far as regulations and performance improvement. As such, I fully expect that the inspectors (AABB/CAP) are going to find something that I have missed. I did do my self-inspection and I know we are strong in some areas and need clarification in others. It is impossible for me to fully address everything in the short time I have been there and with so many other things going on (new hospital computer system with CPOE, four new pieces of equipment, laboratory move within the inspection window period...).

The window period starts Monday and I have been nervous for the past week. I know who my inspectors are, and due to their education level (SBB and master's degree), I am already intimidated. I am very hard on myself when I am criticized, so the virtual certainty that they will find something (no matter how minor), is going to be difficult for me emotionally. I do know that this is a great learning opportunity, so I look forward to that aspect of the inspection.

Is there anything that will help make this time easier for me so that I can calm down and stay focused, rather than being on edge? I would much prefer to just get this thing over with, but I doubt they are going to come earlier in the inspection cycle.

[Deny Morlino]

Kathy,

First breathe. From your presentation you seem to be very focused and a perfectionist to an extent. This is a mixed blessing as you are meticulous about the details, but drive yourself crazy at the same time. Relax (I know easier said than done). The end game of the inspection process is to improve patient safety throughout the transfusion process. With that approach in thought process none of us are perfect or do everything correct all of the time. With 20 years of experience and 18 months as chief tech, you are going to handle the process fine. Inspections are intimidating until you have been through several. The point of the inspection is not (usually) to pick apart your facility. It is to point out the places where there is room for improvement in your processes. Hang in there. I am sure you will do fine.

[David Saikin]

Deny has hit the nail on the head. It's not like you are going to be personally ostracized. The process should be educational - for both parties. Don't hesitate to rebut a proposed deficiency, either to the inspector or the regulatory agency. You know your operation and what works. If you feel you are within the standard you can rebut - the inspector is not always right. Worst case is that you have to adjust a process/procedure. I have found that I win the rebuttal about 60% of the time. EXUDE CONFIDENCE in your operation - even if you are not - it will make your staff feel better. Even if you have a disastrous inspection you don't have to fix everything immediately. You will have to have an implementation plan and implement it but not within the 30days.

I am certain you will do fine. I ALWAYS leave a little something for the inspector to cite (but hey never find it). You want them to find the stuff you have missed. That is one of the positive points of an inspection. It should improve your operation. I have performed very few assessments/inspections where I discovered zero non-conformances. Most of what I find are paper fixes to updated standards . . rarely anything that impacts patient care/safety. Don't sweat it!

[SMILLER]

kathy

I can only echo the nice comments made here. Its natural you are feeling a bit jumpy.

If you have been working for a while, as a tech you have already gone through a number of inspections. And inspections reflect on and impact everyone in your organization, not just the management. You must already be aware from those previous inspections that things usually go better than one expects. As management, the only difference will be that you will have more of an active role in the inspection and whatever follow up is necessary. On my first inspection as a manager, I found that as I became engaged in the process, any nervousness i had anticipated seemed to be less and less of a problem for me.

So on the next inspection, you should be even more at ease! (or at least, relatively less uneasy!)

regards, Scott

[Liz]

They say walk, jog until the you are so tired the anxiety/worry is gone. It works. I believe in the breathing method too. Yoga, meditate. The inspectors btw are stressed

Its all alright believe me NO ONE IS OUT TO GET YOU. and please dont be the one to criticize yourself. You definitely are a perfectionist and thats hard to live with, be easy on yourself. You seem to be doing a great job!

[Kathy]

Very useful advice from all of you. I will definitely work on thinking of this in a positive way, increasing my confidence level, and adding more exercise. It looks like we have a few more standards to work into our policies, so I will be working on that as well.

[Dr. Pepper]

I've been on the giving and receiving end of many inspections, and I will echo what everyone else has said. Breathe deep, relax, and I'm sure you'll do fine. It's an educational experience for both parties, the only goal being to improve your services. The worst that can happen is that they find something (usually minor) amiss, you correct it and everyone moves on.

[OxyApos]

Ditto the others advice. I would also add being very organized for the Inspector's benefit. I make a spread sheet with every single question and the "answer" to the question. Page numbers in the procedure manual that address xyz, where in the file cabinet, etc. I have print outs of everything that wants documentation with the TRM # on it so they can reference it on their own. I have had over 10 inspections with this approach and its gone great. This is all in an envelope that I can then just hand them after their arrival.

Good Luck.

[Dr. Pepper]

Ditto the others advice. I would also add being very organized for the Inspector's benefit. I make a spread sheet with every single question and the "answer" to the question. Page numbers in the procedure manual that address xyz, where in the file cabinet, etc. I have print outs of everything that wants documentation with the TRM # on it so they can reference it on their own. I have had over 10 inspections with this approach and its gone great. This is all in an envelope that I can then just hand them after their arrival.

Good Luck.

As a CAP inspector, this makes the process go SO much easier! I do the same thing with a notebook. It's also helpful to have in your notebook, folder etc the other odds and ends documents: agreement with blood supplier, agreement with your medical staff, FDA approval of blood warmers, strategy to reduce TRALI, nursing ed documentation, and so on. I also have in the front of my notebook an intro letter in case I am not there and instructions as to what notebooks, manuals etc to have available for the inspector.

[Eagle Eye]

All great comments. I would recommend same. Have SOP# written next to each questions so when the inspector is asking you a question, you can say it is in policy Ln-1, pg 2. They wil be impressed. If there were any non comformances, please make sure they were corrected and as inspector do look at them. Also if any PT failure (hopefully none), make sure you have root cause analysis done and ahve documents ready. All your validation, please make sure you have signature of your medical director/designee. New staff training: please make sure you have 6 month & 12 month evaluation documented for them. Any new equipment---make sure validation done and you are doing PMs required by manuf. also have reference ranges on the forms or in SOP(need to make sure staff knows this).

Do not forget regarding standard 1.5, have the sign posted in the lab and make sure the staff know what does it mean.

I am sure you will do fine.

Once the inspectors are there tell your heart, " I am fine, I did everything I could" and stop worrying about anything you missed. instead focus on the day, have paper and pen ready, write down what the inspectors are requesting and give them what they are asking for.

DO NOT TRY TO WASTE THEIR TIME. LOTS OF INSEPCTORS DO NOT LIKE THAT THEN THEY THINK THAT YOU ARE TRYING TO HIDE SOMETHING AND GETS IRRITATED.

Good Luck....

[Jody]

Kathy-

You have been getting some very good advice. I would like to add one more suggestion. If you have inspectors that are willing to let you watch them review your critical documents, please do. I had a great FDA inspector that showed me how she reviews temperature charts. It was very enlightening. Now, I use a process similar to what she showed me as my monthly review of the temperature charts.

Best wishes. My AABB inspection is this week. Needless to say, I understand the stress!

[Liz]

Ditto the others advice. I would also add being very organized for the Inspector's benefit. I make a spread sheet with every single question and the "answer" to the question. Page numbers in the procedure manual that address xyz, where in the file cabinet, etc. I have print outs of everything that wants documentation with the TRM # on it so they can reference it on their own. I have had over 10 inspections with this approach and its gone great. This is all in an envelope that I can then just hand them after their arrival.

Good Luck.

Yes absolutely, we do that!!

[martha]

I have been the chief tech at my current employer for 1 1/2 years. Prior to that I was a blood bank tech for 20 years. I know blood banking, but having only been a chief tech for a short time, I know that there is a lot that I don't know as far as regulations and performance improvement. As such, I fully expect that the inspectors (AABB/CAP) are going to find something that I have missed. I did do my self-inspection and I know we are strong in some areas and need clarification in others. It is impossible for me to fully address everything in the short time I have been there and with so many other things going on (new hospital computer system with CPOE, four new pieces of equipment, laboratory move within the inspection window period...).

The window period starts Monday and I have been nervous for the past week. I know who my inspectors are, and due to their education level (SBB and master's degree), I am already intimidated. I am very hard on myself when I am criticized, so the virtual certainty that they will find something (no matter how minor), is going to be difficult for me emotionally. I do know that this is a great learning opportunity, so I look forward to that aspect of the inspection.

Is there anything that will help make this time easier for me so that I can calm down and stay focused, rather than being on edge? I would much prefer to just get this thing over with, but I doubt they are going to come earlier in the inspection cycle.

Kathy, Relax! I have no doubt in my mind that you will do good. Have confidence in your team and in your self.

[MAGNUM]

When I took over as the BB supervisor here, I really got thrown into the mix. Within 6 months of accepting the position and taking over I went through my first CAP inspection for a department that I was in charge of. What a sigh of relief when it was finally over and I had no deficiencies to fix. I too am very hard on myself, so I take it as a personal affront when I receive deficiciencies.

[Eagle Eye]

And I hope your hire ups are appreciating your hard work!!!!! Becuase many times they use you and will get you out once their need is over!!!

[John C. Staley]

I may have missed someone else mentioning this so here is my 2 cents worth. You are not alone, I'm making the assumption that you have a competent staff. Allow them to help shoulder their share of the burden. You did not mention the size of your facility but I'll make another assumption that you have department supervisors and most of them have been through the process before. Let them do their job. You concentrate on the parts of the inspection you are immediately (not ultimately, but immediately) repsonsible for. Then share that with others as well. The more people who are aware of the details of the inspection process and involved in it the better.

Most of all, view it as a learning process but remember that the inspectors are human and have been known to make mistakes. I found it worked best to not challenge the findings immediately but when I was putting together the final response to the written findings.

Good luck and always remember: "They can't kill and eat you. That's against the law!"

[Mabel Adams]

Even if they have fancy degrees and certifications they are not smarter than you nor more valuable humans. They still put their pants on one leg at a time. Most of them won't think that they are superior to you so don't decide it for yourself.

Figure out what is the worst thing that is likely to happen and realize that you can manage it. No one will die, as John says.

We had a "knucklehead list" for our recent inspections. It reminded us to do the basic things we all know need to be done: documentation of temperatures, competencies etc. etc. I guess your self-inspection probably covered that.

[Kathy]

Thanks for more great advice. I have everything you guys mentioned...the spreadsheets, competencies, validations, documentation, etc. and I have a very competent team. My medical director also looked over my spreadsheet and made a few comments which I addressed, so it looks like I am good to go.

[Likewine99]

You will be fine and after the intros are over and you actually get into the lab your anxiety level will come down, I guarantee it. A wise friend of mine once said that when an inspector asked her a question and it either appeared that she was going to be cited or that she didn't know the answer she asked the inspector, "how do you do this in your lab" knowing that she was probably doing it fine in hers but was sort of trying to find out where the inspector was going with the question.

And another wise friend of mine said, "answer the question (and shut up!)" Don't overthink it, just answer the question the best you can. I agree with the others, organization is the best advice. If you look prepared they will know that you are. If your policies and procedures are neat, look nice, etc that will also go a long way on the first impression. If you do get a deficiency you can always contest it if you feel that it is not appropriate.

I've participated in inspections on both the receiving and performing side and in the true spirit of the inspection process, try and learn as much as you can on inspection day.

Good luck, go get 'em and keep us posted.

[SMILLER]

Yeah, Likewine's about not overanswering a question from the inspector is kind of a classic. Most of us have a tendency to over explain things when dealing with co-workers in healthcare. But you do not want to volunteer too much info to an inspector if you can help it!

Scott

[goodchild]

Thank you for posting this Kathy. I am in a vaguely similar situation. Our FDA inspection is coming up in a few months and I'm not really sure how you prepare for an FDA inspection. CAP was easy to prepare for; I just had a copy of the checklists that listed the applicable procedure/documentation references that answered each checklist requirements. How do you handle an FDA inspection? This will be my first one from the more administrative (as opposed to bench-tech) side.

[Liz]

as mentioned above: DO NOT VOLUNTEER INFORMATION and JUST ANSWER THE QUESTION AND STOP. You may suddenly even get comfortable but be careful at that point NOT TO BLURT OUT things that you shouldnt or things that will lead him/her to ask you certain things. Stick to his questions and be short and have back up docs if he asks. and agree on things that you will refer to your director, we did this as certain things were ordered but had not arrived.. so that works.

[David Saikin]

Thank you for posting this Kathy. I am in a vaguely similar situation. Our FDA inspection is coming up in a few months and I'm not really sure how you prepare for an FDA inspection. CAP was easy to prepare for; I just had a copy of the checklists that listed the applicable procedure/documentation references that answered each checklist requirements. How do you handle an FDA inspection? This will be my first one from the more administrative (as opposed to bench-tech) side.

The FDA wants to see that you: 1. Follow the CFR regualtions and 2. Follow your own policies and procedures. If you do donors, they will want to watch a collection (from start to finish, though your donor may ask them to NOT attend the history/physical); they will want to see that you handle your collected units as per your SOP; all units that should be discarded are (according to your policy). cGMP training on all staff involved; they may ask for any BPDs you have (they will know so don't hold back); Do Not offer more info than they ask for. They will want copies of policies/procedures and possibly pt/donor information - they are entitled to all of it. They like to see that uncrossmatched rbcs are ultimately crossmatched. If you are computerized, they may want to see your validation studies or at least see that you performed them.

Their process is a lot more congenial than it used to be. My FDA inspectors for the past 20 yrs have been great - actually helped my operation improve. Don't be daunted - when they come they may be in uniform, they show their badge/credentials and will want to speak with the Medical Director or supervisor. You will receive a letter stating you are being inspected . . . and a f/u letter or citation a few weeks/months later. High anxiety for the first one, after that it should be easier.

[adiescast]

Not much to add to this great advice except this: in addition to not over talking, give the inspectors what they ask for and no more. You get a list from AABB of things to have ready, so that part is easy. Procedure manuals are generally presented as a whole. If the inspector/auditor/surveyor asks for component receipt records for May 16, 2012, give that to them. Do not give them records from the entire month of May. As it is said, Murphy is on the side of the inspector. If there is one paper in a file with an error on it and they put their hand into the file and pull out a piece of paper, it is highly likely to be the one with the error on it.

On the other hand, I had a record that showed that a unit had been over irradiated. It was circled in red and had notes all over it. An FDA inspector reviewed a pile of papers that had that one in it and did not ask or say anything about it.

Remember that you are the content expert for your facility. You are experienced and knowledgable. Treat the inspection as an interesting new experience and not as a judgement on yourself or your facility. Even if you have a lousy inspector, being open, honest, and curious can get you through.

[PAWHITTECAR]

Kathy,

I know how you feel. I just took over here last month, my first technical supervisor position after 18 years as a bench tech. Our "window" opens January 1st. I'm scrambling around madly to try to get things up to par. They were without a Blood Bank technical sulervisor for 5+ months so a lot of stuff was not done. I've even got a procedure manual that hasn't been reviewed in a couple years and antiquated procedures that have not been revised since the 90's.

I will send good thoughts your way if you will do the same for me:o