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Surprise inspection schedule


Mabel Adams

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Ours was during the very last month and when we went and inspected another facility, it was also within their last month. I don't know if that is how they are all falling or it just worked out that way with us. Also, I'd look more for a Tuesday, Wednesday, or Thursday...

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We are due to be inspected by May 6th. We had to get our paperwork in to CAP by January 15th. We figure it takes a few weeks to get it processed and out to the inspection team. We also think we will be inspected toward the end of the cycle, especially if the team is from outside the region. It is difficult enough to get a team together without having to worry about possible cancellation due to snow days (you folks in Upstate NY are probably safe from inspections until July). As it turns out, most of our blackout dates are in April since there are several meetings (CLMA, and state BB association) as well as a school vacation week in April. We are thinking late March, early April, or the first week in May.

Has anyone had simultaneous CAP and FDA inspections? I just had FDA a few weeks ago so I am safe this time around.

Has anyone had a multi-day CAP inspection? One of our pathologists was on a CAP team last week and the inspection spanned two days.

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Our last CAP inspection was at the end of the last month in the cycle. We did an inspection recently and it was at the end of their cycle. I don't know if it usually works out that way or not.

I'm wishing I could do an inspection in upstate NY about now!! I miss the snow and one day would be about enough of a fix!!

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Most of the time it is one day for the main lab, but I have had 2-day inspections. In 2004 I had a coordinated CAP/AABB inspection that lasted 3 days. My FDA inspections are on odd-numbered years. I was 1500 miles from the lab when the FDA showed up in 2005. But that was okay, because when I got home 4 days later, they were still there.

BC

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  • 1 month later...

Our CAP inspection team arrived this morning. We are in Massachusetts and the team is from New Brunswick Canada. They plan on staying 3 days. We submitted our inspection materials to CAP January 15th and our due date was May 6th. They said they received the information we submitted to CAP pretty quickly.

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Our CAP inspection team arrived this morning. We are in Massachusetts and the team is from New Brunswick Canada. They plan on staying 3 days. We submitted our inspection materials to CAP January 15th and our due date was May 6th. They said they received the information we submitted to CAP pretty quickly.

Good Luck! Next three days will be too long for you but I am sure you will be fine.

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Three days is not a problem for us in Blood Bank. We have always had to deal with unnanounced FDA inspections, and they can last a lot longer than three days. The rest of the lab was thrown for a loop, though!

The inspection team is very considerate and are not taking up too much of our time. They ask for manuals, read through them then come to us with any questions. They are asking to see all the things they are expected to observe without interfering with our workflow. I would have to say spreading things out over several days is better than an inspector cramming everything into a day and then citing us for things they didn't see and assumed we did not have in place. This has happened to us several times, requiring that we submit documentation to get the deficiency expunged. In the end, we have always prevailed but it did not make for a pleasant experience.

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Yes, they certainly did ask about the wrong blood in tube issue. I showed them minutes from discussions that have been held with the trauma and transfusion committees. We made it perfectly clear that whatever we implement will be for ALL transfusions, not just non-emergent ones. Bedside scanning is still a few years away for us so for patients with no historical type we will most likely use the second blood type method if an initial stick type with anti-A,B is positive. If the physician can not wait for the second type, we will invoke the emergency release protocol. If testing with anti-A.B is negative, we will not require a new sample before releasing blood since we will be issuing Group O blood. We will still test a 2nd sample as soon as possible.

The inspector seemed satisfied with this. My feeling is that CAP will make this "plan" a "requirement" by our next inspection.

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I am about ready to take my patient RFID chip company public. I have hired a fulltime lobbyist to work on convincing the FDA, The Joint Commission (no longer called JCAHO), CAP, and AABB that the only safe way to identify a patient is with my RFID chip, inserted under the skin of the left eyebrow. I have brought Homeland Security into the picture also. They like it, but want to make sure it works with their new skin-deep x-ray system they are installing in airports. So far the chip doesn't appear to be affected by low dose gamma rays, although one of my chips, when exposed to 25 GY (yes, I used my irradiator at work), changed the patient's name from "John Smith" to "Mr. Ed."

BC

;-)

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Bob, this simply won't work.

What are you going to do with your repeat patient who has had his forehead blown off? Where is your chip then, huh???

Name me a body part you can attach it to that will never be injured or surgically removed. You can't even imbed it in the brain, as we all know of some people that seem to lack that organ. Keep trying. I am sure you will think of a sure winner yet.

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Ours happened on the last possible day, so it really was no surprise. We have conducted a few, and have selected Wednesday or Thursday for the day. The date we try to plan somewhere in the middle of their cycle. We have experienced relief on the part of the staff where we have conducted the inspections.

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  • 1 month later...

Our inspectors showed up at the Core Lab today:eek:. My lab director called me and said they were on their way but she wasn't sure to where. I wanted to run out of the building:cries:. Today was just not the day for them to walk in. Luckily they stayed downtown however, we can expect a visit on Wednesday:confused:.

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I have a theory that you can address any issue by using a quote from a movie line. Based on that theory, here is my reply:

Good luck! We are all counting on you!

And don't call me Shirley.

Now, for $10,000 and control of the board, what movie?

BC

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Darn, wouldn't you know my trivia reply started a new page. Anyone just joining this thread is going to think they are in the wrong place. To get back on topic, I wish donnelda luck with her CAP inspection. I hope you are not due for FDA.

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After my 2-week plus FDA inspection, I say bring on CAP, JCAHO, and AABB- all in one day if they want (although I already had those inspections earlier in the year).

Yes, Airplane! it is. I shouldn't have made it so easy with the "And don't call me Shirley" line.

BC

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The FDA is like the Texas Rangers- one lab: one inspector. This reference goes back to the story of a request of the Texas Rangers to prevent a prize fight in Dallas. One Ranger showed up. The mayor asked the Ranger, "where are the others?" The Ranger said, "Hell, ain't I enough? There's only one prize fight!" This evolved into the saying, "One riot, one Ranger."

BC

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