Don't Lose that FDA Form!

We get calls every week from past and current customers in a panic over paperwork. A Department of Health inspector has dropped in, and wants to see a copies of the 2579 form for the c-arm and the bone densitometer. A state Department of Revenue auditor is asking who paid the sales tax on the refurbished CT scanner the facility leased three years ago. Or you’ve finally found a serious buyer for the MRI you’re replacing, but before she finalizes the purchase, she wants copies of the software license codes, user passwords, and operator manuals.

What to keep and where to keep it – solving that (not-so-simple) problem about the new or refurbished diagnostic imaging equipment installed in your facility can save you lots of time, headaches – and money – in the future.

We know that it’s all too easy to get busy scanning patients – and garnering profits – with that newly-installed C-Arm or Rad Room. Paperwork, and filing it in the right places, is the least of your worries. But if you file the important stuff so you (or whoever might be in your job a few years from now) can find it when you need it, you’ll thank your busy self in the future.

Where?

Before we give you a checklist for “What,” here are few suggestions as to “Where”?

In the room with the equipment, preferably closest to the operator’s console.

In the Practice Manager’s office, or the head of the department.

In the care of one person designated solely for FDA and regulatory compliance.

Wherever you choose to stash away these treasures, be consistent about it. You might want to designate a cabinet in the room with the equipment, one that can be locked. Train technicians, IT personnel, service engineers, and other staff to know where the records are, and to be accountable for them. Check frequently to make sure they haven’t “disappeared.”

What?

Ok, so you’ve figured out where, and you’ve vowed to be as consistent with upkeep as you are about going to the gym everyday. Now, what items should you add to this trove?

Your FDA 2579 Form – This is the first, and most important, piece of paperwork you’ll need for your equipment. If you don’t know what that is, don’t worry – we tell you here(link is external).

Inspection Reports – keep copies of all paperwork from federal, state, and local inspections, as well as any Physicist reports that apply to your equipment.

Service Reports – always keep copies of installation and service reports provided by your service company

QA Reports or any reports related to performance

Software – any software disks that came with the equipment

Software key codes

Passwords and any user / service login information

Manuals – if you don’t want to keep bulky paper copies, ask your diagnostic imaging equipment provider to give you a copy on CD.

Small Accessories: Phantoms, Calibration blocks and plates, skin spacers.

Purchase paperwork – copies of original invoices, purchase agreements, lease agreements will have valuable information about sales tax obligations, warranty coverage, etc.

Equipment and site ID numbers (it’s a good idea to keep these in a couple of places – written down in your chosen “treasure chest” of important things to keep with your imaging equipment, and also in a spreadsheet)

The name and telephone number of who to call in case you need a service call

If you’re clutching your temples screaming “Help!” at the mere thought of keeping up with it all, just remember that an ounce of prevention is accomplished in far less time than a pound of cure.…..

We’ve here to help – and to get you started on your project: We’ve already made your Equipment Documentation Checklist for you! Just print it out HERE