Home Grown Computer System..HA

[Pailloz]

Please do not laugh.

After recently being shot down by finance for my bugeted proposal WYdgate system, my pathologist would like ME to BUILD a blood bank system on an excell or access frame. He is dead serious.

After almost laughing in his face, and explaining the vast compexities that have to do with Blood Bank computer systems, he is still relentless.

While I am flattered to know he thinks I am that smart, I need to get him some heavy duty CBEr, FDA, regulations, links,......ANYTHING. to explain what these system involve. ANd that this home grown idea is just not a reality.

ANy idea would be greatly appreciated

Right now we are still usualy manual record, logs, carbon paper, etc.

and while this old fashion method is slow and tedious, I am truly afraid of what his imaginary:eek: Blood Bank system may look like.

Elizabeth

[blut]

Elizabeth - Wow! Please tell us you are kidding...

The pathologist is dangerously out of touch with reality. As you say, he has no understanding of the complexities. Moreover, from a risk management perspective, your facility's legal counsel would nix it in a second!

Both CAP and AABB require that the laboratory information system has been validated for blood banking/transfusion medicine activities.

Some resources:

1. FDA - General principles of software validation (Jan. 2002)

http://www.fda.gov/cdrh/comp/guidance/938.html

2. ISBT Guidelines for Validation and Maintaining the Validation State of Automated Systems in Blood Banking (2003) -just to show it's worldwide:

http://www.isbt-web.org/guidelines.pdf

3. For what's required and standard functionality, see CAP Today's 2004 review of blood bank information systems:

http://www.cap.org/apps/docs/cap_today/surveys/1004_BloodBankSvy.pdf

Cheers, Pat

TraQ: http://www.traqprogram.ca/

Teaching: http://www.ualberta.ca/~pletendr/

Consulting: http://www.patletendre.com/

[CLIMBER514]

Elizabeth...

Once you have successfully designed, scripted, compiled, validated and implemented your homegrown BB-LIS... you can then quit your job and start selling your software worldwide. Please tell the pathologist that such a request is simply impossible... even a software designer would need a great deal of time and help from a TEAM of many people. This guy is off his rocker.

-Tyler

[T. McIntyre]

Elizabeth, we developed a Microsoft Access program to fufill our needs in our transfusion service. We do not track donors, perform electronic crossmatches or anything that needs to be validated according to NY-DOH. The program tracks the units that we recieve and the disposition of each unit. If you would like more information please contact me at terry.mcintyre@viahealth.org. It is a in house system that we have continued to develope over the past six years and has served us well in terms of unit tracking. Our central hospital has used the Wingate system for several years but the system was never purchased for our smaller rural hospital where we do over a thousand transfusions a year. We needed something that our budget would not support and this alternative has worked well for us.

Terry McIntyre, SC(ASCP), MCSE

[Lcsmrz]

Assuming your operation is quite small, it seems possible to develop a small in-house BB computer system from off-the-shelf software that performs no control functions, but you'd have to be very careful not to start relying on it in the future as your primary source of records in the future.

It wouldn't be much more than an automated BB Clerk, and you couldn't start cross-checking blood types at XM or issue time, tracing and tracking things, or archiving data with it -- in other words, pretty useless ...

[T. McIntyre]

We track and can trace all units recieved, the disposition of the unit and to whom it was given, etc. We use this system as an adjunct to our HIS and our Blood Banking records. We do not perform electronic crossmatches, we crosscheck blood types with our hard cards, when available. All of our data since 1999 is online and immediatley available to us and is backed up daily by IT services. If there is a product recall, we can locate the unit information quickly. If we want to see if a patient has recieved any previous units by us we can easily find that information. In addition, the query function allows to compile monthly stats which previously had been performed manually and which are not available through the HIS. You may call it useless, to us it is an affordable alternative that has saved us countless hours, and big bucks, since we started using it. We would have liked to have had the top shelf software available but, we made do with what we had available at the time. Currently the system is tracking over 11,000 components that have come through our transfusion service and over 8,000 patients with multiple encounters. The program speaks for itself and the price was right!

[Kochman]

Terry

You state "We do not track donors, perform electronic crossmatches or anything that needs to be validated according to NY-DOH." This causes me concern because there are FDA requirements for use of software in the blood bank, whether you are only registered or are licensed.

Please see 21 CFR 211.68 and, more importantly, Compliance Program, Chapter 42 - Blood and Blood Products, Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001 (Issued 7/18/2003), Attachment H at http://www.fda.gov/cber/cpg/7342001bld.htm#attH. This is the guidance that invesitagtors use when conducting inspections of blood establishments. They will be looking to "Determine which operations are computerized and how the user validated the computer system on-site to demonstrate that it performs the intended functions accurately and reliably." Others who have used Off-the-Shelf Software (OTSS) (as software such as Microsoft Access is called) have found that it does not always perform as they expected it would.

Elizabeth,

The following quotes, also from the Compliance Program referenced above might help you convince your pathologist that his idea is a bad one.

"All software, including software developed in-house, used to manufacture blood and blood components, or to maintain data for making decisions about donor (suitability) eligibility, release products for transfusion or further manufacture are devices under Section 201(h) of the FD&C Act. The device provisions such as: registration as a device manufacturer, product listing, medical device reporting and compliance with the quality system regulation and pre-market notification 510(k) or application apply to the device software manufacturer."

"FDA has previously advised blood banks to transition to either a cleared software product or to one for which a manufacturer was actively pursuing clearance or to submit a plan to convert its in-use computer software."

"Blood establishments that developed software for their own use and that did not ship it interstate are subject to the Quality System Regulation requirements (21 CFR 820), the CGMPs for Blood and Blood Components (21 CFR 606), and the CGMP’s for Finished Pharmaceuticals (21 CFR 211)."

"FDA deems a blood establishment that develops software for its own use as a medical device manufacturer and; therefore, subject to the Quality System Regulation."

I hope this helps!

Sheryl Kochman

Chief, Devices Review Branch

DBA/OBRR/CBER/FDA

[T. McIntyre]

Sheryl, thank you for your input and the FDA links. We are a small transfusion service that uses this program to track the receipt and disposition of components. We do not rely on this program to select units for transfusion, nor does the program perform any interpretative functions. It is strictly an electronic record of the units that we recieve and the final disposition. We have included patient data, which is manually input from the BB hard cards, so that the final disposition reflects to whom the unit was given.

[Pailloz]

Thank you to everyone who has given me valuable information. While my pathologist is clearly out there, the higher ups have listened to me in the absurdity of his request. In good part due to the feedback and emails you have provided her, i brought to them much data supporting my proposed of Wyndgate. Hopefully it will be approved on the 2006 buget!!

thank you to all