CLIMBER514

Would it be a big deal if you were a FDA inspector and noticed that a site was running two different versions of software in a live environment? Say, for instance the server software was on 2.1.5, and the client software was on 2.1.3. Would it be the responsiblity of the hospital/donor center to make sure the correct versions were synched? OR Would it be the responsiblity of the software company to make sure there functionality built into the software that ONLY allowed server version 2.1.5 to talk/communicate with client version 2.1.5. Curious what your opinions are... what you would do if you discovered such a problem in the midst of implementation?

We are currently implementing HCLL to replace our Hemocare system... If I was to make the decision again - I would select the same vendor (Mediware). One thing to consider is if the new BB-LIS uses a SQL database. This will allow for more robust reporting and versitile use of your data... without having to master a proprietary database format. Your IT department will appreciate this. Another big issue is - having your data accessible in the event of a downtime. We found that Misys Blood Bank could not provide downtime data in an acceptable format... HCLL mirrors essential patient information to a desktop PC (called the APBC) which allows techs to access the data VERY easily in the event of a downtime. Your techs will appreciate this. I also caught wind that Misys Blood Bank had an FDA recall - you might want to research this a bit more...

We are currently implementing HCLL to replace our Hemocare system... If I was to make the decision again - I would select the same vendor (Mediware). One thing to consider is if the new BB-LIS uses a SQL database. This will allow for more robust reporting and versitile use of your data... without having to master a proprietary database format. Your IT department will appreciate this. Another big issue is - having your data accessible in the event of a downtime. We found that Misys Blood Bank could not provide downtime data in an acceptable format... HCLL mirrors essential patient information to a desktop PC (called the APBC) which allows techs to access the data VERY easily in the event of a downtime. Your techs will appreciate this. I also caught wind that Misys Blood Bank had an FDA recall - you might want to research this a bit more...

Curious if anyone has implemented digital signatures for SOPs in their blood banks. We would like to go a more paperless route in our blood bank. Part of this would involve SOPs to be routed, reviewed and digitally signed by out pathology group and blood bank manager. We would like to use Adobe Acrobat coupled with Verisign PKI signatures to ensure document and signature integrity. Is anyone aware of any guidences surrounding signing and review of SOPs that would address digital signitures?

The FDA is suggesting an overhaul of an 18 year old regulation that determines the frequency of platelet donations. This has the potential to decrease donations by up to 50% and potentially increases medical costs to those receiving the blood. In my opinion - changing this regulation does not offer any additional level of safety to donors or patients. I knew about the suggested ruling about a week before I read this link on Yahoo: http://news.yahoo.com/s/ap/20060225/ap_on_he_me/donating_platelets You might consider contacting/petitioning the FDA and/or getting public support via contact with the press. This makes our jobs even more difficult and compromises our commitment to supply platelets to the community! Lets standup and say NO to this new proposed regulation!

BACKGROUND: We had the best practices databases loaded standard at our site in Denver, CO - but had some difficulties getting thawed FFP to successfully pool. We had always been attempting to pool thawed FFP. We had been starting with FFP 18201 and have been successful in thawing to FFT 18900. The problem arose in the last half of the pooling process - where the drop down did not work to display the pooled FFT product 18900 as a new product code for pooled plasma. The steps that we took to fix this: *Product Code File Maintenance: a product code had to be built for 18291 Fresh Frozen Plasma Pooled THIS TABLE WAS CONFIGURED AS: Facility; Product code = 18291; Product Code Des = Fresh Frozen Plasma Pooled; Component Class = 040; Product Group = FFP; Product Cellular = N; Check Truth Table = N; Calculation = N; Expiration Hours = 4; Product Expiration = H; Allow Mod = Y; Unit of Measure = mL; Automatic = Y; Codabar = 18291; Split Exp = 4; Split = Y *Product Process File Maintenance: this part was in place showing product code 18900 associated with process PLS-A *Product Process System File Maintenance: the 'system' had to be built for product code 18900 undergoing process PLS-A to become product code 18291 THIS TABLE WAS CONFIGURED AS: Facility; Product Code = 18900; Process Code = PLS-A; System = OPEN; New Product Code = 18291; Change Exp = Y; Exp = 4; Product Exp = H For more tips and tricks like this... VISIT: http://www.hcllusers.org

Our Hemocare system maintains a list of triggered errors which can be exported... (lists user, error type, time...) Additionally - Mediware maintains a database of all problems... in the past they have been nice and mailed a list of our call log, problems and solution... when we asked for it.

The HCLL users board has a new article on possible enhancements that maybe included in the Spring 2006 release. To find out more and to VOTE on your preferred enhancements go to: http://www.hcllusers.org/modules.php?op=modload&name=News&file=article&sid=22&mode=thread&order=0&thold=0

Much work and research has gone into the HCLL Users Board. This site is intended as a sounding board for users to collaborate, communicate and ellucidate various issues as they pertain to the Mediware HCLL software. Please visit the site if you are an Hemocare Life Line user. http://www.hcllusers.org

Has anyone utilized automated software scripts as part of a information system validation? We would be internally developing our scripts per our configuration... but are there third party applications that will specifically test HCLL or Misys? We will be validating a new Blood Bank information system, and had thoughts of utilizing software scripts to automate a certain percentage of the process. For instance - with a manual method - you might be able to test number and alpha values for a certain field. But with software scripts, you could automate this and test 0-9 & a-z without feeling like you are wasting a real person's time. Plus, it eliminates potential for human error. As for validation of the validation scripts... this is irrelevant since the product of the script would be evident in the validation itself. The Visual Basic script would drive the same applications, processes and keystrokes that a normal person would. I think it would lead to a more comprehensive validation and be a better attempt to 'break the system'. You could also use these scripts to attempt to max out system capacity. Imagine testing your system to determine the effective threshold of for the max number of patient inqueries, etc.? The advantage of running software scripts is - you can pre-program every conceivable combination of events - hit the record button in an application like Camtasia - document the computer actually running each combination (with preprogrammed pauses, etc. to simulate real workflow)- while you are in the lab attending to your mounds of paperwork.

http://www.medicaltechnologists.org A site that includes up-to-date news and articles for the medical technology community - as well as discussions on a wide variety of topics. This is a newly created site.

Anyone have comparable consultant fees for: Interfaces Temp workers Our interface person is charging at $100 per hour... for BB-LIS, LIS and HIS interface work... We are looking at bring on temp workers to cover bench while other techs work on the BB-LIS implementation for a 3 hospital system... we have found that temp agencies are charging $60 for temp techs... Any comparable market analysis in other cities ?

Hi... we are possibly migrating to a new BB-LIS. Has anyone used a consultant as a project manager before? Can anyone recommend a firm or individual consultant? We are looking at $175 per hour as a hefty consulant fee and would like to see if cheaper alternatives are available. Thanks, climber514d@hotmail.com

John - we are migrating to HCLL as well... Let me know if you need anyone to write customized reports for any of your facilities... I'm pretty good at Crystal Reports and SQL based reports.

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