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korchek

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Everything posted by korchek

  1. korchek
    Any bedside transfusion system must be cleared by the FDA. All cleared devices can be found at http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm134987.htm The vendor should be able to give you a BK #.
  2. korchek
    We have validated them. They seemed pretty straight forward.
  3. korchek
    How about "Transfusion Talk"
  4. korchek
    Korchek Technologies has the CareChek product suite that does more than the Bridge product.
  5. korchek
    Positive identification systems that use bar-code scanning at the bedside for transfusions are considered blood bank software. Make sure that your vendor is cleared by the FDA.
  6. korchek
    Thanks for all your information. My main concern is that the software manufacturer themselves are now doing the validations and this was written into the contract with the sale of the product. Will the software makes disclose all/ any problems associated their product? Will they test it outside of the scope of what their product does? This is my main concern. Of course I think the best way is to validate it yourself but if you don't have the staffing an 'independant' consulting group would be my next choice and that would not be the company that created the product.
  7. korchek
    Please don't advertise in the forum.
  8. korchek
    Mobea- We have done hundreds of conversions of all different vendors and departments ranging from Donor, Transfusion, AP, Radiology, Laboratory... and more. We have also performed validations of Donor Doc and e Donor for several institutions. Feel free to contact us with any questions you may have. You can review our services at www.korchek.com or you can contact me directly at lori@korchek.com.
  9. korchek
    I am not sure how they present it to the end user. I would not be comfortable with the vendor telling me everything is OK, don't worry about it. Would you?
  10. korchek
    I don't think you will have much choice with web based systems. BBCS may have one. Most of the large vendors like Wyndgate, Cerner, Sunquest, Soft are client server and will probably be costly.
  11. korchek
    How does the FDA feel about vendors validating their own software? Isn't independent review a covenant of Quality Assurance? Mediware started by restricting who can validate their systems. Now Wyndgate has followed in their footsteps by offering validation through PeopleMed, another Global Med company. Don't these companies have a vested interest in how their software is tested? The blood bank does not even know this is happening because these services are buried in contracts that are signed in the "ivory tower". Blood bankers need to be involved with selection process and contract negotiation.
  12. korchek
    You must be more specific. Delphyn is not a known blood bank system in the US.
  13. korchek
    Most sites use a third party to validate their computer systems. In the long run it saves time, money, and a lot of aggravation.
  14. korchek
    We work with many Cerner clients in building their system to accomodate ISBT as well as validation of their ISBT component. There are several ways in which you can handle this. Feel free to contact us: Korchek Technologies www.korchek.com 203-452-8295
  15. korchek
    Cleansing of data can be done during the migration. We have Cerner consultants that can handle this migration and give you solutions how to cleanse it.
  16. korchek
    Facilities should be ready whether or not their supplier is ready. We have transitioned many facilities and it is always best to be prepared rather than delay the inevitable.
  17. korchek
    Your best bet is to get a new computer system. There are very few live sites
  18. korchek
    Our company performs validations for many different Blood Bank systems. Our execution phase is a 12 week process from the time we receive access to your system to completion of the validation. If you plan to do in house and have to create all your test scripts, this process may take longer depending on the amount of resources you have on this project.
  19. korchek
    Donna, I work for a consulting firm that specializes in the Validation of software that is used in hospital blood banks. Part of our validation process is to provide a Risk Assesment of each functional requirement within the system. If you need any additional information feel free to contact me. Lori Giannetta Korchek Technolgies 203-452-8295
  20. korchek
    You cannot do a risk assesment on the whole upgrade. You should break it down by processes and do a risk assessment of each step in the process.
  21. korchek
    I belileve Meditech used to market a product like this through other companies. We offer the CareChek Patient Identification system that uses barcoding for positive ID for specimens, blood products, and medications. It is one of three ID systems cleared by the FDA for blood products. Gregory Francis Korchek Technologies 877-567-2435 greg@korchek.com
  22. korchek
    We have implemented Meditech upgrades. Contact Lori Giannetta, Director of Operations, Korchek Technologies, 203.452.8295
  23. korchek
    Softbank is a very good system. Company and support are very good. Only drawback is that there are too many different ways to do the same thing.
  24. korchek
    Validation guidelines issued by the regulatory agencies state that the software must be validated as it is intended to be used. Unless you plan on using software to enter your day to day results into the software you are not validating the intended use. Who validated the software that is doing the validation?
  25. korchek
    So many considerations to cover. Interfaces, validation, data conversion, where to start? Email me if you want to discuss.
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