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Please join us for a presentation by compliance expert Sudha Poosa.


It is critical to properly implement Laboratory Information Systems not just from an information technology perspective but with a clear vision of creating a safe and compliant interaction with all other hospital systems. To achieve that goal, the expertise of IT specialists must be complemented by the experience of clinical professionals. This helps create a system that not only complies with the letter of the law, but also fully integrates the Laboratory while improving patient safety, ordering, results, and billing.

This webinar covers 7 key components needed to ensure compliance in your laboratory.


To learn more about these 7 critical steps, register for our next free webinar!

“Understanding LIS Compliance: 7 Steps to Achieve Compliance”,

Thursday, December 17, 2020, at 1:00pm ET.

System Build & Testing

Pre-Validation Testing begins with a comprehensive database review that evaluates the system build and client specific software settings for errors, omissions and adherence to regulatory guidelines.


The BC Solutions team provides a summary of findings uncovered during the database review to the end user. Based on this information, the end user will perform the necessary adjustments to database settings prior to executing formal testing procedures. Systematic testing of database table settings are then performed providing verification of build compliance in specified categories.


BC Solutions has identified areas of Blood Bank software configuration that are “high risk” or “high build”. These are areas of configuration where build errors can negatively affect patient safety or where table builds require an unusually high amount of specific data that may be prone to manual data entry errors.

Categories for Testing:

Orders

Verification that orders and product requests are functioning as expected. Verification that when orders are placed in the Blood Bank software Orders application, they include all defined order components and can be accessed in the appropriate result entry application.


Receipt of Blood Products

Verification that defined product codes can be successfully received into Blood Bank inventory and that system default settings are applied to products upon receipt as expected. Verification that barcodes can be accepted using ICCBBA guidelines for the use of ISBT 128 barcodes. Testing includes receipt of Autologous, Directed, and Divided Products.


Product Modifications

Verification that defined product modifications such as Thawing, Irradiation, Dividing, and Pooling can be performed according to client’s procedures. Verification that ICCBBA guidelines for modification of blood products has been followed. Label verification of modified products is performed as needed.


Logic Tables and Test Interpretations

Verification of each valid line of logic defined for selected tables. Testing selections include ABORh tests, Antibody Screens, DATs, Crossmatch tests, and Unit Confirmation tests where logic tables are used to determine interpretation. Additionally, testing includes up to 10% invalid lines of logic designed to produce warnings and messages for invalid results.


ABORh Compatibility Testing

Verification of compatibility settings for all standard patient blood types. compatibility will be demonstrated in the appropriate application(s) for all product groups (Red Cells, Plasma, Cryoprecipitate, Platelets, etc.) and can also include Autologous and/or Directed products and Neonatal compatibilities where indicated.

pre-validation(unit)-testing-pdf

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 (480) 346-7011 

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System 

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Compliance

Data Conversion & Archive

System Integration Testing 

Other Custom Solutions 

 

Can’t find what you need? Call us at (480) 346-7011 or email us at info@bcsolutionsrfn.com. We probably have just the resource for your project.

System Build & Testing

Read more about our System Build and Testing solutions!

Setting up the system correctly means you get more value at go live. We help your blood bank and laboratory be more efficient while ensuring regulatory compliance. 

Formal Testing Procedures

High Risk Emphasis

Table Build and Testing

Database Review

Documentation & Summary

Workflow Optimization

Validation & Compliance

From required FDA blood bank validation to verification of functionality, our consultants are experts in providing the proof your system is operationally safe and audit ready.

Operational Qualification

Compliance Plans

Client Specific Test Plans 

SOP Consulting

Audit Ready Documentation

Database Review

Data Conversion & Archive

Experience is the difference when it comes to moving your data from one system to another. We make sure you have the data you need, where you need it. Change doesn’t have to be a challenge.

Extraction

MPI Conversion

Data Conversion Validation

Data Archive Solutions 

Translation Tables

HIPAA Compliant

System Integration Testing

Don’t let your process fall through the cracks. We test the system to ensure results set-up in complete and interfaces are working as designed.

Mapped Record Testing

HL7 Interfaces

Orders and Results

Billing Testing

Instrument Interfaces

Epic Certified Consultants

Custom Solutions

Time and resources are at a premium. Talk to us about your challenges and needs. We can find the right consultants to work for you.

Project Management

System Selection Consulting

Compliance Plans

Mock Inspection Audits

Training Services

On Site Consulting