Blood Bank Validation

Following the International Society for Blood Transfusion (ISBT) guidelines for Validation and Maintaining a Validated State, BC Solutions has developed a unique methodology that reduces the total validation testing time by 50% to 60%, or as much as 500 labor hours.

In our Operational Qualification (OQ) Validation, Transfusion or Donor software is validated against a set of User Requirement Specifications (URS) which describe the processes and safety checks expected from all Blood Bank or Donor software applications.

Using worst case scenario testing, we stress the system by targeting high risk areas that could potentially cause harm or injury to patients or donors if undetected.

Operational Qualification (OQ) Validation

  • IQ - Installation Qualification
    - Validates software and hardware installation
    - Qualifies equipment, databases and operating systems
  • OQ - Operations Qualification
    - Ensures system meets all requirements
    - Stresses riskiest system components
  • PQ - Performance Qualification
    - Demonstrates process is meeting all requirements
    - Includes your staff
    - Provides validation of your SOP’s

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Cerner Millennium Pathnet®

Functions & Workflows Validated:

  • Critical System Messages
  • Combine
  • Correct Inventory - Demographics
  • Computer Crossmatch at Result Entry and Dispense
  • Department Order Entry
  • Discern Expert Rules
  • Dispense, Emergency Dispense, Return Products
  • Final Disposition
  • Modify Crossmatch
  • Modify Products
  • Product Patient Compatibility
  • Receive Products
  • Result Entry
  • Release Products
  • Quarantine Products

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Haemonetics ElDorado Donor®

Functions & Workflows Validated:

  • Prohibiting Factors
  • Donor Registration
  • Medical History
  • Physical Exam Results
  • Blood Collections
  • Component Manufacture
  • Component Modification
  • Disease Testing Management
  • ABORh, Antibody and Other Testing
  • Donor Merge
  • Deferral Codes
  • Special Requests
  • Donor Doc
  • Shipment
  • Transfusion Reactions

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Haemonetics SafeTrace Tx®

Functions & Workflows Validated:

  • Prohibiting Factors
  • Delivery
  • Component Modification
  • Derivative Management
  • Electronic Crossmatch
  • Patient Administration
  • Order Management
  • Patient Merge
  • Product Issue
  • Product Test Batch
  • Results
  • Selection, Issue and Return of Products
  • Shipment
  • Multi-Site or Centralized Transfusion Service
  • Transfusion Reactions

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Mediware LifeTrak®

Functions & Workflows Validated:

  • Registration
  • Donor Deferral/Donor Interdictions
  • Donor Eligibility
  • Donor Health History
  • Donor Merge
  • Donor Physical Findings
  • Donor Notifications
  • Special Donation
  • Labeling
  • Component Attributes & Interactions
  • Component Production
  • Component Production – Aliquots
  • Component Production Modifications & Conversions
  • Component Production – ISBT Pheresis
  • Laboratory testing: ABORh, IAT, CMV, HLA, & Disease marker testing
  • Material Check-In
  • Pack Products including Reject, Expired, Recovered plasma, and
    Research products

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Mediware HCLL™

Functions & Workflows Validated:

  • Exceptions
  • Electronic Crossmatch
  • Emergency IssueDerivatives
  • Issue of Products
  • Multi-Facility
  • Neonatal Management
  • Patient Registration & Admission
  • Patient Orders
  • Patient Test Results
  • Patient Merge
  • Product Receipt
  • Product Modification
  • Product Testing
  • Valid Patient ABORH

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SCC SoftBank®

Functions & Workflows Validated:

  • Test Resulting: Patient Orders, Inventory Orders, Result Worksheets,
    Mother/Baby Link
  • Patient Transfusions
  • Patient Maintenance Admit
  • Patient Maintenance Merge/Stay Merge/Stay Move
  • Patient Maintenance Link
  • Patient Edit Demographics
  • Patient Multisite
  • Patient History Review
  • Patient Orders
  • Inventory POS Select
  • Inventory POS Issue
  • Inventory POS Emergency Issue
  • Inventory IN/Out Delivery
  • Inventory IN/Out Batch Delivery
  • Inventory IN/Out Unit Recall
  • Inventory Edit Status 
  • Inventory Edit Unit
  • Inventory Segment
  • Inventory POS Create Products
  • Inventory Edit Create Products
  • Inventory POS Return
  • Electronic Crossmatch
  • Bit-Locking
  • Management Exceptions

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SCC SoftDonor®

Functions & Workflows Validated:

  • Donor Demographics
  • Donor Deferrals
  • Donor Edit
  • Donor History Review
  • Donor Eligibility
  • Donor Visits
  • Donor Physical Examination
  • Donor Questionnaire
  • Donor Phlebotomy
  • Confidential Unit Exclusion
  • Test Orders
  • Test Results
  • Worksheets
  • Labeling
  • Inventory Receive
  • Inventory Ship
  • Inventory Recall
  • Inventory Status Change & Edit
  • Management Exceptions

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Sunquest Blood Bank™

Functions & Workflows Validated:

  • QA Warnings and Failures
  • Blood Administrative Data
  • Blood Component Preparation
  • Blood Label Check
  • Blood Order Processing
  • Blood Order Processing Worklist
  • Blood Product Issue
  • Blood Product Entry
  • Blood Product Testing
  • Blood Status Update
  • Blood Status Correction
  • Blood Testing Review
  • Computer Assisted Crossmatch
  • Linking
  • Merges

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The R.F. Nozick Validation

The R.F. Nozick OQ Validation Program was developed by a team of Blood Bank experts and laboratory clinicians who understood the need for an efficient system of validation that could save laboratories valuable time and resources while maintaining a high degree of patient safety. This program is what our company was founded on.  Our passionate team of Blood Bank "Ninjas" are committed to providing an impartial third party validation because they know the importance of the work you do, and systems you rely on.

With the R.F. Nozick OQ Validation Program, you can rest assured you are audit ready and operationally safe for your patients.

Elements of the R.F. Nozick Validation:

RF Nozick Blood Bank Validation
RF Nozick Blood Bank Validation

System Review – Secure remote access allows us to evaluate our client’s system design while looking for inherent risks to patient safety.

Regulatory Requirements – By matching regulatory requirements (FDA, AABB, ISBT, EU, etc.) with system functionality, we not only ensure a compliant system, we also provide complete traceability in an easy to understand matrix that links the user requirements to the testing scenarios performed.

Risk Assessment – Each software function to be validated is evaluated by our team and subsequently rated as high, high-moderate, low-moderate, or low risk. The URS and risk assessment is subject to client approval prior to the start of validation and will guide the scope of the testing scenarios performed.

Test Plans – Client specific OQ test plans are developed by BCS subject matter experts. Test plans are designed to ensure all applicable high and high-moderate user requirements are validated.

Validation scripts are then executed by following very detailed test steps. System responses are evaluated by the implementer for adherence to user requirements and regulatory compliance.

Screen captures of the results are recorded, providing physical proof that the individual function has been validated. The screen capture files are permanent verifiable evidence of the test case performance and result.

Matrix Analysis & Validation Report – In addition to a formal final report, clients also receive our Matrix Analysis Document that links each requirement, test script, screen capture and test result in a clear format that makes it simple for an auditor to review.

The final report describes the validation process, strategy, results, and includes any problem forms generated because of non-conforming results. This report along with the Matrix Analysis is provided electronically (CD or USB drive) to our client.