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Lab Informatics
    Deep Dive
Business Processes - General
• Submission of Samples       • Results Evaluation
  • Metadata Recording     • Analysis Review
  • Test Selection         • Results Reporting
• Sample Scheduling        • Billing
• Sample/Test Assignment   • Management
• Analysis                    • Metrics Acquisition
  • Testing                   • Process Performance
                                Evaluation
  • Data Recording
Specific Challenges
•   Clinical Labs

    •   CLIA Regulations

        •   Pre-, Post-, Analytic Systems

        •   Other Test Specific Quality Requirements

        •   Personnel Requirements

        •   Images as results

        •   Pathology often requires interpretations

        •   HL7 Standards

        •   Medicare Reimbursement
Pharmaceutical
• PreClinical
   • GLP Regulations
   • Data Mining Support
• Development
   • QBD
   • Turnaround
   • Integration with Process Data
• QC
   • GMP Regulations (21 CFR 211, 606)
   • Electronic Records/Signature (part 11)
Device



• Similar Challenges to Pharma
• Quality Systems Regulations more advanced
Specific Challenges

• Environmental
• Government
  • DEA
  • Customs
  • Agriculture
  • FDA

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Li101 deep dive

  • 1. Lab Informatics Deep Dive
  • 2. Business Processes - General • Submission of Samples • Results Evaluation • Metadata Recording • Analysis Review • Test Selection • Results Reporting • Sample Scheduling • Billing • Sample/Test Assignment • Management • Analysis • Metrics Acquisition • Testing • Process Performance Evaluation • Data Recording
  • 3. Specific Challenges • Clinical Labs • CLIA Regulations • Pre-, Post-, Analytic Systems • Other Test Specific Quality Requirements • Personnel Requirements • Images as results • Pathology often requires interpretations • HL7 Standards • Medicare Reimbursement
  • 4. Pharmaceutical • PreClinical • GLP Regulations • Data Mining Support • Development • QBD • Turnaround • Integration with Process Data • QC • GMP Regulations (21 CFR 211, 606) • Electronic Records/Signature (part 11)
  • 5. Device • Similar Challenges to Pharma • Quality Systems Regulations more advanced
  • 6. Specific Challenges • Environmental • Government • DEA • Customs • Agriculture • FDA

Editor's Notes

  1. \n
  2. The first thing to be evaluated is what are the business processes involved. Here is a non-exhaustive list of some processes to keep in mind. Following are some sample questions which should be addressed to begin the implementation process are:\n\n1. Who are the key players (actors) for this process?\n2. How often will they be performing the actions?\n3. Where will the data be coming from that will feed this process?\n4. What existing systems are currently in use. Do they have a place in the future state? If not, what will you do with the data they hold?\n5. Where will the data need to go from here? What sorts of transformations are involved?\n6. Is the ontology established, or is there potential for multiple meanings for terms?\n\nOnce basics like this are addressed, the processes should start to be mapped - always looking for both fundamental inefficiency (something that is a bad process regardless of whether or not it is automated) and for those things which could be eliminated or fundamentally altered by leveraging technology. For instance, the manual entry of metadata for manufacturing samples could be replaced with a link to a manufacturing system. If samples are part of a sample plan created by another group, consider having them prepare the plan in one of the LI systems and use that to create samples in LIMS.\n\nOnce we’ve gone down this road, we can then take a look at specific challenges based on the industry involved, which need to be addressed.\n\n\n
  3. \n
  4. \n
  5. \n
  6. \n