Attachment 41- LIMS Mandatory Requirements Checklist.xlsx

XLSX spreadsheet 15 KB Posted Apr 12, 2011

Attached to: Laboratory Information Management System
Solicitation number: 11-223-SOL-00082
Issued by: Department of Health and Human Services Food and Drug Administration

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LIMS Mandatory Requirements Checklist

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File	Type	Posted
11-223-SOL-00082-0002 SF30.pdf	PDF	May 2, 2011
11-223-SOL-00082 1449.pdf	PDF	Apr 21, 2011
LIMS Questions and Answers.pdf	PDF	Apr 21, 2011
LIMS Amendment 1 1449.pdf	PDF	Apr 21, 2011
LIMS Task Order Two.pdf	PDF	Apr 12, 2011
Content Summary for LIMS RFP.pdf	PDF	Apr 12, 2011
LIMS Request for Proposal.pdf	PDF	Apr 12, 2011
LIMS Glossary-Acronyms.pdf	PDF	Apr 12, 2011
ATTACHMENT 3 - Past Performance Questionnaire.doc	DOC document	Apr 12, 2011
LIMS Task Order One.pdf	PDF	Apr 12, 2011
Attachment 4 - Labor Category Descriptions.pdf	PDF	Apr 12, 2011
Attachment 2 RFP Pricing Spreadsheet.xls	XLS spreadsheet	Apr 12, 2011
Attachment 5 - Offerors Questionnaire.doc	DOC document	Apr 12, 2011
Attachment 42-Demonstration Instructions.pdf	PDF	Apr 12, 2011
Attachment 1 - LIMS IDIQ SOW.pdf	PDF	Apr 12, 2011

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Sheet1

The Offeror shall fill in this checklist and mark all functions and processes that the LIMS will fully support. Refer to the IDIQ and Laboratory Pilot TO SOWs for details.

Mark an X beside every supported Process or Function		Mark one of the following fo each row.
	Mandatory Priority IV business processes for microbiology	Out of the Box	With Configuration	With Customization	Requires add-on (Not integrated)
	1. Receiving samples
	2. Assigning samples
	3. Tracking status of samples
	4. Returning samples
	5. Disposing of samples
	6. Prioritizing samples
	7. Categorizing samples
	8. Storing samples
	9. Managing sample inventory
	10. Obtaining analysis material, including but not limited to media, reagents, and supplies
	11. Preparing samples
	12. Analyzing samples
	13. Recording analysis results
	14. Approving analysis results
	15. Tracking analysis metrics
	16. Providing specific methodological guidance (access to methods including online resources)
	17. Enabling system notifications and alerts
	18. Tracking of workflow, including sample chain of custody
	19. Maintaining supply information
	20. Maintaining laboratory equipment information
	21. Maintaining inventory, preventative maintenance, and calibration of instrumentation
	22. Maintaining sample and reagent physical storage information
	23. Maintaining laboratory human resources capacity information (i.e., people available to do work and their skills/training)
	24. Assessing sample analysis capacity
	25. Enabling standard and ad-hoc reporting
	26. Providing a management dashboard
	27. Supporting data export and import
	28. Performing contextual searches
	29. Ensuring data integrity
	30. Archiving data (maintaining record of completed work)
	31. Maintaining analysis reference data
	32. Maintaining laboratory geographical location information
	33. Performing system administration
	34. Supporting ISO accreditation (ISO standard 17025)

Mark an X beside every supported Process or Function		Mark one of the following fo each row.
	Major LIMS functions	Out of the Box	With Configuration	With Customization	Requires add-on (Not integrated)
	1. Ability to manage user accounts by utilizing ARRMS, if available, SSO capability.
	2. Ability to manage sample types.
	3. Ability to manage laboratory administrative processes.
	4. Ability to insert data from integrated laboratory instruments into analyst’s work package data.
	5. Ability to print barcodes.
	6. Ability to scan barcodes and associate the item with an assignment.
	7. Ability to use the data from the barcode to populate fields in the LIMS.
	8. Ability to interface effectively with MARCS WAAM functionality.
	9. Ability to check human resource availability to assist in making assignments.
	10. Ability to check qualifications and training of the laboratory analysts.
	11. Ability to check equipment availability for conducting analyses.
	12. Ability to assign work to laboratory analysts.
	13. Ability to route automatic email notifications (MARCS services NS).
	14. Ability to generate secure worksheets via Microsoft Word.
	15. Ability to audit the electronic equivalent of logbooks for maintenance and calibration schedules.
	16. Ability to maintain inventory levels of instruments.
	17. Ability to audit inventory supply levels of reagents and managed substances.
	18. Ability to record in an audit trail any change to the sample record by any user.
	19. Ability to split samples and maintain the relationships to each other and the original assignment.
	20. Ability to split samples and forward an assignment between the two laboratories in the Pilot for one or more of the sub-samples.
	21. Maintain chain of custody and sample analysis, sub-sample, and split information throughout sample lifecycles, including MARCS chain of custody.
	22. Ability to handle sample disposition at multiple different physical locations.
	23. Ability to relate media preparation assignments to samples (even in the scenario where media are prepared for batch process samples).
	24. Ability to generate ad-hoc worksheets: new worksheet templates can be generated for high priority or emergency response methods, allowing data to be captured into the sample record.
	25. Ability to transfer a sample between the two laboratories in the Pilot along with the accompanying data.
	26. Ability to support ISO 17025 accreditation for laboratory accreditation.
	27. The Pilot shall demonstrate the integration with external systems, including an interface with MARCS demonstrating providing and consuming Web Services.

Sheet2

Sheet3

File details come from the government source that posted it. Updated Nov 14, 2017.