DOH21-034_Addendum 3 Questions and Answers_Final.pdf

Mission:

To protect, promote & improve the health of all people in Florida through integrated state, county & community efforts.

Ron DeSantis Governor

Joseph A. Ladapo, MD, PhD

State Surgeon General

Vision: To be the Healthiest State in the Nation

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Addendum #3

ITB DOH21-034

Cannabis Testing Laboratory Information System (LIMS)

DATE: September 20, 2022

TO: Prospective Respondents

FROM: Niki Branch, Procurement Officer

Florida Department of Health Central Purchasing Office

SUBJECT: Addendum #3

The purpose of this addendum is to answer questions received in accordance with section 2.7, Questions, of the Invitation to Bid. Please see the Department’s response to questions below.

Deletions are indicated by “strikethrough” or reference. Additions, updates or replacements are indicated by highlighting.

A. Responses to Questions received pursuant to section 2.7, Questions: Please see the

Department’s response to questions received by the due date outlined in section 2.5. Timeline, of the ITB, below:

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# Question Answer

Oracle is interested in offering Cloud Hosting and Cloud Database services, just that portion of the service. Would that be helpful? Will DoH accept partial response from us?

No, the Department is requesting all services, products, and functions specified in the ITB to be provided.

The timeline for response to both questions and the ITB are quite short and I would like to know if the state would consider extending the due date for questions and the ITB response by three weeks to allow us proper time to prepare a response.

No, the Department will not extend the Timeline.

Could you please provide a list of the instruments to be integrated and if uni-directional or bi-directional?

Uni-directional communication of cannabis testing result data passed from the cannabis testing instrumentation to the LIMS will need to be performed. The instruments involved in the testing, at this time, will include the following:

GC-MSMS (Agilent 7010) LC-MSMS (Agilent 6470) GC-MSD (Agilent 5977B) HPLC (Agilent 1260 Infinity II, Thermo Scientific Dionex Ultimate 3000) ICP-MS (PerkinElmer NexIon 2000) TEMPO (bioMerieux) GENE-UP (bioMerieux)

Are there any systems within the FLDOH or external systems the LIMS will need to connect with?

There are no other system integrations planned at this time, and the need for it is not currently anticipated. If external system integration should become a requirement, the Department expects the LIMS provider to work with us to determine how the system can be leveraged to aid in facilitating any extended system integrations being considered. See section 5.1.5, Modifications to LIMS System As Needed, of the ITB.

How many remote users does FLDOH anticipate for sample collection data entry in the field?

The Department estimates 10 active users will be conducting sample collections in the field.

How many concurrent users for the customer web portal?

See the answer to question #5; these users may potentially use the web portal concurrently.

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Does FLDOH have barcoding scanners and label printers? If not, how many would you like quoted?

Yes, the Department will provide any needed label printers and barcode scanners.

Will any historical LIMS data need to be migrated into the new LIMS? If so, what is/are the size(s) and format(s) of the database(s)?

No, historical LIMS data will not need to be migrated., What is the LIMS tool implementation stage? The Department cannot provide a response to this question as the terminology is not in the ITB and the context of the question is not fully understood.

Is there a LIMS tool implemented in DOH or yet to implement? If the answer is NO, is the requirement assessment & Tool selection complete or Is it part of the scope?

No, there is no LIMS to support cannabis testing at the Department.

That is the intent of this ITB. Please see Attachment A, Scope of Work, for details. The questions regarding the Requirement Assessment and Tool Selection are not fully understood.

Are there any preferred LIMS tools by DOH? If Yes what are those?

No, the Department has no LIMS tool preferences. Please see Attachment A, Scope of Work, for the requirements of this ITB.

How the data is managed at present? Is there any Legacy LIMS tool in place or What is the present mechanism to manage the test sample data?

See the answer to question 10.

Are you already having partnership with any LIMS Vendors in terms of LIC management & AMC? If Yes, what kind of partnership? Gold/Silver/Platinum? If No, are you planning to have any partnership? Should we acquire the license and supply to DOH?

The Department does not have partnerships with any LIMS vendors.

Without further explanation, LIC management and AMC are unknown terms to the Department.

Scope-We understand that following are the areas fall in scope. Please confirm. If missed any, please state.

Pre-study [LIMS Product Selection] Implementation & Configuration on cloud

The respondent must have a cannabis LIMS solution that meets the requirements outlined in Attachment A, Scope of Work, of the ITB.

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LIMS user license Management Instruments configuration & Integration LIMS Administration [Application & Cloud] & User Management Level 2 Support Level 3 Support includes Customization & Configuration requests LIMS user Training

Any thoughts on level of customization of LIMS tool on top of OOTB to be implemented? 5%? 10%?

This is impossible to ascertain without knowing the product’s OOTB offerings. Customizations, if needed, would largely be centric to integrating data from testing instrumentation (likely in the format of .csv files) into the LIMS and customizations needed to the OOTB testing result report that may be required.

What is the LIMS user training frequency? The Department desires a one-time training for each group referenced in Section 5.1.2, Attachment A, Scope of Work.

LIMS global presence - We understand that the lab is headquartered in Jacksonville.

Is the LIMS presence confined Jacksonville alone or will it be deployed in other location of the state / globe?

If Yes, please share the list of all locations Provide the Estimated Users count in each location Provide the Concurrent Users count in each location

The sample collections will be performed in the field and delivered to the Jacksonville laboratory. The laboratory in Jacksonville will perform all other functions associated with cannabis testing. The Jacksonville laboratory anticipates approximately 10 users needing access to the LIMS. The number of concurrent users should be the same. We also anticipate 10 users, total and concurrent, to be in the field collecting samples and using the vendor-provided web portal to log the collection data.

We understand that this engagement involves complete onsite support. Or are you ok with Onsite / Offshore support Model?

This initiative does not require complete onsite support. There may be some instances where onsite support may be necessary, such as during instrumentation integration, but otherwise, domestic offsite support is acceptable.

Post implementation, this will be a 8X5 Support engagement. Please confirm.

Yes, the laboratory and field inspectors will work 8-hour days, 5 days per week, excluding State of Florida holidays. During this time, LIMS technical support services will be required. Please refer to section 5.1.3 in the ITB for technical support requirements.

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Do you have any inputs on the SLAs for each support area? Please specify if any.

See section 5.1.3, LIMS Technical Support Services, of the ITB.

Please confirm whether Legacy data Migration is part of scope?

No, see the answer to question 8.

List the make of major equipment & Names of the instrumentations needed to be integrated with LIMS

GC-MSMS (Agilent 7010) LC-MSMS (Agilent 6470) GC-MSD (Agilent 5977B) HPLC (Agilent 1260 Infinity II, Thermo Scientific Dionex Ultimate 3000) ICP-MS (PerkinElmer NexIon 2000) TEMPO (bioMerieux) GENE-UP (bioMerieux)

Cloud Deployment Do you have any private cloud where the solution is expected to get deployed? Are you expecting the LIMS solution to be available for DOH as SaaS directly from the Product Vendor?

The solution should be hosted by the product vendor, as well as the data. As specified in the ITB, maintenance, backup, and redundancy are requested. See sections 5.1.1.1.23 and 5.1.1.2 in Attachment A, Scope of Work, in the ITB.

Please provide a ‘system landscape’ depicting the co-existence of various applications, major data flows & application integrations

This will be a stand-alone system not integrated with any other system.

The only integration will be with the testing instrumentation to accept files from the instrumentation to be used by the LIMS for result reporting.

Which database is currently in use to store the data of IT systems? If multiple databases are in use, is there any connection is (sic) available among them?

See the answers to question #8 and question #10.

Is ERP Integration part of the scope? If yes, specify the ERP details.

No, Enterprise Resource Planning (ERP) is not part of the services requested in this ITB.

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Who will be responsible for database and network activities ( Is Florida DOH has separate IT support team for all these activities )

See the answer to question #23.

Will the system be deployed in a validated (GxP) environment?

The Department is requesting a cannabis LIMS system that will be hosted by the provider and conforms to ISO/IEC 17025:2017 standards.

How is labelling & label printing managed currently? The Department has not yet begun collecting cannabis samples, so there is no solution for labeling and label printing currently in place. The Department will need label creation and label printing capability and will provide any needed label printers and barcode scanners.

Please provide details of all External application interfaces/integration with LIMS system.

There are no external interfaces expected other than those with the testing instrumentation that will need to be in place to supply testing result data from the instrumentation to the LIMS for processing.

Please clarify whether there is integration between LIMS and Quality Management System?

The LIMS will be used to track all tasks within the quality assurance program.

What is the criticality and Complexity of the application (High, Medium or Low)?

The criticality of system availability is high. The complexity is subjective, as the provider will be supplying the system. The laboratory does not anticipate it will receive a highly complex system that is difficult to use from the vendor.

Please confirm the expected commercial model for this engagement? (Fixed price / T&M)

See section 6 of Attachment A, Scope of Work, and Attachment B, Price Page.

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What are the different interfaces been configured to log / process samples ( IP21, SAP etc... )

Interfaces to log / process samples have yet to be developed but are required as indicated in section 5.1.1 of Attachment A, Scope of Work, of the ITB.

What are the available environments (Training, Development, Test, Staging, Production)

This is a new system that is being requested as specified in this ITB. It will be housed in the provider’s cloud. The environments needed to support the product development and eventual testing and migration to Production are to be determined by the provider. See section 5.1.1.1 and 5.1.1.2 of Attachment A, Scope of Work, in the ITB.

Is data flow with external applications is uni-directional or bi-directional? Please explain briefly about each interface.

There are no planned interfaces with external applications, however, the testing result data from the testing instrumentation should flow unilaterally to the LIMS for result reporting and storage. No communication back to the instrument from the LIMS is needed.

What is the current team size and the structure supporting the application?

There is no existing application. See sections 5.1.1.1 and 5.1.1.2 of Attachment A, Scope of Work, in the ITB.

Documentation - Please comment on availability of documentation like functional specification, manuals, system architecture, configuration / customizations made for each site? Any such documentation currently provided online to end Users

System documentation is not available as this will be a new system.

The Department is requesting a cloud-based system to support cannabis testing.

Is there any knowledge repository currently used for storing the support history? Problem/service ticket details with resolutions.

No.

Please specify whether there is any requirement to support the application in a language other than English?

If yes, Please provide the languages in which support is required?

English is the only language required to be supported.

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Is there any ticketing system currently in use? Can you please share the most common tickets and challenges faces in these applications/systems?

No. The awarded vendor must have a means to track the tickets opened when the Department employee calls in a problem and requires the vendor’s support. See section 5.1.3, LIMS Technical Support Services, in Attachment A, Scope of Work, of the ITB.

Currently, how are the escalations being resolved?

Please explain.

We do not have a system in place for this, so there is no escalation policy at this time.

What is your support notification and escalation process for System alerts/outages?

See the answer to question 10.

Please classify the instruments in terms of data output method ( File based, RS232 etc. )

The output of the cannabis testing instrumentation will be in the format of .csv files.

Is the output generated by all instruments notepad/word readable?

See the answer to question #44.

Are all IT systems currently inter-connected in network domain?

This is not relevant, as the system the Department is requesting is to be housed in a cloud by the provider. See sections 5.1.1.1.23 and 5.1.1.2 in Attachment A, Scope of Work, of the ITB.

Which database is currently in use to store the data of IT systems? If multiple databases are in use, Is there any connection is available among them?

The databases that will be used to house the new cannabis-related data are to be provided by the awarded vendor of this ITB. The data will be housed, maintained, and backed up by the vendor as per section

5.1.1.2 in Attachment A, Scope of Work, of the ITB.

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All the required IT systems and Interfaces have been identified and no need to discover IT systems, interfaces during the consulting exercise

The new LIMS would not be expected to interface with any other external systems. Interfaces are limited to those involving instrumentation used for cannabis testing purposes, as they will need to provide testing data to the LIMS for processing. The output files from the instrumentation are going to be .csv formatted files.

We assume steady state application support excluding user helpdesk as the scope of work, Please confirm?

Excluding Help Desk Support, the expectation is minimal support from the awarded vendor will be needed. Any requests outside the scope of the resulting purchase order would be addressed separately. See sections 5.1.1.2.3, 5.1.3. and 5.2.2 in Attachment A, Scope of Work, of the ITB.

List the make of major equipment/instrumentations needed to be integrated with LIMS

See the answer to question #22.

background Expectations of technical personnel (Functional , Technical - Any key technologies, Domain - Pharma)

See section 4, Contractor Qualifications and Experience, and section 5, Contractor Responsibilities, in Attachment A, Scope of Work, of the ITB.

What is the main objective of LIMS at various Lab sites?

Are there disparate needs at different sites?

The LIMS will only be used by the Jacksonville laboratory. The inspectors performing the cannabis collections will need a web-based tool, or portal, to log the data regarding the samples into the LIMS so that the data is available when the samples physically arrive at the lab before the testing begins. See sections 5.1.1.1 and 5.1.1.2 in Attachment A, Scope of Work, of the ITB.

What are the current pain points wrt automation requirements/ operations / technology etc.?

There are none at this time. The Department requires that the system be intuitive, configurable, responsive, and reliable.

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Please provide the monthly ticket volumes - Incidents, Problems, Change Requests etc. for the mast 12 months?

See the answers to question #8 and question #10.

Please specify whether Electronic Lab Notebook Solution (ELN) is being used in QC labs? If yes, what is the solution being used?

No, this is not a requirement of this ITB.

Will DOH provide the team to perform the performance & load testing or should Vendor plan for this in their scope?

The awarded vendor will provide the team to perform load testing, though the Department should be able to provide feedback regarding response time performance.

Will DoH consider 2 week extension for this RFP, this extension will help vendors to include DOH's Q&A feedback into their proposal

See the answer to question #2.

Failure to file a protest within the time prescribed in section 120.57(3), Florida Statutes, or failure to post the bond or other security required by law within the time allowed for filing a bond shall constitute a waiver of proceedings under Chapter 120, Florida Statutes.