5354 RFQ NBS LIMS PreWork Final 3.23.22 na.pdf

REQUEST FOR QUOTES (RFQ)

***THIS IS NOT AN ORDER***

Best Value Analysis Process

RFQ #OHA-5354

GSA #RFQ 1547773S

Focused Market Research for Public Health Lab Newborn

Screening and Laboratory Information Management System

(LIMS)

Issue Date: March 23, 2022

Issuing Office: Office of Contracting & Procurement (OC&P) On behalf Oregon Health Authority (OHA) Public Health

RFQ Single Point of Contact (SPC):

Name: Nancy Alameda Office of Contracts and Procurement Address: 635 Capitol St NE, Suite 350 Salem, Oregon, 97301 E-mail: Nancy.i.alameda@dhsoha.state.or.us

Offer Due Date and Time: April 6, 2022, 4:00PM

Event Schedule:

EVENT DATE TIME

RFQ Release 3/23/2022 Due Date for Questions/Clarifications 3/30/2022 4:00 PM Answers to Questions/Clarifications (estimated) 04/01/2022 Quote Due Date 4/06/2022 4:00 PM Estimated Evaluation and Best Buy Determination Completed 4/18/2022 Estimated Intent to Award 4/19/2022

RFQ #5354 Page 2 of 11 Market Research – Newborn Screening LIMS

Estimated Contract Execution 5/10/2022

1. Introduction

The Office of Contracting & Procurement (OC&P), on behalf of OHA (authorized Purchaser), is issuing this Request for Quote (RFQ) for gaining responses from qualified General Services Administration (GSA) 70 Contractors for required professional services supporting Oregon State Public Health Lab (OSPHL). Services include providing in-depth system requirements, market research and analysis for the purpose of establishing key information and requirements supporting the future development of a Request for Proposal (RFP) solicitation for a specialized OSPHL specific Newborn Screening (and potentially laboratory-wide) Laboratory Information Management System (LIMS).

2. Background Information:

The OSPHL requires a fully scoped and compliant Newborn Screening Laboratory Information Management System (LIMS) to support the timely, electronic, automated, and paperless testing of Oregon newborns for serious or life-threatening conditions. Test results from the Newborn Screening Laboratory are used by health care providers at birthing hospitals, pediatric physicians, and Oregon Health & Sciences University (OHSU) medical consultants to provide the urgent critical care needed for infants identified with newborn disorders. OSPHL serves all 34 county jurisdictions in the state, covering an area of about 100,000 square miles, and receives over 400,000 specimens annually. Its focus is on providing testing to support public health programs and to perform specialized reference testing for clinicians and county health departments.

The contract for the current Newborn Screening LIMS, with Natus Medical, Inc. has been in place since July 1, 2005, and was recently extended by Special Procurement, through June 30, 2025. This extension was necessary to accommodate the lengthy process of conducting a large and complex solicitation and subsequent contract award through implementation of a new system.

At present, the Newborn Screening LIMS works with a second system created by Perkin Elmer (SpecimenGate) that manages specimen tracking and instrument interfacing for newborn bloodspot screening. This work is an opportunity to assess whether a single LIMS product can manage newborn patient demographics, specimen tracking, instrument interfacing, result reporting and case management or if multiple products are needed to serve these different purposes in the future. Importantly, this work is also an opportunity to assess whether a single LIMS product could support both Newborn Screening and communicable disease testing, thus modernizing data systems at OSPHL and streamlining Information Technology (IT) infrastructure, contracting support and consolidating costs. To achieve this goal, this RFQ requests a quote for compiling LIMS system requirements for all OSPHL services and an assessment of available LIMS systems for compatibility.

Currently the OSPHL does not have sufficient staffing and experience to conduct the planning required for this RFP, nor to provide support to inside agency staff throughout the RFP process and is therefore looking to contract with a qualified organization for this work.

RFQ #5354 Page 3 of 11

3. Purpose:

The objective of this RFQ is to obtain 3 quotes under GSA Schedule 70 covering the services for an experienced and qualified Contractor who will execute a contract with OHA for the delivery of professional market research, requirements development supporting RFP process and associated services, more fully described below in Section 5. Scope of Services.

4. Definitions:

Business Model: description of how the business supports itself and provides quality services, includes proprietary products, Software-as-Service (SaaS), open source, consulting, or customer developed.

FHIR: HL7 Fast Healthcare Interoperability Resources® are standards that define how healthcare information can be exchanged between different computer systems regardless of how it is stored in those systems.

Needs Assessment: A needs assessment is a systematic process for determining and addressing needs, or "gaps" between current conditions and desired conditions or "wants". The discrepancy between the current condition and wanted condition must be measured to appropriately identify the need.

5. Scope of Services:

Organizations submitting Offers are referred to as Offerors in this RFQ. After execution of a Contract, the awarded Offeror will be designated as a Contractor. Contractor will perform the services, complete the tasks, and provide the deliverables described in this Scope of Work.

The OSPHL envisions the contracted work to consist of three phases as described more fully in Section 5.1-5.3 below. In Phase I, VENDOR will evaluate the current LIMS that the Oregon State Public Health Laboratory (OSPHL) uses for newborn screening and communicable disease testing for related business operations. In Phase 2, Contractor will complete a Needs Assessment to meet OSPHL’s established goal of an OSPHL-wide, paperless, and interconnected LIMS and conduct market research to determine the feasibility of this goal. In Phase 3, Contractor will provide project management on behalf of OSPHL Management Team and interface with Agency’s IT Project Manager for the LIMS RFP process, either for an OSPHL-wide or a Newborn Screening LIMS as determined by the feasibility assessment.

During the performance of the services, the Contractor selected must thoroughly understand the OSPHL’s current operations, connectivity, data exchange, electronic transfer of records (ETOR) status and understand the OSPHL’s overall goal for an OSPHL-wide, paperless, and interconnected LIMS. Additionally, the Vendor must be able to provide the necessary support on behalf of and liaise with OSPHL staff to ensure a thorough procurement process is conducted. Given the central role a LIMS plays in laboratory operations and the complexity of the issue, determining the viability of a single-LIMS approach and whether such a system would benefit OSPHL is an important and difficult objective. Successful

RFQ #5354 Page 4 of 11 completion of this goal will result in a determination that indicates whether an OSPHL-wide LIMS approach is feasible or if the Newborn Screening LIMS should remain separate from a communicable disease LIMS and what the technical options are for the provision of these healthcare services.

5.1 Phase 1: Current State Analysis

The purpose of Phase 1 is to document how the Public Health Laboratory’s current workflows are performed and interact with the LIMS, perform a gap analysis, and evaluation with other LIMS to recommend upgrade or replacement. For Phase 1, the Contractor must:

• Define and document laboratory data flows;

• Evaluate how well the current LIMS meets the requirements of the laboratory's needs;

• Recommend what changes would be needed to streamline OSPHL workflows, reduce manual processes, and eliminate manual interventions in data processing.

• Recommend what changes would be needed to convert current workflows to be paperless.

Phase 1: Proposed Major Deliverables/Milestones (estimated total 2-4 months)

Deliverable Name Description & Value – Current State Analysis

Target Due Date / Milestone

Project Management Plan with updates

Create a Project Management Plan (PMP) for completing the work in Phase 1.

tbd

Documented workflows

For all areas in the laboratory and for all tests and processes in those areas document the current workflows: define inputs, outputs, requirements, and resources tbd

LIMS Gap Analysis Summary Report

The Gap Analysis Summary will provide an overview of the findings of comparing the As Is state to the To Be state, and the role that a LIMS could play in achieving the desired To Be.

tbd

Process Improvement Summary Report

The current workflows will be used to conduct a value stream mapping exercise to identify areas of waste, inefficiency and opportunities for improvement. From this a desired To Be state will be defined. The Process Improvement Summary Report will capture the steps and resources needed to streamline workflows, reduce manual processes, and eliminate manual interventions in data processing.

tbd

LIMS

Comparison Report

This report will use public information to compare functions, interactions, and corresponding IT needs.

Description of the system capabilities for ETOR / FHIR). Determine if the vendor meets industry standards for ETOR / FHIR.

tbd

RFQ #5354 Page 5 of 11

Deliverable Name Description & Value – Current State Analysis

Target Due Date / Milestone

Project Management Plan with updates

Project Management Plan (PMP) will be updated to reflect the transition into Phase 2.

5.2 Phase 2: Needs Assessment and Market Research

The purpose of Phase 2 is for the Contractor to perform a Needs Assessment for the OSPHL to meet its goal of an OSPHL-wide, paperless, and interconnected Laboratory Information Management System (LIMS), as support for the planning phase of a future RFP. Contractor will then conduct a vendor analysis to compare the current LIMS to other LIMS systems currently available. Contractor will provide the OSPHL with a formal recommendation to pursue an RFP for a LIMS either to support the entire OSPHL or to support Newborn Screening. At the end of Phase 2, Contractor will submit all findings and recommendations in the form of a report.

This section of the PMP is focused on Phase 2, in which Contractor will:

• Define and document the optimal laboratory Business Processes.

• Define and document software informatics features list.

• Create a detailed and complete list of System Requirements for the desired future state.

• Create a detailed estimate of on-going support and maintenance costs, including variable business models for support.

• Work with PHL Laboratory leadership to rank system requirements into priority groups including Must Have, Important Business Function, Would Be Nice, Can Live Without.

• Determine cost / benefits of an OSPHL-wide vs. Newborn Screening specific LIMS and summarize their formal recommendation in a report for the OHA Executive Leadership.

Phase 2: Proposed Major Deliverables/Milestones (estimated total 2-4 months) Deliverable Name (hours estimate)

Description & Value – Needs Assessment & Market Research

Target Due Date / Milestone

New Business Processes

For all areas in the laboratory and for all tests and processes in those areas document the current workflows: define inputs, outputs, requirements, and resources tbd

Software Features

A non-technical description of the desired software features that are needed to perform the business processes more effectively and more efficiently.

Must include operability and maintainability characteristics.

tbd

System Requirements

A technical translation of the features into software functional requirements to which the vendors will be required to submit responses in their proposals.

RFQ #5354 Page 6 of 11

Deliverable Name (hours estimate)

Description & Value – Needs Assessment & Market Research

Target Due Date / Milestone

LIMS

Comparison Report / Market Research

This report will use public information to compare software features, interactions, and corresponding IT needs. Description of the system capabilities for ETOR. Determine if the vendor meets industry standards for ETOR.

tbd

Cost / Benefit Analysis

Compare the pros and cons of the OSPHL LIMS replacement options, including OSPHL-wide or Newborn Screening specific LIMS.

Cost / Benefit Analysis for Support Options

Compare the pros and cons of on-going support and maintenance options, including labor requirements and costs. Variable business models for support must be considered.

tbd

Recommendation for OSPHL RFP plan

This recommendation will influence the LIMS project plan prior to the RFP process to determine if the RFP is for an OSPHL-wide or Newborn Screening specific LIMS.

tbd

Project Management Plan with updates

At the conclusion of Phase 2 PMP will be updated to reflect the transition into Phase 3.

5.3 Phase 3: RFP Development and Selection

The purpose of Phase 3 is for services to support OSPHL to select a LIMS vendor(s) to replace the legacy LIMS. Contractor will provide assistance with developing RFP requirements documents.

This section of the PMP is focused on Phase 3, in which Contractor will:

• Draft RFP System Requirements and Scope of Services to meet OSPHL system and service needs.

• Develop a list of documents that must be updated or created to transition the future laboratory processes to a new LIMS, including policies, procedures and training.

• Develop scoring criteria for the evaluation of proposals, and for demonstrations.

Coordinate with DAS PS to establish final Proposal review team, roles, and timeline.

• Assist with preparing RFP materials as requested by OSPHL staff or management to support DAS PS procurement effort.

Contractor will assist with the process to evaluate vendor proposals and demonstrations as requested by OSPHL Management until the completion of the RFP process and selection of a LIMS system solution.

RFQ #5354 Page 7 of 11

Phase Three: Proposed Major Deliverables/Milestones (estimated total 2-4 months) Deliverable Name (hours estimate)

Description & Value – RFP Development and Selection

Target Due Date / Milestone

RFP System Requirements

Draft a technical translation of the features into software functional requirements to which the vendors will be required to submit responses in their proposals.

tbd

RFP Scope of Services

Development of LIMS vendor services and support requirements for the RFP package to meet the OSPHL service needs.

tbd

RFP Package Inputs

Scoring criteria to evaluate proposals, for written submission and for demonstrations. Provide inputs for final Proposal review team, roles, and timeline.

RFP packet materials will include:

Opportunity description narrative Evaluation criteria Demonstration requirements and timeline Systems Requirements matrix Vendor company information References list Detailed Cost Proposal Service Level Agreement options Targeted vendor list tbd

Draft LIMS Implementation Project Plan

Draft LIMS implementation project plan to include the following:

Summary of key findings in the RFP development process Recommendations for phased LIMS implementation approach Controlled Document List of new procedures related to processes that use that software.

Other key findings to allow laboratory leadership to begin planning for and managing implementation.

tbd

Evaluation Process Assistance

Evaluation team members receive access to all proposal materials, score them, join facilitated discussion sessions. Vendors are chosen for Demonstrations. Contractor coordinates with DAS PS to schedule vendor demos. Demos are to be recorded and made available to team members for viewing and scoring.

tbd

Summary Findings Reports

A document supporting the final Laboratory purchase decision. Supporting materials will include but not be limited to scoring results for vendor analysis of LIMS solution(s) that meet the collaboratively defined functional requirements.

RFQ #5354 Page 8 of 11

6. Offeror Qualifications:

To be considered for a Contract, Offeror must demonstrate how Offeror meets the requirements of this Section 6. Offeror’s responses will be used by the SPC and the Evaluation Committee to verify if an Offeror has met these Offeror Qualifications.

6.1 Development of an OSPHL-wide, paperless and interconnected LIMS requires knowledge of public health laboratory practice (including specimen handling, laboratory workflows, outbreak investigation, and patient follow-up) and the combination of multiple regulatory standards specific to public health / clinical laboratory practice (College of American Pathology, HIPAA, 21st Century CURES Act), HL7/FHIR data exchange standards and infrastructure, public health surveillance reporting, continuity of operations planning, in all parts of the lab, along with creation of multiple planning documents (gap analyses, technical planning documents) required for creating the RFP.

6.2 The RFP development process will require a full understanding of Oregon Newborn Screening laboratory processes (how specimens are received and tested, how results are generated and reported, and how Newborn Screening Follow-up is performed and tracked) and planning work for the creation of a future, paperless, and interconnected LIMS (supported by Market Research of current functionality of available LIMS products).

7. Value Added Services

If Offeror desires to propose any additional value-added service(s) that will enhance the Services of the Project, include a description of such value-added Service(s). Additional services should not be identical to those required in this RFQ. If there are options available for the proposed value-added service(s), identify the options and describe what each option provides. OHA reserves the right to add such value-added services to the resulting Contract as needed.

8. Questions and Requests for Clarification:

All questions and requests for clarification regarding this RFQ must be submitted in writing by e-mail, regular mail or hand delivery to the RFQ Contact and must be received at the date and time listed in the Events Schedule.

9. Quotation Submittal:

Quotes must be received on or before the Offer Due Date and Time identified in the Events Schedule to be considered. Quotes will not be accepted after the Offer Due Date and Time.

Quotes will be accepted by e-mail, regular mail or hand delivery to the SPC identified on the cover page. SPC may extend the Offer Due Date when it is in the best interest of the Agency.

OC&P may reject all Quotes or cancel this RFQ if in its sole determination if it is in the best interest of the Agency.

10. Submittal Requirements:

RFQ #5354 Page 9 of 11

a. Quotes must include a description of Offeror’s methodologies for providing the Services and a draft Statement of Work based Section 5, Scope of Services with estimated schedule.

b. Quotes must include a description of Offeror’s Key Persons, other staff, and their experience. Include Key Person(s) resumes, maximum 2 pages.

c. Quotes must include a description of past projects Offeror has completed that are similar in scope to what is being requested in this RFQ within the past 5 years.

d. Quotes must include submission of the Pricing Sheet (Attachment A). The Pricing Sheet must be signed by an Authorized Representative of the Offeror.

e. Quotes must include three (3) references using the Reference Check Form (Attachment B).

Forms must be completed by the reference, returned to the Offeror and submitted with the quote. References must be from customers for whom Offeror has performed similar projects within the past five (5) years.

11. Evaluation and Award:

Quote submissions will be reviewed to determine if all Submittal Requirements have been met.

Those meeting the Submittal Requirements will be evaluated to determine the “Best Value” for the Agency. “Best Value” is based solely on the evaluator’s determination of what best meets the needs of the Agency taking into account price as well as the following considerations:

• Experience and expertise,

• References,

• Price, and

• Sample SOW.

OHA may conduct further rounds of evaluation if deemed in the best interest of the Agency.

Additional rounds may consist of but will not be limited to:

• Interviews (Interviews may be held on site or via video conferencing.)

• Best and Final Offer

Authorized Purchaser’s determination is final.

RFQ #5354 Page 10 of 11

ATTACHMENT A

RFQ PRICING SHEET

Offeror will complete the deliverable and payment information below based on the Scope of Services outlined in Section 5. The Scope of Services deliverable pricing must directly align with the Statement of Work being submitted with this RFQ (see 10.a). If the Offeror is providing any value-added Services, the Offeror needs to include those services in the pricing sheet in order to be considered.

SCOPE OF SERVICES

DELIVERABLE PRICING

Deliverable Description Deliverable Payment

VALUE ADDED SERVICES (and rates)

RFQ #5354 Page 11 of 11

RFQ #5354

ATTACHMENT B

REFERENCE CHECK FORM

Offeror Name:

Reference Entity:

Reference Contact Name:

Contact Telephone Number:

Contact Email Address:

**Please feel free to additional pages for comments**

Please rate the following questions on a scale of 0-10:

0 = Not satisfied 5 = Moderately satisfied 10 = Extremely satisfied.

1. How would you rate the Offeror’s overall quality of services provided and your overall relationship with the Offeror?

Score:

Comments:

2. How would you rate the Offeror’s delivery of service?

3. How would you rate the Offeror’s responsiveness to customer service issues and special requests (e.g., reported problems, changes billing, etc.)?