RFP - NBS Surveillance System 2025.pdf

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STATE OF SOUTH DAKOTA

Department of Health

Office of Lifespan Health

1310 Main Ave S Brookings SD 57006

Statewide Newborn Screening Surveillance System

PROPOSALS ARE DUE NO LATER THAN May 29 th, 2025, 5:00pm Central Time.

RFP #: 25-0904004-022

BUYER: Hope Kleine, on behalf of the

SD Newborn Screening program E-mail: NBSRFP@state.sd.us

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FIRM NAME: AUTHORIZED SIGNATURE:

ADDRESS: TYPE or PRINT NAME:

CITY/STATE: TELEPHONE NO:

ZIP (9 DIGIT): FAX NO:

E-MAIL:

PRIMARY CONTACT INFORMATION

CONTACT NAME: TELEPHONE NO:

FAX NO: E-MAIL:

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1 GENERAL INFORMATION

1.1 BIT STANDARD CONTRACT TERMS AND CONDITIONS

Any contract or agreement resulting from this RFP will include the State of South Dakota’s (the “State”) standard I/T contract terms listed in Appendix A, along with any additional contract terms as negotiated by the parties. As part of the negotiation process the contract terms listed in Appendix A may be altered or deleted. The offeror must indicate in its response any issues it has with specific contract terms. If the offeror does not indicate that there are any issues with any contract terms, then the State will assume those terms are acceptable to the offeror. There is also a list of technical questions, Security and Vendor Questions which is attached as Appendix B, the offeror must complete. These questions may be used in the proposal evaluation. It is preferred that the offeror’s response to these questions is provided as a separate document from the RFP response. If the offeror will be hosting the solution, the file name must be “(Your Name) Hosted Security and Vendor Questions Response”. If the solution will be hosted by the State, the file must be named “(Your Name) Security and Vendor Questions Response State Hosted”. If the solution is not a hosted solution, the file name must be “(Your Name) Security and Vendor Questions Response”. If there are multiple non-hosted solutions, please provide some designation in the file name that indicates which proposal it goes

to. This document cannot be a scanned document but must be an original. If the offeror elects to make the Security and Vendor Questions part of its response, the questions must be clearly indicated in the proposal’s Table of Contents. A single numbering system must be used throughout the proposal.

1.2 BACKGROUND

South Dakota’s current newborn screening data infrastructure is split across multiple systems that were not designed to support centralized surveillance, long-term follow-up, or modern interoperability. This fragmentation has led to gaps in care coordination, limited access to timely data, and inconsistent workflows across providers and programs.

1.2.1 Current Situation: Hearing Screening

Initial hearing screening results are currently entered manually into the South Dakota Vital Records System by birth facilities at the time of birth registration. Some providers with access to the system may also enter limited follow-up information. However, the Vital Records System was not designed to support longitudinal care tracking, clinical documentation, or structured case management for hearing screening.

Because no centralized, program-owned platform currently exists for hearing data, the South Dakota NBS team must manually monitor follow-up status using spreadsheets, email, and file folders to track infants with incomplete or missing data. This process is labor-intensive and highly dependent on individual provider participation and documentation.

As a result:

• Follow-up tracking is incomplete and varies widely depending on provider access and reporting practices.

• There is no unified system to manage hearing screening data from initial screen through diagnosis and intervention.

• Hearing-related data cannot be easily linked with public health analytics systems or used for state-level reporting and compliance.

• Row data was not available for hearing screens via vital records system interface.

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1.2.2 Current Situation: Bloodspot Screening

Bloodspot screening and short-term follow-up for South Dakota newborns are conducted by the Iowa State Hygienic Laboratory, using its Laboratory Information Management System (OpenELIS). While a small subset of screening data is transmitted to South Dakota’s Vital Records System via flat file uploads, most data related to bloodspot screening and follow-up remains housed within Iowa’s OpenELIS platform.

Iowa provides access to select information through a secure online portal, allowing South Dakota staff to query individual records as needed. This access supports immediate care coordination and basic data retrieval for short-term follow-up activities. However, the SD DOH NBS Program does not currently have direct access to the full dataset of structured, raw screening data for all South Dakota infants screened through Iowa. As a result:

• The SD NBS team has very limited capacity to generate comprehensive or customizable reports, such as what would be required for internal monitoring, external stakeholders, in-depth hospital "report cards", federal compliance/annual national reports (e.g. CDC, HRSA, APHL), etc.

• There is no centralized system to store data and analyze screening trends, assess disparities, or evaluate program effectiveness beyond Quality Indicator and Turn Around Statistics.

• South Dakota lacks the ability to automatically reconcile or correct records, resulting in manual workarounds and limited data control.

While the partnership with Iowa continues to effectively support the state’s short-term follow-up needs, South Dakota must establish a solution that allows for complete and program-owned access to newborn screening data in a secure, interoperable system. The planned Newborn Screening Surveillance System (NBSSS) will provide that foundation—enabling SD DOH to integrate, analyze, and manage all newborn screening records in-state, while continuing to collaborate with Iowa for laboratory processing and initial follow-up.

1.3 GOALS AND OBJECTIVES

The NBSSS will serve as a secure, interoperable, and configurable system of record for South Dakota’s newborn screening program. Its purpose is to unify and modernize how the state tracks, follows up on, and reports newborn screening results, while ensuring timely care coordination for all infants screened.

1.3.1 Objectives Specific to Hearing Screening

• Establish the NBSSS as the centralized system of record for all hearing screening and follow-up activities in South Dakota.

• Enable entry and tracking of hearing screening results, diagnostic evaluations, and interventions within a unified case management platform.

• Support timely provider reporting through automated data exchange or secure web-based forms for facilities without HL7 capabilities.

• Replace hearing-related data entry in the Vital Records System with structured, longitudinal data entry and workflows in the NBSSS.

• Support 1-3-6 tracking standards (screening by 1 month, diagnosis by 3 months, intervention by 6 months), with performance monitoring dashboards and reports.

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1.3.2 Objectives Specific to Bloodspot Screening

• Enable seamless data integration with the Iowa State Hygienic Laboratory’s OpenELIS system, receiving all screening and short-term follow-up data directly into the NBSSS.

• Support bi-directional exchange with Iowa to allow corrections, deduplication, and case updates in both systems.

• Build the internal infrastructure needed to manage and document care beyond initial screening and diagnosis.

• Provide SD DOH with full visibility and the ability to manage long-term follow-up for conditions identified through bloodspot screening.

• Centralize all bloodspot-related documentation, recommendations, confirmatory testing, and condition outcomes within NBSSS for case continuity and analytics.

• Eliminate the need for Vital Records to serve as an intermediary for bloodspot data, keeping their scope focused on birth and death records.

1.3.3 Shared Objectives for Both Hearing and Bloodspot Screening

• Centralize all newborn screening data—including demographic, clinical, laboratory, and follow-up information—into a single, secure, and fully owned system.

• Provide automated case management workflows with configurable triggers, alerts, escalation paths, and resolution tracking.

• Support interoperability with external systems using HL7, FHIR, IJE, and secure file-based methods.

• Ensure data integrity and quality, including support for real-time validation, deduplication, cross-system matching, and correction workflows.

• Enable flexible data entry options, including structured uploads and manual forms, for facilities that lack integration capabilities.

• Deliver robust reporting, analytics, and dashboard tools for compliance (e.g., CDC, HRSA), performance monitoring, and epidemiological analysis.

• Guarantee full access to raw, structured, and historical data for authorized SD DOH analysts to conduct independent research and generate program insights.

• Enable biostatisticians and epidemiologists to access row-level data and apply code (e.g., SAS, R, SQL) to generate automated reports for public health surveillance at the state level and mandated reporting at the national level (e.g., HRSA, CDC, APHL, NewSTEPs, etc).

• Implement role-based access controls and integration with South Dakota’s identity and access management standards (Azure Entra ID and Azure B2C).

• Ensure the system is modular, configurable, and scalable to support additional screening conditions, workflow updates, or policy changes.

• Provide training, technical support, and sustainable maintenance to ensure long-term system effectiveness and user adoption.

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1.4 ISSUING OFFICE AND RFP REFERENCE NUMBER

The Office of Lifespan Health (hereafter referred to as OLH) is the issuing office for this document and all subsequent addenda relating to it, on behalf of the South Dakota Department of Health. The reference number for the transaction is RFP #25-0904004-022. This number must be referred to on all proposals, correspondence, and documentation relating to the RFP.

1.5 SCHEDULE OF ACTIVITIES (SUBJECT TO CHANGE)

RFP Publication ............................................................................................................................. 04/14/2025 Offeror questions due .................................................................................................................... 04/30/2025 Responses to offeror questions posted ......................................................................................... 05/08/2025 Proposal submission deadline ................................................................................. 05/29/2025, 5:00 pm CT 1st round of evaluation: eligibility & compliance review (initial screening) ............. 06/02/2025 – 06/06/2025 Notification to offerors advancing to 2nd round of evaluation ........................................................ 06/09/2025 2nd round of evaluation: demonstrations e presentations ...................................... 06/26/2025 – 07/03/2025 3rd and final round of evaluation: BIT technical review & full proposal scoring ..... 07/07/2025 – 07/16/2025 Final selection & award recommendation ..................................................................................... 07/18/2025 Anticipated award decision & contract negotiation ....................................................................... 07/25/2025

1.6 SUBMITTING YOUR PROPOSAL

All proposals must be completed and received by the OLH of the South Dakota Department of Health by the date and time indicated in the Schedule of Activities. Proposals received after the deadline will be late and ineligible for consideration.

The bidder must submit one identical electronic copy of the proposal by email, which may include an electronic signature. The electronic copy must be emailed by the date and time indicated in the Schedule of Activities. Acceptable document formats are PDF, Excel, or Word, and the submission should be sent to NBSRFP@state.sd.us. The e-mail attachment shall be sent unencrypted, and attachments shall be less than 20 MB in size. If the total number of attachments exceeds 20MB, vendors are authorized to send multiple e-mails, as long as the e-mail subject line indicates that multiple e-mails compose the proposal.

Email Subject Line: REQUEST for PROPOSAL #25-0904004-022 (email x of x).

No proposal shall be accepted from, or no contract or purchase order shall be awarded to any person, firm or corporation that is in arrears upon any obligations to the State of South Dakota, or that otherwise may be deemed irresponsible or unreliable by the State of South Dakota.

1.7 CERTIFICATION REGARDING DEBARMENT, SUSPENSION, INELIGIBILITY AND VOLUNTARY

EXCLUSION – LOWER TIER COVERED TRANSACTIONS

By signing and submitting this proposal, the offeror certifies that neither it nor its principals is presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation, by any Federal department or agency, from transactions involving the use of Federal funds. Where the offeror is unable to certify to any of the statements in this certification, the offeror shall attach an explanation to its offer.

1.8 NON-DISCRIMINATION STATEMENT

The State of South Dakota requires that all contractors, vendors, and suppliers doing business with any State agency, department, or institution, provide a statement of non-discrimination. By signing and submitting their proposal, the offeror certifies they do not discriminate in their employment practices with regard to race, color, creed, religion, age, sex, ancestry, national origin, or disability.

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1.9 RESTRICTION OF BOYCOTT OF ISRAEL

For contractors, vendors, suppliers, or subcontractors with five (5) or more employees who enter into a contract with the State of South Dakota that involves the expenditure of one hundred thousand dollars ($100,000) or more, by submitting a response to this solicitation or agreeing to contract with the State, the bidder or offeror certifies and agrees that the following information is correct:

The bidder or offeror, in preparing its response or offer or in considering proposals submitted from qualified, potential vendors, suppliers, and subcontractors, or in the solicitation, selection, or commercial treatment of any vendor, supplier, or subcontractor, has not refused to transact business activities, has not terminated business activities, and has not taken other similar actions intended to limit its commercial relations, related to the subject matter of the bid or offer, with a person or entity on the basis of Israeli national origin, or residence or incorporation in Israel or its territories, with the specific intent to accomplish a boycott or divestment of Israel in a discriminatory manner. It is understood and agreed that, if this certification is false, such false certification will constitute grounds for the State to reject the bid or response submitted by the bidder or offeror on this project and terminate any contract awarded based on the bid or response. The successful bidder or offeror further agrees to provide immediate written notice to the contracting executive branch agency if during the term of the contract it no longer complies with this certification and agrees such noncompliance may be grounds for contract termination.

1.10 RESTRICTION OF PROHIBITED ENTITY

For contractors, vendors, suppliers, or subcontractors who enter into a contract with the State of South Dakota by submitting a response to this solicitation or agreeing to contract with the State, the bidder or offeror certifies and agrees that the following information is correct:

The bidder or offeror, in preparing its response or offer or in considering proposals submitted from qualified, potential vendors, suppliers, and subcontractors, or in the solicitation, selection, or commercial treatment of any vendor, supplier, or subcontractor, is not a prohibited entity, regardless of its principal place of business, that is ultimately owned or controlled, directly or indirectly, by a foreign national, a foreign parent entity, or foreign government from China, Iran, North Korea, Russia, Cuba, or Venezuela, as defined by South Dakota Executive Order 2023-02. It is understood and agreed that, if this certification is false, such false certification will constitute grounds for the State to reject the bid or response submitted by the bidder or offeror on this project and terminate any contract awarded based on the bid or response. The successful bidder or offeror further agrees to provide immediate written notice to the contracting executive branch agency if during the term of the contract it no longer complies with this certification and agrees such noncompliance may be grounds for contract termination.

1.11 MODIFICATION OR WITHDRAWAL OF PROPOSALS

Proposals may be modified or withdrawn by the offeror prior to the established due date and time.

No oral, telephonic, telegraphic or facsimile responses or modifications to informal, formal bids, or Request for Proposals will be considered.

1.12 OFFEROR INQUIRIES

Each offeror may submit questions via email concerning this RFP to obtain clarification of requirements. All written questions should be sent to NBSRFP@state.sd.us. Only emailed questions will be accepted. No questions will be accepted after the date and time indicated in the above schedule of activities.

Email questions to NBSRFP@state.sd.us with the subject line “RFP #25-0904004-022”. The questions and their answers will be sent to all offerors that submitted questions via email before the proposal submittal date and will be sent by the date and time indicated in the above calendar of events. Offeror may not rely on any other statements, either of a written or oral nature, that alter any specification or other term or condition of mailto:NBSRFP@state.sd.us

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1.13 PROPRIETARY INFORMATION

The proposal of the successful offeror(s) becomes public information. Proprietary information can be protected under limited circumstances such as client lists and non-public financial statements. An entire proposal may not be marked as proprietary. Offerors must clearly identify in the Executive Summary and mark in the body of the proposal any specific proprietary information they are requesting to be protected.

The Executive Summary must contain specific justification explaining why the information is to be protected.

Proposals may be reviewed and evaluated by any person at the discretion of the State. All materials submitted become the property of the State of South Dakota and may be returned only at the State's option.

1.14 LENGTH OF CONTRACT

The contract will begin on after final award and contract negotiations, following contract execution and approval. The contract will end on May 30th, 2030, unless terminated earlier in accordance with contract terms.

Automatic renewals will be contingent upon continued availability of funding and the Contractor maintaining compliance with all contractual obligations, including system functionality, security, and support services.

1.15 DEMONSTRATIONS & PRESENTATIONS

At its discretion, the State may require a presentation or demonstration by an offeror to clarify a proposal.

However, the State may award a contract based on the initial proposals received without a presentation or demonstration by the offeror. If presentations or demonstrations are required, they will be scheduled after the submission of proposals. Presentations and demonstrations will be made at the offeror’s expense.

1.16 DISCUSSIONS

At the State’s discretion, the offeror may or may not be invited to have discussions with the State. The discussions can be before or after the RFP has been submitted. Discussions will be made at the offeror’s expense.

1.17 NEGOTIATIONS

This process is a Request for Proposal/Competitive Negotiation process. Each proposal shall be evaluated, and each respondent shall be available for negotiation meetings at the State’s request. The State reserves the right to negotiate on any component of every proposal submitted. From the time the proposals are submitted until the formal award of a contract, each proposal is considered a working document and as such, will be kept confidential. The negotiation discussions will also be held as confidential until such time as the award is completed.

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2 STANDARD CONTRACT TERMS AND CONDITIONS

Any contract or agreement resulting from this RFP will include the State’s standard terms and conditions as listed below, along with any additional terms and conditions as negotiated by the parties:

2.1 The Contractor will perform those services described in the Scope of Work, attached hereto as

Section 3 of the RFP and by this reference incorporated herein.

2.2 The Contractor’s services under this Agreement shall start on ______________________ and end on

______________________, unless terminated sooner pursuant to the terms hereof.

2.3 The Contractor will not use State equipment, supplies or facilities. The Contractor will provide the

State with its Employer Identification Number, Federal Tax Identification Number or Social Security

Number upon execution of this Agreement.

2.4 The State will make payment for services upon satisfactory completion of the services. The TOTAL

CONTRACT AMOUNT for the first year shall not exceed U$ ______________________. Funding for subsequent years will be subject to negotiation as additional grant funds and other resources become available. The State will not pay the Contractor’s expenses as a separate item. Payment will be made pursuant to itemized invoices submitted with a signed state voucher and will be processed in accordance with SDCL chapter 5-26.

2.5 The Contractor agrees to indemnify the State of South Dakota, its officers, agents, and employees, from and against all claims or proceedings for actions, suits, damages, liabilities, other losses or equitable relief that may arise at least in part as a result of an act or omission in performing services under this Agreement. The Contractor will defend the State of South Dakota, its officers, agents, and employees against any claim, including any claim, action, suit, or other proceeding related to the claim. The Contractor’s obligation to indemnify includes the payment of attorney fees and other costs of defense. In defending the State of South Dakota, its officers, agents, and employees, the Contractor will engage other professionals, subject to the written approval of the

State which will not be unreasonably withheld. Notwithstanding the foregoing, the State may, in its sole discretion and at the expense of the Contractor, engage attorneys and other professionals to defend the State of South Dakota, its officers, agents, and employees, or to assist the Contractor in the defense. This section does not require the Contractor to be responsible for or defend against claims or proceedings for damages, liabilities, losses, or equitable relief arising solely from errors or omissions of the State, its officers, agents, or employees.

2.6 The Contractor, at all times during the term of this Agreement, shall obtain and maintain in force insurance coverage of the types and with the limits as follows:

A. Commercial General Liability Insurance:

The Contractor shall maintain occurrence based commercial general liability insurance or equivalent form with a limit of not less than $1 million for each occurrence. If such insurance contains a general aggregate limit, it shall apply separately to this Agreement or be no less than two times the occurrence limit.

B. Professional Liability Insurance or Miscellaneous Professional Liability Insurance:

The Contractor agrees to procure and maintain professional liability insurance or miscellaneous professional liability insurance with a limit not less than $1 million.

C. Business Automobile Liability Insurance:

The Contractor shall maintain business automobile liability insurance or equivalent form with a

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D. Workers’ Compensation Insurance:

The Contractor shall procure and maintain workers’ compensation and employers’ liability insurance as required by South Dakota law.

Before beginning work under this Agreement, Contractor shall furnish the State with properly executed Certificates of Insurance which shall clearly evidence all insurance required in this

Agreement. In the event a substantial change in insurance, issuance of a new policy, cancellation or nonrenewal of the policy, the Contractor agrees to provide immediate notice to the State and provide a new certificate of insurance showing continuous coverage in the amounts required.

Contractor shall furnish copies of insurance policies if requested by the State.

2.7 While performing services hereunder, the Contractor is an independent contractor and not an officer, agent, or employee of the State of South Dakota.

2.8 The Contractor agrees to report to the State any event encountered in the course of performance of this Agreement which results in injury to the person or property of third parties, or which may otherwise subject Contractor or the State to liability. Contractor shall report any such event to the

State immediately upon discovery.

The Contractor's obligation under this section shall only be to report the occurrence of any event to the State and to make any other report provided for by their duties or applicable law. Contractor's obligation to report shall not require disclosure of any information subject to privilege or confidentiality under law (e.g., attorney-client communications). Reporting to the State under this section shall not excuse or satisfy any obligation of Contractor to report any event to law enforcement or other entities under the requirements of any applicable law.

2.9 This Agreement may be terminated by either party hereto upon thirty (30) days written notice. In the event the Contractor breaches any of the terms or conditions hereof, this Agreement may be terminated by the State at any time with or without notice. If termination for such a default is affected by the State, any payments due to Contractor at the time of termination may be adjusted to cover any additional costs to the State because of Contractor's default. Upon termination the State may take over the work and may award another party an agreement to complete the work under this Agreement. If after the State terminates for a default by Contractor it is determined that Contractor was not at fault, then the

Contractor shall be paid for eligible services rendered and expenses incurred up to the date of termination.

2.10 This Agreement depends upon the continued availability of appropriated funds and expenditure authority from the Legislature for this purpose. If for any reason the Legislature fails to appropriate funds or grant expenditure authority, or funds become unavailable by operation of law or federal funds reductions, this Agreement will be terminated by the State. Termination for any of these reasons is not a default by the State nor does it give rise to a claim against the State.

2.11 This Agreement may not be assigned without the express prior written consent of the State. This

Agreement may not be amended except in writing, which writing shall be expressly identified as a part hereof and be signed by an authorized representative of each of the parties hereto.

2.12 This Agreement shall be governed by and construed in accordance with the laws of the State of

South Dakota. Any lawsuit pertaining to or affecting this Agreement shall be venued in Circuit Court, Sixth Judicial Circuit, Hughes County, South Dakota.

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2.13 The Contractor will comply with all federal, state and local laws, regulations, ordinances, guidelines, permits and requirements applicable to providing services pursuant to this Agreement, and will be solely responsible for obtaining current information on such requirements.

2.14 The Contractor may not use subcontractors to perform the services described herein without the express prior written consent of the State. The Contractor will include provisions in its subcontracts requiring its subcontractors to comply with the applicable provisions of this Agreement, to indemnify the State, and to provide insurance coverage for the benefit of the State in a manner consistent with this Agreement. The Contractor will cause its subcontractors, agents, and employees to comply, with applicable federal, state and local laws, regulations, ordinances, guidelines, permits and requirements and will adopt such review and inspection procedures as are necessary to assure such compliance.

2.15 The State reserves the right to reject any person from performing services under this Agreement who the State believe would be detrimental to the services, presents insufficient skills, presents inappropriate behavior or is considered by the State to be a security risk.

2.16 The Contractor hereby acknowledges and agrees that all reports, plans, specifications, technical data, miscellaneous drawings, software system programs and documentation, procedures, or files, operating instructions and procedures, source code(s) and documentation, including those necessary to upgrade and maintain the software program, and all information contained therein provided to the

State by the Contractor in connection with its performance of services under this Agreement shall belong to and is the property of the State and will not be used in any way by the Contractor without the written consent of the State. Papers, reports, forms, software programs, source code(s) and other material which are a part of the work under this Agreement will not be copyrighted without written approval of the State.

2.17 The Contractor certifies that neither Contractor nor its principals are presently debarred, suspended, proposed for debarment or suspension, or declared ineligible from participating in transactions by the federal government or any state or local government department or agency. Contractor further agrees that it will immediately notify the State if during the term of this Agreement Contractor or its principals become subject to debarment, suspension or ineligibility from participating in transactions by the federal government, or by any state or local government department or agency.

2.18 By signing this Agreement, the Contractor certifies and agrees that is has not refused to transact business activities, have not terminated business activities, and have not taken other similar actions intended to limit its commercial relations, related to the subject matter of this

Agreement, with a person or entity that is either the State of Israel, or a company doing business in or with Israel or authorized by, licensed by, or organized under the laws of the State of Israel to do business, or doing business in the State of Israel, with the specific intent to accomplish a boycott or divestment of Israel in a discriminatory manner. It is understood and agreed that, if this certification is false, such false certification will constitute grounds for the

State to terminate this Agreement. During the term of this Agreement, if the Contractor no longer complies with this certification, the Contractor agrees to provide immediate written notice to the State and agrees such noncompliance may be grounds for termination of this Agreement.

2.19 Pursuant to South Dakota Executive Order 2023-02, by entering into this Agreement with the State of South Dakota, the Contractor certifies and warrants that the Contractor is not a prohibited entity, regardless of its principal place of business, that is ultimately owned or controlled, directly or indirectly, by a foreign national, a foreign parent entity, or foreign government from China, Iran, North

Korea, Russia, Cuba, or Venezuela, as defined by South Dakota Executive Order 2023-02.

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The Contractor agrees that if this certification is false, the State may terminate this Agreement with no further liability to the State. The Contractor further agrees to provide immediate written notice to the State if during the term of the contract it no longer complies with this certification, and the

Contractor agrees such noncompliance may be grounds for contract termination.

2.20 The Contractor

(i) understands neither a state legislator nor a business in which a state legislator has an ownership interest may be directly or indirectly interested in any contract with the State that was authorized by any law passed during the term for which that legislator was elected, or within one year thereafter, and

(ii) has read South Dakota Constitution Article 3, Section 12 and has had the opportunity to seek independent legal advice on the applicability of that provision to this Agreement. By signing this

Agreement, the Contractor certifies that this Agreement is not made in violation of the South Dakota

Constitution Article 3, Section 12.

2.21 Any notice or other communication required under this Agreement shall be in writing and sent to the address set forth above. Notices shall be given by and to __________________ on behalf of the

State, and by and to ________________, on behalf of the Contractor, or such authorized designees as either party may from time to time designate in writing. Notices or communications to or between the parties shall be deemed to have been delivered when mailed by first class mail, provided that notice of default or termination shall be sent by registered or certified mail, or, if personally delivered, when received by such party.

2.22 In the event that any court of competent jurisdiction shall hold any provision of this Agreement unenforceable or invalid, such holding shall not invalidate or render unenforceable any other provision hereof.

2.23 All other prior discussions, communications and representations concerning the subject matter of this

Agreement are superseded by the terms of this Agreement, and except as specifically provided herein, this Agreement constitutes the entire agreement with respect to the subject matter hereof.

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3 SCOPE OF WORK

The South Dakota Department of Health (SD DOH) is seeking proposals from qualified offerors to design, develop, implement, and maintain a Newborn Screening Surveillance System (NBSSS). This system will serve as a centralized data management platform that ensures real-time tracking, follow-up, case management, and reporting to facilitate early detection and intervention for newborns at risk of genetic, metabolic, and auditory conditions, as well as new conditions that may be added to the SD Screening Panel.

The selected system must be secure, scalable, and interoperable with existing state and federal health data systems, including laboratories, electronic health records (EHRs), public health databases, and vital records systems. The offeror must propose a comprehensive solution that includes software development, system integration, user training, technical support, and ongoing maintenance. The offeror must also comply with South Dakota BIT guidance, including submission of the BIT Security and Offeror Questions document.

The full scope of work will be implemented in phases to ensure successful deployment and sustainability.

Each phase builds on the previous one to incrementally deliver functionality, increase system intelligence, and support statewide integration. Offerors must clearly demonstrate how their proposed solution aligns with this phased approach and describe in detail how it meets or exceeds all outlined functional requirements.

3.1 PHASE 1: CORE SYSTEM IMPLEMENTATION FOR PROGRAM OPERATIONS

Objective: Deploy a foundational, centralized newborn screening surveillance system to manage bloodspot and hearing screening program operations.

Estimated Timeline: 6–12 months, depending on vendor platform maturity, integration readiness, and stakeholder availability. Proposals should include a detailed project schedule with key milestones.

3.1.1 Integrated Case Management, Follow-up Tracking, and Workflow automation

The system must support comprehensive, automated case tracking to ensure timely follow-up and resolution of newborn screening results, specifically for both bloodspot and hearing screenings. It must allow public health professionals and authorized contractors to efficiently manage the full case lifecycle, from initial screen through diagnosis and resolution.

At a minimum, the system must:

• Automatically initiate, update, and close cases based on real-time bloodspot and hearing screening data received via Health Level Seven (HL7), Fast Healthcare Interoperability Resources (FHIR), or other standardized data exchange formats, minimizing manual entry.

• Support the manual creation, update, and closure of cases by authorized users to account for scenarios not captured through automated data exchange (e.g., screenings performed by facilities or providers that don’t have automation capabilities, missing data feeds, or special population cases).

• Enable case assignment and routing based on configurable rules (e.g., screening type, geography, user role), ensuring that follow-up responsibilities are directed to the appropriate personnel (e.g., audiologists for hearing, follow-up nurses for metabolic conditions).

• Generate real-time alerts and automated reminders for missed bloodspot or hearing screenings, diagnostic evaluations, and follow-up steps.

• Allow configurable escalation triggers, role-specific thresholds, and alert workflows to ensure that high-priority cases are flagged and acted upon quickly.

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• Provide visual indicators (e.g., color-coded flags or case status dashboards) to help users identify and prioritize time-sensitive or at-risk newborns.

• Support role-based notification settings that can be tailored by screening type, status, result, or diagnosis confirmation.

For documentation and compliance, the system must:

• Log all case management activities with a complete audit trail, including timestamps, user identification, actions taken, and resolution outcomes.

• Support structured and narrative documentation of outreach attempts, referrals, clinical interventions, and parent/provider communications.

The system should also:

• Provide workflow automation that guides users through follow-up procedures tailored to bloodspot and hearing screening pathways, based on South Dakota’s program rules and nationally recognized best practices.

• Align with follow-up protocols recommended by the Centers for Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA), American Academy of Pediatrics (AAP), and Joint Committee on Infant Hearing (JCIH),

• Offer configurable tools for benchmark tracking and compliance reporting that reflect adherence to follow-up standards for both screening types.

The system must support tracking of bloodspot screening milestones, including specimen collection by 24–48 hours of life, laboratory receipt within 1–2 days, result reporting within 3–5 days, and timely initiation of follow-up and diagnostic testing, particularly for time-critical conditions.

The system must also support hearing milestone tracking such as 1-3-6 timelines (screening by 1 month, diagnosis by 3 months, intervention by 6 months).

To support ongoing case oversight and operational performance, the system must include:

• A dashboard view of active and closed cases, with filters to sort by case type (bloodspot or hearing), status, priority, provider, or geography.

• Export and reporting tools for program staff to generate follow-up summaries, identify delays, and assess program performance.

3.1.2 Data Quality Monitoring & Error Resolution Mechanisms

The system must incorporate robust, automated data quality tools to ensure that newborn screening data — from initial screening through follow-up — is accurate, complete, and actionable. These tools must function both at the point of data entry and during system-wide data ingestion and integration.

At a minimum, the system must:

• Validate data in real time at the point of entry using field-level rules (e.g., required fields, accepted value ranges, logical date relationships). The system must immediately flag missing, incomplete, or invalid entries before submission to the central database.

• Support configurable validation rules that can be modified by authorized system administrators without vendor intervention. Validation logic must be adaptable to accommodate changes in screening protocols, data formats, or regulatory requirements.

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• Detect and flag data inconsistencies such as mismatches between screening results, duplicate specimen entries, invalid date sequences, or missing diagnosis fields. The system must notify users through real-time alerts or error queues and prompt corrective action.

• Support cross-validation with external reference datasets (e.g., vital records, laboratory rosters) to confirm demographic accuracy, ensure correct facility assignment, and flag suspicious discrepancies.

• Log all data quality alerts and user actions taken in response, maintaining an audit trail for compliance and reporting.

To ensure the integrity of longitudinal case records and prevent duplication, the system must:

• Implement a probabilistic matching algorithm that evaluates multiple data fields (e.g., infant name, date of birth, mother’s name, specimen ID, facility code) to identify potential duplicates or fragmented records across bloodspot and hearing data streams.

• Automatically classify new data entries as high-confidence matches, possible matches, or new records, and route possible matches for user review and resolution.

• Include tools for authorized users to review, merge, separate, or dismiss potential duplicates using a guided side-by-side comparison interface.

To streamline the resolution of flagged errors and exceptions:

• The system must include a dedicated data quality queue where users can view, filter, and resolve validation errors and flagged records.

• Include resolution workflows that allow assignment of flagged records to specific users or roles, with built-in status tracking (e.g., pending, in progress, resolved).

• Provide reporting tools to track unresolved errors, resolution timelines, and data quality performance across programs and time periods.

To support appropriate case closure and improve operational efficiency, the system must also support automated matching of newborn screening records with death records from the South Dakota Vital Records system. When a confirmed match is found, the system must flag the record for closure and enable authorized users to review and finalize the closure with minimal manual effort. This feature must be integrated into the broader data quality framework and included in validation, audit logging, and reporting processes.

These features are essential to ensure that newborn screening data is accurate, complete, and reliable — enabling timely case management, follow-up, and public health reporting.

3.1.3 Document Management and Upload Capabilities

Core System Requirements The system must provide robust document management and upload functionality to support the secure storage, retrieval, and processing of newborn screening-related documentation. This functionality must be fully integrated into case management workflows and accessible to authorized users across roles and programs.

At a minimum, the system must:

• Support Optical Character Recognition (OCR) to digitize paper-based records, including screening results, refusal forms, diagnostic reports, and case management documentation.

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• Use OCR to enable automated extraction and population of key data fields, reducing manual data entry and minimizing transcription errors.

• Include error detection and validation mechanisms to improve the accuracy of structured data generated from scanned documents.

• Allow secure upload and storage of documents in various formats (e.g., PDF, JPG, DOCX), enabling public health staff to attach documents directly to patient records or screening cases.

• Ensure that uploaded documents—such as birth records, bloodspot and hearing screening results, clinical notes, and refusals—are categorized and stored in appropriate sections within the system for easy reference.

• Require metadata tagging for all uploaded documents, including dropdown options for document type (e.g., “Refusal Form,” “Lab Results,” “Hearing Screening,” “Bloodspot Screening”) and optional fields such as provider name, upload date, and screening facility.

• Enforce document access controls aligned with user roles and permissions, in compliance with HIPAA and applicable state and federal privacy regulations.

• Provide a bulk upload function to ingest multiple documents at once, supporting scenarios such as historical record import, mass scan processing, or transition from legacy systems.

• Track chain-of-custody metadata for each uploaded document, including upload timestamp, user identity, and any edits or deletions applied to the file.

• Include a search and filter interface that allows users to retrieve documents based on patient ID, document type, upload date, keyword, or metadata tags.

• Log all document interactions (uploads, edits, views, deletions) in the system audit trail.

• Support offline document capture and delayed upload workflows for rural providers and field-based users (e.g., midwives), ensuring that documents can be securely submitted once connectivity is restored.

Use of FileDirector as the State Document Management Standard The South Dakota Department of Health (DOH) utilizes FileDirector as its standard, centralized document management system. FileDirector supports secure document storage, retention, and retrieval through API-based integrations. The state’s Bureau of Information and Telecommunications (BIT) requires that all systems handling document workflows use FileDirector for storage and management whenever feasible.

Required Integration with FileDirector In alignment with state standards and BIT guidance, the NBSSS must be developed to integrate with

FileDirector via API for all document storage and retrieval functions.

At a minimum, the system must:

• Be capable of storing uploaded documents to FileDirector using secure, state-approved API endpoints.

• Retrieve and display documents stored in FileDirector within the NBSSS user interface, directly linked to the relevant infant or case record.

• Maintain traceability by referencing FileDirector document IDs in NBSSS records.

• Ensure that audit trails of all document interactions (uploads, edits, views, deletions) are captured within NBSSS and can be linked to FileDirector logs for compliance purposes.

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• Support error handling and reconciliation workflows for failed uploads, metadata issues, or access restrictions returned by the FileDirector API.

Note: OCR and post-processing of extracted fields must be performed within the NBSSS. FileDirector does not support OCR and serves only as a storage and retrieval system.

Milestone Requirement:

The system does not need to have pre-existing integration with FileDirector at the time of proposal, but the vendor must demonstrate their ability to implement this integration during development. This includes working collaboratively with DOH and BIT to ensure compliance with security, metadata, and infrastructure requirements.

Full integration with FileDirector must be developed, tested, and operational by the end of Phase 1 – Core

System Implementation. The vendor must work collaboratively with DOH and BIT to configure endpoints, define metadata standards, and implement secure authentication and access protocols in accordance with state requirements.

3.1.4 Tracking of Refusals

The system must include a dedicated refusal tracking module to ensure accurate documentation, secure storage, and meaningful reporting of screening refusals across all relevant screening types, including bloodspot, hearing, and any condition included in or added to the South Dakota newborn screening panel. This functionality is essential to support program accountability, provider education, and population-level analysis of screening gaps.

At a minimum, the system must:

• Capture and categorize refusals based on:

The specific screening type declined (e.g., bloodspot, hearing, or other panel screening)

Whether the refusal pertains to an initial or subsequent screening attempt

• Allow for electronic submission of refusal forms, including digitally signed forms submitted by providers or parents/guardians.

• Support secure upload and storage of scanned or electronically submitted refusal documentation, ensuring files are directly linked to the infant's record and accessible only to authorized users.

• Integrate with the system’s document management module, enabling metadata tagging (e.g., “Refusal Form”), indexing, and retrieval alongside other screening-related documentation.

• Generate real-time alerts when a newborn screening record is missing both a result and a documented refusal, prompting timely outreach or provider follow-up to resolve data gaps.

• Enable tracking of ambiguous or incomplete records, such as cases marked “No Test/No Refusal on File,” to support follow-up investigation and provider re-education.

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