Opportunity Detail

Questions and Answers

Integrated Newborn Screening System (iNBS)
Document #:  0A1250


Question:   T-SS-8 says, "System must support emergency access of tables and data." Please explain this requirement. What constitutes an emergency? What type of access is required, and what type of data is required (all data or specific tables/data)?

Answer:   Must have the capability to sustain essential functions on a continuous basis and to perform those functions regardless of circumstances which also include access to the non-lab portions of the data system. Essentially a mechanism in place for getting ODH the data needed to perform work if the system is not accessible for longer than planned.

Date: 7/24/2019

Inquiry: 63860


Question:   Does ODH have a preference for the type of licensing agreement? That is, does ODH prefer a subscription based approach or does ODH prefer to purchase the licenses up front and then pay the support costs annually?

Answer:   Enterprise Level plus support.

Date: 7/17/2019

Inquiry: 63865


Question:   Can you please provide a list of application interfaces required (and, if possible, the name and type of each interface) or, at least, the *number* of expected application interfaces?

Answer:   No data interfaces exist with the current system. ODH wishes to interface with Disease Reporting, Vital Stats, Hospital systems, and other during this contract period.

Date: 7/17/2019

Inquiry: 63865


Question:   How does ODH envision the support process? Will ODH provide triage via its Core users (trained during the implementation process) or is ODH expecting the vendor to handle all support calls and provide all levels of support (front-line/Level 1 and beyond) for all 6,000 users? If the vendor is to provide Level 1 (and beyond) support for all 6,000 users, does ODH have a preferred method for the vendor to validate user credentials (i.e. to verify that the user calling in for support is one of the valid 6000 users)?

Answer:   Yes, the Contractor will provide all levels of support; ODH expects a ticketing system that would be used by the Contractor to track request.

Date: 7/17/2019

Inquiry: 63865


Question:   T-SO-3 says, "The system must limit how much data can be exfiltrated at one time." Please explain this requirement. What data is being exfiltrated, how, when, and why?

Answer:   No data extracts are allowed from the system. Any request from data will be coordinated between ODH and the vendor.

Date: 7/17/2019

Inquiry: 63860


Question:   Can you please provide the make (manufacturer), model, and quantity for each EHDI, CCHD, and NBS device to be interfaced with the iNBS?

Answer:   See "Instrument Manufacturers" document posted to the Procurement Website.

Date: 7/16/2019

Inquiry: 63865


Question:   T-L-20 says, "System must be able to accept and store mutation analysis results as well as numeric and text values." What format are the mutation analyses in (the non-text and non-numeric portions)? From what instrument?

Answer:   Results of mutation analysis should be stored using standard sequence variant nomenclature.
(see http://onlinelibrary.wiley.com/doi/10.1002/humu.22981/pdf

Date: 7/11/2019

Inquiry: 63860


Question:   Can you please provide a list of the devices from the Newborn Screening Laboratory (manufacturer, model number, and quantity of each) to be interfaced with the iNBS?

Answer:   The link below lists newborn hearing screening equipment that has capability to transmit data from the screening device to the hospital EMR or a state data system. Additionally, hospitals have connected newborn hearing screening equipment to laptops that also automatically transmit data to the EMR.

https://www.infanthearing.org/newborn-hearing-screening/equipment.html

The majority (if not all) newborn hearing and CCHD screening equipment have functionality to transmit results to the EMR and/or to state data systems. ODH does not have a list of approved screening devices. For newborn hearing screening, the device must conduct physiologic screening for hearing (otoacoustic emissions and automated brainstem response). For CCHD screening the pulse oximeter must be motion-tolerant and reports functional oxygen saturation, has been validated in low-perfusion conditions, has been cleared by the food and drug administration for use in newborns, and has a two per cent root-mean-square accuracy.

Date: 7/11/2019

Inquiry: 63861


Question:   P-F-31 says, "System should be able to support electronic transfer of data from hearing and pulse oximeter devices." Can you please provide a list of devices (manufacturer and model numbers) to be interfaced with the iNBS?

Answer:   The link below lists newborn hearing screening equipment that has capability to transmit data from the screening device to the hospital EMR or a state data system. Additionally, hospitals have connected newborn hearing screening equipment to laptops that also automatically transmit data to the EMR.

https://www.infanthearing.org/newborn-hearing-screening/equipment.html

The majority (if not all) newborn hearing and CCHD screening equipment have functionality to transmit results to the EMR and/or to state data systems. ODH does not have a list of approved screening devices. For newborn hearing screening, the device must conduct physiologic screening for hearing (otoacoustic emissions and automated brainstem response). For CCHD screening the pulse oximeter must be motion-tolerant and reports functional oxygen saturation, has been validated in low-perfusion conditions, has been cleared by the food and drug administration for use in newborns, and has a two per cent root-mean-square accuracy.

Date: 7/11/2019

Inquiry: 63861


Question:   Supplement 1: Section 1.5 Pg. 9
What person, party, or entity is currently sending test results (i.e. Dried Blood Spot screening results) to Primary Care Physicians (PCPs) and/or health care providers from the Ohio Department of Health?

Answer:   Currently one hospital is sending order messages by HL7 through SFTP. Another hospital is receiving screening results via SFTP transfer of PDF. These were both started as pilot projects with the intention of expanding to the ~ 120 birthing facilities within Ohio.

Date: 7/11/2019

Inquiry: 63864


Question:   T-L-28 says, "The system must support an option for linking results of testing done for QC purposes (not reported) on a given sample to the rest of the records for that sample." Please explain this requirement.

Answer:   Specimens are used for quality control purposes (improving and developing assays, monitoring assay performance, etc.). The system must have a mechanism of recording and linking the use of specimens for QC purposes. Results of assays run as QC should be viewable through patient record, but should not be included as screening results or interpretation.

Date: 7/11/2019

Inquiry: 63860


Question:   ODH Disaster Recovery Requirements
• Supplement #2; Section 3.3, pg.13 and Section 4.3, pg. 17
• If the platform is hosted on the Ohio Cloud, what is the lead time for the vendor to have access to the stored artifacts to restore the applications? Do you have a mechanism already in place?

Answer:   The Ohio Private Cloud incorporates backup/restore services. Based on customer requirements, backups are generally scheduled on a nightly basis with retention periods of 30, 60, 90, 180, or 365 days. Server restores are performed on customer request by the Ohio Private Cloud staff in a timely manner. Severity 1 issues are worked on with immediate priority. Database backup and restores are under the control of the DBA for the environment. All database restores would be performed by the DBA. If the DBA required a full system restore, the Ohio Private Cloud staff would perform that service.

Date: 7/10/2019

Inquiry: 62755


Question:   In reference to pages 17 and 64: "MANDATORY REQUIREMENT: The offeror or proposed subcontractor must demonstrate experience as the prime contractor implementing the proposed software solution in at least three (3) clinical environments with 20+ concurrent users. At least one of the environments must have been for a federal, state or local environmental health entity where the solution has been successfully implemented in a production environment within the past 60 months."

Based on our experience and ODHs requirements, a large amount of custom development for ODH-unique system integrations and certain features will be required for any proposed solution. In this context, will you please clarify the meaning of the requirement in Attachment Eight that the proposed solution is implemented in three different clinical environments?

Would our experience implementing similar solutions with client-specific system integrations and features suffice?

Answer:   ODH is aware that the software package will require development and customization specific to the state program and it is unlikely that an off the shelf solution exists for this project. The offeror or proposed subcontractor must demonstrate experience as the prime contractor implementing software that has components similar to those requested: laboratory information system, electronic medical record, medical case management, electronic transfer of medical information. A clinical environment would directly involve patients (i.e., hospital, outpatient clinic, doctors office, emergency room, long term care facility).

The State cannot evaluate whether or not your similar solutions will meet the Mandatory Requirement through the inquiry process. The evaluation team will have to review the proposed Offeror Profile Form.

Date: 7/9/2019

Inquiry: 63832


Question:   T-DT-12 says, "While importing data from non-ODH sources, system must be error proof and complete the transaction even if errors are found in the data and be able to flag errors."

Please explain this in more detail. What non-ODH sources? How is the data exchanged? How will the system know what constitutes an error vs. what is considered good data?

Answer:   Demographic and clinical data imported from hospitals and specialists must have logic checks (e.g. birth date must be prior to screen date). Records failing the logic are not rejected but flagged for review and editing before accepting data into system. Contractor must propose how data is received; the preferred method would be through web-services/open API, etc.

Date: 7/9/2019

Inquiry: 63835


Question:   T-SY-17 says, "The system must provide multiple access points for main topics."

Please explain this requirement - is it for online help or something else?

Answer:   The system must allow role based access to different screening areas (Hearing, CCHD, blood spot, clinical follow-up) at multiple sites.

Date: 7/9/2019

Inquiry: 63835


Question:   Section 2.6 of Supplement #2 - Database Platforms. Are other databases acceptable if the database is hosted on a Windows Server and the vendor provides all Database Management Support and Services?

Answer:   Yes, however, the team would have to evaluate the proposed solution.

Date: 7/9/2019

Inquiry: 63835


Question:   What are the addresses of the primary locations associated with the iNBS? (Are there three...one each for Bloodspot/IEM, CCHD, and Hearing?) What are the approximate number of users at each location?

Answer:   ODH State Locations for Hearing and CCHD: 246 N. High Street, Columbus, OH 43215; ODH State Laboratory location for Bloodspot: 8995 East Main Street, Building 22, Reynoldsburg, OH 43068

Hearing/CCHD has 7 users at the N High location and bloodspot has 30 users at the 8995 E Main location; however there are additional users throughout the state at various locations, including users at every birth hospital and multiple medical specialists and audiologist offices in the state.

Date: 7/9/2019

Inquiry: 63835


Question:   P-F-11 says, "System must be able to store screening, diagnostic and treatment information for multiple newborn screening programs."

Please clarify what is meant by "multiple nbs programs?" Is this multiple programs within the state (i.e. ODH NBS, ODH CCHD, and ODH EHDI) or across states (i.e. Ohio and Michigan have a disaster recovery/emergency processing agreement in place).

Answer:   Multiple newborn screening programs within Ohio - storing data for bloodspot, hearing and CCHD.

Date: 7/9/2019

Inquiry: 63836


Question:   Reference to Scored Criteria (RFP # 0A1250_RFP_iNBS) section, page 17/77, the below message needs some clarification for us (At least one of the environments must have been for a federal, state or local health entity where the solution has been successfully implemented in a production environment within the past 60 months. ).

Our Organization(Ohio based incorporation) acquired a product which is implemented in India, Iraq and now in South African Government Sector and is utilized currently along with references. Since the Product is implemented in Government Sectors outside US, will this impact our meeting the Mandatory requirement.

Answer:   The State cannot evaluate the offeror's proposed solution through the inquiry process. The offeror would have to submit a response and the evaluation team would determine if the offeror meets the requirement.

Date: 7/3/2019

Inquiry: 63838


Question:   T-Q-3 says, "Access roles must be defined at predefined ODH levels such as page level, field and data element level for iNBS and IPHIS data."

Please explain this in more detail.

Answer:   Because the system will collect personal health information, multiple user roles are necessary. There will be user roles with more administrative rights, and user roles that are more limited based on the work they would do within the newborn screening system and the program they specifically work in, etc. Users who assist children diagnosed with hearing loss get into early intervention services would not need to have access to bloodspot screening results and vice versa.

Date: 7/3/2019

Inquiry: 63835


Question:   T-DT-13 says, "Must provide users with the flexibility to select the frequency, format, source, and destination of secure transmissions."

Can you please explain this in more detail and provide an example? What data is being exchanged, with whom, how, for what purpose, etc.?

Answer:   Screening as well as diagnostic results will need to be shared with various providers and ODH bi-directionally. An audiologist in private practice will want to see newborn hearing screening results, as they prep for diagnostic testing for a child. After the diagnostic testing, the audiologist must submit the results to ODH per OAC.

Date: 7/3/2019

Inquiry: 63835


Question:   P-F-7 says, "System must be extensible so that it does not require a redesign every time new data sources or tables are added."

Please clarify what types of data sources or tables might be added? Please explain a situation where this might occur?

Answer:   As newborn screening evolves, there may be situations where new screening equipment (bloodspot laboratory, hearing, CCHD) with capability to link with the data system need to be added to the system. Additionally, new data fields may need to be added to enhance the data collection for the state.

Date: 7/3/2019

Inquiry: 63835


Question:   Page 26 and 31 of the 0A1250_RFP_iNBS.docx notes an Attachment 13, Business Associate Agreement must be completed. I do not see this document in the package. Is this document required and will it be provided?

Answer:   The Business Associate Agreement is Attachment Eleven. It was erroneously referred to as "Attachment Thirteen" in the RFP.

Date: 7/1/2019

Inquiry: 63799


Question:   ODH Application Requirements for Open APIs
• Supplement #2, Sec 2.5.2, pg. 6
• Can you please elaborate on “Open APIs?” What application access (inbound / outbound) would be permitted? What would be technologies and needs of these applications?

Answer:   The proposed system must be able to communicate with other applications. The applications will be inbound and outbound. Some examples include. Vital Statics, Hospitals, Lab Information Management Systems, Hospital EMR’s, ETC. Exact details will be worked out during the discovery process.

Date: 6/25/2019

Inquiry: 62755


Question:   Workflow Management
• Exhibit #1, Requirement #P-F-26, pg. 2
• Can examples be provided of workflow management systems including definitions, modeling, and workflow processes including constituent activities?

Answer:   The offeror’s solution should have a workflow management system built into the base product. The State does not have any examples. Exact details will be worked out during the discovery process.

Date: 6/25/2019

Inquiry: 62755


Question:   ODH General Security Requirements and VPN
• Supplement #2, Section 3.4, pg. 14
• If you decided to go for 3rd party cloud environment for the deployments, would you allow VPN tunnel between 3rd party cloud and your networks?

Answer:   No

Date: 6/25/2019

Inquiry: 62755


Question:   ODH General Security Requirements
• Supplement #2, Section 3, pg.11
• Is the expectation a 24x7 managed services support for the platform applications of the NBS lab? • • Do you have a need for Single Sign On (SSO) capabilities for lab users? Would this be extended to external users at any point of the lifecycle of the application? • If SSO is a requirement, what systems do you currently have in ODH?

Answer:   Yes, the expectation is for a 24x7 managed services support for the platform applications of the NBS lab.
Yes, the State has a need for Single Sign On.
Yes, this would be extended to external users at any point of the lifecycle of the application.
Integration must be Open ID Connect.

Date: 6/25/2019

Inquiry: 62755


Question:   Help Desk Function
• Supplement #1, Section 1.7, Pg. 11
• Are the help desk functions requested of the contractor expected to support all 6,000 active users mentioned in Section 1.5?

Answer:   Yes

Date: 6/25/2019

Inquiry: 62754


Question:   Batch processing
• Supplement #1, Section 6.14, pg. 53
• Can details be provided about current batch processing activities and details about ODH processing requirements?

Answer:   Jams is an enterprise job scheduling and workload automation solution. Jams automates IT tasks that programs need to run on a regular basis and with high degree of certainty which can include (transfer of files, data, etc). The State will also need the capability to transmit new born screening results to external entities such as (hospitals, clinics, etc.)

Date: 6/25/2019

Inquiry: 62755


Question:   The documentation makes reference to the contractor working with an IV&V partner. Is IV&V part of this submission, or is the state planning to issue a separate RFP for IV&V? If so, is there a timeline for that RFP?

Answer:   No decisions have been made regarding an IV&V for this Project.

Date: 6/25/2019

Inquiry: 62775


Question:   Corrective Action Plans
• Exhibit #2, Requirement #T-Q-27, pg. 7
• What records will Corrective Action Plans be associated with?

Answer:   Corrective action plans are written when any process fails affecting the quality of screening results or case management. The report must be accessible when reviewing the affected records.

Date: 6/21/2019

Inquiry: 62755


Question:   Non-business hours messages
• Exhibit #2, Requirement #T-Q-14, pg. 6
• Can examples be provided of non-business hours messages?

Answer:   This is regarding how and when will error messages from the system be managed. Offerors should address if errors will be addressed immediately (requiring on-call personnel) or addressed during business hours.

Date: 6/21/2019

Inquiry: 62755


Question:   What-if scenarios
• Exhibit #2, Requirement #T-L-13, pg. 4
• Can examples be provided of what-if scenarios?

Answer:   In the lab, an example would be to create different scenarios that look at deleting a point on a calibration curve and see how it would affect results.

Date: 6/21/2019

Inquiry: 62755


Question:   Moving data within a case
• Exhibit #2, Requirement #T-DA-9, pg. 3
• Can examples be provided of moving data within a case?

Answer:   This is regarding how the current system works. When a screen is abnormal for more than one analyte, notes and clinical documentation concerning follow-up from one analyte sometimes gets entered and linked to the wrong analyte. The State wants to have control over how information is linked within a record and be able to fix a record when information has been incorrectly assigned.

Date: 6/21/2019

Inquiry: 62755


Question:   Information that is not in an electronic format
• Supplement #1, Section 1.6, pg. 9
• Can examples be provided of information that is currently collected and not available in an electronic format?

Answer:   Clinical data from primary care providers, such as lab results, visit summaries, and differential diagnoses are currently faxed or mailed to programs, and summaries are keyed into data system by programs.

Date: 6/21/2019

Inquiry: 62755


Question:   Alternate Processing Site
• Supplement #1, Section 6.25.6, pg. 63
• Can you provide more specific details on what is required at the “Alternate Processing Site?” o For example, does instrumentation and reagents used to process all required tests in the ODH lab need to be available at an alternate location?
o If yes, is a third-party laboratory a possibility if they can test for all required disorders?

Answer:   The Contractor must be able to set up access to the iNBS at an alternate processing site, should the lab be nonfunctional. The Contractor would be responsible for re-establishing connections to the lab instruments. The Contractor would not be responsible for setting up laboratory equipment or supplies.

Date: 6/21/2019

Inquiry: 62755


Question:   ODH Application Requirements for SOA
• Supplement #2, Section 2.5.3, pg. 6
• In addition to SOA, are you open to micro-services architecture which goes beyond SOA architecture?

Answer:   Yes. Please see Roadmap that was attached to the Procurement website.

Date: 6/20/2019

Inquiry: 62755


Question:   ODH Ohio Cloud / Ohio Data Center
• Supplement #2, Section 2.2.2, pg. 5
• The description in the section indicate a Data Center with VMs / Hypervisor Environment. Would you be open to a highly secure cloud from a 3rd party to take advantage of current trend in the infrastructure technologies?

Answer:   Yes, provided it meets security requirements.

Date: 6/20/2019

Inquiry: 62755


Question:   ODH Compute Requirements: Server/OS
• Supplement #2, Section 2.2.1, pg. 5
• ODH Compute requirements suggest Windows Server 2012 R2. However, ODH Technology Roadmap on Supplement #1 (pg. 19) suggests that support of Windows Server 2016. Are both Windows version acceptable? If yes, is one more preferred? Please confirm OS should be compatible with MS DB higher than 2012, as suggested in Supplement #2, Section 2.6.
• Is RedHat Linux 7.x acceptable, in addition to 7?

Answer:   Yes, OS should be compatible with MS DB higher than 2012, as suggested in Supplement #2, Section 2.6.

New Technology Roadmap posted to the Procurement website; a SaaS solution using RedHat Linux 7.x would be acceptable.

Date: 6/20/2019

Inquiry: 62755


Question:   ODH-defined security reports
• Exhibit #2, Requirement #T-SS-11, pg. 7
• Can examples be provided of all ODH-defined security reports?

Answer:   ORC 1347.15 CPI reporting

Date: 6/20/2019

Inquiry: 62755


Question:   Monitoring tools
• Exhibit #2, Requirement #T-SY-6, pg. 1
• What are the specific monitoring tools?

Answer:   AppDynamics for system performance.

Date: 6/20/2019

Inquiry: 62755


Question:   ODH Preferred browser
• Supplement #1, Section 3.6, pg. 19
• The Technology Road Map has IE v11 ending in July 2019. What is the state’s preferred browser for a web-based platform?

Answer:   Roadmap has been posted to the Procurement website.

Date: 6/20/2019

Inquiry: 62755


Question:   Case Disposition form
• Exhibit #2, Requirement #T-R-17, pg. 3
• What is a case disposition form?

Answer:   The Case Disposition Form is a form generated from the NBS Lab that includes the newborn bloodspot screening results for newborns who have screened positive for hemoglobinopathies. The form includes the demographic information of the child, their parent’s contact information, primary care physician and the screening results. The Case Disposition Forms are sent to the ODH-funded Sickle Cell Projects for follow-up. The form includes space to complete the follow-up information for the child – i.e., diagnostic testing results, not able to contact, families declines services, physician handling case on their own, etc. The form is sent back to the ODH Lab to inform case closing activities.

Date: 6/20/2019

Inquiry: 62755


Question:   Educational Events
• Exhibit #1, Requirement #P-P-6, pg. 3
• What is the intended interaction with this information?

Answer:   ODH currently collects educational events (presentations, lectures, poster exhibits, health fairs, speakers at schools and other group meetings for the purpose of educating health professionals and the public about newborn screening and other genetic disorders, the importance of following up from abnormal newborn screening results. ODH collects data about each presentation made, the audience, the topic(s) covered, who the presenter was, the geographic location, etc. Completing these events are deliverables in the grants ODH has with local genetics and sickle cell programs. Data from these events is used to determine whether deliverables were accomplished, whether events were held in target areas and/or with target audiences.

Date: 6/20/2019

Inquiry: 62755


Question:   ODH Project Manager
• Supplement #1, Section 5.3, pg. 48
• Will the ODH Project Manager be 100% dedicated to this project? If not, what % time allocation will be committed?

Answer:   ODH is planning to have a project manager dedicated 100% for the contract period.

Date: 6/20/2019

Inquiry: 62755


Question:   When responding to the RFP, do you want exceptions red-lined in the document or do you want us to submit a letter with the exceptions that we would like to propose?

Answer:   In lieu of taking exceptions to RFP requirements, including but not limited to terms and conditions, scope of work requirements, etc., or providing assumptions that may be unacceptable to the State, offerors are strongly encouraged to use the inquiry process in Part Three of the RFP.

Note that on page 9 of the RFP, it states, "The State may reject any Proposal if the offeror takes exception to the terms and conditions of this RFP, includes unacceptable assumptions or conditions in its Proposal, fails to comply with the procedure for participating in the RFP process, or fails to meet any requirement of this RFP. In its sole discretion, the State also may reject any Proposal it believes is not in its interest to accept and may decide not to award a contract to any or all of the offerors responding to this RFP."

Date: 6/20/2019

Inquiry: 62756


Question:   Does ODH have a list of preferred cloud services providers? Does ODH have a list of preferred managed services providers?

Answer:   There is no list of preferred cloud providers or managed service providers. Contractors must follow any security standards provided in Supplement 2.

Date: 6/18/2019

Inquiry: 62751


back

Inquiry period ended:  7/11/2019 8:00:00 AM