RFP 260000001722 - Bidder Q&A.xlsx
XLSX spreadsheet 42 KB Posted
- Attached to
- RFP - Newborn Screening LIMS
- Solicitation number
- RFP 171 260000001722 2
- Issued by
- Michigan
About this file
This is a Bidder Q&A document for RFP 260000001722 issued by the State of Michigan Department of Public Health (MDHHS) for a Newborn Screening Laboratory Information Management System (LIMS), including maintenance and support services. The RFP solicits proposals for a comprehensive LIMS solution to replace the incumbent Revvity Specimen Gate system, which currently screens for over 50 disorders across multiple laboratory testing methodologies. The project encompasses integration with approximately 14 laboratory instruments (including Sciex 4500MD, Illumina MiSeQ DX, BioRad Variant II, and multiple Revvity GSP analyzers), migration of existing databases totaling approximately 1.2 TB with over 2.5 million newborn screening records and 7.5 million attachments, and support for approximately 250 concurrent users across various roles. The implementation must be completed within approximately 18 months from contract execution (anticipated April 9, 2027 go-live by October 2028), with the State indicating willingness to consider timeline extensions if technically justified. The RFP requires a single enterprise go-live, though bidders may propose phased deployment approaches if they demonstrate greater efficiency and effectiveness.
The contract will be awarded as a separate vehicle outside any existing Clinisys agreements and will be either vendor-hosted, state-hosted, or hybrid-hosted with 99.98% availability requirements. Pricing models may include subscription-based or perpetual licensing options, with bidders permitted to propose either or both models using milestone-based payment structures tied to deliverable acceptance rather than time-based payments. The incumbent vendor is Revvity, which currently supports the on-premises Specimen Gate version 2020.1.52 and LifeCycle version 3.1.8 systems operating on Microsoft SQL Server. Key requirements include support for 22-year historical data retention (with read-only archive acceptable), interfaces with CCHD (Critical Congenital Heart Disease) data submission systems via flat file, HL7, or web portal, proficiency testing functionality, comprehensive audit trails, HIPAA and FDA 21 CFR Part 11 compliance, NIST and FedRAMP standards, offline data entry capability for continuity of operations, and provision of detailed transition-out plans with technical assistance to successor vendors.
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Other files
| File | Type | Posted |
|---|---|---|
| RFP 260000001722 - NBS LIMS, Maintenance, & Support.docx | DOCX document | |
| RFP 260000001722 - Bidder Q&A & Amendment 1.docx | DOCX document | |
| RFP 260000001722 - Schedule C.docx | DOCX document | |
| RFP 260000001722 - Schedule J - Federal Provisions Addendum.docx | DOCX document |
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Sheet1
| VENDOR QUESTIONS & ANSWERS |
| RFP 260000001722 |
Newborn Screening - Laboratory Information Management System, Maintenance, and Support Bidders who have questions for the above Solicitation must fill the sections below and attach the document in an email to the Solicitation Manager, as described in the Instruction to Bidders.
| Q # | Document and Section | Page # | Bidder Question | Answer (to be completed by the State) |
| 1 | DM0048_RFP_260000001722_-_NBS_LIMS_Maintenance_Support | NA | For implementation planning purposes, can the State provide the current test catalogue and identify how the listed disorders map to laboratory tests, assays, analytes, screening panels, and reportable results? Because a single disorder may be associated with multiple tests and a single test may support multiple disorders, this information is needed to accurately assess the scope of laboratory configuration activities. | We screen for over 50 disorders. List of the testing we perform see under 2. Background |
Amino Acid/Acyl Carnitine Disorders: Revvity Neobase II Kit - Sciex 4500MD X-Linked Adrenal Leukodystrophy - 1st tier is in the Revvity Neobase II Kit - 2nd tier LC-MS/MS - C-24-LPC & C26-LPC - QSight 225 Biotindiase Deficiency - Revvity GSP Biotinidase Kit - GSP Congenital Adrenal Hyperplasia - Revvity GSP 17OHP Kit - GSP Congenital Hypothyroidism - Revvity GSP TSH Kit - GSP Cystic Fibrosis: Immunoreactive Trypsinogen - Revvity GSP IRT Kit - GSP; 2nd Tier Illumina TruSight Cystic Fibrosis 139 variant panel - MiSEQ Dx Galactosemia - Revvity Neonatal GALT Kit - Victor 2D Severe Combined Immunodeficiency (SCID) - T-Cell Receptor Excision Circles (TRECs), Quant Studio, multiplexed with SMA with reference gene Spinal Muscular Atrophy (SMA) - SMN1, Quant Studios, mulitplexed with SCID with reference gene Lysosomal Disorders: Pompe & MPS I - Revvity NeoLSD Kit - QSight 210s; MPS II - LaCAR RUO substrates, controls, and calibrators, Victor Nevo Hemoglobinopathies - BioRad Variant NBS system - BioRad Variant II
| 2 | DM0048_RFP_260000001722_-_NBS_LIMS_Maintenance_Support | NA | What instruments will the LIMS need to interface with (make and model)? Please include the devices used for point of care pulse oximetry testing. | See Schedule A: 14.1.1 under Instrument Integrations |
| 3 | DM0048_RFP_260000001722_-_NBS_LIMS_Maintenance_Support | NA | How many total Staff? | See 6. User Type and Capacity |
| 4 | DM0048_RFP_260000001722_-_NBS_LIMS_Maintenance_Support | NA | What is the existing LIMS database size | See Schedule A: 31. Migration |
| 5 | DM0048_RFP_260000001722_-_NBS_LIMS_Maintenance_Support | NA | Are any Instruments connected through a middleware? If so, what middleware and which instruments? | No, but we need information to get from behind the firewall into the LIMS and vice versa. We use customized scripts currently for this. Current Vendor is not involved in this process. |
| 6 | DM0048_RFP_260000001722_-_NBS_LIMS_Maintenance_Support | NA | Is it possible for bidders to propose a simplified payment schedule built around a small number of major project phases or payment events (e.g., four milestone-based payments), rather than a payment schedule aligned to every individual implementation milestone? | The bidder can propose a simplified payment schedule as long as payment is associated with deliverable acceptance and not solely time-based (Firm Fixed Price contract versus a Time and Materials contract). |
| 7 | DM0048_RFP_260000001722_-_NBS_LIMS_Maintenance_Support | NA | Given that Clinisys has a current agreement in place with DPH, can this NBS opportunity be procured under our existing contract through a DO or would a separate contract vehicle be required. | Separate contract vehicle will be required. |
| 8 | DM0048_RFP_260000001722_-_NBS_LIMS_Maintenance_Support Section 31 | 143 | Section 31: Migration. For each source system identified for migration, can the State provide the underlying database technology and version (e.g., Oracle, Microsoft SQL Server, PostgreSQL, MySQL)? This information will help respondents assess data extraction approaches, migration effort, and potential technical dependencies. | Microsoft SQLServer; DHHS Lab FW and NBS SpecimenGate (2011-126) v19 - |
DHHS NGDI DB
2015-115
| 9 | DM0048_RFP_260000001722_-_NBS_LIMS_Maintenance_Support | NA | Can the State confirm the number of locations at which newborn screening laboratory testing is performed, excluding point-of-care pulse oximetry testing? If testing is conducted at multiple locations, are laboratory workflows, procedures, and business processes standardized across all sites, or do regional variations exist that would require location-specific configuration and implementation considerations? | One location. | |
| 10 | DM0048_RFP_260000001722_-_NBS_LIMS_Maintenance_Support | ||||
| Section 19.2 | 113 | Section 19.2 – Integrated Case Management (Follow-up) & Section 24.4 - Integrated Case Management & Follow Up: Can the State provide workflow diagrams for the case management processes, along with representative examples of the data elements captured and managed throughout the case lifecycle? | Follow-up cases create based on result codes and follow pre-determined pathways based on disorder. Follow-up algorithms include prompts to notify medical management and physicians and the creation of letters/faxes. Algorithms have set time frames to check for any additional specimens received from the patient or for additional actions to be taken by staff. Data elements captured include dates of actions, comments and final outcomes. | ||
| 11 | Schedule A – Current Environment | 138 | Please identify the incumbent LIMS solution, its version, hosting model (cloud/on-premises), and the incumbent vendor currently supporting the system. | Revvity Specimen Gate version 2020.1.52 & LifeCycle ver. 3.1.8 Suite hosted on-premises; Revvity is the vendor supporting | |
| 12 | Schedule A – Data Migration | 148 | Can the State provide an estimate of the total data volume to be migrated (number of newborn screening records, patient records, documents, attachments, and total database size)? | See Schedule A: 31. Migration for database size |
There are over 2.5 million NBS records with over 7 million attachements.
| 13 | Schedule A – Interfaces | 168 | Please provide a complete inventory of existing and planned interfaces, including external systems, instrument vendors/models, messaging standards (HL7/FHIR/API), and expected interface volumes. | See Schedule A: Sections 9, 12, & 14 |
| 14 | Schedule A – Implementation | 62 | Is the State expecting a phased implementation by laboratory function/module, or a single enterprise go-live? If phased, could the State provide the expected deployment sequence? | single enterprise go-live, however, the bidder can propose a phased deployment if it feels the phased deployment approach can be more efficient and effective for the State. |
| 15 | Schedule A – User Community | 63 | Please provide the anticipated number of named users, concurrent users, and user roles requiring access to the proposed LIMS. | See Schedule A: Section 6 |
| 16 | Schedule A – Reports | 74 | Can the State provide an estimate of the number of existing reports, labels, dashboards, and regulatory reports that will need to be recreated or migrated into the new solution? | approx. 7.5 million reports and attachments |
| 17 | Schedule A – Instrument Integration | 95 | Will the State provide technical documentation and vendor contacts for existing laboratory instruments requiring integration, or is the Contractor expected to independently obtain this information from instrument manufacturers? | We can provide for the vendor contacts. |
| 18 | Schedule A – Testing | 62 | Will the State provide dedicated Subject Matter Experts (SMEs) and User Acceptance Testing (UAT) resources throughout the implementation? If so, what level of participation is anticipated? | Yes we will provide SME participation, level of participation will be discussed at onset of project. We have available resouces to dedicate to this project. |
| 19 | Schedule A – Historical Data | 66 | The RFP requires retention of 22 years of historical data. Is the expectation to migrate all historical data into the new operational LIMS, or would a read-only historical repository/archive be considered acceptable provided all records remain searchable and accessible? | A read-only historical repository/archive be considered acceptable provided all records remain searchable and accessible as long as laboratory reports are maintained. |
| 20 | Schedule A – Project Schedule | 160 | Beyond the anticipated contract start date, can the State provide key milestone dates for requirements validation, configuration, testing, data migration, training, and production go-live to assist bidders in developing a realistic implementation plan? | The bidder is expected to provide a "realistic implementation plan" (which includes key milestone activities and timeframes) as part of its proposal response. See section 44.2 - Milestones/Deliverables for Implementation |
| 21 | Proposal Instructions | Pricing evaluation | Can you clarify the pricing evaluation methodology (lowest price, price to technical ratio...)? | See page 5 - Evaluation Process |
| 22 | A | 7.3. Transition Plan & Change Management Plan | In order to propose an optimal transition plan, please let us know the specific goals/business requirements for the data migration. Specifically: |
1. Is a ".pdf report only" migration sufficient? If so, what specific metadata must be migrated along with the .pdf to ensure that users can successfully search/find lab reports?
or
2. Does the program want to migrate some / all of the current data from the old system to the new system?
If 2 is the strategy, can the program let us know:
1. How many years worth of data must be migrated?
2. What type of data (QC, raw data results, follow up case note, result interpretation, etc..) must be migrated, and do you have schemas for each dataset?
3. What data is to be migrated for CLIA/CAP purposes and what type of data is to be migrated for Michigan's data retention policy(ies)? Are there different data sets required for different purposes?
| 23 | A | 7.6.1. The new LIMS should provide the ability to store and access historical data, including any patient identifiers, lab reports, and consent forms. The system must support a 22-year data retention schedule, ensuring that historical data can be readily accessed when needed. | Please confirm if historical data includes only patient identifiers, lab reports and consent forms. How long do you require to keep QC/QA and raw data result? | The QC and raw data would be required to be kept for a minimum of 2 years per CAP requirements. Patient identifiers, lab reports, and consent forms are in addition to assay data |
| 24 | A | 7.6.2. The new LIMS shall have the ability to transfer and integrate existing CCHD data into the system to ensure seamless access and continuity of data analysis. The system should facilitate the migration of this data, including relevant fields, from the legacy system to the new LIMS to avoid any breaks in data continuity, especially for historical CCHD results | We need to understand the current workflow of CCHD in Michigan. What is the file format and field name convention in this legacy system? |
| Please explain this requirement further. Can you provide a specification for the CCHD interface and a schema for the CCHD data? In addition, please explain how patient matching is performed. Specifically: 1. Are CCHD data matched to Metabolic and/or EHDI data? 2. Is there one algorithm used to match NBS/EHDI/CCHD data or are there separate algorithms used based upon the data being matched? | In our current system, records are only created within the LIMS if a blood spot specimen is received. CCHD data is matched to the demographics that accompanied the blood spots. When CCHD data is submitted (regardless of format), limited demographics are included to support this matching process. A stepwise linkage process, first relying on unique patient numbers and then other demographics, is deployed. | ||||
| 25 | A | 7.8.11 The LIMS must support the receipt of file transfers containing multiple patient records of pulse oximetry screening results within a single file. The system must be capable of handling data files that contain up to 2 MegaBytes of data. | Please provide a specification or an example data file with fake/test data/file format. | Regardless of type of submission (flat file, Hl7 or manual entry), CCHD submissions include demographic information, test result information (pulse ox values and differences), and screening outcomes (pass, fail, rescreen). |
26 A 7.8.13. The LIMS should include built-in validation rules that automatically check for data integrity and adherence to predefined algorithms during result entry. This should apply to all methods of data submission, including flat files and web portals. The system must validate fields to ensure they conform to the correct format and algorithm specifications. Additionally, the system must notify users if the data does not meet these standards, preventing further entry until corrections are made. For any results that do not follow the algorithm, the system should generate an automated notification to the submitting hospital, informing them of the discrepancy and recommending educational resources to address the issue. Please explain this requirement further. Is this requirement related to CCHD data only or to every data import? This requirement is only related to CCHD. It is intended to ensure that hospitals are following the Michigan approved CCHD screening algorithm.
27 A 9.5.1. The LIMS must include a web portal for CCHD user roles Is this existing functionality or a new request? Can you please provide a specification showing the CCHD workflow and requirements to get data into the system, share it via the portal, provide reports, etc. This is existing functionality. Users are granted access by program staff. Portal can be used to search for a patient to enter CCHD screening results or to enter diagnostic information following a failed screen. No reports are generated for users.
| 28 | A | 9.6.4. | The system must provide a streamlined interface for identifying and resolving failed linkages between CCHD and dried blood spot records, eliminating the need for time-intensive manual investigation of each unlinked record. | Please provide requirements as to how CCHD and DBS are to be linked and how the program identifies unlinked or mismatched records? | CCHD data is to be submitted with supporting demographic information that can be linked to existing patient records within LIMS. Unlinked records should be able to be reviewed and if no match to a blood spot record is found, the system should allow for creation of a record based on CCHD results alone. |
| 29 | A | 9.7.1. | The LIMS must ensure that administrative configuration changes made through authorized interfaces fully propagate through all relevant workflows and result reporting logic without requiring vendor intervention or manual synchronization. | Please explain this requirement further | When there is a configuration change we do not want to update any locally installed software, but would like for the updates to be applied to all applications/modules as the same time. |
| 30 | A | 14.1.1. | The State has instruments that require interfacing into the LIMS identified in the table below. | Can the program share with us the workflow of their current Illumina MiSeq DX? Are the program using Illumina Emedgene? | No, not using Emedgene. The MiSeqDx outputs a text file table with sample name + variants found. This is imported into the LIMS as a qualitative assay. It does not involve bioinformatic analysis/computation, nor does it involve variant classification. |
| 31 | A | 16.5.2. | The system should not allow for the test results to be verified if the submission form information is incomplete or optionally if the information is not marked as approved. | Please explain this requirement in more detail. |
| Can the program clarify this request? Does this mean that a test result should not be in queued for review if the DBS demographic information is missing? | If critical demographic information is missing then test results will not be automatically released. There should be a way to "hold" the process of releasing results until the critical information is obtained or marked as approved to be released. | |||||
| 32 | A | 16.8.2. | If the test preparer is different from the person doing the data entry into the system, the system must be able to capture both roles. | Please clarify this requirement. | There can be more than 1 individual performing different tasks for the plates. Being able to capture who punched controls vs who punched patients vs who analyzed the plate's QC is what is desired. | |
| 33 | A | 19.2.7. The LIMS shall support the receipt, storage, and visibility of Hearing screening results even when a dried blood spot (DBS) specimen is not submitted. In such cases, the system must allow a standalone Hearing case to be created and tracked, independent of an existing DBS-linked patient record | Does Hearing require its own portal separate from NBS and/or CCHD? Please explain further. |
| Is there a separate hearing portal that Michigan uses like the CCHD web portal? | Hearing does not have its own portal. | |||||
| 34 | A | 19.2.9. | The LIMS shall include functionality to track follow-ups for failed Hearing screening cases. This feature should allow users to record each failed case along with follow-up actions and timestamps. The system should prompt users automatically for follow-up actions based on predefined timelines (e.g., one week after a follow-up is initiated). | How does the program receive hearing data at the moment? Can the workflow be shared with us? | Initial Hearing results are received via paper as part of the NBS kit. They are scanned in and using OCR are attached to the patient record. All repeat hearing screen and diagnostic tests are manually entered. | |
| 35 | A | 19.2.10. | The LIMS must support tracking of second-tier testing, including the ability for the follow-up team to track test status and results, generate and distribute final second-tier result reports to designated recipients (e.g., coordinating centers), and create and distribute letters for faxing. | Which 2nd tier testing does the program currently support? Are they all send out or performed in house? | We do 2nd tier testing both in-house and send out, but this requirement is for our send outs. We send out to multiple different labs for C3 disorders, LDs, GAMT deficiency, and hemoglobin sequencing. | |
| 36 | A | 22.1.1. | The entire life cycle of the sample and its products/isolates from receipt to storage and destruction must be tracked and traceable to the unique accession number. | How does the program currently track this with the current system? Can you please provide a specification? | Through "Notes" saved to the patients demographic record and a dropdown on the demographic entry screen saying Destroyed or Returned. | |
| 37 | A | 24.1.13. | The LIMS could provide functionality to track and log hospital performance on POC tests such as CCHD result submission rates, including identifying hospitals that fall below expected or goal thresholds. The system should automatically generate monthly result submission rates, and trigger notifications or alerts for underperforming hospitals. | Please explain this requirement further. What data will be tracked? Will all data be provided as part of normal daily activities (i.e. system can track submissions received, data quality for each submission etc.) or are there additional interfaces or data collection mechanisms required? For instance, does the program compare the submission data with vital records to identify hospital with low submission rates? | This is a wishlist item. No interface to vital records would be needed. Comparisons for CCHD result submission rates would refer to the total number of blood spot screens received for that facility. Other items that may be included are timing of screening and results entry and adherence to the MI CCHD screening alorithm. |
38 A 25.5.1. Electronically transfer QA data associated with other process support files Please explain this requirement further.
| Can the program which QA data they would like to transfer into the LIMS? | These are future wishlist items QA data may include tracking of hospital performance metrics. | ||||
| 39 | A | 25.5.2. Manually enter QA data not captured in the LIMS as a part of other process support | Please clarify which QA data is being entered manually. | These are future wishlist items QA data may include tracking of hospital performance metrics. | |
| 40 | A | 25.6.3. Should trigger special reports when QA measures have exceeded acceptable limits. | Please explain this requirement further. Does the lab expect the LIMS to automatically create a corrective action report every time a QC exceeds acceptable limits? | This requirement is a "should" not a "must". Individual QC is not the intent, so no this is not what is expected. Whole plate or assays having to be rejected would be something that could trigger a report. | |
| 41 | A | 29.3 Calculation of an assay (96 wells) | Please clarify the "Calculation" speed of an assay | The actual time it takes for the system to take the raw data and calculate into values and/or calculate the various ratios needed for data analysis. | |
| 42 | A | 31. Migration | Please provide a specification for each application, including the data to be migrated and use cases once the data is migrated. | Vendor is responsible for a data migration plan. Need to be able to maintain demographics, QC, results, lab reports, consent forms, and for data to be querried. | |
| 43 | A | 31. Migration | Please clarify the type of data in each of the listed database in the table | Question is unclear. In all, the data must be compatibly transferrable. | |
| 44 | D | Service Level Agreement (Hybrid Hosted) | This section is titled Hybrid Hosted. The Proposal Instructions refer to State Hosted. Are these the same? | This should say "hybrid hosted" rather than "state hosted" so, for all intents and purposes, they are the same for this instance | |
| 45 | A | 14.1 Instrument interfaces | Please provide the quantity of each instrument | Sciex 4500MD - 3 |
QSight 225 - 1 Revvity GSP - 3 currently will be adding a 4th in the next year.
Illumina MiSEQ Dx - 2 Victor 2D - 2 Quant Studio - 2 QSight 210 - 2 BioRad Variant II - 3 currently will be adding a 4th in the next year.
Panthera Puncher - 3 currently will be adding a 4th in the next year.
DBS Punchers - 3
| 46 | A | 30. System to System Interfaces | Is this list of interfaces complete or are other interfaces required? For instance, there are numerous references to file imports. Is there one list highlighting all the software/electronic data interfaces including all the required transfers of data in/data out (interfaces, file imports, file exports, direct database communications etc.)? | In this context, the file imports and the databases containing results can be considered as part of the umbrella of the LIMS itself. This system-to-system interface table would then be connections outside of that umbrella. |
| 47 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 7.6.1 | 66 | Is the expectation to migrate all data, the past 22 years of data, or a smaller subset? Does this data need to be actionable or just accessible? | data needs to be accessible not actionable |
| 48 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 7.7 | 67 | What is included in "master data"? What need does master data loading fulfill? | In section 7.7, master data is referring to raw or modified result data (i.e. from lab instruments) and point of care testing data (transmitted from hospitals) |
| 49 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 9.6.1 | 83 | For data queries, what data and timeframes are expected? This is directly tied to response of Q1. | Any data stored in the LIMS (analyte results, patient demographics, aggregate data, qc results, etc). Timeframes are reasonable wait times (seconds to low minutes) |
| 50 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 7.2.1 | 62 | For a cloud hosted solution, what data is expected to be captured on-premise while offline? How long does a system need to be functional while offline? | Demographic data entry and worklist creation from pantheras and DBS punchers. System should be function for 2-3 days. Ability to manually create critical case prelim lab reports and follow-up cases for those criticals. |
| 51 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 7.2.6 | 63 | For an on-prem/hybrid solution, is the vendor responsible for providing all hardware or will this be shared with MDHHS (software database hosting)? | DTMB will provide hardware (virtual machines/hardware). |
| 52 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 7.3 | 64 | Does the Change Management refer to software configuration changes or transition from existing LIMS to new LIMS? If it refers to software configuration changes, please define the changes responsible by the vendor vs LIMS administrator. | Transition from existing LIMS to new LIMS…which can involve configuration changes. The division of responsibility is part of the bid. |
| 53 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 7.5.13 | 67 | Will you define the core functions needed which cannot be classified as Future Enhancement? | Instrument integration, assay review, algorithm integration, QC rules, QC tracking, reporting, follow-up case management, and CCHD result import. |
| 54 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 7.8.12 | 71 | What are the contents of the flat file imports: demographic information, test result information, or a combination? It appears this may be related to CCHD information. If so, is this different from 9.1.10 and receiving CCHD results via HL7? | Regardless of type of submission (flat file, Hl7 or manual entry), CCHD submissions include demographic information, test result information (pulse ox values and differences), and screening outcomes (pass, fail, rescreen). |
| 55 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 9.5 | 82 | How are CCHD results received? Flat file, HL7, manual entry, or any of the options? | All three options (flat file via FTP site, HL7, or manual entry through web portal) are supported in our current workflow. |
| 56 | RFP 260000001722 - NBS LIMS, Maintenance, & Support - Section 7.6.1 | 68 | The RFP requires a 22-year data retention schedule. Can the State clarify whether historical data currently stored in the incumbent system must be fully migrated and queryable in the new LIMS, or whether a read-only archive solution would be acceptable for records older than a defined threshold? | A queryable, read-only archive solution would be acceptable. As long as we have access to the lab reports and consent forms |
| 57 | RFP 260000001722 - NBS LIMS, Maintenance, & Support - Section 7.5.13 | 67 | Section 7.5.13 requires the vendor to provide "an existing, well-established LIMS solution that has been thoroughly tested and is production-ready, rather than relying on beta testing or promising future versions." Can the State define the criteria it will use to evaluate whether a solution meets this standard (e.g., minimum number of production installations, minimum years in market)? | This will be based on the bidder's related experience with labs who are using the bidder's LIMS solution in Production and their satisfaction with the bidder's solution |
| 58 | RFP 260000001722 - NBS LIMS, Maintenance, & Support - Section 10.2.3 | 86 | Section 10.2.3 requires compliance with "NITS Standards and FedRAMP standards." Can the State confirm this is a typographical error and should read "NIST Standards," and clarify whether FedRAMP authorization is required for the LIMS application itself, or only for the underlying cloud hosting infrastructure? | Yes, we can confirm that it should be NIST Standards |
| 59 | RFP 260000001722 - NBS LIMS, Maintenance, & Support - Schedule B | 173-174 | Schedule B requires pricing for both a Subscription License Model (Table A) and a Perpetual License Model (Table B). Is the State requiring bidders to provide pricing for both models, or may a bidder propose only one model? | Vendor can provide either one model or both. |
| 60 | RFP 260000001722 - NBS LIMS, Maintenance, & Support - Section 44.2 | 163 | The RFP states "implementation to be completed no later than a year and a half from Contract execution" (contract start April 9, 2027 = go-live by approximately October 2028). Given the complexity of migrating six databases totaling ~1.2 TB and implementing 250+ concurrent user capacity, will the State consider timeline extensions if a bidder's technical approach demonstrates that a longer timeline reduces implementation risk? | Yes we would consider a longer timeline. |
| 61 | RFP 260000001722 - NBS LIMS, Maintenance, & Support - Section 19.2 | 40 | Section 19.2 (Limitation of Liability) caps Contractor liability at "the total of the amounts paid to Revvity for the Software giving rise to such claim." This language appears to reference Revvity specifically by name. Can the State confirm this is a drafting artifact from the incumbent contract and will be updated to reference the awarded Contractor generically? | Yes, the contract will reflect the awarded contractor. |
| 62 | RFP 260000001722 - NBS LIMS, Maintenance, & Support - Schedule D | 189 | Schedule D (Contractor Hosted SLA) requires 99.98% availability. Can the State clarify whether planned maintenance windows are excluded from availability calculations, and confirm the maximum allowable planned downtime per month? | It depends if it is a vendor or state hosted solution; is it part of the contract the vendor is providing. |
| 63 | RFP 260000001722 - NBS LIMS, Maintenance, & Support - 9.1.9 | 77 | Section 9.1.9 requires that the LIMS "handle all algorithmic decision-making and data formatting internally, without relying on outside tools or third-party software." Does this requirement preclude the use of embedded third-party reporting engines (e.g., Crystal Reports, SSRS) that are fully integrated within the LIMS platform and not separately licensed or operated by the State? | The use of third-party reporting engines that are fully integrated within the LIMS platform and not separately licensed or operated by the State would be allowed. |
| 64 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 9.7.7 | 81 | Can you clarify what functionality is expected in regards to "real-time feedback on access levels"? | When assigning a user role/access level to a user, there should be an accurate indication of what role/level the user is assigned. The scenario that is to be AVOIDED configuration of roles that then requires users to go and test functionality to determine if the role is correctly configured. |
| 65 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 10.4.2 | 86 | Does "any upgrade or release" include: |
- Minor version updates and patches?
- Security hotfixes?
- Infrastructure/platform updates?
- Third-party library updates (e.g., framework security patches)?
| - Configuration changes? | Vendor is responsoble for the application support. DTMB is responsible for any hosted solutions. | |||
| 66 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 10.4.2 | 86 | For SaaS/cloud-hosted solutions, how does this reconcile with continuous deployment models where the vendor deploys platform updates across all tenants? |
- Who is responsible for generating the security report:
- Vendor performs and provides testing?
- State DTMB/SOM performs testing?
- Third-party security firm?
- What types of security testing are required:
- Automated vulnerability scanning?
- SAST (Static Application Security Testing)?
- DAST (Dynamic Application Security Testing)?
- Full penetration testing?
- What is the approval process and SLA for:
- Reviewing security reports?
- Approving releases?
| - Handling critical security patches that need rapid deployment? | It depends if it is a vendor or state hosted solution; is it part of the contract the vendor is providing. | ||||
| 67 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 10.4.2 | 86 | Who bears the cost of security testing (especially for recurring pen tests)? | It depends if it is a vendor or state hosted solution; is it part of the contract the vendor is providing. | |
| 68 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 13.1.5 | 94 | Regarding the import of second tier results in PDF format, what is the expected functionality for this format? Should the results only be stored as a document attachment to the patient or specimen record? Are you expecting the results from the PDF to be extracted and have cutoff and disorder logic applied and have the result value available for reporting without having to manually enter the result from the PDF? | Do not expect the results to be extracted from the PDF, only PDF attached to the patient record. If we are able to receive the results from an external lab using a file transfer we would like to be able to upload those results without manual entry. | |
| 69 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 14.2.1 | 96 | Please explain your current process for periodic verification of minimum detection limits (MDL). What documentation is required? | Our current process is outstide the system, this requirement is a "could" | |
| 70 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 14.2.6 | 96 | What types of images are captured (i.e. gel images, chromatograms, spectra, etc.)? | Chromatograms | |
| 71 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 15.1.2 | 97 | Does the system need the ability to fax the form or will the user do this outside of the system? | It is not a requirement for faxing to be internal to the system, but is preferred. | |
| 72 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 16.2.5 | 99 | Further define the scenario where you receive multiple specimens with the same test form. Does this mean that you can receive multiple specimens from the same baby but only one demographic form? | No, this should not happen and is not the intent of the requirement. The intent is that we receive mulitple samples on the same day from the same infant and run the same test panel on all of them and we need same day specimens to link. | |
| 73 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 16.5.2 | 102 | What does "optionally" mean here? Are you asking for configuration to restrict approving the test results if 1) initial demographic entry is incomplete or 2) if double entry has not been completed? If this is a configuration, would this be a global configuration or configured per test, disorder, assay, sample type (i.e. first specimen vs second specimen), or something else? | It is a global config for both: if initial demo entry or double entry are not complete. The "optionally" is trying to convey that "the results can be released with incomplete info IF they are marked as 'approved' to override the hold on release" | |
| 74 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 17.4.4 | 109 | It seems like there are words missing from this requirement. | It is implied that "The LIMS could report lab test kit performance..." | |
| 75 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 18.1.4 | 110 | Are mutual assistance laboratories only utilized as emergency backups or when are they utilized? What is the current diversion workflow and expectations? | This is only for emergency continuity of operations purposes. | |
| 76 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 21.1.10 | 117 | Does "reporting of flags, trigger values and warning levels settings" mean a report showing the current configuration or a report which shows which flags/alerts were trigger or something else? | This allows for the tracking and define specimen, control, and assay level flags. Not an actual report. | |
| 77 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 22.1.3 | 120 | Are flags just labels for categorization, or do they drive system behavior and workflow logic? | Categorization | |
| 78 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 25.1.15 | 130 | Is the release of the normal results done automatically by the system without user intervention or is it that the system automatically returns the batch of normal results for a user to release? | The system automatically returns the batch of normal results for a user to release. | |
| 79 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 33 | 147 | Regarding training services, can the State clarify: |
(a) The expected duration of onsite training support during the go-live period (e.g., number of weeks onsite, number of trainers required)?
(b) Whether the State expects ongoing refresher training beyond the initial implementation period?
| (c) The approximate number of staff requiring training across each role category (administrators, laboratory technicians, data analysts, supervisors, etc.)? | The State is relying on the bidder to provide an effective training plan for this implementation. The bidder should have previous experience in providing training for previous implementations and use that experience to provide an effective training plan for the State of Michigan. For the train the trainer approach the training of the system admins must involve collaborative building of tests and workflows. | |||
| 80 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 33 | 147 | Regarding train the trainer services, can the State clarify: |
(a) What certification or competency assessment (if any) does the State expect for internal trainers?
(b) Whether the Contractor is expected to provide training materials and documentation that internal trainers can use independently after the operational handoff? The State is relying on the Bidder to provide experienced and competent trainer(s).
A) We would need some sort of initial competency for the internal trainers to show they have mastered what was shown.
B) Yes, Contractor is expected to provide training materials and documentation that the State will be able to use independently after the operational handoff.
81 RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 33 147 Regarding role-specific training, can the State clarify:
(a) A list of the specific roles requiring training (e.g., laboratory technicians, data analysts, system administrators, supervisors, medical directors)?
| (c) Whether the State expects customized training curricula for each role, or whether role-based access to a common training program is sufficient? | Similar to Q80, the State is relying on the bidder to provide a training approach that will be effective for the State. This approach should be based on the bidder's prior implementation experience and refined based on the State of Michigan's specific needs. There are roles what will not use certain modules/functions. This would be determined by the product being presented. There should be at least 3 custom circula - one for Admins (super users), one for general lab users, one for general follow-up users. | |||
| 82 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 34 | 148 | For transition responsibilities, Schedule G requires both a Transition-In Plan and a Transition-Out Plan. Regarding the Transition-Out Plan, the RFP states it must "describe the steps required to migrate between the Bidder's Solution and any third-party solutions." To ensure Michigan maintains maximum flexibility and avoids vendor lock-in, can the State clarify: |
(a) What data formats and schemas does the State expect the awarded Contractor to provide during Transition-Out (e.g., raw database exports, HL7/FHIR-compliant formats, CSV extracts with comprehensive data dictionaries)?
(b) Must the Transition-Out Plan include provisions for the Contractor to provide technical assistance to a successor vendor (e.g., schema documentation, API specifications, data mapping support), and if so, for what duration and under what compensation structure? a) That is up to the Contractor to determine in their transition-out plan. Obviously preference would be given to plans that detail flexible, easy, and highly-compatible data formats/schemas
b) yes, the state expects the Contractor to provide technical assistance to a successor vendor.
83 RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 35 148 Regarding documentation, can the State clarify
(a) What specific documentation deliverables does the State require (e.g., end-user guides, administrator guides, API documentation, database schema documentation, disaster recovery procedures)?
(b) What format(s) does the State prefer (e.g., PDF, online help system, searchable knowledge base, video tutorials)?
(c) What constitutes a "discrepancy or error" requiring documentation updates (e.g., software bugs, feature changes, workflow modifications, content clarifications)?
(d) What is the expected turnaround time for documentation updates after changes are identified or software updates are released?
(e) Are routine documentation updates subject to the same State approval process as initial documentation, or is there an expedited review process for minor corrections? a) Provide any and all documentations to implement and support the system.
b) All formats are acceptable.
c) Documentation updates are expected whenever there is material change affecting system funcitionality, configuaration, operation, maintenance, security, or end-user process.
d) Documentation for changes should be provided within a minimum of 48hrs.
e) Yes, based on PSP requirements.
| 84 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 37 | 149-151 | Under Contractor Personnel, several role classifications are described, including skill set and years of experience. Are these the roles that the State expects to have as key personnel or just simply roles the State expects to see as a part of this project? | These roles are expected to be key personal. |
| 85 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 38 | 152 | For key personnel, are the roles noted in section 37, contractor personnel, also the roles listed as Key Personnel for this contract? If not, can the State then clarify: |
(a) What specific roles are designated as Key Personnel for this contract (e.g., Project Manager, Implementation Lead, Technical Architect, Training Lead, Data Migration Lead)?
| (b) Are there minimum qualifications for each Key Personnel role (e.g., years of experience, certifications, LIMS-specific experience)? | The roles noted in the table in Section 37 are deemed Key Personnel by the State for this contract (Project Manager, Technical Specialist/Database Specialist, Business Analyst, Data Migration/Conversion Specialist, Training Expert, Lead Developer, Security Analyst). Expected type of experience with minimum number years of experience for each of these roles is specified in the table in Section 37. | ||||
| 86 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 7.2 | 62 | Section 7.2.1 and 7.2.2 require support for secure offline data entry with automatic synchronization upon reconnection and local encryption for offline sessions. If the proposed solution is cloud-hosted with a documented, contractually guaranteed uptime SLA (e.g., 99.9% or higher), will the State consider these offline session requirements satisfied or waived? If not, what is the minimum uptime percentage at which offline data entry capability would no longer be required, and which specific workflows must remain functional during a connectivity outage? | Ability to have offline data entry is essential for COOP. We need a solution that can synchronize offline processes. | |
| 87 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 38 | 152 | For dual role assignments, can the State clarify: |
(a) Is there a maximum number of Key Personnel roles one individual may fill?
(b) How will the State evaluate "sufficient hours" — is there a minimum hours per week or percentage of time required for each role?
(c) If one individual is proposed for multiple roles, must their combined role allocation total 100% of their available time, or may they be partially allocated across roles?
| (d) Will the State penalize proposals that rely heavily on dual-role assignments, or is this evaluated neutrally? | Vendor needs to provide the appropriate team and yes, people can have mulitple roles as long as they have the appropriate experience and bandwidth for the project. State will not penalize proposals that rely heavily on dual-role assignments. | |||
| 88 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 38 | 152 | For Letter of commitment requirements, can the State clarify: |
(a) Must the Letter of Commitment be signed by the individual employee, or is a letter signed by the Contractor's authorized representative on behalf of the employee acceptable?
(b) If a Key Personnel candidate is a subcontractor rather than a direct employee, what form of commitment documentation is acceptable?
| (c) Given that contract award may be 6-12 months after proposal submission, will the State accept Letters of Commitment that include a reasonable availability window (e.g., "available within 60 days of contract execution") rather than an open-ended commitment? | This will fall under ICHAT requirements. | |||
| 89 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 38 | 152 | The RFP addresses Key Personnel requirements at the proposal stage but does not address personnel changes after contract award. Can the State clarify: |
(a) What is the process for substituting Key Personnel after contract award if an individual becomes unavailable due to resignation, illness, or other circumstances?
(b) Must replacement Key Personnel meet the same qualifications as the originally proposed individual, and does the State have approval rights over substitutions?
(c) What notice period is required before substituting Key Personnel, and are there penalties for unauthorized substitutions?
| (d) If the State requests removal of a Key Personnel member, what is the process and timeline for providing a qualified replacement? | All changes and substitutions must be submitted and approved of by the State. If there is need to remove a Key Personnel member the State would work with the vendor on timelines for replacement. | ||||
| 90 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 38 | 152 | The RFP notes references required for key personnel. Can the State clarify: What is the State's process if a reference cannot be reached or declines to respond — will this result in a non-responsive determination? | The bidder is expected to contact potential references prior to proposal submission to ensure the reference will respond accordingly to a State request. The bidder risks being non-responsive if a reference cannot be contacted or declines to respond to a State request. | |
| 91 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 40 | 157-158 | Regarding background checks, can the State clarify for ICHAT and drug test results requirements: |
(a) Must background check certifications be submitted with the proposal, at contract execution, or prior to each individual staff member beginning work on the project?
(b) What is the acceptable timeframe for background check results — must checks be completed within a specific number of days prior to assignment (e.g., within 30, 60, or 90 days)?
| (c) For staff who may not be assigned until later phases of the project (e.g., training staff, go-live support personnel), must background checks be completed at contract execution or immediately prior to their assignment? | All background checks and drug screening needs to be completed prior to starting work on the project. | |||
| 92 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 40 | 157-158 | The RFP requires background checks for "all staff identified for assignment to this project." Can the State clarify: |
(a) Does this requirement apply to all Contractor employees who may work on the project at any point, or only to personnel who will have direct access to State Data or State facilities?
(b) Does the requirement apply to remote staff who access State systems virtually but never physically visit State facilities?
(c) Does the requirement apply to subcontractor personnel, and if so, is the prime Contractor responsible for certifying subcontractor background check compliance?
| (d) Does the requirement apply to executive or management personnel who provide oversight but are not directly assigned to day-to-day project tasks? | Anyone who is going to access to our system and data needs to complete the background check. The prime contractor is responsible. | |||
| 93 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 40 | 157-158 | The RFP states that "proposed Contractor personnel will be required to complete a Michigan State Police background check and/or submit an RI-8 Fingerprint Card for the NCIC, if required by project." Can the State clarify: |
(a) What criteria will the State use to determine which personnel require Michigan State Police background checks and/or NCIC fingerprint cards vs. ICHAT checks only?
(b) Will the State notify the Contractor at contract execution which personnel require the higher-level background checks, or will this be determined on a case-by-case basis throughout the contract?
(c) What is the expected turnaround time for Michigan State Police background checks and NCIC fingerprint card processing, and will the State allow personnel to begin work while checks are pending?
| (d) For out-of-state Contractor personnel, what is the process for submitting RI-8 Fingerprint Cards, and are there alternative procedures available? | The criteria used will be ICHAT checks only. | |||
| 94 | RFP 260000001722 - NBS LIMS, Maintenance, & Support Section 40 | 157-158 | The RFP requires the Contractor to "perform an ICHAT for all staff identified for assignment to this project" annually. Can the State clarify: |
(a) What is the anniversary date for annual ICHAT renewals — is it based on the contract execution date, the individual's assignment start date, or a fixed calendar date?
(b) Must annual ICHAT results be submitted to the State Program Manager proactively on a scheduled basis, or only upon request?
(c) If an annual ICHAT reveals a disqualifying result for a currently assigned staff member, what is the expected process and timeline for removing and replacing that individual?
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