PHSA 10706 Newborn Screening Laboratory LIMS
Solicitation number BC168646
Publication date
Closing date and time 2023/06/14 15:00 EDT
Last amendment date
Description
PHSA invites Proposals from qualified parties for the supply of the Products to the Health Authorities in accordance with the specifications and requirements set out in this RFP.
The Scope of this RFP comprises the software, required customization/configuration and ongoing software support to maintain a Newborn Screening-Specific Lab Information Management System for the daily functioning of the BC Newborn Screening Laboratory located at BC Children’s Hospital. The laboratory information management system will be utilized at this single site by 25-50 simultaneous users. Proponents should provide fixed pricing for an initial Contract term of five (5) years plus five, one year option year extensions which will be permitted under the Contract.
Unless otherwise stated in this RFP, all statistical information is estimated. PHSA reserves the right to alter the RFP by adding or deleting service delivery requirements/levels as required by the Health Authorities.
Vendors Q&A as of June 01, 2023
Q. I wondered if you could kindly provide me with a rough/ballpark/guestimate/range of the budget for this project. Any insight, no matter how vague, would be greatly appreciated.
A. “At this time, we aren't disclosing our budget range for this project. We will be assessing the quality of the deliverables based on the answers provided in the requirement template and will be using these answers to assess the overall value that each vendor provides. We're interested in understanding how you would approach this project within the constraints of your proposed budget. As highlighted in Criteria and Weightings section of the RFP there are a number of selection criteria that will be evaluated. Therefore, we encourage all vendors to propose a a complete and competitive bid that balances quality and cost efficiency.“
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Q7 Response: Current state, calibration curves are required for Perkin Elmer GSP assays (immunoassays and enzyme assays) and tandem-MS assays (Neolynx). Our current solution calculates calibration curves for tandem-MS targetlynx files on the MS instrument and imports only final values. This is acceptable but within-LIS calculation for these targetlynx assays would be viewed as valuable if available.
Q8 Response: This could be done if an assay is showing a borderline unacceptable analytical bias based on QC results and we wanted to evaluate patient samples against a more conservative analytical cutoff (factored by the observed bias) to identify and retest any samples with borderline results rather than repeating the entire assay.
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Technical Worksheet Questions:
Q1 Response: Question was withdrawn from vendor.
Q2 Response: If it’s a cloud solution, it is strongly preferred that the data resides in Canada:
Q3 Response: They can be added in the yearly hosted costs in Section 2 (see screen capture) and also included in the total yearly cost of ownership (Total cost of ownership section)
Q4 Response: All responses are expected in the Schedule I2 spreadsheet (Schedule I1 was just intended to give an overview of the scope of the program to help inform the answers provided in I2).
Q5 Response: Appendix L should be in envelope 2, the others in envelope 1
Q7 Response: Relevant legislation
Q8 Response: Cost recoverable refers to a billing mechanism for testing that is not covered under a global budget and is to be billed back to individuals, providers, or health authorities.
Q9 Response: The vendor will not be expected to provide or maintain servers but will need to be able to provide PHSA with required specifications and have a system architecture that allows for testing, staging, and production environments along with a mechanism for copying and anonymizing production data back to the staging and test environments. The software solution needs to be able to run on servers with current operating systems and patches (no requirement to downgrade security settings from current industry standards).
new patient record. This minimal data set should be customizable, sample independent and should include a check for pre-existing entries.
Q10 Response: The vendor response does not need to be a complete set of technical specifications but should provide sufficient detail for the evaluation team to determine the degree to which the vendor can address the requirement.
Q11 Response: The requirement is asking for both searching for siblings and having a mechanism to establish that relationship long term (ie once a sibship is established the user should be able to link between sibs directly).
Q12 Response: By customizable worklists we are referring to rules for the generation of worklists based on specific specimen types (NBS vs clinical samples vs proficiency testing) or phases of testing (initial vs confirmation vs repeat).
Q13 Response: Reverting a plate to review stage after accepting can occur when a user accepts a plate in error or in a case where a recalculation is required based on a discovery of an invalid calibration curve.
Q14 Response: EQA refers to external quality assurance such as the US CDC Proficiency Testing Program. We are requesting that the solution be able to incorporate the results of EQA program returns (acceptability, bias to peer means, etc) and record actions taken in response to EQA failures as a mechanism to meet accreditation requirements for documenting EQA activities and responses.
Q15 Response: At a minimum we are looking for the ability to manually enter, track and store this information but if the vendor has a solution that allows for instrument interfacing that would be viewed as valuable.
Q16 Response: We are essentially referring to a context-specific help function with content populated by the user to provide information for clinical decision making when evaluating results. (ie information on secondary causes of elevations in markers specific to the assay under review).
Q17 Response: In addition to the listed scenarios, at times reports could be generated from initial testing results even when the protocol calls for confirmation of those results prior to reporting (ie abnormal initial Phe elevation on a Friday afternoon).
Q18 Response: Ad hoc is referring to a scenario where an individual report or set of reports would need to be sent to only a subset of downstream systems due to a downtime or linking failure in one of those systems (ie transmission failed in one system for part of a batch and the reports need to be resent only to that system).
Q19 RESPONSE: F.212 is primarily referencing inbound ADT systems which will be from a variety of health authorities. The reference to downstream systems in this item is with respect to the systems receiving outbound messages after testing (currently CERNER, EXCELLERIS, PLIS). The intent of this item is to be sure the system can receive demographics updates from ADT systems and generate updated downstream messages with the new demographics even after the original report was generated.
Q20 Response: Templates to be archived could include individual disease-specific auxiliary reports or periodic audits (ie submitter report cards).
Q21 Response: Recurring reports could include items such as periodic audits (ie submitter report cards), or program update notices.
Technical Worksheet Questions:
The Scope of this RFP comprises the software, required customization/configuration and ongoing software support to maintain a Newborn Screening-Specific Lab Information Management System for the daily functioning of the BC Newborn Screening Laboratory located at BC Children’s Hospital. The laboratory information management system will be utilized at this single site by 25-50 simultaneous users. Proponents should provide fixed pricing for an initial Contract term of five (5) years plus five, one year option year extensions which will be permitted under the Contract.
Unless otherwise stated in this RFP, all statistical information is estimated. PHSA reserves the right to alter the RFP by adding or deleting service delivery requirements/levels as required by the Health Authorities.
Vendors Q&A as of June 01, 2023
Q. I wondered if you could kindly provide me with a rough/ballpark/guestimate/range of the budget for this project. Any insight, no matter how vague, would be greatly appreciated.
A. “At this time, we aren't disclosing our budget range for this project. We will be assessing the quality of the deliverables based on the answers provided in the requirement template and will be using these answers to assess the overall value that each vendor provides. We're interested in understanding how you would approach this project within the constraints of your proposed budget. As highlighted in Criteria and Weightings section of the RFP there are a number of selection criteria that will be evaluated. Therefore, we encourage all vendors to propose a a complete and competitive bid that balances quality and cost efficiency.“
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- Can you please provide a list of instruments (and the quantity of each) you would like interfaced to the new LIMS?
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- 4 Waters Tandem MS (both NeoLynx and TargetLynx File formats)
- 1 SCIEX Tandem MS
- 2 Biorad NeoNBS
- 2 Perkin Elmer GSP
- 2 Perkin Elmer Panthera Punchers
- 2 ABI QuantStudio 7 Flex
- Can you please provide a list of external systems you would like interfaced to the new LIMS?
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- Inbound HL7 ADT messages from 5 Health Authority Systems funneled through a single Biztalk Broker
- Inbound CSV Submitter file (daily file drop)
- Outbound HL7 ORU to 3 downstream systems (CERNER, Excelleris, PLIS) funnelled through a single Biztalk Broker
- Outbound Flatfile file drop to Sunquest LIS (clinical sample results)
- If there are existing interfaces in place, are you able to provide any example messages to/from these interfaces?
- Response: We will share detailed specifications with the shortlisted vendors
- Are these interfaces bi-directional (e.g. demographics in, results out)?
- Response: Currently none of the interfaces are true order-in/result-out bidirectional, but if the vendor has a viable solution for this it would be viewed as valuable.
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- Is there a preferred deployment model e.g. local vs. cloud, physical vs. virtual?
- Can you please provide an image of a requistion/sample card?
- The following requirements are quite similar. Can you please explain the intent/difference in the requirements?
- 216 - Solution should provide configurable report generation queues for various patient reports The solution should be able to configure report generation (HL7, printer etc.) queues based on rules (i.e. unsatisfactory samples, screen negative and positive samples)
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- 217 - Solution should allow for multiple configurable report mechanisms which group patient reports based on results The solution must have multiple configurable report mechanisms: All negative, unsatisfactory, positive, test level unsatisfactory, transfusion and non-screen samples should have unique rules and report generation (HL7, printer etc.) workflows.
- Can you please explain this requirement in more detail?
- 48 - Solution should provide an accessible data dictionary. The solution should have an accessible, up-to-date data dictionary
- The following requirements mention calibration curves. What instruments/assays do these apply to? Do they apply to a specific instrument and a single assay or is this required for all instruments/assays?
Q7 Response: Current state, calibration curves are required for Perkin Elmer GSP assays (immunoassays and enzyme assays) and tandem-MS assays (Neolynx). Our current solution calculates calibration curves for tandem-MS targetlynx files on the MS instrument and imports only final values. This is acceptable but within-LIS calculation for these targetlynx assays would be viewed as valuable if available.
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- 119 - Solution should allow users to edit the calibration curve The solution should be able to edit calibration curve (e.g. removal of one or more points).
- Response: This applies to all instruments and assays listed above
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- 120 - The solution should allow the calibration curve to be copied and applied to another plate The solution should allow one calibration curve to be copied and applied to another plate (recalculation of the counts off the new curve)
- Response: This applies to all assays listed above
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- 142 - Solution should allow for generation of multiple calibration curves for multianalyte assays. Solution should allow for generation of multiple calibration curves for multianalyte assays including the use of surrogate curves for individual analytes without their own calibrators.
- Response: This currently applies to only the tandem MS Neolynx assay but could also apply to tandems Targetlynx assays if within LIS calibration was possible.
- Can you please provide more background for this request? Can you please describe an example/scenario where this functionality will be used?
- 148 - Solution should allow for ad hoc filtering of results based on analytical values Solution should allow for ad hoc filtering of results based on analytical values independent of the stated cutoff values (e.g. Review data against a specific ad hoc cutoff on that assay in case of an analytical bias)
Q8 Response: This could be done if an assay is showing a borderline unacceptable analytical bias based on QC results and we wanted to evaluate patient samples against a more conservative analytical cutoff (factored by the observed bias) to identify and retest any samples with borderline results rather than repeating the entire assay.
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Technical Worksheet Questions:
- How would you like vendors to proceed in redlining their provided templated agreements when our proposal includes both on-prem and cloud-based products?
Q1 Response: Question was withdrawn from vendor.
- For cloud-based solutions, can it be located in the USA, or must it be located in Canada?
Q2 Response: If it’s a cloud solution, it is strongly preferred that the data resides in Canada:
- In the pricing spreadsheet in appendix J, where should Software as a Service (SaaS) fees be listed?
Q3 Response: They can be added in the yearly hosted costs in Section 2 (see screen capture) and also included in the total yearly cost of ownership (Total cost of ownership section)
- Can further information be shared as to what is expected to be included in the RFP response for schedule I1: Functional/ Technical/Services, in envelope 1?
Q4 Response: All responses are expected in the Schedule I2 spreadsheet (Schedule I1 was just intended to give an overview of the scope of the program to help inform the answers provided in I2).
- Should the following documents be included as a part of the submission in envelope 1?
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- National Standard for Vendor Credentialing
- Attestation form
- Appendix L
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Q5 Response: Appendix L should be in envelope 2, the others in envelope 1
- Question: Regarding technical specification A.29, can you specific what is meant by reports? Is this sending results electronically back to submitters?
- Ref – A.29: Solution should be able to generate HL7 compliant reports and related documents.
- Question: Regarding technical specification A.49, can PIPA, FOIPA, and E-Health Act compliance documents please be shared for thorough review?
Q7 Response: Relevant legislation
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- PIPA: https://www.bclaws.gov.bc.ca/civix/document/id/complete/statreg/03063_01
- FOIPA: https://www2.gov.bc.ca/gov/content/governments/policies-for-government/bcea-policy-and-procedure-manual/foippa/information-privacy-and-security-foippa
- E-Health Act: https://www.bclaws.gov.bc.ca/civix/document/id/complete/statreg/08038_01
- Question: Regarding technical specification A.68, can you further define what is meant as cost recoverable?
Q8 Response: Cost recoverable refers to a billing mechanism for testing that is not covered under a global budget and is to be billed back to individuals, providers, or health authorities.
- Question: Is it the expectation for vendors to provide and maintain on-prem servers as a part of this response?
- Ref – A.25: Solution should provide separate testing and staging environments as part of a proper change management process (in addition to the production environment)
- Ref – A.26: Solution should allow for an accurate representation of the live environment through a regular copy of live to test process. Solution should provide a method to do this manually prior to any specific tests and a process for anonymization of production data in test.
- Ref – A.47: The solution's database(s) should be compatible with and configured on current industry standard best practices, including most current server operating systems and patches.
Q9 Response: The vendor will not be expected to provide or maintain servers but will need to be able to provide PHSA with required specifications and have a system architecture that allows for testing, staging, and production environments along with a mechanism for copying and anonymizing production data back to the staging and test environments. The software solution needs to be able to run on servers with current operating systems and patches (no requirement to downgrade security settings from current industry standards).
- Question: Regarding technical requirement B.76 for initial data entry sets, are you asking the vendor to provide complete technical specifications as a part of the response?
new patient record. This minimal data set should be customizable, sample independent and should include a check for pre-existing entries.
Q10 Response: The vendor response does not need to be a complete set of technical specifications but should provide sufficient detail for the evaluation team to determine the degree to which the vendor can address the requirement.
- Question: Regarding technical requirement B.95, are you expecting to have a way to link siblings, or just search for siblings?
- Ref – B.95: The solution should be able to search for siblings based on maternal identifiers and provide any required linking.
Q11 Response: The requirement is asking for both searching for siblings and having a mechanism to establish that relationship long term (ie once a sibship is established the user should be able to link between sibs directly).
- Question: Regarding technical requirement C.127, can you provide more detail on what is meant by configuration rules for worklists?
- Ref – C.127 : The solution should be able to create/modify/import worklists and should have in place configurable rules around implementation of customized worklists
Q12 Response: By customizable worklists we are referring to rules for the generation of worklists based on specific specimen types (NBS vs clinical samples vs proficiency testing) or phases of testing (initial vs confirmation vs repeat).
- Question: Regarding technical requirement C.131, Can you provide a scenario which would require you to restore a plate to the review stage after acceptance?
- Ref – C.131: Users with the appropriate permissions should be allowed to bring a plate from the accepted status back to the review stage
Q13 Response: Reverting a plate to review stage after accepting can occur when a user accepts a plate in error or in a case where a recalculation is required based on a discovery of an invalid calibration curve.
- Question: Regarding technical requirement C.162: Can you provide an example EQA?
- Ref D.162: Records should be kept of quality control and EQA reviews, documenting corrective action taken.
Q14 Response: EQA refers to external quality assurance such as the US CDC Proficiency Testing Program. We are requesting that the solution be able to incorporate the results of EQA program returns (acceptability, bias to peer means, etc) and record actions taken in response to EQA failures as a mechanism to meet accreditation requirements for documenting EQA activities and responses.
- Question: Regarding technical requirements D.170 and D.171, are you expecting the software to interface and pull this information, or allow for a central location to manually enter, track, and store this information?
- Ref – D.170: Solution should be able to add/track scheduled maintenance checks for non-instrument equipment.
- Ref – D.171: Solution should log preventative maintenance
Q15 Response: At a minimum we are looking for the ability to manually enter, track and store this information but if the vendor has a solution that allows for instrument interfacing that would be viewed as valuable.
- Question: Regarding technical requirement E.200, can you provide an example(s) of the type of information you would expect to see in a knowledge base?
- Ref – E.200: Solution should provide a user maintainable Knowledge Base
Q16 Response: We are essentially referring to a context-specific help function with content populated by the user to provide information for clinical decision making when evaluating results. (ie information on secondary causes of elevations in markers specific to the assay under review).
- Question: Regarding technical requirement F.205, outside of second tier analysis or instrument analysis delays, are there other scenarios in which you would need to send a preliminary patient report?
- Ref – F.205: Solution should generate preliminary reports
Q17 Response: In addition to the listed scenarios, at times reports could be generated from initial testing results even when the protocol calls for confirmation of those results prior to reporting (ie abnormal initial Phe elevation on a Friday afternoon).
- Question: Regarding technical requirement F.211, Can you further describe what is meant by ad-hoc?
- Ref – F.211: The solution should have the ability to generate HL7 ORU messages compatible with multiple downstream systems and have the user be able to select whether the message is going to all or just selected systems on an ad hoc basis. (e.g. resending reports to only one system in response to a transmission error.
Q18 Response: Ad hoc is referring to a scenario where an individual report or set of reports would need to be sent to only a subset of downstream systems due to a downtime or linking failure in one of those systems (ie transmission failed in one system for part of a batch and the reports need to be resent only to that system).
- Question Regarding technical specification F.212, can you share what the downstream systems are?
- Ref – F.212: Solution should be able to accept ongoing demographics updates through ADT messaging and include the most recent information on any electronic reports issued, including after the generation of the original report (e.g. Reprinting of reports to allow for matching in downstream systems.)
Q19 RESPONSE: F.212 is primarily referencing inbound ADT systems which will be from a variety of health authorities. The reference to downstream systems in this item is with respect to the systems receiving outbound messages after testing (currently CERNER, EXCELLERIS, PLIS). The intent of this item is to be sure the system can receive demographics updates from ADT systems and generate updated downstream messages with the new demographics even after the original report was generated.
- Question: Regarding technical requirement F.219, in addition to patient reports, what are the templates you are looking to archive?
- Ref – F.219: Solution should provide the ability to archive templates
Q20 Response: Templates to be archived could include individual disease-specific auxiliary reports or periodic audits (ie submitter report cards).
- Question: Regarding technical requirement F.220, in addition to patient reports, what are examples of recurring reports?
- Ref – F.220: Solution should be able to issue recurring reports and alert users when they are ready for distribution
Q21 Response: Recurring reports could include items such as periodic audits (ie submitter report cards), or program update notices.
Technical Worksheet Questions:
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Contact information
Contracting organization
- Organization
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Provincial Health Services Authority (Incl. BCCSS)
- Address
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1795 Willingdon AveBurnaby, British Columbia, V5C 6E3Canada
- Contracting authority
- Ted Gagnon
- Email
- ted.gagnon@phsa.ca
- Address
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1795 Willingdon AveBurnaby, British Columbia,Canada
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