Questions and Answers from Combined Synopsis 36C25220Q0122-0003.pdf

Questions and Answers from Combined Synopsis/Solicitation 36C25220Q0122

Answers are provided in RED for each question and provided as Amendment 0003

1. DI licenses: How many does each site have and how many are in use?

The table below shows the current number of Chemistry/Immunochemistry IM connections at each site.

SITE NAME

CURRENT IM

CONNECTIONS

Danville 3

Peoria 1

Hines 3

Iron Mountain 2

Jesse Brown 2

Crown Point 1

Lovell FHCC 1

Red Rover 1

Madison 2

Rockford 1

Milwaukee 3

Appleton 1

Green Bay 1

Tomah 1

2. Will extra DI licenses be required during installation?

Yes. Extra licenses will be required during installation. The quantity is dependent upon the instrumentation proposed for each site.

3. Networking:

a. Are any of the sites in the RFP connected to a common Data Innovations Interface Manager via a network currently? If so, which ones?

Yes. The following facilities share Data Innovations Interface Managers:

1. Milwaukee, Appleton, and Green Bay

2. Madison and Rockford

3. Jesse Brown and Crown Point

4. Danville and Peoria

5. Lovell FHCC and Red Rover

b. Could VISN 12 supply a Network diagram related to DI IMs?

c. Would the VISN find value in networking an Interface Manager server at some of the sites?

No.

4. Vendor will plan to connect to existing Data Innovation IMs at sites without automation. Is this acceptable?

No. Contractor should connect to existing Data Innovations Instrument Managers at all sites, regardless of automation.

5. Is PCR COVID‐19 testing required as a response to this solicitation due to the Cepheid National Contract?

The SARS‐COV‐2 RT‐PCR test is being removed from the optional list of tests in Attachment A‐E.

(See the updated Attachment A‐E) Reverse Transcription – Polymerase Chain Reaction (RT‐PCR) is not a methodology that is commonly available on chemistry or immunochemistry equipment.

6. Will each site be able to provide us a one‐day LIS file with the hourly tube arrival times? Want to make sure the instruments can meet the hourly workloads.

LIS Data was provided for each site with Amendment 0002 to the subject combined synopsis/solicitation.

7. While onsite conducting the site survey, can we also conduct a high‐level process mapping of your current processes so we can include the impact of our solution in our response?

On site surveys are limited to two (2) hours as the laboratory operations allow.

8. Will we be getting a copy of CAD Drawing for each site to ensure we work within the space or do we need to reach out to each site for those?

CAD Drawings are not provided. None will be provided.

9. Requirement SOW 2.4.3 notes aliquoter(s) however attachment A does not show any sites requiring aliquoters. Please confirm that the requirement for aliquoters is not applicable to this solicitation.

No sites will require aliquoters.

10. Requirement SOW 2.4.5 – please confirm the VA information system interface that is currently being utilized by the sites.

The VA utilizes the VistA (DHCP) system as its LIS. Interfaces with VistA must be made utilizing the existing Data Innovations Instrument Manager system at each site.

11. Requirement SOW 2.4.5.4.2. – please confirm how the VA would prefer the Contractor should monitor instrument performance.

Vendors have different methods. An example would be remotely accessing the instrument to monitor function (remote diagnostics), or some method for the instrument to alert the user when a component is not performing optimally and may fail (real time monitoring). Another example may be moving averages for analytes.

12. Attachment A‐E: Tab A. The requirement for both cap piercing and a decapper is redundant. Please confirm that if a decapper is provided as part of the solution, there will not be a need for a cap piercer?

If a decapper is provided, the cap piercer is not needed.

13. Attachment A‐E: Tab C. Please confirm what is meant by Specialty Albumin.

This is specific to current vendor. Please combine tests counts with regular albumin and provide pricing for the bromocresol purple (BCP) and bromocresol green (BCG) methods, if available.

14. CSF Protein & Urinary Protein – volumes have been combined for two separate tests. Please provide breakout as the combined test is specific to a certain vendor.

Approximate volumes

Fluid protein Urine protein

Milwaukee 50 3185

Madison 54 2616

Tomah 0 207

Iron Mountain 2 470

Hines 133 20,548

Jesse Brown 37 7076

Crown Point 0 5703

Lovell FHCC 39 551

Danville 2 457

15. Please clarify Albumin and Total Protein Volumes for all sites – based on the test mix, these volumes appear incorrect, for example: Rockford Clinic volumes for Total Protein is 0 while Albumin is 9,090 comparatively.

The test counts are correct.

16. Drugs of Abuse Volumes:

a. Barbiturate volumes appear low when compared with Benzodiazepine volumes. For example:

Jesse Brown volumes for Barbiturates is 20 while Benzodiazepines volume 21,133 comparatively.

These counts are correct.

b. Confirm PCP Volumes for Milwaukee, Madison, Hines, Tomah, Iron Mountain, and Jesse Brown.

These counts are correct.

c. Confirm Amphetamines for Milwaukee.

The count is correct.

17. LIS files: to ensure a Contractors solution will meet the requirements, please provide a recent LIS file with the following information for VA Hines to conduct simulations with the proposed solution(s).

a. Excel (*.xls) format

b. Select one full (24 hrs) busy day that includes both Chemistry and Immunoassay testing

c. Please include the following:

i. Date Received in Lab

ii. Time Received in Lab

iii. Sample ID or Accession #

iv. Tests or Panels ordered

v. Priority – STAT or Routine

vi. Optional

1. Verification Time

2. Inpatient or Outpatient

LIS Data provided as part of Amendment 0002 to the subject combined Synopsis/Solicitation.

18. May Offeror add HbA1c testing to this RFP with the understanding it would be converted at a later date? If so please provide estimated volumes.

No.

19. May Offeror add Procalcitonin testing to this RFP with the understanding it would be converted at a later date? If so please provide estimated volumes.

Procalcitonin is optional

The estimated annual volume for each site is listed below:

Site Annual Volume

Hines 1872

Milwaukee 627

Jesse Brown 1260

Madison 1481

Tomah 180

Iron Mountain 938

Danville 466

Peoria 0

Crown Point 0

Lovell FHCC 0

Red Rover 0

Green Bay 0

Appleton 0

Rockford 0

20. Will VISN 12 have interest in performing IL‐6 testing especially in light of COVID‐19? If so, may Offeror add this to the RFP?

21. Should it be required that SARS‐CoV‐2 Antibody test should be able to be run as “random access” (not batch mode) and NOT require additional maintenance processes?

22. Can you VISN provide a package insert or details for the “Specialty Albumin” assay listed in Exhibit A?

Please combine test counts with regular albumin and provide pricing for the bromocresol purple (BCP) and bromocresol green (BCG) methods, if available.

23. Should it be a requirement to provide one cardiac Troponin assay methodology across all sites with identical cut‐offs and reference ranges?

Preferred, not required.

24. Should it be a requirement for vendors to offer a “high sensitive” Troponin at all locations?

All methods of troponin will be considered.

25. BNP or NT‐proBNP?

a. Sacubritil / valsartan (Entresto) is on the National VA Formulary (NAVF). Entresto’s mechanism of action prevents the degradation of BNP, causing those levels to rise. However, this action does not occur with NT‐proBNP. NT‐proBNP levels actually decline, reflecting the cardiac effects of the medication and resulting in reduced risk of death and hospitalization for heart failure. In fact, a number of publications caution clinicians to avoid using BNP levels when making treatment decisions for patients’ taking Entresto. Given this, do you plan on standardizing to NT‐proBNP as the primary diagnostic test for CHF?

All methods of BNP will be considered.

b. With NT‐proBNPs greater sample stability of 72 hours at room temperature compared to BNP’s sample stability of 4‐24 hours, would VISN labs prefer to utilize NT‐proBNP to enable lab flexibility for outreach and add‐on testing?

All methods of BNP will be considered.

26. Women’s Health Services support:

a. Will the VISN offer TORCH panels as part of its Women’s Health initiatives? If so, should offerors be required to expand the menu to include Toxo‐IgG & IgM, CMV and HSV? If so can you provide estimated volumes?

b. To support Women’s Health Initiatives should offeror include the Anti‐Mullerian‐Hormone (AMH) assay so Women Veterans can understand a component of their reproductive health? If so, can you provide estimated volumes?

27. Reagent and Instrument Specifications:

a. Should offeror include sample volume requirements on Excel Tab E to inform VISN 12 of how analytes and proposed vendor solutions can help drive VISN 12 blood conservation efforts within their Veteran patient population?

Not required.

b. Shall offerors be required to submit the number of installed systems currently reporting patient results in the U.S. by instrument model? This will provide VISN 12 confidence in the viability and market acceptance of the solutions proposed.

Not required.

28. Pertaining to paragraph SOW 2.4.10.4: Is the equipment relocation and/or reinstallation referenced in this paragraph related to the initial installation and implementation of instruments and necessary due to staging and phasing in of new equipment?

Yes.

29. Pertaining to paragraph SOW 2.4.18.1: How will “as needed” maintenance items be factored into the time required for instrument maintenance? Should offeror be required to quantify the average frequency “as needed” maintenance is performed, and how much time is required per incidence?

Nonscheduled, per incident, instrument maintenance will not be factored into the time required for regularly scheduled instrument maintenance.

30. Pertaining to 2.14.6.1: Can VISN supply an estimated cost of DI consulting needed to re‐establish the AV interfaces in order for Offeror to account for these costs?

The estimated cost to re‐establish the AV interface is $20,500.00

31. Pertaining to 2.4.7.27: Contractor Middleware Management System must have...What features does VISN wish to require?

Sufficient memory to store patient information and test records with downloading capability to an external medium for long term storage of patient records and other information.

Patient status display for technologist review.

Supports workflow management that supports all integrated (linked) testing instrumentation.

Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

Technology to automatically repeat testing based on customer configurable testing criteria

(repeat testing).

Technology to automatically direct additional specimen testing based on customer configurable testing criteria (reflex technology).

Awardee shall collaborate with each lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity post award.

32. Pertaining to SOW 2.4.8:

a. Do any sites reuse or recycle sample IDs, and if so at what interval?

All sites are using Unique sample identifiers that include the Julian date. They are recycled every 10 years.

b. Are the sites grouped in any way today such as an interface to common Middleware or LIS?

The following facilities share Data Innovations Interface Managers:

6. Milwaukee, Appleton, and Green Bay

7. Madison and Rockford

8. Jesse Brown and Crown Point

9. Danville and Peoria

10. Lovell FHCC and Red Rover

All sites have independent, separate LIS (VistA) systems.

c. Do any of the sites commonly share IT resources?

d. Are there any concerns about putting any sites together on a common IT platform? If so, please explain.

Yes. Each site has an independent, separate LIS system and Data Innovations Interface Manager.

They are configured, maintained, and supported by different groups of people at each facility.

There is no overlap in support personnel amongst the facilities.

e. Are there any concerns about sites being on the same IT Platform and having conflicting needs or downtime schedules? If so, please explain.

Yes. As described above, each site operates independent, separate LIS systems and Data Innovations middleware that support their site. Current network configurations, access control lists (ACLs), and firewalls do not support all sites sharing the same IT platform.

f. Are there any internal policies or procedures we should be aware of relating to how sites are distributed across IT Servers? If so, please explain.

*** This concludes the questions and answers section of the combined synopsis/solicitation

36C25220Q0122. No other information follows***