RFIs_36C26122R0037_06022022_VA Response.pdf

RFIs 36C26122R0037

2.3 Chemistry Instrumentation:

3. Closed Tube Sampling Capability. Instrumentation must have cap piercing or alternately offer a de-capping mechanism if no closed tube sampling is available.

An external de-capping device is acceptable. Automated recapping of sample tubes for storage is preferred.

We request that the requirement be rewritten to promote open competition among vendors, for example: “Decapping or close-tube sampling capability. The system must have access to cap-piercing or pre-analytical decapping, and automated recapping of sample tubes for storage if required by the facilities.”

OK, SOW can be amended as above.

7. Walkaway capability. Reagents proposed for each analyzer must ensure that there is at least 24 hours of operational time before requiring replacement.

Preference will be given to QC material that can be stored on board longer than 24 hours.

We request that the requirement be rewritten to promote open competition among vendors, for example, “Walkaway capability. Reagents proposed for each analyzer must ensure that there is at least 24 hours of operational time before requiring replacement.”

Would like to keep the preferred language – it is preferred that provide option with and without QC (sites have the option to choose whether to cut order for

QC or not)

SOW addition: each facility has the ability to determine method and vendor of Quality Control – order for QC line item can be omitted if desired

11. Perform the creatinine, hemoglobin A1C and cholesterol assay testing using a method referenced to an international standard (e.g., WHO standard). If the methodology changes and warrants patient re-baselining, the vendor shall provide necessary services and materials.

We request that the requirement be rewritten to promote open competition among vendors, for example, “Perform creatinine, hemoglobin A1c and cholesterol assay testing using a reference method or a method reference to an international standard (e.g. WHO standard) If the methodology changes and warrants patient re-baselining, the vendor shall provide necessary services and materials.”

Reference method is not the same thing. Provide details with solicitation for technical evaluation.

15. Shall be capable of flagging expiring reagents and calibrations. Must allow quality control (QC) data viewing and report extraction (e.g., Levey Jennings charts, running means & SD’s, etc.), have the ability to retrieve historic QC, reagent, control, and calibrator data for troubleshooting. Preference will be given to databases that store this information for longer periods of time.

We request that the requirement be rewritten to remove preferential language that may exclude vendors and open competition. The following alternative is proposed: “Shall be capable of flagging expiring reagents and calibrations. Must allow quality control (QC) data viewing and report extraction (e.g., Levey

Jennings charts, running means & SD’s, etc.), have the ability to retrieve historic QC, reagent, control, and calibrator data for troubleshooting.”

Keep preferred language.

17. Must have a minimum of 20 facilities reporting in peer groups for QC programs and the College of American Pathologists (CAP) Proficiency Test Program.

Ability to export and upload QC data in real time to peer group program.

We request that the requirement be rewritten to promote open competition among vendors, for example, “Must have a minimum of 20 facilities reporting in peer groups for QC programs and the College of American Pathologists (CAP) Proficiency Test Program. The peer groups can include facilities that report peer results for other FDA cleared analyzers that use the same formulation and are considered to be included in the instrument family of analyzer grouping by the FDA or they can be specific to the proposed system. Ability to export and upload QC data in real time to peer group program.”

Preferred. If vendor does not meet this requirement, sites will have the option to opt out of QC in favor of preferred peer group.

21. Analyzer shall have test methods and /or procedures equivalent to standard reference methods, with high preference for international standardization when possible.

We request that the requirement be rewritten to remove preferential language that may exclude vendors and open competition. The following alternative is proposed: “Analyzer shall have test methods and /or procedures equivalent to standard reference methods.”

Reviewed during technical evaluation, this is not an exclusion.

24. Shall have the ability to prioritize STAT testing over routine testing. Preference will be given to systems that can prioritize STAT samples with the least amount of technologist intervention.

We request that the requirement be rewritten to remove preferential language that may exclude vendors and open competition. The following alternative is proposed: “Shall have the ability to prioritize STAT testing over routine testing with the least amount of technologist intervention.”

OK, SOW can be amended as above.

27. Equipment shall be provided with an Uninterruptible Power Supply (UPS). If possible, provide a single UPS with the capacity to maintain continuous operations for 2 hours.

We request that the requirement be rewritten to promote open competition among vendors, for example, “Equipment shall be provided with an Uninterruptible

Power Supply (UPS). If possible, provide a single UPS with the capacity to maintain continuous operations for 30 minutes, allowing for a controlled shutdown.”

OK, SOW can be amended as above.

2.4 Immunoassay Instrumentation

10. Shall be capable of flagging expiring reagents and calibrations. Must allow quality control (QC) data viewing and report extraction (e.g., Levey Jennings charts, running means & SD’s, etc.), have the ability to retrieve historic QC, reagent, control, and calibrator data for troubleshooting. Preference will be given to databases that store this information for longer periods of time.

We request that the requirement be rewritten to remove preferential language that may exclude vendors and open competition. The following alternative is proposed: “Shall be capable of flagging expiring reagents and calibrations. Must allow quality control (QC) data viewing and report extraction (e.g., Levey

Jennings charts, running means & SD’s, etc.), have the ability to retrieve historic QC, reagent, control, and calibrator data for troubleshooting.”

OK, SOW can be amended as above.

14. Analyzer shall have minimal reagent preparation. 90% of reagents, calibrators, and controls (if available), are liquid ready-to-use with minimal to no equilibration time from storage prior to use on the analyzer.

We request that the requirement be rewritten to promote open competition among vendors, for example, “Analyzer shall have minimal reagent preparation and equilibration. 90% of the vendor’s reagents must be fully liquid and ready to use without reconstitution.”

SOW can be amended to list the above as a preference.

22. Preference will be given to assays that avoid using known interfering substances such as biotin. If assays use biotin the specific information must be provided on potential impact to patient results.

We request that the requirement be rewritten to promote open competition among vendors, for example, “Assays will have demonstrated advantages in the avoidance or mitigation of interferences from both endogenous interferences, e.g. Rheumatoid Factor, and Alkaline Phosphatase, pre-analytical interferences

(e.g., hemolysis, lipemia, and icterus), and exogenous interference from supplements and common pharmaceuticals.”

“Assays will have demonstrated advantages in the avoidance or mitigation of interferences from both endogenous interferences, (e.g. Rheumatoid Factor, and

Alkaline Phosphatase), pre-analytical interferences (e.g., hemolysis, lipemia, and icterus), and exogenous interference from supplements and common pharmaceuticals (e.g. biotin).”

23. Analyzers should be capable of performing a wide range of infectious disease testing. Including, but not limited to HIV, Hepatitis B, and Hepatitis C testing

(refer to attachment A). Preference will be given to analyzers that prevent sites from managing multiple immunoassay contracts to provide this testing.

We request that the requirement be rewritten to remove preferential language that may exclude vendors and open competition. The following alternative is proposed: “Analyzers should be capable of performing a wide range of infectious disease testing. Including, but not limited to HIV, Hepatitis B, and Hepatitis

C testing for sites requiring on-site testing (refer to attachment A), and without managing multiple immunoassay contracts to provide this testing.”

OK, SOW can be amended as above.

24. High/Ultra-sensitive reagent-based assays shall be utilized, alleviating interferences.

We request that the requirement be rewritten to promote open competition among vendors, for example, “In order to alleviate interferences, assays will have demonstrated advantages in the avoidance or mitigation of interferences from both endogenous interferences, e.g. Rheumatoid Factor, and Alkaline

Phosphatase, pre-analytical interferences (e.g., hemolysis, lipemia, and icterus), and exogenous interference from supplements and common pharmaceuticals.”

“Assays will have demonstrated advantages in the avoidance or mitigation of interferences from both endogenous interferences, (e.g. Rheumatoid Factor, and

Alkaline Phosphatase), pre-analytical interferences (e.g., hemolysis, lipemia, and icterus), and exogenous interference from supplements and common pharmaceuticals (e.g. biotin).”

2.5 Power for Chemistry and Immunoassay:

1. Individual components shall not require more than 30 amps, 110V or 220V. It is acceptable for peripheral equipment such as the monitor, computer, and printer, to be plugged into separate outlets or UPS

We request that the requirement be modified to promote open competition among vendors by increasing the amperage limit from 30 amps to 50.

This is to prevent excessive engineering electrical renovations. Equipment over 30 amps will need to be reviewed with engineering for acceptability at the sites.

3. Shall be installed within the existing power capability that exists for each laboratory, regarding both emergency and normal power.

We request that the requirement be rewritten to promote open competition among vendors, “Shall be installed with minimal changes to the existing power capability that exists for each laboratory, regarding both emergency and normal power.”

Significant power changes need to be reviewed with engineering.

2.6 Automation for Chemistry and Immunoassay:

8. Ability to simultaneously accept pre-spun and non-spun samples for processing. Preference will be given to systems that offer spin status detection.

We request that the requirement be rewritten to promote open competition among vendors, “Ability to simultaneously accept pre-spun and non-spun samples for processing; optional spin status detection of samples.”

OK, SOW can be amended as above.

4. Service and Maintenance

5. Failure Mean Time Disclosure: The Contractor shall state the failure mean time (between failure and mean time to repair) for each piece of equipment offered.

The Contractor shall provide emergency backup equipment.

We request that the requirement be rewritten to promote open competition among vendors, for example “Failure Mean Time Disclosure: The Contractor shall state the failure mean time (between failure and mean time to repair) for each piece of equipment offered. Contractor to provide redundant systems to eliminate need of emergency backup equipment.”

OK, SOW can be amended as above.

10. Installation/Implementation

1. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 180 days after the award of the delivery order/s. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractors shall not be penalized for implementation timelines that extend beyond the 180-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government (i.e., construction/ remodeling of facilities). Upon award of a delivery order/s, the transition period for the awarded Contractor to have all equipment and peripherals installed and operational shall be 120 days from the date of award through 180 days. This requirement includes the implementation of autoverification and the transmission of QC data to an external real-time QC service. During this same period, all initial training of VA personnel in the operation and maintenance of said award shall also be completed with exceptions due to delays at the fault of the Government.

We request that the requirement be rewritten to promote open competition among vendors, for example “Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 180 days, or based on the mutually agreed upon timeline by Contractor and VA

OK, SOW can be amended as above.

after the award of the delivery order/s. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe, including possible phased or staggered-timeline to align with site-readiness.

Each healthcare system needs to “go-live together”. Can phase healthcare systems.

Contractors shall not be penalized for implementation timelines that extend beyond the 180-day timeframe, if the extension is through no fault of the

Contractor and is a result of delays due to the Government (i.e., construction/ remodeling of facilities). Upon award of a delivery order/s, the transition period for the awarded Contractor to have all equipment and peripherals installed and operational shall be 120 days from the date of award through 180 days, or based on the mutually agreed upon timeline by Contractor and VA.

OK, SOW can be amended as above.

This requirement includes the implementation of autoverification and the transmission of QC data to an external real-time QC service. During this same period, all initial training of VA personnel in the operation and maintenance of said award shall also be completed with exceptions due to delays at the fault of the Government.”

A few discrepancies between the summary tab and the site-specific tab volumes from the following file:

Draft+V21+Lab+Chem+IA_SOW+Attachment+A+-+Volume+Estimates+and+Individual+Test+Pricing_04142022.xlsx

CHEMISTRY VOLUMES SF NC HI REN FRE Palo Alto Las Vegas

Total Estimated Annual Chem Volumes 1,562,576 2,112,152 531,450 1,443,399 1,029,850 2,054,655 0

Site Specific TAB 1,538,659 2,112,152 531,450 1,443,399 1,029,850 2,054,655 2,607,305

Questions for VISN 21 on Chemistry:

- As CHEM SF tab includes volumes for both SF and Oakland, can we use the volumes in that tab and ignore the volumes in the CHEMISTRY

SUMMARY tab?

- Also note that Las Vegas’s patient volumes are not documented on the CHEMISTRY SUMMARY tab

IMMUNOCHEMISTRY SF NC HI REN FRE PA

Las

Vegas

Total Estimated Annual Immuno Volumes 127,499 375,741 48,801 150,439 74,001 204,576 0

Site Specific TAB 124,198 187,870 48,800 138,135 81,300 201,375 0

Questions for VISN 21 on Immuno Chemistry:

- With the exception of Hawaii, the patient volumes on the site-specific tabs do not match what is one the IMMUNO SUMMARY tab. Shall we just use the site specific tabs as the based for our proposal?

- Note that NC appears to have an inaccurate volume for Hep A IgM (Product ID 24). Removing this volume will allow the volumes above for NC to match.

- Refer to new Appendix A

- Note that no Immunoassay volumes have been provided for VA Las Vegas. Can you provide this information?

- Refer to new Appendix A – Las Vegas may or may not choose to opt in to Immunoassay, they have a contract currently, but automation advantages and pricing advantages would likely make this decision.

1) VA Las Vegas – We were told they weren’t participating

a. Why is it not in the Chem. Summary but listed below in the individual tabs?

b. Why is it not include in the Immuno summary or tabs?

Refer to new Appendix A- there are no longer Chem and Immuno tabs, it is all on one tab

2) Is VISN 21 asking for the (3) automation sites to be bid separately with the upcharge.

Propose a solution for all sites. For those requesting automation, propose an automation solution for those sites. Propose a non-automation solution or partial automation solution for all other sites. Providing more than one option for each site is preferred. Upcharge(s) should be billed to the sites using automation.

3) Attachment B indicates that Automation is a requirement for San Francisco, Palo Alto, Mather and Las Vegas. The table in Section 1.2 of the SOW also lists Automation for Hawaii and Reno. Which list should we use to prepare our response?

Provide an automation and a non-automation solution for sites like Reno and Hawaii. Hawaii likes the idea of Chem and Immuno instruments combined if it limits the amount of work that needs to be done. Reno originally did not want automation but is now busy and short staffed; automation will help them significantly.

4) Can you provide an estimate of how much time you will allow for a response from the RFP release date? 20-30 calendar days

5) Chemistry Summary. The following statement is included, but appears to contradict Attachment B. Please clarify: “*Automation is requested for Palo Alto and San Francisco only. Please provide an Up Charge price per CPRR based on the individual total estimated annual chemistry volumes for Palo Alto and

San Francisco. Total Up Charge for Automation = Up Charge per CPRR X Total Estimated Annual Chemistry Volumes for specific facility.

Refer to Attachment B

6) 2.3.10. Based on the statement “There will be an opportunity for offerors to visit each site to evaluate space needs; or floorplans will be made available upon request.”, can you provide specifics on the time period and process by which we can schedule meetings to evaluate and / or confirm space needs for our proposed products?

Floor plans should be sufficient for all vendors. If a significant need to visit the site is identified, contact the Contracting Officer for approval to visit the site.

7) 3.1 Mather. Is the expectation that Automation is provided for the initial, temporary and final locations, or will Mather entertain interim solutions until the final location is available? Can the VISN 21 and / or Mather provide CAD drawings of the temporary and final locations?

NorCal – we need the automation in all 3 scenarios. Floor plans provided.

8) SOW 2.3.10 Shall be space efficient and can be installed within the existing floor space with no reconstruction or minimal construction. There will be an opportunity for offerors to visit each site to evaluate space needs; or floorplans will be made available upon request. The equipment proposed must accommodate workflow to ensure easy access to other parts/departments of the laboratory and construction shall be at the vendor’s expense. What is

"minimal" construction?

Proposals to be evaluated by site managers and engineering SMEs. Any reasonable construction will be considered.

9) All proposed equipment must fit in the available lab space without construction modifications. Minimal construction may be considered if approved by the engineering department at the site. If site visit is not acceptable, bidding contractor will be provided with floor plans, requirements, measurements. Can vendors meet with each site’s Engineering Dept to understand potential construction impacts? Are vendors allowed to assist with potential construction costs?

Proposals to be evaluated by site managers and engineering SMEs. Any reasonable construction will be considered. Please try to fit proposal in current space. Please try to limit instrumentation.

1) In the solicitation page 3 (Chart), and the required chemistry and automation, it indicates that VA Pacific Islands is interested in automation, while Reno is not. We understand that this request may be due to staffing issues. However, can we clarify specifically what VA Pacific Islands is envisioning considering the space available? Example: An integrated chemistry and immunoassay analyzer that prevents sampling to separate instruments would be partial automation solution for Honolulu

2) 2.3 # 3. For automation lines, we would offer integrated decapping/recapping/sealing/desealing. For standalone locations, we would offer benchtop decappers and recappers. Is this solution what you had in mind for this requirement?

Yes

3) 2.3 # 10. We would like a couple of clarifications on this requirement:

a. We have done the pre-work at all locations. However, we would like the opportunity to revisit each site and confirm our measurements over the course of a week or two.

Can you provide floorplans for all the sites, including the CBOC sites? Yes

b. In another VISN (22 for example), we visited each location with a VA-approved construction company to determine exact costs for any changes needed. While the company with whom we worked mainly does work in VA hospitals, and was fully qualified, questions still arose as to coordination with Facilities. Is the intention to use Facilities for any construction?

Yes

Or can third parties have access?

No, unless coordinated with Engineering Dept

c. “Construction” typically includes moving power and data, or potentially water and drainage. We believe that we have limited needs for anything more than those items. However, it would be helpful to fully explain the process for construction if needed, who is authorized to do the work, how “at the vendor’s expense” would work, etc. We have some recommendations on how to structure a sub-contractor if needed.

Limited is okay. Provide any recommendations in proposal.

4) 2.3 # 17 We interpret this requirement as being able to provide controls outside of using a third party. In the current contract, the requirement was specifically to use Bio-Rad. We understand this limitation has caused problems over the last five years. We seek clarification on this requirement. For example:

“17 Controls are to be included in the CPRR. Must have a minimum of 20 facilities reporting in peer groups for QC programs and the College of American

Pathologists (CAP) Proficiency Test Program. Ability to export and upload QC data in real-time to peer group program.” The question is, if the control product meets the required specifications, does it have to be Bio-Rad? We ask because last time Bio-Rad QC was the specific requirement.

– It is preferred that vendors provide option with and without QC (sites have the option to choose whether to cut order for QC or not)

5) 2.4 #25, #26 In both requirements, the phrase “incubation times” is used in relation to overall Turn Around Time (TAT). While incubation is a factor in

TAT, the overall processing time is the real measure of getting results out, especially in a real-world scenario. For #26, the “10 Minute” cardiac TAT is a specific lockout specification from one vendor, which is only based on the instrument time if no other assays are being processed. We suggest that instead of using, “not to exceed,” use other language that is not a lockout. Potentially for 25-27 you can ask to detail the processing time for key assays. For example, we would be able to show overall TAT time through studies that completely negate the claim of a specific incubation time.

Provide TAT for assays to compare.

6) 2.4 #29 This requirement is a specific sticking point for us. SmartWash technology, which eliminates the need for plastic disposable pipette tips. Not only is our solution greener, but we also have fewer storage needs and do not waste trash space with unneeded plastic disposables. Therefore, we ask that you modify this requirement to ask vendors to state their carryover claim and their design solutions to mitigate carryover.

OK

7) 2.7 Please provide more details/specifics regarding what you are looking for with the Data Management system. For example, your main sites use

Remisol today, which is specific to one vendor. You currently have Data Innovations Instrument Manager, which can provide autoverification, specimen management, and other capabilities. It would be helpful to state the functionalities of your current middleware and specify what you would hope to achieve with a prospective middleware solution.

It will be used for management of a line for automation, sample management and analyzer management. Instrument Manager can handle autoverification.

The following are more general clarifications:

a. Livermore, a CBOC, requested an IA instrument while they currently don’t show any IA volumes. Typically, CBOCs run clinical chemistry tests but rarely immunoassays. Can you please confirm that Livermore will be running immunoassay tests on-site? Refer to Appendix A

b. 2.4 #24 and #25 - the term “High-Sensitive” is used for several assays. Troponin has specific, governing body-established criteria that need to be met for a troponin assay to be called “high- sensitivity.” Can you please provide criteria for “high/ultra-sensitivity” for assays other than troponin, specifically PSA and TSH (as noted in the specified questions)?

Provide your solution for technical evaluation.

c. 2.7 – might you please specify how many Data Innovations Instrument Manager licenses you would be requiring? Also, ideally, how would your current versions of DI and any proposed Instrument Manager solutions interact and/or be replaced?

Propose as a line item – sites may not need this and may not need to cut an order to make additional connections. This will not be a lockout spec.

1. Due to the sites ordering a low annual volume of the below tests, vendor is respectfully requesting that they are updated to “preferred tests” instead of required.

a. Free PSA

b. PSA Complex

c. Vitamin D 125

d. SHBG

e. Sirolimus

Provide test menu(s) for technical evaluation.

2. Respectfully requesting the below requirements be removed as they are unduly restrictive.

a. Requirement: Must have minimal reagent preparation and equilibration. 90% of the vendor’s reagents must be fully liquid and ready to use without reconstitution. Minor reagents transfer for activation is acceptable.

b. Requirement: Analyzer shall have minimal reagent preparation. 90% of reagents, calibrators, and controls (if available), are liquid ready-to-use with minimal to no equilibration time from storage prior to use on the analyzer.

SOW can be amended to list the above as a preference.

3. Please update requirement to read “Equipment shall be provided with an Uninterruptible Power Supply (UPS). If possible, provide a single UPS with the capacity to shut-down the instrument in an orderly manner in the event power outage”.

a. Requirement: Equipment shall be provided with an Uninterruptible Power Supply (UPS). If possible, provide a single UPS with the capacity to maintain continuous operations for 2 hours.

OK

4. Please confirm if daily / weekly / Monthly maintenance is considered downtime.

a. Requirement: Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

Maintenance is not a system failure

5. Respectfully requesting the below requirement be removed as it is unduly restrictive given these tests are not considered STAT.

a. Requirement: Immunoassay high/ultra-sensitive PSA and TSH tests, prefer incubation times not to exceed 20 minutes to maintain or improve turnaround times.

OK

6. Respectfully requesting the below requirement be removed or updated as it is unduly restrictive as written. Given that a one-step assay is not susceptible to the familial dysalbuminemic hyperthyroxinemia interference, it is clinically more acceptable.

a. Requirement: Perform Free T4 using a two-step method to reduce bias from euthyroid sick patients or with patients with familial dysalbuminemic hyperthyroxinemia for consistency and patient testing.

OK

2.1 General

• The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Unexpected changes in methodology/technology shall be at the expense of the

Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the Contracting Officer Representatives (Hereafter referenced as COR). These individuals shall be identified upon award of the delivery order/s.

Question: Are controls required through the vendor or will they be acquired directly through BioRad or Technopath?

Provide proposal with QC and sites can opt-in or opt-out depending on features and technical evaluation..

2.3 Chemistry Instrumentation:

The instrumentation offered shall provide the following capabilities:

4 Complete test menu as specified on Attachment A or provide options such as third party reagent vendors to be used as “user defined assays” on the primary analyzer, if not available from the vendor. The offeror that is able to provide the most comprehensive test menu, instead of referring to “user defined assays” or third-party vendors, will be given additional consideration. If a second or backup analyzer is specified on the attachment, the backup or secondary analyzer must be manufactured by the same vendor receiving the award and must use the same reagents for each test to allow for standardized test builds. Placing a third-party vendor’s analyzer to meet test menu requirements is not acceptable.

Question: Can you remove the highlighted area “Placing a third-party vendor’s analyzer to meet test menu requirements is not acceptable”? We would need to place a DiaSorin to meet the Infectious Disease requirements. We are awaiting approval for our platform that meets the Infectious Disease requirements. We will not be able to meet this requirement if the RFQ is released by December 2022.

Submit the proposal. Let the footprint and the technical approach make the decision.

6 Complete analyzers connected to an automated track system must also be compatible with Immunoassay analyzers connected to the track system.

Analyzers that are not connected to an automated track system must be physically connected and integrated Chemistry and Immunoassay systems (no separate units).

Question: Can you remove the highlighted area “Analyzers that are not connected to an automated track system must be physically connected and integrated Chemistry and Immunoassay systems (no separate units)”? We are awaiting approval for our integrated platform. We will not be able to meet this requirement for all sites that are not receiving proposed automation.

Submit the proposal – Efficiency of the system will be technically evaluated.

2.4 Immunoassay Instrumentation

The instrumentation offered shall provide the following capabilities:

1 Provide immunoassay analyzers with consistent methodology for load balancing (workload) and back up purposes as indicated in the equipment list. If a second or backup analyzer is specified on the attachment, the backup or secondary analyzer must be manufactured by the same vendor receiving the award and must use the same reagents for each test to allow for standardized test builds. Placing a third-party vendor’s analyzer to meet test menu requirements is not acceptable.

Question: Can you remove the highlighted area “Placing a third-party vendor’s analyzer to meet test menu requirements is not acceptable”? We would need to place a DiaSorin to meet the Infectious Disease requirements. We are awaiting approval for our platform that meets the Infectious Disease requirement. We will not be able to meet this requirement if the RFP is released by December 2022.

23 Analyzers should be capable of performing a wide range of infectious disease testing.

Including, but not limited to HIV, Hepatitis B, and Hepatitis C testing (refer to attachment A)

Preference will be given to analyzers that prevent sites from managing multiple immunoassay contracts to provide this testing.

Question: Can you remove the highlighted area “Preference will be given to analyzers that prevent sites from managing multiple immunoassay contracts to provide this testing”? We would need to place a DiaSorin to meet the Infectious Disease requirements. We are awaiting approval for our platform that meets the Infectious Disease requirement. However, we will manage the DiaSorin contract (not the sites).

Submit the proposal – Efficiency of the system will be technically evaluated.

25 Immunoassay high/ultra-sensitive PSA and TSH tests, prefer incubation times not to exceed 20 minutes to maintain or improve turnaround times.

Question: Can you change the incubation time to not exceed 26 minutes?

Reword to provide solutions for STAT turnaround on Immunoassay testing.

26 STAT Immunoassay incubation times not to exceed 10 minutes, to meet chest pain center accreditation requirements and maintain or improve current turnaround times.

Question: Can you change the incubation time to not exceed 17 minutes?

Reword to provide solutions for STAT turnaround on Immunoassay testing.

29 Disposable sample pipette tips to eliminate carryover risks.

Question: Can you remove this requirement? We are awaiting approval for our platform that can meet this requirement.

This was addressed previously with a wash system – if they have a mechanism that is not a disposable sample pipette – that is Ok

2.5 Automation for Chemistry and Immunoassay:

12 Automation with input sorting technology (such as a hopper) and the ability to aliquot are preferred characteristics.

Question: Can you remove (such as a hopper)?

This is preferred and not a lock out.

10. Installation/Implementation

2 Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 180 days after the award of the delivery order/s.

Question: Is this date flexible? Can you provide a longer implementation timeframe?

Ok

Question: Can you require all vendors to submit proposed drawings for each site?

Yes – we like this idea

(End of Questions)