36C24822R0028 0003.docx

36C24822R0028 0003

5. PROJECT NUMBER (if applicable)

CODE

7.

ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF

PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE

OF YOUR

ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERE

D CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES

SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendmen t, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED

STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF

CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF

SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 10-12-2022

VA-20-00024476

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827 To all Offerors/Bidders

36C24822R0028 09-01-2022

X X X October 28, 2022, at 16:00 PM EST.

X The purpose of this amendment is to extend the solicitation and answer questions. As a result:

a. Response to the solicitation is extended from 10/14/2022 at 14:00 PM EST to 10/28/2022 at 14:00 PM EST.

b. See Section A.1 for corrections to the Statement of Work.

c. See Section A.2 for answers to participant questions.

d. Questions and answer requests are closed. Questions will no longer be entertained.

e. Attac hment D.9, D.10 and D.11 CAD Drawings for Orlando, Daytona and Viera are included in the solicitation.

f. Please submit your proposals to the best of your ability no later than 10/28/2022 to Jessica.Kiser@va.gov and Christopher.Bany@va.gov.

A.1 Statement of Work Changes

Section 1.0, paragraph k reads as:

k. A deionized water system which includes all replacement parts, labor and backup system for redundancy for all sites, if required to operate the equipment.

Section 1.0 paragraph k is changed to:

k. A deionized water system which includes all replacement parts, labor and backup system for redundancy for all sites to operate the equipment.

Section 6.2 reads as:

Testing Instrumentation: The testing instrumentation shall be an integrated platform with flexible, components that can be upgraded and or reconfigured on site and is approved by the Food and Drug Administration (FDA) at the time of proposal submission and shall have the following:

Section 6.2 is changed to:

Testing Instrumentation: The testing instrumentation shall be an integrated platform, which reagents/calibrators/QC materials shall be interchangeable between instrumentation at all three site locations, with flexible components that can be upgraded and or reconfigured on site and is approved by the Food and Drug Administration (FDA) at the time of proposal submission and shall have the following:

Section 10, paragraph 10.7 reads as:

10.7 Carryover Studies: Successful carryover studies shall be completed by the contractor on all analyzers during installation, if required. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge.

Section 10, paragraph 10.7 changed to:

10.7 Carryover Studies: Successful carryover studies shall be completed by the contractor on all analyzers during installation and validation. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge.

A.2 Questions and Answers

1) To allow for complete market research on new vendor automation lines and understand the impact on USVA Orlando workflow we request one-day to perform a Process Analysis (with a subsequent 2-hour Report Out 2-weeks later), this will of course require the due date on RFQ be extended.

Answer: We are not authorizing a one-day to perform a process analysis.

2) To allow for complete market research on vendor new instruments and clinical IT software options we request one-day to present to each of your three facilities; Orlando, Daytona, Viera. In lieu of this allowance, we request 1.5 hours to present Virtually via Microsoft Teams to collective sites.

Answer: We are not authorizing a presentation to the facility.

3) Can one set of virtual middleware servers (Prod and Test) be provided for use by all three facilities; Orlando, Daytona, Viera?

Answer: Yes.

4) Or will each facility require their own set of virtual servers?

Answer: See question number 3.

5) SOW 6.2.3. Please consider eliminating “Minimum 70 reagent test slots per chemistry analyzer and 40 for immunoassay analyzer” as this is specific to one vendor and therefore restrictive. For fair and balanced solicitation please revised to “it is preferred, but not required, that vendors have a minimum of 70 reagent test slots per chemistry analyzer and 40 for immunoassay analyzer”.

Answer: This is the minimum number of slots and therefore not restrictive.

6) SOW 7.2 states Middleware system that support Auto-Verification. Please clarify if Orlando, Daytona, and/or Viera are currently autovalidating?

Answer: Yes.

7) What are their current rates?

Answer: Approximately 85% of all results.

8) Does a vendor’s CPRR offering need to include full autovalidation services, meaning auto-verification rules will be housed in vendor middleware?

Answer: Auto-verification rules may need to be housed in vendor middleware with access by customer to amend/delete rule sets. Rule-writing services are not needed.

9) SOW 7.40. Please consider eliminating “license for CAP proficiency testing results using Instrument Manager” as this capability is limited to one vendor and therefore restrictive. For fair and balanced solicitation please revise to “it is preferred, but not required, that vendors provide license for CAP proficiency testing results using Instrument Manager.”

Answer: We are unable to eliminate this requirement, in accordance with our VA National Contract account with CAP Proficiency Testing, we are not authorized to utilize any other CAP profiency vendors.

10) SOW 9.11. Please consider eliminating “inventory management system using RFID technology”. This is restrictive to vendors who product choses to use RFID technology. Other leading inventory management system have chosen to use other, arguably more effective, technologies. For fair and balanced solicitation please revise to “its is preferred, but not required, that inventory management system uses RFID technology” or just eliminate all together.

Answer: Inventory management system must be RFID/Bluetooth/Wireless compatible.

11) Because response to these questions affect quote creation process, and because the opportunity to take measurements at USVA Orlando was pushed back by 1-week, please extend RFQ due date by 1-2 weeks.

Answer: Reference Block 11 and 14 of this amendment for solicitation offer due date.

12) Would USVA Orlando like the option to connect hematology workcell to Chem/IA automation line configuration?

Answer: No.

13) Due to the complex nature of this RFP, vendor is respectfully requesting a 2 week extension post questions answered.

Answer: See question 11.

14) Your current instrument configuration consumes 135 liters of water per hour at the Orlando location and 25 liters of water per hour at Viera and Daytona, what is the preferred total maximum liters of water per hour for each location.

Answer: There is no maximum. This is the minimum required to support all instrumentation with system redundancy at all locations to be accounted for.

15) Can you specify what the preferred maximum amount of time of needed to complete total maintenance (hands-on & automated) daily, weekly and monthly is?

a. 6.2.36 Minimal daily, weekly, and monthly maintenance downtime. Provide total maintenance times, including washes and wait time, for daily, weekly and monthly maintenance. Include any hands on, automated non-maintenance activities. Quarterly and triannual maintenance to be performed by contractor’s service engineers on a scheduled basis.

Answer: The contractor shall provide a breakdown of all maintenance time frames.

16) Can you be more specific in the amount of additional sample processing time that is allowable to assess common interferents.

a. 9.6 The systems shall be able to assess the level of common interferents (hemoglobin, lipemia, and icterus) for each sample without significantly decreasing overall sample throughput. List sample volume requirements and time to result.

Answer: The contractor shall list their sample volume requirements and time to result in their solicitation response.

17) In assessing common interferents is it preferred that no additional reagents or consumables are used during that process?

Answer: Yes.

18) In assessing common interferents is it preferred that only tests that would be impacted by the interference levels be flagged as opposed to flagging all samples?

Answer: Yes.

19) Can you clarify the preferred STAT TAT of < 15 minutes for Troponin, is this time inclusive of the time needed to assess common interferents and inclusive of processing / on analyzer sample time? If not, then what is the total allowable TAT inclusive of interferent assessment and on analyzer processing / sample handling for Troponin?

a. 6.2.16 Minimal operator intervention to introduce STAT specimens or to change a routine specimen to a STAT specimen, as well as introduce STAT specimens during a test run without aborting a run. Vendor will outline STAT procedure. STAT test results available in < 15 minutes is preferred.

b. 9.4 STAT Troponin I assay with a ≤ 15 min analyzer (Turnaround Time) TAT. Contractor shall provide an FDA-cleared, High-Sensitivity Troponin with package claims of ≤ 10% precision at the 99th percentile for both males and females

Answer: The STAT TAT shall be less than or equal to 15 minutes for analyzer processing.

20) To avoid potential bottleneck opportunities on the automation line is it preferred that the proposed centrifuge on the line have separate & multiple robotic arms for loading and unloading specimens into the centrifuge?

a. 6.1.8 Centrifuge: The ability to separate the serum/plasma from the blood cells through the process of centrifugation. Minimum of 2 temperature-controlled centrifuges with adjustable spin time and Revolutions per Minute (RPM) settings, with the option to bypass the centrifuge without manual intervention, which is important for pre-spun samples. Centrifuges shall be able to be programmable to set spin and dwell times and shall be able to spin multiple tube types and sizes simultaneously. Automated placement of specimens into and removal from centrifuges with minimum loading and unloading times for maximum productivity.

Answer: Yes.

21) In terms of sample carryover is it the preference of the VA Orlando to have a system that has zero possibility of sample carryover? If a proposed system does have the potential for sample carryover what is the maximum level of sample carryover that is allowable?

a. 10.7 Carryover Studies: Successful carryover studies shall be completed by the contractor on all analyzers during installation, if required. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge.

Answer: Carryover studies performed by vendor shall be assessed at time of validation and installation.

22) With respect to Linearities, what is the maximum number of tests that can have < 3-point calibrators thus requiring linearity studies to be performed on them?

a. 10.3Analytical Measurement Range (AMR) or Linearity analysis shall be performed on new contracted instrument(s) for each analyte to determine reportable range with data reduction in accordance with CLSI guidelines. The material shall have values, which are near the low, mid, and high values of the Analytic Measurement Range (AMR) and be of appropriate matrix for the clinical specimens assayed by that method. A minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum. Results shall demonstrate at least 5-6 evenly spaced points (i.e., Maximum value, 0.75 of maximum, 0.5 of maximum, 0.25 of maximum, and minimum values) between the lowest and highest values validated for instrument. Alternatively, 2 points near low end of range, 1 in the middle and 2 near the high end (i.e., Max, 0.85 max, 0.5 max, 0.25 max, min) are acceptable. Unacceptable are serial 1:2 dilutions (i.e., max, 0.5 max, 0.25 max…). If the imprecision is greater than 20% on triplicates for the lowest reportable range for the analyte, and if it overlaps with the lower patient reference range in the vendor’s package insert, contractor will have to resolve the issue with the instrument or obtain another reference material. The Clinical Reportable Range (CRR) should approach that specified by the vendors’ package insert. In all cases it needs to extend beyond the reference range.

Answer: There are no maximum number of tests.

23) Since you are requesting multiple analyzers at the Orlando location can you specify the preferred TOTAL Reagent Capacity for each proposed solution instead of listing out your preferred reagent capacity per analyzer.

a. 6.2.3 Sufficient capacity and throughput to meet the volume and service demands as listed in Attachment A. Acceptable reagent capacity: Minimum 70 reagent test slots per chemistry analyzer and 40 for immunoassay analyzer.

Answer: See question number 5.

24) In section 6.2 you requested an integrated platform, if multiple analyzers are quoted for Orlando is it your preference that all of those analyzers be the same model? And do you prefer that the analyzers quoted for Viera, and Daytona be the same model of analysis quoted at Orlando?

Answer: Reference update to SOW 6.2 in Section A.1.

25) Can you elaborate on the need for contractor service engineers to perform quarterly and triannual maintenance?

a. 6.2.36 Minimal daily, weekly, and monthly maintenance downtime. Provide total maintenance times, including washes and wait time, for daily, weekly and monthly maintenance. Include any hands on, automated non-maintenance activities. Quarterly and triannual maintenance to be performed by contractor’s service engineers on a scheduled basis.

Answer: The contractor shall perform all leased equipment maintenance and services.

26) Since a site visit to Daytona and Viera was not offered can you provide a photograph of the height clearance at each location.

a. 6.2.38 Shall meet space limitations of 48” x 127” x 49” (water system to be in separate location) at Viera and Daytona Outpatient Clinics.

Answer: See attachment D.10 Daytona CAD Drawing and D.11 Viera CAD Drawing.

27) Can you expand on the needs of your offline storage, if your automation system is down do you require the ability to access patient samples from the storage module manually via a door?

a. 6.1.3 Specimen archival through mapping of specimen location; for easy retrieval once moved off-line. (Specimen Management System). System shall be able to retrieve specimens from the storage module. Storage capability for minimum of 15,000 specimens shall be included for online or offline storage. Automated delivery and organization of specimens to outlet station based on bar-coded information. Storage and retrieval module will handle waste disposal. Should have archive capabilities to locate samples. This shall be programmable by department or tube type.

Answer: Yes.

28) Can you elaborate on what you mean by “minimal calibration frequency? What is the preferred calibration stability for chemistry reagents and what is the preferred calibration stability for Immunoassay reagents?

a. 6.2.22 The capability to calibrate assays during test run without aborting the run; minimal calibration requirements for all tests; ensure ease of calibration with extended calibration stability and minimal calibration frequency (vendor to provide list of calibration frequency)

Answer: The contractor shall specify the calibration stability times for all assays.

29) Respectfully requesting a copy or an example of the Excel Spreadsheet mentioned in the below requirement.

a. 10.9 Vendor shall provide an Excel spreadsheet to include a side-by-side comparison of each instrument for all sites to include the precision, linearity, slope, intercept, correlation coefficient, clinical reportable range, and interference verification for each reagent method.

Answer: Vendor shall provide excel spreadsheet inclusive of the requested column headers described above in SOW 10.9.

30) Respectfully requesting clarification on the below requirement in regard to the therapeutic range validation criteria.

a. 11.4 Therapeutic range validation studies shall be performed by vendor for applicable analytes.

Answer: Therapeutic range validation studies shall be performed by the vendor with requisite samples for testing to establish range studies.

31) How many total training slots are desired for the contract term?

Answer: Two slots each for Daytona Beach and Viera. 4 training slots for Lake Nona. Two slots per year for each option year.

32) (4.5) Special handling for emergency orders of supplies- can the vendor charge for overnight orders where the vendor was not at fault?

Answer: Please refer to Section 4.5 of the SOW.

33) (8.3) Can existing network printers be used?

Answer: No.

34) (14.3.3) Can details be provided about the moves? Our cost will be determined by the destination and associated travel time to the new location. What floor of the new building will the equipment be to?

Answer: We are unable to give details about this move.

35) Can a CAD be provided Daytona & Viera for the current and proposed locations of laboratory instrumentation?

Answer: See attachment D.10 Daytona CAD Drawing and D.11 Viera CAD Drawing.

36) (1.0 letter l) Can QC with similar/superior functionality be proposed?

Answer: Yes.

37) (7.21) Can QC programs with similar/superior functionality to Bio-Rad Unity Real Time be proposed?

Answer: Yes.

Included in the solicitation: CAD Drawings for Orlando, Daytona and Viera.

image2.emf

D.10 DAYTONA CAD DRAWING.dwg image3.emf

D.11 VIERA CAD DRAWING.dwg image1.emf

D.9 Orlando CAD DRAWING_LAKE NONA BLDG 1 & 2 Floor 2.dwg