36C26323Q0361 A00002.pdf

5. PROJECT NUMBER (if applicable)

CODE7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER3. 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 CODECODE

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 NUMBERED 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 amendment, 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)

1 6

A00002 36C263-23-AP-0886

36C263

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

36C263

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

36C26323Q0361

03-07-2023

X

X X

Tuesday, April 4, 2023 12:00 P.M. CDT

See CONTINUATION Page

THE PURPOSE OF THIS AMENDMENT TO RFQ # 36C26323Q0361 IS TO:

1: POST ANSWERS TO QUESTIONS RECEIVED AFTER RFQ POSTING. PLEASE SEE ATTACHED PAGES FOR QUESTIONS AND ANSWERS.

2: THE PROPOSAL DUE DATE WILL BE EXTENDED FROM 3/28/2023 TO4/4/2023. A TOTAL TIME EXTENSION OF 7 CALENDAR DAYS FROM

THE PREVIOUS TIME EXTENSION FROM AMENDMENT A00001.

3: POST THE STATEMENT OF WORK (SOW) AS IT WAS MISSING FROM THE ORIGINAL RFQ.

4: POST A CORRECTED ATTACHMENT A WITH THE CORRECT BASE AND OPTION YEAR QUANTITIES.

5: ALL OTHER RFQ TERMS AND CONDITIONS REMAIN THE SAME.

Shavokie Gibson

1. Reference: Pricing document – Copy+ of+ Attachment+Clin – excel file

a. Statement: While the file now contains Base year + option volumes, the Order

Period 1-4 (option year) tabs do not match the breakout structure as the Base year tab. In that your Base year tab breaks apart the three options for how you want it priced, albeit on the Order Period 1-4 (option year tabs), it only illustrates a cumulative annual volume for all sites combined not broken out as the base year.

i. Clarification: Please update the Order Period Tabs and repost

2. Reference two sections: #2 on page 2/19: Cost per Patient Reportable Result (CPRR) - Contractors are required to provide a price for a reportable patient result. The Contractor should provide multiple CPRR options to include one CPRR for all fours sites combined; one CPRR for Fargo volume only, and one CPRR for the VA Black Hills Healthcare System (Fort Meade, Hot Spring, and Rapid City combined). The per patient reportable result price shall include costs covering: (1) 5 year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation of a patient reportable result. The per patient reportable result price shall also encompass all costs associated with dilution;

repeat and confirmatory testing required to produce a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI); (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel.

Contractors shall provide delivery, installation and removal of equipment at no additional charge AND #5 page 2/19 SOW: Abstract: 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. Expiration date must be clearly marked on reagent, standards and control containers. 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 designated individuals determined at contract award.

a. Questions:

i. What controls are you using today with your current supplier? i.e. Brand

Names There is a note underneath this section regarding inability to supply a component If they do not manufacture it. If the vendor does not have the capability to supply a control for a certain test, they must indicate that.

“Vendors not having the ability (for manufacturing reasons) to supply a component(s) included in the CPRR and/or CPT as defined in the statement of work and evaluation factors must individually specify the item(s) so that effective comparisons can be made between offers.

Vendors offering third party products (reagents or consumables) must individually specify the product, source, reference information, and indicate whether the third-party reagents will be procured by the offeror and if the costs are included in the quoted CPRR. Offeror should certify their technical support of the third-party method on the equipment systems.”

ii. If the network is purchasing direct: NA

1. do you want us to quote and include on our proposal? NA

2. If so, are you brand name required or equivalent? NA

3. What is your current spend and volume for that purchase so we have apples to apples comparison? NA

iii. Do you want this within the CPT or CPRR pricing or separated as an option? NA

3. Question: Are there adequate water hook ups? Electrical hook-ups? If the vendor requires water to operate, all sites will require a filtration system. Electrical requirements should be listed in the response for evaluation by facility.

Carry forward for questions asked on 3/8 that I did not see included in the modification:

1. Reference #2 and 4 pages 1- 2/19: New equipment is required and it needs to be space advantageous to the government; From SOW: A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. Equipment must maintain or, preferably, reduce the number of workstations or overall labor required to accomplish the required testing by the laboratory.

a. Question: Is a floor plan for each site available? Or a square footage? No – market analysis has been ongoing for over a year

b. Question: how are we to know space advantageous without a floor plan?

Space advantageous refers to highlighted above. The evaluation of submitted materials will determine if it fits in our existing space and reduces number of workstations and overall labor. With the proposal, they generally submit dimensions of the analyzers including the space surrounding the equipment that is required to remain open for ventilation, etc.

2. Reference two sections: Page 3/19 SOW Abstract: An uninterruptible power supply (UPS) with line conditioner for each instrument provided. (This includes UPS units for sites with automation lines, specimen management systems, data management systems, refrigerated storage, etc,) Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records.

AND Page 5/19 SOW Abstract: Equipment Preventative Maintenance/Repair Service.

The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all instrumentation, primary processing automation line instrumentation and any incremental support/ancillary equipment, e.g. water system, printers, etc. offered according to the following terms:

a. Clarification:

1. Please clarify if you are requesting automation and what the requirements are for automation as I do not see any requirements specific to automation, decapper, recapper, etc. There are no requirements for primary processing automation

b. Question:

Will you be allowing site visits? No - this should have been performed by interested parties during market analysis. Each vendor was notified when we began market analysis.

1. Reference: Pricing document – Copy+ of+ Attachment+Clin – excel file and SOW

a. Statement: within the SOW, the requirements are limited in terms of your desired instrumentation at each site, for example, often in these solicitations, we are provided instruction if a site wants to have a backup instruments. We did not find that in this posting.

b. Questions:

i. Do you want back up or mirror instrumentation to be included? See below from the contract. My assumption based on the volume of tests is that Fort Meade and Fargo would require at least two analyzers and Hot Spring and Rapid City would only need one.

2.4.1. Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. For the purpose of this solicitation, the combination (if required) of a chemistry and immunochemistry analyzer will be considered one primary analyzer.

ii. On the excel file referenced, are these “ordered” or “performed” test volumes? The entire contract is for cost-per-reportable. Our request is to pay for the tests we result; therefore, the reference file is tests performed.

The cost-per-reportable results is defined in the SOW.

1. Example, at the Rapid City location which is 30 minutes from the medical center, there are two tests on the list PSA for a quantity of 4,202 and TSH for a quantity of 6,271 , are these ordered or performed at this site. If they are ordered and then sent to the HCS 30 minutes away, we would not then quote one an immunoassay module for this location, as we could save you $125K+ potentially. These are not stat (urgent) tests and if they are being sent down the street for processing, this would be helpful to know so we are not over burdening our proposal. This is not the process intended for Rapid City or what the SOW has requested. Please quote immunoassay for Rapid City.

2. Request, that you update the solicitation to state these are ordered or performed test volumes. I think that is doesn’t need to be reposed with this. In 15 years, 20+ contracts, I haven’t had anyone misunderstand or misinterpret.

Request for response date to be pushed out to 4/7/23 or at least two weeks after the last post on questions.

The Response Due Date will be adjusted to 4/4/2023. This will have allowed four (4) weeks for this solicitation, double the original time.