36C25226Q0070.docx

36C25226Q0070

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

None 36C25226Q0070 11-07-2025 Teresa Beers 414-844-4865 11-25-2025 12:00

CST

Department of Veterans Affairs 36C252 115 South 84th Street, Suite 101 Milwaukee WI 53214-1476 X 334516 1000 Employees N/A X Department of Veterans Affairs 36C252 115 South 84th Street, Suite 101 Milwaukee WI 53214-1476 Department of Veterans Affairs 36C252 Great Lakes Acquisition Center - HC 115 South 84th Street, Suite 101 Milwaukee WI 53214-1476

Department of Veterans Affairs Financial Services Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page

THIS IS A REQUEST FOR QUOTATION PER THE STATEMENT OF WORK

PROVIDED IN THIS DOCUMENT.

See CONTINUATION Page X X X

TERESA BEERS

SECTION B - CONTINUATION OF SF 1449 BLOCKSSECTION

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: ______________________________________ (Contractor’s Name) ______________________________________ (Address) ______________________________________ (City-State-Zip) ______________________________________ (Point of Contact/Title)

PHONE NUMBER ______________________________________

E-MAIL ADDRESS ______________________________________

SAM UEI NO. ______________________________________

MILWAUKEE WI 53214

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

52.232-34, Payment by Electronic Funds Transfer - Other than System for Award Management.

3. INVOICES: Invoices shall be submitted in arrears in accordance with:

a. 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

b. UPON ACCEPTANCE OF ITEMS

4. GOVERNMENT INVOICE ADDRESS: All invoices from the contractor shall be submitted electronically in accordance with 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

FACSIMILE, E-MAIL, AND SCANNED DOCUMENTS ARE NOT ACCEPTABLE FORMS OF SUBMISSION FOR PAYMENT REQUESTS.

For assistance setting up e-Invoice, the below information is provided:

* Vendors must register online at http://www.tungsten-network.com/veteransaffairs/

* Tungsten Network Setup Information: 1-866-340-4980

* Tungsten Network email: VA.Registration@tungsten-network.com

* FSC Vendor Support Section Contact: 1-877-353-9791

* FSC Vendor Support Section email: vafsccshd@va.gov

Vendors can inquire on the status of payments by accessing VIS at: https://www.vis.fsc.va.gov/login.aspx?ReturnUrl=%2fDefault.aspx

SPECIAL NOTES:

This is an unrestricted solicitation limited to responsible parties with the ability to 100% meet the requirements set forth.

Prospective contractors must furnish the information listed herein with their quotations to ensure they receive full consideration.

CONTRACT ADMINISTRATION:

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitment or issue changes that will affect price, quantity or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in cost incurred thereof.

CONTRACTING OFFICER’S POINT OF CONTACT (POC):

The designated VISN 12 VAMC POC will be Courtney Feldmann.

The VISN 12 VAMC POC will be designated to represent the Contracting Officer in furnishing technical guidance and advice regarding the work being performed under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer.

EVALUATION/BASIS OF AWARD:

The Government will select the quote that represents the best benefit to the Government at a price that can be determined reasonable. The Government will evaluate price and technical capabilities. These criteria are not listed in any relative order of importance.

After the solicitation closes, the Government will perform a comparative evaluation of the eligible quotes. All quotes must meet the minimum standards outline in this solicitation. For quotes that meet the minimum standards, the Government will perform a comparative evaluation by comparing quotes against one another to select the quote that best benefits the Government considering all factors. The VA will compare quotes against each other in an impartial and simplified manner based on FAR Part 13. Source selection techniques described in FAR part 15 will not be used.

Contractors may submit more than one quote; however, contractors are strongly encouraged to submit their best technical solutions and prices in response to this request for quote.

Once the Government determines there is/are a contractor(s) that can provide a service that meet(s) the requirements of this request for quote, the Government reserves the right to communicate with only those contractors quoting the best-suited service to address any remaining issues. The Government will evaluate quotes for award purposes by adding the total price for all option years to the total price for the basic requirement.

TYPE OF CONTRACT: VA anticipates a Single Award, Firm-Fixed Price, Indefinite Delivery Indefinite Quantity (IDIQ) contract. The IDIQ will have Five (5), One (1) Year Ordering Periods. Contract is based on the contents of this solicitation and usage estimates in the Statement of Work.

SECURITY & PRIVACY CONTROL:

The Certification & Accreditation (C&A) requirements of VHA Handbook 6500.6 do not apply to this requirement; therefore, a Security Accreditation Package is not required. No C&A or MOU/ISA is required. Sensitive information exposure as part of this contract involves applicable security controls within the facility as part of the VA Information Security Program.

If there are any questions related to privacy, please have a member of your staff contact the VA Privacy Service at (202) 461-6309. If there are any questions related to the information security, please have a member of your staff contact the Office of Cyber Security at (304) 262-7733.

SUPPLIES OR SERVICES AND PRICES/COSTS:

The Contractor shall provide pricing information and items required for testing results per the Statement of Work (SOW) It is the clear intent of the Government to award this contract to a single vendor for the entire VISN 12 electrophoresis and immunofixation business.

All questions and requests for clarification must be submitted by noon on November 17, 2025, via email to Parris Weidenbach at parris.weidenbach@va.gov

Proposals must be submitted to Teresa.beers@va.gov

DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

A. SCOPE OF PROCUREMENT

1. The desired Capillary and Gel Electrophoresis/Immunofixation analyzer(s) must have the capability of performing or reporting the clinical parameters as defined in the statement of work.

2. The instrument must be able to simultaneously perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

3. The electrophoresis and immunofixation instrumentation will be acquired for each of the clinical laboratories located at the following VA facilities:

i. Clement Zablocki VA Medical Center, Milwaukee, Wisconsin (Milwaukee)

ii. Edward Hines, Jr. VA Hospital, Hines, Illinois (Hines)

B. DEFINITIONS

1. Cost per Test (CPT) – as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers – Contractors are required to provide a price for each test that can be performed on its equipment. The per test 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 and reporting of a test result; (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 are required to provide delivery, installation and removal of equipment at no additional charge.

2. Business Associate Agreement (BAA) – A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receive, use, or disclose VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

C. TEST MENU

1. Below are the estimated annual volumes and required test menu.

Estimated Annual Volumes by Site

SITE/TEST

**Protein electrophoretic separation of human serum proteins must include albumin, alpha-1, alpha-2, beta and gamma identification and quantitation.

Estimated Annual Volumes by Site

SITE/TEST

D. GENERAL REQUIREMENTS

1. Primary Analyzers: Electrophoresis/immunofixation/immunotyping - Base equipment offered to each of the VA laboratories listed above that will fully support the scope of their operations (minimal requirements) as defined in this solicitation. 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) will, likewise, be considered primary instrumentation and must meet all technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer will be equivalent to a back-up analyzer (see definition below) and will replace the requirement for offering that category of equipment.

2. Parameter Definitions –

i. Capillary electrophoresis is an analytical technique that separates ions based on their electrophoretic mobility with the use of an applied voltage.

ii. Gel electrophoresis is used to separate and quantitate serum proteins based on their electrophoretic mobility on agarose gel. The separation is based on the rate of migration of the individual components in an electrical field.

iii. Immunofixation permits the detection and typing of monoclonal antibodies or immunoglobulins in serum or urine via gel methodology.

iv. Immunotyping (Immunodisplacement) permits the detection and typing of monoclonal antibodies or immunoglobulins in serum or urine via capillary methodology.

3. Operational Features – The electrophoresis/immunofixation/immunotyping instrumentation offered will have:

i. The capability of performing analysis on 100% of the tests listed in the Test Menu (Attachment A) using either capillary liquid flow electrophoresis or the traditional agarose gel electrophoresis technology.

ii. Sufficient capacity and throughput to meet the volume and service demands as defined in the Test Menu (Attachment A).

iii. A bi-directional, bar-coded computer interface. The fully operational interface (both hardware and software) must be immediately available for implementation to the VA VistA hospital information system (Refer to Brief Summary of VistA Functionality below) at the time of contract award. If the host system software requires the use of a non-proprietary universal interfacing system to provide bi-directional interfacing capabilities, the VISN12 facility laboratories currently use the Data Innovation Instrument Manager system. To achieve connection with those systems, the awarded Contractor shall be responsible for the cost of the interface. Refer to the following section entitled “Support Features – Computer Interfacing Requirements” for specific details.

Brief Summary of VistA Functionality VistA is a proprietary system to the VA whose functionality includes:

· Management of patient information through a database,

· Acceptance of test ordering information,

· Transmittal of patient laboratory test results

· Storage and retrieval of patient laboratory test results

· VistA is very limited in its functionality to manage laboratory quality control, provide Levy-Jennings plots or administer an instrument maintenance program.

4. Technical Features – The Capillary and Gel Electrophoresis analyzer(s) must be approved by the Food and Drug Administration (FDA) and must have:

i. Minimal daily maintenance such that the analyzer is not required to be down for more than 30 minutes per day (this is not to exclude longer times for periodic maintenance).

ii. The ability to use automated or manual sample introduction.

iii. Minimal sample pretreatment.

iv. Instrument should have random access with minimal tech intervention.

v. A data management system that minimally supports:

1. Automatic delimiting of electrophoresis curves.

2. Identification of fractions minimizing operator editing.

3. Customizable printing

vi. A comprehensive quality control package used for daily monitor of system performance and operator notification upon QC failure.

vii. Accurate barcode reading with less than 5% read failures.

1. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

5. Hardware Features – The Capillary and Gel Electrophoresis analyzer(s) must have:

i. A total equipment footprint that when installed in each of the VISN 12 laboratories will not negatively impact the functionality/operations of that laboratory nor will it require significant and/or costly infrastructure changes.

ii. If the instrument uses a Windows based software, the software shall be Windows 10 or newer.

iii. An on-board, adjustable monitor/screen that is easily readable.

iv. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and UID (unique identifier). Replacement printers shall be provided as needed, at no additional charge, for the duration of the contract.

v. Uninterruptible Power Supply (UPS) with line conditioner to provide uninterruptible electrical power without electrical voltage fluctuation. Replacement uninterruptible power supply with line conditioners shall be provided as needed, at no additional charge, for the duration of the contract.

vi. The instrument should be functional without the need for additional plumbing for water and waste disposal.

6. Supplies – The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation and perform all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity. The Contractor shall perform all the statistical analysis and report data in an organized, clearly comprehensible format.

7. Training – The Contractor shall provide an instrument training program to both sites that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training offered in the commercial marketplace. This will include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility per year for each model of instrumentation placed. Utilization of the training slots will be mutually agreed upon between VISN 12 and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room, and board for each participant.

8. Method Performance/Validation Requirements – shall be at the expense of the Contractor, shall include material and reagents required or recommended based on manufacturer’s specifications, and be consistent with current CLSI guidelines and related documents, The Joint Commission (TJC) standards and Federal regulations. The method validation will include the following:

i. Precision Studies – using normal and abnormal control material. This shall consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level of control. Intra-VISN facility variations should be kept at an absolute minimum.

ii. Correlation Studies – A minimum of 20-40 samples spanning the reportable range, shall be run by the present and proposed method. Contractor shall analyze results and provide statistical data to support acceptance of the new method(s).

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

iv. Sensitivity – Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate, and false negative rate are applied.

v. Specificity – A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances.

vi. Reference Range – A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each laboratory. One of the following protocols shall be used:

1. A verification of the manufacturer’s suggested reference range may be performed if the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be used to verify the manufacturer’s range. Any apparent outliers should be discarded, and new specimens obtained to provide a statistical valid verification.

2. If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.

9. Preventative Maintenance/Repair Service – The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all instrumentation and any incremental support equipment, e.g. water system and printers, offered according to the following terms:

i. A technical assistance center must be available by telephone at routine business hours from 8:00AM-4:30PM, Monday through Friday, with a maximum call back response time of 4 hours.

ii. Equipment repair service that cannot be completed through telephone assistance will require on-site repair by qualified personnel supplied by the Contractor. Request for emergency repair will be accepted during routine business hours from 8:00AM- to 4:30PM, Monday through Friday.

iii. On-site repairs will be conducted during routine business hours. Business hours are listed as Monday through Friday, 8:00AM-4:30PM. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements will be coordinated between the Contractor and VA laboratory personnel.

iv. Response to telephone requests for emergency on-site repair service will be within one business day following request.

v. A malfunction incident report will be furnished to the installed site upon completion of each repair call. The report shall include, as a minimum, the following:

control verifying acceptable performance.

vi. If the repair record of any individual piece of Contractor’s equipment reflects a downtime of 10% or greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement.

vii. Each notification for an emergency repair service call will be treated as a separate and new service call.

viii. Preventative maintenance will be performed as frequently as published in the manufacturer’s operators’ manual and within 2 weeks of the scheduled due date.

10. Upgrades – The Contractor shall provide upgrades to both the equipment hardware and software to maintain the integrity of the system and the state-of –the art technology at no additional charge to the Government. These must be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer vendor supported, etc. This does not refer to replacing the original piece of equipment; however, it does refer to significant changes in the hardware operational capability.

11. Ancillary Support Equipment – The Contractor shall provide all ancillary support equipment to fully operate the Capillary and Gel Electrophoresis analyzer(s) as defined in these specifications, e.g. installation of universal interface equipment and cabinetry to support/house the analyzer (if necessary). In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

12. Interface Requirements

i. The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system.

ii. The Contractor shall provide all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself.

iii. The Contractor is responsible for everything leading up to the middleware including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

iv. The vendor hardware and software proposed solution meets all VA Information Security, Hardware, Software and Network requirements (VA 6500). Any wireless equipment must be FIPS 140-2 compliant as well.

v. The Contractor supplies responses to required documents in order to add systems to the VA network including but not limited to the VA Form 6550, Access Control List (ACL) Communication Protocol, MSD2, and the Enterprise Risk Assessment.

vi. If there are software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA Laboratory Interface Middleware.

vii. If the Contractor shall provide remote support, the contractor has established a VA national MOU/ISA between Contractor and VA. If the Contractor currently has a valid MOU/ISA, the Contractor shall include a copy of the MOU/ISA as part of their quote with the file named “VA MOU/ISA”. The Contractor shall provide all hardware and software to implement the remote support system.

viii. Technology must interface to VA licensed Data Innovations Instrument Manager sending all appropriate information to complete auto-verification rules processing within the VA licensed IM. Preferred, but not required, that no additional middleware be necessary to connect instruments beyond the VA licensed DI IM.

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

x. When requested, the contractor shall help sites implement an auto-verification script in VistA from the VA licensed DI IM middleware rules package.

13. Commercial Offerings – The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and will assist in regulatory compliance, e.g. Computer Disc of their procedure manual in CLSI format or an on-line procedure manual in the instrument software.

14. Implementation Timeframe – The implementation of services/requirements described in this solicitation will be completed no later than 120 days after the award of the contract. This timeline is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe. Contractors will not be penalized for implementation timelines that extend beyond the 120-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

i. The transition period for the awarded contract to have all new equipment and peripherals installed and operational at each participating facility shall be from date of award through 120 days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed.

ii. Offerors shall provide with its quotation a plan for transitioning services from the incumbent Contractor to the newly awarded Contractor. Contractor’s submitted transition plan shall not exceed 120 days for the transition of all services including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to confirm to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract.

iii. At the end of 120 days from award of the contract, the awarded Contractor shall have full and sole responsibility for services.

15. Characterization of Hazardous Waste – Contractor shall provide a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations and address the criteria listed in the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et al. The description shall address the following:

i. Waste toxicity (Reference 40CFR261.11 and 40CFR261.24)

ii. Waste ignitability (Reference 40CFR261.21)

iii. Waste corrosivity (Reference 40CFR261.22)

iv. Waste reactivity (Reference 40CFR261.23)

E. PRE-WORK ORIENTATION

1. Contractor will attend a pre-work orientation meeting prior to the commencement of work on site.

2. The Contractor will be responsible to ensure that Contractor employees coming to the work site will receive the information required above.

3. The Contractor will be responsible to ensure Contractor employees providing work on this contract are fully trained and completely competent to perform the required work.

4. The Contractor shall set up and attend at minimum weekly IT/LIS calls with each site’s respective Laboratory Information Managers (LIMs) and/or supervisors/lead technologists until successful interface connectivity and testing has been achieved.

F. VISN 12 ELIGIBLE FACILITIES

Hines, IL 60141

Milwaukee, WI 53295

Instructions to Offerors

G. PROPOSALS

1. It is the clear intent of the Government to award this contract to a single vendor for the entire VISN 12 electrophoresis and immunofixation business.

2. The Government will entertain recommendations only for new state-of-the-art equipment. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, ‘current production’ shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

3. Contractors shall submit their base proposals outlining the proposed equipment. This equipment configuration should be based on the Contractor’s best recommendation for equipment that meets the operational activities and required efficiencies and productivity of the laboratories of the size and scope defined herein.

i. In addition, Contractors are encouraged to offer alternate equipment configurations (optional proposals/packages) that minimally meet the specifications of this solicitation, yet may enhance the operational activities, efficiencies, and the productivity of the laboratory.

4. Contractors shall submit their pricing proposals using a Cost per Test (CPT) format. The cost per test shall include:

i. 5-year equipment use,

ii. 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. This cost per test price will also encompass all costs associated with dilution as well as repeat and confirmatory testing required producing a single patient reportable result. It will 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),

iii. All necessary maintenance to keep the equipment in good operating condition (element includes both preventive maintenance and emergency repairs), and

iv. Training for Government personnel. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge.

5. The Government will make the contract award considering only the basic proposals offered by the Contractor and their compliance with the evaluation factors of this solicitation. Optional proposals/packages will be considered once the award is completed.

6. Contractors shall provide commercial literature and other information describing their compliance with the technical specifications, at least three VA references, and certification of commercially available vendor computer interface to the VA VistA computer system, as well as an equipment implementation schedule. If the commercial literature does not directly address specific specifications identified in this solicitation, the vendor is required to indicate compliance with those specifications in written format.

7. References will include, if possible, references from other VA medical facilities as well as non-VA facilities. Information should include the following: name of customer; contact person; phone number; brief description of equipment and service provided; beginning and ending dates when service and equipment was provided.

8. Contractors shall provide documentation that the instrumentation offered will perform analyses with a precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical Laboratory Standards Institute (CLSI).

9. Contractors shall provide a description of all ancillary support equipment that is needed to operate the Capillary and Gel Electrophoresis analyzer(s) as defined in the specifications and offered as a part of this agreement.

10. Contractors shall provide a summary of operator-performed and vendor-performed maintenance procedures including an estimate of time spent in the performance for each category of maintenance.

i. Operator-performed – Contractors shall summarize their maintenance procedures and provide an estimate of time spent in performance for each category, e.g. daily, weekly, monthly, semi-annually, etc. The estimate of time spent on daily maintenance would take into consideration starting the equipment from a cold start-up.

ii. Contractor-performed - Contractors shall describe the frequency of preventive maintenance and provide an estimate of the time required to perform the maintenance.

11. Contractors shall provide delivery, installation, and removal of equipment at no additional charge.

12. Contractor shall describe the process used to transfer historical data to the new equipment and any verification that will be performed to ensure the accuracy of the data transfer.

H. EVALUATIONS OF OFFERS

1. Minimum Requirements. Each respondent for award shall meet all the minimum specifications as outlined in the Statement of Work.

2. The VA will award to the firm whose quotation is most advantageous to the VA considering price and the factors listed below.

i. Required Information. For the VA to evaluate firms on these factors, firms must provide the technical information described in the Statement of Work section that is entitled Operational Features, in addition to their pricing information. Not providing this information may prevent full consideration of the quotation.

ii. Technical Specifications. Contractor’s equipment will be evaluated to determine whether it meets all the basic technical specifications. All such requirements must be met for the Contractor’s equipment to be considered acceptable. In addition, an analysis of the feature limitations and enhancements of the equipment and associated products will be considered. Specific evaluation criteria will include the following:

1. Instrumentation: number and type of instrumentation proposed, throughput, footprint, and integration.

2. Reportable parameters: the breadth of menu and approved specimen types.

3. Efficiency of operation: maintenance requirements, service, data management, inventory management, and level of customization.

4. Implementation plan: timeline, training, and method validation.

iii. The degree to which the equipment has the following Desired but not Required features:

1. ability to have on-line operator’s manual.

2. ability to have dial-in access for the technical service personnel.

3. ability to send quality control results to the QAP program through the Internet.

4. ability to have on-line maintenance logs, reagent logs, etc.

iv. The degree to which the level of instrumentation being offered is sufficient to perform the workload of VISN12.

v. The degree to which all ancillary support equipment needed to operate the Capillary and Gel Electrophoresis analyzer(s) will be provided by the vendor.

vi. The level of technical and service support will be evaluated. As stated above, this includes technical support with the following:

1. The initial on-site installation process

2. Performance and evaluation of the validation/verification studies

3. Interface connectivity, including weekly calls with the Laboratory Information Managers

4. Initial and continued training of Government personnel

5. Preventative Maintenance

vii. Price. The cost of the acquisition cannot exceed that charged to others for similar services. The prices for Optional Capabilities will be evaluated and these capabilities included in the contract award to the degree that the VA judges these capabilities to be worth the additional cost.

viii. Past Performance. Contractors must submit three VA references. To make an informed decision, the Government retains the right to seek out additional references.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

QUANTITY

0.00

Serum Protein Electrophoresis Contract Period: Option 1 POP Begin:

POP End:

MANUFACTURER PART NUMBER (MPN): TBD

1000AA

Serum Protein Electrophoresis - Hines

POP Begin:

1000AB

Serum Protein Electrophoresis - Milwaukee

POP Begin:

Urine Protein Electrophoresis

POP Begin:

1001AA

Urine Protein Electrophoresis - Hines

POP Begin:

1001AB

Urine Protein Electrophoresis - Milwaukee

POP Begin:

Immunofixation Electrophoresis (IFE)

POP Begin:

1002AA

Immunofixation Electrophoresis (IFE) - Hines

POP Begin:

1002AB

Immunofixation Electrophoresis (IFE) - Milwaukee

POP Begin:

Alkaline Phosphatase Isoenzymes - Hines

POP Begin:

High Resolution Electrophoresis (CSF) - Hines

POP Begin:

0.00

Immunotyping (Immunodisplacement)

POP Begin:

1005AA

Immunotyping (Immunodisplacement) - Hines

POP Begin:

1005AB

Immunotyping (Immunodisplacement) - Milwaukee

POP Begin:

MISC Reagents and Consumables Please provide a list of items, with part numbers and prices if applicable Contract Period: Option 1 POP Begin:

0.00

Serum Protein Electrophoresis

POP Begin:

2000AA

Serum Protein Electrophoresis - Hines

POP Begin:

2000AB

Serum Protein Electrophoresis - Milwaukee

POP Begin:

Urine Protein Electrophoresis

POP Begin:

2001AA

Urine Protein Electrophoresis - Hines

POP Begin:

2001AB

Urine Protein Electrophoresis - Milwaukee

POP Begin:

Immunofixation Electrophoresis (IFE)

POP Begin:

2002AA

Immunofixation Electrophoresis (IFE) - Hines

POP Begin:

2002AB

Immunofixation Electrophoresis (IFE) - Milwaukee

POP Begin:

Alkaline Phosphatase Isoenzymes - Hines

POP Begin:

High Resolution Electrophoresis (CSF) - Hines

POP Begin:

0.00

Immunotyping (Immunodisplacement)

POP Begin:

2005AA

Immunotyping (Immunodisplacement) - Hines

POP Begin:

2005AB

Immunotyping (Immunodisplacement) - Milwaukee

POP Begin:

MISC Reagents and Consumables

Contract Period: Option 1 POP Begin:

0.00

Serum Protein Electrophoresis

POP Begin:

3000AA

Serum Protein Electrophoresis - Hines

POP Begin:

3000AB

Serum Protein Electrophoresis - Milwaukee

POP Begin:

Urine Protein Electrophoresis

POP Begin:

3001AA

Urine Protein Electrophoresis - Hines

POP Begin:

3001AB

Urine Protein Electrophoresis - Milwaukee

POP Begin:

Immunofixation Electrophoresis (IFE)

POP Begin:

3002AA

Immunofixation Electrophoresis (IFE) - Hines

POP Begin:

3002AB

Immunofixation Electrophoresis (IFE) - Milwaukee

POP Begin:

Alkaline Phosphatase Isoenzymes - Hines

POP Begin:

High Resolution Electrophoresis (CSF) - Hines

POP Begin:

0.00

Immunotyping (Immunodisplacement)

POP Begin:

3005AA

Immunotyping (Immunodisplacement) - Hines

POP Begin:

3005AB

Immunotyping (Immunodisplacement) - Milwaukee

POP Begin:

MISC Reagents and Consumables

Contract Period: Option 1 POP Begin:

0.00

Serum Protein Electrophoresis

POP Begin:

4000AA

Serum Protein Electrophoresis - Hines

POP Begin:

4000AB

Serum Protein Electrophoresis - Milwaukee

POP Begin:

Urine Protein Electrophoresis

POP Begin:

4001AA

Urine Protein Electrophoresis - Hines

POP Begin:

4001AB

Urine Protein Electrophoresis - Milwaukee

POP Begin:

Immunofixation Electrophoresis (IFE)

POP Begin:

4002AA

Immunofixation Electrophoresis (IFE) - Hines

POP Begin:

4002AB

Immunofixation Electrophoresis (IFE) - Milwaukee

POP Begin:

Alkaline Phosphatase Isoenzymes - Hines

POP Begin:

High Resolution Electrophoresis (CSF) - Hines

POP Begin:

0.00

Immunotyping (Immunodisplacement)

POP Begin:

4005AA

Immunotyping (Immunodisplacement) - Hines

POP Begin:

4005AB

Immunotyping (Immunodisplacement) - Milwaukee

POP Begin:

MISC Reagents and Consumables

Contract Period: Option 1 POP Begin:

0.00

Serum Protein Electrophoresis

POP Begin:

5000AA

Serum Protein Electrophoresis - Hines

POP Begin:

5000AB

Serum Protein Electrophoresis - Milwaukee

POP Begin:

Urine Protein Electrophoresis

POP Begin:

5001AA

Urine Protein Electrophoresis - Hines

POP Begin:

5001AB

Urine Protein Electrophoresis - Milwaukee

POP Begin:

Immunofixation Electrophoresis (IFE)

POP Begin:

5002AA

Immunofixation Electrophoresis (IFE) - Hines

POP Begin:

5002AB

Immunofixation Electrophoresis (IFE) - Milwaukee

POP Begin:

Alkaline Phosphatase Isoenzymes - Hines

POP Begin:

High Resolution Electrophoresis (CSF) - Hines

POP Begin:

0.00

Immunotyping (Immunodisplacement)

POP Begin:

5005AA

Immunotyping (Immunodisplacement) - Hines

POP Begin:

5005AB

Immunotyping (Immunodisplacement) - Milwaukee

POP Begin:

MISC Reagents and Consumables

Contract Period: Option 1 POP Begin:

SECTION C - CONTRACT CLAUSES

C.1 52.216-18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from TBD through TBD.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor’s fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor’s email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of Clause)

C.2 52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after TBD.

(End of Clause)

C.3 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

The Government may increase the quantity of supplies called for in the Schedule at the unit…