36C24425Q0165.docx

36C24425Q0165

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

36C24425Q0165 12-18-2024 Debra Willard 302-994-2511 x36035 01-15-2024

10:00 AM

EST

00244 Department of Veterans Affairs Network Contracting Office 4 WVAMC Wilmington VA Medical Center 1601 Kirkwood Highway Wilmington DE 19805 X 325413 1250 Employees N/A X

PER SOW

00244 Department of Veterans Affairs Network Contracting Office 4

Austin Payment Center

PO Box 149971 Austin TX 78714-9971

(877) 353-9791

(512) 460-5429 See CONTINUATION Page RFQ for A1c Hemoglobin VISN 4 Wide.

Email only to debra.willard@va.gov RFQ must be submitted by January 15, 2025, 10:00 AM EST.

See CONTINUATION Page X X Debra Willard Contracting Officer Table of Contents

See attached document: VISN 4 HbA1c SOW Attachments.

See attached document: VISN 4 Estimated HbA1C Volumes.

See attached document: SCLA Delaware.

See attached document: SCLA Lebanon.

See attached document: SCLA Erie.

See attached document: SCLA Wilkes Barre.

See attached document: SCLA Allegany.

See attached document: SCLA Philadelphia.

See attached document: SCLA Chester.

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C244 Debra Willard

Network Contracting Office 4 WVAMC Wilmington VA Medical Center 1601 Kirkwood Highway Wilmington DE 19805

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

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

Page 1 of Page 1 of

B.2 STATEMENT OF WORK

Intent:

It is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 4) to establish an Indefinite Delivery Indefinite Quantity (IDIQ) for Automated Glycohemoglobin Instrumentation. The government will award the IDIQ to a single Contractor for Automated Glycohemoglobin Instrumentation. Contractor agrees to the following terms of the IDIQ exclusively with the VISN 4 facilities listed by Attachment/herein and awarded in the final IDIQ. However, as requirements change, facilities within VISN 4 may be added or deleted by supplemental agreement of the Government or Contractor. Additional tests/reagents/instrumentation may be added to the IDIQ as new technology becomes available on the market and added to the base resulting contract.

Prices and Terms:

VISN 4 will provide an estimated volume by test as reflected in Attachment A for each individual medical center and outpatient clinic laboratory. Pricing is based in the AVERAGE daily test volume per instrument/analyzer for each facility. The Government estimates the volumes per facility as listed in Attachment A but does not guarantee volumes as listed; they are estimates only.

Period of Performance:

VISN 4 intends to establish the base year with four (4) option years. Period of Performance of April 1, 2025, through March 31, 2030.

Ordering Method:

The participating facilities may order products via Electronic Data Exchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

Description/Specifications/Statement of Work

Scope of Procurement:

1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability (if discrete testing is required) and 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).

2. Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory.

3. If the Contractor offers a family of analyzers, VISN 4 technical panel will determine if instrumentation proposed meets the needs of the using facility.

4. Equipment shall be acquired for each of the clinical laboratories at the VISN 4 facilities listed in Attachment B and Attachment C.

5. 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 reagents, 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.

6. Special handling for emergency orders of supplies: In the event the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

Definitions:

1. Cost per Patient Reportable Result (CPRR) – as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Reportable Clinical Laboratory Analyzers- 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. This per patient reportable result price shall also encompass all costs associated with dilution, repeat and confirmatory testing required producing 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 CLSI. (3) All necessary maintenance to keep the equipment in good operating condition. This element includes both preventive maintenance and emergency repairs, (4) and training for Government personnel. Contractors shall provide delivery, installation, and removal of equipment at no additional charge.

2. 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.

3. 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 receives, uses, or discloses 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.

General Requirements:

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 the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer shall be equivalent to a back‐up analyzer (see definition below) and shall replace the requirement for offering that category of equipment.

2. Back‐up Analyzer(s) (Applies only if selected) ‐ Equipment required in support of operations for the VA VISN 4 laboratories in the event the primary analyzer(s) becomes non‐operational/non‐functional. This category of equipment shall only be operated during periods of time when the primary instrumentation is not available for use. As such, the requirements for consumable supplies, i.e. reagents, quality control material, calibrators, etc., shall be minimal and corollary to the successful operation of the primary instrumentation. Specific tests that require back‐up performance are listed in Attachment A.

3. Parameter definitions

a. The system must be certified by the National Glycohemoglobin Standardization Program.

b. Coefficient of Variation (CV) must be less than 2.5%.

4. Operational features - The instrument shall have the following:

a. The capability of performing analysis on 100% of the tests listed in Attachment A.

b. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment B.

c. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

d. A bi-directional, barcoded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

1) The accuracy of the barcode reading must have less than a 1% failure rate.

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

3) Equipment must accept, at a minimum, BCBC characters in the specimen identifier that is alpha and/or numeric depending on site.

e. Ability to prioritize STAT testing without compromising existing programmed testing.

f. Minimal daily, weekly, monthly, and periodic maintenance.

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

h. On-board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least 3 months for reagents.

i. No requirements for sample pre-treatment.

j. A specimen handling/loading system:

1) Primary specimen container(s) loaded into a storage area, i.e. tray, wheel, etc. for automated processing.

2) Diluting and injecting of the specimen is handled with minimal operator intervention.

3) Ability to accept various sample containers.

k. Minimal reagent preparation.

l. Capability to store at least 5000 patient results in database for immediate recall.

5. Technical Features – The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following:

a. Ability to monitor instrument performance.

b. On-board reagent inventory system.

c. Minimal carryover.

d. Long calibration stability.

e. Internal ability to assess column and detector functionality over time. A method determination of column and detector integrity must be provided.

f. Complete separation of the labile and stabile hemoglobin A1C.

g. Methodology that provides minimal interference from common hemoglobin (Hb) variants.

6. Hardware Features – The instrumentation shall have the following:

a. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

b. An on-board monitor/screen that is easily readable.

c. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the accession or unique identifier number (UID).

d. An uninterruptible power supply with line conditioner for each instrument provided.

e. Primary tube sampling.

7. Specific Equipment Requirements – The instrumentation shall have the following:

a. Controls for primary use (assayed) will be provided at a minimum of two levels; normal and elevated/abnormal levels.

b. Third party manufacturer preferred for primary (assayed) controls.

c. Linearity materials which are required every 6 months for all analytes due to a CAP requirement for maintaining assays and CLSI method validations to be provided by the Contractor.

d. Capability to detect out of range quality control.

e. On-board QC data management system with a minimum storage capacity of 4 QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store, and electronically transfer QC data. Must have the ability to participate in a VISN 4 QC peer comparison program at no additional charge.

f. Equipment installation and possible reinstallation should the equipment need to be moved due to construction or laboratory redesign at no additional cost for one (1) location within each site.

g. Ability to continuously load specimens.

h. Utilize HPLC methodology.

i. Primary and backup analyzers (for larger facilities) shall be from the same manufacturer and offer the same technology.

j. Printer accommodates both single patient result (for STATS) or batch print options.

k. All reagents, controls, and calibrators will be of the same lot number for all users. Lot numbers will be in use at least six (6) months. All sites covered under this IDIQ will convert to the new yearly lot number within 2 months of each other.

8. Method Performance/Validation – The instrumentation shall have the following:

a. Method performance/comparison will be at the expense of the Contractor and will include linearity materials and reagents as required and based on manufacturer’s specifications and be consistent with Clinical Laboratory Standards Institute (CLSI) guidelines and related documents, College of American Pathologists (CAP) standard, and Federal regulations.

b. Correlations will be performed for each analyte using a minimum of 20 samples that span the reportable range, shall be run by the current method and proposed method. The systems where multiple sampling modes exist, mode to mode correlation studies must also be performed.

c. The Contractor will analyze results and provide statistical data to support acceptance of the new method. Statistics include at least the mean, bias, slope, y-intercept, correlation coefficient and meet current standards defined by CLSI.

d. Analytical Measurement Range (AMR) validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. The material must have values which are the low, mid, and high values of the 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 that be performed as a minimum.

e. Precision study using abnormal material will be performed and 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 for a total of 20 values per level. Can be run twice per day if necessary. Intra-VISN 4 facility variations should be kept at an absolute minimum.

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

g. Specificity studies will be done by review of product literature and assay inserts to determine adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances.

h. Carryover Studies are required to ensure instrument properly flushes probes between specimens. Successful carryover studies shall be completed on all analyzers during installation. These studies shall be performed using either Contractor developed program(s) or program(s) developed by a third party (CAP/CLSI, formerly NCCLS). The program(s) shall be provided to each laboratory at no cost.

9. 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 lab. One of the following protocols shall be used:

a. A verification of the manufacturer’s suggested reference range may be performed when 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 statistically valid verification.

b. 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.

c. If a laboratory is currently using the proposed instrument/reagent system, the “in-use” reference range can be transferred to the “new” system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed.

10. Reports – The Contractor shall provide to the Contracting Officer (CO) and other individuals (designated post award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter’s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge shall not be accepted. There will be no additional charges for any reports required as part of the IDIQ. Attachment D may be used as a template to provide these quarterly reports.

11. Support Features

a. Commercial marketing – The equipment models being offered shall be 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.

b. Start-Up Reagent – 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 resulting contract and required to establish instruments for operation for performance of acceptable testing. The Contractor shall perform, to the satisfaction of the Government, 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 at no cost to the Government. The Contractor shall perform all the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format.

c. Training. The Contractor shall provide an instrument training program 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 defined in the resulting contract. This shall 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 at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room, and board for each participant.

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

1) The Contractor will provide access to a technical assistance center that is available 24 hours per day, 7 days per week with a maximum call back response of two hours.

2) Equipment repair service call shall be provided during routine business hours which are typically 8a.m. to 430 p.m. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. The Contractor is required to maintain analyzers in working order (able to perform patient testing). The Contractor must be prepared to provide services outside of normal routine hours.

3) Equipment repair response time shall be no more than 3 hours.

4) Preventive maintenance will be performed according to published manufacturer operator’s manual and within two weeks of the scheduled date.

5) Reports of service shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

a) Date and time notified,

b) Date and time of arrival,

c) Serial number, type, and model number of analyzer,

d) Time spent for repair and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

e) Each notification of an emergency repair service call is treated as a new separate service call if both the primary and back-up analyzers are not functioning properly. Contractor is required to provide emergency service after core business hours and on weekends.

e. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of-the-art technology at no additional charge to the Government. These shall 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 Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the IDIQ; however, it does refer to significant changes in the hardware operational capability.

f. Ancillary support equipment - The Contractor shall provide, install, and maintain through the life of the IDIQ, as indicated, all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. 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.

g. Interface requirements –

1) Contractor will provide 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 analyzer is added to the existing universal interface system.

2) Contractor will provide any, and all necessary software support for insuring successful interfacing is established. Specific requirements for the communication of the data stream will be unique to the analyzers’ system involved and dictated by the manufacturer itself. The Contractor will supply the information necessary to make the determination for type and amount of interfacing analyzers to be supplied.

3) When the Government site has a universal box, the Contractor will be responsible for everything leading up to the box including any incremental fees required to add additional analyzers (i.e. licenses, port/cards, cable, software, etc.) to the universal interfacing system.

4) When the Government site does not have a universal interface, and one is needed to optimally interface the analyzer, the Contractor will be responsible for the acquisition of the universal interface box and everything else needed to connect to the VA computerized hospital information system.

5) If there are any software upgrades in the instrument during its life, the Contractor is responsible for ensuring the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

6) Interface capability for back-up analyzer.

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

i. Characterization of Waste – The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste, as described in the Code of Federal Regulations Title 40, to make a determination if the waste is a hazardous waste or otherwise regulated.

1) The determination and description shall address the following:

a) Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

b) Waste ignitability (Reference 40 CFR §261.21)

c) Waste corrosivity (Reference 40 CFR §261.22)

d) Waste reactivity (Reference 40 CFR §261.23)

e) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31)

f) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33)

g) Solid Waste (Reference 40 CFR §261.2)

h) Exclusions (Reference 40 CFR §261.4)

2) The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

3) Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with Contractor response:

a) Barium (Total)

b) Cadmium (Total)

c) Chromium (Total)

d) Copper (Total)

e) Cyanide (Total)

f) Lead (Total)

g) Mercury (Total)

h) Nickel (Total)

i) Silver (Total)

j) Zinc (Total)

k) Arsenic (Total)

l) Selenium (Total)

m) Tin (Total)

n) pH

o) Flash point (to higher than 200F)

p) BOD; biochemical oxygen demand

4) The documentation the Contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system.

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

1) Upon award of an IDIQ, the transition period for the awarded IDIQ to have all equipment and peripherals installed and operational 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 award shall also be completed.

2) Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 120 days for the transition of all services under the awarded IDIQ 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 conform to the transition period shall be considered as sufficient cause to terminate IDIQ for cause under the Termination for Cause clause of the IDIQ.

3) At the end of 120 days from award of the IDIQ, the awarded Contractor shall have full and sole responsibility for services under the awarded IDIQ.

k. Standard and Quality of Performance - This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or IDIQ] is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any IDIQ at an effectiveness level of 90% or more.

1) In the event the equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

2) If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled “Termination for cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

3) 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 a 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.

4) During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when more than the minimum of 100 hours.

5) The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

6) During the term of the IDIQ, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR 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 for equipment.

l. Government’s Responsibility- The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

m. Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

n. The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

o. Prior to termination or completion of this IDIQ, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this IDIQ without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the IDIQ.

p. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the IDIQ or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the IDIQ or disposal or return of the IT equipment, whichever is earlier.

q. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are:

1) Contractor must accept the system without the drive;

2) VA’s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or

3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

r. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

1) The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

2) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or IDIQ.

3) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.

End of Document

B.3 PRICE SCHEDULE

ITEM INFORMATION

VISN 4 BPA for Hemoglobine A1C testing, equipment, and service.

Contract Period: Base POP Begin: 03-31-2025 POP End: 03-30-2026 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: Q508 - Medical - Hematology and Oncology LOCAL STOCK NUMBER: Service

VISN 4 BPA for Hemoglobine A1C testing, equipment, and service.

Contract Period: Option 1 POP Begin: 03-31-2026 POP End: 03-30-2027 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

VISN 4 BPA for Hemoglobine A1C testing, equipment, and service.

Contract Period: Option 2 POP Begin: 03-31-2027 POP End: 03-30-2028 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

VISN 4 BPA for Hemoglobine A1C testing, equipment, and service.

Contract Period: Option 3 POP Begin: 03-31-2028 POP End: 03-30-2029 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

VISN 4 BPA for Hemoglobine A1C testing, equipment, and service.

Contract Period: Option 4 POP Begin: 03-31-2029 POP End: 03-30-2030 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line-item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the…