36C24120Q0386.docx

36C24120Q0386

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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.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C24120Q0386 06-12-2020 Julie Lemire 603-629-3293 06-29-2020 09:00 Department of Veterans Affairs VAMC Manchester 718 Smyth Road Manchester NH 03104 X 325413 1250 Employees N/A X Department of Veterans Affairs VISN1 Consolidated Laboratory Labs See Delivery Schedule for Locations

Department of Veterans Affairs VAMC Manchester 718 Smyth Road Manchester NH 03104

Department of Veterans Affairs Financial Services Center per VAAR 852.232-72 Electronic Submission of Payment Request http://www.fsc.va.gov/einvoice.asp See CONTINUATION Page This solicitation is a RFQ for the VISN1 Automated Lab Blood Culture Testing CPT. The government intends to award a Firm Fixed Price BPA. The Contractor shall provide all necessary personnel, supervision, labor, equipment, materials and dis-posal necessary to provide this to the VISN1 Lab pursuant to the Statement of Work described herein.

Quoters should carefully follow instructions included in 52.212-1 and for evaluation criteria specified in Section E.

Pricing should be identified in B.1 Price/Cost Schedule attached to the RFQ.

All quotes shall be emailed only to Julie.Lemire@va.gov Any quote that is not compliant with RFQ requirements will not be considered.

Any RFI’s must be submitted NO Later than Friday, June 19,2020 At 12:00pm EST. Questions will not be accepted after 6/19/20.

See CONTINUATION Page x X x Julie Lemire Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

36C24120Q0386 Intentionally Blank / No Text Page 1 of Page 1 of

STATEMENT OF WORK

Clinical Laboratory Microbiological Blood Culture System

1.1. INTENT: Pursuant to Federal Supply Schedule (FSS) and FSS Contract Clause I-FSS-646, it is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 1 ) to establish a Cost-Per-Test (CPT) Blanket Purchase Agreement (BPA) for Automated Microbiological Blood Culture Systems. The Government will award this CPT BPA to a single Contractor for Automated Microbiological Blood Culture Systems. The BPA shall be under the FSS Contract, Federal Supply Class (FSC) Group 66 III Cost Per Test (CPT), Clinical Laboratory Analyzers. Contractor agrees to the following terms of the BPA exclusively with the VISN facilities listed by Attachment/herein and awarded in the final BPA. However, as requirements change, facilities within VISN 1 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the BPA as new technology becomes available on the market and added to the base FSS contract.

1.2. ORDERS: All products ordered under this BPA, placed against the Federal Supply Schedule Award Contract(s), are subject to the terms and conditions of the FSS contract. This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by authorized individuals.

1.3. PRICES AND TERMS: VISN 1 will provide an estimated volume by test as reflected in Attachment A for each individual medical center and outpatient clinic laboratory. Firm Fixed Pricing (FFP) shall be based on the AVERAGE daily test volume per instrument/analyzer for each facility. Pricing shall be based on the CPT (i.e., per blood culture bottle). The Government estimates the volumes per facility as listed in Attachment A but does not guarantee volumes as listed; they are estimates ONLY.

1.4. TERM OF AGREEMENT: This will be a single award, firm-fixed price BPA for 5-Years and shall be effective for the term of the BPA including any additional extensions. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time the BPA upon which this BPA is based, is no longer in force. In addition, where a BPA replaces Contractor’s current BPA, the resulting BPA may be reassigned under the new BPA for the remaining term of the BPA with written agreement between Contractor and the CO. This BPA is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This BPA shall be reviewed annually. VISN intends to establish the base year of the agreement for the period of 8/1/2020 through 7/31/2021.

1.5. IDENTIFICATION: Delivery Orders issued shall be identified by their applicable FSS Contract Number and BPA Number. FSS & BPA identification numbers are assigned through the VHA Procurement Activity.

1.6. ORDERING METHOD: The participating facilities may order products via Electronic Data Interchange (EDI), telephone, or facsimile, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

SCOPE OF PROCUREMENT:

1.6.1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall be able to simultaneously perform the complete profile as described below 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).

1.6.2. Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory. (i.e. size of instruments for footprint, and number of workstations)

1.6.3. If Contractor offers a family of analyzers, VISN 1 technical evaluation panel will determine if instrumentation proposed meets needs of using facility. (vendor needs to propose instrument mix, with quantity of tests that can be accomplished to fulfill needs)

1.6.4. Equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed in Attachment A.

1.6.5. 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 reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

1.6.6. Special handling for emergency orders of supplies: In the event that 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.

1.7. DEFINITIONS:

1.7.1. 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 (a) 5 year equipment use, (b) 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, (c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (d) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

1.7.2. 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 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.

1.8. TEST MENU: Refer to Attachment A for desired test menu and estimated annual volumes.

1.9. GENERAL REQUIREMENTS:

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

1.9.2. Operational Features- The instrumentation offered shall have the following:

1.9.2.1. The system shall provide self-contained, continuous, computerized, automated monitoring of blood culture bottles with immediate, active (e.g. audible alarm) notification of microorganism growth based upon preprogrammed criteria and notification of termination of maximum programmed incubation period when no microorganism growth is detected.

1.9.2.2. The system shall allow for operator extension of programmed incubation times, while testing is in progress, without interruption of automatic continuous monitoring.

1.9.2.3. The system shall accept manual entry of organism identification and other additional microbiological information (i.e. gram stain and organism identification).

1.9.2.4. A varied selection of blood culture bottle configurations (low volume samples; antimicrobial agent removal resins) and formulations capable of maximizing growth potential of various microorganisms (e.g. aerobic and anaerobic bacteria, fungi, and mycobacteria) shall be available.

1.9.2.5. Sufficient capacity and throughput to meet the volume, blood culture bottle variety, and service demands as defined in Attachment A.

1.9.2.6. 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.

1.9.2.7. A bi-directional, bar-coded 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.

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

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

1.9.2.7.3. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric

1.9.2.8. An operational system that is automated and provides continuous unattended testing throughout the day for a minimum of five days.

1.9.2.9. The system will be capable of processing inoculated bottles that have been incubated off -line for up to 12 hours.

1.9.2.10. Minimal daily and periodic maintenance.

1.9.2.11. The reading chambers must be modular in nature allowing for the isolation of a given problem without having to shut the entire system down

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

1.9.3.1. Bar-Code System:

1.9.3.1.1. The system shall support bar-code recognition of inoculated bottles for tracking of bottles at entry into the system and throughout incubation until such time as the incubation has finalized as positive or negative for growth.

1.9.3.2. Data Management System:

1.9.3.2.1. The capability to record, store and print the following information:

1.9.3.2.2. blood culture bottle location

1.9.3.2.3. length of incubation

1.9.3.2.4. time to detection

1.9.3.2.5. growth curve analysis of positive vials

1.9.3.2.6. required quality control and instrument maintenance information

1.9.3.2.7. patient demographic information and specimen results

1.9.3.2.8. the fill volume of the blood culture bottle

1.9.3.2.9. detailed epidemiology reports

1.9.3.3. Shall be capable of maintaining all data and if interfaced, retransmit data for up to 24 hours in the event of normal electrical power interruptions via battery backup.

1.9.3.4. Shall have a built-in quality control program to regularly monitor performance of vital components.

1.9.3.5. Shall possess capability to backup all data to a secondary external storage format (e.g. compact disk).

1.9.3.6. Shall have sufficient memory to store patient information and test results for a 3-month period with downloading capability to an external medium for long term storage of patient records and other information.

1.9.3.7. Blood Culture Bottles:

1.9.3.7.1. Shall be easily distinguished (e.g. color coded) for utility or intended purpose.

1.9.3.7.2. Shall be bar-coded with unique identifiers for loading and system monitoring.

1.9.3.7.3. Shall be formulated as not to require venting prior to incubation of aerobic bottles.

1.9.3.7.4. Shall have expiration date clearly marked. The minimum acceptable expiration date will be no less than 6 months.

1.9.4. Hardware Features- The instrumentation shall have the following:

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

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

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

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

Specific Equipment Requirements- Transparent Plastic Bottles are required for safety (glass bottle could break if dropped) and disposal cost savings (glass bottles weigh more).

Shall have direct draw compatibility with vacutainer blood collection systems so as not to need any special adaptors for direct blood draw into the collection bottles.

Shall be formulated as not to require venting prior to incubation of anaerobic bottles.

Shall have ample availability/supply of FDA approved media bottles so as to ensure no shortages during life of contract Availability of AFB bottle media is desirable Blood media in bottles do not interfere or hamper gram staining when taken from bottles as needed.

Minimum 6-month expiration date on bottles.

Additional small unit required dedicated to VACT BSL3 Laboratory for mycobacterial blood cultures.

Ability to measure bottle fill levell Remote diagnostics capability desired A BAA will be required Method Validation Requirements- The Contractor shall assist each site in the performance of all comparison and validation studies to include any materials and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all statistical analysis, as applicable, and report data in an organized, clearly comprehensible format. This process shall be consistent with current CLSI Standards and related documents, CAP standards, and Federal Regulations.

1.9.5. Reports- The Contractor shall provide to the Contracting Officer 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.

1.9.5.1. Reports are to reflect, at a minimum:

1.9.5.1.1. Total, quantities purchases, Original price, discount off original price, 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.

1.9.5.1.2. Associated charges with reagent (i.e. supply wastage, repairs and parts) included at no charge (per BPA) shall not be accepted. There will be no additional charges for any reports required as part of the BPA. Attachment C may be used as a template to provide these quarterly reports.

1.9.6. Support Features-

1.9.6.1. Commercial marketing. 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.

1.9.6.2. Start-Up Reagents. 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 for performance of acceptance testing. The Contractor shall assist the Government with validation and method comparison studies. All materials and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all of the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations.

1.9.6.3. 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 Contractor’s Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers 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.

1.9.6.4. 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:

Service Requirements A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of one (1) hour.

Equipment repair service shall be provided during normal business hours. See Attachment A defining business hours of each facility included in this solicitation. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

Equipment repair response time shall be no more than two (2) hours.

Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date. Schedule will be put in place once BPA is in place.

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

date and time notified date and time of arrival serial number, type and model number of equipment time spent for repair, and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

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

Two Service Manuals will be provided to each site for their Clinical Engineering Department’s information and use.’

The desirable Mean between time failure rate is in excess of 365 days.

1.9.6.5. 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 BPA; however, it does refer to significant changes in the hardware operational capability.

1.9.6.6. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the BPA , as indicated, any and 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.), thermometers 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.

Interface Requirements 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 (See Attachment A).

The Contractor shall provide any and 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. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment A.

If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system.

If there are any 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 computerized hospital information system.

1.9.6.7. 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.

1.9.6.8. 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.

1.9.6.8.1. The determination and description shall address the following:

1.9.6.8.1.1. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

1.9.6.8.1.2. Waste ignitability (Reference 40 CFR §261.21)

1.9.6.8.1.3. Waste corrosivity (Reference 40 CFR §261.22)

1.9.6.8.1.4. Waste reactivity (Reference 40 CFR §261.23)

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

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

1.9.6.8.1.7. Solid Waste (Reference 40 CFR §261.2)

1.9.6.8.1.8. Exclusions (Reference 40 CFR §261.4)

1.9.6.8.2. 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.

1.9.6.8.3. 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 vendor response:

1.9.6.8.3.14. pH

1.9.6.8.3.15. Flash point (to higher than 200F)

1.9.6.8.3.16. BOD; biochemical oxygen demand

1.9.6.8.4. 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

1.9.6.9. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the BPA. 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 90-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

1.9.6.9.1. Upon award of a BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

1.9.6.9.2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 90 days for the transition of all services under the awarded BPA 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 BPA for cause under the Termination for Cause clause of the BPA.

1.9.6.9.3. At the end of 90 days from award of the BPA, the awarded Contractor shall have full and sole responsibility for services under the awarded BPA.

1.9.7. 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 BPA] 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 BPA at an effectiveness level of 90% or more.

1.9.7.1. In the event that 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.

1.9.7.2. 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.)

1.9.7.3. 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 that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

1.9.7.4. 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 in excess of the minimum of 100 hours.

1.9.7.5. 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.

1.9.7.6. During the term of the BPA, 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.

1.9.8. 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.

1.9.9. 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.

1.9.10. 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.

1.9.11. Prior to termination or completion of this BPA, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this BPA 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 BPA.

1.9.12. 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 BPA 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 BPA or disposal or return of the IT equipment, whichever is earlier

1.9.13. 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:

1.9.13.1. Contractor must accept the system without the drive;

1.9.13.2. 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

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

1.9.14. 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;

1.9.14.1. 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

1.9.14.2. 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 BPA.

1.9.14.3. 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.

B.1 PRICE/COST SCHEDULE

ITEM INFORMATION

0.00

VISN1 Lab Automated Blood Culture Testing CPT BPA Year 1/5:

POP: 8/1/2020 - 7/30/2021

0.00

VISN1 Lab Automated Blood Culture Testing CPT BPA Year 2/5:

POP: 8/1/2021 - 7/30/2022

0.00

VISN1 Lab Automated Blood Culture Testing CPT BPA Year 3/5:

POP: 8/1/2022 - 7/30/2023

0.00

VISN1 Lab Automated Blood Culture Testing CPT BPA Year 4/5:

POP: 8/1/2023 - 7/30/2024

0.00

VISN1 Lab Automated Blood Culture Testing CPT BPA Year 5/5:

POP: 8/1/2024 - 7/30/2025

Cost Per Bottle/Set (Price includes: Equipment Rental, Bottle/Set and any applicable costs)

Cost Per Bottle/Set Year 2 Cost Per Bottle/Set Year 3 Cost Per Bottle/Set Year 4 Cost Per Bottle/Set Year 5 Cost Per Bottle/Set

Aerobic Bottle

Anaerobic Bottle

Anti-Microbial Resin Bottle

Pediatric Bottle

Mycobacteria Bottle

B.2 DELIVERY SCHEDULE

* This will be used by the following Labs at the following VISN1 Locations:

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B.3 ADMINISTRATIVE DATA

A Blanket Purchase Agreement (BPA) is hereby established between and the Department of Veterans Affairs under the following terms and conditions incorporated in this BPA:

Primary Point of Contact:

Alternate Point of Contact:

DUNS NUMBER:

Cognizant Office (Include complete address):

Department of Veterans Affairs VAMC Manchester 718 Smyth Road Manchester NH 03104

B.4 INTRODUCTION

In the spirit of the Federal Acquisition Streamlining Act, the Department of Veterans Affairs (DVA) and hereby enter into a cooperative agreement, otherwise referred to as a Blanket Purchase Agreement (BPA), to further reduce the administrative costs of acquiring supplies/services.

The agreement details all with accompanying prices and descriptions, which may be ordered under this BPA.

All orders placed against this BPA are subject to the terms and conditions of all the clauses and provisions in full text or incorporated by reference in this document.

B.5 BPA TERMS AND CONDITIONS

This order is subject to the terms referenced in BPA that will be established with this RFQ.

B.6 TERMS AND CONDITIONS

The Contractor agrees to the following terms of a Blanket Purchase Agreement (BPA) EXCLUSIVELY WITH the Department of Veterans Affairs:

B.7 PERIOD OF PERFORMANCE

This BPA will expire on 07-31-2025 or such later ending date as determined by the exercise of any option.

B.8 PERFORMANCE

The following terms and conditions are applicable:

a. All services will be initiated within 5 calendar days following receipt of a valid order, unless otherwise specified in the order.

b. The BPA holder shall be familiar with Federal Government and Department of Veterans Affairs acquisition regulations, directives and instructions. If a particular document is required in a specific order, it will be cited within the order's PWS.

c. The BPA holder shall not provide technical direction to any other acquisition BPA holder(s) or government personnel at any time. Neither shall the Government directly supervise BPA holder employees. The BPA holder Task Leader should conduct day to day supervision of BPA holder personnel wherever the BPA holder personnel are located. All direction of the BPA holder shall be through the Contracting Officer (CO) of the ordering organization specified in each individual order. Technical "tasking" assignments for the BPA holder will be transmitted by the program office's COR (or program manager) to the BPA holder's Task Leader.

d. The "ordering period" will run from BPA award date of 8/1/2020 to 07/31/2025. The "performance period" will terminate with the end of the BPA, unless the ordering CO elects to extend performance as provided under the BPA.

e. Capitalization Requirements: The BPA holder shall provide their employees sufficient computer equipment to support orders. The BPA holder shall be able to support the automatic transmission of unclassified data only to the requiring Program Office by modem if so requested. Any computers connected to or transmits to (connected or via magnetic media) the government shall be properly protected from computer viruses. The BPA holder shall be capable of supporting the software packages utilized by Department of Veterans Affairs for the indicated processors. Specific software packages utilized within a program office shall be stated in the order PWS if it is other than Microsoft Office Professional or Microsoft Project.

f. Cancellation: This BPA may be canceled if the BPA holder fails to perform in accordance with the terms and conditions of this BPA, any order established under this BPA, or if deemed as in the best interests of the Government. The BPA holder must strictly comply with all terms and conditions or the Department of Veterans Affairs/ Contracting Officer may determine that performance by the BPA holder has been unsatisfactory and cancel this BPA.

B.9 AUTHORIZED LIMITS

The Government estimates, but does not guarantee, that individual BPA Orders placed against this Agreement may reach $ to be determined/per Order. This Order Limit may be increased by mutual agreement of the parties as necessary, in whole or part. The authorized Ceiling Limit of the Agreement is set at $ to be determined over the period covered by the Agreement; this ceiling is also not a guarantee. The Ceiling Limit may also be raised in association with Order Limit increases or other conditions which, by mutual agreement of the parties, maybe considered necessary. Authorization for individual orders above the stated order and/or Ceiling Limits must be coordinated through the Contracting Officer before larger valued orders can be issued and prior to commencement of work. All unauthorized work, regardless of amount, will be processed through the ratification process.

B.10 PRICING

Contract as listed below, with associated pricing, can be ordered under this BPA. The Contractor shall be allowed to vary within the categories for successful and efficient task completion not to exceed funded values of each order awarded under this agreement. As proposed, the Contractor will apply applicable extended/tier pricing to all categories used in the performance of orders issued under this Agreement. Orders may be awarded on a Firm-Fixed-Price basis only. All Calls/Orders placed against this BPA are subject to the terms and conditions of the referenced BPA, the Contractor's proposal and this Agreement, except where noted below. Contractor's proposal dated is hereby referenced.

B.11 PRICING DATA

1. The prices included on the BPA list (or applicable "discounted" rates submitted in a proposal response to an RFQ resulting in award) that are in effect on the effective date of an order shall govern that order's basic performance period.

2. The BPA holder can voluntarily reduce offered prices at any time by giving 24-hour advance notice (by facsimile…