36C25520Q0039-001.docx

36C25520Q0039

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.

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

36C25520Q0039 11-18-2019 Emilio Ballentos emilio.ballentos@va.gov 913-946-1981 12-18-2019 11:00am EST 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 X 325413 1250 Employees N/A X

VISN 15

See Section B - Delivery Schedule for Details

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

36C255 Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin TX 877-353-9791 512-460-5429 See CONTINUATION Page See Section B for Details

- Blood Culture System for VISN 15 Non-OEM vendors must be an Authorized Distributor and must provide a Distributor Letter.

This is a Firm-Fixed Price procurement. FAR 4.11 states that prospective contractors shall be registered in the System For Award Management (www.SAM.gov) database.

See CONTINUATION Page X X Donald Hannah Contracting Officer Table of Contents

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: NAME: ___________________________________

DUNS #: __________________________________

b. GOVERNMENT: CONTRACTING OFFICER 36C255

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE (NCO) 15

3450 S 4th STREET

LEAVENWORTH, KS 66048

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System for Award Management

3. INVOICES: Invoices shall be submitted:

[X] Monthly

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.

Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp

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

B.2 GOVERNING LAW

Federal law and regulations, including the Federal Acquisition Regulations (“FAR”), shall govern this Contract. Commercial license agreements may be made a part of this Contract but only if both parties expressly make them an addendum. If the commercial license agreement is not made an addendum, it shall not apply, govern, be a part of or have any effect whatsoever on the Contract; this includes, but is not limited to, any agreement embedded in the computer software (clickwrap) or any agreement that is otherwise delivered with or provided to the Government with the commercial computer software or documentation (shrinkwrap), or any other license agreement otherwise referred to in any document. If a commercial license agreement is made an addendum, only those provisions addressing data rights regarding the Government’s use, duplication and disclosure of data (e.g., restricted computer software) are included and made a part of this Contract, and only to the extent that those provisions are not duplicative or inconsistent with Federal law, Federal regulation, the incorporated FAR clauses and the provisions of this Contract, including other attached addenda; those provisions in the commercial license agreement that do not address data rights regarding the Government’s use, duplication and disclosure of data shall not be included or made a part of the Contract. Federal law and regulation, including without limitation, the Contract Disputes Act (41 U.S.C. §601-613), the Anti-Deficiency Act (31 U.S.C. §1341 et seq.), the Competition in Contracting Act (10 U.S.C. §2304), the Prompt Payment Act (31 U.S.C. §3901, et seq.) and FAR clauses 52.212-4, 52.227-14, 52.227-19 shall supersede, control and render ineffective any inconsistent, conflicting or duplicative provision in any commercial license agreement. In the event of conflict between this clause and any provision in the Contract or the commercial license agreement or elsewhere, the terms of this clause shall prevail. Claims of patent or copyright infringement brought against the Government as a party shall be defended by the U.S. Department of Justice (DOJ). 28 U.S.C. § 516. At the discretion of DOJ, the Contractor may be allowed reasonable participation in the defense of the litigation. Any additional changes to the Contract must be made by contract modification (Standard Form 30). Nothing in this Contract or any commercial license agreement shall be construed as a waiver of sovereign immunity.

This Contract is Firm Fixed Price (FFP). The Contractor is required to provide the software, media, software license, and software maintenance/upgrade and technical support services for the computer software identified below. Software maintenance includes periodic updates, enhancements and corrections to the software, and reasonable technical support, all of which are customarily provided by the Contractor to its customers. Distribution of maintenance copies shall be accomplished by using an appropriate magnetic, electronic or printed media.

B.3 STATEMENT OF WORK

VISN 15 Blood Culture System

• The Government will award a CPT to a single Contractor for Automated Microbiological Blood Culture Systems.

• This will be a single vendor award with one base year and four, one-year options. VISN 15 intends to establish the base year of the agreement starting on 04/01/2020, with contract completion 03/31/2025.

• Facilities within VISN 15 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the award as new technology becomes available on the market.

• New equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed below:

• VISN 15 will provide an estimated volume by test as reflected in Attachment A for each individual medical center. Pricing is based on 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.

• The desired instrumentation shall have the capability of performing and 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).

• A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. Equipment must maintain or, preferably, reduce the number of work stations or overall labor required to accomplish the required testing by each laboratory.

• If Contractor offers a family of analyzers, VISN 15 technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

• 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.

• 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.

DEFINITIONS

• Cost per Test (CPT) - 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.

• Cost per Patient Reportable Result (CPRR) - Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) 5-year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation of a patient reportable result. The per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required to produce a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI); (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge.

• 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

• 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.

• Vendor shall provide latest model/version of instrumentation

Operational Features

• 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.

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

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

• 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, and fungi) shall be available.

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

• Capability to auto-verify negative cultures.

• Provide all materials required for validation including blood culture bottles, organisms, collection/transfer devices and sterile defibrinated horse blood.

• Blood culture bottles must be compatible with Steri-path collection device.

• Ability for instrument to detect blood culture volume automatically

• Ability for instrument to unload automatically

• Ability to have a conveyor belt with auto load function

• Ability to run automatic cell QC

• 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.

• 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.

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

• The system will be capable of processing inoculated bottles that have been incubated off –line at room temperature for up to 12 hours.

• Minimal daily and periodic maintenance.

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

• Analyzer utilizes windows operating software or another VA approved operating system.

• Vendor will complete and return the following attachments:

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

• Bar-Code System:

O 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.

• Data Management System:

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

• blood culture bottle location

• length of incubation

• time to detection

• growth curve analysis of positive vials

• required quality control and instrument maintenance information

• patient demographic information and specimen results

• the fill volume of the blood culture bottle

• detailed epidemiology reports

• Shall be capable to connect and integrate results through a middleware system.

• 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.

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

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

• Shall have sufficient memory to store patient information and test results for 10,000 records with downloading capability to an external medium for long term storage of patient records and other information.

• Blood Culture Bottles:

Specific Equipment Requirements

• Transparent Plastic Bottles are desirable for safety (glass bottle could break if dropped) and disposal cost savings (glass bottles weigh more).

• If special adapters are needed for direct blood draw into the collection bottles, cost of adapters must be included in price proposal.

• Shall be approved for culture of normally sterile body fluids other than blood.

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

Hardware Features – The instrumentation shall have the following:

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

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

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

• An uninterruptible power supply with line conditioner for each instrument provided, including replacement of batteries.

Method Validation Requirements

• The Contractor shall assist each site in the performance 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.

Implementation/transition timeframe

• Need validation of equipment completed validated 90 days before final award. Current contract expires on 03/31/2020.

• The implementation of the services/requirements described in this solicitation shall be completed no later than 120 days after the award. 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 120-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

• Upon award, the transition period for the award to have all equipment and peripherals installed and operational by April 1, 2020. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

• Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall project for the transition of all services under the award including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations with a start date of April 1, 2020. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate.

Support Features

• 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.

• 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.

• Training O Upon Installation: The Contractor shall provide advanced (key operator) Instrument training program for at least two operators per facility at no charge to the Government that is coordinated with and timely with the equipment installation, sufficient to the size and scope of the facility’s services. This shall include training on the operation of the system, data manipulation, and basic troubleshooting and repair.

O 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.

• Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary 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 1 hours.

• Equipment repair service shall be provided during core business hours. See Attachment A defining core 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 24 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.

• 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.

• 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 award; however, it does refer to significant changes in the hardware operational capability.

• Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the award, as indicated, any and all ancillary support equipment to fully operate or place the analyzer within a laboratory as defined in these specifications, e.g. cabinetry to support/house the analyzer, 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, line conditioners, UPS and UPS batteries, 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).

• Shall be capable to connect and integrate results through a middleware system

• Work with the Laboratory LIMs to interface the middleware system with vendor provided instruments.

• Provide remote or onsite guidance on validation techniques and assist troubleshooting.

• The Contractor shall provide any and all necessary software support 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.

• Vendor must supply the following documentation for all analyzers and data management systems proposed to VISN 15:

• MDS2 - Manufacturer Disclosure Statement for Medical Device Security.

• VA Directive 6550 Appendix A- Pre-Procurement Assessment

• ACL Communication Profile

• 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.

• 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.

• The determination and description shall address the following:

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

• Waste ignitability (Reference 40 CFR §261.21)

• Waste corrosivity (Reference 40 CFR §261.22)

• Waste reactivity (Reference 40 CFR §261.23)

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

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

• Solid Waste (Reference 40 CFR §261.2)

• Exclusions (Reference 40 CFR §261.4)

• 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.

• 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:

• pH

• Flash point (to higher than 200F)

• BOD; biochemical oxygen demand

• 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.

Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the award 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 award at an effectiveness level of 90% or more.

• 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.

• 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.)

• 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.

• 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.

• 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.

• During the term of the award, 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.

• 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.

• 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 at no cost to the Government. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

• 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.

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

• 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 award 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 award or disposal or return of the IT equipment, whichever is earlier.

• 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:

• Contractor must accept the system without the drive;

• 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

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

• 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;

• 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;

• 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 award.

• 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.

*** See Section D for Security Requirement *** *** Please advise if your firm has an existing BAA for Security Requirement ***

Blood Culture Bottles – Estimated Annual Requirements

B.4 PRICE/COST SCHEDULE

ITEM INFORMATION

Wichita VAMC Blood Culture System to include:

259790 BACT/ALERT SN (PLASTIC)

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

S _______

259790 BACT/ALERT SN (PLASTIC)

410851 BACT/ALERT FA PLUS (PLASTIC)

279012 BACT/ALERT BLD COLLECT ADAPTER

YR

EA

EA

EA

S _______

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

450181 BLOOD CULT.HOLDER NON-STERILE

YR

EA

EA

EA

S _______

233766 STERILE AIRWAY NEEDLES

259790 BACT/ALERT SN (PLASTIC)

410853 Bact/Alert PF Plus Resin Pediatric

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

EA

EA

S _______

279012 BACT/ALERT BLD COLLECT.ADAPTER

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

S _______

259790 BACT/ALERT SN (PLASTIC)

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

S _______

259790 BACT/ALERT SN (PLASTIC)

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

S _______

Base Year Period of Performance 04/01/2020 – 03/31/2021 GRAND TOTAL

Wichita VAMC Blood Culture System to include:

259790 BACT/ALERT SN (PLASTIC)

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

S _______

259790 BACT/ALERT SN (PLASTIC)

410851 BACT/ALERT FA PLUS (PLASTIC)

279012 BACT/ALERT BLD COLLECT ADAPTER

YR

EA

EA

EA

S _______

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

450181 BLOOD CULT.HOLDER NON-STERILE

YR

EA

EA

EA

S _______

233766 STERILE AIRWAY NEEDLES

259790 BACT/ALERT SN (PLASTIC)

410853 Bact/Alert PF Plus Resin Pediatric

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

EA

EA

S _______

279012 BACT/ALERT BLD COLLECT.ADAPTER

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

S _______

259790 BACT/ALERT SN (PLASTIC)

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

S _______

259790 BACT/ALERT SN (PLASTIC)

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

S _______

Option Year One Period of Performance 04/01/2021 – 03/31/2022 GRAND TOTAL

Wichita VAMC Blood Culture System to include:

259790 BACT/ALERT SN (PLASTIC)

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

S _______

259790 BACT/ALERT SN (PLASTIC)

410851 BACT/ALERT FA PLUS (PLASTIC)

279012 BACT/ALERT BLD COLLECT ADAPTER

YR

EA

EA

EA

S _______

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

450181 BLOOD CULT.HOLDER NON-STERILE

YR

EA

EA

EA

S _______

233766 STERILE AIRWAY NEEDLES

259790 BACT/ALERT SN (PLASTIC)

410853 Bact/Alert PF Plus Resin Pediatric

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

EA

EA

S _______

279012 BACT/ALERT BLD COLLECT.ADAPTER

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

S _______

259790 BACT/ALERT SN (PLASTIC)

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

S _______

259790 BACT/ALERT SN (PLASTIC)

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

S _______

Option Year 2 Period of Performance 04/01/2022 – 03/31/2023 GRAND TOTAL

Wichita VAMC Blood Culture System to include:

259790 BACT/ALERT SN (PLASTIC)

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

S _______

259790 BACT/ALERT SN (PLASTIC)

410851 BACT/ALERT FA PLUS (PLASTIC)

279012 BACT/ALERT BLD COLLECT ADAPTER

YR

EA

EA

EA

S _______

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

450181 BLOOD CULT.HOLDER NON-STERILE

YR

EA

EA

EA

S _______

233766 STERILE AIRWAY NEEDLES

259790 BACT/ALERT SN (PLASTIC)

410853 Bact/Alert PF Plus Resin Pediatric

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

EA

EA

S _______

279012 BACT/ALERT BLD COLLECT.ADAPTER

410851 BACT/ALERT FA PLUS (PLASTIC)

410852 BACT/ALERT FN PLUS (PLASTIC)

YR

EA

EA

EA

S _______

259790 BACT/ALERT…