36C25519Q0151.docx

36C25519Q0151

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

116-19-1-4160-0036/37/38 36C25519Q0151 12-28-2018 Zaritz, Larry | larry.zaritz@va.gov 913-946-1977 01-08-2019 10:00 am 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 X X 325413 1250 Employees N/A X Department of Veteran Affairs Kansas City VA Medical Center 4801 E. Linwood Blvd Kansas City MO 64128-2226 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 The purpose of this solicitation is to establish a Cost Per Test (CPT) use of analyzers for;

Automated Gel Protein Electrophoresis Testing System See Section B, Statement of Requirements (SOR) for additional details See CONTINUATION Page

TBD

X X Zaritz, Larry 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:

Offeror DUNS #:

Company Name and Address:

Point of Contact:

Phone Number:

Email Address:

GSA or VA NAC Contract Number

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 52.232-33, Payment by Electronic Funds Transfer—System For Award Management.

3. INVOICES: Invoices shall be submitted in arrears UPON ACCEPTANCE OF ALL ITEMS RECEIVED

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.

36C25519Q0151

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B.2 STATEMENT OF REQUIREMENTS – AUTOMATED PROTEIN ELECTROPHORESIS SYSTEM

1.1. SCOPE OF PROCUREMENT

1.1.1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in this statement of requirements. The instrument shall have random access capability and be able to simultaneously perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

1.1.2. Equipment shall consolidate all electrophoresis testing steps to include sample application, electrophoretic migration, drying, staining, de-staining and drying into one compact workstation due to space requirements. Unit must fit counter space of;

· Length 6’ 10”

· Depth 29”

· Height 23”

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

1.1.4. Equipment/Reagents required for each of the clinical laboratories shall be listed in Attachment B.

1.1.5. 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 bottles. 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, lab chiefs, and the VISN program office.

1.1.6. 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.

2.2. DEFINITIONS

2.2.1. Cost per Test (CPT)

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) equipment use, (b) all reagents, standards, 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.

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

2.4. GENERAL REQUIREMENTS

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

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

2.4.2.1. The capability of performing analysis on 100% of the tests listed in Attachment B.

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

2.4.2.3. A bi-directional, bar-coded computer interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

2.4.2.4. Minimal daily, monthly, and periodic maintenance.

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

2.4.2.6. On board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least three (3) to six (6) months for reagents.

2.4.2.7. Analyzer utilizes windows operating software or other VA approved operating system. Vendor will complete and return the following attachments:

2.4.2.7.1. 6550 Pre-Procurement Assessment

2.4.2.7.2. MDS2 Manufacturer Disclosure Statement for Medical Device Security

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

2.4.3.1. On-board QC data management system with a minimum storage capacity of QC, QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data.

2.4.3.2. Have minimal reagent and control preparation, preferably no reconstitution required.

2.4.3.7. Provide all necessary pipettors and pipet tips for analysis of samples.

2.4.3.8. Any special items required maintaining the equipment/analyzer in optimal condition such as but not limited to tables, printers, water supply, drainage systems, UPS, surge suppressors etc. will be the responsibility of the vendor. Any maintenance, time and materials needed to keep the special items in working order will be the responsibility of the vendor.

2.4.3.9 Provide necessary reagents to mitigate Daratumumab drug interference on Immunofixation tests.

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

2.4.4.1. Due to space constraints, a small footprint equipment is preferred to accommodate space limitations. The total equipment footprint should fit on a counter with the following measurements:

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

2.4.4.3. A color 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).

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

2.4.4.5. All necessary procedure manuals, troubleshooting manuals and operator manuals (available on computer or CD format). Procedures should be editable CLSI format on diskette or other electronic format. Updates provided when required.

2.4.5. Method performance/comparison: Shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSII guidelines and related documents, College of American Pathologists (CAP) Standards and federal regulations, for the following:

2.4.5.1. Correlation studies for each analyte. A minimum of 20 samples, spanning the reportable range, shall be run by the present and the proposed method. Contractor shall analyze results and provide statistical data to support acceptance of the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI.

2.4.5.2. Precision study using normal and abnormal control material. This shall consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal controls and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level of control. Intra-VISN facility variations should be kept at an absolute minimum. Contractor shall provide at no charge and run their assayed controls (minimum of two levels) in parallel with third party controls during the establishment of facility specific control ranges.

2.4.5.3. Sensitivity. Sensitivity may be validated concurrently with the linearity verifications.

2.4.5.4. Specificity Studies. This shall determine whether or not there are adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances.

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

2.4.5.6. Vendor will assist the user in setting up and maintaining/trouble shooting user-defined assays.

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

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

2.4.6.2. If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI C28-A2 guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.

2.4.6.3. If a laboratory is currently using the proposed instrument/reagent system, the “in-use” reference range can be transferred to the “new” system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, the 2.4.6.1 or 2.4.6.2 above must be performed.

2.4.7. Support Features

2.4.7.1. 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.

2.4.7.2. 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 all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity. 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

2.4.7.3. 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. 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 two operators per facility per year for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. As applicable, any training off-site shall should include the cost of airfare, room and board for each participant.

2.4.7.4. 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:

2.4.7.4.1. A technical assistance center shall be available by telephone 24 hours Monday – Friday, 8am to 5pm with a maximum call back response time of 2 hours excluding holidays.

2.4.7.4.2. Equipment repair service shall be provided during core business hours, Monday through Friday, 8am to 5pm.

2.4.7.4.3. Equipment response time shall be no more than 24 hours.

2.4.7.4.4. A minimum of 1 scheduled preventative maintenance calls per year.

2.4.7.4.5. 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.

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

2.4.7.5 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.

2.4.7.6 Ancillary support equipment - The Contractor shall provide, install and maintain , 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.), 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.

2.4.7.6.1. 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 requirements below).

2.4.7.6.2. The Contractor shall provide any and all necessary software support for insuring 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 the chart below.

2.4.7.6.3. 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.

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

2.4.7.8. 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.

2.4.7.9. The determination and description shall address the following:

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

2.4.7.9.2. Waste ignitability (Reference 40CFR261.21)

2.4.7.9.3. Waste corrosivity (Reference 40CFR261.22)

2.4.7.9.4. Waste reactivity (Reference 40CFR261.23)

2.4.7.9.5. Hazardous waste from non-specific sources (F-listed) (Reference 40CFR261.31)

2.4.7.9.6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40CFR261.33)

2.4.7.9.7. Solid Waste (Reference 40 CFR261.2)

2.4.7.9.8. Exclusions (Reference 40 CFR261.4)

2.4.7.10. 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.

2.4.7.11. 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, thimerasol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with Contractor response:

2.4.7.12. 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.

2.4.7.13. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 60 days after the award of the BPA. This timeline is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe. Contractors shall not be penalized for implementation timelines that extend beyond the 60-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

2.4.7.13.1. Upon award of a BPA, the transition period for the awarded to have all equipment and peripherals installed and operational shall be from date of award through 60 days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed.

2.4.7.13.2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 60 days for the transition of all services under the awarded including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the contractor to confirm to the transition period shall be considered as sufficient to terminate for cause under the Termination for Cause clause of the BPA.

2.4.7.13.3. At the end of 60 days from award of the BPA, the awarded contractor shall have full and sole responsibility for services under the awarded BPA.

2.4.8. 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 Contract at an effectiveness level of 90% or more.

2.4.8.1 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.

2.4.8.2. 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.)

2.4.8.3. 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.

2.4.8.4. The government will maintain daily records to satisfy the requirements of this paragraph 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.

2.4.8.5. During the term of the contract, 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.

2.4.9. 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.

2.4.10. 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.

2.4.11. The vendor/contractor, as applicable, 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 vendor/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.

2.4.12. Prior to termination or completion of the contract, contractor/subcontractor must not destroy information received from VA or gathered/created by the contractor in the course of performing this Contract 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 contract.

2.4.13. 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 Contract 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 Contract or disposal or return of the IT equipment, whichever is earlier.

2.4.14. As applicable, 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 vendor at the end of lease, for trade-in, or other purposes. The options are:

2.4.14.1. Vendor must accept the system without the drive;

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

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

2.4.15. As applicable, 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;

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

2.4.15.2. 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.

2.4.15.3. Applicable media sanitization specifications need to be pre-approved and described in the contract.

2.4.15.4. 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 ISO needs to maintain the documentation.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Automated Gel Protein - Electrophoresis Cost Per Test Section D, Attachment B for estimated usage of Reagents Contract Period: Base POP Begin: 02-01-2019 POP End: 01-31-2020

Automated Gel Protein - Electrophoresis Cost Per Test Section D, Attachment B for estimated usage of Reagents Contract Period: Base POP Begin: 02-01-2019 POP End: 01-31-2020

Automated Gel Protein - Electrophoresis Cost Per Test Section D, Attachment B Estimated usage of Reagents Contract Period: Option 1 POP Begin: 02-01-2020 POP End: 01-31-2021

Automated Gel Protein - Electrophoresis Cost Per Test Section D, Attachment B Estimated usage of Reagents Contract Period: Option 1 POP Begin: 02-01-2020 POP End: 01-31-2021

Automated Gel Protein - Electrophoresis Cost Per Test Section D, Attachment B Estimated usage of Reagents Contract Period: Option 2 POP Begin: 02-01-2021 POP End: 01-31-2022

Automated Gel Protein - Electrophoresis Cost Per Test Section D, Attachment B Estimated usage of Reagents Contract Period: Option 2 POP Begin: 02-01-2021 POP End: 01-31-2022

Automated Gel Protein - Electrophoresis Cost Per Test Section D, Attachment B Estimated usage of Reagents Contract Period: Option 3 POP Begin: 02-01-2022 POP End: 01-31-2023

Automated Gel Protein - Electrophoresis Cost Per Test Section D, Attachment B Estimated usage of Reagents Contract Period: Option 3 POP Begin: 02-01-2022 POP End: 01-31-2023

Automated Gel Protein - Electrophoresis Cost Per Test Section D, Attachment B Estimated usage of Reagents Contract Period: Option 4 POP Begin: 02-01-2023 POP End: 01-31-2024

Automated Gel Protein - Electrophoresis Cost Per Test Section D, Attachment B Estimated usage of Reagents Contract Period: Option 4 POP Begin: 02-01-2023 POP End: 01-31-2024

DELIVERY SCHEDULE

Department of Veteran Affairs Kansas City VA Medical Center Kansas City, MO 64128 2226

ATTN: TBD

Base *Estimated February 1st 2019 – January 31st 2020

Department of Veterans Affairs Columbia VAMC 800 Hospital Dr. Bldg D218 Columbia, MO 65201 5275

ATTN: TBD

Base *Estimated February 1st 2019 – January 31st 2020

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

(End of Clause)

C.2 52.216-18 ORDERING (OCT 1995)

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

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

(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

(End of Clause)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than The quantity specified in Attachment B, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of; The annual quantity specified in attachment B. for that particular facility;

(2) Any order for a combination of items in excess of The annual quantity specified in attachment B. for that particular facility; or

(3) A series of orders from the same ordering office within TBD that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 4 Business days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

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

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

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

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

(End of Clause) C.5 52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY PRICED LINE ITEM (MAR 1989) The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within the current Period of Performance specified in the contract and any remaining options not yet exercised. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

(End of Clause)

C.6 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.7 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (DEC 2009)

The offeror agrees, if awarded a contract, to use the service-disabled veteran-owned small businesses or veteran-owned small businesses proposed as subcontractors in accordance with 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, or to substitute one or more service-disabled veteran-owned small businesses or veteran-owned small businesses for subcontract work of the same or similar value.

(End of Clause) C.8 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE (JUL 2018)

(a) This solicitation includes FAR 52.219-6 Notice of Total Small Business Set-Aside.

(b) Accordingly, any contract resulting from this solicitation is subject to the limitation on subcontracting requirements in 13 CFR 125.6, or the limitations on subcontracting requirements in the FAR clause, as applicable. The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) retained by VA to assist in assessing the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to Contractor's offices where the Contractor's business records or other proprietary data are retained and to review such business records regarding the Contractor's compliance with this requirement.

(c) All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs.

(d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

(End of Clause) C.9 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)

(a) This solicitation includes the clause: 852.215-70 Service-disabled veteran-owned and veteran-owned small business evaluation factors. Accordingly, any contract resulting from this solicitation will include the clause 852.215-71 Evaluation factor commitments.

(b) The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) to assist in assessing Contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the Contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement.

(c) All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs.

(d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect…