36C25219Q0205.docx

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

General Information

Contracting Office Address Great Lakes Acquisition Center 115 S. 84th Street Milwaukee, WI 53214-1476 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued.

This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-101.

The associated North American Industrial Classification System (NAICS) code for this procurement is 325413, with a small business size standard of 1,250 employees.

The Great Lakes Acquisition Center, 115 S. 84th Street, Milwaukee, WI 53214-1476 is seeking to lease a 10-color Flow Cytometer with ancillary sample/reagent prep equipment on a Cost per Patient Reportable Result (CPRR) or Cost Per Test Result (CPT) bases per the Statement of Work.

All interested companies shall provide quotations for the following:

Services – Statement of Work

Flow Cytometer

VISN12 Pathology and Laboratory Medicine Service Line Milwaukee, WI 10/22/2018

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

2.0 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 Contracting Officer and the Point of Contact (POC).

3.0 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.

4.0 DEFINITIONS:

4.1 Cost per Patient Reportable Result (CPRR) or Cost Per Test Result (CPT) as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers - The per patient reportable result price shall include costs covering: (1) 5 year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor’s equipment and necessary for the generation of a patient reportable result. It will also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI-formerly NCCLS). (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. If the Contractor submits an offer in the per patient reportable result price format, the price shall include all costs associated with dilutions, as well as repeat and confirmatory testing required to produce a single patient reportable result.

4.2 Cost per Test (CPT) as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers – Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) 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.

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

5.1 Features:

5.1.1 A 10-color Flow Cytometer with ancillary sample/reagent prep equipment is being acquired due to increased workload in flow cytometry at Milwaukee. This instrument performs analysis of TBNK cells and CD markers and is used as an aid in the diagnosis of leukemias and lymphomas. Samples used for analysis are whole blood, bone marrow, lymph nodes and body fluids.

5.1.2 This can be a CPRR (Cost per Patient Reportable Result) or CPT (Cost per Test). This is not a capital purchase.

5.1.3 Current flow cytometry tests panels are listed in Attachment A at the end of this document.

5.1.4 Current annual test volumes:

5.2 Operational Features:

5.2.1 The ability to efficiently and productively meet the operational demands of the clinical laboratory. Annual tests panels are listed in Attachment A at the end of this document.

5.2.2 A minimum of 10-color fluorescence with an additional 2 channels for light scatter properties;

5.2.3 The flow cytometer shall be new; no refurbished equipment;

5.2.4 Adequate lasers/filters with fixed optical alignment;

5.2.5 Temperature Control mechanism that can regulate internal temperature fluctuations;

5.2.6 Capable of mixing each sample tube before being delivered to the system;

5.2.7 FDA approved system and software with ability to use a single platform for absolute counts;

5.2.8 Windows-based operating system;

5.2.9 Minimal daily maintenance such that the analyzer is not required to be down for more than 60 minutes per day (this is not to exclude longer times for periodic maintenance);

5.2.10 Bi-directional interface with hospital computer system;

5.2.11 Remote diagnostics capability, including remote laser alignments through software, to minimize lab downtime;

5.2.12 A stand-alone, automated/semi-automated sample preparation system capable of reagent addition, incubation, washing (if necessary) and fixative addition. The sample preparation system may be new, refurbished or currently in use;

5.2.13 A stand-alone pipetting system capable of accurately pipetting samples, reagents and controls. The pipetting system may be new, refurbished or currently in use.

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

5.3.1 Data Management System with:

5.3.2 Automatic and manual system compensation;

5.3.3 Capable of real time compensation, data analysis and gating;

5.3.4 Fully digital electronics for linear, log, etc. for all collected parameters, with post-acquisition electronics;

5.3.5 The ability to create custom test panels;

5.3.6 Software for remote data analysis, manipulation and interpretation by technologists and pathologists at Milwaukee VAMC and the Jesse Brown VAMC;

5.3.7 A quality control package used for daily monitoring of system performance and operator notification upon QC failure;

5.3.8 Ability to use automated or manual sample introduction;

5.3.9 Minimal sample carryover %;

5.3.10 Adjustable flow rates.

5.4 Hardware Features:

5.4.1 Uninterrupted Power Supply (UPS) to provide uninterruptible electrical power without electrical voltage fluctuations;

5.4.2 A color printer that will print minimally two forms of patient identification on the test report;

5.4.3 Accurate barcode reading with less than 5% read failures;

5.4.4 A minimally 22-inch LCD Monitor.

5.5 Support Features:

5.5.1 The vendor shall assist the VA Milwaukee staff with initial instrument setup and panel design.

5.5.2 Installation and validation of equipment: Vendor must install and verify that instrument, software and ancillary workstations are in acceptable working order per manufacturer requirements and as determined by the COR. All reagents and controls used for validation of FDA approved assays are at the expense of the vendor. Validation studies of the instrument, software and ancillary workstation must be acceptable.

5.5.3 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 shall be 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 consistent with current CLSI and related documents, CAP Standards and Federal Regulations. The Government intends to implement testing in phases with the T cell subsets being the first test implemented and, subsequently, leukemia/lymphoma panels at a later date.

5.5.4 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.

5.5.5 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. This shall include training of both the technical staff and pathologists 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. In addition, the Contractor shall provide additional on-site training 6-12 months after test implementation, if requested.

5.5.6 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:

5.5.7 A technical assistance center must be available by telephone 8 hours per day, 5 days per week, Monday through Friday, with a maximum call back response time of 2 hours.

5.5.8 Equipment repair service must be provided during core business hours. Business hours are defined as Monday-Friday, 8:00AM-4:30PM. 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.

5.5.9 Equipment repair response time shall be less than 24 hours from notification. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

5.5.10 Ancillary equipment repair response time shall be less than 48 hours from notification. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

5.5.11 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:

5.5.11.1 date and time notified

5.5.11.2 date and time of arrival

5.5.11.3 serial number, type and model number of equipment

5.5.11.4 time spent for repair, and

5.5.11.5 proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

5.5.12 In the event that the product fails to perform to manufacturing specifications, the Customer will provide the Contractor written notification of such non-performance and the Contractor will be given 60 days from the receipt of this notification to correct the performance issues. The Contactor will attempt to resolve these performance issues by either fixing/replacing defective parts or by replacing the non-performing equipment.

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

5.5.14 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 must be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the original contract; however, it does refer to significant changes in the hardware operational capability.

5.5.15 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 vendor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

5.5.16 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. PC computer diskette of their procedure manual or an on-line procedure manual in the instrument software.

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

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

5.5.17.2 Waste ignitability (Reference 40CFR261.21)

5.5.17.3 Waste corrosivity (Reference 40CFR261.22)

5.5.17.4 Waste reactivity (Reference 40CFR261.23)

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

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

6.0 Reports - The Contractor shall provide to the Contracting Officer and the POC at the VA Milwaukee a copy of a quarterly report of sales, within 30 calendar days after the close of each quarter’s business. Reports are to minimally reflect the total number of patient tests performed, total net sales, amounts before discount, and discount amounts, the raw data used to develop these reports, the total cost per the FSS contract and the net savings. These reports shall be used to monitor the commitment and to report the savings realized and shall be shared with personnel associated with acquiring the products, and respective Laboratory personnel. Contractor will not make additional invoice charges associated with reagent and/or supply wastage or repair parts. There will be no additional charges for any reports required as part of the contract.

7.0. Business Associate Agreement (BAA) - A business associate is an entity, including an individual, company, or organization that, on behalf of the VHA facility, 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 everyone 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.

8.0 Standard and Quality of Performance:

8.1 This paragraph establishes a standard of performance that shall be met before any equipment listed on a purchase 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. (These vary based on type of testing and are to be customized for individual VISN needs)

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

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.

8.4 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.

8.5 The government shall maintain appropriate 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 performance period. Operations use time and downtime shall be measured in hours and whole minutes

9.0 Government’s Responsibility: The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user will maintain appropriate records to satisfy the requirements of this paragraph and will notify the contractor in writing of the date of the first day of the successful performance period.

10.0 Ownership of Equipment:

10.1 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.

10.2 The vendor/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 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.

10.3 Prior to termination or completion of this contract, 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.

10.4 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 purchase order or disposal or return of the IT equipment, whichever is earlier.

11.0 SECURITY ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS:

11.1 A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

11.2 All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

11.3 The contractor or subcontractor must notify the Contracting Officer as soon as reasonably possible when the sales representative or service engineer assigned to the VA Milwaukee is no longer employed by the Contractor.

12.0 VA INFORMATION CUSTODIAL LANGUAGE

12.1 Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

12.2 VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

12.3 Prior to termination or completion of this 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 of the contract.

12.4 The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

12.5 The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

12.6 If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

12.7 If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

12.8 The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

12.9 The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request. Except for uses and disclosures of VA information authorized by the contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations:

12.9.1 in response to a qualifying order of a court of competent jurisdiction, or

12.9.2 with VA’s prior written approval.

12.10 The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

12.11 Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

12.12 For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

13.0 SECURITY INCIDENT INVESTIGATION

13.1 The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

13.2 To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

13.3 With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

13.4 In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

14.0 LIQUIDATED DAMAGES FOR DATA BREACH

14.1 Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

14.2 The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

14.3 Each risk analysis shall address all relevant information concerning the data breach, including the following:

14.3.1 Nature of the event (loss, theft, unauthorized access);

14.3.2 Description of the event, including:

14.3.2.1 date of occurrence;

14.3.2.2 data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

14.3.3 Number of individuals affected or potentially affected;

14.3.4 Names of individuals or groups affected or potentially affected;

14.3.5 Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

14.3.6 Amount of time the data has been out of VA control;

14.3.7 The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

14.3.8 Known misuses of data containing sensitive personal information, if any;

14.3.9 Assessment of the potential harm to the affected individuals;

14.3.10 Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

14.3.11 Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

14.4 Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

14.4.1. Notification;

14.4.2 One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

14.4.3 Data breach analysis;

14.4.4 Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

14.4.5 One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

14.4.6 Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

15.0 TRAINING

15.1 All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

15.1.1 Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

15.1.2 Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

15.1.3 Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

15.1.4 Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access.

15.2 The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

15.3 Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

16.0 ELIGIBLE FACILITIES

VISN 12 testing to be performed at: Clement J Zablocki VA Medical Center 5000 W National Avenue Milwaukee, WI 53295-0001

Attachment A: Zablocki VA Leukemia/Lymphoma Panels Lymphoma Panel

Added T/NK cells

Added Hairy Cell

Added Plasma Cell

Added cyto B cell

CD45

CD45

Added Elution / Wash

Added cytoplasmic T cell

Screen (Bone Marrows only)

Acute Panel

CD45

BAL T-cell Panel

FMC7/CD200 Lymphoma Add-on

(END OF SOW)

The period of performance is for a base year with four option years.

Delivery shall be provided no later than 30 days after receipt of order/award of contract. The contractor shall deliver line item 0001 to Clement J Zablocki VA Medical Center, 5000 W National Avenue, Milwaukee, WI 53295-0001

Award shall be made to the quoter whose quotation offers the best value to the government. The government will evaluate information based on the following evaluation criteria: Price.

The full text of FAR provisions or clauses may be accessed electronically at:

http://acquisition.gov/comp/far/index.html and http://www.va.gov/oamm/oa/ars/policyreg/vaar/index.cfm.

The following RFQ provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Items” (Oct 2018)

2. ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS Provisions 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 provisions are incorporated into 52.212-1 as an addendum to this solicitation:

· Gray Market Prevention Language:

(a) Gray market items are Original Equipment Manufacturer’s (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable.

(b) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM’s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.

(c) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA’s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.

· 52.216-1, Type of Contract (APR 1984).

The Government contemplates award of a Firm-Fixed-Price contract resulting from this solicitation.

(End of Provision)

· 52.233-2, Service of Protest (SEP 2006).

(a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

Hand-Carried Address: Mailing Address:

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

(End of Provision)

· VAAR 852.233-70, Protest Content/Alternative Dispute Resolution (SEP 2018).

· VAAR 852.233-71, Alternate Protest Procedure (SEP 2018).

End of Addendum to 52.212-1

3. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items” (Oct 2018)

Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required.

· The following contract clauses apply to this acquisition:

· FAR 52.212-4, “Contract Terms and Conditions–Commercial Items” (Oct 2018).

· 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:

· 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 1 day of contract end; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause)

· 52.203-17, Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (Apr 2014).

· 52.204-18, Commercial and Government Entity Code (Jul 2016).

· 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Dec 2013).

· 852.203-70, Commercial Advertising (May 2018).

· VAAR 852.219-11, VA Notice of Total Veteran-Owned Small Business Set-Aside (Jul 2016)(Deviation).

· VAAR 852.219-74, Limitations on Subcontracting - Monitoring and Compliance (Jul 2018).

· VAAR 852.232-72, Electronic Submission of Payment Requests (Nov 2018).

· VAAR 852.246-71, Rejected Goods (Oct 2018).

End of Addendum to 52.212-4

· FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” (Oct 2018)

The following subparagraphs of FAR 52.212-5 are applicable:

· 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

· 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109–282) (31 U.S.C. 6101 note).

· 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (OCT 2015) (31 U.S.C. 6101 note).

· 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

· 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

· 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C 632(a)(2)).

· 52.222-3, Convict Labor (June 2003).

· 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2018).

· 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

· 52.222-26, Equal Opportunity (Sep 2016).

· 52.222-35, Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212).

· 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014).

· 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

· 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

· 52.222-50, Combating Trafficking in Persons (Mar 2015).

· 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011).

· 52.225-1, Buy American--Supplies (May 2014).

· 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

· 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013).

(End of Clause)

End of Provisions and Clauses Section

This is an open-market combined synopsis/solicitation for the product and associated services as defined herein. The government intends to award a contract as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the RFQ are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the RFQ are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoter shall list exception(s) and rationale for the exception(s).

Submission shall be received not later than 3:00 p.m. EST on 4 January 2019. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). E-mailed quotes will be accepted.

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Contracting Officer – Parris S. Weidenbach @ parris.weidenbach@va.gov Point of Contact Parris S. Weidenbach, 414-844-4895, parris.weidenbach@va.gov