36C24718Q9722-000.docx

36C24718Q9722 FedBizOpps Combined Synopsis/Solicitation Notice

CLASSIFICATION CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE DATE (MM-DD-YYYY)

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 CPT Coagulation Analyzers 30084 36C24718Q9722 09-24-2018 N 339112 Department of Veterans Affairs VISN 7 Network Contracting Office LaVista Business Park - Bldg A 2008 Weems Road Tucker GA 30084 Demetrius Kittrell Demetrius.Kittrell@va.gov Charlie Norwood VAMC Lab 1 Freedom Way Augusta, GA 30904 Demetrius.Kittrell@va.gov Contracting Email

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

509-19-1-549-0018 36C24718Q9722 09-19-2018 Demetrius Kittrell 404-321-6111ex 202430 09-24-2018 noon Department of Veterans Affairs VISN 7 Network Contracting Office LaVista Business Park - Bldg A 2008 Weems Road Tucker GA 30084 X 339112 1000 Employees N/A X Charlie Norwood VAMC Lab 1 Freedom Way Augusta GA 30904 Department of Veterans Affairs VISN 7 Network Contracting Office LaVista Business Park - Bldg A 2008 Weems Road Tucker GA 30084

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page CPT Coagulation Services for the Charlie Norwood VAMC See SOW and Schedule Below.

See CONTINUATION Page X X Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

Left Blank

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C247 Department of Veterans Affairs VISN 7 Network Contracting Office LaVista Business Park - Bldg A 2008 Weems Road Tucker GA 30084

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

3. INVOICES: Invoices shall be submitted in arrears:

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

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes FAR 52.219-4 Notice of Price Evaluation Preference for HubZone Small Business Concerns. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO 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. 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 CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. 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 CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

B.3 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO 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. 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 CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. 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 CO to assess the contractor compliance with the subcontracting commitments.

36C24718Q9722

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HEMATOLOGY COAGULATION ANALYZER

(COST PER TEST)

1. GENERAL

1.1. AUTHORITY: Service are being procured by Authority Title 38 USC 8153

1.2. SERVICES REQUIRED: Contractor will provide a cost per test agreement for a base and option year contract as a contract for continuation of services for two identical Hematology Coagulation Analyzers to include an estimated test volume of 50 PT/INR per day, 30 APTT per day, 2 D-Dimer per day, seven days per week and a fibrinogen test volume of 1 per day. The current equipment is the ACLTOP 500 and ACLTOP 700 and are self-contained, freestanding without requiring the additional purchase of tables, platforms, counter tops, printers, PC’s, UPS battery backup, and other equipment necessary to maintain the instruments full function and operation in completing the testing and reporting patient data. The coagulation analyzers have the capability of performing/reporting the clinical parameters as defined in this statement of work. The instruments have random access capability and are able to simultaneously perform the PT/INR, APTT, D-Dimer, and Fibrinogen. The performance characteristics for accuracy and precision must meet or exceed national regulatory and accreditation standards such as College of American Pathologists, Joint Commission or Clinical Laboratory Standards Institute (CLSI). Equipment must function to have a continuous output of test results that does not require more than one technologist to operate, perform maintenance, quality control testing, and result reviews in order to accomplish the highest test volume (such as morning collection) or highest average daily test volume for each shifts turn-around-times of at least 30 samples per hour. The reagents, supplies, quality controls, calibrators, standards, 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 for proper operation must be the same for both instruments and can be used interchangeably. 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 the equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. In the event that the supplies or the reagents performance fails upon testing, the contractor will replace them at no additional cost and deliver the replacements within 24 hours of receipt of the verbal order for emergency delivery. Expiration date must be clearly marked on the reagent, standards, and control containers. The shipping schedule for all bulk supplies and reagents shall be determined by the controlled climate storage space available at the facility. 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 individual determined at contract award and the Contracting Officer Representative, COR.

1.3. PLACE OF PERFORMANCE: Services shall be performed at the Charlie Norwood VAMC, Pathology/Laboratory Medicine Services located at 950 15TH Street, Augusta, GA.

1.4. DEFINITIONS:

PT- Prothrombin Time INR- International Normalized Ratio APTT- Activated Partial Thromboplastin Time CAP- College of American Pathologists CLSI- Clinical Laboratory Standards Institute COR- Contracting Officer Representative CPARS- Contractor Performance Assessment Reporting System FDA- Food and Drug Administration VA-Veteran’s Administration CNVAMC- Charlie Norwood Veterans Administration Medical Center

2. PERSONNEL:

2.1. QUALIFICATIONS:

2.1.1. Technicians/Technologist performing under this contract shall present active license or certification for installation/service of analyzers.

2.1.2. Contract personnel do NOT have VA Employee status

2.1.3. Technicians/technologists shall be trained on applicable trouble shooting codes relating to the specific analyzers.

2.2. NON-PERSONAL SERVICES:

2.2.1. Contract personnel performing under this contract are not considered to be federal employees. They shall provide services as specified in this statement of work.

2.3. KEY PERSONNEL AND EMERGENCY SUBSTITUTIONS:

2.3.1. Personnel entering the medical center are required to complete annual HIPPA training due to the access of patient information.

3. HOURS OF OPERATION:

3.1.1. Business Hours: 24 hours/ 7 days per week including holidays and weekends.

4. CONTRACTOR RESPONSIBILITIES

4.1. Contractors staff shall comply with annual HIPPA Training and reports of completion shall be submitted to the COR for file documentation.

4.2. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Contract Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts.

4.3. Contractor provides all technical direction for the performance of service and technical specialist on site for trouble shooting for the analyzers. Contractor personnel interacts with designated VA staff in completing work to provide fully functioning analyzers prior to the completion of service call.

4.4. Services required: Maintaining the full operation and reagents/controls/calibrators required to perform patient testing for PT, APTT, D-Dimer, and Fibrinogen; daily, weekly, monthly, annual quality control, and the maintenance requirements to meet patient testing according to all regulatory guidelines must be provided. Contractor provides the reagents, controls and calibrators per the shipping schedule in attachment D.

4.5. Standards of practice: Contractor shall be responsible for meeting or exceeding VA, CAP, and Joint Commission (or equivalent) standards.

4.6. Maintain a current Business Associate Agreement between the Department of VA, VHA.

4.7. Provides customer service hot line telephone number.

4.8. Contractor must provide a trained CPARS representative to respond on the contractor’s behalf.

4.9. Contract personnel who require access to national security programs must have a valid security clearance to meet the National Industrial Security Program (NISP) that was established by Executive Order 12829 to ensure the U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts.

5. GOVERNMENT RESPONSIBILITIES:

5.1. Annual instrument calibration and daily quality control testing will be performed by trained and certified technologist personnel of the Charlie Norwood VAMC in collaboration, oversight, and monitoring by the COR or designee regarding the direct operation of the instruments.

5.2. CNVAMC support personnel, services or equipment will be subject to the terms and conditions of the contractor in order to not void the contractor’s warranty.

5.3. Servicing by VA staff will only be performed as instructed by the contactor under technical support’s authorization or standard methods of operation as guided by the onboard help menu.

5.4. All equipment and supplies will be supplied by the contractor except consumables such as computer paper, ink cartridges, labels, and glass/plastic sodium citrate tubes.

5.5. The Government shall contact the contractor within (1) one hour of any nonfunctional analyzer.

5.6. The Government shall ensure that the contractor has access to the location of all analyzers.

5.7. The COR will provide the CPARS evaluation of services received.

6. PERFORMANCE STANDARDS, QUALITY ASSURANCE AND QUALITY IMPROVEMENT:

6.1. Methods of Surveillance: Timeliness of shipments, the physical condition of receipt for integrity, quantity ordered, and quality of performance in passing all levels of QC testing as designated by the manufacturer.

6.2. Performance Standards: Contract personnel shall be subject to the following standards and acceptable quality levels:

6.2.1. CAP, FDA guidelines, and Joint Commission or CLSI for accrediting hospitals.

6.2.2. Capability of interfacing with the CAP website

6.2.3. Testing of Critical patient test results and delta checks that will meet the 1 hour turn-around-timeframe for reporting patient results without requiring any additional equipment such as extra tracks and lanes.

6.2.4. Reflex testing capability.

6.2.5. Current Business Associate Agreement between the Department of Veterans Affairs Veterans Health Administration and the Vendor.

6.2.6. Instrument has an automatic drain capability without operator involvement for biohazard exposure.

6.2.7. Calibration on the instrument is stable for a minimum of 12 months without validation and calibration kit is included as a product within the cost per test agreement.

6.2.8. The PM is provided by the vendor’s service engineer and is not performed as a procedure by the CNVAMC technologist.

6.2.9. The automation technology must report the test results in the parameters that are currently in place for seconds for PT and APTT, INR, mg/dL for Fibrinogen, and mcgFEU/mL for D-Dimer.

6.2.10. Instruments include a printer and a UPS with batteries for each and both are replaced if nonfunctional by the vendor at no cost to the VA for installation and shipping.

6.2.11. Instruments include a sturdy mobile surface or tabletop for the instrument to reside on while it is within CNVAMC facility.

6.2.12. All consumable reagents required for operation, cleaning solutions, controls, calibrators, test and control racks, and rack barcodes are supplied by the vendor at no cost to the VA.

6.2.13. Controls are stable and require testing every 8 hours of testing.

6.2.14. An external monitoring system to show comparison data with other hospital users of the same equipment, and the same commercial controls lot # for quality monitoring and performance of the instrument. CAP HEM.20050 Numeric QC Data and CAP HEM.20070 Precision Statistics require that this quality control measure be used to assist in the accuracy and precision when detecting instrument malfunction and is currently in the hematology quality plan.

6.2.15. The technology interfaces with VISTA computer system through Data Innovations without an install cost generated to the VA.

6.2.16. The instrument’s computer must read interleave 2 of 5 with a check digit labels.

6.2.17. The system must have the capacity to connect to the current VA LIS system (VISTA) and include a bi-directional LIS host query interfacing for both.

6.2.18. If the SQL server is included on the computer, it must be 2012 SQL server or greater.

6.2.19. The instrumentation is 508 compliant.

6.2.20. VA form 6500, 6550, Risk Analysis, and MSD2 must be completed and signed by all parties before the contract can be awarded.

6.2.21. The instrument has a cap piercing ability and uses Becton Dickinson 5 ml Sodium Citrate sample tubes.

6.2.22. Continuous operation of testing without interruption while changing reagents during the test operation mode.

6.2.23. Technical support is provided for servicing instrumentation to prevent service interruptions to patient testing. One instrument must be fully operational at all times and service provided to comply with having a minimal of one instrument operational on a 24/7 basis.

6.2.24. The reportable ranges include extended reportable ranges.

6.2.25. The instruments printer capability must include the ability to print all patient results as required during computer downtime automatically.

6.2.26. The instrumentation has updated equipment available for offering sensitivities for detecting minimum number of reagents used for testing, bar-coded reagents, change reagents during operation, remote troubleshooting, on-board video troubleshooting, positive patient ID, and digital technology.

6.2.27. The instrument’s interfacing is comparable to the VA Vista test reporting format.

6.2.28. The instrument has a maximum database storage capacity of a minimum of 20,000 retrievable patient results.

6.2.29. The instrument’s methodology has first pass efficiency.

6.2.30. The instrument’s methodology is capable of producing accurate results without interference by lipemia, bilirubin, and hemolysis.

6.2.31. The instrument’s methodology is capable of detecting clots and reducing the amount of technologist exposure to biological samples.

6.2.32. The instrument’s reagents have a lengthy on-board stability, to minimize reagent waste, prep time, and storage requirements.

6.2.33. The instrument’s methodology has low hemolysis interference ratios.

6.2.34. The instrument’s methodology has a low-tech review rate of 10% or less.

6.2.35. The waste contains no increased azides or hazardous chemicals leading to increased hazardous exposure or disposal for the VA.

6.2.36. Compatible with current space limitations of not greater than 10 ft. long x 32 in. wide and 62 in. high (including the tabletop) in order to access the instrument from the rear and accommodate present workstations for two analyzers. It would be 5 ft. long, 32 in. wide, and 62 in. high for each instrument.

6.2.37. All startup reagents and controls will be provided by the contractor upon install at no additional cost to the VA facility.

6.2.38. 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 the equipment operations are not interrupted.

6.2.39. The reagents, supplies, quality controls, calibrators, standards, 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 for proper operation must be the same for both instruments and can be used interchangeably.

6.2.40. Vendor personnel are to perform software and equipment upgrades, training, and troubleshooting via phone if necessary.

6.2.41. Vendor will provide a peer review evaluation program of quality control results obtain by the facility.

6.2.42. Vendor will provide method validation studies required by CLIA and CAP regulatory agencies and shall cover precision, linearity, current system to new system correlations, as well as establishment of normal and therapeutic ranges.

6.2.43. The VA will provide the necessary samples for method validation and lot number conversions of the chosen test menu (PT/INR, PTT, Fibrinogen, and D-Dimer).

6.2.44. Vendor will perform lot-to-lot comparisons between the current lot of reagents and new lots of reagents that are utilized on the instrument throughout the contract period.

6.3. A QASP should mirror the above standards and be attached to the resultant contract.

6.4. Required registration with contractor performance assessment reporting system (CPARS).

6.5. QASP table:

On time; 100% within 7 days of requested ship date

7. SPECIAL CONTRACT REQUIREMENTS

7.1. CONTRACTOR SECURITY REQUIREMENTS (HANDBOOK 6500.6)-

7.1.1. General: contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same federal laws, regulations, standards, and VA directives and handbooks as VA and VA personnel regarding information and information system security.

7.1.2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

A. 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.

B. 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.

C. Contract personnel who require access to national security programs must have a valid security clearance. National industrial security program (NISP) was established by executive order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a memorandum of agreement with defense security service (DSS). Verification of a security clearance must be processed through the special security officer located in the planning and national security service within the office of operations, security, and preparedness.

D. The contractor or subcontractor must notify the contracting officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The contracting officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination VA information and information system security/privacy language

7.1.3. VA INFORMATION CUSTODIAL LANGUAGE

A. 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).

B. 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.

C. 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.

D. 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.

E. 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.

F. 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.

G. 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.

H. 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.

I. 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.

J. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. 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.

K. 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.

L. 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.

7.1.4. SECURITY INCIDENT INVESTIGATION

A. 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.

B. 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.

C. 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.

D. 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.

8.1.1 LIQUIDATED DAMAGES FOR DATA BREACH

A. 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.

B. 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.

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

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

(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.

8.1.2 TRAINING:

A. 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:

b. The contractor shall provide to the contracting officer and/or the COTR 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.

c. 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.

B.4 PRICE/COST SCHEDULE

ITEM INFORMATION

COST PER TEST AGREEMENT FOR THE PERIOD: OCTOBER 1, 2018 THROUGH SEPTEMBER 30, 2019.

Contract Period: Base POP Begin: 10-01-2018 POP End: 09-30-2019

LOCAL STOCK NUMBER: ACL TOP 350

INSTRUMENTS: TWO (2) ACL TOP 350 CTS SYSTEM: QTY. 1 COAG TOP TRADE-IN ALLOWANCE: QTY. 1 ACCESSORIES: KIT, 2D BARCODE UPGRADE: QTY. 2 INR VALIDATE: QTY. 6 PRINTER TOP, LEXMARK MS811N KIT: QTY. 2 S/S

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: CONSUMABLES

REAGENTS, CALIBRATORS AND CONTROLS, AND SOLUTIONS ESTIMATED MONTHLY CONSUMABLE SPENDING. SEE PRODUCT ADDENDUM FOR COMPLETE PRICING BREAKDOWN. SHIPMENTS OF REAGENTS AND SUPPLY PRODUCTS PL

POP Begin: 10-01-2018

COST PER TEST AGREEMENT FOR THE PERIOD: Option 1 Contract Period: Option 1 POP Begin: 10-01-2019 POP End: 09-30-2020

INSTRUMENTS: TWO (2) ACL TOP 350 CTS SYSTEM: QTY. 1 COAG TOP TRADE-IN ALLOWANCE: QTY. 1 ACCESSORIES: KIT, 2D BARCODE UPGRADE: QTY. 2 INR VALIDATE: QTY. 6 PRINTER TOP, LEXMARK MS811N KIT: QTY. 2 S/S

POP Begin: 10-01-2019

REAGENTS, CALIBRATORS AND CONTROLS, AND SOLUTIONS ESTIMATED MONTHLY CONSUMABLE SPENDING. SEE PRODUCT ADDENDUM FOR COMPLETE PRICING BREAKDOWN. SHIPMENTS OF REAGENTS AND SUPPLY PRODUCTS PL

POP Begin: 10-01-2019

COST PER TEST AGREEMENT FOR THE PERIOD: Option 2 Contract Period: Option 2 POP Begin: 10-01-2020 POP End: 09-30-2021

INSTRUMENTS: TWO (2) ACL TOP 350 CTS SYSTEM: QTY. 1 COAG TOP TRADE-IN ALLOWANCE: QTY. 1 ACCESSORIES: KIT, 2D BARCODE UPGRADE: QTY. 2 INR VALIDATE: QTY. 6 PRINTER TOP, LEXMARK MS811N KIT: QTY. 2 S/S

POP Begin: 10-01-2020

REAGENTS, CALIBRATORS AND CONTROLS, AND SOLUTIONS ESTIMATED MONTHLY CONSUMABLE SPENDING. SEE PRODUCT ADDENDUM FOR COMPLETE PRICING BREAKDOWN. SHIPMENTS OF REAGENTS AND SUPPLY PRODUCTS PL

POP Begin: 10-01-2020

COST PER TEST AGREEMENT FOR THE PERIOD: Option 3 Contract Period: Option 3 POP Begin: 10-01-2021 POP End: 09-30-2022

INSTRUMENTS: TWO (2) ACL TOP 350 CTS SYSTEM: QTY. 1 COAG TOP TRADE-IN ALLOWANCE: QTY. 1 ACCESSORIES: KIT, 2D BARCODE UPGRADE: QTY. 2 INR VALIDATE: QTY. 6 PRINTER TOP, LEXMARK MS811N KIT: QTY. 2 S/S

POP Begin: 10-01-2021

REAGENTS, CALIBRATORS AND CONTROLS, AND SOLUTIONS ESTIMATED MONTHLY CONSUMABLE SPENDING. SEE PRODUCT ADDENDUM FOR COMPLETE PRICING BREAKDOWN. SHIPMENTS OF REAGENTS AND SUPPLY PRODUCTS PL

POP Begin: 10-01-2021

COST PER TEST AGREEMENT FOR THE PERIOD: Option 4 Contract Period: Option 4 POP Begin: 10-01-2022 POP End: 09-30-2023

INSTRUMENTS: TWO (2) ACL TOP 350 CTS SYSTEM: QTY. 1 COAG TOP TRADE-IN ALLOWANCE: QTY. 1 ACCESSORIES: KIT, 2D BARCODE UPGRADE: QTY. 2 INR VALIDATE: QTY. 6 PRINTER TOP, LEXMARK MS811N KIT: QTY. 2 S/S

POP Begin: 10-01-2022

REAGENTS, CALIBRATORS AND CONTROLS, AND SOLUTIONS ESTIMATED MONTHLY CONSUMABLE SPENDING. SEE PRODUCT ADDENDUM FOR COMPLETE PRICING BREAKDOWN. SHIPMENTS OF REAGENTS AND SUPPLY PRODUCTS PL

POP Begin: 10-01-2022

B.5 DELIVERY SCHEDULE

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STATEMENT OF WORK

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SECTION C - CONTRACT CLAUSES

C.1 52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST (DEC 2011)

(a) Definitions. As used in this clause— "Acquisition function closely associated with inherently governmental functions" means supporting or providing advice or recommendations with regard to the following activities of a Federal agency:

(1) Planning acquisitions.

(2) Determining what supplies or services are to be acquired by the Government, including developing statements of work.

(3) Developing or approving any contractual documents, to include documents defining requirements, incentive plans, and evaluation criteria.

(4) Evaluating contract proposals.

(5) Awarding Government contracts.

(6) Administering contracts (including ordering changes or giving technical direction in contract performance or contract quantities, evaluating contractor performance, and accepting or rejecting contractor products or services).

(7) Terminating contracts.

(8) Determining whether contract costs are reasonable, allocable, and allowable.

"Covered employee" means an individual who performs an acquisition function closely associated with inherently governmental functions and is—

(1) An employee of the contractor; or

(2) A subcontractor that is a self-employed individual treated as a covered employee of the contractor because there is no employer to whom such an individual could submit the required disclosures.

"Non-public information" means any Government or third-party information that—

(1) Is exempt from disclosure under the Freedom of Information Act (5 U.S.C. 552) or otherwise protected from disclosure by statute, Executive order, or regulation; or

(2) Has not been disseminated to the general public and the Government has not yet determined whether the information can or will be made available to the public.

"Personal conflict of interest" means a situation in which a covered employee has a financial interest, personal activity, or relationship that could impair the employee's ability to act impartially and in the best interest of the Government when performing under the contract. (A de minimis interest that would not "impair the employee's ability to act impartially and in the best interest of the Government" is not covered under this definition.)

(1) Among the sources of personal conflicts of interest are—

(i) Financial interests of the covered employee, of close family members, or of other members of the covered employee's household;

(ii) Other employment or financial relationships (including seeking or negotiating for prospective employment or business); and

(iii) Gifts, including travel.

(2) For example, financial interests referred to in paragraph (1) of this definition may arise from—

(i) Compensation, including wages, salaries, commissions, professional fees, or fees for business referrals;

(ii) Consulting relationships (including commercial and professional consulting and service arrangements, scientific and technical advisory board memberships, or serving as an expert witness in litigation);

(iii) Services provided in exchange…