Statement of Work.pdf

STATEMENT OF WORK

Polymedco OC-Auto SENSOR DIANA

I. INTRODUCTION

Alexandria VA Health Care System (AVAHCS) currently uses the OC-Auto® Micro 80 analyzer to perform fecal immunochemical testing (FIT) for the detection of fecal occult blood.

Polymedco is sunsetting this analyzer, along with service/support, in 2026.

In an effort to support VISN-wide standardization of the Polymedco family of instruments, to continue use of existing FIT collection vials, and to utilize existing the VISN BPA for pricing of reagents and consumables and service per contract terms, the Alexandria VA Health Care System (AVAHCS) is requesting sole source procurement with Polymedco Cancer Diagnostic Products, LLC to provide the OC-Auto SENSOR DIANA instrument for fecal occult blood testing located at the located at the Alexandria VA Medical Center, Pathology & Laboratory Medicine Service, 2495 Shreveport Highway, Pineville, Louisiana, 71360.

II. SCOPE

In the measurement of occult blood, the instrument must 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).

As guaiac-based testing and other CLIA-waived methods are shown to have lower sensitivity and specificity, the Alexandria VA is requiring moderately complex immunochemical methodology to support better detection of advanced colorectal neoplasms.

III. PERIOD OF PERFORMANCE

This contract is for the purchase of one (1) OC-Auto SENSOR DIANA Analyzer with a 1-year Manufacturer’s Warranty. ).

IV. EQUIPMENT SPECIFICATIONS

Must be a moderate complexity fecal immunochemical test (FIT)

Must be automated

Must be able to fit in the allocated space (30”x24”x24”)

Must be FDA approved for one specimen per patient

Must be able to interface with Vista or Cerner, whichever LIS system is being used at the time.

Must have barcoded sample processing for interfacing and reporting of results.

Must be compatible with Data Innovations middleware.

Calibration must be easily performed and must maintain stability on the analyzer between calibrations.

Calibrators must be traceable to a recognized national standards organization as stated by the Clinical and Laboratory Standards Institute (CLSI) and/or College of Clinical Pathology (CAP).

V. REQUIREMENTS:

a. Transportation: Equipment will be delivered by Contractor to the Pathology and Laboratory Medicine Service of the Alexandria VA Medical Center. Equipment will be installed and set up by Contractor.

c. Installation: The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation or anything that will affect optimum performance once installation is completed. If progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated, and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed.

d. Training: The contractor shall provide the services of a qualified technical person, at the time of equipment installation and at such time designated by Contracting Officer (CO) or Contracting Officer's Representative (COR) to on-site orientation and training to designated personnel in:

operation and care of equipment; techniques and procedures recommended by manufacturer to achieve maximum dependable, efficient, and economical utilization of equipment. Training for a minimum of 2 personnel shall be provided to ensure the equipment maintenance necessary to fulfill the test requirements. This training shall include actual demonstration and operation of the equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment. This training shall include at least (1) on-site training sessions upon installation and acceptance of equipment.

e. Site Preparation Specifications shall be furnished in writing by the contractor as part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer’s claimed specifications.

The government shall prepare the site at its own expense and in accordance with the specifications furnished by the contractor. Any alterations or modifications in site preparation which are attributable to incomplete or erroneous specifications provided by the contractor which would involve additional expense to the government, shall be made at the expense of the contractor.

f. Service & Maintenance:

Contractor will provide operator’s manual and CLSI procedures for operation.

Contractor must provide a timeline for phase-in, delivery and installation of proposed equipment, and training of end users.

6. Performance Monitoring

a. 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 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.

1.1.a.1. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

1.1.a.2. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled “Termination for cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

1.1.a.3. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

1.1.a.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. [reference: Master FSS]

1.1.a.5. The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

1.1.a.6. 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. [reference: Master FSS] Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment.

7. Security Requirements

Service & Maintenance will follow the security requirements as per VA’s Medical Device Protection Program (MDPP) which protects VA’s medical devices through a comprehensive security initiative that encompasses pre-procurement assessments, medical device isolation architecture (MDIA), communication, validation, scanning, access control list remediation, patching, and secure remote connectivity.

7.1 General Security

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.

7.2 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.

A BI is not required per VA Information and Information System Security/Privacy Requirements for IT Contracts dated August 2008 if the following exception applies:

Contract Personnel with limited and intermittent access to equipment connected to facility networks on which limited VA sensitive information may reside, including medical equipment contractors who install, maintain, and repair networked medical equipment such as CT scanners, EKG systems, ICU monitoring, etc. In this case, Veterans Health Administration facilities must have a duly executed VA Business Associate Agreement (BAA) in place with the vendor in accordance with VHA Handbook 1600.1, Business Associates, to assure compliance with the Health Insurance

Portability and Accountability Act of 1996 (HIPAA) in addition to the contract. Contract personnel, if on site, should be escorted by VA IT Staff.

7.3 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:

(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;

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

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

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.

7.4 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. 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.

7.5 Information Systems Hosting, Operations, Maintenance, or Use

a. 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:

(1) Vendor must accept the system without the drive;

(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

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

(4) 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;

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

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract.

(c) 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.

7.6 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.

7.7 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. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

b. 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:

(1) Notification;

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

(3) Data breach analysis;

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

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

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

7.8 SYSTEM INTERCONNECTIONS

a. Computer System interconnections between VA Systems on the VA Network and VA Business Partner Systems residing outside the VA Network will require a signed Memorandum of Understanding (MOU) and Interconnection Security Agreement (ISA) collectively known as MOU ISA between the VA and the VA Business Partner.

8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

N/A

9. Other Pertinent Information or Special Considerations.

a. Identification of Possible Follow-on Work.

Any additional work that may result from completion of this contract, which may be added at a later date as a modification to this contract, or that may be helpful to the contractor in determining the best overall approach for the contract.

b. Identification of Potential Conflicts of Interest (COI).

N/A

c. Identification of Non-Disclosure Requirements.

N/A

Contractors must execute non-disclosure agreements when they work with sensitive and/or proprietary information. Your SOW must identify any sensitive or proprietary information to which the contractor will have access during contract performance so the non-disclosure agreements can be signed by the time the contract is awarded.

d. Packaging, Packing and Shipping Instructions.

Vendor will need to coordinate delivery & install with P&LMS.

e. Inspection and Acceptance Criteria.

The COR is responsible for certifying that the work done under the contract is performed to time and standard. They are also responsible to assure the inspection and acceptance of products provided incidental to services. A demo period or trial is not inspection of a product.

10. Risk Control

N/A

11. Place of Performance.

Alexandria VA Medical Center, Bldg 7, 3rd Floor Pathology & Laboratory Medicine (113) 2495 Shreveport Hwy Pineville, LA 71360

12. Period of Performance.

One year from Contract for manufacturer’s warranty.

13. Delivery Schedule.

N/A