VISN Point of Care (POC)

STATEMENT OF WORK (SOW)

Point of Care Testing

1. SCOPE:

1.1 Contractor shall provide all equipment, reagents, standards, controls, printers and any other item required for the proper operation of its' contractor owned analyzers and peripherals necessary for the generation of a combination of the following test results: blood gas and blood gas with HCT (arterial, venous, mixed venous), chemistry testing (glucose, creatinine, Sodium, Potassium, chloride, BUN, ionized calcium, lactic acid), Hemoglobin/hematocrit, troponin, Kaolin and Celite Activated Clotting Time, fingerstick INR and other possible tests for cost per test (CPT) services on behalf of the VA (Veterans Administration) Eastern Colorado Health Care System (ECHCS), 1055 Clermont Street, Denver, CO 80220; Cheyenne VA Medical Center, 2360 East Pershing Blvd., Cheyenne, WY 82001; Grand Junction VA Medical Center, 2121 North Ave, Grand Junction, CO 81501; Oklahoma City VA Health Care System, 921 NE 13th Street, Oklahoma City, OK 73104 (beginning year 2); Jack C. Montgomery VA Medical Center, 1011 Honor Heights Drive, Muskogee, Oklahoma 74401 (beginning year 2); VA Montana Healthcare System, 3717 Veterans Drive, Ft. Harrison, Montana 59636; Sheridan VA Health Care System, 1898 Fort Road Sheridan, WY 82801 and Billings Montana VA Health Care System 1766 Majestic Lane, Billings, MT 59102 . Services shall be required for a 5 year BPA.

1.2 Analyzers are specialized instruments for the testing of specific parameters of whole blood for therapeutic monitoring and routine screening. The analyzer(s) offered by the contractor shall be portable, bedside units for use primarily in the clinical areas of the hospital. Services shall be provided to the Laboratories as in 1.1.

2. DEFINITION/ACRONYMS:

1. Cost Per Test (CPT): The loaded cost charged to the VA by the contractor each time the equipment is used by the VA. The loaded cost shall be all inclusive and incorporate, as a minimum, the following:
(a) Equipment use
(b) All reagents, standards, controls, supplies, parts, accessories and any other item required for the proper operation of the contractor's equipment
(c) Any software or program necessary for data management
(d) Any middleware necessary for the generation and reporting of a test result in VISTA. This middleware must not interfere with other middleware systems.
(e) All necessary maintenance to keep the equipment in good operation condition (this element includes both preventive maintenance and emergency repairs).
(f) Training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.
2. CAP - College of America Pathologists
4. JC - Joint Commission
5. QC - Quality Control
6. VISTA - Veterans Information System and Technology Architecture

3. GENERAL REQUIREMENTS:

3.1 Offered models of clinical laboratory analyzers shall be capable of producing accurate and reproducible assays on blood by established in vitro diagnostic methods. Models shall provide accurate test assay result for sample specimens up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

3.1.1 Offered equipment shall be current state-of-the-art equipment. Discontinued models will not be accepted.

3.1.2 The awarded contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government. The contractor shall provide or include in the Cost per Test technical support for the software programs required for data management and interfacing results into VISTA. These enhancements shall be delivered and installed at each participating VISN 19 medical facility within 60 days of issuance to the commercial market.

3.1.3 The 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 manufactured as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

3.1.4 An operator's manual shall be furnished with each instrument supplied to VA and updates to the manual shall be provided within 60 days of issuance to the commercial market.

3.1.5 Contractors offered analyzer shall conform to all facilities' existing space constraints. The hand held portable point of care unit, capable of being used at the bedside, provided by the contractor shall fit within an approximate 12" X 12" X 12" space.

3.2 In the event that the consumables 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 shall ship the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall ship to all participating facilities 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).

3.3 Reagents, Supplies and Disposable: These items shall be of the highest quality ensuring sensitivity, specificity and tested to assure precision and accuracy. The quality of the products shall be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission (TJC).

3.4 Maintenance and Repairs:

3.4.1 Emergency repairs and/or replacements shall be performed after initial telephone notification that the equipment fails any parameters. The contractor shall provide the Government with a designated point of contact and telephone number and shall make arrangement to enable his maintenance representative to receive such notification.

3.4.2 The contractor shall repair or replace (replace defined as in place and functioning in the facility), at any/all locations specified in the Statement of Work, any malfunctioning equipment within forty eight (48) hours after receipt of initial telephone notification of a malfunction. Contractor shall provide technical support service to assist in troubleshooting 24-hours per day, seven days per week including Federal holidays.

3.4.3 Training and installation: Contractor shall provide training, installation and validation assistance as needed by each facility.

4. SPECIAL REQUIREMENTS: In addition to the general requirements for the Cost-Per-Test requirements stated above, the contractor's instrument and system shall meet the following special requirements:

4.1 The contractor's unit shall have software/middleware that is fully VISTA compatible, capable of simultaneous data transfer from the unit to the VISTA system (without upgrade or other software modification to VISTA), and all hardware /software necessary to transfer data into patient files in VISTA shall be provided at no additional cost to the VA.

4.2. System shall provide appropriate quality control analysis and all components necessary to interface with VISTA.

4.3 Shall have auto quality control to meet CAP standards (minimum 1 level per 8 hour shift).

4.4 Provide QC lock out and operator lock out.

4.5 QC shall be available in Levy Jennings format, or statistical reporting available.

4.7 Shall have ability to run venous, mixed-venous and arterial samples for blood gases.

4.8 Shall provide a
4.9 Shall provide data management of patient and QC results with remote access.

4.10 Shall be capable of operating at high altitudes with no interferences.

4.11 Shall provide calibrations per CAP requirements.

4.12 Requires minimal maintenance.

4.13 Shall provide ease of use.

4.14 Shall have ability to correct for patient temperature, if required, for blood gases.

4.15 Shall be easy to troubleshoot.

4.16 All controls and calibrators shall be included in the CPT.

4.17 Instruments shall be moveable for transport to bedside without recalibration.

5. General Requirements of Connectivity solution:

5.1 Facility contact information as below:

Facility Name Contact Person Contact Number Email address
VA Montana WEST Rachael Abelin 406-447-7512 Rachael.abelin@va.gov

VA Montana EAST Robert Riplett 406-373-3900 Robert.riplett@va.gov

VA Cheyenne Melinda Woodworth 307-778-7550 x7098 Melinda.woodworth @va.gov

VA Billings Sandra Dunning 406-373-3901 sandra.dunning@va.gov

VA Grand Junction Katy Lashell 970-242-0731 x2257 Kathleen.kadlec@va.gov

Sheridan VA HCS Nina Williams
Mary Redman 307-675-3681 nina.williams3@va.gov
mary.redman2@va.gov

VA ECHCS Shawn Froom 303-399-8020 x2714 Shawn.froom@va.gov

Jack C. Montgomery VAMC Pete Amann 918-577-3690 Pete.amann@va.gov

Oklahoma City VA Health Care System Trenda Brown 405-456-5243 Trenda.McFarland@va.gov


5.2 The middleware uses direct device connectivity. The instruments should connect directly to the middleware which will connect directly to the laboratory information system (LIS).

5.3 If an upgrade to a data manger is required for improved test system management, the middleware connectivity should be able to accommodate these upgrades at no extra charge to the facility.

5.4 Single program point of contact for point of care administrators. The point of care administrator will be able to manage the instruments connected as well as all of the point of care users from one system.

5.5 The middleware system should be able to produce standard laboratory reports; which may include statistics.

5.6 Standard training, instruction, and consultation for the customer are required.

5.7 The middleware system must be compliant with all Office of Information and Technology regulations.

5.8 There will be no minimum or maximum number of instruments required to be connected to the middleware and all connection costs will be included in offer.

5.9 The program should provide secure email function within its program.

5.10 Can capture test results and manage quality control and operator information.

5.11 Annual support fees shall be a set all-inclusive cost and shall not be modified due to additional testing locations or additional docking station locations. No annual device or location license fee.

5.12 The middleware system shall handle multiple time zones.

5.13 Supports Advance quality control features.

5.14 Must be capable of both HL7 and scripted interface.

5.15 Must support solicited and unsolicited interface.

5.16 Must be able to provide historical quality control data without loss of lot specific information.

5.17 Middleware must be able to display in Levey-Jennings chart all results of quality control immediately on use.

6. TRANSITION PERIOD: Upon award, the transition period for the awarded contractor to have all required analyzer's, peripherals, consumables, training, correlation studies, reagents, controls, interfaces, etc., installed and fully operational shall be within 30 calendar days after award. Offerors shall provide with its' offer a plan for transitioning services from the incumbent contractor to the new awarded contractor. Contractor's submitted transition plan shall not exceed the required 30 day period contained herein. Failure of the contractor to conform to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract. The VA shall have sole discretion in the decision to terminate for failure to comply.

7. INFORMATION SECURITY AND PRIVACY:

7.1 VA INFORMATION CUSTODIAL LANGUAGE 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).

7.2 SECURITY INCIDENT INVESTIGATION 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 COR 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.

7.3 LIQUIDATED DAMAGES FOR DATA BREACH
7.3.1 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.

7.3.2 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:
(a) Notification;
(b) One year of credit monitoring services consisting of automatic daily monitoring of at least
3 relevant credit bureau reports;
(c) Data breach analysis;
(d) Fraud resolution services, including writing dispute letters, initiating fraud alerts and
credit freezes, to assist affected individuals to bring matters to resolution;
(e) One year of identity theft insurance with $20,00.00 coverage at $0 deductible; and
(f) Necessary legal expenses the subjects may incur to repair falsified or damaged credit
records, histories, or financial affairs.

7.4 TRAINING
7.4.1 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:

(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 Privacy and Information Security Awareness and Rules of Behavior training and annually complete required privacy and security training; and
(3) Successfully complete any additional information security or privacy training, as required for VA personnel with equivalent information system access.

7.4.2 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.

7.4.3 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.