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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 04, 2016 FBO #5368
DOCUMENT

Q -- Point of Care - Attachment

Notice Date: 8/2/2016
Notice Type: Attachment
NAICS: 621511 — Medical Laboratories
Contracting Office: Department of Veterans Affairs;Network Contracting Office;NCO 19;4100 E. Mississippi Avenue, Suite 900;Glendale CO 80246
ZIP Code: 80246
Solicitation Number: VA25916Q0396
Response Due: 8/8/2016
Archive Date: 9/7/2016
Point of Contact: Cynthia Reese
E-Mail Address: Contract Specialist
(cynthia.reese@va.gov)
Small Business Set-Aside: Total Small Business
Description: STATEMENT OF WORK (SOW) Point of Care Testing 1. SCOPE: 1.1Contractor 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. 1.2Analyzers 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: 3.1Offered 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. 3.1.1Offered equipment shall be current state-of-the-art equipment. Discontinued models will not be accepted. 3.1.2The 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. 3.1.3The 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. 3.1.4An 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. 3.1.5Contractors 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. 3.2In 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). 3.3Reagents, 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). 3.4Maintenance and Repairs: 3.4.1Emergency 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. 3.4.2The 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. 3.4.3Training 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: 4.1The 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. 4.3Shall have auto quality control to meet CAP standards (minimum 1 level per 8 hour shift). 4.4Provide QC lock out and operator lock out. 4.5QC shall be available in Levy Jennings format, or statistical reporting available. 4.7Shall have ability to run venous, mixed-venous and arterial samples for blood gases. 4.8Shall provide a <5 minute turnaround time for tests other than immunoassay and coagulation tests which shall be <20 minutes. 4.9Shall provide data management of patient and QC results with remote access. 4.10Shall be capable of operating at high altitudes with no interferences. 4.11Shall provide calibrations per CAP requirements. 4.12Requires minimal maintenance. 4.13Shall provide ease of use. 4.14 Shall have ability to correct for patient temperature, if required, for blood gases. 4.15Shall be easy to troubleshoot. 4.16All controls and calibrators shall be included in the CPT. 4.17Instruments shall be moveable for transport to bedside without recalibration. 5. General Requirements of Connectivity solution: 5.1Facility contact information as below: Facility NameContact PersonContact NumberEmail address VA Montana WESTRachael Abelin406-447-7512Rachael.abelin@va.gov VA Montana EASTRobert Riplett406-373-3900Robert.riplett@va.gov VA CheyenneMelinda Woodworth307-778-7550 x7098Melinda.woodworth @va.gov VA BillingsSandra Dunning 406-373-3901 sandra.dunning@va.gov VA Grand JunctionKaty Lashell970-242-0731 x2257Kathleen.kadlec@va.gov Sheridan VA HCSNina Williams Mary Redman307-675-3681nina.williams3@va.gov mary.redman2@va.gov VA ECHCSShawn Froom303-399-8020 x2714Shawn.froom@va.gov Jack C. Montgomery VAMCPete Amann918-577-3690Pete.amann@va.gov Oklahoma City VA Health Care SystemTrenda Brown405-456-5243Trenda.McFarland@va.gov 5.2The middleware uses direct device connectivity. The instruments should connect directly to the middleware which will connect directly to the laboratory information system (LIS). 5.3If 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. 5.4Single 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. 5.5The middleware system should be able to produce standard laboratory reports; which may include statistics. 5.6Standard training, instruction, and consultation for the customer are required. 5.7The middleware system must be compliant with all Office of Information and Technology regulations. 5.8There 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. 5.9The program should provide secure email function within its program. 5.10Can capture test results and manage quality control and operator information. 5.11Annual 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. 5.12The middleware system shall handle multiple time zones. 5.13Supports Advance quality control features. 5.14Must be capable of both HL7 and scripted interface. 5.15Must support solicited and unsolicited interface. 5.16Must be able to provide historical quality control data without loss of lot specific information. 5.17Middleware 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: 7.1VA 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). 7.2SECURITY 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. 7.3LIQUIDATED DAMAGES FOR DATA BREACH 7.3.1Consistent 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. 7.3.2Based 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. 7.4TRAINING 7.4.1All 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. 7.4.2The 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. 7.4.3Failure 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.
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VARMCCC/VARMCCC/VA25916Q0396/listing.html)
Document(s): Attachment; File Name: VA259-16-Q-0396 VA259-16-Q-0396_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2916704&FileName=VA259-16-Q-0396-000.docx); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2916704&FileName=VA259-16-Q-0396-000.docx; Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
Place of Performance: Address: VISN 19 - five (5) stations in multiple states.; Zip Code: 80246
Record: SN04205391-W 20160804/160802235522-0d018be241c8972e33e2cac35b66444f (fbodaily.com)
Source: FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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Q -- Point of Care - Attachment