ATTACHMENT A - SOW - CURIAN ANALYZER.docx

STATEMENT OF WORK

Curian HpSA Assays, Analyzer, Equipment and Consumables

SECTION A

1. INTRODUCTION, DESCRIPTION, AND SCOPE OF THE CONTRACT

1.1. It is the intent of the Department of Veterans Affairs, Phoenix Healthcare System to establish a Blanket Purchase Agreement (BPA) for HpSA reagent cartridges. The BPA shall be procured as Cost Per Test (CPT).

1.2. The Contractor shall provide all equipment, reagents, standards, controls supplies, parts, accessories, service maintenance, including network support, training, installation, shipping, and any other item required for the proper operation of all equipment and supplies necessary for reading H. pylori stool antigen (HpSA) test and providing an automated analyzer readout throughout cost per test (CPT) services on behalf of VA Phoenix Healthcare System.

1.3. Place of Delivery: All supplies and services in support of this requirement shall be delivered to and performed at the location listed below. Additional Facilities may be added to this contract with an exercise of a supplemental agreement between the CO and Contractor. Line items within the schedule reflect the overall volume and take into consideration the potential of additional quantities for all line items needed to support future locations.

1.3.1. Phoenix VA Healthcare System

650 East Indian School Rd. Phoenix, AZ 85012

1.4. VA Phoenix Healthcare System has provided estimated requirements below. Additional quantities for analyzers, barcode scanner, keyboard, and printer may be added.

Phoenix VA Healthcare System plus CBOCs Curian Analyzers – 1 with additional units as needed Barcode Scanner – 1 with additional units as needed Keyboard 1 – with additional units as needed Printer 1 – with additional units as needed

2. PERIOD OF PERFORMANCE:

2.1. Base Period: (To Be Determined (TBD) upon award)

2.2. Overall with Options: (TBD upon award)

3. DEFINITIONS/ACRONYMS

3.1. Cost Per Test (CPT): The loaded cost charged to the VA by the contractor per each test that can be performed on its proposed equipment. The loaded cost shall be all inclusive and incorporate, as a minimum, the following:

3.1.1. equipment use,

3.1.2. all reagents, supplies, consumables, parts, accessories, and any other item required for the proper operation of the contractor’s equipment.

3.1.3. all necessary maintenance to keep the equipment in good operation condition (this element includes both preventive maintenance and emergency repairs).

3.1.4. training for Government personnel

3.1.5. delivery, installation and removal of equipment.

3.2. QC – Quality Controls

4. Business Associate Agreement (BAA) - A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule (see Attachment D – Business Associate Agreement Template).

SECTION B

5. MINIMUM TECHNICAL REQUIREMENTS

5.1. The analyzer must be capable of reading H. pylori stool antigen (HpSA) test and providing an automated analyzer readout.

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5.2. The analyzer must be capable of transmitting results into VISTA using existing Data Innovation Instruments Manager middleware.

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5.3. The analyzer must be FDA-Cleared.

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5.4. Verification samples must have a > 90% agreement with all test results.

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5.5. QC and calibration for all equipment must have a 100% pass rate.

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6. STATEMENT OF WORK

6.1. In addition to the general requirements for the Cost-Per-Test stated above, the contractor shall meet the following requirements for instrumentation and consumables pertaining to all Glucometer related testing.

6.2. The contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government. The contractor shall provide technical support for the software programs required for data management and interfacing results into VISTA. These enhancements shall be delivered and installed at the medical facility within 60 days of issuance.

6.3. The contractor shall provide access to digital operator’s manual for all instruments supplied under the awarded BPA, for the entire duration of this BPA, including all option years.

6.4. The system shall be easily able to accommodate standard infection control practices such as isolation protocols and cleaning in-between patients with most common hospital approved disinfectants and/or wipes.

6.5. All instruments, controls, calibrators, and reagents shall be included in the CPT.

6.6. Additional supplies purchased through this BPA shall be covered for all necessary, training, installation, service, and maintenance to keep the equipment in good operation condition (this element includes both preventive maintenance and emergency repairs) stated in the SOW and RFQ.

6.7. The contractor shall be responsible for supporting all aspects of the installation of the analyzer and all accessories, as needed.

6.8. The contractor shall provide training on all aspect of the analyzer operation during the initial installation and implementation phase.

6.9. The contractor shall provide service on all equipment for the life of the lease.

6.10. The contractor shall replace the analyzer, barcode scanner, keyboard, and printer should they become irreparable and shall be responsible for all cost associated with their placement.

7. MAINTENANCE REQUIREMENTS

7.1. Emergency repairs 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 the maintenance representative to receive such notification.

7.2. 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 maintenance coverage 24-hours per day, five days per week including all Federal holidays. Contractor shall provide technical support service to assist in troubleshooting 24-hours per day, seven days per week including Federal holidays.

7.3. Contractor shall provide written report/email of notification of corrective action.

7.4. Should the repair record of any individual piece of laboratory equipment reflect a downtime of 5% of greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government at the using facility to replace the equipment requiring repair(s) with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instruction, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 95% in each month of the term of the agreement.

7.5. Training: All shifts shall be provided operator training and end user training resources required to fully train 100% of end users working on the 1st shift.

8. TRANSITION PERIOD:

8.1. Upon award, the transition period for the awardee to have all required analyzer’s, peripherals, consumables, training, correlation studies, reagents, controls, interfaces, etc., installed and fully operational shall be within 2-months of award. Offerors shall provide with its’ proposal 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.

9. DELIVERY: The Contractor shall deliver all supplies and services identified in the schedule to the locations identified in Section 1.5.

9.1. The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The facility Person of Contact (Hereafter referenced as facility POC) shall be required to notify the Contractor when delivery locations have been changed.

9.2. Deliveries shall be made during normal working hours from 8:00am to 4:00pm and a copy of the packing list/slip shall be provided at time of delivery. The packages packing list/slip shall contain the complete purchase order number, contract number, shipping address, delivery location, items/quantity ordered, and items/quantity shipped. Orders for equipment shall be delivered within no more than 30 working days after receipt or placement of order. Orders for all consumables shall be delivered within no more than 3 working days.

9.3. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

10. HOURS OF WORK

10.1. The contract shall include a full-service agreement to include all necessary service calls minimum equal to five (5) days a week, nine (9) hours a day. Contractor shall also provide technical support via phone seven (7) days a week, twenty-four (24) hours a day. After hours and weekends in person service are chargeable as per line items within Attachment A.

10.2. Any service performed during other than normal work hours must be approved in advance by the facility POC or CO.

10.3. Holidays: Only emergency service shall be provided on National Holidays and only if authorized by the facility POC in advance as approved in the delegation of authority. The rates shall be chargeable as per Attachment A.

10.4. When a National Holiday falls on a Sunday, the following Monday shall be observed as a National Holiday. When a National Holiday falls on a Saturday, the proceeding Friday is observed as a National Holiday by U.S. Government agencies. Also included, would be any other day, specifically declared by the President of the United States of America to be a National Holiday.