SoW.pdf

Department of Health and Human Services Indian Health Service

Lawton Indian Hospital

Statement of Work (SOW) Ortho Vision Automated Blood Bank System Purchase

1. PURPOSE OF THE PROJECT

The Lawton Indian Hospital, Indian Health Services has a requirement for an Ortho Vision Automated Blood Bank System with a 5-year extended warranty. This Ortho Vision System is required for use in the Blood Bank section of the Lawton Indian Hospital Laboratory where it will be used to ensure accurate & timely test results to front-line providers and provide the highest standard of patient care. The Vision System will interface with the Ortho ID-MTS Workstation, already purchased by the Lawton Indian Hospital Laboratory.

2. DETAILED DESCRIPTION OF THE TECHNICAL REQUIREMENTS

2.1. Equipment to be provided:

1. One New, non-refurbished, Ortho Vision Automated Blood Bank System, that meets the following criteria:

A. Must be compatible with the Ortho ID-MTS Workstation B. System must use Column agglutination technology C. The system must not utilize proprietary system liquids.

D. The system must offer up to 24hrs. of walkaway time.

E. When operational, the system must always be in a ready mode and at no time go into a hibernation or “sleep” state.

F. The system must have the capability for a minimum of three pre-diluted antibody identification panels that are FDA-cleared for use in conjunction with the instrument.

G. The system must be able to run selected cell antibody identification panels.

H. The vendor’s pre-diluted reagent red blood cells must utilize United States-based donors. Reagent red blood cells and column agglutination technology cards must use United States-based manufacturing.

I. The system must have the ability to be installed on a benchtop.

J. The system must have a pipette conditioning (e.g., dead) volume <20 µl.

K. The vendor must have a semi-automated option.

L. The vendor must have a demonstrated ability to supply automated and non-automated FDA-licensed reagents for blood bank or transfusion service testing under their brand.

M. The vendor must have FDA approval for automated confirmatory testing to include rare antisera including E, e, C, c, JKa, JKb, FYa, FYb, S, s, N, P1, Lea, Leb, K, and weak D.

N. A fully loaded waste container shall not weigh more than 11 lbs. and be accessible at waist height.

O. The optical resolution of the onboard camera must be at least 5-megapixel resolution down to 32 x

32 microns and store a digital image of both the front and back of each gel card to record test results.

P. The system must interface with the laboratory information system (LIS).

Q. The system must have an uptime in-service guarantee of 98%.

R. A Field Engineer must be within 100 miles.

S. Artificial Intelligence (AI) antivirus software is included for cybersecurity protection.

T. A business intelligence dashboard is available for real-time operational insights.

U. The system must have Authority to Operate (ATO) designation.

V. Capable of bi-directional interface to Laboratory Information System W. Customizable Workflow Settings to enable enhanced traceability and reporting X. Uses ID-MTS Gel technology Y. Includes Barcode Scanner Z. New & Not Refurbished AA. 5-Year Extended Warranty BB. Estimated annual test volume: 250 samples/year CC. Size/Space Limitations (Counter Top): Height 1-54” min-max

Depth 1-31” min-max Width 1-43” min-max

(W/Bench) Width 1-61” min-max Height 1-84” min-max Depth 1-31” min-max

2. The contractor shall provide the following all-inclusive services:

A. 5-Year Extended Warranty B. 24-hours-a-day, 7-days-a-week on-site or telephone technical support C. On-site training, installation, set-up and performance of all studies to correlate and/or validate reader D. Consumables necessary for installation, set-up & performance of all correlation and/or validation studies

The Extended Warranty shall include repair service calls as needed with telephone technical support and all travel, parts and labor costs included. Barcode Scanner must be supplied. The Preventive Maintenance and repair services contracts shall include an annual preventive maintenance visit and repair service calls as need with telephone technical support and all travel, parts, and labor costs included. The contractor shall provide a toll-free telephone number for service calls, which must be answered 24-hours-a-day, 7-days-a-week. The contractor shall provide install and set-up. The contractor shall perform all studies to correlate and/or validate instrument. The contractor shall provide on-site training post-installation.

3. PERIOD OF PERFORMANCE

The Period of Performance will be 12 months from date of award with four (4) twelve (12) month option years.

4. LEVEL OF EFFORT

4.1 Contractor shall deliver an Ortho Vision Automated Blood Bank System within 30 to 90 days from date of signature of contract. Contractor shall provide all consumables necessary for installation, set-up, performance of all correlation and/or validation studies within 30 to 90 days from date of signature of contract.

4.2 The contractor shall provide install & setup as part of the price of the contract. On-site correlations, calibrations, setup, precision studies, linearity studies & AMR studies will be included with install. All consumables necessary for installation, set-up, performance of all correlation and/or validation studies shall be provided within 30 to 90 days from date of signature of contract.

4.3 The contractor shall schedule maintenance in such a way that when it is started, it will be completed without interruption.

4.4 The contractor shall respond within twelve hours of a service request to confirm with Laboratory Medical

Technologist on a time to be on-site to provide necessary maintenance. Issues requiring technical support or service calls shall be resolved within three business days of initial call.

4.5 Training: Contractor shall provide on-site training post installation to site staff. Additional supplemental training would be provided as needed if there was a changeover in primary operator for the equipment.

4.6 The contractor shall provide a new, non-refurbished Ortho Vision Automated Blood Bank System from a line of technological standardized platforms that is compatible with the Ortho ID-MTS Workstation.

4.7 The vendor would provide a 5-year extended warranty. Additionally, this support agreement would provide for service calls when the equipment is experiencing issues that cannot be resolved through the telephone technical assistance services.

4.8 Deliverables to be received by Lawton Indian Hospital Laboratory include the following:

An Ortho Vision Automated Blood Bank System 5-Year Extended Warranty that includes repair services Barcode Scanner

5 SPECIAL REQUIREMENTS

5.1 In accordance with HHSAR 304.1300(b) non-routine contractor employees shall comply with OPDIV

DHHS/SE Region – Human Resources, Security Clearance Guidance – Visitors (3/29/12) policy for contract performance period. Contractor employees will be required to obtain a visitor’s pass upon arrival for services from Facilities Management.

5.2 The US PHS Lawton Indian Hospital is a tobacco/smoke free environment (buildings and grounds). No tobacco/smoking use will be tolerated during service.

5.3 Security Requirements: Contractor personnel will be required to contact the government designated point of contact upon arrival when reporting for service calls or delivery supplies. The contractor shall be responsible for the security of all organizational information. Current rules and regulations applicable to the premises, where the work shall be performed shall apply to the contractor and its employees while working on the premises. These regulations include but are not limited to, escort by Lawton Indian Hospital official, presenting valid identification, smoking restriction and any safety procedures.

5.4 The contractor shall not disclose or cause to disseminate any information concerning operations of Lawton

Indian Hospital. Such action(s) could result in violation of the contract and possible legal actions.

5.4.1 All inquiries, comments, or complaints arising from any matter observed, experienced or learned of as a result of or in connection with the performance of the contract, the resolution of which may require the dissemination of official information, shall be directed to the government’s designated representative.

5.5 Termination Amortization Schedule: A termination amortization schedule shall be included as an attachment of the awarded contract. If the Government does not exercise any of the options listed in the price / cost schedule, the Government’s not exercising the options will have the same effect as if the Government terminated for convenience. All remedies afforded to contractor in regards to a termination for convenience shall be available to the contractor.

6 DELIVERABLES AND REPORTING REQUIREMENTS

6.1 Delivery: The contractor will coordinate the delivery, installation and training date with the designated government employee. Items will be delivered by a standard shipping source. The government will provide the contractor with dock access and building access for this sole purpose. The designated government employee will work with the pertinent government agency(ies) to secure the needed dock access. No deliveries can be made after 4:15pm. Deliveries cannot be made on weekends or Federal Holidays. Driver needs a valid ID.

6.2 Contractor Point of Contact: The contractor shall furnish one designated point of contact (POC) to the government’s designated representative for coordination of supplies, delivery, and/or maintenance. The POC will be empowered to make daily decisions to ensure that the contract implementation and day-to-day maintenance meets the terms and conditions of this contract.

6.3 Contractor’s Phone Numbers: The contractor shall provide a toll-free telephone number for service calls, which must be answered 24-hours-a-day, 7-days-a-week.

6.4 Personnel Qualifications:

Contractor shall be authorized, trained & certified by instrument manufacturer to provide maintenance & support on the supplied instruments.

7 GOVERNMENT FURNISHED PROPERTY, FACILITIES AND SERVICES

7.1 The Government shall supply use of government furnished facility space for the provision of services set forth in the contract only.

8 CONTRACTOR FURNISHED PROPERTY, FACILITIES AND SERVICES

8.1 Required personnel, materials, supplies and equipment: The contractor shall furnish all personnel, materials, supplies and equipment required to perform work under the contract, to include but not limited to listed supplies, consumables & parts.

9. CHANGES TO THE STATEMENT OF WORK (SOW)

Any changes to this SOW shall be authorized and approved only through written correspondence from the Contracting Officer. Costs incurred by the contractor through the actions of parties other than the Contracting Officer shall be borne by the contractor.

10. DELIVERABLES/PERFORMANCE MATRIX

10.1 A new, non-refurbished Ortho Vision Automated System Yes No

10.2 Installation, set-up, training and correlations/validations performed Yes No

10.3 Extended Warranty provided Yes No

10.4 Barcode Scanner provided Yes No

Department Supervisor Signature:_________________________

Administrative Officer Signature:_________________________