SOW-Lab Histology Equipment SMA.pdf

STATEMENT OF WORK

1. Contract Title. Lab Histology Equipment Service Maintenance Agreement (SMA).

For VA owned Histology Lab Equipment for the VA Texas Valley Coastal Bend (VCB) Health Care System, 2601 Veterans Drive, Harlingen, TX 78550.

2. Background.

This service contract is required to keep the Richard Allen Scientific (a subsidiary of Epredia Holdings) equipment operational to OEM specifications for repair and preventative maintenance. Biomed currently does not have the training or equipment necessary to service this equipment to meet OEM specifications.

3. Scope of Work.

Epredia shall provide all the management, tools, supplies, equipment and labor necessary to maintain and repair government owned equipment listed in section 4.3.1 located at the VA campus in Harlingen, TX. Service maintenance, preventative maintenance and repair task shall be in accordance with the procedures recommended by the respective Original Equipment Manufacturer (OEM). The certified contractor/vendor/Full-time Equivalent (FTE) must be an Epredia trained certified service technician and provide a manufacturer technical training certificate from the OEM if requested. Only OEM parts can be used and any refurbished parts have to come from the OEM and if requested documentation must be provided for parts origins.

Epredia shall provide copies of all field service maintenance work orders related to the equipment listed in section 4.3.1 Epredia shall furnish all propriety parts, paints, lubricants, cleaning supplies, special tools, service manuals, software updates, firmware updates, hardware updates, and diagnostic equipment that are necessary to service, maintain, and certify as required.

4. Specific Tasks.

4.1.1. Service Call Response: The Contracting Officer’s Representative (COR) will act as the first responder to establish the severity of the failure. The Biomedical Department or COR will then notify the contractor’s Customer Service Dispatch Office to initiate a service call. The contractor shall respond by phone within 8 hours, and the certified service technician will arrive at the hospital to start the repair request within 48 hours not including Saturday, Sunday and federal holidays of initial service call.

4.1.2. Preventative Maintenance: Epredia shall ensure that all equipment listed in section

4.3.1 is maintained to the OEM’s specifications and recommendations by performing Preventive Maintenance (PM) task. Epredia shall ensure all equipment listed operates safely, are clean, free of defects, and free of corrosion. Epredia shall minimize disruptions and inconveniences to users and complete the PM within the first fifteen business days of the month the PM is scheduled. If unable to complete scheduled service within the first 15 business days, the Biomed Department or COR must be notified prior to the last business day. Copies of the PM Service reports must be provided to the Biomedical Supervisor and COR.

4.1.3. Schedule: A minimum of one business work week prior to scheduling a preventative maintenance (PM) visit to the medical center, the contractor shall call the COR at 956-453-9952 or Biomed Supervisor at 956-291-9096 to verify equipment availability for inspection.

4.1.4. Signs, Barriers, and Labels: If a hazardous condition might exist the contractor shall place signs and all necessary barriers to warn of a potentially hazardous condition or equipment. A signed and dated label indicating the contractors’ name, date of service/pm and next service/pm due date and initials of service technician shall be prominently affixed to the equipment.

4.1.5. Property Control: The contractor shall obtain approval of the COR before removing any item from its existing location on campus.

4.1.6. Equipment Repair Service: After notification of service requirement, unless otherwise approved by the COR, the Epredia shall return the equipment to operational condition within 48 hours (not including weekends or government holidays). The contractor shall notify the Biomedical staff and COR when any replacement part must be ordered, repair delays are expected and availability of loaner equipment. The contractor must sufficiently notify users of the expected delay and provide a replacement or loaner at no cost to the VA via next day delivery of the same kind in the event that the repair time exceeds 10 work days.

4.1.7. Parts: All replacement parts will be new OEM parts. No reconditioned or remanufactured parts are acceptable unless they meet or exceed OEM’s specifications for reconditioning. Only OEM parts can be used and any refurbished parts have to come from the OEM and if requested documentation must be provided for parts origins. The contractor shall not exceed established repair cost limits without prior approval by the contracting officer. Contractor is responsible for the return of any exchange or repair parts that need to be returned to the manufacture.

4.1.8. Telephone Assistance: The contractor shall provide telephone assistance 24 hours per day for the equipment covered under this contract. Telephone assistance shall be a toll free to the Government. The Biomedical Department or COR shall be able to call and receive assistance in correcting problems with equipment operation.

4.1.9. Updates: Epredia is responsible for providing and installing manufacture designed and issued field modifications, safety corrections and revisions for correcting software and equipment deficiencies. The contractor will verify that all devices listed in section 4.3.1 have the most current firmware, hardware and software updates available by manufacturer during the first on-site visit in the contract year.

4.1.10. Training: Epredia shall provide training manuals to both the biomed and lab department who will service the equipment listed in section 4.3.1 It must indicate that they are approved/trained by the Epredia OEM to service, calibrate, maintain and install all software and hardware upgrades. Contractor or FTE must be trained by the Epredia OEM and provide a technical training certificate from the OEM if requested.

4.2 Task 1. General Information

4.2.1. Quality Control: Epredia shall develop and maintain a quality program to ensure services are performed in accordance with commonly accepted commercial practices for equipment maintenance and repair. The contractor shall develop and implement procedures to identify and prevent defective services from recurring. As a minimum, the contractor shall develop quality control procedures that address the items identified in section 4.3.1.

4.2.2. Quality Assurance: The government will periodically evaluate the contractor’s performance.

4.2.3. Hours of Operation: The VA Medical Centers normal hours of operation are from 8:00 a.m. to 4:30 p.m., Monday through Friday, workweek excluding Federal Government Holidays.

Overtime, weekend, and holiday service, if requested will be billable to the customer at 1.5 (1 ½) times the normal rates. The COR must approve any billable charges (OT, parts, etc.) failure to receive approval could result in non-payment for billable services provided. The Federal Government Holidays are New Year’s Day, Martin Luther King’s Jr’s Birthday, Presidents Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day. In the event one of the holidays fall on a weekend then the adjoining work day is then considered a Federal Government Holiday.

4.2.4. Security Requirements: When the Epredia Contractor Service Technician(s) arrive at the VA Medical Center they will go to check in with the police and alert the Biomed Department in Harlingen Healthcare Clinic (HCC) building, Room 1B-172 to check in. If contractor does not have a VA contractor ID badge provided by this campus a biomed representative will escort the contractor to the VA Police station to be issued a Visitor Pass which must be returned at the end of each day unless otherwise instructed.

4.2.5. Special Qualifications: All Epredia Service Technicians shall be trained and certified on all equipment identified in section 4.3.1. Training shall be on the same manufacture and model of the equipment identified in section 4.3.1. The contractor shall provide current completion of training certificate indicating the date training took place, training provider, date certificate was signed, and signature of certifying official for each Service Technician who will be assigned to work on the equipment under this contract.

4.3 Task 2. Equipment Maintenance Services

4.3.1 Contracted Equipment: Equipment service shall be rendered according to the OEM’s recommendations. The following is a list of equipment to be included in this agreement along with the OEM peripherals associated with each device, carts, foot switches, and hand pieces.

Quantity Manufacture Product Serial # Location 1 Fisher

Scientific Clearvue Glass Coverslipper

CV74692404EP 3rd Floor Lab

1 Thermo Scientfic

Embedding Unit Paraffin HS9517A2008T 3rd Floor Lab

1 Thermo Scientific

Tissue Embedding Unit HS9515C2008 3rd floor Lab

1 Thermo Fisher Scientific

Excelsior AS ET71132101EP 3rd floor Lab

4.3.2 Performance Period: The period of performance of this contract shall consist of one 12-month base period. At the discretion of the Contracting Officer, the Government may exercise up to four 12-month option periods.

4.3.3 Type of Contract: Firm fixed price.

4.3.4 Place of Performance: The preventive maintenance will be performed at the VCB Health Care Center at Harlingen (HCC), located at 2601 Veterans Drive, Harlingen, Texas 78550.

5. Performance Monitoring

This will be monitored by the contractor providing the Biomed Supervisor and COR copies of all service reports during the contract period of performance. The contractor must also check-in and out prior to starting any type of work (pm, repair, updates) on the VA campus and at the completion of services performed. All devices listed in section 4.3.1 must have a current inspection/PM tag on it at all times.

6. Security Requirements

The contractor will have access to the equipment that is listed in section 4.3.1 above but none of these devices are connected to the network. Any hard drive that is replaced must be returned to Biomed for disposal and must not leave this campus.

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

N/A.

8. Other Pertinent Information or Special Considerations.

Epredia will provide service technicians that are specialized in serving the Lab Histology equipment listed in section 4.3.1 have OEM training on these devices.

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

N/A

b. Identification of Non-Disclosure Requirements.

Only the OEM will have access to the manufactures proprietary software/hardware.

These devices listed in section 4.3.1 do not connect to the hospital network.

c. Packaging, Packing and Shipping Instructions.

If contractor decides to have materials or parts drop shipped to the VA facility, they must use the following address below to ensure that shipment is received to reduce any delays.

Department of Veteran Affairs Texas Valley Coastal Bend Attn: Biomed 2601 Veterans Dr

Harlingen, Tx 78550

Epredia is responsible for the cost of return packaging and shipping on any parts or materials that have to be returned back to the manufacture. Packaged and pre-paid shipments can be delivered to the logistics warehouse for UPS or FedEx pickup.

d. Inspection and Acceptance Criteria.

Epredia will provide the Biomedical Supervisor and COR with copies of all service reports and ensure all PM tags are current on devices listed in section 4.3.1. Contractor will also check in and out at the police window and then biomed department HCC building room 1b-172 upon each visit and departure ensuring that COR is aware of any/all visits.

9. Information Systems Officer, Information Protection:

The contractor will not have access to VA Desktop computers nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

10. Privacy Officer:

The contractor will not have access to protected Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

11. Records Management:

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VCB and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VCB or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity.

Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VCB. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VCB control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts.

The Contractor (and any sub-contractor) is required to abide by Government and VCB guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VCB policy.

8. The Contractor shall not create or maintain any records containing any non-public VCB information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The VCB owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VCB shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

12. Changes To Statement Of Work.

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

13. Travel.

The Government anticipates travel under this effort to perform the tasks associated with the effort through the period of performance. Include all estimated travel costs in your firm-fixed price line items. These costs will not be directly reimbursed by the Government.

(END OF STATEMENT OF WORK)