SOW_MiLabs Imaging.pdf

STATEMENT OF WORK

Background:

The National Institutes of Health (NIH) has constructed and is operating a biological high containment BSL4 (Biological Safety Level 4) Integrated Research Facility (IRF) at Fort Detrick, Maryland, to enable the National Institute of Allergy and Infectious Diseases (NIAID) researchers to track disease processes and clinical outcomes of select agents and other emerging infectious diseases.

The IRF contains BSL2, 3, and 4 lab and support space with an advanced Imaging Core facility inside BSL4 containment. Commissioning and operating imaging suites within the BSL4 containment area is unprecedented. The Imaging Core is a central point of research activity at the IRF focusing on wholeanimal imaging to understand and monitor disease progression.

The Imaging Core in the BSL4 facility is equipped with several imaging scanners. T h e M i L a b s V E C T o r s c a n n e r , i s a k e y t o o l h o u s e d i n s i d e t h e I R F F r e d e r i c k B S L 4 a r e a . The MiLabs VECTor is instrumental in IRFFrederick research, allowing the lab to gain crucial insights into disease progression.

Purpose:

This Statement of Work aims to outline service requirements for imaging equipment in the NIAID IRF. The equipment contains commercial components provided by the system vendor (MiLabs). The contractor, as a crucial part of our team, shall perform preventive, remedial maintenance, and repair services to maintain the equipment in good working condition in accordance with the equipment manufacturer's specifications.

Requirements:

1. The contractor shall provide all service reports, and all materials, parts, test equipment, transportation, labor, and all other related services for servicing the imaging equipment at the

IRF.

2. No charge for planned maintenance visits and/or for repairs.

3. Software maintenance, technical support and upgrades when possible.

4. Guaranteed priority response time after receipt of a service call during working days and unlimited telephone and email support, excluding during holidays.

5. Priority telephone and email access to instrument technical support.

6. Contractor shall provide Customer Services Mondays through Fridays, 8:00 am to 5:00 pm customer local time, excluding Federal Holidays (“Service Coverage”).

7. Labor, travel, software patches and updated, and unlimited telephone technical assistance to maintain the equipment.

8. Contractor must return all calls for service with two (2) hours and must be onsite within four

(4) hours for emergency repairs.

9. NIAID and the Contractor shall cooperate in defining the details required of each of the reports listed herein. Unless otherwise indicated, reports, documents, and manuals hereunder shall be provided in electronic format. Reporting Requirements: The contractor shall provide the following reports to NIAID within thirty (30) days of occurrence:

a. Minutes of any meetings relating to equipment performance or service issues.

b. Detailed reports of all service calls.

c. Validation test reports.

d. Quality and Regulatory status reports.

e. Other reasonable reports as identified.

f. Factory testing and validation is required for all material to be used in the containment area.

g. Testing, validation, and maintaining operation of peripheral accessories connected to the

Philips imaging equipment includes but not limited to ECG gating capabilities and power injectors.

h. All interim testing and validation results will be reviewed, witnessed, and proved by the Government, its contractors, or its representatives before being used for any system modification. Contractors shall provide seven (7) business days’ notice of such test.

While the contractor's personnel are at the Government facility, the contractor is responsible for complying with all the laws, rules, and regulations governing conduct at the IRF. T h e contractor should adhere to all Federal, State, and local laws related to the safety and health of personnel and property damage. Due to the security requirements imposed by the government, the contractor’s personnel must make appropriate arrangements for escorted entrance into the IRF and into the imaging suites in order to perform diagnostics, preventive maintenance, and service on the equipment.

The IRF imaging personnel will assist in filling of phantoms and placing phantoms on imaging tables during the scheduled preventive maintenance and perform tasks related to service on the highcontainment side of the imaging suites. The Contractor and the Government agree that the contractor's personnel will only access highcontainment areas if the ill functioning imaging system parts residing within the highcontainment environment cannot be serviced by one of the IRF imaging staff members, t h e opening of a highcontainment area requires performing a decontamination process and approval of entry by the Division of Occupational Health and Safety.

Maintenance and calibration that cannot be performed outside the containment zone shall be performed either once annually (postfumigation of space) or shall be performed in compliance with the standard and special practices as described in the Centers for Disease Control and Prevention Biosafety in Microbiological and Biomedical Laboratories (BMBL) for BSL4 suit laboratory space: https://www.cdc.gov/safelabs/resources tools/biosafetyresourcesandtools.html. I t i s c r u c i a l t h a t t h e c o n t r a c t o r , a s a k e y p l a y e r i n t h i s p r o c e s s , e n s u r e s c o m p l i a n c e a n d http://www.cdc.gov/safelabs/resources-tools/biosafety-resources-and-tools.html http://www.cdc.gov/safelabs/resources-tools/biosafety-resources-and-tools.html m e t i c u l o u s l y d o c u m e n t s i n t h e i r r e q u i r e d r e p o r t s .

As the Contractor, you may continue to use your existing control processes and systems that are currently in place as part of the Quality Control systems.

The material used within the containment area must undergo decontamination and cleaning processes u s i n g the following sprayed chemicals: Lysol, MicroChem, ClidoxS and the following gas delivered chemicals: paraformaldehyde, chloride dioxide, vaporized hydrogen peroxide (VHP), and Quat TB.

Factory testing and validation are required for all material to be used in the containment area.

In the case of a proposed modification to the installed equipment or surrounding environment, all interim testing and validation results shall be reviewed, witnessed, and approved by the Government, its contractors, or its representatives before being used for the modification. T o e n s u r e e v e r y o n e i s p r e p a r e d a n d o r g a n i z e d , t h e contractor shall provide seven (7) business days’ notice of such test.

Equipment to Be Serviced:

MiLabs VECTor is located at the IRFFrederick, along with all ancillary workstations and equipment.

Service Requirements:

Our equipment quality performance assurance service is designed to be flexible and accommodating. It is scheduled to include a general system inspection and review of system operation, calibrating the system as necessary, system lubrication and filter replacement or cleaning, completing minor operational and reliability field engineering change notices or updates, and other remedial maintenance of a nonemergency nature.

The Assurance Service named above shall include, but not be limited to, Performance Assurance Checks. T h e Contractor shall provide such planned maintenance during the Service Coverage hours (as defined below) at a mutually agreed upon time and repair service due to equipment malfunction, as required. Repair service includes the cost of replacement parts as needed on an exchange (refurbished) or new OEM part basis and labor to install replacement parts. T h e C o n t r a c t o r m a y retain replaced parts. Preventative maintenance will be performed once a year, and servicing for software/hardware issues will be done on a perneed basis.