SOW_AID_iSpot_FY24_15Apr2024_rev..docx

DESCRIPTION/ SPECIFICATION/ WORK STATEMENT

Contractor service representatives must check in with the Medical Maintenance (Bldg. 503, Room GN05, 301-319-5461, before and after rendering routine or emergency service.

Period of Performance (POP): one full year starting immediately upon contract award date anticipated as: 09/30/2024 – 09/29/2025. See DELIVERY INFORMATION.

Equipment Covered by this contract:

1. AID iSpot Reader System ELRIFL07, Serial No.: Reader- ELRIFL071203148 Includes the Microplate Reader, AID Fluorescent Lamp (s/n FL012866), a computer (Dell Precision 3450, SN F3GJ1G3), a computer monitor (S/N:CN-0MHVY4-WSL00-134-BBBW-A12) and computer keyboard all a single plant account number. ECN 094140. Origin ID: N32398. NMRC Bldg. 503, Room 3W40.

(Purchased/installed 5/31/2012, AID)

2. AID iSpot Reader System ELR08IFL. Serial No.: Reader- ELR08IFL1609253 Includes Microplate Reader, AID Fluorescent Lamp, AID Enzymatic lamp, PC computer (SN: GB00DD2), computer monitor (S/N: CN-0M2GCR-74261-28H-2YNL); , computer and keyboard all a single plant account number. ECN: 101281. Origin ID: N32398. NMRC Bldg. 503, Room 3W40.

(Purchased 09/26/2016. Installed 12/07/2016 & 01/18/2017, AID)

Contact Information:

End User POC: for Dr. Martha Sedegah Primary – Harini Ganeshan, 301-319-7555, harini.d.ganeshan.ctr@health.mil, Rm 3W40 Alternate – Jun Huang, 301-319-9422, jun.huang.ctr@health.mil, Rm 3W40 Administrative-Noelle Patterson, 301-319-7362, noelle.b.patterson.ctr@health.mil, Rm 3W41

Medical Maintenance (aka BMET): Bldg. 503, Room GN05, 301-319-7415 or 301-319-7507 [Mr. Brian Doyle, brian.j.doyle39.ctr@health.mil; Mr. Albert Velez-Crespo, albert.d.velez-crespo.civ@health.mil] , 301-319-9581

Preventive Maintenance:

Includes 1 Preventive Maintenance (PM) service per instrument/reader system (see 9.b.).

Reporting Requirements:

Contractor will submit a legible copy of the field service report to Medical Maintenance, (usn.detrick.navmedrschcensvsmd.mbx.bmet-fsr@health.mil) and the End-User POC (see above) within two (2) business days after completion of all service performed detailing each item and what was serviced. The report should provide at a minimum:

A) Contract number and Contractor’s log number, B) The complaint C) Identification of the equipment serviced.

D) Type of service performed (preventive maintenance or repair) E) Detailed description of the service(s)/repair(s) performed including itemized list of parts and supplies furnished and the cost of each if available F) Replacement parts(s) information (part number, part value, nomenclature, unit price, manufacturer, if not OEM, and whether the part is new/used/reconditioned G) Completion date and time H) Total man-hours expended, including labor cost, if available.

I) Name of technician/field service engineer performing the service

Maintenance coverage shall be performed on-site Monday thru Friday during normal working hours 8:00 am – 5:00 pm.

1. Statement of Work.

This contract shall provide for maintenance services that includes one onsite preventive maintenance per annum (contract POP) with one-year technical support via email/phone/online included, software upgrade, training, and one year warranty extension. Services include onsite repairs (remedial repairs; as travel restrictions allow) as needed and system check/repair at manufacturer’s site if issue cannot be resolved at customer site, replacement parts (excluding camera and PC), and shipping costs. Normal working hour coverage or 24-hour emergency service (indicate below, level of coverage required). Department of Defense owned equipment, as listed on the SF 1449 Form “Commercial Item”. Coverage shall include all systems, subsystems components, and assemblies which were part of the original system purchased. All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated. Note: 1. The external light source replacement (if either broken or meets its lifespan) is included in this coverage, 2. There is no additional cost to the Government for repair or exchange of internal components, 3. There is no extra costs incurred by the Government for servicing plan(s) put in place to resolve check/repair issues.

Service Contract services are as detailed: Order No. PP-5, reference Quote: 15 April, 2024 and email clarifications (incorporated in the previous paragraph and as AID Reader System Protection Package Overview_MS-AID_clarification.pdf).

1.a. General

1.b. The Contractor shall comply with Federal, State, Local laws, and Federal Regulations as applicable to the performance of this contract.

1.c. The Contractor shall not accept any instructions issued by any person employed by the U.S. Government, other than: the Contracting Officer (KO), or NMRC Medical Maintenance, all acting within the limits of their authority. However, the Contractor shall coordinate with the DoD-appointed equipment custodian/End User (see End User POC on previous page) regarding scheduling of routine maintenance and responding to emergency service calls authorized under this contract. The DoD-appointed Equipment Custodian (systems operator) authorized to call in emergency service is: Harini Ganeshan, 301-319-7555 or any of the above listed End-User POC.

2. Scope of Work

2.a. The Contractor shall provide trained, experienced, English-speaking personnel, labor, tools, diagnostic equipment, software, test phantoms, material, supplies, transportation, parts, and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety testing (ST) and remedial repairs.

2.b. The Contractor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator will be made available to answer technical questions regarding system operations and applications.

2.c. Equipment listed in this contract will be maintained to meet the original equipment manufacturers (OEM’s) specifications.

2.d. Equipment and associated components shall be serviced as listed on: SF Form 1449, “Order for Commercial Item”.

2.e. The Contractor Point of Contact (POC). The Contractor shall provide in writing the name and telephone number of a primary and alternate English-speaking individual to act as their representative for the scheduling and coordination of service calls, and to be responsible for the coordination of the contract with the Government.

2.f. The Contracting Officer (KO), Medical Maintenance, and the End User POC shall immediately be notified in writing whenever changes are made to the contract.

3. Identification of Contractor Personnel.

3.a The Government will provide an Identification Badge to the Contractor which they shall wear during the performance of services at the Government site.

4. Government Furnished Property, Materials and Services.

4.a. The Contractor Representative(s) at each site may request a pre-maintenance inspection prior to the onset of the contract. Any equipment found to be inoperable during this pre-maintenance inspection, will be repaired using a separate purchase order. The Government certifies that the equipment to be maintained under this contract will be in good operating condition on the effective date of this contract. For the purpose of this contract, the clause, “good operating condition” means the conditions necessary for the equipment to function as intended without the need for remedial maintenance. The Contractor agrees to leave the equipment in good operating condition at the expiration of this contract. During the final week of this contract, final inspection of the equipment will be made by the Government. Any correction of deficiencies noted during this inspection shall be resolved prior to contract end.

4.b. The Government will furnish expendable supplies (i.e. film, chemicals) consumed during normal procedural sequence and necessary for the completion of the required maintenance services when conducted on-site. The Contractor must inform the End User POC of what expendable supplies may need to be on-hand for PM ~2 weeks in advance of a scheduled on-site PM; to ensure required expendable supplies are available or provide them (bring with them at time of service). Contractor will furnish expendable supplies for services done at Contractor/Contractor-appointed site (see 5.a).

4.c. The Contractor will be responsible for delays encountered due to the non-availability of Government furnished property. The time allowed for the completion of remedial repairs will be extended to equal the amount of time the government caused the delays.

4.d. The Government will be responsible for maintaining the proper environment, including utilities and site requirements necessary for the system to function properly as specified by the OEM.

4.e. The Government will operate the system in accordance with the instruction manual provided by the OEM.

4.f. The Government will not be responsible for damage or loss due to fire, theft, accident, or other disaster of Contractor supplies, materials or for the personal belongings brought onto Government property by Contractor’s personnel.

5. Contractor Furnished Property and Material.

5.a. Only the material referenced in section 4.b., will be furnished by the Government. All other material required in the performance of the contract shall be furnished by the Contractor, unless otherwise stated in 10.g., under exclusions.

5.b. The Contractor shall provide all service literature, reference publications, laptop computers and diagnostic software to be used by the contractor service technicians and as required for the completion of the services in accordance with this contract.

6. Replacement Parts.

6.a. The Contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. See Parts Exclusions, if applicable, are listed in 10.g.

6.b. The Contractor shall replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM.

6.c. Contractor installed replacement parts shall become the property of the Government and the replace malfunctioning part shall become the property of the Contractor.

6.d. Freight, postage, and storage charges associated with shipment and receipt replacement parts, and the return of parts shall be the responsibility of the Contractor.

6.e. The Contractor shall use only new or warranted replacement parts where the quality is equal to or better than the OEM’s original part. When discrepancies occur, the Government will make the final determination on whether a replacement part is of equal or better quality.

6.f. The Contractor must include software revisions and upgrades (field service changes) which are required due to a manufacturer announced safety-hazard and FDA recall as part of the contract at no additional cost to the Government. This contract includes upgrade of AID ELISpot and AID iSpot Reader software that may become available within the time period covered by the service contract. The Contractor must provide the End-User POC with the installation disk/software upgrade in media appropriate for backup and/or re-installation (i.e. CD/DVD) of any upgrades made under the service contract.

7. Specific Tasks.

7.a. Contractor Report Requirements

7.b. During normal duty hours, Contractor personnel shall check-in with Medical Maintenance, upon arrival at the Government site and again prior to departure. The Contractor FSEs shall personally notify Medical Maintenance and the End-User POC of problems that result in the equipment being left disabled upon their departure. During other than normal duty hours, Contractors FSEs shall notify the systems operator designated by Medical Maintenance.

7.c. The Contractor shall provide a full service report to Medical Maintenance and the End-User POC within two (2) days after completion of all service performed. The service report shall include, but not be limited to: contract number, contractors log number, detailed description of the services(s) performed, replacement parts(s) information (part number, part value, nomenclature, unit price, manufacturer, if not OEM, and whether the part is new/used/reconditioned, the completion date and time, man-hours expended and the hourly rate normally charged for the type of service performed, and the name of the technician performing the service.

8. Contractor Responsibility.

8.a. The Contractor shall be responsible for all items of Government equipment throughout the period under his control.

8.b. The Contractor shall be responsible for any damages to Government owned equipment and property and shall replace or repair any property damaged due to a fault of the Contractor or his representatives. All such replacement or repairs shall be at the Contractor’s expense and approved by the KO.

8.c. The Contractor shall ensure all areas where equipment is serviced on-site are left in a clean, neat, safe and orderly condition. To prevent safety hazards, no equipment shall be left pulled out or apart upon Contractor departure from the work site. Equipment being repaired shall be safely secured at all times.

8.d. The Contractor is not responsible for service required due to Government misuse, abuse, or damage to the system or its components when it has been determined that the damage resulted from an act of God. The Contractor has four hours to make this determination and submit it to Medical Maintenance for resolution.

9. Preventative Maintenance Services.

9.a. The Contractor shall, as a minimum, perform all preventative maintenance services in accordance with the OEMs suggested service intervals, unless otherwise stated in 9.b.

9.b. The Government will establish the required intervals for the performance of preventive maintenance services. Preventive maintenance shall be performed 1_time annually each instrument (2 instruments total; to be performed during the same on-site visit). System check/repairs (requested by either the Government representative or the Contractor) are provided onsite then at manufacturers’ site as needed throughout the contract year per the PP-5 (Protection Package 2) Service (two iSpot Reader Systems). NOTE: Onsite service is expected; if emergency health related restrictions require, where possible, service will be conducted at manufacturer site and Contractor is responsible for all shipper, freight, postage, and storage charges (to and from manufacturer site/depot center) associated with shipment and receipt of covered systems requiring manufacturer site repairs/service. The Contractor and End User will coordinate shipment to include property documents (see #11). Should alternate methods/times prove impossible, the Contractor will either cancel this contract or invoice at a reduced amount reflective of actual services received/provided and close-out the contract.

9.c. The Government shall select the month in which preventative maintenance services are to be performed. The preventative maintenance visits shall be performed during the following month(s) as bolded/highlighted: 10_11_12_1_2_3_4_5_6_7_8_9.

(The Government POP Date: 09/30/24 thru 9/29/25).

The Contractor shall schedule on-site preventative maintenance services prior to the 15th of the month and complete the PM service by the end of the month.

One PM per instrument is included in this contract.

Target PM date: 08/15/2025 ± 2 weeks. [Time and date agreeable to both parties] Actual PM Service may be at some other time in the contract period of performance (POP) as mutually agreed between the AID Service Technicians/Contractor representative and the NMRC Primary End User POC.

-Additional notes, see 10.c.

9.d. The Contractor shall confirm scheduled dates with Medical Maintenance and the End-User POC at least seven working days prior to performing preventative maintenance services.

9.e. The Contractor shall schedule preventative maintenance for other than peak equipment-use times determined by the End-User POC and Medical Maintenance at each site.

9.f. The Contractor shall, at a minimum, perform all preventative maintenance services as prescribed by the OEM using a detailed services checklist. The completed checklist will be provided to the Government with the Contractor’s service report.

9.g. All test equipment used in the performance of this contract will be routinely calibrated and the calibration shall be in compliance with Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Original Equipment Manufacturer (OEM) and Federal Drug Administration (FDA) standards.

10. Remedial Repairs.

10.a. There shall be two levels of Remedial Maintenance service available. These two levels are:

1) 24-Hour Emergency Service and;

2) Normal Working Hour Maintenance Coverage

INDICATE WHICH LEVEL OF COVERAGE IS NEEDED

10.b. _____24-hour Emergency Service.

Monday thru Sunday and Scheduled Government Holidays with published telephone number that is active 24 hours a day. (No separate charge shall be made for labor, travel or living expenses). *The Contractor shall telephonically respond within___ hours after receipt of notification of equipment failure and shall provide on-site service within ___ hours. Equipment shall be operational within ___ hours. Emergency Service calls MUST BE requested by Medical Maintenance Facilities at ALL TIMES. The Government reserves the right to deduct from the Contractor’s payment an amount per hour equal to the number of hours the Contractor fails to respond, *as listed above.

10.c. __X___ Normal Working Hour Maintenance Coverage.

Maintenance Coverage shall be performed Monday thru Friday, between 8: 00 a.m. to 4: 30 p.m. The Contractor shall telephonically respond within_16_ business hours after receipt of notification of equipment failure, and shall provide service within _24 business hours. Equipment shall be operational within _40 business hours. The Government reserves the right to deduct from the Contractor’s payment an amount per hour equal to the number of hours the Contractor fails to respond, *as listed above. Emergency services outside the normal working hours by the Government site shall be billable to the Government at published commercial rates, and negotiated prior to services rendered.

Service objectives and notes

· AID GmbH aims to speak with the relevant personnel on the day of notification of a system problem, provided AID GmbH receives the call before 2 PM German time.

· If AID GmbH cannot resolve the problem over the phone AID GmbH will put in place a servicing plan to resolve the problem.

· All systems need to be decontaminated prior to return shipment. Decontamination of the system will be the responsibility of the customer. If AID GmbH has to decontaminate the system, then AID GmbH reserves the right to charge the customer 80.00 €/ hour at a minimum of four hours.

· Contractor (AID GmbH) will keep End User, cc: Medical Maintenance, informed of the repair progress and the estimated time for returning the instrument.

10.d. Government request for remedial repairs will be placed by Medical Maintenance and/or End-User POC, to the Contractor’s POC. Remedial Maintenance shall be made available during normal duty hours associated with each site.

10.e. The Contractor shall assign a unique Log Number to each Government request for remedial repairs.

10.f. The Contractor’s response to requests for remedial repairs may include telephone consultation between the equipment user/operator and a Contractor FSE. The purpose of this telephone consultation shall be: 1) to provide instruction in determining operator error; 2) to determine the most likely cause of the problem; 3) to determine if resolution of the problem requires the dispatch of a FSE; and 4) to identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.

10.g. Each level of service shall include all parts to be furnished by the Contractor at No cost to the Government, unless otherwise indicated. Any/all exclusions are listed as follows: _Excludes camera and PC_________________________________________________________________

10.h. The Contractor shall have his/her own service manuals, specifications, schematic diagrams and parts lists to assist in the evaluation/repair of all equipment included in this contract.

11. Removal of Government Property

11.a. Whenever the repair of equipment cannot be performed at the Government site as determined by the Contractor, the Contractor shall notify Medical Maintenance who will make arrangements for the Contractor to remove the items to the Contractor’s designated site. The Contractor may be required to sign a Government form accepting responsibility for the Government equipment.

11.b. All charges resulting from a Contractor determined requirement to transport Government owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the Contractor.

12. Equipment Modification Upgrades.

12.a. The Contractor shall only incorporate OEM specified modifications, alterations and upgrades. Approval shall be obtained from the Medical Maintenance prior to the Contractor installation of any modification, alteration, or upgrades.

12.b. The Contractor shall perform all OEM field modifications and safety inspections without charge to the government.

12.c. The Contractor shall maintain contact with the OEM to determine the requirement for field modifications and to ensure accomplishment of these field modifications in accordance with the time schedule set forth by the OEM.

12.d. The Government shall not alter the system without prior notification to the contractor.

12.e. Software upgrade shall be provided by the contractor at no additional cost to the Government. Installation of upgrades will be left to the discretion of the Government.

13. Service Beyond the Scope of the Contract.

13.a. The Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify Medical Maintenance, in writing, of the existence or the development of any defects in, or repair required to the scheduled equipment which the Contractor considers they are not responsible for under the terms of this contract.

13.b. At the same time of the notification, the Contractor shall furnish Medical Maintenance with a written estimate of the cost to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this contract shall not be covered under this contract but shall be ordered under a separate purchase order.

Y2K COMPLIANCE

All information technology (including both hardware and software) delivered under this contract shall be “Year 2000 Compliant”. “Year 2000 Compliant” means that information technology accurately processes date and time data (including, but not limited to, calculation, comparing, and sequencing) from into, and between the twentieth and twenty-first centuries, and the years 1999 and 2000 and leap year calculations. Furthermore, Year 2000 compliant information technology shall accurately process date and time date when used in combination with other information technology, if the other information technology properly exchanges date and time data with it.