SOW EQUIPMENT MAINTENANCE SPECIFICATIONS FY24 BDFortessa.docx

N3239824

DESCRIPTION/ SPECIFICATION/ WORK STATEMENT

POP: one full year from award date (see contract), for FY24 Service

Covered Equipment: BD Flow Cytometer, see Equipment Identification.

Bldg Room S/N 503 3W48 H64780000028 Model #: BD LSRFortessa™ Cell Analyzer

ECN: 097848

Contractor service representatives must check in with the NMRC Medical Maintenance 301-319-7415 or 301-319-7507, Bldg. 503, Room GN05, before and after rendering routine or emergency service.

Reporting Requirements: (see 7.c.) The Contractor shall provide a full-service report to Medical Maintenance: 1. Brian Doyle brian.j.doyle39.ctr@health.mil

2. HM1 Russell Hill russell.g.hill6.mil@health.mil

3. Albert Velez-Crespo albert.d.velez-crespo.civ@health.mil and End-User POC 1. Tanisha Robinson, tanisha.m.robinson3.ctr@health.mil

2. Noelle Patterson noelle.b.patterson.ctr@health.mil within two (2) days after completion of all service performed detailing each item and what was serviced. The report should provide at a minimum:

A) The complaint B) Identification of the equipment serviced C) Type of service performed (preventive maintenance or repair) D) Description of the repair performed including itemized list of parts and supplies furnished and the cost of each if available E) Total man-hours expended, including labor cost, if available.

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

1. Statement of Work.

This contract shall provide for maintenance services which include on-site remedial repairs, normal working hour coverage or 48-hour emergency service on the BD LSRFortessaTM/LSR series Cell Analyzer Special Order System (LSRFortessa™) and two routine preventive maintenance (PM) services during a 12 month period of performance (POP: 09/27/2024-09/26/2025 or upon contract award) for the LSRFortessa™ Department of Defense owned equipment, as listed on the DD Form 1155 “Order for Supplies or Services”. It shall include all systems, subsystems, components, and assemblies that were part of the original system purchased. All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated.

Covered Equipment (FY24, 2PM visits):

· LSRFortessaTM Cell Analyzer (Special Order System) to include lasers [Sapphire: 488 nm, 50 mw (Blue). COHR Cube, Red: 640 nm, 100 mw. COHR COMPASS GRN; 315 nm, 150 mw (Green315M, 532 nm, 150 mw). Violet: 405 nm, 50 mw. Genesis UV: 355 nm, 20 mw], one computer workstation, and all LSRFortessaTM Cell Analyzer accessories/components, Service Contract, 2PM

· LSRFortessaTM Cell Analyzer, High Throughput Sampler, 1PM

LSR FortessaTM Service covers 2 Preventive Maintenance (PM) Inspections each unit, including 2 PM kit units; M-F emergency on-site service (48-hour response for LSR Series), software revisions released during the Agreement term, unlimited service visits M-F excluding BD Biosciences holidays, and unlimited telephone support for instruments, reagents, and applications.

BD High Throughput Sampler Service covers all parts (excluding consumable items) for the following: Depot Level Repair between BD Biosciences Repair Center, San Jose, CA and Customer. One (1) Preventive Maintenance Inspection performed during a twelve-month period in conjunction with the superior equipment's Preventive Maintenance Inspection. One (1) PM Kit. Unlimited telephone support for instruments, reagents and applications. Provision of an emergency replacement within two (2) working days. The user agrees to return the malfunctioning High Throughput Sampler within 5 business days upon receipt of replacement to the BD Biosciences Repair Center, San Jose, CA. BD may opt to return malfunctioning equipment through their technical, sales, or service representatives. BD Biosciences assumes all costs associated with labor, shipping and parts, excluding consumable items.

Service coverage incorporated by reference: BD Service Contract Quotation # 440077300 (LSRFortessa™).

All PM should be Scheduled PRIOR to service. Scheduling for PM should be done by contacting Elke Bergmann-Leitner, 301-319-9278 elke.s.bergmann-leitner.civ@health.mil or Tanisha Robinson, tanisha.m.robinson3.ctr@health.mil and keep Medical Maintenance informed (see 1.c).

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), NMRC Medical Maintenance, 301-319-7415 or 301-319-5461, all acting within the limits of their authority. However, the Contractor shall coordinate with the DoD-appointed equipment custodian/End User 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:

1. Tanisha Robinson Flow, Cytometry Core, 3W48

2. Elke Bergmann-Leitner, Flow Cytometry Core, 3W48, office 3W53

Other authorized users to call in service under this Service Plan are:

1. Noelle Patterson noelle.b.patterson.ctr@health.mil Please refer to #14 for POC phone numbers and emails)

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: DD Form 1155, “Order for Supplies or Services”.

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. Only the Contracting Officer is authorized to make changes 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. Contractor will supply PM kits for preventive maintenance.

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 of 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. BD High Throughput Sampler replacement parts will be either new or like new parts at the discretion of BD Biosciences. When part quality is in question, the Government will make the final determination on whether a replacement part is of appropriate (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.

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 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

1. Brian Doyle brian.j.doyle39.ctr@health.mil

2. HM1 Russell Hill russell.g.hill6.mil@health.mil

3. Albert Velez-Crespo albert.d.velez-crespo.civ@health.mil and End-User POC 1. Tanisha Robinson, tanisha.m.robinson3.ctr@health.mil

2. Noelle Patterson noelle.b.patterson.ctr@health.mil 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 (BMR) 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 __2__ times per year, to include PM on all installed lasers.

9.c. The Government shall select the month in which preventative maintenance services are to be performed The two preventive maintenance and inspection visits for the LSRFortessa shall be performed during the following months as bold/highlighted: 10_11_12_1_2_3_4_5_6_7_8_9. (POP: 09/27/2024-09/26/2025 or upon contract award). The Contractor shall schedule and complete preventative maintenance services prior to the 15th of the month. PM kits will be provided by Contractor.

9.d. The Contractor shall confirm scheduled dates with Medical Maintenance at least five working days prior to performing preventative maintenance services.

9.e. The Contractor shall schedule preventative maintenance for other than peak patient examination times determined by 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. __see 10.c.___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__1_ hours after receipt of notification of equipment failure and shall provide on-site service within __24 hours. Equipment shall be operational within _24_ hours. Emergency Service calls MUST BE requested by Biomedical 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__1_ business hours after receipt of notification of equipment failure and shall provide on-site service within _1-2_ business days (see quote: 48 hrs for emergency on-site LSRFortessa™; LSRFortessaTM HTS emergency replacement provided in 2 working days). Equipment shall be operational within _2_business days. 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 (Response Time Credit(s) apply. Quote 440077300 states: “BD Biosciences guarantees its response time for certain INSTRUMENT(s), pursuant to the description of the INSTRUMENT contained in the quotation or maintenance service agreement. Failure to meet the BD Biosciences guaranteed response time shall result in a credit as BUYER's sole remedy.” 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.

10.d. Government request for remedial repairs will be placed Medical Maintenance, 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 an 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: _Work station printers no longer have on-site or mail-in repair.

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.

Note:

This plan covers the FACSLoader for labor, travel expenses and parts (excluding consumables), for the following: - Unlimited service visits, Monday-Friday, excluding BD Biosciences holidays. - Unlimited telephone support for instruments, reagents and applications will be provided at no additional charge.

This plan covers the FACS Flow Supply System for labor, travel expenses and parts (excluding consumables) for the following: - Unlimited service visits, Monday through Friday, excluding BD Biosciences holidays. - Unlimited telephone support for instruments, reagents and applications will be provided at no additional charge.

Coverage includes the BD LSRFortessa™ Special Order System Flow Cytometer with one Computer Workstation (excluding printers; lasers covered under separate contract line items) for labor, travel expenses and parts (excluding consumables), for the following: - 2 Preventive Maintenance Inspections to be performed during the 12-month period of performance (POP: 09/27/2024-09/26/2025 or upon contract award)- 2 PM kits will be provided. - Software Revisions released during the Agreement term (POP). - Unlimited service visits, Monday-Friday, excluding BD Biosciences holidays. - Unlimited telephone support for instruments, reagents and applications will be provided at no additional charge. - Every reasonable effort will be made to respond to a request for emergency on-site service (Monday through Friday, excluding BD Biosciences holidays) within 48 hours. Each Laser is covered under the same terms/conditions as individual contract line items: Sapphire 488-50 Blue, COHR Cube 640-100 Red, COHR COMPASS Green 315M-150, COMPASS 405-50 Violet, and Genesis 355-20 UV.

This Agreement covers the BD High Throughput Sampler for all parts (excluding consumable items) for the following:

- Depot Level Repair between BD Biosciences Repair Center, San Jose, CA and Customer. - One (1) Preventive Maintenance Inspection will be performed during the contract POP in conjunction with the superior equipment's (LSRFortessa™) Preventive Maintenance Inspection. - One (1) PM Kit will be provided. - An emergency replacement will be provided within two (2) working days. The use of new or like new parts will be at the discretion of BD Biosciences (Government reserves the right to receive parts of equal or better quality to manufacturer specifications). – Where BD opts not to have their service technician, sales representative, etc. return the unit, the user agrees to return the malfunctioning High Throughput Sampler within 5 business days upon receipt of replacement to the BD Biosciences Repair Center, San Jose, CA. If the High Throughput Sampler is not received, customer will be invoiced for the full value unless Medical Maintenance or the EndUser and the BD Biosciences Repair Center representatives have mutually agreed to a longer return time to accommodate logistics issues - Unlimited telephone support for instruments, reagents and applications will be provided at no additional charge. - BD Biosciences will assume all costs associated with labor, shipping and parts, excluding consumable items.

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.

14. End User POC:

Medical Maintenance: Bldg 503, Room GN05

1. Brian Doyle brian.j.doyle39.ctr@health.mil

2. HM1 Russell Hill russell.g.hill6.mil@health.mil

3. Albert Velez-Crespo albert.d.velez-crespo.civ@health.mil

End-User POC: Bldg 503, Room 3W48

1. Tanisha Robinson, 301-319-9636, tanisha.m.robinson3.ctr@health.mil

2. Elke Bergmann-Leitner, 301-319-9278, elke.s.bergmann-leitner.civ@health.mil

3. Elizabeth Duncan, 301-319-9075, elizabeth.h.duncangooden.civ@health.mil

Administrative POC: Noelle Patterson (301-319-7362), 3W41, noelle.b.patterson.ctr@health.mil

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.