Attachment I - PWS Siemens Sysmex CA660 Reagents and Maintenance.pdf

DHA PWS Template Under SAT August 2022 Rev. 1

Department of Defense Defense Health Agency

Performance Work Statement

CA-660 Reagents and Maintenance Services

01 September 2026

Naval Hospital Guantanamo Bay, Cuba (NH GTMO)

August 2022 Rev. 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide laboratory reagents via a drop shipment delivery schedule and maintenance services for the Sysmex CA-660 coagulation analyzer.

1.1.1 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to provide laboratory reagents and analyzer maintenance services as defined in this Performance Work Statement (PWS).

1.1.2 Background: Naval Hospital Guantanamo Bay (NH GTMO) has a temporary service agreement with Siemens Healthcare Diagnostics for preventative maintenance services on the laboratory department’s Siemens CA660 coagulation analyzer. This period of performance on the agreement is valid for one-year, from 05 May 2025 through 04 May 2026. The service agreement was acquired using their local Government Purchase Card. NH GTMO has a continued need for maintenance services and reagent supplies to ensure the functionality of the instrument, in accordance with Original Equipment Manufacturer (OEM) standards.

1.1.3 Scope: Siemens CA660 Reagent Supplies and Maintenance Services. The contractor is responsible for providing reagents and performing maintenance of NH GTMO’s coagulation analyzer. The analyzer is manufactured by Siemen, specific model CA660. The contractor will schedule preventative maintenance checks once per year and corrective maintenance/repairs will be scheduled as needed.

1.1.4 Period of Performance (PoP):

Base Period: 01 September 2026 – 31 August 2027 Option Period 1: 01 September 2027 – 31 August 2028 Option Period 2: 01 September 2028 – 31 August 2029 Option Period 3: 01 September 2029 – 31 August 2030 Option Period 4: 01 September 2030 – 31 August 2031 FAR 52.217-8: 01 September 2031 – 29 February 2032

1.2 Administrative specifications

1.2.1 Place of performance: The work shall be performed at Naval Hospital Guantanamo Bay, PSC 1005 Box 110185, FPO, AA 34009

1.2.2 Recognized Federal holidays: Contractor is not required to provide services on Federally recognized holidays, due to facility closure.

1.2.3 Hours of operation: The contractor is responsible for conducting business Monday thru Friday 0730 – 1700, except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings, including Executive Orders. The contractor must at all times maintain an adequate

August 2022 Rev. 1 workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.3 Contractor Identification

1.3.1 Contractor personnel performing services in a contractor capacity in a Government facility shall possess and wear an identification badge that displays his or her name and the name of their company. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the Government understands that the person is contractor support personnel.

1.4 Travel:

1.4.1 Contractor’s unit pricing shall be inclusive of all associated costs to perform the work including travel, per-diem, lodging, transportation, miscellaneous travel expenses, and shipping of contractor tools, supplies, and misc. equipment. Dates for any site visit is required to be provided to the Sponsor 45 – 60 days prior to each visit.

1.5 Base Access and Entry Requirements

1.5.1 Complete the Entry Clearance Form and email it back to the sponsor no later than 21 days prior to travel (45 days for personnel with dual citizenship). Guantanamo Bay Security Office requires social security number and one other identity source document. Digital Signatures are acceptable, but do not use the premade generic option where you type and it converts to a signature as this will be returned and cause delay. If the form is not received in time, the Contractor will not be allowed access to the base. Once the form has been approved, the base POC will email the Contractor a signed copy.

1.5.2 The Contractor shall be responsible for coordinating flight arrangements through NH GTMO POC for AMC flight.

1.5.3 PKI – If you do not have a CAC, a PKI certificate is needed to access Synchronized Predeployment and Operational Tracker (SPOT). There is one PKI per person so request the PKI for the person/s who will be submitting the SPOT request. PKI information is found at https://public.cyber.mil/eca/obtain-an-eca-certificate/ and states there are 2 approved vendors for DoD PKI. Approved ECA vendors are: WidePoint (formerly ORC) at https://www.eca.orc.com/ and IdenTrust at https://www.identrust.com/certificates/eca/index.html

1.5.4 SPOT ACCESS – Once the PKI certificate is received, register in SPOT by going to https://spot.dmdc.mil and click "New User Register." A CAC or PKI Certificate is needed in order to complete the registration process. Please use the name of the current NHGB POC as the sponsor. SPOT HELPDESK – SPOT helpdesk can be reached at dodhra.beau-alex.dmdc.mbx.spot-helpdesk@mail.mil or by calling (703) 578-5407 if there are any issues in obtaining a SPOT access.

2.0 SPECIFIC TASKS

2.1 Reagent and supply delivery

https://public.cyber.mil/eca/obtain-an-eca-certificate/ https://www.eca.orc.com/ https://www.identrust.com/certificates/eca/index.html https://spot.dmdc.mil/ mailto:dodhra.beau-alex.dmdc.mbx.spot-helpdesk@mail.mil mailto:dodhra.beau-alex.dmdc.mbx.spot-helpdesk@mail.mil

2.1.1 Frequency of Services: The Contractor shall provide the following products and quantities at the defined drop shipment delivery schedule below:

Item # Description Annual Quantity

10445731 CITROL1/20X1ML 8

10445733 CITROL3/20X1ML 8

10445724 OV Buffer 1 8 10445713 Actin FSL 10x2ml 8 10446006 D Dimer Controls 8

10446232 CALCIUM CHLORIDE SOLUTION 0.02 8

10873566 Dade Innovin 8

10445689L CLI 8

10708787 CL II 8

10445861 CA Calibrator 4

10445981 INNOVANCE D-DIMER (150 TESTS) USA 8

10445720 Dade Thrombin Reagent 10 x 1ml 8

10445719 LOW FIBRINOGEN CONTROL 1 4

10445687 Reaction Tubes 8

10487098 STANDARD HUMAN PLASMA 10XF.1ML (USA) 4

2.1.2 The manufacturer lot numbers shall be identical for each batch of reagents being shipped.

2.1.3 All the products shall be covered by Application Support Service and Testing in order to cover any post-sale products failure and issues. If any problem occurs with the products, a Product Specialist is required to assist NH GTMO to fix these problems and / or replace the product immediately, no later than 24 hours after the product service call is opened.

2.1.4 The location of NH GTMO may prevent the receipt of replacements within 24 hours.

However, supplies shall be shipped to the contract destination in an expeditious manner to facilitate timely forwarding.

2.1.5 All items shall have a minimum of six (6) months shelf life when received at United States Naval Hospital Guantanamo Bay, Cuba.

2.1.6 The Contractor shall ship all products to:

US Naval Hospital Guantanamo Bay DDNV Medical Mission

ATTN: HT0446

1933 Cold Storage Road

BLDG CEP 156

August 2022 Rev. 1

Norfolk, VA.23511

2.1.7 The Contractor shall be required to provide billing electronically via the WAWF Electronic Invoicing Method. For additional information, a review of the following web site may be required: https://piee.eb.mil

2.1.8 All supplied items and reagents shall be certified for use with the vendor equipment provided.

2.1.9 All items ordered must be exactly the same as the current in-use items that have had validation procedures performed and policies & procedures written.

2.1.10 All supplied items and reagents that require special handling (e.g. refrigeration, time sensitive, immediate open, etc.) shall be marked in a clear manner with a label that is easily read, understandable, and a minimum of 3” x 3” (9 sq. inches). The label shall be placed in three (3) or more locations on the container (top & two sides). Supplies/items that require refrigeration shall have both the required Celsius and Fahrenheit temperature identified.

2.2 Maintenance Services

2.2.1 Preventive maintenance and corrective maintenance coverage shall be provided and include 24/7 telephone support, troubleshooting support via phone within one hour of call during analyzer downtime and one scheduled preventive maintenance visit annually. If onsite service is needed, vendor shall arrive on-site within seven days of request.

2.2.2 Contractor shall be an OEM authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

2.2.3 The vendor shall provide OEM-trained, experienced, English-speaking personnel. The vendor shall provide all labor, tools, diagnostic equipment, software, material, supplies, transportation, parts, and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety Testing (ST), and corrective maintenance.

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

2.2.5 Equipment listed in this contract shall be maintained to meet and retain the original equipment manufacturer’s specifications/equipment certification.

2.2.6 The vendor shall provide maintenance services Monday through Friday from 0730-1700 local time, excluding Federal Government holidays as seen at the following site:

https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-https://piee.eb.mil/ https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay

August 2022 Rev. 1 work-schedules-and-pay. This includes annually required performance maintenance. Customer and Technical support should be available by phone 24 hours, 7 days a week.

2.2.7 Preventive Maintenance (PM) Services.

a. Normal Business Hour Maintenance Coverage shall be Monday through Friday, from 0730- 1700 local time, excluding Federal Government holidays. Vendor shall provide full-service preventive maintenance.

b. Preventive maintenance shall be performed in accordance with OEM recommendations.

c. The vendor shall perform PM service checks during the base contract period at the OEM’s recommended intervals. Vendor shall perform PM service checks during each option year at a date and time mutually agreed upon by the vendor and the Government.

d. All test equipment used in the performance of this contract shall be calibrated, as required by the OEM, and shall be in compliance with Joint Commission (JC), OEM, the College of American Pathologist’s (CAP), Food and Drug Administration (FDA), and National Institute of Standards and Technology (NIST) standards.

e. The vendor’s quoted annual pricing shall be inclusive of all costs including parts, consumables, labor, travel, and shipping.

2.2.8 Corrective Maintenance

a. The vendor shall provide on-site corrective maintenance from 0730-1700 EST, Monday- Friday, to include unlimited service calls. Telephonic technical support shall be available 24 hours per day, 7 days per week.

b. The vendor’s response to requests for service shall include telephone consultation with the equipment user/operator and a vendor Field Service Engineer (FSE). Telephone consultation shall: 1) provide instruction in determining operator error; 2) determine the most likely cause of the problem; 3) determine if resolution of the problem requires the dispatch of an FSE; and 4) identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.

c. A vendor service technician shall respond via telephone within two (2) hours after receipt of trouble call and provide on-site service as first available Military Airlift Command (MAC) flight after receipt of trouble call.

d. The Government’s request for corrective maintenance will be placed by Biomedical Engineering Division (BIOMED) personnel, directly to the vendor or its representatives.

Corrective maintenance shall be completed during the hours specified in the contract.

e. The vendor’s quoted annual pricing shall be inclusive of all costs including parts, consumables, labor, travel, and shipping.

https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay

f. The vendor shall have and provide, to its representatives, its own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation and/or repair of all equipment included in this contract.

2.3 Replacement Parts/Upgrades

2.3.1 The vendor and its representatives shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. In the event that replacement parts require shipment, shipping shall be performed in the fastest reasonable means possible at no additional cost to the Government.

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

2.3.3 Freight, postage, and storage charges associated with shipment and receipt of replacement parts and the return of parts shall be the responsibility of the vendor.

2.3.4 All replacement parts shall be new and certified as OEM replacement parts.

2.3.5 The vendor shall provide software revisions, updates, and upgrades (field service changes) required by FDA-announced or manufacturer-announced hazards, alerts, or recalls, including those falling under the FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Upgrades shall be performed as soon as possible after release, but no later than during the first scheduled PM inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment, the vendor shall provide installation within 30 days of release regardless of PM schedules.

2.3.6 With approval from the Government, the vendor shall perform hardware/software upgrades as they become available.

3.0 Qualifications/Considerations

3.1 Special Qualifications/Considerations: The equipment listed in this contract shall be maintained to meet all Siemens’, as the original equipment manufacturer (OEM), specifications.

The OEM is the sole authorized maintenance provider of the equipment. As such, OEM trained service providers are the only qualified/authorized personnel for the maintenance and repair of the equipment listed within this contract.

4.0 Points of Contact

4.1 Points of Contact:

TBD

USNH Guantanamo Bay, Cuba USNMRTC Guantanamo Bay, Cuba Email: TBD

Phone: TBD