3.3 Statement of Work_ID Now_Draft_20250219.docx

STATEMENT OF WORK

ATTACHMENT NO. 1

1. Contractor shall provide Cost-Per-Kit result (CPK) for Rapid, Molecular Analyzers. The Contractor shall provide all labor, materials, equipment, preventative maintenance of equipment, training, transportation, installation/removal of equipment and major/incidental repair services of equipment in accordance with the Statement of Work.

2. The units shall be capable of performing isothermal nucleic acid amplification technology (NAAT) rapid testing for the detection of infectious diseases and have FDA approval for a minimum estimated annual workload of 22,317 specimens. The analyzers shall be capable of performing the tests listed below with the minimum estimated workload indicated.

3. Technology Required:

a) Analyzer must be easy to use with minimal training requirements operating at a Clinical Laboratory Improvement Act (CLIA)-waived testing level of expertise and minimum training requirements.

b) Single load compact benchtop analyzer capable of rapid testing.

c) The analyzer must contain software with a bi-directional connectivity.

d) The system should offer fully reportable, FDA approved isothermal Nucleic Acid Amplification Testing (NAAT) for rapid molecular qualitative results on the following single target assays:

i. Influenza A and B

ii. SARS-CoV-2

iii. Group A Strep

iv. Respiratory Syncytial Virus (RSV)

e) The analyzer must be able to handle an estimated workload of 22,317 thousand tests per year.

f) Analyzer must possess, internal quality control management.

g) The analyzer must be a compact tabletop analyzer that does not exceed facility allowable footprint of 10” (in) width; 10” (in) depth; 18” (in) in height.

h) The analyzer must be able to complete testing within 15 minutes or less.

i) The analyzer must be able to run direct Swabs or Viral Transport Media on Nasal or Nasopharyngeal Swabs and must be able to run direct throat swabs for strep.

4. Interface Connectivity to Government Computer Systems

a) System must be FDA cleared for use in the United States and contain an Authority to Operate (ATO) for use on government computer systems. Analyzers shall be compatible with and maintain bi-directional interface with Health Level Seven (HL7), the DOD Laboratory Information System (LIS)/ MHS GENESIS (Cerner Millennium). Be capable of reading specimen barcode labels (see below) with integrated molecular testing using a Food and Drug Administration (FDA)-approved methodology. Must include the ability to analyze swabs using FDA-approved methodology. The system, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations.

b) Analyzers must be capable of reading barcode labels printed by Cerner Millenium Electronic Health Record, Laboratory Modules.

5. Estimated Annual Test Volumes

Influenza A and B

8,533

Group A Strep

4,983

6. Installation, Set-up, Validation and Training

a) The equipment must operate at a CLIA-waived testing, minimal expertise operating level to accommodate current laboratory operations and personnel expertise.

b) The vendor shall provide installation, operation and performance validation testing, onsite training at Naval Hospital Pensacola or off-site training, training shall include functionality, maintenance, and general operations of the analyzer and preventive maintenance coverage.

c) Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it through the facility to the correct location as required by the government for installation, and removing of all trash created in this process. In the event of equipment inoperability, a replacement shall be provided by the vendor within 14 days.

d) The vendor shall provide all service literature, reference publications, laptop computers and diagnostic software to be used by the Vendor Field Service Engineers and as required for the completion of the services.

e) Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM technical support and service are provided and maintained by the OEM in collaboration with Naval Hospital Pensacola Biomedical Department. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

f) The vendor shall provide one complete set of user manuals for use by Government Personnel. The vendor shall provide two (2) operational and two (2) service manuals, each in English.

7. Reagent and Supply Requirements

a) All items and reagents shall be certified for use with the OEM equipment provided.

b) All Contractor supplied items that require special handling (e.g., refrigeration, time sensitive, immediate open, etc.) will 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 will be placed in three (3) or more locations on the container (top & two sides). Supplies/items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified.

c) The contractor shall provide deliveries to the delivery point identified below:

Naval Hospital Pensacola Attention: Laboratory Department

6000 W HWY 998

Pensacola, FL 32512

d) Government POC:

a. Octave Dealminana, octave.e.dealminana.civ@health.mil, 850-505-6438

b. Brigitte Keith, brigitte.a.keith.civ@health.mil, 850-505-6435

8. Facility Constraints:

a) Laboratory Footprint: The analyzer must be a compact tabletop analyzer that does not exceed facility allowable footprint of 10” (in) width; 10” (in) depth; 18” (in) in height.

b) NHP has biohazard collection capability.

c) Equipment must be able to operate within the following environmental conditions: Ambient room temperature ranging from 15 – 30 degrees C; humidity levels ranging from 20-80%.

d) Power requirements: The equipment must have power supply ratings of 12 V (+/- 10%): operating at a frequency of 50 to 60 Hz. UPS is required, with OEM recommended battery changes.

9. Maintenance.

a) The equipment must be maintenance-free with no serviceable parts.

b) The vendor shall provide support for instrumentation failure or damage and be able to supply replacement analyzer(s) within 14 days of request.

10. Replacement Analyzer/Upgrades

a) Replace broken equipment within 14 days.

b) 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.

c) The vendor shall provide software revisions, updates, and upgrades (field service changes) required by FDA-announced or manufacturer-announced hazards, alerts, or recalls.

d) With approval from the Technical POC, the vendor may perform hardware/software upgrades as they become available at no additional cost to the government.

e) The contractor shall provide deliveries to the delivery point identified below:

Naval Hospital Pensacola Attention: Laboratory Department

6000 W HWY 998

Pensacola, FL 32512

f) ISSM POC:

a. Jennifer Dilday, jennifer.l.dilday2.civ@health.mil, 850-505-6074

g) Laboratory POC

a. Octave Dealminana, octave.e.dealminana.civ@health.mil, 850-505-6438

b. Brigitte Keith, brigitte.a.keith.civ@health.mil, 850-505-6435

11. Vendor Technical Service Report Requirements.

a) During normal duty hours, contracted personnel shall be escorted through Naval Hospital Pensacola and check-in with the Biomedical Engineering Division (BIOMED) upon arrival at the Government site and again prior to departure. The vendor contracted personnel shall personally notify BIOMED personnel of problems that result in the equipment being left disabled upon their departure.

b) The vendor shall provide to BIOMED personnel a full-service report within two (2) days after completion of any services performed. Each service report shall at a minimum document the following data legibly, in complete detail, and in English:

i. Name of Vendor

ii. Contract or BPA Number

iii. Name of field service engineer performing service

iv. Vendor log/control number

v. Date, time (beginning and ending), and hours on-site for service call

vi. Description of problem reported by user

vii. Equipment identification factors to include manufacturer, make, model, serial number and Facility Equipment Control Number (ECN)

viii. Itemized description of service performed to include labor and travel costs, parts used, parts number/nomenclature, part new or reconditioned, part manufacturer, and problem/corrective action taken or recommended

ix. Problem resolution or pending action

x. Calibration and Quality Control Reports (if applicable)

xi. Signatures:

1. Vendor Contracted Personnel

2. Laboratory Molecular or Shift Supervisor acceptability of repair/ PM

xii. In the event that agents/sub-vendors are used in the performance of repairs, said agent shall be identified on the service report by company name, point of contact, and contact information (i.e., telephone number and email)

12. Removal of Contractor Furnished Equipment

a) No equipment shall be removed without the approval of the Contracting Officer and Materials Management Department (MMD) of the Medical Treatment Facility (MTF).

b) In regard to patient information confidentiality and privacy, all vendors and/or service vendors shall not remove equipment containing personally identifiable information (PII) or patient health information (PHI) from the Government site until the Vendor has demonstrated to the government that their equipment has been sanitized of such data. The equipment hard drive (HDD) shall be removed and provided to the MTF for proper disposal prior to equipment removal from the site.