Attachment I Statement of Work.pdf

Statement of Work

1. Scope: The requirement is for an single award Indefinite Delivery Indefinite Quantity (IDIQ) Cost

Per Test (CPT) contract for three (3) slide strainers, immunohistochemistry, reagents, quality control, maintenance, and consumables for Naval Medical Center (NMC) Portsmouth. The contracted units shall be a single model platform. All equipment and accessories shall be new from the manufacturer. Used equipment, refurbished equipment, or equipment obtained from a third party will not be accepted. The system shall be capable of performing the stains listed below with an expected historical workload of 11,000 immunohistochemical (IHC) slides, and 2,750 special stain slides.

Stains 2-Oct CD56 HER 2 S100

AFP CD68 HMB-45 SMA

ALK-1 CD7 IGD SOX10

BCL-2 CD79a Inhibin Synaptophysin

BCL-6 CD8 Kappa TAG B72.3

Beta catenin CD99 Keratin 34 beta

E12 TDT

Calponin CDX2 Ki-67 TTF

Calretinin CEA Lambda Vimentin

CAM5.2 Chromogranin Melan-A WT1

CD10 CK20 MOC-31 PAS

CD138 CK5/6 MS Actin PAS-D

CD15 CK7 MTS Iron

CD163 C-kit MUM-1 Alician Blue

CD1-A Cyclin D Myeloperoxidase Alcian Blue PAS

CD20 D2-40 NSE Congo Red

CD21 Desmin p16 Mucicarmine

CD23 E-Cadherin p53 Reticulin

CD3 EMA p57 Trichrome

CD3 ER p63 AFB

CD30 Factor VIII Pankeratin

AE1/AE3

GMS

CD31 Factor XIIIa PAX5 Elastic

CD34 GATA3 PAX8 Giemsa

CD43 H. pylori PLAP

CD45 HCG PR

CD5 Hemoglobin PSAP

a. The system shall support staining of immunohistochemistry, fluorescent staining, and in-situ hybridization (ISH), using the same detection system for all testing methodologies on a continuous and random access platform. The system must be fully-automated, from deparaffinization through antigen retrieval to completion of staining. The system shall have individual slide processors and shall allow the user to stain the slides independently. The system shall have a capacity of at least 30 slides with continuous access to each individual slide.

b. The system shall be able to use antibodies from various manufacturers. The system shall be capable of single, dual, and triple IHC staining and immunofluorescent (IF) staining concurrently. The system shall be able to use the FDA-approved estrogen receptor (ER) antibodies, progesterone receptor (PR) antibodies, human epidermal growth factor receptor 2

(HER2) antibodies, and P16. The system shall be able to use biomarker P16 for clinical use.

The system shall be capable of independent processing and slide drawer temperature control.

The system shall have a free-standing configuration. The electrical requirements for this system are 120V, 60 Hz.

c. System installation, validation, correlation, onsite and offsite training, corrective and preventive maintenance coverage shall be included. Corrective system maintenance coverage shall include response times as specified below in Section III. The vendor shall provide initial on-site operator training for a maximum of four (4) laboratory personnel prior to the initial use of the equipment.

The vendor shall provide a maximum of twenty five (25) off-site operator training at the

Vendor’s training facility during the entire five year ordering period

d. Support shall be provided for ordering period from 01 October 2020 to 30 September 2025.

e. The system, including claims made for the product, shall be compliant with Food and Drug

Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with OSHA requirements.

f. Vendor shall be an Original Equipment Manufacturer (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.

g. Upon equipment delivery, the Vendor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the Vendor shall make arrangements for the storage. The Vendor is also responsible for the initial instrument operational and performance validations.

2. Reagent and Supply Delivery.

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

b. All supplied items and reagents shall have a minimum shelf life of 6 months upon receipt by the

Government.

c. All supplied items and reagents 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.

d. Delivery times at NMC Portsmouth shall be Monday through Friday between the hours of 0700

1500 Local Time.

e. The Contractor shall provide deliveries to the delivery point identified below:

Naval Medical Center Portsmouth

Attn: Laboratory Department

620 John Paul Jones Circle

Portsmouth, VA 23708

3. Maintenance.

a. 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.

b. 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.

c. Equipment listed in this contract will be maintained to meet and retain the original equipment manufacturer’s (OEM’s) specifications/equipment certification.

d. The Vendor shall provide maintenance services Monday through Friday from 0800-1700 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-work-schedules-and-pay. This includes annually required preventive maintenance. Customer and Technical support should be available by phone 24 hours, 7 days a week.

4. Preventive Maintenance Services.

a. Normal Business Hour Maintenance Coverage will be Monday through Friday, from 0800-1700 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 entire five (5) year ordering period at the OEM’s recommended intervals.

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

American Pathologist’s (CAP), Food and Drug Administration (FDA), and National Institute of

Standards and Technology (NIST) standards.

5. Corrective Maintenance.

a. Vendor shall provide on-site corrective maintenance from 0800-1700 Local Time, Monday-

Friday, to include unlimited service calls. Telephonic technical support shall be available 24 hours per day, 7 days per week.

b. A vendor service technician shall respond via telephone within two (2) hours after receipt of trouble call and provide on-site service within twenty four (24) hours after receipt of trouble call. Equipment shall be repaired and deemed operational within forty eight (48) hours.

c. 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.

d. The Vendor’s response to requests for service may 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 a 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.

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

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.

6. Equipment Uptime Rate and Calculation.

a. Equipment shall be returned to operational condition within 48 hours after telephone notification from BIOMED. The Contractor shall maintain an overall uptime rate of 95% or better for all equipment. Uptime is equal to equipment availability minus down time. Uptime and down time are values used to calculate the mean time between failures (MTBF).

b. Uptime Calculation: Uptime is calculated on a rolling 6 month basis. Until the Contractor has at least 6 months of performance experience at NMC Portsmouth, the uptime shall be calculated cumulatively for the entire duration of the contract. The downtime indicator in

DMLSS or manual calculations may be used to compute these metrics.

c. Variables Definitions:

U= Possible Equipment Uptime (100%)

H= Hours of Coverage per day

H1= Begin Coverage Time during each day

H2= End Coverage Time during each day

A= # of covered days of the week

W = Weeks of Coverage in a Year

C= Uptime Commitment (95%)

d. Known (for this contract):

H1= 0800 hours

H2= 1700 hours

A= 5 days per week

W= 52 weeks per year

C = 95%

e. Calculations:

D= Hours of Calculated Downtime (Unknown)

T= Total Actual Uptime Percentage (Unknown)

Δ= % difference from Uptime Commitment (Unknown)

f. *Note* - Downtime hours shall fall within the Contractor’s hours of coverage listed in

Section 6. Downtime hours outside of the coverage timeframe listed in Section 6. shall not be calculated as a metric of vendor performance. Downtime ends once the system is available for full clinical use. Assessment

7. Replacement Parts/Updates.

a. 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.

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

c. 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.

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

e. 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 with approval from the Biomedical Engineering Division personnel. 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.

f. With approval from the BIOMED, the vendor may perform hardware/software updates as they become available.

8. Composite Health Care System (CHCS).

a. The system shall be capable of bi-directionally interfacing with the CHCS and the laboratory information system (LIS). Government Furnished Property, Materials and Services.

b. If the Vendor is not already approved to connect to CHCS bi-directionally, the vendor shall agree to complete any bi-directional interface integration at no additional cost to the Government.

Interface integration must be completed prior to final acceptance of the system.

9. Government Furnished Property, Materials, and Services.

a. 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.

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

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

10. Vendor Furnished Property and Material.

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

11. Vendor Report Requirements.

a. During normal duty hours, Vendor FSE personnel shall check-in with the Biomedical

Engineering Division upon arrival at the Government site and again prior to departure. The

Vendor FSEs shall personally notify BIOMED personnel of problems that result in the equipment being left disabled upon their departure. If equipment is left disabled, a method of physical use prevention of the disabled equipment shall be implemented, and the disabled equipment shall be locked out with a letter of intent in compliance with OSHA regulation to prevent any patient hazards. After normal duty hours, Vendor FSEs shall notify the Officer of the Day Desk and the systems operator designated by BIOMED personnel.

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

i. Name of Vendor

ii. Contract Number

iii. Name of field service technician 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: 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. Signatures:

1. Field Service Technician performing services

2. BMET verifying service rendered (Identify Medical Treatment Facility)

xi. 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 and contact information

(i.e., telephone number)

12. Vendor Responsibility.

a. The Vendor shall be responsible for the repair/replacement of damaged Government-owned equipment and property due to the negligence of the Vendor or his representatives. All such replacement or repair shall be at the Vendor's expense and shall be inspected to the satisfaction of the Contracting Officer (KO) or his/her appointed representative.

13. Removal of Government Property.

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

Property passes for equipment removal shall be obtained by the Vendor via the MMD of the

MTF. Any failure to obtain such passes which results in detainment or prosecution of service

Vendor personnel, is the sole responsibility of the service Vendor and their personnel.

b. The Vendor shall provide a detailed description of removed items on the vendor’s company letterhead. For associated items/accessories, the Vendor shall provide a detailed written description and quantities of items to be removed. Descriptions shall include, at a minimum, the manufacturer’s serial numbers and facility equipment control numbers (ECNs) of all equipment/items removed. In the event that items/sub-assemblies/accessories are “repaired by replacement”, a detailed description of replaced items is to be included upon return of repaired components.

c. No additional charge shall be allowed for work performed off-site, or any additional time required. All charges resulting from a Vendor determined requirement to transport Government-owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the Vendor. The Vendor shall provide insurance coverage for damage to or loss of equipment while in vendor or service Vendor’s custody.

d. In regards to patient information confidentiality and privacy, all Vendors and/or service Vendors shall not remove equipment containing personally identifiable information or patient health information from the Government site. The equipment hard disk drive (HDD) or solid state drive (SSD) shall be removed by MTF personnel prior to equipment removal from the site.

Furthermore, equipment removed from the MTF will be prorated from the date of removal for service maintenance fees. If HDD or SSD are to be replaced, the HDD or SSD in disrepair shall be left at the MTF for disposal.

e. Hard Disk and Solid State Drives (HDD & SSD): In regards to patient information confidentiality and privacy, all Contractors and/or service Contractors shall not remove equipment containing patient information from the MTF. HDD nor SSD shall ever be removed from the MTF, by the Contractor under this contract. Removal of protected health information

(PHI) and personally identifiable information (PII) from the equipment prior to removal from site must be properly coordinated with the BIOMED personnel and Command Equipment

Manager.

14. Any Service Beyond the Scope of the Contract without the approval of the KO; the contractor bears fully responsibility financially.

a. The Vendor shall immediately, but not later than twenty four (24) consecutive hours after discovery, notify BIOMED, in writing, of the existence or the development of any defects in, or repair required to the scheduled equipment which the Vendor considers they are not responsible for repairing under the terms of this contract.

b. At the same time of the notification, the Vendor shall furnish BIOMED with 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 may be ordered under a separate purchase order.