W81K0224Q0091_Request for Quote.pdf

W81K0224Q0091

REQUEST FOR QUOTATION (RFQ) - W81K0224Q0091

Immunohistochemistry (IHC) Slide Staining Platform/s, Antibody stains, Reagents, and Supplies

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal

Acquisition Regulation (FAR) Subpart 12.6 and FAR Part 12 and 13, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued.

This is a request for quotation (RFQ) and the solicitation number is W81K0224Q0091. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-05.

The North American Industry Classification System (NAICS) code for this acquisition is 334516 Analytical

Laboratory Instrument Manufacturing. The size standard is 1,000 employees. The Product Service Code (PSC) is

6515, Medical and Surgical Equipment and Supplies.

Medical Readiness Contracting Office – Pacific intends to award firm fixed priced contract resulting from this RFQ on the basis of quotation conforming to the solicitation and at an evaluated fair and reasonable price.

Offeror shall complete the line-item pricing structure below in addition to any provided quote material in company format. Typically, in accordance with FAR Part 29, the Federal Government is exempt from state and local sales taxes; however, the total contract price shall include any other non-exempt applicable federal, state, local taxes, or duties.

Contract Period of Performance: 9 months from effective date of contract award. Estimated effective award date is on or around 01 October 2024.

Places of Performance: Madigan Army Medical Center, Joint Base Lewis McChord, Washington

FAR Provision 52.212-1, Instructions to Offerors - Commercial Products and Commercial Services, applies to this acquisition. FAR Provision 52.212-3 ALT I, Offeror Representations and Certifications - Commercial

Products and Commercial Services, applies and is incorporated by reference; however, the Offeror is not required to complete the provision if they are currently registered in the System for Award Management (SAM) and representations and certifications are current, complete, and accurate as of the date quotations are due. All other applicable FAR Provisions are shown herein.

In order to determined technically acceptable; offeror’s must submit all submittals shown below in FAR

Provision 52.212-2.

FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Products and Commercial Services, and FAR

Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial

Products and Commercial Services, applies to this acquisition. All other applicable FAR Clauses are shown herein.

Permits and Licenses: Unless otherwise specified in this combined synopsis/solicitation, the Contractor shall obtain any necessary licenses and permits, give all notices, and comply with any applicable federal, state, county, and municipal laws, codes, and regulations in connection with this requirement.

The Defense Priorities and Allocations System (DPAS) and assigned rating is not applicable.

DEADLINE for QUOTE SUBMISSION is 10:00 AM Pacific Standard Time on Friday, 20 September 2024.

Please submit quote via email to Matthew Kohler, Contract Specialist at matthew.e.kohler2.civ@health.mil and

George Rutt, Contracting Officer, at george.r.rutt.civ@health.mil. All questions can be sent to the above POCs.

Additionally, as part of the provided quotation, the Offeror shall provide a cover page that identifies the Offeror’s name, full address, telephone number (facsimile number if applicable), CAGE Code, Unique Entity ID number, and points of contact (POCs) authorized to negotiate with the Government on the Offeror’s behalf.

https://www.acquisition.gov/far/part-52#FAR_52_212_1 https://www.acquisition.gov/far/part-52#FAR_52_212_4 mailto:george.r.rutt.civ@health.mil

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 9,900 Each Cost Per Stain

FFP

Immunohistochemistry reagents, stains, instrument, and maintenance. Maintenance will be at no cost to government. All reagents and stains will be billed under CLIN

0001.

FOB: Destination

NET AMT

0002 9,900 Each IHC Bulks and Ancillaries

FFP

Immunohistochemistry reagents, stains, instrument, and maintenance. Maintenance will be at no cost to government. All reagents and stains will be billed under CLIN

0003 9,900 Each Primary Antibodies

FFP

Immunohistochemistry reagents, stains, instrument, and maintenance. Maintenance will be at no cost to government. All reagents and stains will be billed under CLIN

0004 2 Each Roche/Ventana Benchmark Ultra Platform

FFP

Roche/Ventana Benchmark Ultra Immunohistochemistry (IHC) slide staining platform IAW the attached performance work statement. All maintenance and associated support to keep the platform fully mission capable will be at no cost to the Government.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government

0002 Destination Government Destination Government

0003 Destination Government Destination Government

0004 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 01-OCT-2024 TO

30-JUN-2025

N/A JOINT BASE LEWIS MCCHORD

JOINT BASE LEWIS MCCHORD

9040A FITZSIMMONS DR

TACOMA WA 98431

HT0864

0002 POP 01-OCT-2024 TO

N/A (SAME AS PREVIOUS LOCATION)

0003 POP 01-OCT-2024 TO

N/A (SAME AS PREVIOUS LOCATION)

0004 POP 01-OCT-2024 TO

N/A (SAME AS PREVIOUS LOCATION)

PERFORMANCE WORK STATEMENT

Immunohistochemistry (IHC) Platform Solicitation

1. GENERAL REQUIREMENTS

1.1 Scope of Work. The Contractor shall provide automated Roche/Ventana Benchmark Ultra

Immunohistochemistry (IHC) slide staining platform/s, antibody stains, reagents, and supplies used to support the

Anatomic Pathology mission at Madigan Army Medical Center, Tacoma, WA. The Contractor will be responsible for furnishing IHC antibody stains automated platform/s (inclusive of instruments and peripheral equipment to include but not limited to a computer, external drives, paper printer (reports), slide label printer, barcode scanner, back up batteries, UPS, etc.), maintenance, services, repairs, and parts are as required in order to maintain the systems in optimal working condition at no extra cost to the Government.

1.2 Hours of Operation.

1.2.1 Normal hours of operation for Anatomic Pathology are Monday through Friday between the hours of 0500 to 1630.

1.2.2 Holidays. Routine staining platform servicing and stain/reagent delivery will not be required on standard federal holidays observed by the Government. Any holidays that are declared by Presidential

Executive Order shall be observed in the same manner as federal holidays. If an emergency arises, equipment servicing and IHC/reagent delivery will be provided in accordance with Section 3.3.2 of this PWS.

1.3 Removal of Equipment. The Contractor shall not remove any equipment from the

Government work site without prior approval of the COR or designee.

1.4 Upgrade of Equipment. Subject to mutual agreement between the Government and the

Contractor, instrumentation will be upgraded within the specifications of the contract as new technology becomes available. Additionally, the Government will add IHC stains and reagents through the life of this contract as a result of advances in technology or changes to clinical practice guidelines. Any such change to IHC stains and reagents shall be mutually agreed upon by the Contractor and the Government through a bilateral modification.

2. DEFINITIONS AND ACRONYMS

2.1 Definitions. The following is a list of basic definitions.

2.1.1 Contracting Officer. The ONLY individual with the authority to enter into, administer, change, and/or terminate contracts and make related determinations and findings.

2.1.2 Contracting Officer Representative (COR). A Government employee selected and designated in writing by the Contracting Officer to act as the designated representative in administering a contract.

NOTE: The COR is not authorized to make any changes to the terms and conditions of the contract.

2.1.3 Quality Assessment. Those actions taken by the Government to validate services to determine if they meet the requirements of the DoDM CLIP Procedures, College of American Pathologists (CAP), The Joint Commission (TJC), Defense Health Agency (DHA), U.S. Army Medical Command (MEDCOM) quality management and risk assessment programs, and ensure compliance with the terms and conditions of the contract.

2.1.4 Quality Control. Those actions taken by the Contractor to control the performance of services to ensure that they meet the requirements of the contract.

2.1.5 Services. Includes incidental maintenance services and support performed and materials furnished or utilized to maintain the equipment.

2.1.6 Quality Improvement (QI) and Quality Management (QM). Those actions taken by the

Government in accordance with the Madigan Anatomic Pathology Quality Management Plan aligned with the CLSI

Quality System Essentials (QSEs), to ensure services meet the requirements of the PWS.

2.2 Acronyms/Abbreviations. The following is a list of basic acronyms/abbreviations used in the contract.

AR Army Regulation

CAP College of American Pathologists

CLSI Clinical Laboratory Standards Institute

COR Contracting Officer Representative

DA Department of the Army

DHA Defense Health Agency

DoD CLIP Department of Defense Clinical Laboratory Improvement Program

HIPAA Health Insurance Portability & Accountability Act of 1996

IHC Immunohistochemistry

ISH In-situ hybridization

MAS Minimum Acceptable Standards

MEDCOM U.S. Army Medical Command

OSHA Occupational Safety and Health Administration

PMS Preventive Maintenance Services

PRS Performance Requirements Summary

PWS Performance Work Statement

QA Quality Assurance

QC Quality Control

QM Quality Management

TJC The Joint Commission

3. SPECIFIC TASKS

3.1 Description.

3.1.1 The Contractor shall provide fully automated Roche/Ventana Benchmark Ultra slide staining platform/s capable of providing an array of IHC antibodies listed, but not limited to, those identified in

Table 1. The IHC staining platform system will be from a single contractor. The system shall provide simultaneous operation of IHCs and ISHs in a single platform to ensure seamless and timely operations. The Contractor shall provide training to staff as needed i.e., new or changes in processes (at no cost to the government), stains, reagents, supplies, unscheduled maintenance, and preventive maintenance for the system. All equipment displays and supporting literature must be in the English language. Contractor shall include delivery, installation, all stains/reagents and supplies necessary to perform the specified stains, optimization and validation per CLSI technical guidance and the Anatomic Pathology Quality Management SOP. The Contractor will also provide platform removal at the termination of the contract. Costs will be calculated as a staining unit, reagent unit or a combination of both as one single unit. The cost will be identified in the 9-month contract.

Table 1. IHC Stains

CD117 (c-KIT)

CD3

CD34

CD68

CD5/6

ER

HELICOBACTER PYLORI

K167 (MIB-1)

ALPHA-FETOPROTEIN (AFP)

ANAPLASTIC LYMPHOMA KINASE (ALK1)

B-CELL LYMPHOMA 2 (BCL2)

B-CELL LYMPHOMA 6 (BCL6)

BETA-CATENIN

CALRETININ

CARBONIC ANHYDRASE IX (CAIX)

CD10

CD117/ c-KIT

CD123

CD13M CD15/ Leu-M1

CD163

CD1a

CD2

CD20/ L26

CDX2

CEA

CHROMOGRANIN A

CK 19

CK 20

CK 5/6

CK 7

CK 8/18

CMV

c-MYC

CYCLIN D1/BCL1

D2-40/PODOPLANIN

DESMIN

DOG-1

EBV, LMP

E-CAD

EMA

EP-CAM

ER

ERG

FACTOR XIIIa

GATA-3

GFAP

K167 (MIB-1)

Ki67/MART-1

(DUAL STAIN)

LAMBDA

MAMMAGLOBIN

MART-1, RED

CHROMOGEN

MELAN A (MART-1)

MLH-1 (MMR)

MOC-31

MSA (MUSCLE

SPECIFIC ACTIN)

MSH2 (MMR)

MSH6 (MMR)

MUM-1

MYELOPEROXIDAS

E (IHC)

MYOD1

NAPSIN A

NKX3.1

OCT 2

OCT-4

p120

P16

CD21

CD23

CD3

CD30/ Ki-1

CD31

CD33

CD34

CD4

CD43

CD44

CD45/ LCA

CD5

CD56

CD61

CD78 CD79a

CD8

CD99

PROSTATE COCKTAIL (PIN3) or comparable

S100

SALL-4

SMMHC (MYOSIN, SMOOTH MUSCLE)

SMOOTH MUSCLE ACTIN (SMA)

SOX-10

SOX-10, RED CHROMOGEN

SYNAPTOPHYSIN

TDT

THROMBOMODULIN

TTF-1

UROPLAKIN II

VIMENTIN

WT1

GLYPICAN-3

HELICOBACTER PYLORI

(RED)

HELICOBACTER PYLORI

HER2/NEU

HMB-45 (MELANOMA

MARKER)

HMB-45, RED CHROMOGEN

H-S-A (HEPATOCYTE

SPECIFIC ANTIGEN)

HSV II

HUMAN CHORIONIC

GONADOTROPHIN- BETA

hCG

INHIBIN

KAPPA

P40

P504S/ RACEMASE

P53

P57

P63

PAN CK

(AE1/AE3/PCK26)

PAX-5

PAX-8

PD1

PMS2 (MMR)

PR

OCT 3/4

PAX-8

S100, RED CHROMOGEN

SOX-10, RED CHROMOGEN

TOXOPLASMA

Satb2

Claudin-4

EBER-ISH

Kappa ISH

Lambda ISH

3.1.1.1 The Roche/Ventana Benchmark Ultra IHC staining platform/s will be located at:

Madigan Army Medical Center

Department of Pathology – Anatomic Pathology

9040 Jackson Avenue

Room G35-17A

Tacoma, WA 98431-1100

3.1.2 Within ten (10) working days after the contract award, Contractor shall coordinate and conduct a post award site visit for the purpose of coordinating a schedule for platform deployment.

3.1.3 Platform staining optimization and validation will be conducted in accordance with the

Anatomic Pathology Quality Management Plan (these protocols are in concordance with applicable standards as described by CLSI and/or CAP). Additional requirements may be required depending on additional regulatory requirements.

3.1.3.1 The Contractor shall provide a qualified technical service representative who possesses a thorough knowledge of staining optimization and validation to assist with these staining processes. The assigned technical service representative will be responsible for the entire optimization and validation of all identified special stains.

3.1.3.2 The optimization and validation plan will be completed and approved by the Chief, Anatomic Pathology prior to reporting patient results based on stain evaluation. Payment for services will not begin until the platform has been approved for reporting of patient results.

3.1.3.3 All IHC antibodies, stains, reagents, and supplies used in the optimization and validation studies will be provided by the Contractor at no additional cost to the Government. These materials will not be used in the staining of specimens for patient care.

3.1.3.4 The Government’s technical supervisor will identify and provide tissue used for stain optimization and validation.

3.1.4 The Contractor shall provide a PDF copy of the Operator’s and Maintenance manuals and the statement of the warranty terms in English language. The level of detail required of appropriate instrument maintenance manuals extends only to routine maintenance procedures performed by the user. All instrumentation specified is non-Government owned leased equipment that is serviced and maintained by the Contractor.

3.1.5 The Contractor shall provide Safety Data Sheets (SDS) for each item delivered under this contract that is considered to be hazardous material by the United States or contract COR. The SDS shall contain information on the hazards associated with each specific chemical or material and meet all regulatory agencies (CAP, TJC, etc.) requirements. The SDS shall be printed in the English language and contain, at a minimum, the following information:

- The hazardous material.

- The specific hazard.

- The required practices for the safe use of the product.

- First aid procedures.

- Guidance on what to do in the event of a spill, exposure, or other accident.

- Evaluation of carcinogenic potential, reproductive toxicity, and acute toxicity.

3.2 Roche/Ventana Benchmark Ultra IHC Staining Platforms.

3.2.1 The Roche/Ventana Benchmark Ultra platforms shall have fully automated staining capability with the ability to run simultaneous IHC and ISH in a single platform to optimize workflow and be able to add new staining protocols to meet future testing/workflow requirements.

3.2.2 The Roche/Ventana Benchmark Ultra IHC staining platform, stains and reagents shall be approved by the Food and Drug Administration (FDA). All platforms and associated parts/peripherals shall be new.

No used, refurbished, or like-new equipment shall be provided in support of this contract at any time.

3.3 Antibody Stains and Reagents.

3.3.1 The Roche/Ventana Benchmark Ultra platforms must have the on-board ability to maintain reagents at the proper storage temperatures for the antibody stains listed in Table 1.

3.3.2 The workload listed in Appendix 1 is an estimate based on projected patient workload.

Actual workload may vary. The workload numbers represent patient stains and do not include controls, proficiency testing, validation studies, or re-stains due to troubleshooting. The contractor must have at least 90% of the

Madigan staining menu available to run on the automated platform (see Table 1).

- Stains and reagents must have a shelf life not less than 90 days upon receipt at the Receiving Activity

(consignee), or as stated with the individual line item (i.e. invoice).

- All stains and reagents will be provided by the manufacturer of the platform or approved by the FDA to be run on the manufacturer platform.

- Delivered on time at the appropriate storage temperature and marked with any required temperature controls as necessary.

- Routine or scheduled orders will arrive within one week upon order confirmation. Emergency orders will be delivered within 48 hours after the order is placed.

- Preservation and packing shall be performed in accordance with the best commercial packing practice and in such a manner to afford adequate protection against any damage during shipment from source to destination.

- All reagents and stains provided with be identical to those used in the FDA 510K approval application. If the bulk reagents and stains are produced overseas, they will be manufactured in conformance with ISO or CE standards and must be equal to or better than the U.S. products in quality/manufacturing. Documentation of item equivalency must be provided.

3.3.3 The actual workload may fluctuate due to changes in

IHC staining methodologies and/or fluctuations in patient volume and with the inclusion of other medical facilities located within the Regional Health Command – Pacific. Appendix 1 provides the estimated workload for the duration of the contract (9 months). All workload numbers represent total estimated billable/reportable stains for the indicated timeframe.

3.4 Ancillary Maintenance, Repairs, and Preventive Maintenance Service.

3.4.1 Ancillary Maintenance. The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the Roche/Ventana Benchmark Ultra platform/s in optimal operating condition. The Contractor shall maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the Government. The Contractor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and schedule preventive maintenance/safety inspections and calibration of the platform/s. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level shall be performed by the Contractor service personnel in accordance with requirements as specified in the Contractor’s instrument maintenance manual. The Contractor shall provide a full unscheduled and preventive maintenance service for the lease period at no additional cost. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer’s maintenance manuals), and a “hotline” telephone service to assist operators with troubleshooting problems.

3.4.2 Repairs. Upon notification of platform failure, the Contractor’s qualified service technician shall establish telephonic contact within 60 minutes of the Government notification to the Contractor’s

Customer Service “hotline” and shall be onsite to provide unlimited emergency service (service requiring immediate repair) within 24 hours of establishing contact. The Roche/Ventana Benchmark Ultra platforms shall be repaired and operational within 48 hours after initial response by the Contractor. Should platform/s become inoperable, the

Contractor’s technical specialist must be onsite within four (4) hours of initial notification. If the platform/s cannot be repaired, a replacement platform shall be provided within 72 hours. The Contractor shall provide replacement parts as necessary for operator level maintenance. The Contractor shall provide IHC stains, reagents, and any other supplies necessary to troubleshoot the reasons for platform failure at no additional cost. If Government purchased

IHC stains, reagents or supplies are used, the Contractor will replace these used items at no cost to the Government.

All work shall be performed in a professional manner by an authorized service representative. If any deficiencies are found due to negligence of the service representative, the Contractor shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the Government.

All correspondences, service reports, and invoicing shall be in English.

3.4.2.1 Preventive maintenance inspections and service shall be performed in accordance with

Contractor’s guidance as specified in the Contractor’s instrument maintenance manual. Preventive maintenance services shall be performed in accordance with the manufacturer’s standards/procedures. A preventive maintenance service shall include, but is not limited to, stain quality improvement and operation testing, lubrication, adjustments, and cleaning of equipment to which the operator does not have access. This also includes the installation of all non-operator parts required to ensure proper operation. The Contractor shall notify the COR of the exact date and time for performance of a preventive maintenance service no less than ten (10) days prior to the scheduled preventive maintenance services. Within one (1) week after completion of the repair, the Contractor shall furnish the COR one

(1) copy of a service report for all services performed. The report shall be in English and shall contain, at a minimum, the following information:

- Nomenclature and serial number.

- Date of Service.

- Description of services performed.

- Location of services performed.

- Duration of performance (hours).

- List of parts replaced or other actions taken to restore operability of the Roche/Ventana Benchmark Ultra platform.

- Name of service technician.

3.4.3 Service.

3.4.3.1 The Contractor shall provide direct customer service and support, 24 hours/7 days a week, to include a “hotline” telephone service (provided in English) and on-call emergency repair service support, to assist operators in correcting equipment operation problems.

3.4.3.2 The Contractor shall perform preventive maintenance services (PMS), safety tests, calibrations, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the platform/s.

3.4.3.3 The Contractor shall provide a full unscheduled and PMS throughout the contract. PMS shall be at no additional cost to the Government inclusive of all costs for the performance of scheduled periodic maintenance (as required by the Contractor’s instrument maintenance manuals), unscheduled maintenance and repair of analyzers and any associated equipment provide by the Contractor as part of the staining system, including replacement parts, replacement part shipping costs, and service technician travel costs for performance of maintenance services.

3.4.3.4 Scheduled routine shall be performed between 0700 – 1800 Monday through Friday, excluding Federal holidays.

3.4.3.5 The Contractor’s qualified service technician shall be onsite to provide routine services;

service requiring immediate repair; and one (1), two (2), or four (4) scheduled preventive maintenance services (as specified in the Contractor’s instrument maintenance manual), safety and calibration as required by this PWS. The staining platforms shall be repaired and operation within 48 hours after initial response by Contractor.

3.4.3.6 Should the Roche/Ventana Benchmark Ultra IHC platform/s become inoperable, the technical repair specialist shall be onsite within four (24) hours. The Contractor’s qualified service technician shall be onsite to provide unlimited emergency services.

3.4.3.7 During service, If the Roche/Ventana Benchmark Ultra IHC platform/s are still inoperable after 48 hours, the Contractor shall pay all costs associated with the provision of alternative staining at an outside reference laboratory for as long the platform/s remain inoperable.

3.4.3.8 If the Roche/Ventana Benchmark Ultra platform/s is/are out of service for longer than 48 hours (from the time of the service technician’s arrival onsite), the Contractor shall notify the Chief, Clinical

Engineering and the COR in writing as to the reason(s) (e.g. non-availability of parts, etc.) for non-compliance.

3.4.3.9 The Contractor shall provide all necessary user-replaced maintenance items required to support the Roche/Ventana Benchmark Ultra analyzer and any analyzer specific tools/supplies necessary to perform operator level periodic maintenance tasks, at no additional cost to the Government.

3.5 Training.

3.5.1. The Contractor shall provide onsite operator training as needed for added tests or change in processes due to advances in technology prior to initiation and during the entire term of the contract. Training should encompass basic operation, maintenance and troubleshooting.

3.5.2. The Contractor shall provide training at the Contractor’s training site, if needed, at no additional cost to the

Government (includes transportation airfare, rental car, lodging, per diem, incidentals, etc.).

3.5.3. All training manuals, instructional literature, and any other related written/electronic material shall be in the

English language. Training shall include basic operation of the staining platforms, troubleshooting procedures, performance of operator-level period preventive maintenance procedures, and use of associated computer programs.

3.6 Information Management.

3.6.1. The Roche/Ventana Benchmark Ultra IHC staining platforms shall (must) include a data management system for control of the operation of the staining system, management of the quality control program, management of the instrument reagent and stain levels, and management of all staining runs.

3.6.2. All software shall be the most current version, be fully supported by the software manufacturer, and be current with security updates. Software updates will be provided at no additional cost to the Government throughout the term of the contract.

3.6.3. The software shall provide a single operator interface for workload management, data management, and instrument operational status monitoring. The software controls the operation of the platforms and monitors the lot numbers and expiration dates of stains and reagents.

3.6.4. The software shall provide proactive monitoring of key instrument parameters to allow for predictive diagnostics.

3.7 Delivery of Roche/Ventana Benchmark Ultra Staining Platforms, Peripheral Devices, and Equipment.

3.7.1 The I Roche/Ventana Benchmark Ultra HC staining platforms shall (must) be delivered to the location as indicated below as soon as the news of the contract award is out in order to start the validation process, ideally 30 calendar days prior to the start of the new fiscal year (1 October 2024). Platform and peripheral setup, onsite and offsite training, staining optimization and validation studies shall be completed by the Contractor at the Contractor’s expense. During the initial deployment, a dedicated technical representative must be available onsite throughout the entire implementation period. Substitutions must be coordinated with the COR.

3.7.2 Primary Locations of Platforms.

3.7.2.1 The staining platforms shall be delivered and installed at:

Department of Pathology

9040 Jackson Avenue

Tacoma, WA 98431-1100

3.7.2.2 Exact installation location shall be coordinated by the Contractor with the point of contact listed below:

Department of Pathology

Anatomic Pathology

Administrative Director

Telephone: (253) 968-1698

4. INFORMATION SECURITY

4.1 Telecommunication.

4.1.1. All Contractor systems that will communicate with Department of Defense (DoD) systems shall interconnect through established Virtual Private Network (VPN) Business to Business (B2B) gateway. The VPN B2B type required shall be determined only after an official VPN B2B request submission to appropriate approving agencies.

The required VPN B2B type and procedure for establishing that type will be disclosed to the Contractor upon discovery at the time after contract award. All software must be able to pass Government testing and review and be awarded an Authority to Operate (ATO) from DHA. Submission of the ATO request must be completed within six

(6) months of contract award.

4.1.2. The Contractor shall follow Army Regulation 25-1 Army Knowledge Management and Information

Technology, AR 25-2 Information Assurance (IA), and DoD 6025.18-R DoD Health Information Privacy

Regulation.

4.1.3. In accordance with contract requirements, Contractors shall connect to the B2B via a Contractor procured

Internet Service Provider (ISP) connection. The Contractor shall assume all responsibility for establishing and maintaining their connectivity to the B2B gateway. This shall include acquiring and maintaining the circuit to the

B2B gateway and acquiring a Virtual Private network (VPN) device compatible with the MHS VPN device.

4.1.4. The Contractor shall comply with DoD guidance regarding allowable ports, protocols, and risk mitigation strategies and will provide, maintain and configure VPN concentrator that complies with DoD security standards.

4.1.5. All costs for VPN hardware and software shall be incurred by the Contractor.

4.1.6. The Contractor shall initiate, maintain, and document personnel security investigations appropriate to the

Business Associate Representative’s responsibilities and required access to MEDCOM Sensitive Information (SI) as determined by the site Chief Information Officer.

4.2 Defense Health Agency (DHA) Cyber Logistics (CYBERLOG) Cybersecurity/Risk

Management Framework (RMF) Requirements.

4.2.1 The Contractor shall provide an up-to-date operating system that includes all software patches and updates for all program installed on the operating system. The operating system and all the programs on the operating system must stay up to date with all software patches and updates throughout its lifecycle.

4.2.2 The Contractor shall include all costs to achieve the initial Authority to Operate (ATO) and maintain it during the lifecycle.

4.2.3 The Contractor shall pass pre-validation technical screening (vulnerability scans utilizing

NESSUS, Security Content Automation Protocol (SCAP) scans, and Security Technical Implementation Guides

(STIGs) checklists) within six (6) months of the contract award.

5. PROGRAM MANAGEMENT

5.1 General. The Contractor shall provide comprehensive Program/Project Management services.

5.2 Program Manager (PM). The Contractor shall provide a dedicated PM, who shall be responsible for the initial platform implementation, instrument upgrades, implementation of new methods or procedures and optimization of workflow processes and procedures.

5.2.1. The PM and an alternate who shall act for the Contractor when the PM is unavailable, shall be designated in writing to the Contracting Officer and COR within 10 days of contract award.

5.2.2. The PM and alternate PM shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract.

5.2.3. The PM and/or alternate shall be actively engaged in all aspects of this PWS.

5.2.4. The Contractor shall provide an Information Technology Project manager for implementation of the instrument interface and middleware if applicable.

5.2.4.1. The IT PM shall have demonstrated working knowledge of Information Security Requirements specific to

DoD installation.

5.2.4.2 The IT PM shall have a demonstrated working knowledge and competency in the installation, troubleshooting, and development of the instrument interface requirements as they relate to the Government’s LIS.

5.2.5. The PM or alternate PM shall be available during normal duty hours to meet on the installation with

Government personnel (designated by the Contracting Officer0 to discuss problem areas. After normal duty hours, the manager or alternate shall be available within 48 hours.

5.3 Specific platform layout and selection of pre-analytic, analytic, and post-analytic stain delivery systems will be determined by a detailed, comprehensive workflow analysis.

5.3.1 The workflow analysis shall be conducted in accordance with commonly accepted industry standards for maximizing efficiency.

5.3.2 The workflow analysis shall focus on maximizing efficiency, menu and throughput, and minimizing turnaround times.

6. Anti-Terrorism/Operations Security

6.1. AT Level I training. All contractor employees, including subcontractor employees, requiring access to DHHQ, Direct Reporting Markets (MTFs), Small Markets and Stand Alone (SSO) facilities and controlled access areas, shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable and annually thereafter. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the

COR or to the contracting officer, if a COR is not assigned, within 05 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website:

http://jko.jten.mil.

6.2. Access and general protection/security policy and procedures. Contractor and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office.

Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, DHHQ and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition

(FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

6.3. For contractors requiring CAC. Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with DHA-AI 5200.04. The contractor employee will be issued a CAC only if duties involve one of the following: (1) both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) physical access http://jko.jten.mil/ to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of

Personnel Management.

6.4. For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National

Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

6.5. iWATCH/Suspicious Activity Reporting Training. This standard language is for contractor employees with an area of performance within a DHA-controlled installation, facility, or area.The contractor and all associated subcontractors shall brief all employees on the local Suspicious Activity Training program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 05 calendar days of new employees commencing performance, with the results reported to the COR NLT 30 calendar days after contract award.

6.6. For contracts that require OPSEC Training. Per DHA-AI 5200.03, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

6.7. For Cyber Awareness (Information Assurance (IA)/information Technology (IT) training. All contractor employees and associated subcontractor employees must complete the DoD Cyber Awareness training before issuance of network access and annually thereafter. All contractor employees working IA/IT functions must comply with DoD requirements DoD 8570.01 and DoD 8570.01-M within six months of appointment to IA/IT functions.

DoD Cyber Awareness Challenge Training is available at the following website:

https://jkodirect.jten.mil/Atlas2/page/login/Login.jsf?ORG=NAVSEA , DOD Course US1364-22 DOD Cyber

Awareness Challenge 2022.

Appendix 1

Estimated IHC Volume/Year

IHC Stain Estimated Annual Volume

CD117 (c-KIT) 1

CD3 1

CD34 1

CD68 1

CD5/6 19

ER 1

HELICOBACTER PYLORI 1

K167 (MIB-1) 1

ALPHA-FETOPROTEIN (AFP) 4

ANAPLASTIC LYMPHOMA KINASE (ALK1) 6

B-CELL LYMPHOMA 2 (BCL2) 27

B-CELL LYMPHOMA 6 (BCL6) 25

BETA-CATENIN 8

CALRETININ 42

CARBONIC ANHYDRASE IX (CAIX) 14

CD10 52

CD117/ c-KIT 69

CD123 8

CD138 38

CD15/ Leu-M1 5

CD163 32

CD1a 2

CD2 2

CD20/ L26 121

CD21 44

CD23 7

CD3 121

CD30/ Ki-1 27

CD31 14

CD33 3

CD34 86

CD4 7

CD43 4

CD44 3

CD45/ LCA 13

CD5 25

CD56 15

CD61 4

CD7 4

CD79a 3

CD8 8

CD99 1

CDX2 36

CEA 4

CHROMOGRANIN A 18

CK 19 4

CK 20 67

CK 5/6 82

CK 7 87

CK 8/18 8

CMV 44

c-MYC 5

CYCLIN D1/BCL1 28

D2-40/PODOPLANIN 42

DESMIN 17

DOG-1 10

EBV, LMP 18

E-CAD 50

EMA 15

EP-CAM 38

ER 188

ERG 16

FACTOR XIIIa 15

GATA-3 54

GFAP 1

GLYPICAN-3 15

HELICOBACTER PYLORI (RED) 32

HELICOBACTER PYLORI 99

HER2/NEU 79

HMB-45 (MELANOMA MARKER) 8

HMB-45, RED CHROMOGEN 9

H-S-A (HEPATOCYTE SPECIFIC ANTIGEN) 17

HSV II 7

HUMAN CHORIONIC GONADOTROPHIN- BETA

hCG 5

INHIBIN 3

KAPPA 30

K167 (MIB-1) 75

Ki67/MART-1 (DUAL STAIN) 11

LAMBDA 30

MAMMAGLOBIN 1

MART-1, RED CHROMOGEN 8

MELAN A (MART-1) 72

MLH-1 (MMR) 18

MOC-31 39

MSA (MUSCLE SPECIFIC ACTIN) 2

MSH2 (MMR) 18

MSH6 (MMR) 18

MUM-1 7

MYELOPEROXIDASE (IHC) 6

MYOD1 4

NAPSIN A 33

NKX3.1 29

OCT 2 2

OCT-4 10

p120 44

P16 218

P40 64

P504S/ RACEMASE 10

P53 43

P57 8

P63 177

PAN CK (AE1/AE3/PCK26) 228

PAX-5 26

PAX-8 22

PD1 1

PMS2 (MMR) 18

PR 108

PROSTATE COCKTAIL (PIN3) 167

S100 50

SALL-4 4

SMMHC (MYOSIN, SMOOTH MUSCLE) 171

SMOOTH MUSCLE ACTIN (SMA) 32

SOX-10 49

SOX-10, RED CHROMOGEN 160

SYNAPTOPHYSIN 31

TDT 9

CLAUSES

INCORPORATED

BY REFERENCE

52.204-7 System for Award Management OCT 2018

52.204-13 System for Award Management Maintenance OCT 2018

52.204-16 Commercial and Government Entity Code Reporting AUG 2020

52.204-18 Commercial and Government Entity Code Maintenance AUG 2020

52.204-21 Basic Safeguarding of Covered Contractor Information

Systems

NOV 2021

52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment

NOV 2021

52.204-29 Federal Acquisition Supply Chain Security Act Orders--

Representation and Disclosures.

DEC 2023

52.212-1 Instructions to Offerors--Commercial Products and

Commercial Services

SEP 2023

52.212-3 Alt I Offeror Representations and Certifications--Commercial

Products and Commercial Services (MAY 2024) Alternate I

FEB 2024

52.212-4 Contract Terms and Conditions--Commercial Products and

Commercial Services

NOV 2023

52.223-5 Pollution Prevention and Right-to-Know Information MAY 2024

52.223-22 Public Disclosure of Greenhouse Gas Emissions and

Reduction Goals -- Representation.

DEC 2016

52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

MAR 2023

THROMBOMODULIN 1

TTF-1 64

UROPLAKIN II 3

VIMENTIN 4

WT1 22

OCT 3/4 1

PAX-8 20

S100, RED CHROMOGEN 1

SOX-10, RED CHROMOGEN 1

TOXOPLASMA 2

Satb2

Claudin-4

EBER-ISH

Kappa ISH

Lambda ISH

(End of Performance Work Statement)

Clauses Incorporated by Reference

Currently being sent to reference labs

52.247-34 F.O.B. Destination JAN 1991

252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights DEC 2022

252.203-7005 Representation Relating to Compensation of Former DoD

Officials

SEP 2022

252.204-7008 Compliance With Safeguarding Covered Defense Information

Controls

OCT 2016

252.204-7012 (Dev) Safeguarding Covered Defense Information and Cyber

Incident Reporting (DEVIATION 2024-O0013 REVISION

1)

MAY 2024

252.204-7015 Notice of Authorized Disclosure of Information for Litigation

Support

JAN 2023

252.204-7016 Covered Defense Telecommunications Equipment or Services

-- Representation

DEC 2019

252.204-7017 Prohibition on the Acquisition of Covered Defense

Telecommunications Equipment or Services -- Representation

MAY 2021

252.204-7018 Prohibition on the Acquisition of Covered Defense

Telecommunications Equipment or Services

JAN 2023

252.204-7024 Notice on the Use of the Supplier Performance Risk System MAR 2023

252.211-7003 Item Unique Identification and Valuation JAN 2023

252.223-7008 Prohibition of Hexavalent Chromium JAN 2023

252.225-7000 Buy American--Balance Of Payments Program Certificate FEB 2024

252.225-7001 Buy American and Balance of Payments Program FEB 2024

252.225-7002 Qualifying Country Sources As Subcontractors MAR 2022

252.225-7012 Preference For Certain Domestic Commodities APR 2022

252.225-7055 Representation Regarding Business Operations with the

Maduro Regime

MAY 2022

252.225-7056 Prohibition Regarding Business Operations with the Maduro

Regime

JAN 2023

252.225-7056 Prohibition Regarding Business Operations with the Maduro

Regime

JAN 2023

252.225-7059 Prohibition on Certain Procurements from the Xinjiang

Uyghur Autonomous Region - Representation

JUN 2023

252.225-7060 Prohibition on Certain Procurements from the Xinjiang

Uyghur Autonomous Region

JUN 2023

252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006

252.243-7002 Requests for Equitable Adjustment DEC 2022

252.244-7000 Subcontracts for Commercial Products or Commercial

Services

NOV 2023

252.247-7023 Transportation of Supplies by Sea JAN 2023

ADDENDUM TO FAR Clause 52.212-4

(w) UNILATERAL MODIFICATIONS

In addition to 52.212-4(c), the Government may make unilateral modifications considered administrative in nature.

These include, but are not limited to, changes in the accounting and appropriation data, payment and issuing office addresses, and other corrections that have no effect on the terms and conditions of the contract.

(x) The non-FAR Part 12 discretionary FAR, DFARS, and AFARS clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 for locations where full text can be obtained.

(End of Addendum)

CLAUSES INCORPORATED BY FULL TEXT

52.212-2 EVALUATION--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) The Government will award a purchase order resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

The Government intends to award a single purchase order on the basis of the lowest priced, technically acceptable quote meeting or exceeding the acceptability standards for all the below listed technical and past performance factors. Each technical factor below has a submission requirement that must be included with the quote.

Technical Evaluation Factors

Evaluation Criteria Submission Requirement

Technical Factor 1- The prospective offeror must demonstrate specific experience providing

Immunohistochemistry (IHC) Slide Staining

Platform/s, Antibody stains, Reagents, and Supplies of the complexity similar to or exceeding the scope identified in the Performance Work Statement (PWS) through a narrative of one (1) contract within the last two (2) years.

The narrative portion of the Corporate Experience Data

Sheet has sufficient explanation how the referenced contract relates to the requirement identified in the attached PWS.

Offerors are required to provide a completed Corporate

Experience Data Sheets (Exhibit A) on one (1) of the firm’s recently completed contracts (not to exceed two years older than date of solicitation) that demonstrate experience providing Immunohistochemistry (IHC)

Slide Staining Platform/s, Antibody stains, Reagents, and Supplies. The Government will also accept current, ongoing contract actions if at least one (1) year has elapsed since date of award.

The narrative portion of the data sheet must be clear, coherent, and prepared in sufficient detail for effective evaluation.

Altered or substituted data sheets may not be evaluated.

Technical Factor 2-

The prospective offeror has provided documentation showing that they are able to provide two

Roche/Ventana Benchmark Ultra Platforms as required by the PWS and attachment 001 (brand name only determination) of the solicitation.

The offeror shall provide sufficient documentation to show they are able to provide two Roche/Ventana

Benchmark Ultra Platforms as required by the PWS or that they are the original equipment manufacturer

(OEM) of the required platform. If the offeror is not the OEM, documentation must show evidence of the third-party method of acquiring the platforms (i.e.

OEM dealer agreement or informational quote or correspondence from a supplier/subcontractor agreeing to supply the unit for the contract period).

Past Performance Evaluation Factor

Evaluation criteria Submission Requirements

Evidence of successful past performance that demonstrates performance relevant to providing

Immunohistochemistry (IHC) Slide Staining

Platform/s, Antibody stains, Reagents, and Supplies similar to or exceeding the work required in the PWS.

Past performance information shall be obtained from established systems such as the Past Performance

Information Retrieval System (PPIRS), Federal

Awardee Performance and Integrity Information

System (FAPIIS), Electronic Subcontract Reporting

System (eSRS), or other databases. Past performance information may also be obtained from other sources available to the Government, such as the Defense

Contract Management Agency; and interviews with

Program Managers, Contracting Officers, Fee

Determining Officials.

NOTE: In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available or so sparse that no meaningful past performance rating can be reasonably assigned, the offeror may not be evaluated favorably or unfavorably on past performance (see FAR 15.305

(a)(2)(iv)). Therefore, the offeror shall be determined to have unknown (or “neutral”) past performance. In the context of acceptability/unacceptability, a neutral rating shall be considered “acceptable.”

Offerors are not required to submit any additional documentation in support of this evaluation criterion.

(b) Options. If options are included in this solicitation, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the

Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services--

Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications-

Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph

(d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided…