Attachment 0001 PWS.pdf

PERFORMANCE WORK STATEMENT

Immunohistochemistry (IHC) and In-situ Hybridization (ISH) Platform Solicitation

1. GENERAL REQUIREMENTS

1.1 Scope of Work. The Contractor shall provide automated Immunohistochemistry (IHC) and In-situ Hybridization (ISH) slide staining platforms, 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/ISH antibody stains automated platforms (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 3.4.2 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.

3.1.1The Contractor shall provide two (2) fully automated IHC/ISH staining platforms capable of providing an array of IHC antibodies listed, but not limited to, those identified in Table 1 and meet the minimum salient characteristics as outlined in attachment 0002. The IHC staining platforms 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 key operator training to at least two (2) staff at the contractor’s facility and up to 8 staff in-house, 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 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

CD21

CD23

CD3

CD30/ Ki-1

CD31

CD33

CD34

CD4

CD43

CD44

CD45/ LCA

CD5

CD56

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

GLYPICAN-3

HELICOBACTER PYLORI (RED)

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

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

MYELOPEROXIDASE

(IHC)

MYOD1

NAPSIN A

NKX3.1

OCT 2

OCT-4

p120 P16 P40

P504S/ RACEMASE

P53 P57 P63

PAN CK

(AE1/AE3/PCK26)

PAX-5

PAX-8

PD1

PMS2 (MMR)

PR

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

OCT 3/4

PAX-8

S100, RED CHROMOGEN

SOX-10, RED CHROMOGEN

TOXOPLASMA

Satb2 Claudin-4

EBER-ISH

Kappa ISH Lambda ISH Kappa/Lambda Dual ISH

CLDN18

FOLR1

PD-L1

MMR

ALK

Cintec Plus Cintec Histology (P16)

BRAF (V900)

3.1.1.1 The IHC/ISH staining platforms 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 five (5) 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/ISH antibodies, stains, reagents, and supplies used in the optimization and validation studies will be provided by the Contractor in accordance with CLIN 0002 of the solicitation and resulting contract. 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 IHC/ISH Staining Platforms.

3.2.1 The IHC/ISH Staining 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 IHC/ISH 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 IHC/ISH staining 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). The contractor is required to provide all stains, reagents, and related supplies and consumables necessary to operate the platforms. The Government personnel identified at time of award shall submit order for supplies to maintain operation of the platforms as needed up to the expenditure of all tests issued on a task order basis.

- 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. All workload numbers represent total estimated billable/reportable stains during the first year of contract and subsequent years.

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 IHC/ISH staining platforms 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 platforms. 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 on-site (MAMC) to provide unlimited emergency service (service requiring immediate repair) within 24 hours of establishing contact.

The IHC/ISS Staining platforms shall be repaired and operational within 48 hours after initial response by the Contractor. Should platforms become inoperable, the Contractor’s technical specialist must be on-site (MAMC) within four (4) hours of initial notification. If the platforms 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 IHC/ISH 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 platforms.

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 maintenance shall be performed between 0700 – 1800 Monday through Friday, excluding Federal holidays.

3.4.3.5 The Contractor’s qualified service technician shall be on-site (MAMC) 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 IHC/ISH platforms become inoperable, the

technical repair specialist shall be on-site (MAMC) within twenty-four (24) hours. The Contractor’s qualified service technician shall be on-site (MAMC) to provide unlimited emergency services.

3.4.3.7 During service, If the IHC/ISH platforms 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 platforms remain inoperable.

3.4.3.8 If the IHC/ISH platforms is/are out of service for longer than 48 hours (from the time of the service technician’s arrival on-site (MAMC)), 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 IHC/ISH platform 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 key and on-site (MAMC) (MAMC) operator training prior to initiation and during the entire term of the contract as needed (i.e., new tests or program updates). Training should encompass basic operation, maintenance and troubleshooting.

3.5.2. The Contractor shall provide training for at least two (2) key operators at the Contractor’s training site and up to eight (8) staff training on-site (MAMC) (MAMC), per CLIN 0003 of the solicitation and resulting contract. Government personnel shall be responsible for all transportation lodging costs for staff sent to train at the contractor’s site.

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 IHC/ISH 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 IHC/ISH Staining Platforms, Peripheral Devices, and Equipment.

3.7.1 The I HC/ISH staining platforms shall (must) be delivered to the location as indicated below within 10 business days of notification of contract award to accomplish platform and peripheral setup, on-site (MAMC) and offsite training, and staining optimization and validation studies. During the initial deployment, a dedicated technical representative must be available on-site (MAMC) 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 Officer 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 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.

6.4. 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.

6.5. 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.

6.6. 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

IHC Stain Estimated Annual Volume Estimated 5 Yr Volume

ALK 50 250

ALK1 25 125

ALPHA-FETOPROTEIN (AFP) 4 20

Basal Cell (34BE12 /P63) 170 850

B-CELL LYMPHOMA 2 (BCL2) 28 140

B-CELL LYMPHOMA 6 (BCL6) 35 175

BETA-CATENIN 22 110

B-HCG 10 50

BOB.1 50 250

BRAF 20 100

CALRETININ 64 320

CARBONIC ANHYDRASE IX (CAIX) 18 90

CD10 71 355

CD117/ c-KIT 119 595

CD123 (100) 4 20

CD138 76 380

CD15/ Leu-M1 24 120

CD163 79 395

CD1a 5 25

CD2 16 80

CD20/ L26 159 795

CD21 60 300

CD23 12 60

CD25 50 250

CD3 172 860

CD30/ Ki-1 87 435

CD31 24 120

CD34 144 720

CD4 15 75

CD43 7 35

CD45/ LCA 15 75

CD5 47 235

CD56 33 165

CD57 2 10

CD61 17 85

CD68 50 250

CD7 12 60

CD79a 7 35

CD8 17 85

CD99 6 30

CDX2 47 235

CEA 6 30

CHROMOGRANIN A 24 120

CK 19 18 90

CK 20 83 415

CK 5/6 57 285

CK 7 113 565

CK 8/18 7 35

CK HMW (CK34BE12) 3 15

CLDN18 RxDx Assay 50 250

CMV (100) 43 215

c-MYC 10 50

CO-25 50 250

CYCLIN D1/BCL1 48 240

DESMIN 36 180

DOG-1 20 100

EBER-ISH 50 250

E-CADHERIN 45 225

EMA 13 65

EP-CAM 47 235

ER (250) 161 805

ERG 27 135

FACTOR XIIIa 41 205

FOLR1 100 500

GATA-3 67 335

GFAP 3 15

GLYPICAN-3 14 70

HELICOBACTER PYLORI 151 755

HER2/NEU 152 760

HMB-45 (MELANOMA MARKER) 21 105

H-S-A (HEPATOCYTE SPECIFIC

ANTIGEN)

15 75

HSV II (100) 20 100

INHIBIN 11 55

INI-1 50 250

INSM-1 50 250

K167 (MIB-1) 246 1230

Kappa/Lambda Dual ISH Stain 50 250

LEF-1 50 250

MAMMAGLOBIN 11 55

MELAN A (MART-1) 206 1030

MLH-1 (MMR) 38 190

MOC-31 65 325

MSA (MUSCLE SPECIFIC ACTIN) 4 20

MSH2 (MMR) 38 190

MSH6 (MMR) 38 190

MUM-1 16 80

MYELOPEROXIDASE (IHC) 7 35

MYOD1 3 15

NAPSIN A 51 255

NKX3.1 32 160

Oct 2 12 60

Oct-4 14 70 p120 35 175

P16/ CINtec 335 1675

P40 74 370

P504S/ RACEMASE 183 915

P53 63 315

P57 24 120

P63 99 495

PAN CK (AE1/AE3/PCK26) 322 1610

PAX-5 55 275

PAX-8 46 230

PD1 9 45

PD-L1 100 500

PHH3 10 50

PMS2 (MMR) 41 205

PODOPLANIN 57 285

PR (250) 98 490

PRAME 200 1000

S100 77 385

SALL-4 16 80

SATB2 50 250

SMMHC (MYOSIN, SMOOTH

MUSCLE)

97 485

SMOOTH MUSCLE ACTIN (SMA) 57 285

SOX-10 425 2125

SOX-11 50 250

STAT-6 50 250

SYNAPTOPHYSIN 70 350

TDT 9 45

Treponema pallidum 20 100

TTF-1 65 325

UROPLAKIN II (100) 18 90

VIMENTIN 2 10

WT1 21 105