Special Stain Platform Performance Work Statement.docx
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- Attached to
- AUTOMATED SPECIAL SLIDE STAINING PLATFORMS & REAGENTS Federal contract opportunity
- Solicitation number
- PANHCA-21-P-006883
- Issued by
- Department of the Army Medical Command
About this file
This performance work statement outlines requirements for a contractor to provide two automated slide staining platforms and associated reagents, stains, and supplies to support the Anatomic Pathology mission at Madigan Army Medical Center. The contractor will be responsible for furnishing two exactly similar special stain automated slide staining platforms from a single manufacturer, including all necessary instruments, peripheral equipment, maintenance, repairs, and parts to maintain the systems in optimal working condition at no additional cost to the government. The contractor must also provide training, information management systems, delivery and installation of the platforms and peripheral devices, and comply with all information security and program management requirements detailed in the document. The period of performance is from 1 October 2021 through 30 September 2026, consisting of a one-year base period and four one-year option periods.
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PERFORMANCE WORK STATEMENT
Special Stain Platform Solicitation
1. GENERAL REQUIREMENTS
1.1 Scope of Work. The Contractor shall provide two (2) automated slide staining platforms with 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 two (2) exactly similar special stain automated slide stainer 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, 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 stain/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 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 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 |
| DoD CLIP |
| Department of Defense Clinical Laboratory Improvement Program |
| HIPAA |
| Health Insurance Portability & Accountability Act of 1996 |
| 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 two fully automated slide staining platforms capable of providing an array of special stains listed, but not limited to, those identified in Table 1. The staining platform system will be from a single contractor. The system shall provide redundancy to ensure continuous operations. The Contractor shall provide the system, two (2) training slots at the Contractor’s training site/facility (no cost to the government), initial operator training on-site for up to six (6) technicians (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 base year as well as each option year.
Table 1. Special Stains
| Acid – Fast Bacteria |
| Gram Yellow |
| PAS w/ Alpha Amylase |
| Alcian Blue pH 2.5 |
| Grocott’s Methenamine Silver |
| PAS w/ Green |
| Colloidal Iron |
| Iron |
| Reticulin w/ Nuclear Fast Red |
| Congo Red |
| Masson’s Trichrome |
| Warthin – Starry |
| Elastic |
| Mucicarmine |
| Fontana Masson |
| Gram |
| Period Acid – Schiff (PAS) |
| Melanin Bleach |
*The contractor must have at least 85% (15/18) of the staining menu available to run on the automated platform.
3.1.1.1 The 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 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 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 Staining Platforms.
3.2.1 Platforms shall have fully automated staining capability with the ability to add new staining protocols to meet future testing/workflow requirements.
3.2.2 The staining platform, stains and reagents shall be approved by the Food and Drug Administration (FDA). All platforms and associates 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 Stains and Reagents.
3.3.1 The platforms must have the on-board ability to maintain reagents at the proper storage temperatures for the 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 85% (15/18) 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 the first year (base) of the contract due to changes in staining methodologies. In addition, workload may expand in subsequent option years due to 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 (base plus four option years). All workload numbers represent total estimated billable/reportable stains for the indicated year.
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 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 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 onsite to provide unlimited emergency service (service requiring immediate repair) within 24 hours of establishing contact. The platform(s) shall be repaired and operational within 48 hours after initial response by the Contractor. Should both platforms be inoperable, the Contractor’s technical specialist must be onsite 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 stains, reagents, and any other supplies necessary to troubleshoot the reasons for platform failure at no additional cost. If Government purchased 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 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 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 both staining platforms become inoperable, the technical repair specialist shall be onsite within four (4) hours. The Contractor’s qualified service technician shall be onsite to provide unlimited emergency services.
3.4.3.7 The repair of at least one (1) staining platform must be completed within 48 hours of notification. If both 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 as both platforms remain inoperable.
3.4.3.8 If the platforms 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 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 initial onsite operator training for up to six (6) technicians assigned to the Government site (i.e. Madigan Army Medical Center Department of Pathology personnel) prior to initiation of use of the staining platforms for patient testing. Training should encompass basic operation, maintenance and troubleshooting.
3.5.2. The Contractor shall provide two (2) training slots at the Contractor’s training site, at no additional cost to the Government (includes transportation airfare, rental car, lodging, per diem, incidentals, etc.). The Contractor may charge the Government only for training services exceeding these two identified slots.
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 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 Staining Platforms, Peripheral Devices, and Equipment.
3.7.1 The staining platforms shall (must) be delivered to the location as indicated below within 30 calendar days after the start of the new fiscal year (1 October 2021). Platform and peripheral setup, onsite training, and staining optimization and validation studies shall be completed by the Contractor. 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:
Madigan Army Medical Center 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:
Madigan Army Medical Center Department of Pathology Anatomic Pathology Administrative Director Telephone: (253) 968-1697/1698
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.
Appendix 1
Estimated Stain Volume/Year
| SPECIAL STAIN |
| ESTIMATED ANNUAL VOLUME |
| % VOLUME |
| Acid Fast Bacillus, Fite's |
| 60 |
| 2.40% |
| Acid Fast Bacillus, Ziehl-Neelsen |
| 125 |
| 5.00% |
| Alcian Blue, pH 2.5 |
| 25 |
| 1.00% |
| Colloidal Iron |
| 25 |
| 1.00% |
| Congo Red |
| 45 |
| 1.80% |
| Elastic-Verhoff's |
| 60 |
| 2.40% |
| Fontana Masson Argentaffin |
| 30 |
| 1.20% |
| Fungal PAS, Diastase |
| 15 |
| 0.60% |
| Fungal PAS, Green |
| 220 |
| 8.80% |
| Gram/Gram Yellow |
| 45 |
| 1.80% |
| Grocott's Methenanine Silver |
| 880 |
| 35.20% |
| Iron (and Prussian Blue) |
| 460 |
| 18.40% |
| Melanin Bleach |
| 15 |
| 0.60% |
| Mucicarmine |
| 40 |
| 1.60% |
| Periodic Acid Schiff |
| 50 |
| 2.00% |
| Periodic Acid Schiff, Diatase/Digest |
| 105 |
| 4.20% |
| Reticulum, Gordon/Snook |
| 130 |
| 5.20% |
| Thioflavin T |
| 10 |
| 0.40% |
| Trichrome-Masson/Gomori |
| 120 |
| 4.80% |
| Warthin-Starry/Steiner |
| 40 |
| 1.60% |
| Total Estimated Annual Stain Volume (Base) |
| 2500 |
| Option Year 1 Estimate |
| 2625 |
| Option Year 2 Estimate |
| 2750 |
| Option Year 3 Estimate |
| 2875 |
| Option Year 4 Estimate |
| 3000 |
**Note: Estimates based on three year data analysis (CY2018 - CY2020)
PWS Attachment # 1
Exclusion from Participation in Federal Health Care Programs (October 2015)
1. The Contractor shall not employ or contract with any individual or entity (hereinafter collectively referred to as “person”) to provide items or services that will be included in invoices submitted to the Government under this contract if such person is listed on the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) List of Excluded Individuals and Entities (LEIE) or the TRICARE Sanctioned Provider List. The Government is legally prohibited from paying for provision of items or services by such persons. The prohibition extends to services beyond direct patient care, such as services of persons in executive or leadership roles and administrative and management services, whether or not such services are billed separately. The LEIE may be found at http://oig.hhs.gov/fraud/exclusions.asp, and the TRICARE Sanctioned Provider list at http://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Quality-And-Safety-of-Healthcare/Program-Integrity/Sanctioned-Providers. The LEIE and TRICARE Sanctioned Provider List are hereinafter collectively referred to as “the Lists.”
2. Prior to start of contract performance, the Contractor shall (a) query the Lists to determine whether the name of any person the Contractor employs or contracts with to provide services or items for which payment may be made under this contract appears on the Lists, and (b) certify to the Contracting Officer that the Contractor has queried the Lists and no such names appear on either of the Lists.
3. During performance of the contract, and prior to persons other than those whose names were queried in accordance with paragraph 2, above, (hereinafter “new persons”) providing services or items under the contract, the Contractor shall (a) query the Lists as in paragraph 2, and (b) certify to the Contracting Officer that the names of such new persons do not appear on either of the Lists.
4. The Contractor is advised that during performance of the contract, MTF personnel will perform a recurrent recheck of the names of contractor personnel working in the MTF against the Lists, as specified in OTSG/MEDCOM Policy Memo 15-037. The Government will notify the Contractor in the event any contractor personnel working in the MTF appear on either of the Lists.
5. Should any person providing items or services under the contract appear on either of the Lists at any time during contract performance, the Contractor shall (a) in cases where the Contractor identified the person, notify the Contracting Officer, and (b) promptly remove that person from the contract.
6. Violation of any aspect of the above paragraphs shall be considered a material breach of the contract and may result in termination of the contract.
7. The Contractor is further advised that, in accordance with Civil Monetary Penalties Law [CMP] (codified at 42 USC § 1320a-7a):
a. There are steep civil monetary penalties associated with billing the Government for providing items or services by a person on either of the Lists, and with failing to return to the Government any overpayments received for provision of such items or services.
b. Billing under the contract for provision of items or services by a person on either List may also result in exclusion of the person that employs or contracts with such person.
8. HHS OIG has issued a Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs with additional information on the CMP. The Special Advisory Bulletin may be found at http://oig.hhs.gov/exclusions/files/sab-05092013.pdf.
End of PWS Attachment # 1
PWS Attachment # 2
TOBACCO FREE MEDICAL CAMPUS (TFMC)
In accordance with Army Regulation 600-63, paragraph 7-3, 14 April 2015; Operations Order 15-48 (Army Medical Command (MEDCOM) Tobacco Free Living – USAMEDCOM), 8 May 2015; and any Operations Order, regulation or other instruction implementing, defining or otherwise addressing the Tobacco Free Medical Campus (TFMC) on any military installation or DoD-controlled location, Contractor personnel are prohibited from using any tobacco product on or within any TFMC while performing under this contract. TFMCs are established at each installation or DoD-controlled location and include: (1) any property or non-residential building that is operated, maintained or assigned to support medical activities, including but not limited to, hospitals, medical laboratories, outpatient clinics (including medical, dental, and veterinary facilities), or aid stations operating for the primary purpose of delivering medical care and services for DOD eligible beneficiaries and /or meeting the mission of the Army Medical Command; (2) all other facilities in which medical activities or administration take place, to include HQ MEDCOM and Defense Health Headquarters; (3) all internal roadways, sidewalks and parking lots; and (4) all sidewalks, parking lots and grounds external but adjacent to the building or related to the migratory corridors surrounding the medical facility. The Contractor shall obtain from the COR any orders, regulations, instructions or other documents implementing, defining or otherwise addressing the TFMC for any given installation or DoD-controlled location where Contractor personnel may perform under this contract and shall instruct Contractor personnel on the TFMC limitations for installations or DoD-controlled locations where they may perform under this contract.
(End of PWS Attachment # 2 )
PWS Attachment # 3 POLICY FOR REPORTING INCIDENTS OF SEXUAL ASSAULT AND SEXUAL HARASSMENT UNDER SEXUAL ASSAULT PREVENTION AND RESPONSE PROGRAM (SHARP)
1. The contractor shall comply with OTSG/MEDCOM Policy Memo 19-019, Sexual Harassment/Assault Response and Prevention (SHARP) Program, Mar 21, 2019. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.
2. The contractor shall require all HCPs with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.
(END OF SHARP)
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