SOW_for_FedBizOpps.docx

STATEMENT OF WORK (SOW)

ALLERGY TESTING

WOMACK ARMY MEDICAL CENTER (WAMC)

FORT BRAGG, NORTH CAROLINA 28310

SITE VISIT. The Point of Contact (POC) for the site visit is __________, __________. Alternate POC is __________, __________. The site visit will be conducted on __________ at _________ AM, Eastern Standard Time. The site visit location is the Department of Pathology, Womack Army Medical Center (WAMC), Building 4-2817, Room BG0800, Reilly Road, Fort Bragg, NC 28310. This location is the Ground Floor of WAMC. Contractors shall gather at the Specimen Receiving window of the Department of Pathology. Contractors that haven’t obtained a WAMC Visitor Badge will be escorted to the Equipment Maintenance Department to receive a WAMC Visitor Badge. Contractors MUST coordinate and conduct a site visit for the purpose of surveying and assessing current laboratory set-up, laboratory environmental control, and available utilities with regard to potential placement of their instruments in the laboratory. Any changes to the layout of the laboratory, environmental control, or to utilities as currently in existence to accommodate placement of their proposed analyzers must be identified in the Contractor’s proposal (i.e., must identify all site preparation requirements necessary for potential placement of their analyzers in the laboratory). The Contractor shall be responsible for safeguarding all Government property provided for contractor use or access. Contractor vehicles may be searched at the Fort Bragg entrance. Contractor must obtain a Visitor Badge upon entering WAMC from the Equipment Maintenance Department. Contractor must allot for enough time at the Fort Bragg entrance and obtaining a WAMC Visitor Badge in order to start the site visit.

1. SCOPE OF WORK.

1.1. The Contractor shall provide non-personal services to include, but not limited to, all reagents, testing systems, equipment, personnel, transportation, materials, supervision, maintenance of all equipment, training, and all other items and services necessary in order to provide allergy testing. This testing is for the Department of Pathology, WAMC, Building 4-2817 Reilly Road, Fort Bragg, NC 28310. The period of performance is shown in the Table below.

1.2. The contract pricing must be an all-inclusive price with-in the Cost Per Kit (CPK).

1.3. For the purpose of this SOW, the testing system includes at a minimum, analyzer and peripherals to include: Uninterruptable Power Sources (UPS), instrument specific computers, Central Processing Units (CPU’s), printers, barcode scanners, terminals, monitors, etc. Testing system shall be delivered and installed at WAMC, Fort Bragg, NC.

2. TESTING SYSTEM.

2.1. The testing system must be manufactured, sold and supported by one Contractor. The testing system shall be serviced and supported by the awarded Contractor. This includes all on-site and off-site training, Information Technology (IT) management, IT implementation services, phone support, on-site and off-site services, as well as any future FDA approved testing that can be performed on contractor supplied testing system. The testing system must be capable of interfacing with the military hospital computer system, i.e., the Composite Health Care System (CHCS). The Contractor must have an established driver compatible for interfacing the analyzer with the CHCS. The interface between CHCS and the analyzer must be bi-directional.

2.2. The testing system must include a data management system for control of the operation of the analyzers, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results; and a printer for the production of hard copy patient reports and other reports generated via the data management system.

2.3. All equipment displays and supporting literature must be in the English language. Lease of this equipment shall include delivery, installation, all calibrators/standards, reagents/reagent packs, linearity material, and quality control materials necessary to perform the specified assays, initial Method Validations per Clinical Laboratory Improvement Act (CLIA)/College of American Pathology (CAP) guidelines and analyzer removal at the termination of the contract.

2.4. The analyzers shall be fully automated with at least 500 tests per batch, overnight runs, continuous access for samples, a true walk-away system, automatic shut-down of the system, and barcode reading for all reagents and samples.

2.5. All analyzers and associated parts and accessories will be new. Neither used, refurbished, or like-new equipment will be provided in support of this contract at any time.

2.6. The testing system must come equipped with an un-interruptible power supply capable of providing all necessary electrical power to each analyzer system, to operate the data management and testing system for at least 15 minutes.

2.7. Contractor shall provide updates and upgrades of testing system upon availability at no charge. The Contractor and Contracting Officer’s Representative (COR) shall agree upon a date of installation of updates and upgrades.

3. INFORMATION MANAGEMENT.

3.1. Contractor Information Systems (IS)/Network that are involved in the operation of systems in support of WAMC shall operate in accordance with controlling laws, regulations, DoD, and local policy. The Contractor will comply with DoD guidance regarding allowable ports, protocols and risk mitigation strategies.

3.2. The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data, to ensure the confidentiality, integrity, and availability of Government data. As a minimum, this shall include provisions for personnel security, electronic security and physical security. The Contractor will provide information for the Risk Assessment Analysis to the COR for all networking IT applicability. All costs for hardware and software will be incurred by the Contractor.

4. REAGENTS.

4.1. The Contractor shall provide all of the tests listed in exhibits, to include reagents and calibrators. These products must be manufactured by the Contractor and not by a third party. The testing system and all assays must be Food & Drug Administration (FDA) approved. All reagents provided will be identical to those used in the FDA 510K approval application. For reagents with hazardous constituents, Contractor must provide a mechanism for the Laboratory to meet local discharge requirements. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alerts and notifications of all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the COR, Chemistry Supervisor and Lead Medical Technologist.

4.2. The Contractor will also estimate the volume of user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks. The contractor shall provide the operator level maintenance tool/spare parts kits and replenish all expended items. Replenishment will be made as needed or on a periodic basis not to exceed the normal preventive maintenance cycle.

4.3. Delivery of the reagents will be on an as needed basis. Individual orders will be placed by the COR or other designated authorized government personnel. Name and point of contact of authorized personnel will be provided to the Contractor.

4.4. The workload listed in the exhibits is an estimate based on projected annual volume. Orders of required items will be called or emailed to the Contractor. Deliveries shall arrive within five working days after the order is placed. No deliveries shall be accepted on weekends or federal holidays. Emergency orders placed before 2:00 PM Eastern Standard Time (EST) will be delivered within 24 hours after the order is placed.

4.5. All reagents/reagent packs will be provided as follows:

· Be provided by the manufacturer of the equipment.

· Be marked with the required storage temperature.

· Be maintained at the proper storage temperature during transportation from the Contractor’s storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.

4.6. In the event that the supplies are found to be defective and unsuitable for use with the Contractor's equipment or the contractor has failed to comply with the requirements, the Contractor shall replace the supplies within 24 hours of receipt of the order. The Contractor shall reimburse the government for any costs/supplies related to tests performed by another contractor or sent to a referral laboratory when reagents were not available due to product issues or instrumentation failure.

4.7. Safety Data Sheets (SDS). For all products the contractor must provide a mechanism for the laboratory to meet local discharge requirement. The Contractor shall provide one set of paper copy and two electronic copies on Compact Disk (CD) of SDS of all reagents and consumables to be used on the system.

5. INSTALLATION AND INITIAL SET UP.

5.1. Prior to reporting to the laboratory, the contractor or contractor’s representatives shall report to and obtain a visitor badge from the Equipment Maintenance Department of the facility. The badge must be returned to the department prior to departing the facility.

5.2. The Contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the contract and connections of all equipment and interconnecting wiring and cabling if applicable in coordination with the facility biomedical engineer. Upon receipt of notice from the COR, an agreed date will be established to proceed with installation. It shall be the Contractor's responsibility to inform the COR of any problems which may be anticipated in connection with installation or which will affect optimum performance once installation is completed. The Contractor will provide a qualified Technical Service Representative, who possesses a thorough knowledge of method validation and is familiar with the use of statistical evaluation software as determined by the Laboratory Director (e.g. EP Evaluator®), to provide technical assistance for the method validation studies.

5.3. During the initial implementation, a technical representative must be available on site throughout the entire implementation period, ensuring the installation and validations be completed within 30 days of equipment arrival. The same technical representative should be available throughout the entire implementation; there must be documentation of information "hand off" between the different Technical Representatives.

5.4. Upon completion of installation, on-site training, method validation studies, and analytical measurement range/linearity verification must be performed by Contractor personnel within a period of time to ensure that equipment is fully operational as negotiated.

5.5. Method Validation will be conducted in accordance with method validation protocols established by the Clinical Laboratory Standards Institute (CLSI) and/or required by the College of American Pathologists (CAP). Method Validation will include but not be limited to, correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of precision (replication study) and establishment or verification of quality control ranges. All reagents, quality control materials, calibrators and linearity materials used in the Method Validation Study will be provided by the Contractor at no cost to the Government. These materials will not be used in the analysis of specimens for patient care.

5.6. Contractor shall perform all validation studies at no cost to the government, to include manpower, linearity material and reagents, calibrators, controls and be consistent with current CLSI Standards and related documents, CAP Standards and Federal Regulations, for the following:

· Correlation studies should include a minimum of 30 samples, spanning the reportable range, shall be run by the present and the new method. Contactor shall analyze numbers and provide statistical data to accept the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, and meet current standards defined by CLSI.

· Linearity analysis shall be performed on new contracted instrument for each analyte to determine reportable range using statistical tool in accordance with CLSI.

· Precision study shall be performed utilizing normal an abnormal control material. This should consist of a within run precision study of 10 normal and 10 abnormal controls or patient samples.

· Carryover studies must be performed, as applicable, as part of the initial evaluation of the instrument. Contractor shall provide interpretation of raw data and validate no carryover exists within the testing system.

5.7. The Contractor will provide statistical reports of method validation study and all result print outs, package inserts of materials used for method validation study in an organized fashion to the chemistry supervisor before using the analyzer systems for patient testing. In addition to the hard copy, the Contractor will provide method validation study results and reports electronically, on a CD or DVD. The Contractor will provide instrument settings and other configurations on a paper as well as electronically on a CD or DVD.

6. MAINTENANCE AND SERVICES.

6.1. Prior to performing maintenance and repair work, the contractor or contractor's representative shall report to and obtain a visitor badge from the Equipment Maintenance Department of the facility. The badge must be returned to the department prior to departing the facility.

6.2. The Contractor shall provide a list of maintenance agreement options. The Contractor shall provide a full preventative 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 hotline telephone service, to assist operators in troubleshooting problems.

6.3. The Contractor is required to maintain all equipment installed under this contract. The Contractor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment.

6.4. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level will be performed by Contractor personnel in accordance with requirements as specified in the Contractor’s instrument manual. A preventive maintenance service shall include, but is not limited to, safety, calibration, complete operational 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. Completion of installation of the analyzers will establish time zero for determination of time frames for performance of the above periodic services.

6.5. The Contractor shall provide direct customer hotline telephone service and support, 24 hours/7 days a week, and on-call emergency repair service support, to assist operators in correcting equipment operation problems. The Contractor shall respond to telephonic requests for unscheduled repair within one working day.

6.6. 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. During the contract period, should the repair record of any laboratory equipment reflect a downtime of more than 72 hours in one calendar month, a determination will be made by the COR to replace the initial laboratory equipment with new equipment.

6.7. Within one working day after completion of work, the contractor shall furnish the copy of a service report for all services performed to the COR and chemistry supervisor.

The report shall be in English and shall contain, as a minimum, the following information:

· Nomenclature and serial number.

· Date.

· Description of services performed (i.e., preventive maintenance service, or unscheduled repair service).

· Location and services performed.

· Duration of performance (hours).

· List of parts replaced or other actions taken to restore operability of the instrument.

· Name of Technician.

7. TRAINING.

The Contractor will provide initial on-site operator training of all technicians assigned to the Government. In addition, the Contractor will provide training for two primary operators at the Contractor’s training site at no additional cost to the Government. The Contractor will provide one training slot per contract year, at the Contractor’s training site at no additional cost to the Government. Operator training at the Contractor’s training site shall include all costs of off-site training, i.e., transportation (air and ground), room and board.

8. SPECIAL TASKS.

8.1. The Contractor will provide one paper and one CD copy of the Operator and Maintenance manuals and a statement of the warranty terms in the 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 as non-Government owned equipment are serviced and maintained by the Contractor.

8.2. The Contractor will provide one paper and one CD copy of Standard Operating Procedures (SOPs) for each and every methodology included under the Proposal. The SOPs will include all relevant technical information regarding the methodology and shall be provided in Microsoft Word, capable of being customized/modified by the end user.

8.3. Updates, upgrades or Replacement: Request for instrumentation updates, upgrades or replacement, due to workload increase, menu changes, technological upgrades, excessive instrumentation failures/malfunctions, breakdowns, or service calls will be evaluated as needed with communication to the contractor for resolution of the issue. A high incidence of problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the Government to its replacement with another analyzer(s) that can produce the required criteria of this contract satisfactorily to the user at no additional cost to the Government. Removal of instrument by the contractor shall be performed within 60 days after request.

9. EQUIPMENT REMOVAL.

At the end of the contract term, the contractor shall remove all equipment within 60 days after notification of the expiration of the terms of this contract but not until the completion of new contractor’s equipment installation inclusive of completed cross over studies. Contractor shall not remove hard drive from premises. All drives with patients’ information remains the property of the Government.

PERFORMANCE WORK STATEMENT – ADDENDUM FOR

ANTI-TERRORISM/OPERATIONS SECURITY

Access and general protection/security policy and procedures. This standard language is for Contractor employees with an area of performance within Army controlled installation, facility, or area. 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, HQDA 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.

For Contractors requiring Common Access Card (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 Army Directive 2014-05. 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 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.

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) (Army Directive 2014-05/AR 190-13), 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.

Threat Awareness Reporting Program. For all Contractors with security clearances. Per AR 381-12 Threat Awareness and Reporting Program (TARP), Contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b.

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