SOW.pdf

Statement of Work Holter ECG System

VA Eastern Colorado Health Care System Rocky Mountain Regional VA Medical Center

Aurora, CO

1. SCOPE

1.1. The Contractor shall deliver and install all items listed in section 2.5.

1.2. Equal items must meet all salient characteristics defined in section 2.5.

1.3. Installation must meet manufacturer specifications.

1.4. The Contractor shall furnish all personnel, supplies, and equipment required for delivery and installation.

2.5 ITEM SPECIFICATIONS AND SALIENT CHARACTERISTICS

2.5.1. Holter Analysis System

Item #: 2093156-001 Quantity: 1 Basis of Design: CardioDay V2.5 Holter Analysis System

Specifications/Salient Characteristics:

• ST analysis

• Pacemaker detection and analysis

• Advanced Afib analysis

• Advanced Heart Rate Variability (HRV) analysis

• PR Trend Analysis

• QT Measurement analysis

• Heart Rate Turbulence Analysis

• T-wave alternans analysis

• MUSE connectivity

• Supports two and three channel recordings up to seven days

• Supported recorders include SEER 1000, SEER Light, SEER Light Extend, SEER 12, CM 3000 series, and CM 4000 series

• ECG channels:

2 channel 3 channel

• Recording time options:

24 hours 48 hours 7 days†

• Pacemaker detection:

Standard (all channels)

• LED’s:

Event button status indicator LED Hookup Guidance LED

• Demographic data entry & hookup preview:

PC Application via Bluetooth communication Mobile Application via Bluetooth communication

• Download & data transfer:

USB 2.0 Hi-Speed Cable

• Non-removable digital memory

• Input voltage range ECG: ± 6 Mv

• Input impedance: > 10 MΩ

• Ingress Protection Rating: IP43

• Sampling rate: 256 sps with 12 bit resolution

• Frequency response: 0.05 Hz – 70 Hz

• Dimensions: 70 mm x 63 mm x 18 mm

• Weight: 50g (1.76 oz)

• 1 LR03/AAA alkaline battery

• 1 HR03/AAA NiMH rechargeable battery

• Mobile Application Compatable with:

iOS6, iOS7 iPod® touch (4th and 5th generation) iPhone® 5 iPhone 4S iPhone 4 iPad® Mini™ iPad (3rd and 4th generation) iPad II

• PC Application Compatable with:

Windows® 8 Windows 7 Home, Professional, Ultimate (64 bit) Windows 7 Home, Professional, Ultimate (32 bit) Windows XP (SP3)

2.5.2. Licenses

Item #: 2093156-043 Quantity: 5

Basis of Design: GE CardioDay V2.5 Floating License Specifications/Salient Characteristics

Accessories/Configuration Options:

• Floating license

2.5.3. Holter Analysis Test System

Item #: 2093156-059 Quantity: 1

Basis of Design: CardioDay V2.5 Holter Analysis Test System Specifications/Salient Characteristics

Accessories/Configuration Options:

• QTY Two (2) floating licenses

• Holds ten (10) studies

• ST analysis

• Pacemaker detection

• Advanced Afib analysis

• Advanced Heart Rate Variability (HRV) analysis

• PR Trend Analysis

• QT Measurement analysis

• Heart Rate Turbulence Analysis

• T-wave alternans analysis

• MUSE connectivity

• Supports two and three channel recordings up to seven days

• Supported recorders include SEER 1000, SEER Light, SEER Light Extend, SEER 12, CM 3000 series, and CM 4000 series

2.5.4. ECG Holter

Item #: 2067634-003

Quantity: 35 Basis of Design: GE SEER 1000 Specifications/Salient Characteristics:

• SEER 1000 Recorder Kit

• 3 days with MARS, 7 day with CardioDay

• Operators Manual

• Quick Start Guide

• Supplies & Accessories manual

2.5.5. ECG Leadwire Set, 7 Leadwire, 3 Channels

Item #: 2104817-001 Quantity: 30

Basis of Design: GE SEER 1000 Leadwire Set, 7 Leadwire, 3 Channels Specifications/Salient Characteristics

• 7 Leadwire

• 3 Channels

• 105 cm (41 in)

2.5.6. ECG Leadwire Set, 5 Leadwire, 2 Channels

Item #: 2104816-001 Quantity: 5

Basis of Design: GE SEER 1000 Leadwire Set, 5 Leadwire, 2 Channels Specifications/Salient Characteristics

• 5 Leadwire

• 2 Channels

• 105 cm (41 in)

2.5.7. USB Download cable, PC App, and Bluetooth Kit

Item #: 2061634-165 Quantity: 4 Basis of Design: GE SEER USB Download Cable, PC App, & Bluetooth Kit

Specifications/Salient Characteristics Accessories/Configuration Options:

• USB cable to download ECG and patient data via USB to the holter acquisition workstation

• SEER 1000 PC Application

• Bluetooth adaptor for a PC

2.5.8. Project Managment

• The Contractor shall draft a Contractor Project Management Plan (CPMP) that lays out the

Contractor’s approach, timeline, and tools to be used in execution of the contract. The CPMP should take the form of both a narrative and graphic format that displays the schedule, milestones, risks and resource support. The CPMP shall include the contractor’s plans for managing all subcontractors.

• Topics to be addressed shall include oversight and communications with subcontractors while onsite at VA locations, as well as executing the timely distribution and delivery of all materials to subcontractor personnel. The CPMP shall also include how the Contractor shall coordinate and execute planned, routine, and ad hoc data collection reporting requests as identified. The initial baseline CPMP shall be concurred upon and updated monthly thereafter. The Contractor shall update and maintain the VA Contracting Officer’s Representative (COR) approved CPMP throughout the period of performance. The CPMP will include, but not be limited to:

o Project Schedule to include Milestones, Deliverables, and Critical Path o Implementation Plan o Verification & Validation (V&V) Plan o Training Plan o Risks Management Plan o Project Closeout Activities/Procedures

• Reporting Requirements o The Contractor shall provide weekly progress reports, to include schedule updates, to the

VA COR and shall cover all work completed during the reporting period and work planned for the subsequent reporting period. The reports shall also identify any problems that arose and a description of how the problems were resolved. If problems have not been completely resolved, the Contractor shall provide an explanation. The Contractor shall monitor performance against the CPMP and report any deviations. It is expected that the

Contractor will remain in communication with the VA accordingly so that issues that arise are transparent to both parties to prevent escalation of outstanding issues.

o The Contractor shall provide the COR with Weekly Installation Progress Reports in electronic form in Microsoft Word, Project formats or PDF. The report shall include detailed instructions/explanations for each required data element, to ensure that data is accurate and consistent. These reports shall reflect data as of the last day of the preceding

Month. These reports shall include a summary of the task order deliverables.

• Verification and Validation Requirement (Testing) o The Contractor shall provide a final test plan that includes updates addressing any comments provided by the VA to the draft test plan.

o The Contractor shall perform all installation and configuration necessary to complete the work, plus perform technical service checks to ensure product is fully operational in accordance with each manufacturer’s operating standards.

o Acceptance testing is to be performed by the Contractor and VA personnel.

o Disputes shall be resolved by the Contracting Officer.

o The Contractor shall conduct a joint inspection with the onsite POC upon completion of delivery.

o In the event deficiencies are identified, the Contractor shall provide a date when the identified deficiencies will be addressed if not addressed on the date of delivery.

o The Contractor shall conduct a joint inspection with the onsite POC after addressing all deficiencies.

o All deficiencies identified during joint inspections shall be corrected by the Contractor before Government's acceptance of the item.

• Project Estimate Time Line o Phase I: Project Kickoff. Estimated Start Date: As soon as contract Award.

➢ Kickoff meeting

➢ Workflow design o Phase II: Software installation and testing. Estimated Start Date: As soon as Phase I is complete o Phase III: Verification and Validation: Estimated Start Date: As soon as Phase II is complete

➢ Workflow testing

➢ Pre Go-Live training o Phase IV: Go Live: Estimated Start Date: As sson as Phase III is complete.

o Phase V: Post Go-Live: Estimated Start Date: 6 months after Go-Live

➢ Follow up training

➢ Validate and review workflow

• Project Phase Requirements:

o Provide a single point of contact for the implementation of this project.

o On-site attendance for one business day for Project kick-off meeting with the Client and our engineering staff.

o Develop a project plan in accordance with site so not to affect any other deployments.

o Confirm and communicate the hardware delivery and implementation schedule.

o Manage implementation and associated risk.

o Contractor’s senior supervisor shall be on-site during equipment/software installation phase.

o Schedule startup of all new equipment.

o The Contractor’s project manager shall communicate any issues and notify the appropriate resources for resolution.

o The Contractor shall provide an implementation plan and schedule an implementation meeting within two weeks from order shipment. The Contractor shall identify specific deployment tasks and milestones in the implementation plan.

o The Contractor shall provide and maintain an accurate, detailed Inventory List of the

Contractor installed equipment and software including serial numbers, version release, and licenses.

2.6 DELIVERY AND INSTALLATION

• COORDINATION:

• The Contractor shall coordinate delivery, staging areas, installation, site safety requirements, and parking with the On-site Point of Contact (POC). The On-Site Point of Contact will be designated after contract award.

• The Contractor shall participate in a pre-delivery meeting as specified in 2.6.2.3 below to determine delivery and installation dates.

• The Contractor shall verify delivery date three business days prior to scheduled delivery.

• DELIVERY

2.6...01. The Contractor shall contact the On-Site Point of Contact to schedule a pre-delivery meeting to be conducted approximately 60 days prior to the initial award delivery date for verification of delivery and installation dates. The Contractor may be required to adjust the delivery date from the date specified in the contract award document. A government-requested delivery delay up to 90 days after the delivery date specified in the contract award shall be at no additional cost to the government.

• Delivery Location: Contractor shall deliver all equipment to the Eastern Colorado Health Care System, 1700 N. Wheeling Street, Aurora, CO 80045

• Delivery Markings: Contractor shall deliver items in manufacturer's original sealed containers with manufactures’s name marked thereon. Deliveries shall be marked with the PO and contract number.

• Items on delivery vehicles not equipped with a Lift Gate will not be accepted. The delivery will have to be rescheduled and any delivery charges will be the responsibility of the Contractor.

• A pre-delivery meeting will be conducted 60 days prior to initial award delivery date for verification of delivery and installation dates.

• Delivery and Installation will be coordinated through the On-Site Point of Contact (POC). POCs for delivery and install are:

➢ Rob Fanning, (W) 720-723-3695, robert.fanning@va.gov

• INSTALLATION

• The Contractor shall deliver and install all equipment to manufacturer’s specifications and in accordance with Federal and local safety standards.

• Installation/Configuration shall commence upon day of delivery. All work shall be completed between

8:00 a.m. and 4:30 p.m. MST. Monday through Friday, excluding all Federal holidays

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

• The Contractor shall remove all related shipping debris and cleanup any materials and tools associated with delivery and installation of the specified items. Contractor shall remove all packaging from the ECHCS premises.

• The Contractor shall be responsible for any damage to the building that occurs due to Contractor error or neglect (refer to Section 5 below).

• The Contractor shall provide remote installation and configuration of the Holter analysis software with over 5 clients on VA supplied hardware at the Rocky Mountain Regional VA Medical Center in Aurora, CO

• The Contractor shall provide on-site installation and configuration of the Holter analysis software on customer supplied software at two (2) faclilites: Grand Junction Colorado VA and Cheyenne Wyoming VA

2.7. TRAINING

• The Contractor shall provide QTY three (3) Computer Based Training (CBT) programs o Self-paced computer learning module program which instructs the user on setting up a system, how to hook up a recorder, how to analyze the data, and how to generate a report

• The Contractor shall provide QTY one (1) two hour Holter remote follow up training

• The Contractor shall provide QTY six (6) One Day on-site Clinical Product Training for MUSE or Holter system.

o Includes faciliration of system configuration, system overview, physician and clinician support, and system maintenance

2.8. SITE CONDITIONS

• There shall be no smoking, eating, or drinking inside the construction site at any time.

3. INSPECTION AND ACCEPTANCE

3.1. The Contractor shall conduct a joint inspection with the On-Site Point of Contact upon completion of installation.

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

3.2. In the event deficiencies are identified, the Contractor shall provide date when the identified deficiencies will be addressed if not addressed on the date of installation.

3.3. The Contractor shall conduct a joint inspection with the On-Site Point of Contact after addressing all deficiencies.

3.4. All deficiencies identified during joint inspections shall be fixed by the Contractor prior to government acceptance of the item.

3.5. Disputes shall be resolved by the Contracting Officer.

4. Operation and Maintenance Manuals

4.1.1. Binders - Quantity (2) each for items identified in section 2.5.

4.1.2. Digital Copies - Quantity (1) each for items identified in section 2.5.

4.2. Deliver compilation of all manufacturer recommended maintenance schedule and operation materials packaged in binder(s) to On-Site Point of Contact upon completion of installation.

5. PROTECTION OF PROPERTY

5.1. Contractor shall protect all items from damage during delivery and installation. The Contractor shall take precaution against damage to the building(s), grounds, and furnishings.

5.2. Contractor shall be responsible for providing adequate floor and wall protection to minimize damage to the facility during delivery/installation of the items in section 2.5. It is recommended that all material handling equipment have rubber wheels to minimize potential damage to floors.

5.3. The Contractor shall perform an inspection of the building(s) and grounds with the On-Site Point of Contact prior to commencing work. The Contractor shall be responsible for repairing or replacing any items that require simple repair, components, building(s), or grounds damaged due to negligence and/or actions taken by the Contractor or its employees. The source of all repairs beyond simple surface cleaning is the facility construction contractor (or appropriate subcontractor), so that building warranty is maintained. Concurrence from the VA Facilities

Management POC and On-Site Point of Contact is required before the Contractor may perform any significant repair work. In all cases, repairs shall utilize materials of the same quality, size, texture, grade, and color to match adjacent existing work.

5.4. The Contractor shall be responsible for securing the items identified in section 2.5 and its own work tools and equipment during delivery/installation.

6. SECURITY REQUIREMENTS

6.1. Any software connecting to the VA Network must be currently approved by VA IT.

7. WARRANTY

7.1. The contractor shall provide all manufacturer(s) warranties on all parts and labor at time of delivery.

7.2. The warranties shall include all travel and shipping costs associated with any warranty repair.