Section_3__Statement_of_Work_and_Functional_Requirements_V2.xlsx
XLSX spreadsheet 50 KB Posted
- Attached to
- DINPACS IV Federal contract opportunity
- Solicitation number
- SPE2D1-15-R-0004
About this file
This solicitation notice seeks proposals for the Digital Imaging Network - Picture Archiving and Communications System (DIN-PACS) IV contract to provide PACS systems and services to Department of Defense and Department of Veterans Affairs medical facilities. Offerors are to supply DIN-PACS systems and components, system options and accessories, upgrades, training, and maintenance services. The DIN-PACS is an open system network of digital imaging devices designed for effective acquisition, transmission, display, and management of diagnostic images to support radiology practices throughout the Military Health System. The goal is to create a virtual radiology department enabling access to images anywhere and anytime to dynamically shift workloads between facilities based on clinical expertise. Ordering offices include the Defense Supply Center Philadelphia and Veterans Administration National Acquisition Center to serve customers at all federally funded DoD and non-DoD medical facilities.
Section 3 - Statement of Work and Functional Requirements V2
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INSTRUCTIONS
| STATEMENT OF WORK AND FUNCTIONAL REQUIREMENTS V2 |
| For tabs A through K, the vendor may respond using the format provided, or may substitute its own formatted material, as long as it addresses the topics identified. All other sections must be completed with the provided format. All responses should be submitted using Excel Spreadsheet named: “Section 3 – Statement of Work and Functional Requirements” and into the appropriate Worksheet (1 electronic copy and 2 hardcopy formats). |
TABLE OF CONTENTS
TAB A VENDOR QUALIFICATIONS
TAB B PACS PRODUCT OVERVIEW
TAB C VENDOR CONFIGURATION RESPONSE
TAB D SYSTEM FUNCTIONALITY
TAB E SYSTEM ACCEPTANCE (SEE APPENDIX 4)
TAB F SYSTEM RELIABILITY (SEE APPENDIX 5)
TAB G SYSTEM MAINTENANCE
TAB H DIN-PACS SYSTEM SUPPORT
TAB I SYSTEM DOCUMENTATION AND TRAINING
TAB J DICOM REQUIREMENTS
TAB K INTEROPERABILITY
VENDOR RESPONSE REQUIREMENTS
The vendor shall provide a response for each outlined paragraph of the Statement of Work and Functional Requirements Section below. Each response shall provide a code indicating the status of the response, along with an explanation of the response. Coding explanations are as follows:
| Code | Description |
| C | Current product fully complies. |
| P | Not part of current product, but planned in a scheduled release. The vendor shall indicate the time frame when requirement will be available. |
| X | Requirement is neither available nor planned by the vendor. |
| In addition to the above responses, the vendor is requested to provide a summary discussion of any and all exceptions or areas of non-compliance with the Statement of Work and Functional Requirements Section. This would include any items coded with a “P” or “X”. | |
| NOTE: PLEASE ADD YOUR COMPANY NAME TO THE FOOTER OF THE WORKBOOK. |
&F SPM2D1-10-R-0011
OFFEROR NAME &P of &N
TAB A
TAB A VENDOR QUALIFICATIONS
| Please describe: | Description | |
| A.1 | Overall company and description of DIN-PACS product line. | |
| A.2 | Does your company have a history with integrating the proposed PACS soution with various Government and commercial Radiology Information Systems (RIS)? | |
| A.3 | Company/Product Literature – Please enclose company and product literature which highlights the company’s stability and position in the industry, as well as formal product literature for each item offered. |
&F SPM2D1-10-R-0011
OFFEROR NAME &P of &N
TAB B
TAB B PACS PRODUCT OVERVIEW
| Please describe: | Description | |
| B.1 | Briefly describe sites where the product is installed in an enterprise–distributed radiology environment. | |
| B.2 | Please describe what business partners your solution uses to provide the total solution. | |
| B.3 | Briefly list and describe all sites, in the DoD or VA where your PACS product is installed. | |
| B.4 | Briefly list and describe your commercial client references – minimum of five (5) (i.e. installed base of equipment) – Please include a point of contact and phone number for each listing |
&F SPM2D1-10-R-0011
OFFEROR NAME &P of &N
TAB C
TAB C VENDOR CONFIGURATION RESPONSE
| Compliance Status | Description | ||
| C.1 | Network Proposal – If requested at a specific site, the vendor will be required to assess the capability of the existing hospital network to support the DIN-PACS, and provide recommendations for network upgrades, supplements, etc. to the Government. |
The requested proposal shall identify necessary augmentation or reconfiguration to provide maximum capability of the PACS.
The vendor may also be required to review PACS network augmentation designs to be installed (at the Government’s request) by a third party, and validate that the proposed PACS will optimally perform over this network.
| C.2 | The DIN-PACS shall permit a system administrator to age patient records out of the database (for example, to remove records after twenty-seven years or after the age of majority of the patient). | |
| C.3 | The database shall support, as a minimum, ad hoc queries (i.e. one time custom query) using search criteria based on the values, or range of values, of Table 1 data items, combined using logical operators, and with the ability to sort results. The purpose of this requirement is to assure that worklist query and administrative report queries can be constructed to support a range of needs. | |
| C.3.1 | The database must support a direct DICOM Query/Retrieve. | |
| Table 1: DICOM Attribute Name/Tag | ||
| DICOM Attribute Name (Searchable Item) | DICOM Tag | |
| Patient’s Name | (0010, 0010) | |
| Patient ID | (0010, 0020) | |
| Accession Number | (0008, 0050) | |
| Requested Procedure Code Sequence | (0032, 1064) | |
| Study Date | (0008, 0020) | |
| Study Description | (0008, 1032) | |
| Study Status ID | (0032, 000A) | |
| Study Priority ID | (0032, 000C) | |
| Modality | (0008, 0060) | |
| Body Part | (0018, 0015) | |
| Institutional Department Name | (0008, 1040) | |
| Placer Order Number (DMIS ID) | (0040, 2016) | |
| Other Patient IDs | (0010, 1000) |
&F SPM2D1-10-R-0011
OFFEROR NAME &P of &N
TAB D
TAB D SYSTEM FUNCTIONALITY
| Compliance Status | Description | ||
| D.1 | Storage System. In this document, the term “storage system” refers to on-line storage for rapid access to exams. The basic element of storage and retrieval for the storage system shall be the exam. An “exam” includes both images and associated reports. | ||
| D.1.1 | The vendor shall describe their alternatives for storage systems. In particular, the Vendor should address the scalability of their storage system and the rationale behind their storage system selection, sizing, and architecture. All known limits on capacity of the storage system should be addressed. | ||
| D.1.2 | The system shall allow the selection of exams for automatic deletion from the storage system in order of priority as follows: | ||
| D.1.2.1 | retrieved exams not associated with other exams | ||
| D.1.2.2 | retrieved exams associated with exams for which the primary diagnosis is complete | ||
| D.1.2.3 | retrieved exams associated with exams for which the primary diagnosis is not complete | ||
| D.1.3 | The policy for automatic deletion of exams from the storage system shall be re-configurable by the system administrator. | ||
| D.1.4 | The storage system shall monitor usage and provide real-time display to authorized administrative level users of usage patterns and statistics. | ||
| D.1.5 | The storage system shall remain operational during the service required to correct a failed disk drive. | ||
| D.1.6 | The storage system shall provide a means for notifying the system administrator in the event of a failure in the storage system. The use of Simple Network Management Protocol (SNMP) for this function is preferred but not required. It is highly desired that this notification be provided automatically by the system (i.e. passive). | ||
| D.1.7 | The Storage System shall be completely redundant, and shall support mirroring and hot swappable technology for failsafe operation without interruption. | ||
| D.1.7.1 | The vendor shall describe RAID (Redundant Array of Independent Disks) or alternative strategy for redundancy. The vendor shall explain how failover occurs and define whether it is automated or requires IT staff involvement. | ||
| D.2 | In this document, the term “archive” refers to storage for long-term access to images. | ||
| D.2.1 | The vendor shall offer various alternative solutions for a PACS archive | ||
| D.2.2 | The archive system shall retrieve exams in response to ad hoc requests from users at workstations. | ||
| D.2.3 | The vendor is encouraged in their proposal to offer various Enterprise Storage Solutions. The vendor shall discuss various enterprise storage solutions being offered. | ||
| D.3 | D.3. Information System Interface |
The Radiology Information System (RIS) will be the primary site of data entry. The PACS must accept radiology orders, changes and updates to radiology orders, radiology reports/amendments, ADT messages, and Master File updates of radiology procedures, Master File updates of radiology locations, and Master File updates of users.
| D.3.1 | The vendor shall be able to accept HL7 (Health Level 7 standard) messages from the RIS. The PACS must support HL7 V2. As industry standards evolve over the term of the DIN-PACS IV contract, vendors will be required to support updated or new standards when they are implemented in the commercial market. Such standards may include, but not be limited to, HL7 V3 or FHIR (Fast Healthcare Interoperability Resources). When appropriate, new standards will be specified in the statements of work for delivery order competitions issued in Requests for Orders (RFO's) |
| D.3.2 | For VA orders, the vendor must already be approved, or apply to be on the approved VA HL7 list. Please use the following link for additional information: https://www.va.gov/IMAGING/HL7.asp |
| D.3.3 | The vendor shall support the Integrating the Healthcare Enterprise (IHE) initiative as it evolves. The vendor shall specify which of the integration profiles for Radiology, Cardiology, Radiology Oncology, and IT infrastructure their system supports, and the list of actors that are implemented with each profile. |
| D.4 | Image Display Workstations. The PACS shall support a variety of PACS workstations, with a variety of configurations for the primary reading and diagnosis, clinical review, and quality control of radiology studies. |
| D.5 | Monitors |
It is generally assumed that the vendor will respond with LCD flat panel technology display monitors. However, vendors are encourag ed to propose alternatives as long as such alternatives are either optional or planned workstation developments, and performance requirements either meet or exceed those defined for LCD flat panel technology.
| D.5.1 | All monitors must meet the American Association of Physicist in Medicine (AAPM), Task Group 18 performance recommendations for Medical Displays. |
| D.5.2 | All monitors must have the capability to be calibrated to the DICOM (Digital Imaging and Communications in Medicine) Grayscale Standard Display Function, Part 14. |
| D.5.2.1 | All color monitors must be capable of being calibrated to a consistent color temperature. |
| D.5.3 | Mammographic Monitors |
| D.5.3.1 | Monitors used for mammographic displays shall meet regulatory requirements for quality assurance under the Mammography Quality Standards Act (MQSA) (21 CFR 900). |
| D.5.3.2 | Mammographic monitors shall have no visual pixel defect artifacts. |
| D.5.4 | Configuration |
| D.5.4.1 | Workstation monitors shall display no fewer than 1024 shades of gray (10 bit depth). |
| D.5.4.2 | Maximum monitor brightness shall be greater than or equal to 500 candela per meter squared (cd/m2) for primary monitors, 400 cd/m2 for secondary monitors and 600 cd/m2 for mammography monitors. |
&F SPM2D1-10-R-0011
OFFEROR NAME &P of &N
TAB E
TAB E SYSTEM ACCEPTANCE (SEE APPENDIX 4)
| Compliance Status | Description | ||
| E.1 | System Acceptance Testing will be conducted in accordance with the Government’s Acceptance Testing (AT) Protocol (or other protocol if mutually agreed upon by both the Government and Contractor); the most current version available at the time of acceptance testing. A copy of the current version of this AT Protocol is available from the Contracting Officer or the applicable Service PACS Program Office. | ||
| E.2 | Other systems or equipment items purchased from this contract, and not covered under the Government’s DIN-PACS AT protocol (e.g. Computed Radiography, Film Digitizers, etc.) may be tested by the Government. Systems will be tested per manufacturer’s commercial testing protocols unless an appropriate Government testing protocol is available. |
&F SPM2D1-10-R-0011
OFFEROR NAME &P of &N
TAB F
TAB F SYSTEM RELIABILITY (SEE APPENDIX 5)
| Compliance Status | Description | ||
| F.1 | The vendor will comply with the Government’s system reliability requirements per Appendix 6, Section 2 of the Solicitation. | ||
| F.2 | The system shall be designed with reasonable redundancy so that no single point of failure can cause a major breakdown of radiology service. | ||
| F.3 | The system shall protect against the loss of acquired images and data. | ||
| F.4 | If a failure interrupts or disables image acquisition, the system shall provide a means to enter the missed images from the imaging equipment at a later time. | ||
| F.5 | Where appropriate to guarantee against loss of image or exam information during acquisition or storage in the PACS in the event of a power failure, the vendor shall supply an Uninteruptable Power Supply (UPS) with sufficient capacity to support the necessary equipment during the operation. This requirement is not intended to require UPS at all locations, only at those locations where a power failure would cause a loss of patient images or information. This requirement is also not intended to require that the system continue to operate for additional acquisitions during the power outage. | ||
| F.6 | The system shall maintain a total system uptime of 99% monthly, and individual component uptimes of at least 99% monthly, calculated monthly during the fist 6 months, and quarterly thereafter. Percentages will be calculated based on the Principal Period of Maintenance (see Appendix 6, Section 2.4 for calculation). Vendors shall document their current experience with their product that would demonstrate to the Government that this requirement can be met. (see Appendix 6 for definitions of uptime and downtime.) | ||
| uptimes of at least 99% monthly, calculated monthly during the fist 6 months, and quarterly | |||
| thereafter. Percentages will be calculated based on the Principal Period of Maintenance (see | |||
| Appendix 6, Section 2.4 for calculation). Vendors shall document their current experience | |||
| with their product that would demonstrate to the Government that this requirement can be met. | |||
| (see Appendix 6 for definitions of uptime and downtime.) |
&F SPM2D1-10-R-0011
OFFEROR NAME &P of &N
TAB G
TAB G SYSTEM MAINTENANCE
| Compliance Status | Description | ||
| G.1 | The vendor will comply with the Government’s system maintenance requirements specified in Appendix 5. | ||
| G.2 | The vendor shall offer maintenance service in accordance with the “maintenance scope of work options” specified in Appendix 5, paragraph 3.13. | ||
| G.3 | The vendor is encouraged to offer their normal, commercial maintenance service plans (based on their standard commercial maintenance service terms and conditions) in addition to the Government specified service options above. | ||
| G.4 | The offered maintenance plans shall specify the level of operations support, including all onsite field engineers, part-time and/or off-site personnel, as well as the hours of coverage. | ||
| G.5 | Maintenance and support response time shall be 4 hours or less during the 0800-1700 time period and 4 hours or less during the remainder of the day. Maintenance may be conducted remotely or onsite, or a combination of the two. Response time is measured from the time the vendor is notified of a need for maintenance or support, until maintenance is started from a remote location or support personnel arrive on-site and begin actively working on the problem. If remote maintenance and support is begun and the problem remains unresolved after the initial 4 hour time period, vendor personnel shall immediately be dispatched to the site and arrive within 4 hours or less. The above response time applies to all CONUS sites. OCONUS response times will be established on a site specific basis. |
&F SPM2D1-10-R-0011
OFFEROR NAME &P of &N
TAB H
TAB H DIN-PACS SYSTEM SUPPORT
| Compliance Status | Description | ||
| H.1 | The vendor shall provide a guarantee that the Government will be able to purchase all required spare parts from the vendor for seven years from the date of final system acceptance. This excludes computer hardware (PC’s and Servers) used within a DIN-PACS. Computer hardware shall be supported for a minimum of 3 years.” Archive Systems (hardware) must be supported for the full seven year requirement as specified above. | ||
| H.2 | If the Government elects not to upgrade existing systems to new versions (either hardware or software), the vendor shall guarantee that they will continue to provide support for hardware, software and spare parts FOR THE INSTALLED SYSTEM for a minimum of three years after release of the upgrade or, for software only, for a minimum of the two versions previous to the current version based on upgrades as defined herein. | ||
| H.3 | The DIN-PACS Software and the system commercial operating system (OS) provided must not be self-canceling, which is interpreted to mean the function of the software will not be stopped due to elapsing time or other condition not identified with the original equipment purchase. The prime contractor is responsible to ensure any third-party provided software is included in this restriction. No “renewable” licenses or agreements will be entered into by either the Contracting Officer or the using facility. |
&F SPM2D1-10-R-0011
OFFEROR NAME &P of &N
TAB I
TAB I SYSTEM DOCUMENTATION AND TRAINING
| Compliance Status | Description | ||
| I.1 | The vendor shall meet the Government’s Documentation and Training requirements specified herein. | ||
| I.2 | With every system purchased vendors shall provide Operation and Maintenance Data as specified in Appendix 2, CDRL AA. | ||
| I.3 | If purchased with a particular system, the vendor is required to provide the following Data Requirements (documentation). Further detail on the required content of this documentation is provided at Appendix 3. The vendor shall provide pricing for the completion and delivery of each of the following Data Requirements with their proposal. | ||
| I.3.1 | Component and Master Parts List - The vendor shall submit, along with their Notice of Readiness to inspect, a detailed component and master parts list for the system as specified in Appendix 2, CDRL AC. | ||
| I.3.2 | Extended Installation Plan - The vendor shall submit an Installation Plan per Appendix 2, CDRL AB. | ||
| I.3.3 | Training Plan - The vendor shall submit a training plan per Appendix 2, CDRL AD. | ||
| I.3.4 | Electronic Security Plan - The vendor shall submit a security plan for each site for safeguard of medical records. Requirements are specified in Appendix 2, CDRL AE. | ||
| I.3.5 | Quality Control Plan - The Contractor shall submit a complete QC program specific to each site per Appendix 2, CDRL AF. | ||
| I.3.6 | Crisis Management Plan - The vendor shall submit a crisis management plan as required for each site to illustrate all steps to be taken by the vendor to insure clinical capability in case of a system crisis/shutdown (should include scenarios to cover all critical subsystems as well as the entire system overall), per Appendix 2, CDRL AG. | ||
| I.3.7 | Ongoing PACS Training to support existing and newly reporting personnel. The vendor shall provide a training solution that is computer based (CBT) for use by the <SITE> training department. CBT should be offered either on standalone compact discs (CD's) or as a local web solution via the MTF intranet. Appendix 5. |
&F SPM2D1-10-R-0011
OFFEROR NAME &P of &N
TAB J
TAB J DICOM REQUIREMENTS
| Compliance Status | Description | ||
| DICOM Connectivity: DICOM requirements are described in detail in Appendix I. The vendor shall meet all requirements for DICOM connectivity as set forth in Appendix I. Major Requirements headings are listed in this section for the vendor’s convenience in describing compliance. | |||
| J.1 | Network Interfaces to DICOM Devices | ||
| J.1.1 | The PACS vendor shall be responsible for providing all appropriate hardware and software to interface and integrate DICOM conforming devices to the PACS network to at least the minimum DICOM functionality specified in Appendix I. |
The PACS vendor shall communicate and work directly with the imaging equipment vendors to ensure seamless integration and interface of the imaging devices to the PACS J.1.2 The PACS vendor shall be responsible for communicating with each device vendor to determine and implement DICOM compatibility and connectivity between the device and the PACS.
The PACS vendor must provide the government a written list of any additional specific software and/or hardware upgrades, or licenses, required for successful integration of the PACS (to be purchased by the government separately).
| J.1.3 | The vendor shall support all new DICOM Correction Proposals and Supplements as soon as practicable, but no later than their next major commercial software upgrade release. This requirement applies to all DICOM requirements relevant to DIN-PACS. |
| J.2 | The DIN-PACS shall support DICOM Structured Reporting. |
| J.3 | The vendor shall provide with their proposal Conformance Statements covering all DICOM functions of the proposed DIN-PACS system. |
| J.4 | The vendor shall provide, upon request, conformance testing results that validate the proposed system’s Conformance Statements. |
&F SPM2D1-10-R-0011
OFFEROR NAME &P of &N
TAB K
TAB K INTEROPERABILITY
| Compliance Status | Description | ||
| K.1 | Interoperability. The vendor shall support IHE initiatives for sending and receiving DICOM images and reports. Vendor shall describe their ability to send/receive images and reports across a wide area network to/from differing medical treatment facilities (MTF) that may or may not have the vendor's PACS installed. | ||
| K.2 | The vendor shall include a copy of their Integrating the Healthcare Enterprise (IHE) integration statement with their proposal, to include 3rd party products offered with their DIN-PACS. At a minimum the DIN-PACS shall support the following Radiology, Information Technology Infrastructure and Cardiology (for Cardiology PACS offerings) Integration Profiles: |
| • Scheduled Workflow (SWF) | |
| • Patient Information Reconciliation (PIR) | |
| • Consistent Presentation of Images (CPI) | |
| • Key Image Notes (KIN) | |
| • Access to Radiology Information (ARI) | |
| • Mammography Image (MAMMO) | |
| • Consistent Time (CT) | |
| • Cardiac Cath Workflow (CATH) | |
| • Echocardiography Workflow (ECHO) | |
| K.3 | The vendor shall work with other PACS vendors within the DoD Medical Healthcare System (MHS) to develop a cooperative solution for interoperability that meets the government’s requirement without proliferating additional equipment to existing sites. |
requirement without proliferating additional equipment to existing sites.
&F SPM2D1-10-R-0011
OFFEROR NAME &P of &N
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