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FBO DAILY - FEDBIZOPPS ISSUE OF JANUARY 29, 2015 FBO #4814
DOCUMENT

65 -- U.S. Department of Veterans Affairs - Home Telehealth - Attachment

Notice Date
1/27/2015
 
Notice Type
Attachment
 
NAICS
339112 — Surgical and Medical Instrument Manufacturing
 
Contracting Office
Department of Veterans Affairs;VA Denver Acquisition & Logistics Center;(003A4D);555 Corporate Circle;Golden CO 80401-5621
 
ZIP Code
80401-5621
 
Solicitation Number
VA79115N0009
 
Response Due
2/17/2015
 
Archive Date
3/19/2015
 
Point of Contact
David Little
 
E-Mail Address
3-6207<br
 
Small Business Set-Aside
N/A
 
Description
DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Title: Sources Sought notice for products and services to support the Department of Veterans Affairs enterprise-wide Home Telehealth (HT) Program. Purpose: The purpose of this Request for Information (RFI) is to conduct market research to support the upcoming procurement and update/refine the statement of work to incorporate new commercial technologies and capabilities to better support the HT program. This RFI encourages potential contractors to submit a non-binding statement of interest and documentation substantiating they have products they feel meet the stated requirements. Requirements Summary: All items that are specified by the VA in this RFI must be commercially available as telehealth/disease management products. With respect to care support in the home, the VA seeks contractors to provide home telehealth technologies for use by Veterans together with the requisite data management, support services and information technology services necessary to provide a comprehensive range of HT services. These home telehealth devices will act as a data access and communication platform that links Veteran patients receiving HT-based care with VA clinicians using a range of telecommunications system options. These devices and associated systems must support and enable bi-directional transfer of prescribed data, as outlined below, from Veteran patients to VA and vice versa. In addition to requiring data exchange from the home telehealth devices ("hubs") it purchases, VA also seeks to access similar chronic disease management and patient monitoring data that is secure and encrypted from Veteran patients via their own telephones and suitably compatible mobile devices, such as computers, tablets and/or smart phones. The Denver Acquisition & Logistics Center (DALC) is requesting responses from qualified business concerns; the qualifying NAICS code for this effort is 339112 "Surgical and Medical Instrument Manufacturing". The broad requirements listed below should be reviewed in order to accurately respond to this notice. The Government is also seeking to gain knowledge of potential qualified sources and their size classifications, Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB), HUBZone Program, 8(a), Small Business (SB), Small Disadvantaged Business, Woman Owned Small Business, or large business (LB) status; relative to NAICS 339112. Preliminary Review of Product Information: Responses to this notice will be used by the Government to make appropriate acquisition decisions. After review of the responses to this notice, a request for proposals will be issued to the government wide point of entry (www.fbo.gov). Responses to this synopsis are not considered adequate responses to any corresponding solicitation announcement. Background: The Home Telehealth technologies used in VA's HT program serve to provide Veteran patients with HT-based services and thereby proactively manage/treat a range of chronic conditions. VA requires Veteran patients in HT programs to exchange Disease Management Protocol (DMP) information bi-directionally with VA clinicians up to a daily basis, dependent on the patient's treatment plan. Plain Old Telephone Service (POTS) and Broadband IP are the VA's minimum requirements for telecommunications access for exchanging HT data between VA and patients' homes. Disease Management Protocols (DMPs) are a series of questions, education and information provided to patients that are derived from routine clinical practice meant to replicate aspects of face-to-face assessments. HT technologies are used to transmit DMPs to patients and receive patient-submitted data in response to DMPs. DMPs are a critical component of VA's current and future clinical armamentarium to care for veteran patients with chronic diseases and conditions. All HT technology solutions must be capable of implementing VHA provided DMPs such as, but not limited to, the following diseases or conditions: "Diabetes Mellitus "Heart Failure "Chronic Obstructive Pulmonary Disease "Hypertension "Major Depressive Disorder "Weight Management "Post-Traumatic Stress Disorder (PTSD) All responses to this RFI shall include the following data: 1.Please provide a full description and images for any of the following technologies being offered, including functionalities and capabilities. Include discussion of how data is transmitted from the patient's assigned technology to the vendor server (telephone landline/POTS, cellular, satellite, broadband, Wi-Fi, etc.); and if any technologies have readily available multi-modal transmission capabilities as standard issue. Types of technologies VA is seeking: "A standalone FDA-listed external messaging device (i.e. "Hub", tablet, etc.) and how these transmit data "Interactive Voice Response (IVR) "Browser-based applications on the patient's own internet enabled appliances (i.e. home computer, cell phone, handheld devices, tablets, etc.) "FDA-listed browser-based applications on a vendor provided home appliance "FDA-listed messaging external device with integrated video telemonitoring hardware providing both bi-directional, synchronous telehealth audio/video conferencing and DMP messaging between the patient's home and VA clinicians, with or without associated peripheral measurement devices. "Any optional or integrated FDA-approved equipment/accessories, such as peripheral devices/technologies for capture of vital sign measurements, biometric data, and/or images (i.e., peripheral measurement devices), and how these interface with the main hub or technology (direct cable, blue tooth/wireless, etc). This may include, but is not limited to, the following items: oBlood pressure monitor oWeight scale oPulse oximeter oBlood glucose meter oDigital imaging hardware/software for applications such as wound care 2.Include a discussion of the capability of messaging technologies to be updated remotely with new DMPs, software and/or firmware, thus negating the need for use of any additional peripherals to accomplish this process, and without requiring any involvement from the patient or VA staff. Also describe any impact to the patient receiving automated/remote upgrades, such as average length of downtime of HT technology and/or utilization of patient's own telephone line during the upgrade process. 3.Describe the vendor viewer used to display data submitted for individual patients and panels of patients to assigned VA staff, including: "The ability of the vendor viewer to provide a summary "dashboard" screen that displays an overview of information for a large panel of patients and automatically indicates to the user which patients on the panel are at high, medium or low health-risk based on parameters established for each individual patient for their DMP responses and vital signs. "The ability to set alert parameters based on individual patients, or across patient cohorts meeting certain criteria. "The ability to send customized messages to individual patients, or across patient cohorts meeting certain criteria. "Various reporting functions that can be used to trend data submitted by patients, identify response/utilization patterns, display different patient groups based on various criteria, etc. "Describe processes in place to identify and flag any potentially inaccurate data, such as a weight that shifts 100 pounds in one day, as well as a method to remove and / or annotate inaccurate readings such that they can be reconciled and displayed correctly and do not adversely affect data averages/trending reports. 4.Provide a listing of current DMPs available, and describe: "Process for developing DMPs, including determining clinical safety, effectiveness, patient usability, etc. "Ability to combine DMP question sets from two or more diseases/conditions (i.e., co-morbid DMPs); and process for determining clinical safety, usability and appropriateness when this is done. "Process for changing DMP content for all patients assigned to a DMP nationally or specific subsets/cohorts based on defined criteria. "Ability to make changes without resetting DMP schedule to first day of DMP cycle. "Average timeframe to perform changes and upgrades to DMPs. "Ability to import DMPs developed by VA for implementation; timeframe needed for implementation of a DMP nationally; and system requirements/format necessary for accepting DMP content directly from VA. "Ability to code each question in a DMP and data submitted by patient for transmission to VA as a separate database from the vendor viewer software used for managing patients. 5.Describe in detail the processes that ensures all patient information submitted is recorded with an accurate date / time stamp (from patient's time zone). A separate date / time stamp is required for the date and time that the patient took the measurement or image (i.e., data collection date/time) and the date and time when the HT technology transmitted this data to the server (i.e., data transmission date/time). More specifically, an accurate date /time stamp for both collection and transmission is required for each of the following: "The DMP question set; "Each individual vital sign, biometric data point and/or image collected as part of the DMP question set; and "Each individual vital sign, biometric data point and/or image collected separate from the DMP question set. Overall, processes should demonstrate how the vendor's technology could be used with utmost confidence of date/time accuracy to safely and efficiently manage large patient panel sizes using alert thresholds so that this data can be accurately documented in the patient's official electronic medical record. More specifically: "Describe how all technologies (hub device, IVR and web-enabled technology, etc.) assigned for patient use meet accurate date / time stamp requirements, including any peripheral measurement devices (blood pressure monitors, blood glucose meters, weight scales, pulse oximeters, etc.,) that would be used by the patient, regardless of the connection type for such peripheral measurement devices (integrated into HT technology, connected via cable, or have wireless transmission capability, entered manually by patient, etc.). "Describe the processes used for testing and verifying date/time stamp accuracy for all technologies and peripheral measurement devices that connect to a vendor's system. "Describe how battery-operated peripheral measurement devices and devices with individual setting functions or with their own internal processors (e.g., blood glucose meters) are designed to reliably integrate with the HT technology (hub device, IVR and web-enabled technology, etc.) so that an accurate date/time stamp will be provided for each measurement taken, despite any additional programming functions that may be available or used by the patient on that peripheral measurement device. "Describe how any data collected and stored in a peripheral measurement device prior to the current HT enrollment would not be transmitted, or would be indicated as such. 6.Provide product information including product specifications and pricing. 7.Describe data exchange for management of the programs at a national and local level. VA types of data reporting include, but are not limited to: "Clinical data (patient identity information, measurements, question responses, surveys, draft progress notes, images, etc.) "Patient Census Data "Patient response data "Patient Survey data "Data for technology inventory "Data for device sales and replacement that includes information for each device delivered including model, serial, date delivered, and VA facility "Monthly report indicating System overall availability 8.OMB and VA policy requires federal information systems be continuously monitored to maintain their authorization and reauthorized when there is a significant change to the system. Examples of situations which may constitute a significant change include: an increase in the sensitivity/criticality of a system; an increase in threat level; policy change, a change in the backup and archiving process, a change in operating system (base platform); a change to security relevant software; a change to hardware that could affect the security architecture; an increase in interconnection with other systems outside the accreditation boundary; or significant changes in the security requirements that apply to the system. 9.All vendor supplied systems and any associated sub-systems that link into these vendor servers must meet VA specified standards for data exchange, specified metrics of quality/timeliness and fully comply with all necessary VA privacy/cyber security requirements, which may evolve over the life of a contract. Wherever applicable to VA's cyber security requirements these must all be provided in a secure encrypted environment. In general, the sources of these policies and requirements include: "VA Directive 6500, Managing Information Security Risk: VA Information Security Program and to update the VA National Rules of Behavior "OMB Circular A-130, Appendix III, "Security of Federal Automated Information Systems" "Information Technology Management Reform Act of 1996 (also known as the Clinger-Cohen Act) "Federal Information Security Management Act (FISMA) of 2002 "NIST Special Publication 800-37 "Guidelines for the Security Certification and Accreditation of Federal Information Technology Systems" "NIST Special Publication 800-39, Managing Information Security Risk: Organization, Mission, and Information System View "NIST Special Publication 800-53, Recommended Security Controls for Federal Information Systems and Organizations "OMB M-03-22, "OMB Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002 "Executive Order 13103, "Computer Software Piracy" "FIPS Pub. 196, Entity Authentication Using Public Key Cryptography "FIPS 199, "Standards for Security Categorization of Federal Information and Information Systems" "FIPS 200, "Minimum Security Requirements for Federal Information and Information Systems" "FIPS 201-1, "Personal Identity Verification of Federal Employees and Contractors" "FIPS 140-2, "Security Requirements for Cryptographic Modules" "5 U.S.C. 552a, "Privacy Act," c. 1974 "18 U.S.C. 1030 (a) (3), "Fraud and related activity in connection with computers." "38 U.S.C. 218, "Security and law enforcement on property under the jurisdiction of the Veterans Administration" "PL 100-322 covers the confidentiality of AIDS patients' data "Health Insurance Portability and Accountability Act of 1996 (HIPAA) "Health Information Technology for Economic and Clinical Health (HITECH) Act "E-Government Act of 2002 "Section 508 of the Rehabilitation Act (29 U.S.C. '794 d) 10.Define and discuss your organization's Product lifecycle management and Change Management tools, techniques, and processes ranging from design, development, implementation, use, ongoing support, replacement and ultimately disposal if necessary. In addition, the respondents must highlight their processes in place that ensure all safety issues are identified, reported and mitigated in a timely manner. 11.Describe any existing global messaging system capability that could be used to communicate issues such as outages and software updates to veterans. Discuss available cellular connectivity options for each device and the manner in which peripherals are connected to the hub/tablet device (wireless, Bluetooth, etc.). 12.Describe Help Desk functions and capabilities that would be available to VA staff, and data/metrics that can be reported to VA related to utilization, types of issues, reported, time to resolution, etc. 13.Other relevant product information to establish the capabilities of your offered products. 14.Corporate contact information. 15.Indicate whether your business is a SB or LB. If small, indicate if your firm qualifies as a small, emerging business, or small disadvantaged business. If disadvantaged, specify the disadvantaged group. 16.Specify if your firm is certified under Section 8(a) of the Small Business Act. 17.Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB). 18. Include the DUNS number of your firm. 19.State whether your firm is registered with the System for Award Management (SAM) at http://www.sam.gov and/or the VetBiz Registry at http://vip.vetbiz.gov. If not, please NOTE that any future solicitation could only be awarded to a contractor who is registered in SAM; in order to receive award based on VOSB or SDVOSB status you must be registered in the VetBiz Registry. Please submit your response electronically to Mr. David Little at david.little@va.gov no later than February 17, 2015. E-mail responses shall not exceed 8 megabytes in size. Please place "Attention: Telehealth RFI" in the subject line of your email.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VADDC791/VADDC791/VA79115N0009/listing.html)
 
Document(s)
Attachment
 
File Name: VA791-15-N-0009 VA791-15-N-0009.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1833270&FileName=VA791-15-N-0009-000.docx)
Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1833270&FileName=VA791-15-N-0009-000.docx

 
Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 
Record
SN03625506-W 20150129/150127234254-2266be3afc48d297c455a8ae68f1cbd6 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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