Q502--Cardiac Monitoring Services for the FHCC

All information should be UNCLASSIFIED or NON-PROPRIETARY. SOURCES SOUGHT NOTICE The Department of Veteran Affairs, Great Lakes Acquisition Center (GLAC), Network Contracting Office (NCO) 12, on behalf of the James A. Lovell Federal Health Care Center (FHCC) in North Chicago, Illinois is seeking information and potential sources for Wireless Cardiac Arrhythmia Monitoring Services. The Contractor shall provide wireless equipment (including monitoring devices), supplies, labor, and management required to perform cardiac arrhythmia monitoring services consistent with the LINs specified below (up to) 48-hour (Holter); (up to) 30-day memory loop (event) monitor; (up to) 15-day ambulatory (mobile) cardiac telemetry (ACT/MCT) and 15-day to 30-day ACT/MCT to FHCC as specified, for patients experiencing infrequent symptomatic cardiac events. Services shall be provided twenty-four (24) hours a day, seven (7) days a week, including federal holidays on an on-demand/as-needed basis. Tracings and reports shall be processed and available to FHCC staff 24 hours per day, seven days per week, 365 days per year via the internet, facsimile (fax) or other electronic method. The period of performance will be July 24, 2025 through July 25, 2026, with four one-year options to extend through July 25, 2030 to renew at the discretion of the Government. It is the intent of the VA to issue a task order against the Federal Supply Schedule (FSS) contract. Ordering/Request for Services: FHCC s cardiac unit personnel are authorized to separately place orders by registering patients for cardiac arrhythmia monitoring services. Registration shall be primarily via Contractor s secure website. Registration via secure facsimile (fax) or via telephone is acceptable in the event primary methodology is temporarily unavailable to the requesting facility. Contractor shall retain separate files for the facility s registered patients. Packaging, marking, and shipping of devices shall be in accordance with industry standards. Shipping containers shall include legibly printed packing slips bearing, as a minimum Name and address of originating organization Name and address of receiving organization/individual Instructions for additional internal handling e.g., department/internal destination, Government point of contact (POC) name and phone/extension to notify of receipt A list of all items in the box/shipping container and applicable obligation (funding order) number against which each should be applied. Individual labels should be affixed to the exterior of each kit container/box. Labels should contain pertinent information including, as a minimum, kit identification (ID) by name, description and kit serial number, as well as the device inside and its serial number. Latest dates of device calibration, battery charge and inspection may also be indicated along with expiration date(s) of any components contained therein. Tracings & Reports Tracings are the raw data that are generated by contractor monitoring devices and are used as backup documentation for reports interim and summary. These reports are the interpretation of the raw data at various intervals as clinically necessary. The contractor will be required to provide two different types of reports interim and summary (end of service). Upon receipt of recorded data, contractor personnel shall perform preliminary interpretation of ECG tracings and compile interim and/or summary reports as specified in this section, below. Interim Reports: Contractor shall provide interim reports when clinically necessary and/or upon request of authorized Government personnel. Contractor shall immediately notify appropriate Government personnel of adverse events followed up with an interim report supported by pertinent tracings including tracings showing 30 seconds before and after said adverse event within 30 minutes of notification. Summary (aka: End of Study) Reports: Contractor shall compile a summary report upon conclusion of each patient s monitoring service. Contractor shall provide any and all associated recorded data upon request including tracings cited as not pertinent or unclear by Contractor clinical personnel for further assessment by the Government. Contractor shall make summary reports available to FHCC personnel within 24 hours after receipt of recorded data by the contractor. These reports must be in MSWord or .pdf format and available for electronic download via a secure site/portal and, if requested by FHCC clinical personnel, transmitted via secure facsimile/line. End of Study Reports shall be error free. Contractor reports shall attain a ninety-five percent (95%) accuracy rate. Authorized medical personnel at FHCC will review the preliminary interpretation and final summary report and will enter final diagnostic interpretation into the Computerized Patient Record System (CPRS). Contractor will be notified if Summary Reports fail to achieve predetermined accuracy rates based on data interpretation and completeness of the report. The contractor shall provide the respective Government facility with a corrective action plan within 14 calendar days of notification. Notification Immediate/Emergent Criteria Contractor shall immediately verbally notify the Government of any recordings/events of an emergent nature. Contractor shall follow up with a written interim report, accompanied by the incident recorded data, within thirty (30) minutes. This interim report should also include details of the date, time, and Government personnel who confirmed receipt of the notification. Customer Support Contractor shall provide customer support to Government personnel including: Training Contractor shall provide on-site training at no charge on use of its service, equipment, system and processes, within 30 days of task order award and as requested, to authorized Government personnel. Contractor shall provide additional on-site training, if required and at no charge, to address system, software or processing changes/upgrades as they are implemented, as well as to accommodate new Government staff members and annual on-site refresher courses as needed. Phone Support Contractor shall provide direct line phone numbers (bypassing menus, recorded messages, etc.) providing authorized Government personnel immediate access to contractor customer service personnel 24/7/365. Wait time for voice/live response to customer and patient calls shall not exceed thirty (30) seconds. Email Support Non-automated response to customer email or website inquiry. Contractor response time shall not exceed four (4) hours from time of inquiry/email. Local Area Account Representatives Contractor shall assign a local area account representative and alternate representative to provide direct and on-site support for each of the Government facilities. Customer Service Contractor shall provide customer service 24/7/365 days per year to FHCC patients. Contractor cardiac technicians (certified preferred) must be available to discuss patient symptoms and then correlate the symptoms with the ECG findings. Patients provided with monitoring devices may make an unlimited number of symptomatic calls to contractor service center(s). Contractor shall not, under any circumstances, furnish reports directly to patients. Contractor shall instruct patients, when applicable, to contact the referring Government physician for all post monitoring follow-up care. Contractor shall, for complications occurring within 48 hours of a completed monitoring service, instruct patients to contact their Government physician or the nearest medical facility offering emergency services. Contractor shall also assist patients (or their authorized designee) with obtaining, understanding and operating contractor monitoring devices. Contractor shall, if required (due to remoteness or inaccessibility of patient to Government medical facilities), instruct/educate patients on use, care and return of monitoring devices. Equipment/Information Technology required General Contractor s system shall include Federal Information Processing Standard (FIPS) 140-2 compliant platform(s) ensuring secure storage and encryption of all veteran data. Additionally, contractor must demonstrate it possesses systemic safeguards minimizing negative impact to veteran care resulting from natural and man-made disasters such as severe weather patterns, earthquakes, etc. Such safeguards may include one or more of the following criteria: Multiple service centers certified as Independent Diagnostic Testing Facilities (IDTFs) and/or Equipment e.g., servers, phones, monitoring devices, etc. and qualified staff co-located in different states [/ environmental zones to ensure uninterrupted monitoring services for at-risk veterans. Equipment All monitoring devices provided in the performance of this contract must be FDA approved. Contractor shall provide and replace any hardware, software, peripherals, instructions and manuals required to support its data collection/reporting system at no charge. Contractor shall provide, at no additional charge, any labor required to tailor contractor-owned equipment, electronics and reports to Government-unique and/or station-specific clinical standards necessary to optimize download, analysis and reporting of recorded data. This shall include, at a minimum, the following: All monitoring devices must transmit data wirelessly. This includes 24-48 hour holter monitors, up to 30-day event monitors, and up to 30-day telemetry monitors. A docking station is neither acceptable nor approved by the FHCC ISSO. Monitoring devices are lightweight, and simple for patients to use; Contractor utilizes two or more cellular services (i.e., Verizon and AT&T). Each Government facility will individually select their preferred cellular provider. In the occasion a patient resides in an area with poor coverage of the facility s preferred cellular provider, the contractor will convert/exchange the monitor to use an alternative cellular provider and continue to troubleshoot with the patient as needed; Monitoring devices encompass an all-in-one, multi-mode device. The monitoring device is capable of functioning as a 24-48 hour Holter monitor, up to 30-day event monitor, and/or up to 30-day telemetry unit based upon the patient s registration; Monitoring device allows the patient to wirelessly transmit his/her symptom and activity level associated with the patient-activated event to the vendor in real-time; Monitoring devices powered by a battery with a history of consistently holding its charge maintaining continuous recording for a minimum of 48-hours even in the absence of cell or wireless service longer is preferable before a recharge is necessary; Complete kits that include pre-paid mailers postage paid return envelopes suitable for return of devices upon completion of monitoring period, packaged and marked in accordance with industry standards and as detailed herein; Devices received by the Government in optimum condition out of the box ; Devices capable of beat-by-beat monitoring of cardiac arrhythmias over the entire monitoring period; Devices and/or protocols that ensure patient is alerted within 24 hours of nonfunctioning equipment in Holter or telemetry mode -- e.g., due to disconnected lead, low battery, full or nearly full storage, etc. consistent with industry standards. Contractor personnel shall remain courteous and sensitive to time of day/night when contacting patients. Holter, event/memory loop and ACT/MCT (mobile telemetry) recorders that accurately, easily and clearly transmit to the contractor wirelessly or via cell phone; Accessory patches, wires, batteries, etc. and all other supplemental/peripheral items, required to operate equipment i.e., diodes, electrodes, instructions, etc. Cardiac monitors that will undergo a baseline with the vendor during patient hookup to ensure contractor receives a clear tracing and confirm that patient s registration/account is accurate and activated. ACT/MCT equipment provided under this contract shall include: Sensor(s) and cell phone/transmitter; An embedded algorithm and/or cellular communication technology capable of monitoring in real time/near real time; A telemetry service that provides auto-trigger and auto-send functionality automatically and instantly detects and transmits both symptomatic and asymptomatic arrhythmia without the necessity of any patient intervention; An auto-trigger for atrial fibrillation, tachycardia, bradycardia, and pause; A feature permitting patients to manually activate and transmit the ECG data to the contractor monitoring facilities; and, Equipment shall enable contractor to pull ECG data at any point during the period of service while patient wears the device and provide a full Holter, memory loop/event, or ACT/MCT analysis including HR variability, PVC count, AF burden summary and other key metrics. Contractor shall retain title and ownership to all equipment provided to the Government during the performance of this contract. Contractor shall, when requested by the applicable Government facility, ship the equipment kit directly to remote patients unable to access their medical facility. Additionally, contractor Customer Service personnel shall follow up with the patient to confirm receipt of equipment. Website/Internet Portal Contractor s website or internet portal to accept, report or transmit patient data, must meet all requirements described herein and, at a minimum, contain the features listed below. Secure internet/website with protection and data accuracy compliant with HIPAA and the Government standards (FIPS 140-2). Direct links to the website for both patient and physician information on the service and monitors. Convenient access to patient reports with sorting and printing capabilities both individually and in a batch mode, as requested). Mandatory unique authentication and identification (logon) access to data. Direct line contact information permitting patients and facility personnel to communicate directly with Contractor customer service personnel 24/7/365. Audit/reporting function within contractor electronic system permitting FHCC Information Security personnel, upon request, remote access to contract-related records/data. Inventory Levels Government Inventory Contractor shall place equipment and related peripheral supplies at FHCC s Cardiology ECG Department within 3 days of task order award to establish the minimum inventory levels stated below. These minimum inventory levels shall be auto-replenished, and maintained by contractor via replacement shipment within 24 hours of patient registration. Tracking information shall be provided to appropriate Government personnel upon shipment. Contractor Inventory Contractor shall maintain dedicated inventory levels in sufficient quantities to handle projected workload. Maintenance Contractor will perform all sanitizing, preventive maintenance, and quality control of all Holter, memory loop/event and ACT/MCT equipment used in performance of this contract to ensure and maintain maximum accuracy prior to packaging and shipment to the Government. Proper documentation of maintenance results and corrective action taken, as necessary, must be made available to the Government upon request. In the event of an equipment failure of any monitor, contractor shall ship a replacement monitor to the patient upon notification to be received by the patient the next day, and the defective monitor will be mailed back by the patient in the prepaid envelope for return via U.S. mail. The size standard for North American Industry Classification System (NIACS) 621999 is $20.5 Million. Interested vendor s responses to this Sources Sought Notice shall include the information below. A brief description of the company including its background, experience in providing Wireless Cardiac Arrhythmia Monitoring Services as the prime contractor/subcontractor, socioeconomic status, and contractor SAM Unique Entity Identifier (UEI) number. Indicate if subcontractors/partners will be used for any part of the delivery of Wireless Cardiac Arrhythmia Monitoring Services. If yes, specify the percentage and duties that will be performed by the prime contractor and each subcontractor(s)/partner(s). Provide information on the available Wireless Cardiac Arrhythmia Monitoring devices for consideration to fulfill this need. If the vendor is a small business and intends to subcontract, indicate if it will comply with the Limitations on Subcontracting at 13 CFR 125.6., which states that for services a small business concern must agree that it will not pay more than 50% of the amount paid by the government to firms that are not similarly situated. Confirmation that the vendor is active in SAM.GOV (https://sam.gov/). Based on the estimated numbers below, provide an estimate of the price. This information is for market research purposes only. Base Year July 24, 2025 through July 23, 2026 LIN Description Est Qty Unit of Issue Rate Est Total 0001 24- to 48-hour Holter (Continuous Rhythm) 564 ea $ $ 0002 30-day Event 24 ea $ $ 0003 14-day (or less) Telemetry 66 ea $ $ 0004 30-day (or less but >14 days) Telemetry 66 ea $ $ Estimated Total Base Year: $______________ Base Year July 24, 2026 through July 23, 2027 LIN Description Est Qty Unit of Issue Rate Est Total 1001 24- to 48-hour Holter (Continuous Rhythm) 564 ea $ $ 1002 30-day Event 24 ea $ $ 1003 14-day (or less) Telemetry 66 ea $ $ 1004 30-day (or less but >14 days) Telemetry 66 ea $ $ Estimated Total Option Year 1: $______________ Base Year July 24, 2027 through July 23, 2028 LIN Description Est Qty Unit of Issue Rate Est Total 2001 24- to 48-hour Holter (Continuous Rhythm) 564 ea $ $ 2002 30-day Event 24 ea $ $ 2003 14-day (or less) Telemetry 66 ea $ $ 2004 30-day (or less but >14 days) Telemetry 66 ea $ $ Estimated Total Option Year 2: $______________ Base Year July 24, 2028 through July 23, 2029 LIN Description Est Qty Unit of Issue Rate Est Total 3001 24- to 48-hour Holter (Continuous Rhythm) 564 ea $ $ 3002 30-day Event 24 ea $ $ 3003 14-day (or less) Telemetry 66 ea $ $ 3004 30-day (or less but >14 days) Telemetry 66 ea $ $ Estimated Total Option Year 3: $______________ Base Year July 24, 2029 through July 23, 2030 LIN Description Est Qty Unit of Issue Rate Est Total 4001 24- to 48-hour Holter (Continuous Rhythm) 564 ea $ $ 4002 30-day Event 24 ea $ $ 4003 14-day (or less) Telemetry 66 ea $ $ 4004 30-day (or less but >14 days) Telemetry 66 ea $ $ Estimated Total Option Year 4: $______________ Estimated Grand Total 5 Years (Base plus 4 Option Years) $________________ This is a Sources Sought Notice that will be used to obtain information regarding the provision of Wireless Cardiac Arrhythmia Monitoring Services from potential vendors, identify potential vendors that would be interested and capable of providing Wireless Cardiac Arrhythmia Monitoring Services within the requested timeframe, and to assist the Contracting Officer in determining the current rates for these services. This Notice and any responses are for market research purposes only and shall not be considered an obligation on the part of the Government to acquire any services. This Sources Sought Notice is not a solicitation, and no contractual arrangement will be made as a result. Vendors are advised that no entitlement to payment of direct or indirect costs or charges by the Government will arise as a result of a vendor submission to this Sources Sought Notice or the Government s use of such information. All costs associated with responding to this Sources Sought Notice are solely at the responding vendor s expense. The Government reserves the right to reject, in whole or in part, any vendor s input resulting from this Sources Sought Notice. Information submitted in response to this Sources Sought Notice will not be returned. All submitted information should be UNCLASSIFIED or NON-PROPRIETARY. Vendors are solely responsible for properly marking and clearly identifying any proprietary information or trade secrets contained with its response. The Government will not be liable for or suffer any consequential damages for any proprietary information not properly marked and clearly identified. By responding to this Sources Sought Notice, the vendor provides the Government permission to share its submitted capabilities and contact information with other Government staff/organizations in relationship to similar requirements for market research purposes. All interested parties, REGARDLESS of socioeconomic status, capable of providing the required services shall submit a response via email to carrie.deswarte@va.gov and Patrice.Bond@va.gov no later than Monday, July 14, 2025, at 1:00 p.m. Central Time. The Subject Line of the email must read as follows: 36C25225Q0574 (Cardiac Monitoring Services) Company Name.