Inactive

STATEMENT OF WORK BACKGROUND Outpatient cardiac monitoring is an accepted method of evaluating patients who present with complaints of palpitations, syncope, near syncope, dizziness, or other potentia... STATEMENT OF WORK BACKGROUND Outpatient cardiac monitoring is an accepted method of evaluating patients who present with complaints of palpitations, syncope, near syncope, dizziness, or other potential rhythm abnormalities. This monitoring can be provided as a disposable, single use unit with full rhythm disclosure, or it can be provided as continuous real time monitoring. These types of cardiac monitoring are supported by extensive literature reviews, and by FDA approval. PART I. GENERAL REQUIREMENTS Scope of Work: Cardiac monitoring for outpatients will be offered in one of two formats. The first is an extended Holter cardiac monitoring system, which is worn by the patient for up to four weeks, and then returned for analysis. The system shall not require cell phone usage, wireless connections, or surface electrodes. This is a single use medical grade device, with the ability to lessen allergic reactions for patients intolerant to standard adhesives, and/or latex. The Device application process shall be simple. The second is a real time Mobile Cardiac Outpatient Telemetry (MCOT) which allows for real time monitoring of patient’s cardiac rhythms even in the absence of symptoms. The contractor shall provide Extended Cardiac Holter monitor services and Mobile cardiac outpatient telemetry for diagnosing arrhythmia patients located at the Washington DC VA Medical Center (Washington, DC VAMC), 50 Irving St, NW, Washington DC 20422. Holter and Cardiac Telemonitoring Technology: The contractor shall provide telemetry device(s) for patients experiencing intermittent symptoms. The device(s) is given to patients to use for up to 30 days. After the evaluation period, the patient returns the device(s) to the company in an envelope provided. PART II SCOPE The contractor will provide Ambulatory monitoring devices (Holter and Cardiac Telemetry) and cardiac monitoring services for patient care in the Cardiology Section. For Extended Holter Cardiac monitoring a two – four-week patch system will be supplied. For Mobile Cardiac outpatient monitoring either a three-lead system, or a patch system will be provided. Contractor will provide a dedicated local Account Executive to support the VA. Contractor shall provide dedicated customer support and 24/7 live customer and technical support. Regular account service and educational in-services shall be provided with roll out of the monitoring system and if any new processes are put in place. Call center(s) shall be staffed 24 hours a day, 7 days a week, 365 days a year by certified cardiovascular technicians who review the recordings and respond according to physician orders. The contractor shall furnish, for the life of the contract, the following equipment at no additional costs to the Government: Personal extended wear cardiac monitors Personal Cardiac Telemetry monitors. Current operator’s and/or maintenance manual(s)(if available) as well as hands on training by local representative. In addition to the electronic copy of the operating/maintenance manual (if available), Contractor shall provide two (2) copies of the Operating and /or Maintenance manuals. Guarantee/Warranty The Contractor warrants that the system will be free from defects from materials and workmanship under normal use for a period of not less than one (1) year for equipment defined herein. Contractor will replace or repair equipment if necessary, to the satisfaction of the Government. Contractor shall provide a copy of the written warranty upon delivery of the equipment The system shall have an on-board manual to include system operation and troubleshooting. The contractor shall repeat the monitoring study at no additional costs to the Government for the following reasons or other unforeseen issues: Device(s) provides unsatisfactory results. Device(s) fails to transmit or download information. Information is not retrievable using the web-based system. There is an imaging defect or artifact determined by the VA to be substandard. Place of Performance: The selected contractor shall be providing equipment and off-site monitoring. No travel fees will apply. All delivery, disposable items, and equipment are included in the item price. Location: Washington DC VA Medical Center, 50 Irving St, NW, Washington DC 20422. Devices shall be provided to patients either directly by VA Facility or by mail directly to the patient by the contractor. Upon completion of wearing the recorder, device(s) shall be mailed directly back to contractor at no expense to patient or VA. Location Hours of Operation: 8:00 am – 5:00 pm Monday through Friday. Performance Period: Base year with Four (4) Option Years. Anticipated Base Period of Performance: 9/17/2020 – 9/16/2021. Anticipated Start Date: not to exceed 15 days after award. Contract Type: Firm fixed price contract. Contractor shall price base and all option year (s). Procedure: The device(s) is given to patients to use for 1 to 30 days depending on the indication for the Holter or cardiac telemetry. Upon receipt of order, contractor shall contact patient within 24 hours by phone, and electrocardiography (ECG) technicians will instruct and explain to the patients about what the device(s) is, how to use it, how to hook it up, and how to place leads. This can be done while at the VA facility or while patient is at home. They will then hook up the device(s) to the patient, with specific instruction in order to continue to have the device(s) on for the duration of evaluation. After the evaluation period, the patient returns the device(s) to the contractor in the envelopes provided or to the healthcare facility. General Requirements: Holter/Telemetry: The contractor will provide monitoring devices that can perform Extended Cardiac Telemetry, or Extended Holter for patient care. The monitors will provide the following: Monitors that are ordered for the patient’s specific needs. Education regarding the set-up and continuous wearing of the devices along with 24/7 technical support that will be offered on the phone. Wireless equipment that is assigned to patients shall require monitoring 24 hours a day, while the devices are in use. Bidirectional communication between our EMR(CPRS) and the contractor is highly desirable Ability to store 100% of the ECG data in the device(s) ECG real time transmissions and analysis to have a minimum of 3 leads, up to 6 leads (views) with no more than 3 electrodes. Ability for 100% of ECG data to be transmitted in real-time to Receiving Center for entire monitoring period. Transmitted ECG data is reviewed in real-time by qualified EGC technicians. Ability to post daily Holter reports analyzing all ECG data over the monitoring period. ECG data is sent via wireless in real time and over each 24 hours, and at end of each 24-hour period, ECG data re-analyzed and posted for physician daily review. Ability to immediately transmit, alert and report Patient Activated Events immediately upon Patient pressing “event” button. No further patient interaction needed. When meets physician notification criteria, physician will also be immediately called per facility instructions. Ability to immediately transmit, alert and report Asymptomatic Events meeting the physician’s notification criteria. Physician will also be immediately called per facility instructions. Technical reading of the device(s) along with a comprehensive report that is available online and will be interpreted by the medical staff. Both patients and VA staff shall have unlimited 24 hours a day, 7 days a week, 365 days a year Call Center telephone access to certified cardiovascular technicians who review the recordings and respond according to physician orders, who are knowledgeable and shall supply help in resolving any monitoring problems. Contractor shall electronically post the data, analysis, and interpretation for immediate review by the appropriate Washington, DC VAMC facility within 24 hours of receipt unless there is a potentially life-threatening arrhythmia and/or event. In the event of a life-threatening arrhythmia and/or event, the contractor shall call 911 and dispatch emergency services to ensure the patient receives adequate treatment. Contractor shall post an all-results-data export file encoded as either XML or HL7 within 24 hours of receipt. All events of an emergency or STAT nature shall immediately be phoned to the appropriate Washington, DC VAMC facility no later than one hour (1) after receipt and recognition of such data. The contractor shall provide detailed reports for all Veteran patients receiving full services to the COR (Contracting Officer Representative) at the end of the current billing period. Full services are defined as patients that have been identified by a VA provider as requiring monitoring services, have been assigned a monitor that has been returned to the contractor for interpretation, the interpretation has been reported back to the appropriate medical center, and the interpretation report is determined to be without technical error. Ability to post an End of Study Remote Telemetry Report compiling all Telemetry and Holter ECG data into one conclusion report. Telemetry: All Events whether symptomatic or asymptomatic will trigger immediately alerts to bring to reviewing technician’s attention. The ECG is automatically transferred to a cardiac monitoring center, where it is immediately reviewed, reported and the cardiologist is informed according to pre-selected notification criteria. Holter Monitoring: All ECG data will be analyzed as both a quality control and to provide comprehensive reporting to physician. Extended Holter results will be posted within 24 hours of download for physician review. Holter reports shall include: Heart Rate ECG data including: Minimum, Maximum and Average Heart Rates, Total number of Analyzed Beats, total number of Analyzed Minutes, total number of minutes in Sinus Bradycardia /Tachycardia and longest episode of each, total Pauses in excess of 2 seconds and max pause. Total number of VE’s, V-Pairs, V-Runs, Longest V-Run, Maximum and Minimum HR V- Run (if applicable), VE’s per 1000/per Hour ratio, and Ventricular R on T. Total number of SVE’s, SVE-Pairs, SV-Runs, Longest SV-Run, Maximum HR SV-Run (if applicable), SVE’s per 1000/per Hour ratio. Atrial Fibrillation / Flutter: Burden, Total number of minutes in A-Fib, Number of Episodes, A-Fib graph. ST Segment Analysis: Max ST Depression and Elevation, Total number of ST minutes, Max ST Episode, and Max HR in ST Episode. QT Analysis: When applicable, Max QT and QTc. Heart Rate Variability: Time Domain and Spectral Power. Full Disclosure capability. End of Study Reports: All ECG data (exceeding 48 hours) will be compiled into an End of Study to provide comprehensive reporting to physician. End of Study ECG report shall include at minimum: Comprehensive compilation of Heart Rate ECG data over the entire monitoring period including: Minimum, Maximum and Average Heart Rates, Total number of Analyzed Beats, Total number of Analyzed Minutes, Total Pauses in excess of 2 seconds and max pause. Representative strips shall be provided. Total number of VE’s, V-Pairs, V-Runs, Longest V-Run, Maximum HR V-Run (if applicable). Total number of SVE’s, SVE-Pairs, SV-Runs, Longest SV-Run, Maximum HR SV-Run (if applicable). Atrial Fibrillation / Flutter: Burden, Minimum, Maximum and Average HR, and Longest episode. Full Disclosure capability. Description of all events, both patient-triggered and automatic (in response to rhythm and/or Heart rate meeting programmed criteria), including date/time stamp, symptoms reported, tracing, preliminary interpretation. Device Services: 30-Day ECG Monitoring Devices: Holter, and Real-Time Remote Telemetry monitor, recording, transmitting and reporting on 100% of the ECG data. Data Management: While patient is wearing the device, transmission patient activated report, urgent asymptomatic event report, daily Holter report and end of study report options will be made available online. The VA shall have access to patient reporting 24 hours a day at the physician’s or authorized representative’s convenience through password protection. Registration information will be entered by VA technician on the contractor’s web site, or by transmission of an XML or HL7 encoded data transfer file from VA to contractor to provide an automated registration process. Workflow: The device(s) is given to patients to use for 1 to 30 days depending on the indication for continuous monitoring. Initially, ECG technicians will instruct and explain to the patients what the device(s) is, how the patient will use it, how to hook it up, and how to place leads. They will then hook up the device(s), and let the patient go home with specific instructions in order to continue to have the device on for the duration of evaluation. Alternatively, the monitor(s) will be sent directly to the patient, and the patient will be hooked up at home with instructions from the vendor. In either of these cases a baseline is always submitted to the monitoring center where trained personnel record and interpret the strip. Physician notification criteria will be established prior to enrollment. When asymptomatic and/or symptomatic ECG events are alerted that meet the criteria, a call is made to the ECG director and an urgent report with the date is prepared and posted for physician evaluation. Each day a daily Holter report will be presented that includes all the data for the prior 24 hours. An end of service summary report shall be available 3-5 days after the service is completed (Access to the data from the website is limited to the physicians and/or any other authorized representative responsible for evaluating the data). Once the ECG data is ready for evaluation, the contractor shall post the End of Study for the department to review. Reports, Turnaround Time & Notifications Daily ECG/Telemetry reports, Urgent/Emergent Reports and End of Summary Reports shall be available via a secure fax and online through the Contractor’s IT access point based on VA’s preference. The Contractor’s IT access point shall provide for customer physicians and their practices a secure online patient prescription process for MCOT enrollment. The Contractor’s IT access point shall provide for customer physicians and their practices a secure repository for cardiac reports to be annotated, approved, and downloaded by the physician. Patients shall be enrolled online by the ordering provider via HIPAA compliant web portal, fax or HIPAA compliant iPad APP. Reports shall be available online via a Contractor HIPAA-compliant web portal. Contractor shall offer customization of MCOT reports including report headers, summary disclosure, full disclosure and strip inclusion based on facility requirements. Online report editing shall be possible. Contractor shall provide service for non-critical event processing of 30 minutes and critical event notification of 20 minutes. Notifications shall be based on the established criteria of the facility, with application possible at the medical group, facility, physician or patient level. All notifications shall occur in real-time following identification of the critical event meeting facility established notification criteria. Equipment: Government Furnished Property (information, materials, etc.), and identify time frame when it will be supplied to the contractor: None All contractor equipment offered shall be U.S. Food and Drug Administration (FDA) approved. Gray market items are Original Equipment Manufacturers’ (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable. Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM’s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions. The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA’s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items. All Holter monitors shall be provided by the contractor for VA use and shall be state-of-the-art equipment, lightweight, and simple for patients to use. Patients will use the monitors for one (1) to thirty (30) days, or as specified by the VA provider. Samples shall be provided to each site during the training or orientation process. The contractor and facility COR will determine an equipment inventory level at the time of contract award that shall always remain at each facility location. This equipment inventory must always be adequately restocked to ensure that the facility can always meet the daily patient demand. All equipment remains the sole property of the contractor including the initial delivery of the units. The contractor is responsible for all service maintenance and repairs of the equipment and hardware. The contractor shall supply a postage-paid return container for all monitors. IT security requirements for certification and accreditation (authorization) (C&A) of the contractor system do not apply, and a Security Accreditation Package is not required. Instrument Capabilities Lightweight and easy to use design that can be held in one hand. Available instruments should include a waterproof patch recorder. Capability of event transmissions being sent via wireless/cell phone or advanced technology. Bidirectional communication between our EMR(CPRS) and the contractor is highly desirable Telemetry real time monitoring Capability transmitting and recording 100% of ECG data. Customizable monitors. Pacemaker pulse detection. Instrument/Monitor has a date and time stamp for clinical reports. Instrument/Monitor can correlate between time and symptom and identify/present all rhythm strips associated with all reported symptoms. All monitoring devices must provide a of 1 to 6 diagnostic leads of continuous ECG data over entire monitoring period, 3 lead pacemaker annotations, and the ability to correlate symptoms and activity with ECG changes. All consumable items (batteries, patches) are provided to patient by contractor who returns the item after monitoring period. Contractor equipment shall be capable of storing up to thirty-day (30) of all ECG data, using standard size batteries readily available, and easily changed by the patient. Training: The contractor shall provide comprehensive training to the Washington, DC VAMC staff. This may require multiple training sessions for numerous staff. The training shall consist of proper use of the monitoring devices, instructions on how to upload patient information into contractor provided software and/or websites, and how to maintain or provide basic quality assurance tests. Contractor shall also provide each participant at each facility copies of manuals, equipment checklists, surveys, and specific contact information if a medical center staff person needed to contact the contractor 24/7. Technical Support: Technical support is required via telephone for troubleshooting of method and/or problems. The response time for telephone technical assistance shall be within one (1) hour from the time of the initial call for technical support. Contractor must also show availability 24/7 for patient support. Contractor must have appropriately trained personnel available by phone throughout the duration of all tests for patient support. Quality Maintenance: All monitors at each location will be kept at OEM specs. All portable ECG monitoring equipment shall be cleaned, disinfected, and decontaminated according to accreditation standards, each time before it is sent back to facility after download by contractor. Unclean equipment should be stored in an area separate from cleaned equipment to prevent cross contamination. Contractor shall demonstrate set procedures for proper inspection and maintenance of the portable monitoring equipment and shall provide each location a copy of the inspection checklist. The contractor shall have a formal procedure to validate the functional integrity of any device before it is provided to a patient, and shall, at a minimum, complete and document such validation procedure whenever a device is returned with non-diagnostic or unsatisfactory results, or when visual inspection suggests the possibility of device damage. Contractor shall report on the failure rate of their equipment and supply maintenance records. When upgrades to the analytical software or hardware are available that are designed to improve the performance of the analytical system, those upgrades shall be made available to the Washington, DC VAMC at no additional costs. The contractor shall coordinate installation of upgrades with the COR. The contractor shall provide customer notifications and latest operator’s manual within 10 days after their release/publication. Quality Program: The contractor shall maintain a quality system that ensures conformance to contractual requirements and meets the requirements of ISO 9001 and/or CMS requirements for equivalent ECG technical monitoring, or an equivalent quality system during performance of this contract. Contractor must have a clearly defined process by which it collects the required data, performs root cause analysis, and can supply easily understandable reports. Contractor must demonstrate that their information systems are HIPAA compliant and that the raw data can be transferred securely and with accuracy to the VA. All work shall be performed, and equipment shall function in conformance with all VA safety standards, manufacturer's/industry standards, the latest published edition of NFPA?99, FDA, OSHA, JCAHO, ISO 9000, UL and other applicable state, local, national and industry standards. Equipment shall meet EMS (Electromagnetic Compatibility) for EIC 601-1-2 CE, CSA, ETL Approved to U.L. 2601-1, second edition. Government holidays: The contractor is not required to provide service on the following National holidays, nor shall the contractor be paid for these holidays. The following national holidays observed by the Federal Government: New Year’s Day 1 January Martin Luther King’s Birthday Third Monday in January President’s Day Third Monday in February Memorial Day Last Monday in May Independence Day 4 July Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day 11 November Thanksgiving Day 4th Thursday in November Christmas Day 25 December If a holiday falls on Sunday, the following Monday shall be observed as the National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government agencies. Also included would be any day specifically declared by the President of the United States. Overtime and holidays: Any overtime or holiday pay that may be entitled to contractor personnel performing under this contract shall be the sole responsibility of the contractor and shall not be billed to nor reimbursed by the Government. Changes to Statement of Work: Only those services specified herein are authorized. Before performing any service of a non-contractual nature, contractor shall advise the Contracting Officer (CO) of the reason(s) for the additional work and/or service. Prior authorization shall be obtained from the CO before performing the services. CONTRACTOR RESPONSIBILITIES Clinical Personnel Required: The Contractor shall provide Contractor’s physician(s) who are competent, qualified per this performance work statement and adequately trained to perform assigned duties. Citizenship Related Requirements The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals; While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations. If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach. This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001. The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document. Conflict of Interest: The Contractor and all Contractor personnel providing cardiac monitoring services are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document. Complaints: Contractor shall promptly and courteously respond to complaints within 3 working days. Including complaints brought to contractor’s attention by the CO. Contractor shall maintain a written record of all complaints, both written and oral showing the identity of the individual, the nature of the complaint, and contractor’s response. Contractor shall permit the Government to inspect such records upon reasonable notice. PERSONNEL Key Personnel Information A list of the proposed key personnel providing services by name, including cardiac technicians or equivalent who may be performing services under this contract by name. Personnel Qualifications Competency Check List(s) Curriculum Vitae (CV) or resume of the proposed key personnel Copy of all current licenses, registrations, certifications Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by Washington, DC VAMC or his/her clinical designee and approval by the Medical Center Director as provided in VHA Handbook 1100.19. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the Washington, DC and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract. Non-Personal Healthcare Services: The parties agree that the Contractor and all Contractor’s staff providing services shall not be considered VA employees for any purpose. Proof of Insurance Indemnification: The Contractor shall be liable for, and shall indemnify and hold harmless the Government against, all actions or claims for loss of or damage to property or the injury or death of persons, arising out of or resulting from the fault, negligence, or act or omission of the Contractor, its agents, or employees. Standards of Care: The Contractor’s performance standards of care shall cover the range of cardiac monitoring related services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by: The American College of Cardiology https://www.acc.org/guidelines#doctype=Guidelines The professional standards of the Joint Commission (TJC) http://www.jointcommission.org/standards_information/hap_requirements.aspx The standards of the American Hospital Association (AHA) http://www.hpoe.org/resources?show=100&type=8 and; PERSONNEL IDENTIFICATION PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS All contractor personnel shall wear visible VA-provided identification (ID) badges at all times while on the premises of the VA property. Contractors shall be required to coordinate with COR in order to obtain the VA provided I.D. badges for all staff. All VA provided I.D. badges shall be returned at the end of the contract or upon completion of service. Failure to wear ID badges may result in removal from any of the VA facilities and/or otherwise referred to federal property. The contractor shall ensure that contractor personnel identify themselves as contractors when attending meetings, answering government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official government acts. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. The VA will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VA. Cellular phones and two-way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations ...