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Ambulatory Cardiac Event Monitoring Services Oklahoma City VA Health Care System VA Medical Center Oklahoma City, OK. 73104 BRIEF SCOPE OF WORK (This is for information only) General: The Contractor s... Ambulatory Cardiac Event Monitoring Services Oklahoma City VA Health Care System VA Medical Center Oklahoma City, OK. 73104 BRIEF SCOPE OF WORK (This is for information only) General: The Contractor shall provide Ambulatory Cardiac Event Monitoring Services to the Oklahoma City Veterans Affairs Health Care System (OKC VAHCS) and any current of future Community Bases Outpatient Care (CBOC) facilities. All services shall be performed in accordance with the terms and conditions listed in the following performance work statement (PWS). Background: It is a teaching hospital, providing a full range of patient services, with state-of-the art technology as well as education and research. We strive to continuously look for technology that increases the efficacy of medical and diagnostic management of our patients. Cardiac symptoms are often transient in nature such that it is difficult to obtain an ECG the exact time they occur. Oftentimes, clinically relevant abnormalities and life threatening rhythms have no cardiac symptoms. Ambulatory Cardiac Event Monitoring on a continuous basis is the solution to this problem. Ambulatory Cardiac Event Monitoring is used for patients experiencing intermittent symptoms, such as palpitations, syncope, dizziness, and shortness of breath. Patients are provided with state of the art technology in the form of a portable device which records the patient s cardiac data, automatically or patient initiated, in real time while symptoms are occurring. Definitions: CBOC: Community Based Outpatient Care CO: Contracting Officer COR: Contracting Officer s Representative ECG: Electrocardiogram FAR: Federal Acquisition Regulations OK: Oklahoma OKC VAHCS: Oklahoma City Veterans Affairs Health Care System Scope If offering a product other than the Brand Name specified herein, the vendors are required to provide descriptive literature in sufficient detail to determine if the items quoted are technically acceptable in terms of Name Brand or Equal. Contractor must be capable, meet, have, and/or has done the following: Proof of FDA approval for any item submitted Proof of Quality Control standards equal or greater than ISO Minimum of 2 years of previous VA contract experience 365/24/7 monitoring of devices/data Proof of VA approved protocol for emergency situations where patient is not reachable and extended time could result in harm or death of the patient Provide reports upon request even if the monitor event has not concluded Proof of shipping capabilities to all locations in OKC VAHCS coverage area Provide technical communication specifications regarding patient data transfer, storage, and submission Meet all VA standards regarding handling patient information Provide data on more than one lead or channel Stock devices at OKC or other locations in the facility s coverage location Ship devices from the company to patients Provide free return shipping for patients to return devices to the manufacture Provide pricing structure allowing OKC VAHCS to use devices but not own them Provide on-site training for staff Provide 24/7/365 assistance for patients with devices Bill on monthly basis Easy method for patient to manually record events on devices VA approved protocol for contacting patients in instances of critical or STAT events Minimum experience of 1 VA Contract in similar size and complexity but no less than 10% of the complete value of this contract Electronic data base, available to VA staff, to track enrollment, verified patient information, and review the progress of tests Provide STAT results immediately to providers Transfer monitor data in real-time to monitoring station(s) using cellular data, WiFi, and/or Internet Patient are able to shower wearing the device Devices or leads can be moved around to prevent sores or irritation Capable of providing on-site demonstrations for VA staff Provide up to 1100 wireless event monitors per year or up to 90 a month during peak times Provide up to 400 Holter monitors per year or up to 30 a month during peak times Provide reports within 48 hours of test being completed VA approved protocol ensuring quality of test results Provide comprehensive training for patients and staff Preferred Characteristic Contractor can transmit patient report directly to CPRS Contractor can transmit patient report directly to Cerner There is a need to have an Auto-Trigger technology which offers ECG monitoring that is programmed to recognize rhythms such as atrial fibrillation, tachycardia, bradycardia, ventricular tachycardia, and asystole. When the device recognizes these rhythms, it automatically records the patient's ECG, independent of the patient physically activating the device. This technology captures dysrhythmias when they would otherwise go undiagnosed. The ECG is automatically transferred to a cardiac monitoring center, where it is immediately reviewed, and the cardiologist is informed according to pre-selected notification criteria. Device Service: Event monitor: Non-Looping, Looping including Auto Trigger, and Wireless While patient is wearing the device, transmission report, urgent report, weekly report (wireless Event only), and End of Service report options will be made available as requested via fax or online. For wireless Event patients, wireless Event reports will be made available by the contractor. The VA would like to have access to patient reporting 24 hours a day at the physician s or authorized representative s convenience through password protection. The device is given to patients to use up to 1 month depending on the indication for continuous monitoring. There are two different scenarios for device delivery to the patients. The first is EKG technicians will instruct and explain to the patients about what the device is, how to use it, how to hook it up, and how to place leads. They will then hook up the device, and let the patient go home with specific instructions in order to continue to have the device on for the duration of evaluation. The second is a monitor 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. Vendor shall provide looping, manually recording, ambulatory cardiac 30 day event monitors and applicable accessories. Devices shall be single or dual channel event monitor devices that operate in a looping mode or event mode and that are attached to the patient through removable electrodes. Monitors must be able to save the selected pre-symptom portion of the ECG rhythm, while continuing to record a post-symptom portion of the ECG. Patient must be able to transmit data by phone to vendor s patient monitoring service. Vendor shall also provide multi-channel ambulatory cardiac telemetry device that can be worn to provide up to 14 days of cardiac telemetry data and all applicable accessories. Devices shall attach to the patient through removable electrodes. The device must automatically record and transmit an arrhythmia without patient intervention to vendor s patient monitoring service. Vendor shall offer optional service of remote retrieval of 48 hour full disclosure of 3-channel ECG. Vendor shall offer transition from full disclosure ECG to telemetry without interruption of service to the patient. The contractor shall be available to receive telephonic transmission of data from device seven days per week, twenty-four hours per day. Patient data must be reviewed by experienced cardiac technicians who prepare thorough diagnostic reports in hard copy or online format. The contractor shall also provide notification of cardiac abnormalities within one hour of discovery of abnormality. If pre-determined criteria are met, the patient's physician is notified immediately. Reports shall be faxed to the OKC VAMC and available on secure website for viewing within twenty-four hours of receipt of device. Patient shall be able to send the event monitor directly back to the vendor at the end of the monitoring period at no cost. The contractor shall supply enrollment forms and a trackable self-addressed postage (ground or equivalent delivery) paid protective container for patients to return devices to the vendor s facility. Monitors will be delivered to the Oklahoma City VA Medical Center at 921 NE 13th Street Oklahoma City, OK 73104. Devices shall come with a minimum of a 30 (thirty) day supply of all accessories required for operation including but not limited to batteries, electrodes, and patient instructions. Training for VA Employees: Performance Monitoring: Performance will be monitored by a COR in Medicine Service and the Section Chief of Cardiology Service. The cardiac event monitor usage will be monitored and will be charted in CPRS under the patient s medical chart. Each patient chart with recorded cardiac event monitoring data will be used for validating invoices. Contractor Security Requirements (Handbook 6500.6) SUBPART 839.2 INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS 839.201 Contract clause for Information and Information Technology Security: Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008) As prescribed in 839.201, insert the following clause: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. (b) To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in VA Information and Information System Security/Privacy Requirements for IT Contracts located at the following Web site: http://www.iprm.oit.va.gov/. SECURITY INCIDENT INVESTIGATION The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. LIQUIDATED DAMAGES FOR DATA BREACH Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. Each risk analysis shall address all relevant information concerning the data breach, including the following: Nature of the event (loss, theft, unauthorized access); Description of the event, including: date of occurrence; data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; Number of individuals affected or potentially affected; Names of individuals or groups affected or potentially affected; Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; Amount of time the data has been out of VA control; The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); Known misuses of data containing sensitive personal information, if any; Assessment of the potential harm to the affected individuals; Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: Notification; One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; Data breach analysis; Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. TRAINING All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; Successfully complete the appropriate VA privacy training and annually complete required privacy training; and Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. VA INFORMATION CUSTODIAL LANGUAGE Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. The A&A requirements do not apply, and the Security Accreditation Package is not required: Training certificates are in place, which ensures the contractor and employee(s) will protect VA sensitive information. SECURITY CONTROLS COMPLIANCE TESTING On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. Example of Pricing/Schedule for Period of Performance to be determined within the full solicitation, once posted. CLIN Description Price Unit Qty Total 0001 Real-time Outpatient Cardiac Telemetry Device 11 to 30 days. each 2 0002 Holter Monitoring 24-48 hrs (with Real-time Outpatient Cardiac Telemetry). each 300 0003 Cardiac Event Monitoring with Telemetry: 1-30 Days Cardiac Event Monitoring with Telemetry Transmitting and Analyzing (real time event monitoring only) MUST INCLUDE: 1. Real-time transmitting of 100% of ECG data to telemetry receiving center with 100% of the ecg and alarms being monitored by cct technicians. 2. All patient events reported, posted and called in if meets physician criteria 24/7 in real-time /upon receipt. 3. All events meeting physician criteria reported, posted and call in 24/7 in real time/ upon receipt. 4. End of Study CE report 5. Minimum heart rate over monitoring period. 6. Maximum heart rate over monitoring period. 7. Average heart rate over monitoring period. 8. Additional ECG strips w/ correlating Full Disclosure providing overall ECG data (VE/SVE / Pauses, blocks, etc.) Showing overall view of patient ECG, as much does not meet criteria. 9. Additional requested customizable strips including 50 speed, color coded full disclosure, 2/3/or 6 Lead view of any ECG strip, onsets and offsets of any ectopy event, strips ranging from 8 seconds to hours, depending on physician s needs and requests. 10. Atrial Fibrillation Burdens each 1200 Location of performance Oklahoma City VA Health Care System VA Medical Center 921 NE 13th St Oklahoma City OK 73104 IMPORTANTR NOTE: This RFI (Request for Information) is for information only. No award will be made from this RFI. Please communicate via e-mail to Lance.Davis2@va.gov by COB January 7, 2020 as to your company s ability to perform service per this brief Scope of Work. If interested, please provide the following: Please state your company s business size Please provide DUNS number If you have a FSS/GSA contract that includes this service Provide FSS/GSA contract number if applicable