36C24819Q0635-004.pdf

SOW – Ambulatory Cardiac Telemetry

Statement of Work

1. Title of Project: Mobile Cardiac Telemetry (MCT) for monitored 24/7 detection and reporting of asymptomatic and symptomatic arrhythmias

2. Scope of Work: The Gainesville VA Medical Center Cardiology Clinic is requesting the purchase of MCT service for their NF/SG cardiology program. The Gainesville VA Medical Center Cardiology Clinic has one of the highest volumes of in diagnostic testing procedures within the VA system.

3. Background: The Gainesville VA Medical Center Cardiology Clinic feel these qualities are especially important/valuable in a cardiology training program. In addition to increased procedural effectiveness and safety, this technology can lead to improved clinical outcomes, with cardiac diagnosis.

• Purpose: 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.

MCT is the solution to this problem. MCT is used for patients experiencing intermittent symptoms, such as palpitations, syncope, dizziness and shortness of breath. Patients are provided with a state of the art sensor and cell phone and monitored in near real time via an embedded algorithm and cellular communication technology.

The MCT provides auto-trigger and auto-send functionality which automatically and instantly detects and transmits both symptomatic and asymptomatic arrhythmia to a monitored station without any patient intervention required. MCT will auto-trigger for atrial fibrillation, tachycardia, bradycardia, and pause.

Additionally, patients can manually activate and transmit the ECG data to the clinical monitoring facilities as needed. Upon transmission of the data to the clinical monitoring facilities, clinicians will interpret the ECG and provide a preliminary finding and send the results back to the clinician for review and final diagnosis.

• Location: Gainesville VA Medical Center Cardiology Clinic

• Procedure: Patients will be enrolled by the Gainesville VA staff and the vendor will ship a device including all supplemental equipment (ie. batteries, electrodes, and instructions) for a period up to 4 weeks of monitoring within 2 business days. The address will be confirmed by VA staff and the telephonic hook up and a baseline transmission will be scheduled by the vendor.

Once the patient has activated the service and successfully submitted a baseline transmission, the device will continue to monitor the patient continuously. The patient is only responsible for ensuring the cell phone remains charged, the batteries for the sensor are changed when needed, and the device is shipped back to the vendor in a prepaid US mailed envelop provided with the kit.

The Gainesville VA Medical Center will establish physician notification criteria for office hour, 24-hour, and emergency criteria in order to effectively triage data and ensure appropriate patient care.

The vendor will post all reports on their FIPS compliant/verified website for retrieval and download to Vista

Imaging/CPRS

• Data Management:

1. Data Transmission - a cellular phone is provided in the kit that automatically sends data to the vendors clinical monitoring facility.

2. ECG Evaluation - Once the ECG data is processed, converted, and ready for evaluation, the company alerts the department in 2 ways. The company initiates a call to the cardiology department and sends the data via fax for prompt evaluation based upon the physician notification criteria referenced above.

3. Documentation - Quality of data is tested initially when the electrodes are first attached to the patient. The vendors technician will test the device as well as transmission to the company with the initial baseline.

The website must be able to enable cardiologists to have access to the patient’s transmission reports available 24 hours a day at the physician’s convenience. The site must provide the following data:

a. Enrollments - Ability to enroll patients directly online.

b. Reports – Access to patient reports. Reports must be sortable by preference and printed individually or in a batch mode.

c. Contact Us – Ability to communicate directly to contractor’s customer service.

d. Account Info – Ability to view or change account set-up and preferences.

When the data is interpreted by the cardiologist, a computerized result is generated and added to the VA clinical records. Results must be available within 3-5 days after the final evaluation period.

Website must be certified FIPS 140-2 compliant for VA to use it for patient care. Please verify that it is compliant by providing the certification certificate.

4. Reports - Key components of MCT reporting should include the following in an easy to ready format:

* Up to 30 days of retrievable ECG data

* Episode, daily summary, end of service and urgent notifications

* heart rate histogram correlated to a-fib, symptoms and activities; this includes easy to read p wave morphology

* A-fib onset and duration

* A-fib burden and rate charts

* Full disclosure report on demand

* End of study report available within 2 business days from study completion.

When the data is interpreted by the cardiologist, a computerized result is generated and this is seamlessly assimilated into the VA clinical records. Results are available within 3-5 days after the final evaluation period.

4. Data/Reimbursement for Services Rendered:

Period of Performance – 5 years (base yr. + 4 option yrs.)

Preferred Performance Start Date: May 1, 2019

• Base Year: Period of award date to end of base year (9/30/2019)

• Option Year I: Period of one year from the end of base year

• Option Year II: Period of one year from the end of option year I

• Option Year III: Period of one year from the end of option year II

• Option Year IV: Period of one year from the end of option year III

5. Scheduling and Hours of Work: Staff requirements are limited to enrollment and downloading of reports to Vista

Imaging. All issues pertaining to the functionality of the device and extra supplemental equipment by the patient will be directed to the vendor.

6. Evaluation/Selection Factor:

1. Technical Capability: units must meet all technical requirements listed in SOW/Salient Characteristics list

2. Delivery: please provide the best delivery schedule possiable

3. Price

Evaluation Team:

Carsten Schmalfuss, MD , Cardiology Chief 352-548-6000 ext. 10-6234

Don Chapman, Cardiology Program Coordinator 352-548-6000 ext. 10-6267

Jamie Dillard, Cardiology Equipment Coordinator 352-548-6000 ext. 10-4388

EKG Department 352-548-6000 ext. 10-2514

7. Privacy Requirements:

• The contractor’s website must be certified FIPS 140-2 compliant for VA to use it for patient care. Contractor must be verified that it is compliant by providing the certification certificate.

• The contractors 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.

• The contractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

• Information made available to the contractor 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).

o VA information should not be co-mingled 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. VA reserves the right to conduct onsite 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.

• 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 shall immediately notify the Cardiology Program Coordinator, 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.

• 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.

o The contractor 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

• The contractor shall provide to the Contracting Officer’s Representative 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. This is only required for contractor employees that are requiring access to VA information and VA information systems.

o 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.

• Records Management Language for Contract (NARA): The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

o Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33;

Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part

1228.

o Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

o Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

o Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

o Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

o The Government Agency owns the rights to all data/records produced as part of this contract.

o The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

o Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

o No disposition of documents will be allowed without the prior written consent of the Contracting

Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

o Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract.

The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.