Q502--Ambulatory Cardiac Event Monitoring Service Oklahoma City VA Health Care System

Ambulatory Cardiac Event Monitoring Services

Oklahoma City VA Health Care System

VA Medical Center

Oklahoma City, OK. 73104

This is a Pre-Solicitation Notice

The Full Solicitation will be posted soon

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 performance work statement (PWS).

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.

This is a Pre-Solicitation Notice

The Full Solicitation will be posted soon