P09 Final PWS_v2.docx

PERFORMANCE STATEMENT OF WORK (PWS)

CARDIAC EVENT MONITORING

1. Purpose

The purpose of this contract is to provide cardiac monitoring services to patients serviced by the Mann-Grandstaff VAMC Healthcare System.

The Contractor shall provide all equipment needed for 30-day event monitoring capable of wireless transmission to a central location and a two-week patch monitoring system, either by hospital delivery or direct mail out to patients. The contracted company will provide continuous twenty-four-hour physical observation of rhythm strips and immediately inform a representative from the vascular lab, AOD, or on call physician/department to any significant changes as specified by a doctor.

2. Contract Title

The contractor agrees in accordance with the terms and conditions stated herein, to furnish to the Department of Veterans Affairs, herein after called Mann-Grandstaff VAMC, located at 4815 North Assembly Street, Spokane, Washington 99205, Cardiac Event Monitoring services as specified and at the prices specified in the schedule of services.

The Spokane VAMC requires approximately (30) event monitors capable of wireless transmission to a central location, and (30) adhering cutaneous variable time cardiac monitors in office at all times to be used by our veteran population. Monitors shall comply with industry standards for 2 channel wireless event monitoring and single 2 channel looping event monitoring. They shall be of such weight and size as to be user-friendly for our predominantly geriatric population. The monitor shall use batteries that are readily available, easily changed, and supplied by the contractor. They shall be capable of monitoring heart rates between 0-500 BPM and recording at least (1.5) minutes, including both pre and post symptoms.

At the beginning of the contract, and any time there is a change in the equipment, the contractor shall provide on-site training for VA personnel.

Contractor shall provide the monitors, which shall be kept on site at the Mann-Grandstaff VAMC, Coeur d’Alene, Wenatchee, and our other rural health clinic and will be issued by Diagnostic Imaging Services (Vascular). The Point of Contact for the Mann-Grandstaff VAMC are the Health Technicians at (509) 434-7339. Patients will use the event monitor for approximately 30 days before returning them to the Contractor, or Mann-Grandstaff VAMC using a postage-paid return container supplied by the Contractor and to be determined time for the cutaneous model.

Additional monitors may be needed during the contract period at times of high usage. In such situations, the Spokane VA will contact the contractor by phone, fax, or email to request additional monitors. The contractor will provide the requested monitors to the Mann-Grandstaff VAMC within 2-3 business days.

Both the patients and Mann-Grandstaff VAMC staff shall have toll-free 24 hour/7 day per week telephone access to the contractor’s support staff who will supply help in resolving any monitoring problems.

The patient will call the staffed toll-free 24-hour phone number to transmit recordings. Upon receipt of a recording, the contractor will review the ECG data and assess the patient’s status using patient assessment techniques appropriate for the phone to determine the urgency of the situation. If it is determined to be potentially life-threatening (e.g. sustained tachycardia, significant bradycardia or pauses,) then the contractor will call the Mann-Grandstaff VAMC Officer of the Day at 509-434-7010. In such situations, the ECG rhythm is to be faxed to the VA within 10 minutes (509-434-7105 AND to 509-434-7131). In the event of life-threatening dysrhythmias (such as sustained ventricular tachycardia) the vendor is expected to follow their standard policies in terms of instructing patients to go to the nearest medical facility or immediately calling 911).

All other transmissions determined to be routine (i.e. not potentially life threatening) are to be faxed within 24 hours of receipt to the Mann-Grandstaff VAMC Diagnostic Imaging department at 509-434-7105.

At the end of the 30-day monitoring period the patient will return the monitor to the Contractor or Mann-Grandstaff VAMC who in turn will return it to the contractor. Upon receipt of the monitor or notification of termination of the study the Contractor will then issue a replacement monitor within 2-3 business days. All patient supplies shall be included in the contract (e.g. monitor, holder, ECG electrodes, batteries, pre-postage paid shipping container).

4. Scope

Although the documentation and interpretation is completely through Spokane VA Medical Center, this contract will also cover Coeur d’Alene, Wenatchee and our other rural health clinic VA patients. The main point of contact is the personnel within the vascular lab who, in turn, coordinates with Coeur d’Alene, Wenatchee; rural health clinics to ensure quality care and follow-up.

5. Specific Tasks

5.1 Process and Policy Management Control

5.1.1 - Integration Management Control Planning - Provide Cardiac event monitors for the vascular lab. Ability to keep floor stock up to par levels. The QASP (Quality assurance surveillance plan) will be utilized for quality assurance. Training will be provided by the contractor for any new software, event monitor, or new process being implemented by the contractor.

5.1.2 - Contract Management - Contractor will Provide a bi-monthly status, or as requested, to assist with monitoring the quality assurance, progress/status reporting and program reviews applied to this contract to the COR (Contracting officers representative).

5.2 Patient Enrollment

5.2.1 - Online Enrollment - The Contractor shall provide means of online/fax patient enrollment for 30-day Event Monitor patient services for approximately 110 studies annually, with an approximate of 10% growth each year.

5.2.2 - Online Access - Online access to database for Primary care providers, Mann-Grandstaff VAMC cardiologists, and vascular lab. Contractor will have 99% uptime of website.

5.2.3 - Transmission Responsiveness/Timeliness - Contractor shall provide live customer service to download transmissions within one minute.

5.2.4 - Patient Service - Contractor will have (24) twenty-four-hour continuous live patient service availability to answer questions or help with proper monitor usage.

5.3 Equipment

5.3.1 - Patient Instructions - Complete and clear written instructions included with every monitor.

5.3.2 Equipment Distribution – Contractor will supply a minimum of 30 event monitors for inventory to be applied in vascular Lab. Monitors will also be distributed to the outlying clinics, as well as ability for monitors to be mailed directly to the patient.

5.3.3 Equipment Supplies – All necessary supplies, cleaned, reset monitors, and accessories in monitor package including, but not limited to, instructions, electrodes, batteries and diaries.

5.3.4 Equipment Condition – Equipment shall be maintained in good working order. Equipment shall arrive in vascular lab/patients address that meets QA standards for cleanliness.

5.3.5 Equipment Inventory – Contractor will supply inventory of monitors and needed supplies at all sites listed for distribution.

5.3.6 EKG tracings – All wireless tracings are acquired in two simultaneous leads.

5.3.7 Monitor device configuration – 30-day wireless and looping event recorders.

5.4 Report Management

5.4.1 Rhythm monitoring – Contractor shall insure that tracings are monitored by trained personnel and overseen by a Cardiologist specialized in rhythm monitoring.

5.4.2 Quality Transmission of Tracing – If indicated Contractor will provide verbal education to patient producing the highest quality tracing possible, with little or no artifact.

5.4.3 Report Information – Contractor shall provide precise information, graphs and analysis as agreed upon between Company and Mann-Grandstaff VAMC Vascular Lab section and Cardiologist to fit need of studies.

5.4.4 Report Information Delivery - Prompt delivery of accurate reports either by fax, or On-Line acquisition as prearranged criteria 24 hours a day, 7 days a week, 365 calendar days of the year.

5.4.5 Equipment Compliance Review – Contractor shall contact patients or vascular lab if no events are transmitted in the first week to ensure compliance, understanding, and quality.

5.4.6 Online Access/Event Monitor - – Contractor shall provide 24 hours online access to full event monitor recording.

5.4.7 Urgent vs. Routine Notifications – Contractor shall provide prompt and accurate notification for any urgent finding. Notification shall be by fax, e-mail and/or phone call to AOD (administrative officer of the day) or the Vascular Lab.

5.5 Billing/Reimbursement

5.5.1 Invoice Billing - Invoices will be provided to Mann-Grandstaff VAMC monthly for Quality assurance, with all information required by COR for certifying invoices in Austin TX.

5.5.2 Pricing and Reimbursement Rates - Company will provide and adhere to agree upon reimbursement rates.

5.6 Customer Service

5.6.1 Help Desk/Phone Line – Contractor shall provide live customer service phone lines that will be available for both patients and hospital employees 24 hours a day, 7 days a week, and 365 days of the year.

5.6.2 Urgent Notifications - In the event of any unexpected findings, key individuals will be alerted, vascular lab during business days M-F 0730-1630 PST, or the AOD after hours at the Mann-Grandstaff VAMC by the contractor.

6. Performance Monitoring

The Government is required to monitor contractor performance and certify the work was done in accordance with the contract. This monitoring is done by the COR.

6.1 Equipment Oversight

COR will randomly select one monitor every two weeks to audit for supplies, cleanliness and performance. Any deficiencies will be documented and immediately reported to Supervisor and Contracted Company. There will be no more than three deficiency reports in a rating period of six months.

6.2 Notification Oversight

Notification failures will require written documentation from the contracted company stating reason for failure and an outline of the process implemented to eliminate issue in the future.

6.3 Rhythm Strip Oversight

COR will randomly select three monitor reports per month to ensure proper process are being followed for rhythm interpretation. The results of these reports will be sent to the vascular lab supervisor. Any deficiencies will be reported to contract Company for follow-up, and documentation outlining the process adjustment to eliminate this issue.

7. Security Requirements

7.1 Patient Information – Mail out Material

The COR shall develop and implement procedure to insure that no sensitive patient identifying information is sent out in the mail. Any breaches will be immediately reported and remedied. There will be no more than one breach per rating period (six months).

7.2 Patient Information – Secure online program

Contractor shall provide an online system that adheres to all standards and policies set by Mann-Grandstaff VAMC Information Security Officer. Any breaches shall be immediately reported and remedied. There shall be no more than one breach per rating period (six months).

7.3 Patient Information – Online access of VA and contract company employees

Only Mann-Grandstaff VAMC and contract company employees with a “need to know” shall have access to the online reporting system. All standards and policies set by VA Information Security Office regarding online system usage shall be strictly adhered to. Any breaches shall be immediately reported and remedied. There will be no more than one breach per rating period (six months).

7.4 Patient Information – Faxing and phone usage -patient information

Contractor shall establish strict standards and procedures for contractor employees, which will be set and followed to ensure patient confidentiality. Any breaches shall be immediately reported and remedied. There shall be no more than one breach per rating period (six months).

7.5 Patient Information – Patient reports

Contractor shall establish strict standards and procedures in regard to patient reports to ensure patient confidentiality. Any breaches shall be immediately reported and remedied. There shall be no more than one breach per rating period (six months).

7.6 Secure Patient Information – Unescorted access to Spokane VAMC facilities

Strict standards to professionalism and patient confidentiality will be adhered to when visiting any Spokane VAMC facilities.

8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI)

There will be no government furnished equipment with this contract.

9. Other Pertinent Information or Special Considerations

9.1 Identification of Non-Disclosure Requirements

The contractor will have access to a significant amount of personal patient information, including full names, birthdates, diagnoses, addresses.

9.2 Packaging, Packing and Shipping Instructions

The contractor shall provide a consistent inventory, whether it is by personal drop off or mail. The contractor shall provide a postage paid process to return monitors for cleaning and interpretation.

9.3 Inspection and Acceptance Criteria

The COR will be responsible for periodically inspecting and certifying that the contracted company is performing to pre-arrange upon standards in regard to timeliness, quality and performance.

10. Risk Control

The Contractor shall be responsible for the proper cleaning and disinfection of equipment prior to each patient use, or as mandated by RME (reusable medical equipment) standards.

11. Place of Performance.

The contractor will only be providing equipment and off-site monitoring. No travel fees will apply. All delivery, disposable items, and equipment are included in the item price.

12. Period of Performance - Base year plus (4) four additional option years.

04/01/2021 – 03/31/2026 reevaluate yearly as needed.