Cardio Remote Monitoring Service - PWS .pdf

PERFORMANCE WORK STATEMENT

Cardiac Implanted Electronic Device Remote Monitoring

Department of Medicine, Cardiology Service; Brooke Army Medical Center (BAMC)

Joint Base San Antonio – Fort Sam Houston, TX

Part 1

GENERAL INFORMATION

1. BACKGROUND. Brooke Army Medical Center’s (BAMC) Department of Medicine’s Cardiology clinic serves active duty service members, retirees, and family members with cardiac implantable electronic devices (CIED), such as pacemakers, implantable cardioverter defibrillators (ICD), and implantable loop recorders (ILR). After implantation, patient care includes management, monitoring, evaluation reporting of cardiac device information. Cardiac Remote Monitoring (CRM) systems provide a means of managing

CIED information remotely. A CRM system integrates implantable device information with interval scheduling and monitoring. Cardiac remote transmissions are sent when an alert, stemming from a cardiac event is indicated as well as updating routine information. Each transmission must be reviewed and interpreted by a trained and certified technician, who then forwards this information to the BAMC

Cardiology clinic for diagnosis and treatment. BAMCs use of a CRM service allows patients to have fewer office visits while maintaining high-quality care.

1.1. General. It is expressly agreed upon and understood that this is a zero-cost contract. The contracting company will bill Medicare and Tricare for the technical Current Procedural Terminology

(CPT) codes for Medicare and Tricare patients. The Contractor will not bill the Government or patients for unsuccessful collection attempts with Medicare or Tricare. The Contractor shall be solely liable for and expressly agree to indemnify the Government concerning any liability producing acts or omissions by its employees or agents. The Government will evaluate the quality of professional and administrative services provided. The contracting company must be a Medicare Accredited Independent Diagnostic

Testing Facility (IDTF); it must meet Medicare Standards, Health Insurance Portability and Accountability

Act (HIPAA) standards, and Heart Rhythm Society (HRS) Guidelines. The Contractor shall provide a current copy of their Malpractice insurance and any renewals of insurance for the contract's duration.

1.1.1. Description of Work. The Contractor will provide cardiac remote monitoring by Certified Cardiac

Device Specialists (CCDS) technicians from an offsite (i.e., remote) location. This contract's target population includes all BAMC beneficiaries with CIEDs requiring remote monitoring impaneled at the

Military Treatment Facility (MTF) BAMC Cardiology Clinic. BAMC will provide the Contractor with a patient list of CIED Medicare beneficiaries; the MTF will update the list with new CIED patients or deceased ones as BAMC Cardiology service is notified. The Contractor will update its patient list within

24-hours of receiving patient information. The Contractor will review transmissions, generate, and distribute reports to BAMC every four-weeks for patients with ILRs and every three-months for patients with pacemakers and ICDs; this represents approximately 5,600 reports annually. Additionally, the

Contractor will respond to alerts of varying severity within the time specified on the Patient Management

Protocol (Table 1). The Contractor will provide technical and administrative services in support of the

CRM system implementation and utilization within the BAMC Cardiology Clinic. These services include training in all aspects of the remote monitoring service.

1.1.2. Period of Performance: This contract will be for base year period of performance 01 June 2021 –

30 September 2021, plus 4 option years (OY) as such: OY1 period of performance - 01OCT2021-

30SEP2022, OY2 period of performance - 01OCT2022-30SEP2023, OY3 period of performance -

01OCT2023-30SEP2024, OY4 period of performance - 01OCT2024-30SEP2025.

1.1.3. The Contractor will assist with compliance of remote transmissions by alerting BAMC Cardiology

Clinic when a patient's device fails to transmit. The Contractor will manage its software system and provide BAMC Cardiology Clinic with access to web-based software, ensuring access to patient data and reports. The software application must be secure, redundant, encrypted, and HIPAA compliant. The

Contractor will collaborate with the Cardiology Clinic for specific guidelines regarding notifications of transmission alerts.

1.1.4. BAMC Point of Contact (POC). A BAMC Cardiology Nurse Practitioner (NP) will serve as the

POC for alert reviews during the duty days, Monday through Friday, from 0730 to 1600; the Cardiac Care

Unit (CCU) Fellow will serve as the POC for alert reviews during non-duty hours, weekends, and holidays.

1.2. PERFORMANCE MEASURES

1.2.1 Outcome. The Contractor will provide CRM services at a standard enabling the BAMC

Cardiology Clinic to deliver high-quality cardiac services to its patients (Table 2).

1.2.2 Standards. Acceptable measures include:

1.2.2.1. Availability to the Contractor’s Customer Service/Operations and Engineering and Systems

Management personnel as deemed necessary by BAMC Cardiology POC to meet the ongoing needs of the CRM service.

1.2.2.2. Primary responsibilities include evaluation, diagnostic review, with longitudinal insight regarding the patient and his/her CIED device, by a CCDS. The data is then communicated to Cardiology personnel at BAMC via reports and alert notifications.

1.2.2.3. No more than one patient/customer complaint quarterly as indicated on patient/customer feedback reports.

1.2.3. Other performance evaluation factors that will be monitored may not be quantified by numerical measures and include but are not limited to:

1.2.3.1. Contractor will provide training and ongoing support of CRM system prior to its implementation and utilization; Contractor will provide training for new BAMC Cardiac personnel; Contractor will provide ongoing training as deemed necessary by BAMC Cardiology POC.

1.2.3.2. Timely communication and distribution of reporting data (e.g., reports) and notifications (e.g., alerts) with BAMC Cardiac personnel

1.2.3.3. Maintenance of efficient communication means (e.g., electronic mail, telephonic, pager, in-person) for reporting data (e.g., reports) and notifications (e.g., alerts)

1.2.3.4. Contractor will provide a list of patients no longer actively remote monitoring at least quarterly or more frequently than quarterly at the Contractor’s discretion

1.2.3.5. Regulatory compliance maintenance with accreditations, standards, guidelines, certifications and licenses, such as IDTF, HIPAA, HRS, IBHRE, and CCDS

1.2.4. How Measured. The Contracting Officer Representative (COR) will monitor the Contractor’s performance with input from the BAMC Cardiology personnel utilizing the CRM Service, CIED patient feedback reports, training records, communication means and frequency records, random audits of reports and alerts, and random audits of Contractor’s compliance records.

1.2.5. Remedy. Non-compliance will be reported to the contracting officer by the COR.

1.3. QUALIFICATIONS. The Contractor will meet the knowledge and experience requirements 100% of the time during the performance of the contract.

1.3.1. The Contracting company staff must be certified/credentialed by the International Board of Heart

Rhythm Examiners (IBHRE) as a CCDS.

1.3.2. The Contracting personnel who interact with BAMC Cardiology personnel must possess fluency in English and speak, comprehend, read, and write in this language.

1.4. ADMINISTRATIVE

1.4.1 Neither active-duty military nor Government civil service employees will be used as either a consultant or contract service provider in matters related to this contract.

1.5. ORIENTATION AND TRAINING

1.5.1. The Contractor will provide initial CMR system training to BAMC personnel before implementing and utilizing the CRM system; the Contractor will provide additional training as necessary for new or additional personnel. The Contractor will respond to customer service issues via telephone or electronically as stated in the formal response time (Table 1) or within 24-hours.

1.6. SECURITY

1.6.1. The Contractor shall abide by federal and local MTF regulations concerning the confidentiality of patient records, as embodied in federal statutes, including the Privacy Act of 1974 and the Health

Insurance Portability & Accountability Act of 1996. All regulations referenced are available for review from the COR, MTF, or the Contracting Officer.

1.7. HOURS OF PERFORMANCE.

1.7.1. The Contractor will provide CRM device data transmission surveillance for all patients on the

CRM device list 24-hours a day, for 7-days a week to include holidays and weekends.

1.8. CONDUCT.

1.8.1. The Contractor shall comply with federal and local MTF regulations and requirements concerning the nature of limited privileged communication between patients and the Contractor as necessary for security and personnel reliability programs. All medical records and reports will remain the property of the government. The Contractor shall not respond to any media inquiries. Any inquiries from the media, third parties, or public agencies shall be immediately relayed to the COR, who will forward them to the Hospital Public Affairs Officer or, after duty hours, to the Day's Administrative

Officer (AOD). There shall be no interviews, comments, or any other response without the knowledge and approval of the MTF Commander.

1.9. CONFLICT OF INTEREST.

1.9.1 The Contractor or contract CRA will not, while performing services under this contract advise, recommend, or suggest to persons eligible to receive medical care at Government expense that such persons should receive care from the Contractor or contract techs at any place other than designated under this contract.

1.9.2 Confidentiality of Information. Unless otherwise specified, all financial, statistical, personnel, and/or technical data furnished, produced, or otherwise available to the Contractor during the performance of this contract are considered confidential business information and shall not be used for purposes other than the performance of work under this contract. The Contractor shall not release any of the above information without the Contracting Officer's prior written consent. The Contractor shall not use patient care rendered according to this contract as part of a study, research project, or publication.

1.10. CONTRACTOR REPRESENTATIVE

1.10.1. The Contractor shall designate, in writing, at least five working days prior to commencement of services, an on-site representative for contract coordination and implementation. Changes in the on-site representative, at any time after the contract commencement, shall require the Contractor to notify the Contracting Officer of the new authorized representative five working days prior to said change.

This notification will be in writing and will state the name of the new on-site representative.

1.10.2. The Contractor’s representative will meet with the Contracting Officer’s Representative and

Contracting Officer at the MTF on a quarterly basis or when requested in accordance with Army

Regulation 70-13, Management and Oversight of Service Acquisitions to discuss any problems that the

Contractor’s personnel may be experiencing during the performance of this contract. Problems experienced by the Government with the Contractor’s performance will be discussed and resolved.

Unresolved problems will be referred to the Contracting Officer for resolution.

1.11. DELIVERABLES: The Contractor will provide the following deliverables:

1.11.1. Monthly (i.e., every four weeks) – reports for patients with ILRs

1.11.2. Quarterly (i.e., every three months) – reports for patients with pacemakers and ICDs

1.11.3. Alert notifications (i.e., varying severity levels) from the Patient Management Protocol (Table 1).

1.11.4. Quarterly (i.e., every three months) – face to face or virtual meetings between the COR and

Contracting Officer

Part 2

ACRONYMS

2. ACRONYMS

2.1. AOD – Administrative Officer of the Day

2.2. BAMC – Brooke Army Medical Center

2.3. CCDS – Certified Cardiac Device Specialists

2.4. CCU – Cardiac Care Unit

2.5. CIED – Cardiac implantable electronic devices

2.6. COR – Contracting Officer Representative

2.7. CPT – Current Procedural Terminology

2.8. CRM – Cardiac Remote Monitoring

2.9. HIPAA – Health Insurance Portability and Accountability Act

2.10. HRS – Heart Rhythm Society

2.11. IBHRE – International Board of Heart Rhythm Examiners

2.12. ICD – Implantable Cardioverter Defibrillators

2.13. IDTF – Independent Diagnostic Testing Facility

2.14. ILR – Implantable Loop Recorders

2.15. MTF – Military Treatment Facility

2.16. NP – Nurse Practitioner

2.17. PMP – Patient Management Protocol

2.18. POC – Point of Contact

Part 3

Appendix

3.1. Table 1. Patient Management Protocol

Patient Management Protocol

Criteria

Ventricular Heart Rate (median / average) ECG Duration Importance / Color Web Publish

Secure E-mail or Page following NP and clinical contact

(M-F 7:30 am-4:00 pm)

Weekend - Contact CCU Fellow After hours, weekends, holidays)

Patient triggered events All events Yellow X Follow Below

VF and Torsade's All events Red X X X

>120 bpm symptomatic >10 sec Yellow X

NSVT >150 bpm >15 sec <30 sec Yellow X

>150 bpm >30 sec Yellow X X

All remaining events <15 sec Yellow

Once per billing cycle

VT Treated successfully All events All events Yellow X

VF Treated successfully All events All events Red X X X

VT / VF Treated unsuccessfully All events All events Red X X X

All events >3 sec Yellow X

Pause/Asystole Due to AF >4 sec Yellow X

All events >6 sec Red X X X

CHB All events All events Red X X X

<40 bpm symptomatic All events Red X X X

2nd Degree HB <40 bpm All events Yellow X

>40 bpm 2:1 All events Yellow X

All events Yellow X

AF/AFL (new onset) All events <7 min Yellow Once per billing cycle

All events >7 min Red Once per billing cycle X X

AF/AFL/AT/SVT/Sinus tach

>150 bpm <200 bpm >8 hr Yellow X X

(known/treated) >200 bpm >10 min Yellow X X

All remaining events Green

Once per billing cycle

<40 bpm symptomatic All events Red X X X

Bradycardia <40 bpm PM only >1 min Yellow X

<30 bpm >30 sec Red X X X

Normal device function All events All events Green

Once per billing cycle

HF Elevated Minor Yellow

Significant and rising Red

Once per billing cycle X

Undersensing Loop recorder Yellow

Oversensing Loop recorder Yellow cycle

Noise / oversensing on V lead Red

Once per billing cycle X X

Noise / oversensing on A lead Yellow

Once per billing cycle

Sub optimal HV impedance Red

Once per billing cycle X X

Sub optimal BiV pacing <90% Yellow

Once per billing cycle

High or Low impedance on V lead Red

Once per billing cycle X X

High or Low impedance on A lead Yellow

Once per billing cycle

Normal ERI/RRT

All devices greater than 3 months remaining Yellow

Once per billing cycle X

Normal ERI/RRT

All devices less than 3 months remaining Red

Once per billing cycle X X

Normal ERI / RRT > 85% paced Red Once per billing cycle X X

Premature ERI / RRT All devices Red Once per billing cycle X X

Definitions

AT

> 100 bpm, < 150 bpm

SVT

> 151 bpm, < 220 bpm

AFL

> 221 bpm, < 300 bpm

AF > 301 bpm

AF w/RVR AF with Median V rate > 150 bpm

* Notification to NP, MD, or staff will occur M-F within 24-hours of the time Cardiac Remote Monitoring service receives patient transmission.

RED = URGENT transmission

YELLOW = Non-Normal transmission

GREEN = Normal transmission

3.2. Table 2. Performance Measures

Performance Measures

Performance Objectives Acceptable Quality Level Method of Surveillance

1. Provide quality service to patients and BAMC Cardiac Clinic

No more than one patient/customer complaint quarterly

Patient/Customer feedback reports

2. Provide initial and ongoing training to BAMC CRM personnel prior to implementation of services

100% of BAMC personnel, including any additional personnel, will be trained on the system before its implementation and/or before the personnel’s use of the service

Record of training

3. Timely and efficient notifications of alerts and scheduled routine reports

No more than one late notification quarterly

Random audits

4. Maintain efficient communication means (e.g., telephone calls, reports, paging, electronic mail, etc.) with BAMC Cardiac clinic

Use of telephonic, e-mail, paging, reporting communication as necessary for alerts and routine reporting

Acquisition of reports, telephonic exchanges, emails, and other electronic messaging

5. Ensure patient and BAMC compliance with the system (e.g., missed transmissions, disconnected monitors)

95% compliance at all times Contractor will submit quarterly reports of patients no longer actively remote monitoring at least quarterly

6. Possess and maintain current accreditations, standards, guidelines, certifications and licenses, such as IDTF, HIPAA, HRS, IBHRE, and CCDS

100% compliance at all times Annual and random review of COR files