004_DOM_FY25_Cardiac_Remote_Renewal_PWS.pdf

Performance Work Statement (PWS) Cardiac Implanted Electronic Device Remote Monitoring

Brooke Army Medical Center (BAMC) Fort Sam Houston, Texas 78234

1. BACKGROUND

Brooke Army Medical Center’s (BAMC) Department of Medicine’s Cardiology Service provides comprehensive care for cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter defibrillators (ICDs), and implantable loop recorders (ILRs), to active-duty service members, retirees, and their dependents. Post-implantation care encompasses device management, monitoring, evaluation, and reporting of cardiac device information. The service utilizes Cardiac Remote Monitoring (CRM) systems to efficiently manage CIED data remotely, integrating implantable device information with scheduled monitoring. CRM facilitates both event-triggered alerts and routine information updates through remote transmissions. These transmissions undergo review and interpretation by trained and certified technicians before being forwarded to the BAMC’s Cardiology clinic for diagnostic and treatment decisions.

By implementing CRM services, BAMC optimizes patient care by reducing the frequency of in-person office visits while maintaining high standards of cardiac care. This approach aligns with BAMC’s mission to provide world-class comprehensive heart rhythm care, ensuring medical readiness for active-duty personnel and delivering quality care to the broader TRICARE beneficiary community.

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 technicians certified as Cardiac Device Specialists (CCDS) or Cardiac Device Remote Monitoring Specialists (CDRMS) 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 1 October 2025 - 30 September 2026, plus 4 option years (OY) as follows: OY1 period of performance - 01OCT2026- 30SEP2027, OY2 period of performance - 01OCT2027-30SEP2028, OY3 period of performance - 01OCT2028-30SEP2029, OY4 period of performance - 01OCT2029-30SEP2030.

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. For non-duty hours, weekends, and holidays, all reports / studies will be processed on next business day. For high-risk findings identified on remote monitoring during after-hours (weekends, holidays, etc), utilize pager number 210-266-8964.

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).

1.2.2.1.1 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 or CDRMS. 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 measure 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, CCDS and CDRMS.

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 or CDRMS.

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 ADMINISTRAIVE

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.

1.1.1. 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.

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

1.2.1. Monthly (i.e., every four weeks) - reports for patients with ILRs

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

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

1.2.4. 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

2.19. CDRMS – Cardiac Device Remote Monitoring Specialist

Part 3

3.1. Table 1. Patient Management Protocol

Importance Create a report

Send notification to clinical team

(M-F 8am-5pm)

ICD/PPM Red X X

LOOP Yellow X X

PPM/ICD Red Once per month X

LOOP Yellow Once per month

PPM - not dependent, initial event Yellow X

PPM - not dependent, repeat events Green Once per billing cycle

PPM dependent or ICD Red X X

Initial event Red X X

Repeat alerts Yellow Once per billing cycle

Red Once per billing cycle X Initial event or atrial dependent Red X X Repeat event (not atrial dependent) Green Once per billing cycle

Yellow Once per billing cycle

CRT Pacing < 90% Yellow Once per billing cycle

PPM/ICD/LOOP: Normal device Function Green Once per billing cycle

LOOP RECORDER: Undersensing / Oversensing Yellow Once per billing cycle

LOOP RECORDER: No R waves - loss of electrode contact Red X X

Green Once per billing cycle

See below

ARRHYTHMIAS/EVENTS

Ventricular Heart Rate

(median/average) ECG Duration Importance Create a report

Send notification to clinical team

(M-F 8am-5pm)

ICD SHOCK - All events Red X X

ATP (Ventricular) - All events Red X X

VF /Torsades Red X X

PPM/LOOP: All rates > 30 seconds Red X X

ICD: Below detection zone > 30 seconds Red X X

>150 bpm 10 - 30 seconds Yellow X X

NSVT All events with symptoms Yellow X

All remaining events <10 sec Yellow Once per billing cycle

All events >6 min Red X X

All events <6 min Red X

Cryptogenic stroke All events Red X X

Patient Management Protocol This protocol is not intended as an immediate 24/7 notification protocol

HV/SHOCK COIL: Impedance out of range

RV LEAD: Impedance out of range

DEVICE INFORMATION/ALERTS

BATTERY at end of life (EOL)

BATTERY at recommended replacement time (RRT/ERI)

RV LEAD: Oversensing/Noise

ATRIAL LEAD: Noise / oversensing

LOOP RECORDER: Patient symptom events without arrhythmia

LOOP RECORDER: Patient symptom events with an arrhythmia

All events

All events

AFIB/AFLUTTER:

(new onset/ not previously documented/not treated)

All events

VT - Sustained

ATRIAL LEAD: Impedance out of range catherine.marshall Highlight catherine.marshall Highlight catherine.marshall Highlight

150 - 200 bpm >30 min Yellow X

>200 bpm >10 min Yellow X

Increase in AF burden Persistent > 48 hours Yellow X

All remaining events Green Once per billing cycle

Nocturnal > 5 seconds Yellow X

Pause/Asystole Daytime > 3 seconds Yellow X

Due to AF > 4 seconds Yellow X

All events > 6 seconds Red X X

COMPLETE HB All events Red X X

< 40 bpm w/ sypmtoms Red X X

< 40 bpm All events Yellow X

> 40 bpm 2:1 Daytime Yellow X

> 40 bpm 2:1 Nocturnal Green X

<30 bpm >30 sec Red X X

<40 bpm w/ pt symptoms All events Red X X

< 40 bpm, Notcturnal > 1 min Yellow X

Minor change from baseline Green Once per billing cycle

Significant change/worsening Yellow Once per billing cycle

Account Name: Authorized Signature:

Please complete the bottom portion for clarification of notifications:

Alert Notification days/times Primary Notification Method

(secure text, email, phone) Back up Notification Method

Monday - Friday 8am - 5 pm

Important Notes:

Definitions Atrial Rate RVR

AT > 100 bpm, < 150 bpm >130 bpm RED = URGENT transmission

SVT > 151 bpm, < 220 bpm >130bpm YELLOW = Abnormal transmission

AFL > 221 bpm, < 300 bpm >150 ventricular rate GREEN = Normal transmission

AF > 301 bpm >150 ventricular rate

TACHYCARDIA

(Known/Treated AF & AFL, AT, SVT, ST)

Effective Date:

2nd Degree HB

Bradycardia

HF Diagnostics: Abnormal

Notification Recipient(s)

Primary Contact Name: EMAIL: PHONE:

Secondary Contact Name: EMAIL: PHONE:

Catherine Marshall catherine.d.marshall3.civ@ health.mil 210-916-1712 text 618-409-9801

SAMMC Cardiology Clinic 210-916-0935 or 210-916-8312

BROOKE ARMY MEDICAL CENTER 7JAN24

Do not encrypt. Add read receipt. If possible, send one email per day. Info for email should include ONLY pt’s last name, year of birth, and vendor. Email addresses:

catherine.d.marshall3.civ@health.mil, Katelynn.m.armstrong2.civ@health.mil, Jacob.cerna.civ@health.mil, michela.novelli2.civ@health.mil, thomas.j.starr-burt.civ@health.mil , and PCS Email Channel 41850e89.cardiacrms.com@amer.teams.ms. In addition to email, for URGENT matters (shocks/reset) text Ms. Catherine Marshall, NP: (618) 409-9801 if no response call office 210-916-0935 (main number, leave a message on the nurse line and they should call you back) catherine.marshall Highlight catherine.marshall Highlight

1. Provide quality service to patients and BAMC Cardiac Clinic Provide initial and ongoing training to BAMC CRM personnel prior to implementation of services

4.

No more than one patienUcustomer complaint quarterly 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 No more than one /ate notification quarterly Use of telephonic, e-mail, paging, reporting communication as necessary for alerts and routine reporting 95% compliance at all times

PatienUCustomer feedback reports

Record of training

3. Timely and efficient notifications of alerts and scheduled routine reports Maintain efficient communication means (e.g., telephone calls, reports, paging, electronic mail, etc.) with BAMC Cardiac clinic Ensure patient and BAMC compliance with the system (e.g., missed transmissions, disconnected monitors) Possess and maintain current accreditations, standards, guidelines, certifications and licenses, such as IDTF, HIPAA, HRS, IBHRE, and CCDS

Random audits

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

100% compliance at all times

Contractor will submit quarterly reports of patients no longer actively remote monitoring at least quarterly Annual and random review of COR files

Method of Surveillance Acceptable Quality Level Performance Objectives

Performance Measures

3.2 Table 2. Performance Measures