Inactive Total Small Business Set-Aside (FAR 19.5)

Cardiac Event Monitoring Performance Work Statement 1. PURPOSE: The purpose of this contract is to furnish the, Department of Veterans Affairs, Hunter Holmes McGuire VA Medical Center (Richmond VAMC) ... Cardiac Event Monitoring Performance Work Statement 1. PURPOSE: The purpose of this contract is to furnish the, Department of Veterans Affairs, Hunter Holmes McGuire VA Medical Center (Richmond VAMC) with the services required for cardiac monitoring to Veteran patients. The Contractor shall provide all equipment needed for up to 30-day wireless, dual alert, and Mobile Cardiac Outpatient Telemetry (MCOT) monitoring by hospital delivery for patients. The contracted company will provide continuous 24-hour physical observation of rhythm strips and immediately inform a representative from the vascular lab, agent on duty, or on call physician/department to any significant changes as specified by a doctor. 2. SCOPE OF SERVICE: In accordance with the terms and conditions stated herein, the contractor shall furnish the Richmond VAMC located at 1201 Broad Rock Boulevard, Richmond, Virginia 23249, Cardiac Event Monitoring service as specified and at the prices specified in the price/cost schedule. The Richmond VAMC requires approximately six (6) MCOTs, ten (10) dual alerts, and ten (10) wireless, 14-30-day event monitors in office at all times to be used by our veteran population. Monitors shall comply with industry standards for two-channel wireless and single three-channel MCOT 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 equipment, the Contractor shall provide on-site training for VA personnel. Contractor shall provide the monitors, which shall be kept at the Richmond VAMC, and will be issued by the Cardiology Department. The Point of Contact (POC) for the Richmond VAMC is the Health Technicians (804-675-5413 or 804-675-5466). Patients will use the event monitor for approximately 14-30-days before returning them to the Contractor or Richmond VAMC using a postage-paid return container supplied by the Contractor. Additional monitors may be needed during the contract period at times of high usage. In such situations, the Richmond VAMC will contact the contractor by phone, fax, or email to request additional monitors. The Contractor will provide the requested monitors to the Richmond VAMC within 2-3 business days. Both the patients and Richmond VAMC shall have toll-free 24 hour/7 day per week telephone access to the Contractors 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 shall review the ECG data and asses 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 Richmond VAMC Officer of the Day at 804-675-5529. In such situations, the ECG rhythm is to be faxed to the Richmond VAMC within ten (10) minutes (804-675-5467 and to 804-675-5907). 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 call 911. All other transmissions determined to be routine (i.e. not potentially life-threatening) are to be faxed with 24 hours of receipt to the Richmond VAMC, Cardiology Department at 804-675-5413. At the end of the 14-30-day monitoring period, the patent will return the monitor to the Contractor or the Richmond 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 containers). EQUIPMENT FEATURES and MINIMAL Requirements The Cardiology Electrophysiology Lab is looking for the following features in a diagnostic kit. 1 or 2 Channel 2 or 3 lead-wires Event recordings up to 30 days Transmission over cell phone network Continuous monitoring & recording Patient activation and Auto-trigger activation A-fib, Brady, Tachycardia, and Pause detection Storage on device for analysis and review Asymptomatic patient, Periodic symptoms. Need for auto trigger feature. Ability to view all the data if necessary. 3. PERIOD OF REQUIRED SERVICES: Services are required from October 1, 2021 through September 30, 2022 with four (1) year option periods. Any resultant contract will be subject to availability of VAMC appropriations. 4. SPECIFIC TASKS 4.1 PROCESS and POLICY MANAGEMENT CONTROL 4.1.1 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 Officer s Representative). 4.2 PATIENT ENROLLMENT 4.2.1. Online Enrollment The Contractor shall provide means of online/fax patient enrollment for 14-30-day Event Monitor patient services for approximately 350 studies annually, with an approximate of 10% growth each year. 4.2.2 Online Access Online access to database for Primary Care Providers, Richmond VAMC Cardiologists, and Non-Invasive Lab. Contractor will have 99% uptime of website. 4.2.3 Transmission Responsiveness/Timeliness Contractor shall provide live customer service to download transmissions within one minute. 4.2.4 Patient Service Contractor will have 24 hour continuous live patient service availability to answer questions or help with proper monitor usage. 4.3 EQUIPMENT 4.3.1 Patient Instructions Complete and clear written instructions included with every monitor. 4.3.2 Equipment Distribution Contractor will supply a minimum of six (6) MCOTs, ten (10) dual alerts, and ten (10) wireless, 14-30-day event monitors to be applied in inventory in the Richmond VAMC, Cardiology Department, ECHO Lab. 4.3.3 Equipment Supplies All necessary supplies, cleaned, reset monitors, and accessories in monitor package including, but not limited to, instructions, electrodes, batteries and diaries. 4.3.4 Equipment Condition Equipment shall be maintained in good working order. Equipment shall arrive in ECHO Lab that meets QA standards for cleanliness. 4.3.5 Equipment Inventory Contractor will supply inventory of monitors and needed supplies at site listed for distribution. 4.3.6 EKG Tracings All wireless tracings are acquired in two simultaneous leads. 4.3.7 Monitor Device Configuration 14-30-day wireless and MCOT event recorders. 4.4 REPORT MANAGEMENT 4.4.1 Rhythm Monitoring Contractor shall ensure that tracings are monitored by trained personnel and overseen by a Cardiologist specialized in rhythm monitoring. 4.4.2 Quality Transmission of Tracing If indicated, Contractor will provide verbal education to patient producing the highest quality tracing possible, with little or no artifact. 4.4.3 Report Information Contractor shall provide precise information, graphs, and analysis as agreed upon between Company and the Richmond VAMC, Cardiology Department, to fit need of studies. 4.4.4 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. 4.4.5 Equipment Compliance Review Contractor shall contact patients or Cardiology Department, ECHO Lab, if no events are transmitted in the first week to ensure compliance, understanding, and quality. 4.4.6 Online Access/Event Monitor Contractor shall provide 24 hours online access to full event monitoring recording. 4.4.7 Urgent vs. Routine Notification Contractor shall provide prompt and accurate notification for any urgent findings. Notification shall be by fax, email and/or phone call to the Administrative Officer of the Day (AOD) or the ECHO Lab. 4.5 BILLING/REIMBURSEMENT 4.5.1 The Contractor shall provide and itemized invoice within fifteen (15) days of the end of each month services were provided. Payments will only be made for services rendered. All invoices, including supporting documents, should be submitted electronically according to the Federal mandate. 4.5.2 Pricing and Reimbursement Rates Company will provide and adhere to agree upon reimbursement rates. 4.6 Customer Service 4.6.1 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. 4.6.2 Urgent Notifications In the event of any unexpected findings, key individuals will be alerted, ECHO Lab during business days M-F 0730-1630 EST or the AOD after hours at the Richmond VAMC by the Contractor. 5. PERFORMANCE MONITORING The COR will monitor contractor performance and certify completion of work in accordance with Table 1 Performance Measures and the Contract. 5.1 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 (2) deficiency reports in a rating period of six months. 5.2 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 of the failure. 5.3 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 ECHO Lab Supervisor. Any deficiencies will be reported to the Contract Company for follow-up and documentation outlining the process adjusted to eliminate this issue. 5.4 Table 1: CARDIAC EVENT MONITORING SERVICES - PERFORMANCE MEASURES Measures PWS Reference Performance Requirement Standard Acceptable Quality Level Surveillance Method Incentive Disincentive/Deduct 1 Equipment Distribution 4.3.2 Supply a minimum of six (6) MCOTS, ten (10) dual alerts, and ten (10) wireless, 30-day event monitors to be applied to inventory in the ECHO Lab. Local Performance Measures 95% Random sampling, periodic inspection, direct observation, complaints received, Quality Assurance Reports Favorable contactor performance evaluation. Failure to distribute equipment as requested will result in a written notice to the contractor to correct the deficiency. A second failure will result in a cure notice and a less than positive contractor evaluation in CPARS. Further failures may result in termination 2 - Privacy, Confidentiality and HIPAA 6 Contractor is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA and complies with all standards. HIPAA, Privacy Act, VHA guidelines 98% Direct observation, customer complaints , documentation provided by contractor Favorable contactor performance evaluation. Immediate removal from contract. 3 Timely Invoicing 4.5 4.5.1 4.5.2 Submission of itemized invoice within fifteen (15) days of the end of each month services were provided. Payments will only be made for services rendered. All invoices, including supporting documents, should be submitted electronically according to the Federal mandate. 95% Periodic inspection, random sampling, direct observation, customer complaints Favorable contactor performance evaluation. Failure to submit invoices in a timely manner will result in a written notice to the contractor to correct the deficiency. A second failure will result in a cure notice and a less than positive contractor evaluation in CPARS. Further failures may result in termination. 4 - Quality 5.3 4.4.3 4.4.5 Performs quality assurance reviews on proper process followed for rhythm interpretation. Local performance measures 95% Periodic inspection, random sampling, direct observation, customer complaints Favorable contactor performance evaluation. Failure to perform quality assurance reviews as stated in the Statement of Work will result in a written notice to the contractor to correct the deficiency. A second failure will result in a cure notice and a less than positive contractor evaluation in CPARS. Further failures may result in termination. 5 - Reporting 4.4.4 Timely submission of Reports Local performance measures Not more than 2 instances of late reports per month Customer complaints, periodic inspection, random sampling, direct observation Favorable contactor performance evaluation. Failure to submit the Dictation & Export Logs timely will result in a written notice to the contractor to correct the deficiency. A second failure will result in a cure notice and a less than positive contractor evaluation in CPARS. Further failures may result in termination. 6. SECURITY REQUIREMENTS 6.1 Patient Information Mail out material. The Contractor shall develop and implement procedure to ensure that no sensitive patient identifying information is sent out in the mail. Any breaches will be immediately reported and remedied. 6.2 Patient Information Secure online program. The Contractor shall provide an online system that adheres to all standards and policies set by the Richmond VAMC Information Security Officer. Any breaches shall be immediately reported and remedied. 6.3 Patient Information Online access of VA and Contract Company Employees Only Richmond 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 Officer regarding online system usage shall be strictly adhered to. Any breaches shall be immediately reported and remedied. 6.4 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 confidentially. Any breaches shall be immediately reported and remedied. 6.5 Patient Information Patient reports The Contactor shall establish strict standards and procedures in regard to patient reports to ensure patient confidentiality. Any breaches shall be immediately reported and remedied. 6.6 Secure Patient Information Escorted access to Richmond VAMC facilities. Strict standards to professionalism and patient confidentiality will be adhered to when visiting any Richmond VAMC facilities. 7. OTHER PERTINENT INFORMATION or SPECIAL CONSIDERATIONS 7.1 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. 7.2 INSPECTION AND ACCEPTANCE CRITERIA The COR will be responsible for periodically inspecting and certifying that the Contracted Company is performing to pre-arranged upon standards in regard to timeliness, quality and performance. 8. 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. 9. 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. 10. PERSONNEL POLICY: Contractor employees, agents and subcontractors shall not be considered VA employees for any purpose. 11. DESIGNATION OF CONTRACTING OFFICERS REPRESENTATIVE: A VA Medical Center representative of the Contracting Officer shall be designated to represent the Contracting Officer in furnishing technical guidance and advice regarding the work being performed under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice or information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested and is the sole responsibility of the Contracting Officer. 12. CONTRACT PERFORMANCE MONITORING: The Contracting Officer s Representative (COR) shall be the VA official responsible for verifying contract compliance. The COR will be responsible for monitoring the Contractor s performance to ensure all specifications and requirements are fulfilled. The Contractor is advised that only the Contracting Officer has the authority to make changes to the contract. After contract award, any incidents of noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.