J065--Cardiac Monitoring system

1. This is a combined synopsis/solicitation for commercial services/items prepared in accordance with the format in FAR Subpart 12.6 in conjunction with FAR Part 13, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a separate written solicitation will not be issued. 1.a. Project Title: Cardiac Monitoring system 1.b. Description: VA Greater Los Angeles Healthcare System is seeking a contractor to provide cardiac arrhythmia monitoring equipment and services for diagnosing patients and monitoring the efficiency of treatment of patients in the Cardiology Section of the Department of Medicine. 1.c. Project Location: VA Greater Los Angeles Healthcare System 1.d. Solicitation Type - Number: Request for Quotes (RFQ) - 36C26223Q0714. 1.e. Set Aside: This solicitation is issued as a Service-Disabled Veteran Owned Small Business set aside. 1.f. Applicable NAICS code: 334510, Electromedical and Electrotherapeutic Apparatus Manufacturing. 1.g. Small Business Size Standard: 1,250 employees 1.h. Type of Contract: Firm Fixed Price 1.i. Period of Performance: Base year plus 4 options 1.j. Wage Determination applicable to this project: SCA WD 2015-5613 revision 23 1.k. Request for Information (RFI) should be submitted via email no later than 10am PST Monday, March 20th, 2023, to contact@example.gov 2. Statement of Work 2.1. Objective. VA Greater Los Angeles Healthcare System is seeking a contractor to provide cardiac arrhythmia monitoring equipment and services for diagnosing patients and monitoring the efficiency of treatment of patients in the Cardiology Section of the Department of Medicine. 2.2. Background. Cardiac symptoms are often transient in nature such that it is difficult to obtain an ECG the exact time they occur. Oftentimes, clinically relevant abnormalities and life-threatening rhythms have no cardiac symptoms. Ambulatory Telemetry on a continuous basis is the solution to this problem. Ambulatory Telemetry is used for patients experiencing intermittent symptoms, such as palpitations, syncope, dizziness, and shortness of breath. Patients are provided with state-of-the-art technology in the form of a portable device which allows them to record their ECG in real time while symptoms are actually occurring. Event monitoring is used for patients with infrequent symptoms. Most models require patient activation. 2.3. Scope. Salient Characteristics of an Ambulatory ECG Monitoring System, Web-based Clinical Reporting Module, cardiac arrhythmia monitoring equipment and services are as follows: Mobile Cardiac Outpatient Telemetry Holter device and monitoring Extended 14-day Holter monitoring Provide Education regarding the set-up and continuous wearing of the device along with 24/7 technical support that will be offered on the phone Technical reading of the device along with a comprehensive report that is available online and will be interpreted by the medical staff at GLA. Algorithm with rate, rhythm, AF with P-wave analysis, and QRS morphology. Auto-Trigger technology which offers ECG monitoring that is programmed to recognize rhythms such as atrial fibrillation, tachycardia, bradycardia, ventricular tachycardia, and asystole Automatically records the patient's ECG, independent of the patient physically activating the device The contractor shall be accredited by the Joint Commission Device Service: Event monitor: Non-Looping, Looping including Auto Trigger, and Wireless Transmission report, urgent report, weekly report (wireless Event only), and End of Service report options shall be made available as requested online. For wireless Event patients, wireless Event reports shall be made available by the contractor. Provide access to patient reporting 24 hours a day at the physician s or authorized representative s convenience through password protection Daily reports shall be made available online while patient is wearing the device Send out ECG alert and an Urgent Report with the date is prepared for physician evaluation Each day a Daily Report shall be presented that includes all the data for the prior 24 hours, including AF burden and AF reporting if applicable Have End of Service Summary Report be available in 3-5 days. Access to the data from the website is limited to the physicians and/or any other authorized representative responsible for evaluating the data Alert using service in 2 days for ECG data evaluation Devices shall be tested and certified by the Biomedical department. The associated web based application has been evaluated secure by IRMS and the Security office. This web site is also accredited by Health and Human Services Holter monitor characteristics: 1 channel, 2 Leads Continuously ECG recording up to 14 days Provision for an extended monitoring report for a concise and accurate summary of findings. ECG data is prospectively analyzed by Certified Cardiac Technicians (CCT) and Certified Rhythm Analysis Technicians (CRAT). Prospective scanning provides improved diagnostic yields compared to retrospective analysis. Small, lightweight (<1 ounce) Simple hook-up process No battery change or charge required Must have the ability to detect slow Atrial Fibrillation as well as higher rate Atrial Fibrillation, because slow Atrial Fibrillation has ambiguous symptoms The following equipment shall be provided by the contractor to patients using the extended holter monitor: Equipment Supplies Information Misc Holter Monitor ECG Prep Kit Patient Education Guide Self-addressed, post-paid envelope to mail back the monitor, lead wires and patient diary to contractor Patient Diary Return Instructions Must have a quality assurance and maintenance program to ensure that all provided equipment is maintained in accordance with the Original Equipment Manufacturer (OEM) specifications and care and maintenance of all equipment is per JC standards . 2.4. General Requirements The device is given to patients to use for 2 weeks to 1 month depending on the indication for continuous monitoring. Initially, 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 to continue to have the device on for the duration of evaluation. Alternatively, the 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. After the evaluation period, the patient returns the device to the company in the pre-stamped/pre-paid return envelopes provided or to the facility. Data Management Data shall be transmitted appropriately, accurately, and in a timely fashion. While patient is wearing the device, daily reports shall be made available online. Physician notification criteria shall be established prior to enrollment. When asymptomatic and/or symptomatic ECG events are transmitted that meet the criteria, an alert is sent out to the ECG director and an Urgent Report with the date is prepared for physician evaluation. The computerized results shall be seamlessly assimilated into the clinical records. Each day a Daily Report shall be presented that includes all the data for the prior 24 hours, including AF burden and AF reporting if applicable. An End of Service Summary Report is often available 3-5 days after the service is completed (Access to the data from the website is limited to the physicians and/or any other authorized representative responsible for evaluating the data.) Once the ECG data is ready for evaluation, the Contractor alerts the department in 2 ways. The Contractor initiates a call to the cardiology department if necessary (or other designated department) and technical staff is alerted online who will then give the report to the Cardiologist to read. Devices shall be tested and certified by the Biomedical department. The associated web based application has been evaluated secure by IRMS and the Security office. This web site is also accredited by Health and Human Services. Extended Holter Data Management: When the patient has completed the testing period and the device has been received by the company, 14 days of continuous ECG recording data is prospectively analyzed and an extended monitoring report is made available online through a dedicated HIPAA compliant website Contractor shall promptly and courteously respond to complaints within 3 working days. Including complaints brought to contractor s attention by the CO. Contractor shall maintain a written record of all complaints, both written and oral showing the identity of the individual, the nature of the complaint, and contractor s response. Contractor shall permit the Government to inspect such records upon reasonable notice 2.5. Performance Monitoring. The Contracting Officer Representative (COR) will monitor contractor performance and certify the work was done in accordance with the SOW. 2.6. Period of Performance. The period of performance will be a Base year plus 4 option years. a. National Holidays: New Year s Day January 01 Martin Luther King s Birthday Third Monday in January President s Day Third Monday in February Memorial Day Last Monday in May Juneteenth June 19 Independence Day July 04 Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11 Thanksgiving Day Fourth Thursday in November Christmas Day December 25 b. If the holiday falls on a Sunday, the following Monday will be observed as a National holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National holiday by U.S. Government Agencies, and any day specifically declared by the President of the United States of America. Overtime & Holiday Pay: Overtime pay is at the rate of one and one-half times the employee's regular rate of pay for all hours worked in excess of eight up to and including 12 hours in any workday, and for the first eight hours of work on the seventh consecutive day of work in a workweek. Overtime pay also includes Federal Holidays. Contractor will bill and be paid for actual services provided by Contractor personnel. Contractor will not be paid for availability or on-call services unless otherwise provided herein 2.7. Contractor Personnel Background Requirements. a. The Office of Security and Law Enforcement provides Department-wide policy on the assignment of appropriate position sensitivity designations associated with Department of Veterans Affairs (VA) positions involving national security and public trust responsibilities, and on the level of background investigations required for applicants for, and incumbents of, those positions. In addition to VA employees, the policy and investigative requirements are applicable to Contractor personnel who require access to VA computer systems designated as sensitive. b. Personnel who require access to VA computer systems shall be subject to all necessary background investigations and receive a favorable adjudication from the VA Office of Security and Law Enforcement to ensure compliance with such policy. If such investigation has not been completed prior to contract commencement, the Contractor shall be responsible for the actions of those individuals performing under the contract. c. Should the contract require Contractor personnel to maintain U.S. citizenship, the Contractor shall be responsible for compliance. Regardless of U.S. citizenship requirements, Contractor personnel are required to read, write, speak, and understand the English language, unless otherwise specified in this contract or agreed to by the Government. d. The cost of such investigations shall be borne by the Contractor, either in advance or as reimbursement to the Government. The level of sensitivity shall be determined by the Government on the basic of the type of access required. The level of sensitivity will determine the depth of the investigation and the cost thereof. Currently, the current estimated costs for such investigations are as follows: Level of Sensitivity Background investigation level Approximate Cost Low Risk National Agency Check with Written Inquiries $ 231.00 Moderate Risk Minimum Background Investigation $ 825.00 High Risk Background Investigation $ 3,465.00 e. The Contractor shall be required to furnish all applicable employee information required to conduct the investigation, such as, but not limited to, the name, address, and social security number of Contractor personnel. The VA will provide all the necessary instructions and guidance for submission of the documents required to conduct the background investigation. Background investigations shall not be required for Contractor personnel who will not be required to access VA computer systems nor gain access to sensitive materials. 2.8. Contractor Employees a. The Contractor shall not employ persons for work on this contract if such employee is identified to the Contractor as a potential threat to the health, safety, security, general well-being or operational mission of the installation and its population. Contract Personnel shall be subject to the same quality assurance standards or exceed current recognized national standards as established by the Joint Commission (JC). b. Badge. Contractor shall obtain a Contractor I.D Badge from the VA Police. All Contractor personnel are required to wear I.D Badge during the entire time on VA facility. The I.D Badge MUST have an identification picture and shall state the name of the individual and the company represented. c. PARKING: It is the responsibility of the contract personnel to park in the appropriate designated parking areas. Parking information is available from VA Police & Security Service Office. The Contractor assumes full responsibility for any parking violations. d. Smoking is strictly prohibited on the grounds of any VHA facility. Per VHA Directive 1085 dated March 5, 2019, it is VHA policy that all VHA health care facilities, including hospitals, community clinics, administrative offices and Vet Centers, will be smoke-free for patients, visitors, contractors, volunteers, and vendors effective October 1, 2019. There will no longer be designated smoking areas. 2.10. Insurance Coverage a. The Contractor agrees to procure and maintain, while the contract is in effect, Workers Compensation and Employee s Public Liability Insurance in accordance with Federal and State of California laws. The Contractor shall be responsible for all damage to property, which may be done by him, or any employee engaged in the performance of this contract. b. The Government shall be held harmless against any or all loss, cost, damage, claim expense or liability whatsoever, because of accident or injury to persons or property of others occurring in the performance of this contract. c. Before commencing work under this contract, the Contracting Officer shall require the Contractor to furnish certification from his/her insurance company indicating that the coverage specified by FAR 52.228-5 and per FAR Subpart 28.307-2 has been obtained and that it may not be changed or canceled without guaranteed thirty (30) day notice to the Contracting Officer. d. The Contractor shall furnish to the Contracting Officer within fifteen (15) days of award an Official Certification from the insurance company indicating that the coverage has been obtained and that it may not be changed or cancelled without guaranteed thirty (30) day notice to the Contracting Officer. New certifications shall be furnished at least thirty (30) days prior to the expiration date of the current insurance policy. The phrase will endeavor is not acceptable terms to the Government and such coverage carrying that phrase will be rejected and services may not be rendered until proper certificate is issued. 3. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-01, dated 10/10/2019. The following provisions and clauses apply to this solicitation and can be found in enclosure 2. 3.a. FAR 52.212-1, Instructions to Offerors Commercial Items 3.b. FAR 52.212-2, Evaluation -- Commercial Items 3.c. FAR 52.212-4, Contract Terms and Conditions -- Commercial Items 3.d. FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items 3.e. Supplemental Insurance Requirements 3.f. VAAR 852.219-10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside 3.g. VAAR 852.219-74, Limitations on Subcontracting Monitoring and Compliance 3.h. FAR 52.233-2, Service of Protest 3.i. VAAR 852.233-70, Protest Content/Alternative Dispute Resolution 3.j. VAAR 852.233-71, Alternative Protest Procedure 4. Submit written offers in accordance with the following instructions, as well as Addendum to FAR 52.212-1, Instruction to Offerors. Oral offers will not be accepted. Complete and submit enclosure 1 via email no later than 10am PST Monday March 27th, 2023, to contact@example.gov. Ensure the following are completed and/or included in the quote packet: 4.3.a. Vendor Information with UEI number 4.3.b. Acknowledgement of amendments 4.3.c. Concurrence/non-concurrence with solicitation terms, conditions, and provisions 4.3.d. Schedule of services 4.3.e. FAR 52.212-3, Offeror Representations and Certifications -- Commercial Items