Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF JULY 31, 2024 SAM #8282
SOLICITATION NOTICE

J -- Cardiac Telemetry Monitoring system

Notice Date

7/29/2024 9:24:15 AM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

334510 — Electromedical and Electrotherapeutic Apparatus Manufacturing
 

Contracting Office

262-NETWORK CONTRACT OFFICE 22 (36C262) Gilbert AZ 85297 USA
 

ZIP Code

85297
 

Solicitation Number

36C26224Q1624
 

Response Due

8/14/2024 10:00:00 AM
 

Archive Date

09/13/2024
 

Point of Contact

Ositadima Ndubizu, Contract Specialist Intern, Phone: (562) 766-2252
 

E-Mail Address

ositadima.ndubizu@va.gov
(ositadima.ndubizu@va.gov)
 

Small Business Set-Aside

SDVOSBC Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)
 

Awardee

null
 

Description

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 Telemetry 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) - 36C26224Q1624. 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 26 1.k. Request for Information (RFI) should be submitted via email no later than 10am PST Monday, August 5th, 2024, to ositadima.ndubizu@va.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. The VA Greater Los Angeles Healthcare System (VAGLAHS) is a part of the Desert Pacific Healthcare Network (VISN 22), and is one of the most diversified tertiary health care providers in the VA. It is a teaching hospital, providing a full range of patient services, with state-of-the art technology as well as education and research. We strive to continuously look for technology that increases the efficacy of medical and diagnostic management of our patients. 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 a portable device which allows them to record their ECG in real time while symptoms are taking place. 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: The contractor shall furnish the following equipment to the Government and/or Veteran Patients: Personal EKG monitoring recorder with or without event/telemetry as specified by the care provider. Current operator s manual(s) to be available electronically and in hard copy. Hands-on training by a local representative as requested by the Contracting Officer s Representative (COR) The contractor shall repeat the monitoring study at no additional costs to the Government for the following reasons: Device(s) provide unsatisfactory results; Device(s) fail to transmit or download information; Information is not retrievable through the web-based system; The selected contractor shall provide equipment and off-site monitoring. No travel fees will apply. All deliveries, disposable items, and equipment are included in the pricing. Devices shall be provided to patients directly by the VA Greater Los Angeles Healthcare System (VAGLAHS) or mailed to the patient by the Contractor. After wearing the recorder for the period prescribed by the requesting care provider, device(s) shall be mailed by the Veteran directly back to contractor. The contractor shall provide a return mailer as part of the equipment package. Any devices given to a patient that are lost or damaged shall be replaced by the Contractor within five business days at no cost to the Government. Procedure The device(s) are given to patients to use from 1 to 30 days depending on prescription of the requesting care provider. The contractor shall stock an adequate number of devices at the VA Greater Los Angeles Healthcare System (VAGLAHS) for patient hookup at that location. After screening by VA technicians, contractor may receive a request to mail a device directly to the patient. Upon receipt of order, contractor shall contact the patient within 24 hours by phone, and electrocardiography (ECG) technicians will instruct patients on the functions of the device(s) to include but not limited to, how to use it, how to hook it up, and how to place leads. During mailed orders, contractor will contact the patient to aide activation of patient monitoring device. After the evaluation period, the patient returns the device(s) to the contractor with provided return mailer or to the VA Greater Los Angeles Healthcare System (VAGLAHS) who will in turn mail the recorder to the contractor. General Requirements Telemetry - External mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days; technical support for connection and patient instructions for use, attended surveillance, analysis and transmission of daily and emergent data reports as prescribed by a physician or other qualified health care professional. Device Philips ECG Mobile Cardiac Outpatient Telemetry (MCOT) (Telemetry Mode). Equipment Shall: Be ordered for the patients specific needs. Monitor the patient for 24 hours a day (365 days a year) Have the capability of event transmissions being sent via wireless/cell phone technology. Have ability to store 100% of the ECG data in the device(s) when patient is in an area of no cellular service; no event can be lost due to memory limitations. ECG real time transmissions and analysis must have a minimum of 2 leads, up to 6 leads (views) with no more than 3 electrodes. Have ability for 100% of ECG data to be transmitted in real-time to Receiving Center for entire monitoring period. Have ability to post daily analysis reports for physician review on all ECG data over the monitoring period. Have ability to immediately transmit, alert and report Patient Activated Events immediately upon patient pressing event button. Have ability to immediately transmit, alert and report Asymptomatic Events meeting the physician s notification criteria. Include technical reading of the device(s) along with a comprehensive report that is available online and will be interpreted by the medical staff. Allow both patients and VA staff to have unlimited 24/7 telephone access to contractor s support staff that are knowledgeable and shall supply help in resolving any monitoring problems. Have ability to post an End of Study Remote Telemetry Report compiling all Event Descriptions and ECG data into one conclusion report. Extended Holter External electrocardiographic recording from 3-14 days by continuous rhythm recording and storage; includes recording, scanning analysis with report. Device Philips ECG Solutions ePatch Extended Holter (3 14-day mail back or office-upload). Traditional Holter External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; includes recording, scanning analysis with report. Device -Extended Holter (24-48hr office-upload) Notification Procedures Contractor maintains customizable notification criteria that will be completed by VA Greater Los Angeles Healthcare System (VAGLAHS) and will dictate all notifications to location with Abnormal Holter Alerts, Urgent MCT Notifications, and Emergent MCT Notifications. Data Management Philips/Cardionet will maintain the following qualifications: Federal Information Processing Standard 140-2 compliance FIPS Certificate #3328 now reflects the information that you provided for the Philips ECG Solutions Cryptographic Module. The certificate is posted at the link below: https://csrc.nist.gov/projects/cryptographic-module-validation-program/Certificate/3328 Memorandum of Understanding Interconnection Security Agreement via LifePoint Informatics (MOU-ISA) Portal While patient is wearing the device, transmission patient activated report, urgent asymptomatic event report, daily Holter report and end of study report options shall be made available online via the Philips/Cardionet Cardiac Ambulatory Workspace Portal. The VA Greater Los Angeles Healthcare System (VAGLAHS) shall have access to patient reporting 24 hours a day at the physician s or authorized representative s convenience through password protection. Registration information will be entered by VA technician on the contractor s web site, or by transmission of an XML or HL7 encoded data transfer file from VA to contractor to provide an automated registration process. Full view of all available inventory and a running log of active and historical patients will be available on the web portal. EMR Integration After a 6 months initial period, contractor should provide an HL7 or XML encoded data file in addition to the PDF Report file. This data file to include identification of the study (Patient, recording period, StudyID), type of study, and results (heart rate range, characterization of all arrhythmias/events and summary statistics) Registration of the patient and study shall initially occur manually.  VA technician will provide information on the contractor s website. Data to include Name, DOB, contact information, type of study requested, duration of study, and any special requests.  The contractor has ability to provide an electronic ordering capability to use HL7 encoding for this data to eliminate the need for manual input. Contractor shall provide study reports via their web-portal.  Contractor can also provide report data through HL7, SFTP, and API integration to align with order interface, as mentioned above. All EMR integration work and timelines are subject to approval from VISN IT leadership. Workflow The device(s) are given to patients to use from 1 to 30 days depending on the indication for continuous monitoring. Initially, ECG technicians will instruct and explain to the patients what the device(s) is, how the patient will use it, how to hook it up, and how to place leads. They will then hook up the device(s) and let the patient go home with specific instructions to continue to have the device on for the duration of evaluation. Alternatively, the monitor(s) 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. Physician notification criteria will be established prior to enrollment. When asymptomatic and/or symptomatic ECG events are alerted that meet the site-specific notification criteria, a call is made to the site to verbally communicate the critical event. Also, a dated urgent report will be prepared and posted on the web portal for physician evaluation and faxed upon request. Daily and weekly MCT/Event reports will be made available within the online portal and faxed upon request. An MCT End of Service Summary Report shall be available 1-2 days after the service is completed. A final Holter Report will be available within 2-3 days of holter device being received to accommodate upload and scan of patient data. (Access to the data from the website is limited to the physicians and/or any other authorized representatives responsible for evaluating the data). Equipment All equipment offered shall be U.S. Food and Drug Administration (FDA) approved. All cardiac MCOT and Holter monitors shall be provided by Philips for VA use and shall be state-of-the-art equipment, lightweight, and simple for patients to use. Patients will use the monitors from one (1) to thirty (30) days, or as specified by the VA provider. Samples shall be provided to each site during the training or orientation process. The contractor and facility COR will determine an equipment inventory level at the time of contract award that shall always remain at each facility location. This equipment inventory must be adequately always restocked to ensure that the facility can always meet the daily patient demand. All equipment remains the sole property of the contractor including the initial delivery of the units. The contractor is responsible for all service maintenance and repairs of the equipment and hardware. The contractor shall supply a postage-paid return container for all monitors. Equipment Salient Characteristics Lightweight (no more than 1 pound) and easy to use design that can be held in one hand. Available instruments should include a wireless waterproof patch recorder. Capability of event transmissions being sent via wireless/cell phone or advanced technology. Bidirectional communication between our EMR(CPRS) and the contractor is highly desirable. Telemetry real time monitoring Capability transmitting and recording 100% of ECG data. Customizable monitors. Wireless 24/48-hour Holter / 3 14-day Holter / Outpatient Telemetry devices providing all three monitoring functions over the 1 -30 days monitoring period. Pacemaker pulse detection. Instrument/Monitor has a date and time stamp for clinical reports. Instrument/Monitor can correlate between time and symptom and identify/present all rhythm strips associated with all reported symptoms. All monitoring devices must provide a of 1 to 6 diagnostic leads of continuous ECG data over entire monitoring period, 3 lead pacemaker annotations, and the ability to correlate symptoms and activity with ECG changes. All consumable items (batteries, patches) are provided to patient by contractor who returns the item after monitoring period. Contractor equipment shall be capable of storing up to thirty-day (30) of all ECG data, using standard size batteries readily available, and easily changed by the patient. Training: The contractor shall provide comprehensive training to the COR and selected VA staff. The training shall consist of proper use of the monitoring devices, instructions on how to upload patient information into contractor provided software and/or websites, and how to maintain or provide basic quality assurance tests. Philips ECG solutions shall also provide copies of manuals, equipment checklists, surveys, and specific contact information in the event that a medical center staff person needs to contact the contractor 24/7. Technical Support: Technical support is required via telephone for troubleshooting of method and/or problems. The response time for telephone technical assistance shall be within one (1) hour from the time of the initial call for technical support. Philips ECG solutions shall also show availability 24/7 for patient support. Philips ECG solutions shall have appropriately trained personnel available by phone throughout the duration of all tests for patient support. Quality Assurance Maintenance: All monitors shall be kept at Original Equipment Manufacturer (OEM) specifications. All portable ECG monitoring equipment shall be cleaned, disinfected, and decontaminated per Joint Commission standards, each time before it is sent back to facility after download by contractor. Unclean equipment should be stored in an area separate from cleaned equipment to prevent cross contamination. Contractor shall demonstrate set procedures for proper inspection and maintenance of the portable monitoring equipment and shall provide each location a copy of the inspection checklist. The contractor shall have a formal procedure to validate the functional integrity of any device before it is provided to a patient, and shall, at a minimum, complete and document such validation procedure whenever a device is returned with non-diagnostic or unsatisfactory results, or when visual inspection suggests the possibility of device damage. Contractor shall report on the failure rate of their equipment and supply maintenance records. Contractor shall provide upgrades to equipment and software that may become available at no additional cost to the government. The contractor shall coordinate installation of upgrades with the COR. The contractor shall provide customer notifications and latest operator s manual within 10 days after their release/publication. Quality Control The contractor shall maintain a quality system that ensures conformance to contractual requirements and meets the requirements of ISO 9001 and/or CMS requirements for equivalent ECG technical monitoring, or an equivalent quality system during performance of this contract. Contractor shall have a clearly defined process by which it collects the required data, performs FboNotice cause analysis, and can supply easily understandable reports. Contractor shall demonstrate that their information systems are HIPAA compliant, and that the raw data can be transferred securely and with accuracy to the VA. Contractor shall track the following events: receipt of the recorders, identification of any events or arrhythmias satisfying criteria for MD notification, efforts to notify VA staff of such events. Data recorder will include date/time and identify the person(s) involved. Billing Procedures Payment shall be made monthly in arrears based upon the Government s certification of a properly submitted invoice. Invoices shall be sent electronically to the assigned Contracting Officer s Representative (COR) by secured email using an Excel Spreadsheet format no later than the 10th business day of each month following service. Email addresses will be provided at the time of the award. The Contractor shall follow invoicing procedures as specified above in Section a., Contract Administration Data Contractor shall adhere to pre-determined reimbursement rates that have been mutually agreed upon. The VA Greater Los Angeles Healthcare System (VAGLAHS) will review invoices against its record and notify the Contractor of invoice discrepancies. Upon resolution of the discrepancies, the VA will approve the invoice and make payment to the Contractor. The Contractor shall not charge patients or 3rd party payers any fees or surcharges for services rendered under this contract, including missing equipment. If the Contractor, VA POC, or designee receives notice of any additional charges, the Contractor shall fully cooperate with the POC and Contracting Officer investigating such allegations and shall promptly refund any payment deemed improper by the Contracting Officer to the party who made the payment. 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 Wednesday August 14th, 2024, to ositadima.ndubizu@va.gov. Ensure the following are completed and/or included in the quote packet: 4.3.a. Vendor Information with UEI number (Company info and quote should be on the Enclosure 1 form) 4.3.b. Acknowledgement of amendments along with your Capabilities Statement and Past Performance 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 Your quote evaluation will be based on price and your ability to provide the following: Capabilities statement showing that they can perform the tasks listed in section 2.3, Scope. Past Performance: Vendor must be an authorized reseller for Phillips/Cardionet products and services.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/4106c7bd62804c76bfd61d5b908510a3/view)
 

Place of Performance

Address: VA Greater Los Angeles Healthcare System 11301 Wilshire Blvd, Los Angeles 90073, USA

Zip Code: 90073

Country: USA
 

Record

SN07146682-F 20240731/240729230115 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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