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Attachment 1: Combined Synopsis-Solicitation for Commercial Products and Commercial Services Description This is a combined synopsis/solicitation for commercial products and commercial services prepar... Attachment 1: Combined Synopsis-Solicitation for Commercial Products and Commercial Services Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-05. This solicitation is set-aside for authorized resellers of the required medical devices and services. Competition is restricted as a result of the brand name requirement. The associated North American Industrial Classification System (NAICS) code for this procurement is 621511, Medical Laboratories, with a small business size standard of $41.5 Million. The FSC/PSC is Q502, Medical - Cardiology. The Southern Arizona VA Healthcare System (SAVAHCS) located at 3601 S 6th St., Tucson, AZ, 85723, is seeking to purchase an Arc Flash Analysis. All interested companies shall provide quotations for the following: Supplies/Services Line Item Period of Performance Description Quantity Unit of Measure Unit Price Total Price 0001 Base Year 48 Hour Holter Monitoring Service 100 EA   0002 Base Year 24-48 Holter Monitoring Services 100 EA   0003 Base Year Extended (Greater than 48 hour) Holter Monitoring Service 100 EA   0004 Base Year Event (LWA kit) 140 EA   0005 Base Year Event (LWA Combo kit) 140 EA   0006 Base Year MCOT (LWA kit) 900 EA   0007 Base Year MCOT (LWA Combo kit) 900 EA   1001 Option 1 48 Hour Holter Monitoring Service 100 EA   1002 Option 1 24-48 Holter Monitoring Services 100 EA   1003 Option 1 Extended (Greater than 48 hour) Holter Monitoring Service 100 EA   1004 Option 1 Event (LWA kit) 140 EA   1005 Option 1 Event (LWA Combo kit) 140 EA   1006 Option 1 MCOT (LWA kit) 900 EA   Line Item Cont. Period of Performance Description Quantity Unit of Measure Unit Price Total Price 1007 Option 1 MCOT (LWA Combo kit) 900 EA   2001 Option 2 48 Hour Holter Monitoring Service 100 EA   2002 Option 2 24-48 Holter Monitoring Services 100 EA   2003 Option 2 Extended (Greater than 48 hour) Holter Monitoring Service 100 EA   2004 Option 2 Event (LWA kit) 140 EA   2005 Option 2 Event (LWA Combo kit) 140 EA   2006 Option 2 MCOT (LWA kit) 900 EA   2007 Option 2 MCOT (LWA Combo kit) 900 EA   3001 Option 3 48 Hour Holter Monitoring Service 100 EA   3002 Option 3 24-48 Holter Monitoring Services 100 EA   3003 Option 3 Extended (Greater than 48 hour) Holter Monitoring Service 100 EA   3004 Option 3 Event (LWA kit) 140 EA   3005 Option 3 Event (LWA Combo kit) 140 EA   3006 Option 3 MCOT (LWA kit) 900 EA   3007 Option 3 MCOT (LWA kit) 900 EA   4001 Option 4 48 Hour Holter Monitoring Service 100 EA   4002 Option 4 24-48 Holter Monitoring Services 100 EA   4003 Option 4 Extended (Greater than 48 hour) Holter Monitoring Service 100 EA   4004 Option 4 Event (LWA kit) 140 EA   4005 Option 4 Event (LWA Combo kit) 140 EA   4006 Option 4 MCOT (LWA kit) 900 EA   4007 Option 4 MCOT (LWA kit) 900 EA   STATEMENT OF WORK (SOW) Contract Title Ambulatory Cardiac Monitoring Service Background The Southern Arizona VA Healthcare System (SAVAHCS) requires ambulatory cardiac monitoring services to serve the veteran patients. Ambulatory cardiac monitoring services are a necessary component of a full-service cardiology program and necessary to the provision of quality care to veterans. This service allows the ability to make timely diagnosis of disorders related to cardiac rhythms. While patients are performing routine daily activities, the chances of documenting arrhythmias causing transient problems are greatly enhanced with monitoring. At the onset of a symptom (flutters, dizziness, presyncopal episodes, etc.), monitoring allows for the detection of symptomatic and asymptomatic cardiac rhythm disturbances. Objective The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform ambulatory cardiac monitoring services as defined in this Statement of Work except for those items specified as government furnished property and services. Scope The contractor shall provide Ambulatory EKG monitoring and data processing for Veterans assigned to the SAVAHCS. Monitoring and analysis shall occur either near-real time via event & telemetry service or after the holter recorder data has been transmitted to the contractor. 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 XYZ 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 XYZ or 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 XYZ 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. Atrial fibrillation detection with 100% sensitivity and 100% and 100% positive predictability for episodes lasting 30 seconds or longer. Device Philips ECG Solutions Mobile Cardiac Outpatient Telemetry (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 - Philips ECG Solutions ePatch 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 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 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. Work Flow 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 the contractor 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. Instrument Capabilities 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 Program 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. Period of Performance Work Hours Normal hours of operation for SAVAHCS are Monday through Friday from 8:00 am to 4:30 pm. Federal 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 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. Period of Performance The contract period of performance is one base and four option years, with an FOB of Destination. Contract Period POP Begin POP End Base 12/1/2024 11/30/2025 Option 1 12/1/2025 11/30/2026 Option 2 12/1/2026 11/30/2027 Option 3 12/1/2027 11/30/2028 Option 4 12/1/2028 11/30/2029 Invoices Payment of services rendered under this contract shall be made in arrears upon satisfactory completion of each service and receipt of a properly prepared invoice and submitted by the Contractor to the payment address specified by Contracting. Invoices shall reference the Contract Number and Purchase Order Number, Manifest Number(s), provide a complete and accurate description of services/ supplies delivered/ rendered, including dates of performance, amounts, unit prices, extended totals and any other data relevant for payment purposes. The Government shall not authorize payment until such time that the SAVAHCS COR all properly executed and signed documentation. No advance payments shall be authorized. Payment shall be made on a monthly arrears for services provided during the billing month in arrears in accordance with FAR 52.212-4, para. (i). Upon submission of a properly prepared invoice for prices stipulated in this contract for services delivered and accepted in accordance with the terms and conditions of the contract, less any deductions stipulated in this contract. Payment of invoices may be delayed if the appropriate invoices as specified in the contract are not completed and submitted as required. Place of Performance/Place of Delivery Address: Department of Veterans Affairs Southern Arizona VA Medical Center (SAVAHCS) 3601 S 6th Ave Tucson, AZ Postal Code: 85723 Country: UNITED STATES The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Products and Commercial Services (SEP 2023) Addendum to FAR 52.212-1, Instructions to Offerors Commercial Products and Commercial Services FAR 52.252-1, Solicitation Provisions Incorporated by Reference (FEB 1998) FAR 52.204-7, System for Award Management (OCT 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (AUG 2020) FAR 52.217-5, Evaluation of Options (JUL 1990) FAR 52.229-11, Tax on Certain Foreign Procurements-Notice and Representation (JUN 2020) VAAR 852.233-70, Protest Content/Alternative Dispute Resolution (OCT 2018) VAAR 852.239-75, Information and Communication Technology Accessibility Notice (FEB 2023) FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance or Equipment (NOV 2021) FAR 52.204-29, Federal Acquisition Supply Chain Security Act Orders Representation and Disclosures (DEC 2023) FAR 52.209-7, Information Regarding Responsibility Matters (OCT 2018) FAR 52.233-2, Service of Protest (SEP 2006) VAAR 852.233-71, Alternate Protest Procedure (OCT 2018) FAR 52.212-2, Evaluation Commercial Products and Commercial Services (NOV 2021) FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services (MAY 2024) Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Products and Commercial Services (NOV 2023) ADDENDUM to FAR 52.212-4, Contract Terms and Conditions Commercial Products and Commercial Services applies to and is included with this acquisition. FAR 52.252-2, Clauses Incorporated by Reference (FEB 1998) FAR 52.203-17, Contractor Employee Whistleblower Rights (NOV 2023) FAR 52.204-13, System for Award Management Maintenance (OCT 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (AUG 2020) FAR 52.242-17, Government Delay of Work (APR 1984) VAAR 852.201-70, Contracting Officer s Representative (DEC 2022) VAAR 852.203-70, Commercial Advertising (MAY 2018) FAR 52.217-8, Option to Extend Services (NOV 1999) FAR 52.217-9, Option to Extend the Term of the Contract (MAR 2000) VAAR 852.232-72, Electronic Submission of Payment Requests (NOV 2018) VAAR 852.242-71, Administrative Contracting Officer (OCT 2020) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (MAY 2024) The following subparagraphs of FAR 52.212-5 are applicable: subparagraph (b)(5), (9), (11), (12), (25), (26), (31), (33), (34), (36), (39), (46), (51), (55), (59), (c)(1), (7), and (8). All invoices from the contractor shall be submitted electronically in accordance with VAAR clause 852.232-72, Electronic Submission of Payment Requests. This is accomplished through the Tungsten Network, located at: http://www.fsc.va.gov/einvoice.asp. This is mandatory and the sole method for submitting invoices. All quoters shall submit the following: All information required by FAR 52.212-1(b) Submission of Offers. All quotes shall be sent to the Network Contracting Office (NCO), at Stephanie.Naron@va.gov. Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. Options will be evaluated at time of award. The following are the decision factors: Price, and past performance, with price more important. Past performance will be based on CPARS and FAPIIS ratings. No rating in CPARS is equal to a neutral rating. The award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoters shall list exception(s) and rationale for the exception(s), if any. Submission of questions shall be received no later than Friday, 10/25/2024, 14:00 PDT at Stephanie.Naron@va.gov only. Subject line shall include QUESTIONS TO RFQ 36C26225Q0059. Submissions shall include your quote, using the attached schedule, as well as a capabilities statement with qualifications proving all certifications and education required for the work being conducted in the SOW. Submissions not meeting all requirements of the SOW will be considered ineligible for award . Submission of your response shall be received not later than Friday, 11/01/2024, 10:00 PDT at Stephanie.Naron@va.gov only. Subject line shall include RESPONSE TO RFQ 36C26225Q0059. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. Point of Contact Stephanie Naron Contract Specialist Stephanie.Naron@va.gov