Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF JUNE 16, 2022 SAM #7503
SOURCES SOUGHT

65 -- Ambulatory Cardiac Monitoring System and Service

Notice Date

6/14/2022 11:27:22 AM
 

Notice Type

Sources Sought
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

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

ZIP Code

85297
 

Solicitation Number

36C26222Q1094
 

Response Due

6/17/2022 1:00:00 PM
 

Archive Date

07/17/2022
 

Point of Contact

won.chae@va.gov, Won Chae, Phone: (562) 766-2315
 

E-Mail Address

won.chae@va.gov
(won.chae@va.gov)
 

Awardee

null
 

Description

THIS REQUEST FOR INFORMATION (RFI) IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. SOURCES-SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a sources-sought/RFI only. The purpose of this sources-sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 339112 (size standard of 1000 Employees). Responses to this sources-sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources-sought, a solicitation announcement may be published. Responses to this sources-sought synopsis are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 22 Network Contracting Office, is seeking Brand Name or Equal Ambulatory Cardiac Monitoring System and Service (Base Year Plus Four (4) Option Years to Renew with estimated annual quantities ordered on an as needed basis) that meets the following Statement of Work (SOW) and salient characteristics for the VA Greater Los Angeles Healthcare System: Statement of Work (SOW) Introduction and Need Cardiology Division within Medical Service at VAGLA has a need for two types of ambulatory electrocardiogram monitors which can be referred as Devices or Monitors, i.e. Long-Term Continuous Monitor (LTCM) and Mobile Cardiac Outpatient Telemetry Monitors. Both types of monitors are single use monitors which can be applied to patients in outpatient clinic setting or at patients home via home enrollment service which the contractor will provide. LTCM are wearable patch-based biosensor which continuously records and stores ECG data from every patient heartbeat for up to 14 days without the need to charge or change battery. MCOT monitors are wearable patch-based biosensor that has internet connectivity. The gateway has internet connectivity, which allows it to send important segments of heart data to the contractor s website for analysis. The MCOT can be worn up to 14 consecutive days without the need to change or charge the battery. 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. Procurement of an Ambulatory Cardiac Monitoring system and service in which this combination of supplying both types of monitors as needed and allow clinicians to have real-time data 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 wearable and portable monitor which allows them to record their electrocardiogram in real time while symptoms are taking place. Scope of Work Customer Responsibilities Cardiology Division providers, refer as Customer, part of Medical Service at VAGLA, will order LTCM or MCOT and Home Enrollment Services after evaluation of patients need register each patient for whom the physicians prescribe and Home Enrollment Service either via website-based platform provided by the vendor, or other available electronic health integration methods at the time of an LTCM or MCOT hook-up/Service activation, prescribing physician must specify notification criteria Customer instructs patients on use and return of LTCM or MCOT device at the end of a prescribed wear period Customer has the responsibility in ensuring a licensed professional prescribes each LTCM or MCOT Device and Service Customer is responsible for patient management and treatment during the entire monitoring period. Customer and vendor acknowledge that neither LTCM and MCOT device have not been cleared by the FDA for use in pediatric patients under the age of 18. Contractor Responsibilities The contractor will: provide the customer with our monitoring devices-LTCM and/or MCOT, (collectively referred to as Device or Devices ) for use with patients provide customer with reasonable training at program start and as needed support reasonable patient training needs throughout the monitoring period notify customer if defined physician notification criteria are met; provide a final report of Our preliminary findings and, with respect to the MCOT Service, certain MCOT reports are in addition to the final report of our preliminary findings, to customer using any of the following methods of communication: a website based platform; a secure electronic interface; or, a secure fax. Both the customer and patients acknowledge the afore mentioned methods of communication are provided as part of our Services and are available to the customer for use at the customer s discretion monitor inventory and ship Devices to you. When Devices are registered thirty (30) or more days after receipt by Us, the ECG data will not be uploaded or analyzed. We will attempt to contact You before discarding the data to determine whether you prefer that the ECG date be uploaded and analyzed. Patient Privacy and Protected Health Information Customer and Contractor will each comply with privacy laws applicable to patient information, including the Health Insurance Portability and Accountability Act of 1996 ( HIPAA ). Customer and Contractor may each, as HIPAA-covered entities, use and disclose protected health information ( PHI ) and de-identified patient data as permitted or required by law. Per the HIPAA Privacy Rule, PHI can be shared between health care providers without written patient authorization for treatment of the patient. In this situation, a BAA is not required. In addition, VHA privacy policy also allows VHA health care providers to share patient information for treatment purposes. Thus, VA clinics can register patients on the Contractor web site and go to the site to download reports and not be concerned that they are inappropriately sharing patient information. It is, however, recommended as policy of minimizing risk that the patients full social security number not used as an identifier when registering patients on the Contractor website. General Requirements Contractor shall provide: LTCM monitors, as prescribed by the customer, that are wearable patch- based biosensor. LTCM must have the ability to continuously records and stores electrocardiograph data from every patient heartbeat for up to 14 consecutive days without the need to charge or change the battery. MCOT monitors, as prescribed by the customer, that are wearable patch-based biosensor and come with internet connectivity which is offered by the contractor via a website-based platform. This website-based platform allows the contractor to access patients heart data for analysis. MCOT monitors are designed to be worn up to 14 consecutive days without the need to change or charge the battery A monitor Skin Preparation Kit which contains one patch card template, one disposable razor, one abrader disc, and four alcohol wipes Application instructions and information pamphlet One postage-paid return envelope FDA approved algorithm for both LTCM and MCOT to curate initial findings reports A cloud-based analysis of the recorded cardiac rhythms from both LTCM and MCOT using FDA approved algorithm Actionable review of recorded and analyzed cardiac rhythm data to prescribing physicians who are referred as the Customer Clinically and actionable information to prescribing physicians via the contractor s FIPS 140-2 certified portal and can be integrated into patients electronic health record Data Management Data shall be transmitted appropriately, accurately, and in a timely fashion. While patient is wearing the device, daily reports are available for the MCOT monitors and a comprehensive final patient report is available for LTCM monitors. Physician notification criteria shall be established prior to enrollment. Quality Assurance Contractor shall 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. Changes to Contract Only those services specified herein are authorized. Before performing any service of a non-contractual nature, contractor shall advise the CO of the reason(s) for the additional work and/or service. Prior authorization shall be obtained from the CO before performing the services. Complaints: 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. Salient Characteristics/Specification Both types of devices must be patch-based and wearable MCOT must be equipped with internet connectivity Website-based platform allow for cloud-based analysis of the recorded cardiac rhythms from both LTCM and MCOT Provide customer with LTCM and MCOT based on defined criteria set by prescribing physicians who are referred as Customer Provide daily reports, data collected from MCOT, to the Customer Provide a comprehensive final report, data collected from LTCM, to the Customer LTCM must have the ability to continuously records and stores electrocardiograph data from every patient heartbeat for up to 14 consecutive days without the need to charge or change the battery. MCOT monitors, as prescribed by the customer, that are wearable patch-based biosensor and come with internet connectivity which is offered by the contractor via a website-based platform. This website-based platform allows the contractor to access patients heart data for analysis. MCOT monitors are designed to be worn up to 14 consecutive days without the need to change or charge the battery A cloud-based analysis of the recorded cardiac rhythms from both LTCM and MCOT using FDA approved algorithm Actionable review of recorded and analyzed cardiac rhythm data to prescribing physicians who are referred as the Customer Clinically and actionable information to prescribing physicians via the contractor s FIPS 140-2 certified portal and can be integrated into patients electronic health record With each prescribed monitor per the customer s request, contractor must send: A monitor Skin Preparation Kit which contains one patch card template, one disposable razor, one abrader disc, and four alcohol wipes Application instructions and information pamphlet One postage-paid return envelope Item Information: ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 2,000.00 EA __________________ __________________ ZIO XT DEVICE LOCAL STOCK NUMBER: N100A102C Base Year Plus Four (4) Option Years to Renew with estimated annual quantities ordered on an as needed basis: Estimated Base Year of 09/01/22 - 8/31/23 Estimated Option Year 1 of 09/01/23 - 08/31/24 Estimated Option Year 2 of 09/01/24 - 08/31/25 Estimated Option Year 3 of 09/01/25 - 08/31/26 Estimated Option Year 4 of 09/01/26 - 08/31/27 0002 125.00 EA __________________ __________________ ZIO AT DEVICE LOCAL STOCK NUMBER: A100A1001 Base Year Plus Four (4) Option Years to Renew with estimated annual quantities ordered on an as needed basis: Estimated Base Year of 09/01/22 - 8/31/23 Estimated Option Year 1 of 09/01/23 - 08/31/24 Estimated Option Year 2 of 09/01/24 - 08/31/25 Estimated Option Year 3 of 09/01/25 - 08/31/26 Estimated Option Year 4 of 09/01/26 - 08/31/27 GRAND TOTAL __________________ *The manufacturer is iRhythm. The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications. If you are interested and capable of providing the sought-out supplies, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Please indicate the size status and representations of your business, such as but not limited to: Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hub zone, Woman Owned Small Business (WOSB), Large Business, etc.)? (2) Is your company considered small under the NAICS code identified under this RFI? (3) Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? (4) If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). (5) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (6) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract number. (7) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? (8) Please provide general pricing of your products/solution for market research purposes. (9) Please submit your capabilities regarding the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes? (10) Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. (11) Please provide your DUNS number. (12) Please provide a list of detail requirements and drawings. *** Submissions addressing Section (8) should show clear, compelling, and convincing*** evidence that all equal to items"" meet all required salient characteristics. Responses to this notice shall be submitted via email to won.chae@va.gov. Telephone responses shall not be accepted. Responses must be received no later than Friday June 17, 2022 at 1:00 P.M. PST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this request for information. Responses to this notice shall not be considered as requests to be added to a prospective bidders list or to receive a copy of the solicitation.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/90265bbb180a40518e1a3e833ea934bc/view)
 

Place of Performance

Address: Department of Veterans Affairs VA Greater Los Angeles Healthcare System 11301 Wilshire Blvd, Los Angeles 90073, USA

Zip Code: 90073

Country: USA
 

Record

SN06358307-F 20220616/220614230118 (samdaily.us)
 

Source

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

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