Inactive

This is a Sources Sought (SS) Notice only, not a solicitation announcement and should not be considered as such. There is no solicitation available at this time. The Government will not pay for any in... This is a Sources Sought (SS) Notice only, not a solicitation announcement and should not be considered as such. There is no solicitation available at this time. The Government will not pay for any information received in response to this SS, nor will the Government compensate any respondent for any cost incurred in developing the information provided to the Government. This SS does not constitute a commitment by the Government. Any information provided in response to this market survey will be used for informational purposes only and will not be released. Vendor participation is not a promise of future business with the Government. The purpose of this Sources Sought is to conduct Market Research to determine an acquisition strategy for the acquisition of Home Sleep Testing. VAMC Cleveland, is seeking sources capable of completing the work as described in the Statement of Work below for Home Sleep Testing. 2. Contract Title. Home Sleep Testing The contractor shall provide home sleep study supplies for the Louis Stokes Cleveland Department of Veterans Affairs Medical Center (hereinafter Cleveland VAMC ). 3. Background. The COVID-19 pandemic caused a severe interruption in access to sleep apnea testing within a traditional in-patient setting. Current requirement and the previous requirements utilized these home sleep test kits to address this need by providing home-based sleep studies with minimal life cycle costs. This effort shall ensure a continuation of high-quality sleep apnea testing and care with little to no risk to patients. Furthermore, this requirement will allow Veterans with a traveling hardship to have easy access to quality sleep care. Cleveland VA Medical Center, sleep section has been offering for the last two years continuously services to many veterans at their home who suffer from sleep problems. The services have traditionally been offered at the medical center VA Sleep Lab only, where patients were coming here and spending the night at the hospital. Once the COVID -19 came around, providing services at the medical center became very difficult, therefore many veterans could not receive these services. It became obvious that our medical center needed to seek other alternatives to provide the service to our veterans. Itamar Medical was one of the vendors that offered home sleep testing, WatchPat Direct, a device that could provide the same results as the patients would get if were seen at the medical center, but now the patients could get this service from the comfort of their home. Not only does the devices offer almost the same results, but they offer comfort, saving time to drive to the medical center, sleep there for the entire night, and occur many other unnecessary expenses. In addition, utilizing home sleep testing equipment increased the number of patients that were using this service. The sleep physician will first attempt to determine the nature of a sleep problem and its treatment. This includes a sleep diary to track sleep-wake pattern, a complete medical history, and a physical examination. If the sleep physician thinks that the patient may have obstructive sleep apnea (OSA), a hypersomnia such as narcolepsy or a parasomnia such as sleep walking or nocturnal eating, then he or she will recommend a sleep study. In most of the cases, the physician will recommend a home sleep apnea test if he or she suspects that the patient has sleep apnea. 4. Scope. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to provide home sleep study supplies and reports on regular basis to the COR and administration of the Medicine Service, for the Cleveland VAMC patients as established in this SOW and in accordance with the terms and conditions established in the contract for the following location: Louis Stokes Cleveland VAMC 10701 East Blvd Cleveland, Ohio 44106 A standard in-lab sleep study (polysomnogram) records information that allows the sleep physician to evaluate the sleep stages, sleep efficiency and sleep and REM latency. The in-lab sleep study records EEG activity, eye movements and muscle tone. The EEG data tells us how quickly an individual takes to fall asleep, and the presence of early onset Rapid Eye Movement (REM) sleep may suggest sleepiness and a possible disorder of alertness. Airflow through the nose and mouth is recorded to figure out if there are abnormalities to help us determine if sleep apnea is present. The simultaneous recording of heart rate, oxygen saturation, airflow flow and respiratory effort allows us to analyze the types of breathing abnormalities present and their impact on oxygenation, cardiac function, and sleep continuity. Limb movements are recorded to detect extraneous movements, possible seizure activity and periodic limb movements of sleep. The in-lab sleep study is recorded on video so that sleep talking, and unusual behaviors may be documented. Home sleep apnea tests collect almost the same data through Home Sleep System, which uses PAT amplitude and pulse rate to differentiate between non-REM and REM therefore creating a Sleep Architecture. In addition, Home Sleep System would provide the added value of detecting REM related sleep apnea with REM and non-REM AHI. The Home Sleep System does not use nasal cannulas which fall out and create unnecessary efforts for the patients and unreliable and faulty results at times. 5. Specific Tasks. For referrals to home sleep testing be processed efficiently, its integration into clinical practice must be as seamless as possible. The technology must be intuitive, and the results must be statistically valid. Patient s comfort is main key to successful testing results. Our medical center is looking for to procure a home sleep testing devise which is easy to use by our patients, produce fast a reliable result, utilize a safe and capable system to restore the data and download the data in a system that would be available for viewing to our providers in minutes after the patient has taken the test. Also, the data should be safely protected and store and available in just a few minutes if needed. At the minimum, our medical center is looking for a device which is capable on measuring the following: PAT signal, heart rate, oximetry, actigraphy, body position, snoring and chest motion, easy to use, comfortable enough so the patient does not have to put too many efforts to get the test done, possibly to avoid using nasal cannulas which fall, and require constant attention, which could result in patient discomfort and faulty data reporting at times. In addition, the medical center is requesting that the devices are disposable to avoid additional steps such as shipping the device back to the vendor for its disposal, immediate access to sleep data for interpretation, any time anywhere with Cloud based solution. At the minimum, the raw data is downloaded and auto-scored differentiating obstructive and central events, providing AHI, RDI and OID based upon True Sleep time and Sleep Staging. Below are the steps that our medical staff and vendor should follow as part of the contract performance: The performance period for this contract will be for a base year and one option year this contract, and is summarized as follows: Purchase of devices to cover Home Sleep Studies Supplies and Services: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to provide home sleep study supplies and services as a turn-key deliverable with contract line-item numbers (CLINs) summarized as follows: CLIN 1 CS2117007 Service for WP Direct using WPOne-M for 2 nights 100 or Equal (Meets or exceeds the SOW) CLIN 2 CS2116055 WatchPAT Direct 2nd Night 100 or Equal (Meets or exceeds the SOW) CLIN 3 CS2117001 WatchPAT® Direct Program 250 or Equal (Meets or exceeds the SOW) CLIN 4 CS2117002 WatchPAT® One Direct Program 4,750 or Equal (Meets or exceeds the SOW) CLIN 5 CS2117008 WPOne-M Probe for WatchPAT Direct service 100 or Equal (Meets or exceeds the SOW) HSAT PROCEDURE STEPS for outpatients: 1. Qualified Sleep Provider must enter the consult order for the HSAT study using Procedure Menu SLEEP TESTING HSAT TECH. a) The order must include the total number of nights the study is required, supplemental oxygen administration and PAP therapy settings, if required. b) When not specified, study will be issued as a one-night study to be performed on room air without supplemental PAP therapy. 2. HSAT Staff a. Export daily pending consult list from Patient Flow Suite and reviews Pending SLEEP TESTING HSAT TECH consults for completeness and pertinent instructions b. Upon receipt of consult order sleep tech will make preliminary contact to the patient (0-2days) - Informing the patient that their provider has ordered an in-home sleep study test and that the device will be mailed to their home for completion. -Explaining the purpose of the test and verify patient willingness to complete testing. -Determining appropriate device to have issued, based on patient s phone and technology capabilities. -Providing an overview of the testing process, including the basic instructions, answering any questions pertaining to the study process. -Providing the 24/7 vendor contact, available for any questions. -Confirm the patient s valid mailing address for device delivery. -Reinforcing the importance of completing testing in a timely manner. c. Documents HSAT equipment order in CPRS under the CLE Sleep HSAT Vendor clinic and place the consult in Scheduled Status d. Make notification to the vendor, requesting HSAT equipment in Somnoware, providing all necessary information so that the device can be issued to the patient. -Enters and updates pt information as necessary in Patient Profile/General Information. -Order device via Send to Dropship, add pertinent instructions and signify device-type (Current equipment WatchPAT 300 vs WatchPAT One) as necessary. e. If unable to contact patient, receive the consult and use Consult Toolbox to document call, consult then changes to active status 3. Vendor after receiving the request for HSAT device to be mail out, shall comply with all components of contracted agreement(?), including: a. Contact patient and mail device within the established timeframes (2-3days) 6. Performance Monitoring To validate the test results sent by the contractor, a Cleveland VA physician will review results to ensure concurrence. Program monitoring will include ensuring that all referrals for sleep testing are completed by the vendor. The vendor will be required to submit the following when invoicing VA: The list of patients (name and patient SSN) Date of delivery of the unit The tracking labels information Number of units/night delivered Invoices will be paid in monthly bases in Tungsten The vendor will invoice VA only for the tests shipped to patients once the orders have been submitted to the vendor by the VA providers. The vendor will not charge VA any additional fees for defective supplies, no-completed tests or any other situation, for unit malfunctioning, lack of all supplies in packages, or any lost items by the vendor. Any additional charges will be discussed with the CO and the COR for approvals. All invoiced items will need to be part of the CLINs as stated in the contract. Vendor is required to email on weekly bases the list of patients that have received the units, and constantly update the COR of the units used and remaining balance. 7. Security Requirements Service & Maintenance will follow the security requirements as per VA s Medical Device Protection Program (MDPP) which protects VA s medical devices through a comprehensive security initiative that encompasses pre-procurement assessments, medical device isolation architecture (MDIA), communication, validation, scanning, access control list remediation, patching, and secure remote connectivity. CloudPAT Platform CloudPAT is a HIPAA-compliant web-based cloud application that allows users to streamline their workflow electronically, without having to operate or maintain an in-house solution. CloudPAT provides instant access to comprehensive study reports from any online location, as well as the option of sending studies for interpretation by a certified sleep physician. 1. SUBPART 839.2 INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS 839.201 Contract clause for Information and Information Technology Security: a. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). b. In solicitations and contracts were VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources. 2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008) Check - In Requirements The Field Service Engineer must report to the BioMed Supervisor to sign in with BioMed staff before work begins. Additionally, one must submit any mobile media devices that would be used on the system for a virus scan. Upon completion of work, the Field Service Engineer must report to BioMed Supervisor to brief BioMed Supervisor or BioMed Staff if Supervisor is unavailable concerning completion of service, and then to sign out. At the end of each briefing, Field Service Engineer will and must sign out. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. A BI is not required per VA Information and Information System Security/Privacy Requirements for IT Contracts dated August 2008 if the following exception applies: Contract Personnel with limited and intermittent access to equipment connected to facility networks on which limited VA sensitive information may reside, including medical equipment contractors who install, maintain, and repair networked medical equipment such as CT scanners, EKG systems, ICU monitoring, etc. In this case, Veterans Health Administration facilities must have a duly executed VA Business Associate Agreement (BAA) in place with the vendor in accordance with VHA Handbook 1600.1, Business Associates, to assure compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in addition to the contract. Contract personnel, if on site, should be escorted by VA IT Staff. APPENDIX C 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. b. The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured. Custom software development and outsourced operations must be in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. c. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. A BI is not required per VA Information and Information System Security/Privacy Requirements for IT Contracts dated August 2008 if the following exception applies: Contract Personnel with limited and intermittent access to equipment connected to facility networks on which limited VA sensitive information may reside, including medical equipment contractors who install, maintain, and repair networked medical equipment such as CT scanners, EKG systems, ICU monitoring, etc. In this case, Veterans Health Administration facilities must have a duly executed VA Business Associate Agreement (BAA) in place with the vendor in accordance with VHA Handbook 1600.1, Business Associates, to assure compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in addition to the contract. Contract personnel, if on site, should be escorted by VA IT Staff. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 3. VA INFORMATION CUSTODIAL LANGUAGE a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). b. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. c. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures follow VA directive requirements. c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor during performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations, and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations, and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. i. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request. j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. m. The C&A requirements do not apply, and that a Security Accreditation Package is not required. 5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor s security control procedures must be equivalent to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA s network involving VA information must be reviewed and approved by VA prior to implementation. d. The contractor/subcontractor s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA s POA&M management process. The contractor/subcontractor must use VA s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary. e. The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost. g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: (1) Vendor must accept the system without the drive. (2) VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or (3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. (4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems if it is not possible for the VA to retain the hard drive, then. (5) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and (6) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract. (7) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. 6. SECURITY INCIDENT INVESTIGATION a. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. b. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (Including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant...