Q403--Home Sleep Study Services
This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products and/or services. Your response to this Sources Sought Notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise because of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort.
The information provided may be used by the Department of Veterans Affairs in developing its acquisition approach, statement of work/statement of objectives and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract based on this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice.
The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this Sources Sought Notice in accordance with (IAW) FAR Part 15.201(e).
The purpose of this Sources Sought Notice announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the products and/or services described below.
Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following:
(a) Company Name;
(b) Address;
(c) Point of Contact;
(d) Phone, Fax, and Email;
(e) UEI Number;
(f) Cage Code;
(g) Tax ID Number;
(h) Type of Small Business, e.g., Services Disabled Veteran Owned Small Business, Veteran Owned Small business, 8(a), HUBZone, Women Owned Small Business, Small Disadvantaged Business, or Small Business HUBZone business, etc.;
(i) State if your business has an FSS contract with GSA, VA NAC, NASA SEWP, or any other federal contract, that can be utilized to procure the requirement listed below and provide the contract number; and
(j) Must provide a capability statement that addresses the organization s qualifications and ability to perform as a contractor for the work described below.
Requirement:
The VA Heartland Network 15 Contracting Office located at 3450 South 4th Street, Leavenworth, KS, 66048-5055 is seeking a potential qualified contractor to provide Home Sleep Study Services for the VA Columbia Missouri Healthcare System, located in Columbia, Missouri. See the statement of work for details.
The North American Industry Classification System Code (NAICS Code) is 621610 (Home Health Care Services), size standard $19 Million. Based on this information, please indicate whether your company would be a Large or Small Business and have a socio-economic designation as a Small Business, VOSB or SDVOSB.
Important Information:
The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to this source sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to an acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Currently a total set-aside for Service-Disabled Veteran Owned Small Business firms is anticipated based on the Veterans Administration requirement with Public Law 109-461, Section 8127 Veterans
Benefit Act. However, if response by Service-Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open may be used.
Responses to this notice shall be submitted via email to Mickeya Linzie at mickeya.linzie@va.gov. Telephone responses will not be accepted. Responses must be received no later than Thursday, July 6, 2023, at 8:00AM CST. 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 sources sought.
Responses to this sources sought notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.
STATEMENT OF WORK
Introduction: The purpose of this Statement of Work (SOW) is to outline the need for Home Sleep testing services for diagnosing patients located at the Harry S Truman Memorial Veterans Hospital (Truman VA) in Columbia, MO. Home Sleep Study Testing: The contractor shall provide home sleep studies for patients experiencing sleep apnea symptoms, such as snoring, daytime sleepiness, poor memory, cognitive impairment, witnessed apneas. The device(s) is given to patients to use for up to 3 nights. After the evaluation period, the patient returns the device(s) to the company in packaging provided by the company.
Scope of Work: The contractor will provide home sleep study services for patients who qualify for home sleep apnea testing. They will provide the following:
The contractor shall furnish, for the life of the contract, the following equipment at no additional costs to the Government:
Home sleep study equipment.
Current operator s manual(s) as well as hands on training by local representative.
The system shall have an operator s manual to include system operation and troubleshooting. The contractor shall repeat the sleep study at no additional costs to the Government for the following reasons or other unforeseen issues:
Device(s) provides unsatisfactory results.
Device(s) fails to transmit or download information.
Information is not retrievable through the use of the web based system.
There is a defect or artifact determined by the VA to be substandard.
Place of Performance: The selected contractor shall be providing equipment and off-site scoring. No travel fees will apply. All delivery, disposable items, and equipment are included in the item price. Location: Harry S Truman Memorial Veterans Hospital, 800 Hospital Drive, Columbia, MO 65201. Devices shall be provided to patients directly from the contractor. Upon completion of the sleep study, device(s) shall be mailed directly back to contractor at no expense to patient or VA.
Performance Period: Base year with (4) Option Years. Anticipated Start Date: 2023
Procedure: The vendor contacts the patient to schedule the patient s study and set up a time to deliver the equipment. The device(s) is given to patients to use for 1 to 3 days depending on the indication for the sleep study. Upon receipt of order, contractor shall contact patient within 24 hours by phone, and polysomnography technicians will instruct and explain to the patients about what the device is, how to hook it up, and how to use the equipment. They will then hook up the device(s) to the patient, with specific instruction in order to continue to have the device(s) on for the duration of evaluation. After the evaluation period, the patient returns the device(s) to the contractor in the envelopes provided or to the healthcare facility.
General Requirements:
Home Sleep Study: The contractor will provide home testing equipment that can perform home sleep studies for patient care. The equipment will provide the following:
Equipment that is ordered for the patients specific needs.
Education regarding the set-up and use of the devices along with 24/7 technical support that will be offered on the phone.
The device to have at least 7 channels (a type 3 device)
Captured sleep study data is reviewed and manually scored by a Registered Polysomnography Technician
The ability to provide data from each night of the study, as well as the cumulative data, if multiple nights.
Scoring of the sleep study along with the raw data of the sleep study will be made available online and will be interpreted by the sleep physicians at Truman VA
Both patients and VA staff shall have unlimited 24/7 telephone access to contractor s support staff that are knowledgeable and shall supply help in resolving any monitoring problems.
Contractor shall electronically post the data and scoring for immediate review by the appropriate Truman VA staff within 72 hours of sleep study completion.
Contractor shall post an all-results-data export file to VA staff within 24 hours of scoring completion.
The contractor shall provide detailed reports for all Veteran patients receiving full services to the COR (Contracting Officer Representative) at the end of the current billing period. Full services are defined as patients that have been identified by a VA provider as requiring a home sleep study, have been assigned equipment that has been returned to the contractor for scoring, the scoring has been reported back to the appropriate medical center, and the sleep study report is determined to be without technical error.
Scoring Reports: All scoring information will be collected and communicated to the physician at the VAMC. The scoring report shall include at minimum:
Respiratory abnormalities
Oxygen desaturations
Snoring
Body position
Heart rate
Data Management: While patient is using the equipment, the scored study will be made available online. The VA shall have access to patient reporting 24 hours a day at the physician s or authorized representative s convenience through password protection.
Work Flow: The device is given to patients to use for 1 to 3 days depending on the indication for the sleep study. The monitor will be delivered directly to the patient, and the patient will be hooked up at home with instructions from the vendor. The contractor staff will instruct and explain to the patients what the device is, how to hook it up, and how the patient will use it. The patient will complete the study as directed and will send the equipment back to the vendor once the study is completed. An end of sleep study, the sleep study data and scoring will be made available within 72 hours after the service is completed (Access to the data from the website is limited to the physicians and/or any other authorized representative responsible for evaluating the data). Once the sleep study has been scored, the contractor shall post it for the VAMC physicians to review and interpret.
Equipment:
All equipment offered shall be U.S. Food and Drug Administration (FDA) approved.
All home sleep testing equipment shall be provided by the contractor for VA patient use and shall be state-of-the-art equipment, lightweight, and simple for patients to use. Patients will use the equipment for one (1) to three (3) days, or as specified by the VA provider. Samples shall be provided to each site during the training or orientation process.
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 equipment.
Instrument Capabilities:
Lightweight and easy to use design
Have at least 7 channels (type 3 device)
Must be compatible with the sleep study system that is utilized for patient care at the Truman VA, which is the Alice 6 system.
Instrument/Monitor has a date and time stamp for clinical reports.
All consumable items are provided to patient by contractor who returns the item after sleep study.
Training: The contractor shall provide comprehensive training to the Truman VA staff. This may require multiple training sessions for numerous 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. Contractor shall also provide each participant at each facility copies of manuals, equipment checklists, surveys, and specific contact information in the event that a medical center staff person needed 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. Contractor must also show availability 24/7 for patient support. Contractor must have appropriately trained personnel available by phone throughout the duration of all tests for patient support.
Quality:
Maintenance:
All home sleep study equipment shall be cleaned, disinfected, and decontaminated according to accreditation standards, before it is sent to the patients. 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 home sleep study equipment and shall provide each location a copy of the inspection checklist.
Contractor shall be responsible for the configuration and calibration of the devices
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.
When upgrades to the analytical software or hardware are available that are designed to improve the performance of the analytical system, those upgrades shall be made available to the Truman VA at no additional costs.
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 home sleep testing, or an equivalent quality system during performance of this contract.
Contractor must have a clearly defined process by which it collects the required data, performs FboNotice cause analysis, and can supply easily understandable reports.
Contractor must demonstrate that their information systems are HIPAA compliant, and that the raw data can be transferred securely and with accuracy to the VA.
Government holidays: The contractor is not required to provide service on the following National holidays, not shall the contractor be paid for these holidays.
The following national holidays observed:
New Year s Day
Martin Luther King s Birthday
President s Day
Memorial Day
Juneteenth
Independence Day
Labor Day
Columbus Day
Veterans Day
Thanksgiving Day
Christmas Day
If a holiday falls on Sunday, the following Monday shall be observed as the National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government agencies. Also included would be any day specifically declared by the President of the United States.
Overtime and holidays: Any overtime or holiday pay that may be entitled to contractor personnel performing under this contract shall be the sole responsibility of the contractor and shall not be billed to nor reimbursed by the Government.
Ordering activity: Contractor shall not accept any instructions issued by any person other than the CO or COR acting within the limits of his/her authority.
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.
Badges: All contractor personnel shall be required to wear VA provided identification (I.D.) badges above the waist at all times while on the VA grounds. Contractors shall be required to coordinate with COR in order to obtain the VA provided I.D. badges for all staff. All VA provided I.D. badges shall be returned at the end of the contract or upon completion of service. Failure to wear ID badges may result in removal from any of the VA facilities and/or otherwise referred to federal property.
36C25523Q0575 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 15
6/22/23, 3:13 PM