36C25520Q0433 SOURCES SOUGHT.docx

Contract Opportunity Sources Sought Notice

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* = Required Field Contract Opportunity Sources Sought Notice W065 Home Sleep Study

66048 36C25520Q0433

11:00

CENTRAL TIME, CHICAGO, USA

N

532283 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048 Jeanine Wallace 3450 S. 4th Street Leavenworth, KS 66048 jeanine.wallace@va.gov

Columbia VAMC 800 Hospital Drive Columbia, MO 65201

65201 jeanine.wallace@va.gov

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 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 as a result 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 into 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 on the basis of this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice.

The purpose of this sources sought 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 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) DUNS 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 and (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below.

The VA Heartland Network 15, Contracting Office located at 3450 South 4th Street, Leavenworth, KS, 66048-5055 is seeking a qualified contractor to provide home sleep study services for the Columbia VAMC located at 800 Hospital Drive, Columbia MO 65201.

Please see the statement of work on following pages.

NAICS Code: 532283 (Home Health Equipment Rental) - $35.0 Million

Important information: The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources 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 a particular 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 competition may be determined. The North American Classification System (NAICS) code for this acquisition is 337215 (Institutional Furniture Manufacturing). The small business size standard is 500 employees. Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM located on the web at www.sam.gov). Additionally, all Service Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. All interested Offerors should submit information by e-mail: to jeanine.wallace@va.gov. All information submissions should be received no later than 11:00 am CST on June 1, 2020. After review of the responses to this announcement, the Government intends to proceed with the acquisition and a subsequent solicitation will be published.

STATEMENT OF WORK

1. 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.

2. 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:

a. The contractor shall furnish, for the life of the contract, the following equipment at no additional costs to the Government:

1) Home sleep study equipment.

2) Current operator’s manual(s) as well as hands on training by local representative.

b. 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:

1) Device(s) provides unsatisfactory results.

2) Device(s) fails to transmit or download information.

3) Information is not retrievable through the use of the web based system.

4) There is a defect or artifact determined by the VA to be substandard.

3. 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.

4. Performance Period: Base year with one (4) Option Years. Anticipated Start Date: 2020

5. 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.

6. General Requirements:

a. 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:

1) Equipment that is ordered for the patients’ specific needs.

2) Education regarding the set-up and use of the devices along with 24/7 technical support that will be offered on the phone.

3) The device to have at least 7 channels (a type 3 device)

4) Captured sleep study data is reviewed and manually scored by a Registered Polysomnography Technician

5) The ability to provide data from each night of the study, as well as the cumulative data, if multiple nights.

6) 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

7) 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.

8) Contractor shall electronically post the data and scoring for immediate review by the appropriate Truman VA staff within 72 hours of sleep study completion.

9) Contractor shall post an all-results-data export file to VA staff within 24 hours of scoring completion.

10) 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.

b. Scoring Reports: All scoring information will be collected and communicated to the physician at the VAMC. The scoring report shall include at minimum:

1) Respiratory abnormalities

2) Oxygen desaturations

3) Snoring

4) Body position

5) Heart rate

7. 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.

8. 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.

9. Equipment:

a. All equipment offered shall be U.S. Food and Drug Administration (FDA) approved.

b. 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.

c. 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.

d. The contractor shall supply a postage-paid return container for all equipment.

10. Instrument Capabilities:

a. Lightweight and easy to use design

b. Have at least 7 channels (type 3 device)

c. Must be compatible with the sleep study system that is utilized for patient care at the Truman VA, which is the Alice 6 system.

d. Instrument/Monitor has a date and time stamp for clinical reports.

e. All consumable items are provided to patient by contractor who returns the item after sleep study.

11. 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.

12. 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.

13. Quality:

a. Maintenance:

1) 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.

2) 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.

3) Contractor shall be responsible for the configuration and calibration of the devices

4) 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.

5) Contractor shall report on the failure rate of their equipment and supply maintenance records.

6) 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.

7) The contractor shall coordinate installation of upgrades with the COR.

8) The contractor shall provide customer notifications and latest operator’s manual within 10 days after their release/publication.

b. Quality Program:

1) 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.

2) Contractor must have a clearly defined process by which it collects the required data, performs root cause analysis, and can supply easily understandable reports.

3) 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.

14. Government holidays: The contractor is not required to provide service on the following National holidays, not shall the contractor be paid for these holidays.

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.

15. 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.

16. 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.

17. 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.

18. 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.

19. 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.

20. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

a. 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.

b. ACCESS to VA INFORMATION AND VA INFORMATION SYSTEMS: A contractor/subcontrator 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 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.

c. VA INFORMATION CUSTODIAL Language: 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).

If VA determines that the contractor has violated any of the information confidentiality, privacy, security, and other 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.

d. SECURITY INCIDENT INVESTIGATION: 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 COR 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.

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.

With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

e. LIQUIDATED DAMAGES FOR DATA BREACH: Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

f. TRAINING: All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

Successfully complete the appropriate VA privacy training and annually complete required privacy training (See below training); and Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access.

The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

Failure to complete the mandatory annual training, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

g. What is VA Sensitive Information/Data?: All Department information and/or data on any storage media or in any form or format, which requires protection due to the risk of harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the information. The term includes not only information that identifies an individual but also other information whose improper use or disclosure could adversely affect the ability of an agency to accomplish its mission, proprietary information, and records about individuals requiring protection under applicable confidentiality provisions.

h. What is Protected Health Information? The HIPAA Privacy Rule defines protected health information as Individually Identifiable Health Information transmitted or maintained in any form or medium by a covered entity, such as VHA.

i. What is an “Incidental” Disclosure? An incidental disclosure is one where an individual’s information may be disclosed incidentally even though appropriate safeguards are in place. Due to the nature of VA communications and practices, as well as the various environments in which Veterans receive healthcare or other services from VA, the potential exists for a Veteran’s protected health information or VA sensitive information to be disclosed incidentally.

For example:

· You overhear a healthcare provider’s conversation with another provider or patient even when the conversation is taken place appropriately.

· You may see limited Veteran information on sign-in sheets or white boards within a treating area of the facility.

· Hearing a Veteran’s name being called out for an appointment or when the Veteran is being transported/escorted to and from an appointment.

j. Safeguards You Must Follow To Secure VA Sensitive Information:

· Secure any VA sensitive information found in unsecured public areas (parking lot, trash can, or vacated area) until information can be given to your supervisor or Privacy Officer. You must report such incidents to your Privacy Officer timely.

· Don’t take VA sensitive information off facilities grounds without VA permission unless the VA information is general public information, i.e., brochures/pamphlets.

· Don’t take pictures using a personal camera without the permission from the Medical Center Director.

· Any protected health information overheard or seen in VA should not be discussed or shared with anyone who does not have a need to know the information in the performance of their official job duties, this includes spouses, employers or colleagues.

· Do not share VA access cards, keys, or codes to enter the facility.

· Immediately report lost or stolen Personal Identity Verification (PIV) or Veteran Health Identification Cards (VHIC), any VA keys or keypad lock codes to your supervisor or VA police.

· Do not use a VA computer using another VA employee’s access and password.

· Do not ask another VA employee to access your own protected health information. You must request this information in writing from the Release of Information section at your facility.

k. What are the Six Privacy Laws and Statutes Governing VA?

1. Freedom of Information Act (FOIA) compels disclosure of reasonably described VA records or a reasonably segregated portion of the records to any person upon written request unless one or more of the nine exemptions apply.

1. Privacy Act of 1974 provides for the confidentiality of personal information about a living individual who is a United States citizen or an alien lawfully admitted to U.S. and whose information is retrieved by the individual’s name or other unique identifier, e.g. Social Security Number.

1. Health Insurance Portability and Accountability Act (HIPAA) provides for the improvement of the efficiency and effectiveness of health care systems by encouraging the development of health information systems through the establishment of standards and requirements for the electronic transmission, privacy, and security of certain health information.

1. 38 U.S.C. 5701 provides for the confidentiality of all VA patient and claimant information, with special protection for their names and home addresses.

1. 38 U.S.C. 7332 provides for the confidentiality of drug abuse, alcoholism and alcohol abuse, infection with the human immunodeficiency virus (HIV) and sickle cell anemia medical records and health information.

1. 38 U.S.C. 5705 provides for the confidentiality of designated medical-quality assurance documents.

l. What are the Privacy Rules Concerning Use and Disclosure?

You are not authorized to use or disclose protected health information. In general, VHA personnel may only use information for purposes of treatment, payment or healthcare operations when they have a need-to-know in the course of their official job duties. VHA may only disclose protected health information upon written request by the individual who is the subject of the information or as authorized by law.

m. How is Privacy Enforced?

There are both civil and criminal penalties, including monetary penalties that may be imposed if a privacy violation has taken place. Any willful negligent or intentional violation of an individual’s privacy by VA personnel, contract staff, volunteers, or others may result in such corrective action as deemed appropriate by VA including the potential loss of employment, contract, or volunteer status.

Know your VA/VHA Privacy Officer and Information Security Officer. These are the individuals to whom you can report any potential violation of protected health information or VA sensitive information, or any other concerns regarding privacy of VA sensitive information.