PWS Home Sleep Apnea Testing Service 657A4.docx

HOME SLEEP APNEA TESTING SERVICES

John J. Pershing VA Medical Center

1. Purpose:

2. Scope of Work: The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to provide HSAT and reports to JJP VAMC for Veteran beneficiaries.

The Contractor will provide HSAT equipment, instruction, and support to Veteran beneficiaries for use for 1 to 3 nights, depending on the JJP VAMC physician’s sleep consultation. After completion of testing, Veteran beneficiaries will return HSAT equipment to the Contractor. Sleep tests shall be reviewed and scored by the Contractor’s certified sleep technician (see Section 11 - Staffing and Employee Requirements). The Contractor shall make sleep test scores and data available through its web-based system for review and interpretation by JJP VAMC physicians and/or authorized representatives.

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

a. HSAT equipment compatible with Somnoware software.

2. HSAT equipment shall have an operator’s manual to include troubleshooting. The Contractor shall repeat the sleep study at no additional costs to the Government for the following reasons or other unforeseen issues:

a. Device(s) provides unsatisfactory results.

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

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

3. Place of Performance: The Contractor shall provide HSAT equipment directly to the residence of Veteran beneficiaries by delivery or shipment. Veteran beneficiaries will utilize the Contractor’s provided HSAT equipment at their own residence for 1 to 3 nights, depending on the JJP VAMC physician’s consultation. Upon completion of testing, HSAT equipment shall be returned to the Contractor at no expense to the Veteran beneficiaries or the Government. The Contractor shall pick up HSAT equipment from Veteran beneficiaries’ residence or provide Veteran beneficiaries with pre-paid return postage. All costs for delivery, disposable items, equipment, and travel shall be included in the line-item pricing and shall not be separately priced. The Contractor shall provide off-site scoring for HSAT.

4. Performance Period: Base plus four (4) Option Years.

Base: 2/15/2026-2/14/2027 Option Year I: 2/15/2027 - 2/14/2028 Option Year II: 2/15/2028 – 2/14/2029 Option Year III: 2/15/2029 – 2/14/2030 Option Year IV: 2/15/2030 - 2/14/2031

5. Equipment/Service Specifications:

1. HSAT equipment shall include the following:

a. Education regarding the setup and use of the equipment along with 24/7 technical support that will be offered on the phone.

b. Captured sleep study data reviewed and manually scored by a certified sleep technician.

c. Scoring of the sleep studies made available through the Contractor’s web-based application for interpretation by a JJP VAMC sleep physician.

d. U.S. Food and Drug Administration (FDA) approval.

2. Equipment Capabilities:

a. Lightweight and easy to use design.

b. Capability to provide data for each night of the study, as well as the cumulative data, if multiple nights.

c. Have at least seven (7) channels (type 3 device).

d. Must be compatible with Somnoware Software that is utilized for patient care at JJP VAMC.

e. Equipment/Monitor must have capability to show date and time stamp for clinical reports.

3. Scoring Reports: All scoring information will be collected and communicated to the JJP VAMC physician and/or authorized representative through the Contractor’s web-based application. The scoring report shall include at minimum:

a. Respiratory abnormalities

b. Oxygen desaturations

c. Snoring

d. Body position

e. Heart rate

4. The Contractor shall electronically make available the data and scoring for review by JJP VAMC physician within 72 hours of sleep study completion. The JJP VAMC physician shall have access to patient sleep study scores via secure email.

5. All equipment remains the sole property of the Contractor including the initial delivery of equipment. The Contractor is responsible for all service maintenance and repairs of the equipment.

6. The Contractor shall provide pre-paid return postage or equipment pickup to patients for all equipment.

6. Orders: The JJP VAMC physicians and/or authorized representatives shall provide the Contractor with the sleep consultation, via facsimile, secured email or through VA approved portal in addition to phone contact to initiate individual Veteran beneficiary service requirements. This shall include the Veterans sleep test duration, services to be provided including the date and place of delivery. The Contractor shall confirm receipt of the request within one (1) business day.

a. The Contractor shall deliver to Veteran’s residence all HSAT equipment required to conduct sleep apnea testing. Delivery shall include a HSAT equipment operator’s manual and training on equipment operations.

b. Veteran beneficiaries shall be notified of expected delivery times by the Contractor. Veteran beneficiaries shall be provided with a four (4) hour delivery time window for expected time of delivery.

c. The Contractor is responsible for scheduling the HSAT appointments with the Veteran. The Contractor is responsible for establishing appointments with patients when initiating set-ups, deliveries and returns.

7. Procedure/Workflow:

1. The JJP VAMC physician will initiate the request for HSAT by placing the sleep consultation order for the Veteran beneficiary.

2. The JJP VAMC physicians and/or authorized representatives will assign the sleep consultation for scheduling with the Contractor.

3. The Contractor schedules the HSAT delivery appointment with the Veteran beneficiary within 24 hours after receipt of order.

4. Prior to delivery, the Contractor will inspect the HSAT equipment. HSAT equipment shall be in good condition and sanitized in accordance with the Centers for Disease Control and Prevention (CDC) guidelines for Disinfection and Sterilization.

5. At the time of the appointment, the Veteran beneficiary will receive HSAT instruction from a trained contractor technician on the following:

a. The use of the device; and

b. Application and hook up procedure, with specific instruction on how to keep equipment operational and affixed for the duration of testing.

6. The trained contractor technician shall provide the patient the instructions for technical support during HSAT.

7. Sleep tests will be 1 to 3 nights, depending on the JJP VAMC physician’s sleep consultation.

8. The Contractor schedules the return appointment for HSAT equipment if date of return is known. Otherwise, the appointment is scheduled when the device is returned.

9. The Veteran beneficiary performs the study and returns HSAT equipment to the Contractor via pre-paid return postage or Contractor pickup.

10. The certified sleep technician shall perform the return encounter with the following steps:

a. If data is not technically adequate, then the certified sleep technician shall cancel the return visit and either:

i. repeats testing; or

ii. reschedule the testing.

b. Once the data is found to be adequate, the Veteran is dismissed and the HSAT equipment is returned to the Contractor to be cleaned in accordance CDC guidelines for Disinfection and Sterilization.

11. The certified sleep technician scores the sleep study and completes the recording information in the sleep study software (I.e., Somnoware).

12. The JJP VAMC physician interprets the study in the sleep study software and communicates the results and subsequent care plan with the Veteran beneficiary.

8. Training: The Contractor shall provide education to each Veteran beneficiary. Education shall be presented verbally, in demonstration and material covered shall be in written form to be left with the Veteran beneficiary. The written material shall be in English as well as the foreign language of the Veteran beneficiary, should the Veteran not speak English. In the case of such an occurrence the Contractor is to advise the VA facility to facilitate adequate instructions. The Contractor shall document that each Veteran beneficiary has been instructed on how to utilize HSAT equipment.

The Contractor shall provide comprehensive training to the JJP VAMC staff on the use of their HSAT equipment, instructions on how to upload patient information into Contractor’s web-based application, and how to manage basic quality assurance tests.

9. Technical Support: The Contractor shall provide technical support via telephone for troubleshooting and/or equipment-related problems. The response time for telephone technical assistance shall be within one (1) hour from the time of the initial call for technical support. The Contractor shall provide 24/7 technical support for Veteran beneficiaries conducting sleep testing.

10. Quality:

1. Maintenance:

a. All home sleep study equipment shall be cleaned, disinfected, and decontaminated according to CDC guidelines for Disinfection and Sterilization before it is provided to Veteran beneficiaries. Unclean equipment should be stored in an area separate from cleaned equipment to prevent cross contamination.

b. The Contractor shall provide proper inspection and maintenance of HSAT equipment. The Contractor shall also provide a copy of the inspection documentation to the Contracting Officer’s Representative (COR) upon request.

c. The Contractor shall be responsible for the configuration and calibration of equipment.

d. The Contractor shall have a formal procedure to validate the functional integrity of equipment before it is provided to a patient, and shall, at a minimum, complete and document such validation procedure whenever equipment is returned with non-diagnostic or unsatisfactory results, or when visual inspection suggests the possibility of device damage.

e. The Contractor shall document and report the failure rate of their equipment and supply maintenance records.

f. The Contractor shall make upgrades to the analytical software or hardware available to JJP VAMC at no additional costs. The Contractor shall provide advanced notice to the Contracting Officer (CO) and/or COR of analytical software or hardware upgrades.

2. Quality Program:

1. The Contractor must have a clearly defined process by which it collects the required data, performs root cause analysis, and can supply technically accurate and comprehensible reports.

2. The Contractor’s information systems shall be Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant and capable of transferring data securely and accurately to the JJP VAMC through the Contractor’s web-based application.

11. Staffing and Employee Requirements:

a. The Contractor shall be staffed to render satisfactory, timely, and courteous service to the Veteran beneficiary at all times. The certified sleep technician scoring HSAT must meet one of the following:

• American Board of Sleep Medicine as a Registered Sleep Technologist;

• Board of Registered Polysomnographic Technologists as a Registered Polysomnographic Technologist; or

• National Board for Respiratory Care as a Certified Pulmonary Function Technologist, Registered Pulmonary Function Technologist, Certified Respiratory Therapist, or Registered Respiratory Therapist.

b. Workload fluctuations and personnel absences are the sole responsibility of the Contractor. The Contractor shall be responsible for the acts and omissions of his/her employees.

c. All HSAT services shall be performed in accordance with the American Academy of Sleep Medicine (AASM), Joint Commission Standards for Diagnostic Sleep Centers, or Accreditation Commission for Health Care (ACHC).

d. Employees providing services must have current education, training, and experience commensurate with the HSAT equipment and scope of services provided. Only employees that have been properly trained and who have demonstrated competence shall perform equipment deliveries, recoveries, and education on the equipment.

e. As a part of the employee’s initial orientation, the Contractor shall provide an orientation on the VA and on the requirements of this contract. Training topics shall cover all aspects of the services provided under this contract, including Veteran confidentiality and infection control procedures.

f. The Contractor shall provide COR with a list of key employees and all employees currently competent to perform delivery/recovery and patient education services within 10 days after contract award and submit a revised listing within twenty (20) days after any changes are made. Key personnel must be given the authority to represent the Contractor in all day-to-day matters. The Contractor shall identify at least one individual who has the authority to fully represent the Contractor in all contract matters.

12. Government holidays: The contractor is not required to provide services on the following National holidays, nor shall the contractor be paid for these holidays.

The following national holidays Are observed by the Federal Government:

New Year’s Day

1 January