B.4 Revised Statement of Work NFSG Home Oxygen_091125 02.docx

B.4 REVISED (A0006) STATEMENT OF WORK

1.0 Description Of Services: The Department of Veterans Affairs (VA) North Florida/South Georgia VA Healthcare System (NF/SGVAHS) located at 1601 S.W. Archer Road Gainesville, Florida has an IDIQ for Home Oxygen and Medical Equipment Management. The contractor shall provide patient education on equipment issued, safety, emergency preparedness, and infection control. The Contractor shall provide supplies, materials, equipment, labor, supervision, equipment management, safety management, repairs, and preventative maintenance. This shall include but it is not limited to; Set-ups, (Initial & Restarts), Switch-outs, Basic & Complex systems. Basic systems consist of equipment capable of providing supplemental oxygen up to 4 liters per minute (LPM) with appropriate interface. Complex system consists of all equipment required to provide supplemental oxygen 5 LPM or more with appropriate interface, to include cough assists, ventilators, and other complex systems. The Contractor shall have an office-warehouse location within 20 miles of the Gainesville VAMC for site visits by the PSAS COR, VA staff or Joint Commission (JC).

The Contractor shall furnish, provide, install and maintain medical oxygen equipment, high pressure cylinder, 50 psi air compressors, POCs, concentrators (if VA owned concentrators, POCs not available) and/or liquid systems, portable systems, emergency back-up systems and all required supplies to eligible VA patients as required by the NF/SGVAHS. The Contractor shall maintain, service, install VA owned equipment; concentrators, POCs, self-fill units and cylinders, cough assists and ventilators and all required supplies to eligible VA patients as required by the NF/SGVAHS. All Government Furnished Equipment (GFE) will be labeled as VA Owned. Government furnished equipment shall be handled in accordance with FAR 52.245-1 Government Property.

1.1. Background. Per VHA Directive 1173.13(1) Home Oxygen Program , the prescribing provider is responsible for completing the annual prescription for home oxygen for veteran patients. The consultation includes the patient’s oxygen prescription, oxygen prescription expiration date, equipment, supplies and services to be provided including the date and place of delivery. All services shall be provided either at the veteran’s residence, or in a SNF where the veteran resides. All efforts in support of this requirement are carried out in accordance with Joint Commission standards. The use of the term’s “beneficiary”, “Veterans”, “Patients”, and “Patient” are used interchangeably and refer to the recipient of required services inclusive of incidental supplies and equipment.

1.2. Objectives. The Government intends to award a single award fixed price IDIQ Contract as a result of this solicitation. In accordance with the prescription received from the NFSG VAHCS, the contractor shall provide the beneficiary with home oxygen equipment and supplies. In addition, the contractor shall deliver, set up, and install all equipment and supplies at the veteran patient’s residence. This full-service contract includes establishing operational parameters of equipment for VA prescription, ensuring purity of O2, veteran training on system operations, review of safety checks, and discussion of home safety issues. The operational parameters shall also include scheduled maintenance visits, emergencies, equipment supply requirements, and removal of equipment upon discontinuation notification. The Contractor shall furnish, install, and maintain medical oxygen equipment, high-pressure cylinders, 50 psi air compressors, and/or liquid systems, portable systems, emergency back-up systems, portable oxygen concentrators (POCs), concentrators, ventilators, cough assist devices and all equipment supplies to eligible VA patients as required by the NF/SG VHA, if VA owned equipment is not available. The contractor shall install and maintain all VA owned equipment including providing all related supplies. All GFE will be labeled as VA Owned by the contractor.

The Contracting Officer Representative (COR) or designee (home oxygen clinical staff) will provide the Contractor with notification of individual patient equipment requirements via fax or encrypted email or other electronic means (telephonic for emergencies). The home oxygen clinics (Gainesville, Lake City, Jacksonville) will be notified by the contractor via fax or encrypted email to confirm receipt of order(s) immediately. The contractor shall contact the home oxygen clinic or COR for assistance in clarifying orders.

1.3. Scope. The contractor shall provide all personnel, equipment, tools, materials, supervision, other items and non-personnel services necessary to perform Home Oxygen Services for beneficiaries of the NF/SG VA Healthcare System (NF/SG VAHCS) catchment areas. NF/SG serves an estimated 1800 patients participating in the Home Oxygen program. NOTE: Total patients serviced under this contract will vary month to month. Eligible VA patients as required by NF/SG are added and discharged and depending on ordered equipment requirements.

1.4. Period of Performance. The period of performance shall be for one (1) base period of 12-months and four (4) 12-month ordering periods. The period of performance reads as follows:

· Base Period

· Ordering Year One

· Ordering Year Two

· Ordering Year Three

· Ordering Year Four

1.5. Locations and Geographic Area of Coverage. The Contractor is responsible for deliveries and service to VA patients in the following Florida and South Georgia counties/North Florida/South Georgia Veterans Healthcare System:

(Middleburg CBOC) Andrew K. Baker VA Clinic 400 College Drive, Suite 200 Middleburg, FL 32068

(St. Augustine CBOC) Leo C. Chase, Jr. VA Clinic 100 Deerfield Preserve Blvd. St. Augustine, FL 32086

(Tallahassee OPC) Sergeant Ernest I. "Boots" Thomas VA Clinic 2181 East Orange Ave. Tallahassee, FL 32311

The following thirty-two (32) Florida counties are covered, Alachua, Baker, Bradford, Calhoun, Columbia, Citrus, Clay, Dixie, Duval, Flagler, Franklin, Gadsden, Gulf, Gilchrist, Hamilton, Jackson, Jefferson, Lafayette, Lake, Leon, Levy, Liberty, Madison, Marion, Nassau, Putnam, St. John, Sumter, Suwannee, Taylor, Union, and Wakulla.

The following nineteen (19) Georgia counties are covered, Atkinson, Berrien, Brantley, Brooks, Camden, Charlton, Clinch, Colquitt, Cook, Decatur, Echols, Grady, Lanier, Lowndes, Miller, Mitchell, Pierce, Thomas, and Ware.

Further information for the locations may be accessed at website: http://www.northflorida.va.gov/NORTHFLORIDA/index.asp

1.6. Point of Contacts. See below points of contacts.

a. Contracting Officer Representative (COR) Primary and Alternate

b. PSAS Staff Rep – Home Oxygen

c. Home Oxygen Clinical Coordinators – Lake City, Jacksonville, Tallahassee and Gainesville

d. Supervisory Outpatient RRT

e. Chief, Prosthetics and Sensory Aids Service (PSAS)

f. Assistant Chief, Prosthetics and Sensory Aids Service (PSAS)

PLACEMENT OF ORDER: Ordering officers (OOs) will be authorized to place orders against this contract. The COR will provide the Contracting Officer with contact names, emails, phone numbers of individuals. Contracting Officer will furnish the Contractor with the names and contact of individuals authorized as OOs, by separate memorandum upon issuance of the contract. When OOs are added after award, the CO will furnish the Contractor with the names of individuals authorized as OOs, by memorandum upon OO appointment. OOs are responsible for issuing and administering orders placed under this contract. OOs have no authority to modify any term of this basic contract. Any deviation from the terms of the basic contract must be approved in writing by the CO responsible for this contract. The Contractor shall accept orders against this contract only from the CO and/or authorized OOs. Fulfilling orders from persons other than the CO or designated OO may result in loss or delay in payment for supplies/services provided under such orders.

Individual orders for Home Oxygen may be authorized by phone/fax/email by the following Ordering Officers appointed by the Contracting Officer in writing.

· Home Oxygen Clinic Coordinators

· Clinical Respiratory Supervisors

· Pulmonary Physician

1.7 Admissions to Home Oxygen Therapy Program: Criteria for admission are stated in the VHA Directive 1173.13, Home O2-Clinical Indications-10-07-2021 recommendations, Home Oxygen Therapy. The Contractor will have no role and is relieved of any responsibility for the admission of patients to NF/SG VA Healthcare Systems Home Oxygen Therapy Program. The Home Oxygen Coordinators, the COR, Alt COR or designee will provide the Contractor with notification to initiate individual patient requirements via fax or encrypted electronic means (telephonic for emergencies) and will also provide the Contractor with notification of VA initiated discontinuance of home oxygen. The Home Oxygen Clinics Medical respiratory staff will notify the vendor that a delivery shall commence by fax, telephonically or by encrypted email. The vendor shall confirm receipt of order immediately and prior to delivery.

The Contractor shall inform the COR of deaths or inability to service or locate a veteran (i.e. due to change of address). The Contractor is still required to provide monthly and quarterly service, replenishment of cylinders and supplies even if it requires making a special or non- scheduled visit to the patient's home.

1.8 Estimated Quantities: The quantities or dollar threshold listed in the Estimated Price Schedule, effective for the periods stated are estimates only and are not purchased by this contract. Except as this contract may otherwise provide if the VA's requirements do not result in orders in the quantities or dollar amount described. That fact shall not constitute the basis for an equitable price adjustment.

1.9 Contractor Qualifications: The Contractor shall possess all licenses, permits, accreditations, and certificates as required by local, state and federal law. Sub-contractors must meet same requirements as Contractor and adhere to ALL the requirements of this contract. The Contractor shall meet the Home Care part of the Joint Commission standards. Therapy in the Home or Alternate Site Health Care Facility-2007 Revision & Update, Association for the Advancement of Medical Instruments (AAMI) the American Association of Respiratory Care (AARC) Clinical Practice Guideline and the American Society for Testing Materials (ASTM) minimum standards specification for electrically powered home care portable ventilators and cough assists. The Contractor shall meet or exceed these and The Joint Commission accreditation for healthcare standards. The Joint Commission standards can be accessed at www.jointcommission.org.

The Contractor shall have at least five (5) calendar years’ experience in successfully administering basic and complex home oxygen, aerosol therapy, cough assists and ventilator care to adult and geriatric patients and experience in providing Home Oxygen and Medical equipment and supplies for gas Oxygen (02), liquid 02, portable and stationary concentrators, cough assists and ventilators. The Contractor staff shall include Licensed Respiratory Therapists (RCP) required for complex setups, i.e. oxygen over 4 LPM, cough assists and ventilators.

1.91 Accreditation: The Contractor shall maintain Joint Commission accreditation through the life of the contract and evidence of accreditation shall be submitted to COR. If the Contractor is resurveyed by an accrediting body during the contract term, the Contractor and COR shall notify the Contracting Officer of survey date, the outcome of the survey and the Contractor shall provide COR copies of new certificates as issued.

1.92 Location: The contractor shall have a physical location at award of the contract which houses the service office, warehouse, dispatch of vehicles and other functions related to the performance of the contract within the North Florida/South Georgia VA catchment areas. The Contractor’s office-warehouse location shall be within 20 miles of the Gainesville VAMC for site visits by the PSAS COR, VA staff or JC. The Contractor shall have telephone, facsimile, and encrypted e-mail communications capability.

The contractor shall designate a specific service representative to coordinate daily matters with COR. VA beneficiary account folders shall comply with the Privacy Act and health Insurance Portability and Accountability Act (HIPAA). All files are subject to review by designated Veterans Affairs Medical Center (VAMC) officials and accreditation surveyors on behalf of the VAMC during accreditation surveys or consultation.

1.93 Hours/Holidays: The Contractor shall, at a minimum, provide home oxygen in performance of this contract through scheduled visits, Monday through Friday between the hours of 8:00am and 5:00 pm EST including Holidays. Exceptions shall include the case of emergencies. The VA observes the eleven (11) Federal Holidays listed below:

New Year’s Day, Birthday of Martin Luther King, Jr., Washington’s Day, Memorial Day, Juneteenth National Independence Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day and Christmas Day.

1.10 Provision of Home Oxygen: The VA is to furnish the Contractor a roster of current patients fifteen (15) calendar days prior to the preceding of the contract. All deliveries (if there is a change of vendors) must be in place and operational within thirty (30) calendar days of the start of the contract. All initial deliveries must be done in a methodical sequence.

a. The Contractor shall replace all non-VA owned NF/SGVAHS equipment presently located in homes of patients as soon as possible after award from the date of contract award without causing a break in service and may not exceed 30 days without prior approval from the Contracting Officer. The CO will confirm with the COR with the acceptability of the replacement.

b. The contractor is to provide a plan of installation to the Contracting Officer within five (5) calendar days after the start of the contract. Installations will be completed in a systematic and methodical manner, i.e. all patients in any two/three counties per week. The CO will confirm with the COR with the acceptability of the transition plan.

c. Set up of all patients in any given area must be completed before beginning installation in another area. Upon completion of installation each patient is to begin using the equipment and cease using the incumbent’s equipment. After completion of the installation, the Contractor will immediately notify the NFSGVAHS who will, in turn, advise the incumbent Contractor to pick up their equipment.

d. This change shall include delivery, setup, instructions, all required supplies until next scheduled visit (30 -90 days) and shall be accomplished with the least disruption to the VAMC patient as possible.

e. Cost(s) will be prorated upon setup and discontinuance with equipment pickup no more than one billing cycle. Failure to perform the switch-outs as specified will result in a forfeit of payment for every day thereafter until switch-out is complete.

f. Upon delivery of oxygen refills, the contractor shall inspect the patient’s existing equipment and supplies, and clean, sterilize or replace same whenever necessary or required the awardee’s contract.

g. Supplies: The number of supplies provided shall be sufficient until next scheduled visit. The cost for supplies will be at no additional charge and shall be included in the initial setup, monthly or quarterly visit fee.

Note: Oxygen tubing shall be green to decrease the risk of falls and not exceed 30 feet. Per VHA Directive1173.13 and must meet the requirements for thermal fuses per the National Patient Safety Alert in 2018.

1.11 General Supply Schedule

a. Daily: Heat and Moisture exchangers used with artificial airways (31/month)

b. Weekly: Aerosol system accessories (e.g. trach mask, tubing, large volume nebulizer) EZWrap (or equivalent); Nasal Cannulas, Oxygen masks (e.g. Oxymask)

c. Monthly Humidifier bottles; Water traps; cough and ventilator circuits with connectors (plus additional one spare in reserve)

d. Replace when required: Thermal Fuses Bidirectional (intended life is 4 years) and to be replaced if actuated or involved in a fire.; Oxygen tubing connection swivel adapters.

1.12 Equipment Specification. The Contractor shall furnish cylinders called for under this contract that are only in accordance with the Interstate Commerce Commission Regulations and transport cylinders in accordance with Code of Federal Regulations (CFR) Part 49, U.S. Department of Transportation, including FDA.

When more than Two (2) portable cylinders are in the home a rack/container to secure the cylinders will be provided at no additional charge to the Government. A carry-bag, shoulder or backpack will be provided based on the patient’s physical condition and ability to carry the portable liquid or M6/B tank system with regulator/OCD at no additional charge.

The Contractor shall provide the following items to veterans as prescribed by the VA physician. The contactor agrees to a short-term rental or loaner of exact match equipment for the NF/SGVAHS veterans/patients home oxygen needs while VA owned equipment is being repaired or replaced.

Note: VA Owned Equipment will be used except when not available or feasible.

a. Monthly Rental Concentrators - electrical device that employs sieves and physical separation to deliver 90% or higher concentration of oxygen at flow rates up to 5 LPM. All related disposables are included. Backup H/K tank is included with monthly rental of Concentrator. Healthcare Common Procedure Coding (HCPC) code: E1390

b. Rental of Portable Oxygen Concentrator (for travel) - Battery operated concentrator to deliver 90% or higher concentration of oxygen at continuous flow rate of 3LPM and pulse dose flow rate up to 6LPM. HCPC code: E1392

c. Fire Safe Valves: Thermal fuse designed to stop the flow of oxygen if the downstream tubing is ignited. Included with supplies at no additional charge

d. Monthly Rental of: Liquid oxygen system - consists of large reservoir.

e. Monthly Rental of Lox portable unit that is filled from the reservoir. HCPC Code: E0439

f. Liquid Oxygen: Refills per pound (#) HCPC Code: E0444

g. Monthly Rental of: Setup of H/K Tank (Equal to 282 cubic ft.) with Stand, appropriate regulator and all related disposables are included. HCPC Code: E0443

h. E-Cylinder System with standard regulator, flowmeter, handcart, and all disposable supplies. HCPC code: E0443

i. Monthly Rental of Portable Oxygen Cylinder with cart, carry bag, continuous flow or Pneumatic Demand/Conserving Regulators.

j. Cylinder Racks and all related disposables are included.

k. Refills of H/M Tanks HCPC Code: E0443

l. Refills of "B" (M6) Cylinders: HCPC Code: E0443

m. Refills of "C" Cylinders: HCPC Code: E0443

n. Refills of "D" Cylinders: HCPC Code: E0443

o. Refills of "E" Cylinders: HCPC Code: E0443

p. Monthly rental of Compressor Air Power Source (High Speed): HCPC Code E0565

2.0 Cylinders. The Contractor shall furnish cylinders required under this contract that are in accordance with the Interstate Commerce Commission Regulations, and transport cylinders in accordance with Code of Federal Regulations (CFR) Part 49, U.S. Department of Transportation. ‘H’ or “M” cylinders furnished by the Contractor shall have ‘H’ or “M” safety stand(s) at no additional charge to the Government. This stand shall remain Contractor-owned.

2.1.1 Oxygen Cylinders provided shall be United States Pharmacopoeia (U.S.P.) oxygen. Cylinder safety racks shall be provided at no charge for all veterans with a prescription of compressed tanks (cylinders).

2.1.2 The Contractor shall provide and maintain the following oxygen equipment to the VA Medical Center Pulmonary Departments Home Oxygen Clinics Gainesville VAMC, Lake City VAMC, Jacksonville OPC, Tallahassee OPC as indicated.

a. A Liquid Oxygen Reservoir with 2 portable units – one Helios and 1 Marathon or equivalent twelve

b. (12) E tanks with cart, (3) conserving/demand flow regulators

c. (12) B/M6 with at least 2 carry bags (one shoulder, one backpack).

d. Replacement cylinders, regulators, lox portable and lox fills shall be approved prior to delivery by the COR via encrypted email.

e. Separate itemized invoices with supporting documentation “signed proof of delivery” for each location shall be submitted no later than the tenth of the month.

2.1 Ventilators: Ventilators are seen monthly.

The Contractor shall follow JC Homecare standards and AARC Clinical Practice Guidelines for Home Ventilators. Equipment and disposables shall be provided to patients receiving home ventilator. The Contractor’s RCP will assist in getting the ventilator patient settled in their home at time of discharge. Follow up weekly visits minimally for the first month may be required to ensure a smooth transition from hospital to home (at no additional charge) then monthly thereafter. The Contractor’s RCP will perform monthly visits for compliance, supplies, and equipment inspection/maintenance.

a. Initial setup/Monthly ventilator visits fee is all inclusive: equipment usage for compliance, 30-day month supply of tubing filters, HMEs; ventilator check/maintenance (Including back up vent). The VA will review and approve the Contractor’s forms to be used for the ventilator patients, i.e. the home inspection, ventilator checklist and training prior to the contract award.

Note: Follow up weekly visits minimally for the first month may be required to ensure a smooth transition from the hospital to home (at no additional charge) then monthly thereafter.

Ventilator patient discharges to the home will be arranged Monday Friday, unless previously agreed to by the contractor and VA. Prior to discharge the Contractor shall perform a Home Inspection of the veteran’s residence. The inspection will include electrical capacity, physical space and caregiver’s ability to provide for the veteran’s needs. The home inspection shall be sent to the ordering clinic for review and approval.

The Contractor will receive preliminary ventilator orders and the Contractor’s RCP will provide training to all caregiver’s and the veteran. Noncompliance or other concerns are to be reported immediately to the ordering clinic.

The discharge of the ventilator patient to the home may be held pending resolutions to caregiver or home environment safety concerns. The Contractor will receive preliminary ventilator orders and the Contractor’s RCP will provide training to all caregiver’s and the veteran. At time of discharge a final set of orders will be provided to the contractor with current ventilator settings and well as requests for any additional equipment.

The contractor shall provide rental of Ventilators (approved equivalent) when VA-Owned ventilator equipment is not available. A rental ventilator and back-up system will include disposable vent circuits with peep valve; all necessary cables and disposables (mask, tubing, filters, humidifiers, etc.), HME's. Contractor shall supply a Respiratory Care Practitioner to provide for monthly visits; annual equipment PM checks, per the manufacturer’s recommendations; and a backup ventilator (to be stored at or close by the location at which ventilator is being used by patient).

a. Contractor shall track ventilators for preventive maintenance in accordance with manufactures' specifications.

b. If there are no manufacturer’s instructions, then the VA designee from the home oxygen clinic and/or COR shall determine maintenance schedule.

c. If a ventilator needs maintenance, either scheduled or unscheduled, the contractor shall pick up the ventilator from the patient’s home and replace with another VA owned ventilator.

d. The patient shall always have two (2) ventilators, one as a backup, on hand. If non-invasive the second ventilator may be stored in the contractor’s warehouse.

e. The Contractor shall always keep one (1) or more ventilators in stock for replacement purposes. If inventory is low the VA COR is to be notified immediately for purchase of additional ventilators. If a rental ventilator is required until VA equipment is purchased, all related supplies shall be included and provided by the Contractor.

f. Contractor shall provide each site a quarterly report due on the 10th day following the end of the quarter containing the following:

1. Name and last four (4) digits of the social security number of the beneficiary.

2. Serial number of the ventilator.

3. Date of last preventive maintenance.

4. Date of next scheduled preventive maintenance.

g. Registered Respiratory Therapist Responsibilities/Competency shall include:

1. Home Ventilator Equipment Management

2. Competency shall be completed annually for each type of mechanical ventilator managed by contractor respiratory therapist.

3. Oxygen delivery.

4. Aerosol equipment.

5. Tracheotomies.

6. Airway care.

7. Suction machines.

8. CPR.

9. Cough Stimulating Device

10. Home Oxygen Risk Safety assessment

h. Competency of the contractor’s Registered Respiratory Therapists (RRT) shall remain the responsibility of the Contractor.

2.2 Cough Assists: Cough assists are seen monthly, and the fee is all-inclusive.

The Contractor’s Respiratory Care Practitioner (RCP) RRT will take the cough assist to the home along with sufficient supplies to allow weekly circuit, filter changes. Perform instruction and observe return demonstration, until confident the veteran can use the device appropriately. A compliance report shall be sent to the ordering VA clinic to include as a minimum current order vs actual usage, interface, cough production/efficacy, hospitalizations since last visit, caregiver/patient comments. Routine preventative maintenance as defined by the manufacturer.

2.3 Air Compressor. Contractor shall provide and maintain 50-PSI compressors to run large volume nebulizers and other various respiratory needs.

a. Setup shall include all disposables large bore tubing, large volume nebulizers, drain bags and masks at no additional charge. Rental and supplies are all inclusive

3.0 Care Plan: The Contractor shall provide an in-home initial patient setup/delivery, restarts, relocation and installation of prescribed equipment within twenty-four (24) hours of notification to include weekends and holidays. If the contractor is unable to meet the 24-hour response time the contractor must notify the ordering clinic. NF/SGVAHS reserves the right to obtain the service from another source and to charge the contractor. A setup includes delivery of prescribed Home Medical equipment with applicable disposables and backup equipment. Orientation to the vendor’s services, an equipment inspection, patient education with return demonstration, a home safety review and inspection, scheduling of ongoing deliveries and preventive maintenance inspection (PMI) service appointments.

Home oxygen services are provided to any patient that is under NFSG/VHS primary care. At times, Veteran’s may live outside of our actual “catchment” or Geographic area. The ordering home oxygen clinic will identify these patients as “Out of Area”. COR will coordinate with the contractor for these veterans/patients. Subcontractors shall adhere to all Joint Commission standards and the requirements of this contract. Home Oxygen services for these designated out of area patients will be on a case-by-case basis.

a. For equipment issued, a care plan shall be completed by a licensed Respiratory Therapist in 24 hours for all complex setups and 78 hours for basic.

b. Prescription renewals/changes shall be reviewed by the contractors.

licensed RCP with the patient.

c. At home training is required for all prescription equipment changes (i.e. B tank via OCD regulator to E tank via Continuous regulator) or change in complexity (i.e. Basic 3lpm to Complex over 4lpm).

d. The Delivery Driver/RCP will provide the patient with a welcome packet on first visit. All patient education material must be presented in written form to the COR for approval prior to the award. The written material shall be in English as well as the foreign language of the beneficiary as applicable. In the case that the beneficiary does not speak English the Contractor is to advise the VAMC of any occurrences so that the VA can assist with language barriers. This includes any coordination of instruction/delivery of equipment for those veterans with special needs. i.e. vision impaired may need a blind rehab specialist to be present at time of instruction This packet will include, but not be limited to, the following:

NF/SGVAHS

· Patients’ Rights and Responsibilities, and other general information. Information regarding Advance Directives

· Contractor’s Toll-Free Number, Hours of Operation, Location

· Contractor’s Mission, Vision.

· Contractor’s Complaint Process.

· Patient Educational Information provided initially and at prescription changes/renewals

· Emergency Preparedness Information.

· Emergency Contact Names and Phone Numbers.

· Fall and Fire prevention.

· “No Smoking, Oxygen in Use” signs minimally two for front door and rear entrance must remain posted. (replace as needed)

· Verification of 2 smoke alarms present, alarm when tested, be tested monthly, if not

· present contractor is to notify the ordering clinic.

· Documentation verifying placement of Thermal Fuses per AL18-01 safety mandate,

· unless there is a documented clinical contraindication (e.g., patients using heated

· humidity, patients with flow rates more than 25 liters per minute, patients with behavioral

· conditions that make use of thermal fuses impractical). This must be documented in the patient’s medical record.

Two thermal fuses must be provided and installed in each home oxygen delivery system (one at the patient end and one at the oxygen source). This shall be done for the patient’s primary oxygen therapy equipment as well as any portable oxygen therapy equipment. Thermal fuses are considered part of the routine oxygen supplies required for setup and will be provided at no additional charge. Thermal fuses are not required for portable pulse dose/intermittent oxygen therapy equipment when the equipment does not have a continuous flow setting.

a. Thermal fuses provided must work regardless of their orientation in the oxygen tubing (bidirectional) or have a design that prevents them from being installed in the wrong orientation (e.g., source end of the thermal fuse has threads or bayonets that make backwards installation impossible).

At the time of installation, education must be provided to the patient describing the proper use and placement of thermal fuses, including that a thermal fuse does not make it safe to smoke, be near people who are smoking or be near any source of sparks or flame while using oxygen. It should be emphasized that the thermal fuses will not prevent burns to the face, neck and airways if the ignition occurs at or near the nasal cannula. The thermal fuse does not prevent the start of a fire nor extinguish a fire; it simply limits the flow of oxygen that might continue to feed the fire.

**The presence of the “Home Oxygen Welcome Packet” and educational materials shall be inspected upon each subsequent delivery to the patient and will be replaced if missing. The contractor will at least once every three (3) months, perform a quarterly visit to the VA beneficiaries and reassess equipment compliance, provide supplies, educational needs, and equipment maintenance. A report supporting documentation of visit will be submitted with the monthly invoices.

The Contractor shall complete a Care plan and a Home Oxygen Equipment check per manufacturer’s instructions and complete a quarterly equipment check at a minimum. An adhesive sticker or service card, depicting the date of inspection/pm and the date of the next required inspection/pm will be annotated using a permanent marker, on said equipment. Documentation shall include analyzation of oxygen and verification of liter flow rate as prescribed. A signed copy shall be left with the patient and/or caregiver. All VA owned equipment will be labeled. Cough assists and ventilators (invasive and non-invasive) require monthly equipment checks.

The Contractor will assess or reassess Home Oxygen Medical Equipment and the patient’s need(s) whenever there is a change in the prescription or renewal. This will include an in-home safety inspection, all patient training with return demonstration, treatment care plan, patient education to insure understanding and appropriate use of equipment. Cough assists, and ventilators require monthly equipment checks. The Contractor shall document the patient receipt of all forms in their patient file, database.

The Contractor’s Delivery Driver, Respiratory Therapist or Contractor designee will immediately contact the NF/SGVAHS COR when one of the following occurs:

a. Non-Compliance of prescription

b. Veteran Abuse/neglect concerns

c. Any unsafe conditions observed which may preclude the installation or continuance of oxygen.

· Fall - safety concerns.

· Oxygen safety or Fire concerns For fires, the Contractor shall perform a Root Cause Analysis (RCA). The information gathered in the RCA shall be provided to the VA. Per VHA Central Office Patient Safety Alert (AL18-01) All identified oxygen safety concerns or fires must be reported immediately to the COR and ordering VA clinic. Additionally, for fires, the required information is reported as follows:

a. What was the reported cause of the fire (primary ignition source)?

b. Where did the fire originate (e.g., kitchen, bedroom, vehicle)?

c. What date and time did the fire occur?

d. What was the first item that ignited (e.g., nasal cannula, clothing)?

e. Describe the extent of injury to the patient, family and others.

f. Describe the extent of property damage.

g. How many thermal fuses were in use and where were they installed in the home oxygen delivery system or tubing?

The COR will inform the Malcom Randall Patient Safety, Home Oxygen Clinic Respiratory Care, Pulmonary, who will alert the clinical staff/provider and communicate appropriate interventions to the Contractor.

3.1 Oxygen Safety Valves: Two thermal fuses must be provided and installed in each home oxygen delivery system (one at the patient end and one at the oxygen source). This shall be done for the patient’s primary oxygen therapy equipment as well as any portable oxygen therapy equipment. Thermal fuses are considered part of the routine oxygen supplies required for setup and will be provided at no additional charge.

a. Thermal fuses are not required for portable pulse dose/intermittent oxygen therapy equipment when the equipment does not have a continuous flow setting.

b. Thermal fuses provided must work regardless of their orientation in the oxygen tubing (bidirectional) or have a design that prevents them from being installed in the wrong orientation.

c. Contractor shall ensure that bi-directional oxygen safety valves are installed on all home oxygen systems (stationary and/or portable equipment) at the next scheduled home visit.

4.0 Quality Assurance, Coordination, Supervision and Evaluation of Care: NF/SGVAHS clinical staff will coordinate, supervise and evaluate the care required by outpatients to include initiation of prescriptions for home oxygen and various equipment items, devices or other appliances which may be medically indicated for the continuation of care in their home environment. The clinical staff will be notified of patient refusal of service against medical advice (AMA), suspected abuse or neglect. Contractor will notify the prescribing VA clinic and COR of needed prescription renewals for patients two (2) months prior to the expiration date of the existing prescription.

4.1 Contractor Quality Reports: The COR will have oversight responsibility to ensure Contractor home oxygen is complying. with the terms of the contract. The contractor shall be required to submit to the COR the following reports:

a. Sub-Contractor Notification; Unsafe Condition Report, Impending Disaster, Incident Report, Sentinel Events, Equipment malfunction/recalls per Federal Drug Administration (FDA) at time of occurrence, certification of required staff training and current license verification.

b. Weekly a VA-Owned Equipment Inventory Status Report will be submitted to the COR at the beginning of the week for all VA-Owned equipment. Report will include all VA-owned equipment delivered to the contractor, for storage, maintenance and issue.

i. identified by make, model and serial number: indicate new or used status (i.e. issued to/returned from name/last 4, defective, replaced with serial#,); sort list by type of item and provide a total for each equipment type.

ii. If VA-owned equipment is stored at various locations, the storage location will also be provided. Any disparity between total equipment provided to contractor and total in Report will be promptly resolved between Contractor and the COR. Used as a method to confirm accountabilities for all VA-owned equipment at any given time.

c. Monthly service report for each patient visited will be submitted in conjunction with submitting the invoices. The contractor shall provide for each VA site an equipment summary listing all items issued to each patient. and picked up.

i. Equipment will be identified by make, model, serial number, new or used VA equipment.

ii. Lists are to be sorted alphabetically by item then the patient’s name.

iii. A total will be reflected at the end of each item column to indicate how many of that item in the patient’s homes (i.e. concentrators, conservers, B-tanks, E-tanks, Lbs. of Liquid Oxygen (LOX), etc.).

iv. A Delivery/Pickup Equipment Report to be submitted by the 10th of each month to assist in updating data into the patient’s VA prosthetics record. The following reports are provided via email as one Excel Report with separate worksheets therein. This spreadsheet will list deliveries, pickups of all VA issued equipment. Concentrators, Portable Oxygen Concentrators (POCs), Self-Fill System with cylinders, Oxygen Conserving Devices, Regulators, Cough Assists and Ventilators and include the patient’s name, last 4, identify equipment as new/used, quantity.

v. Defective VA equipment for repair/replacement or disposal.

vi. A Sales Report to include each item issued to patients, the total amount charged to the VA for the item. List will reflect charges for each VA listing the total for each item and a grand total for all items.

On a quarterly basis a Quality Management (QM) Plan to include:

a. Performance Improvement (PI) reports in accordance with Joint Commission for improving organizational performance.

b. Patient Satisfaction, Infection Control/Communicable Diseases

c. Hand Hygiene Data as required by JC and CDC

d. Influenza Vaccine Data.

The Contractor shall comply with JC and NF/SGVAHS policies and procedures on infection control and infection surveillance. The Contractor employee health files shall contain a copy of The Contractor Staff Member’s annual TB test results and Hepatitis B vaccination documentation. If a Contractor staff member refuses to either test, such refusal shall be documented in writing and shall be maintained in their file. All Contractor staff involved in the delivery, pickup and storage of home oxygen will be instructed on the importance of infection control and personal hygiene and their responsibilities in the infection control program.

a. Procedures shall address personal hygiene, aseptic procedures, staff health and transmitted infections and appropriate cleaning, sanitation and storage of equipment. Appropriate staff shall be instructed in the identification, handling and disposal of hazardous and/or waste materials in a safe and sanitary manner in accordance with applicable laws and regulations.

b. Contractor staff members with contagious illnesses shall have no contact with patients or clean equipment. Exceptions would be Contractor staff members with a mild cold or similar condition. In such cases, gloves will be worn, and contact will be extremely limited.

c. The Contractor Security Control Assessment shall be submitted annually to the COR. COR, PSAS RRTs, or Prosthetic Representatives will make unannounced Contractor site visits quarterly for a vendor site audit.

d. COR, PSAS RRTs will make random patient home visits monthly. COR or PSAS RRTs may request “ride-along” with contractor technician or RCP for observation of service provided. The Contractor will be provided a seven (7) calendar day notification in advanced notice. In addition, the COR may request to take part on a random day delivery schedule to accompany the Delivery Driver or the RCP during their NF/SGVAHS delivery schedule. On a limited basis, it may be necessary to make an emergent visit which will be coordinated with the Contractor.

NF/SGVAHS Chief of Prosthetics, COR or designee will communicate with the Contracting Officer any high risk, problem-prone, and quality improvement issues.

5. SCHEDULING VISITS

5.1 VETERAN/PATIENT RELOCATION: NF/SGVAHS will be responsible to provide home oxygen for the first ninety (90) days after a patient permanently relocates to another VAMC catchment area. It will be the veteran’s responsibility to enroll at the nearest VAMC, make an appointment with the Respiratory/Pulmonary Clinic for home oxygen and receive a new prescription. The contractor shall provide contractor owned equipment for veterans/patients relocating to another VAMC location, unless otherwise approved by the COR for the veteran/patient to utilize VA-owned equipment. The contractor shall inform the veteran/patient, care giver or veteran/patient representative and both parties must agree in writing and sign that the veteran/patient, care giver or veteran/patient representative will be financially responsible for any/all non-returned contractor equipment. Recovery of contractor-owned equipment will be at no cost to the VA.

If applicable, the contractor shall recover all VA- owned equipment from the veteran, care provider or veteran/patient representative and ship directly to the contractor’s warehouse.

Contractor will verify operation per manufacture guidelines before placing back into service.

Note: The contractor shall include the following information on the monthly invoice for the return shipment of VA owned equipment: an itemized list of equipment to include the patients name, billing receipt(s), documentation (i.e., FedEx or UPS) estimated charges.

6. EMERGENCIES: The Contractor shall have an established communication system that supports 24-hour emergency services seven days a week. The Contractor shall be able to provide emergent home oxygen at the patient’s home within a maximum of four (4) hours of call and for patients being discharged on the same day from inpatient care.

a. The Contractor shall ensure all patients have minimum backup to maintain prescription requirements. The Contractor shall provide battery backup for cough assists, ventilators up to 24 hours and non-electrical oxygen supply to last three (3) times the contractors response time to a call. The minimum supply for oxygen shall consider each patient’s prescription flowrate and distance from the contractor’s location; actual supply levels may differ from patient to patient, as long as each patient has oxygen supply to last a minimum of three times the contractor’s response time.

b. If the Contractor is unable to respond to an emergency service within four (4) hours a written explanation of Contractor’s inability to provide emergency service shall be provided to the COR or designee within one (1) business days.

c. Liquid oxygen supply may be considered for backup oxygen; however, oxygen must be maintained at the minimum three (3) times the Contractor’s response time, and the cost of any additional equipment, such as extra stationary units used solely to maintain the minimum level of backup oxygen or for contractor convenience of outspreading the time between fills shall be borne by the Contractor. No cylinder size “E” or smaller shall be used as back up.

d. The Contractor shall notify the COR or his/her designee immediately in the event of a disaster, natural or otherwise, that may affect patients of the home oxygen program covered under the contract. Contractor shall submit an Emergency Contingency Plan for natural disasters with a detailed proposal. During a disaster or other emergency, the contractor is responsible to ensure all veterans are contacted:

· At initiation

· During and post response of the emergency

· Updates on veterans contacted.

· Those not contacted.

· Contingency plans

· Response effort

Oher information will be provided to the VAMC on request. A Post Emergency Plan activation report shall be provided at the end of the response.

Additional back-up equipment and supplies will be provided for as long as the emergency lasts to ensure the Veteran’s prescription needs are met. These excess deliveries will be annotated on the next month’s invoice as “disaster response” for; i.e. Hurricane Smith for appropriate reimbursement. Failure to annotate in the invoices accordingly will result in non-payment by the VAMC.

Contractor shall develop Special Equipment Identification Codes to identify North Florida/South Georgia VA owned equipment and services to veterans from other catchment areas provided as a result; of hurricanes, acts of God and/or emergency situations.

· Invoice to list veteran, location, equipment, service provided and type of emergent situation.

· An updated Emergency Contingency Plan shall be provided annually to the COR.

· The Contractor will communicate with the COR during yearly hurricane or natural disaster drills as decided by NF/SGVAHS leadership.

· Contractor shall provide names and phone numbers of suppliers that will provide home oxygen in the event of any disaster where the Contractor cannot meet the needs of VA patients.

· A safety/emergency checklist shall be completed, then signed by the veteran or his/her caregiver and retained in the beneficiary account folder.

7. SCHEDULING HOME VISITS: The Contractor’s responsibility for the scheduling of equipment installation, monthly equipment checks, quarterly equipment checks, and equipment pickup shall adhere to the contract requirements. When scheduling visits, every effort should be made to accommodate the patient and/or caregiver.

a. Initial delivery of equipment is to be completed within 24 hours of receipt of the order. A licensed RCP shall see all basic setups within 78 hours and complex setups within 24 hours for the initial education.

b. Monthly equipment checks shall be completed by the RCP for all ventilator and cough assists.

c. Quarterly visits shall reassess equipment compliance, educational needs, equipment maintenance.

d. Equipment pick-ups shall be completed within 3 days of receipt of the order.

e. Contractor’s responsibility for the scheduling of equipment installation, monthly and quarterly equipment checks, and equipment pickup shall adhere to the contract requirements. When scheduling visits, every effort should be made to accommodate the patient and/or caregiver.

f. Instruction shall include a return demonstration from the patient/caregiver showing that they understand what they were shown.

Any accidents or injuries related to equipment and safety management will be investigated by the Contractor. Equipment malfunctions resulting in any sentinel event such as serious injury or death will be reported to the manufacturer and the Chief of Prosthetics or COR within forty-eight (48) hours of the Contractor’s knowledge of said event(s). The contractor will promptly notify the PSAS of any hazards, defects or recalls by the manufacturer for any equipment purchased from the Contractor.

8. Safety: At the time of initial setup and during home visits, the Contractor shall perform a home risk safety inspection of the patient’s home and environment, for safety concerns (i.e. proper storage of cylinders, signs of unsafe oxygen use as in smoking) including a Fall Risk Assessment, in accordance with JC standards. And maintain documentation in the individual patient’s file or folder. At the time of setup and during home visits, the Contractor shall ensure smoke alarms are present and test the alarms to ensure functionality. In the event the Contractor finds no smoke alarms present in the home, the Contractor shall contact the ordering Home Oxygen Clinic and COR or designee, in writing, so appropriate action can be taken.

The Contractor shall notify the ordering Home Oxygen Clinic and COR or designee during any home visit if the Contractor’s staff determines that the presence of oxygen in the home presents such a danger that the oxygen must be removed, on in the initial case of setup, not placed in the residence.

The Contractor shall verbally notify the ordering home oxygen clinic, COR or designee immediately and in writing by the next business day of any unsafe conditions observed in the VA patient’s home that preclude the installation or continuance of oxygen.