VA259-17-R-0100-A00006002.docx

PERFORMANCE WORK STATEMENT (PWS)

23 June 2017

1. General:

The Department of Veterans Affairs (VA) has a requirement for home oxygen services to VA beneficiaries throughout Veteran Integrated Service Network (VISN) 19 comprising of the states of Montana, Wyoming, Colorado, Utah, and Oklahoma with some service into Nevada, Idaho, North Dakota, Kansas, Texas and Nebraska.

2. Description of Services/Introduction:

The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to provide home oxygen as defined in this Performance Work Statement (PWS); except for those items specified as Government furnished property. The services associated with this contract include: all logistical/administrative functions involved with the day to day operation of providing the service to the Veteran and their families, including furnishing warehouse space, surplus supplies, and in home respiratory therapy visits. This includes providing a Quality Control (QC) Plan about how the contractor will comply with the requirements of the contract to include coordinating and managing patient care, deliveries consisting of pickup and delivery of supplies, briefing patient on proper use of equipment, documenting use of supplies and inspection of home in relation to home oxygen in accordance with The Joint Commission (TJC) concerning patient use/safety of home oxygen standards. The requirement includes providing in home supplies such as the following: low decibel concentrator (rental) with two broad categories of flow rates and replacement parts; various cylinder sizes (rental) to provide oxygen [ex. A (smallest)-E (largest)H and/or M] and replacement parts; liquid oxygen; valved fireproof cannula; procurement/distribution of two types of oxygen and backup/spare parts; nasal cannula to include micro nasal cannula, high flow, OCD and or Dual OCD, Oxymizer pendant, nasal cannula with cushion ear piece, soft pronged nasal cannula/masks to include Oxymask, tracheostomy mask, bi-flow nasal mask, aerosol mask and replacement parts, and any interface, adapter or connection to enhance oxygen delivery/masks and replacement parts; oxygen bleed in connector, portable oxygen systems (used when a Veteran travels); Contractor is responsible for delivery and associated services related to delivery/proper use of equipment.

3. Objectives:

The Contractor shall provide home oxygen services for VA outpatients. These services include delivery, set-up, education, pick-up, cleaning, preventative maintenance, after-hours support, and storage of equipment. Services apply to vendor provided and Government supplied equipment.

4. Scope:

This PWS defines the effort required for the delivery, setup, education installation, and management of home oxygen services, in accordance with applicable TJC home care standards, to Veteran beneficiaries serviced by the VISN 19. All content contained herein regarding TJC standards shall be interpreted in the following manner. In other words, the Contractor shall be TJC accredited throughout the life of this contract. All issuing and follow-up care provided under this contract shall be provided in accordance with all current TJC standards. If the Contractor is re-surveyed by The TJC during the contract term, the Contractor shall notify the Contracting Officer (CO) and Contracting Officer’s Representative (COR) of survey dates, the outcome of the survey and provides copies of new certificates. Contractor’s facility(ies) may be inspected by the VA prior to the contract award. The use of the terms “beneficiary”, “Veteran”, “Patients”, and “patient” are used interchangeably and refer to the recipient of required supplies, equipment, and incidental services required under the contract.

5. Work Load Data:

VISN 19 currently serves an estimated 20,791 oxygen-using Patients per month. The volumes or amounts shown in the Contract Line Item Numbers (CLINs) are estimates only and impose no obligation on the VA. The contract shall be for the actual requirements of the VA as ordered by the VA during the life of the contract. Below is a list of each location estimated oxygen-using Patients per month.

6. Ordering Process:

The COR or designee shall provide (via encrypted email and/or fax) the Contractor with notification to initiate individual patient service requirements, including the patient's oxygen prescription by authorized Licensed Independent Practitioner (LIP), equipment, supplies and services to be provided including date and place of delivery. The Contractor shall confirm receipt (via encrypted email and/or fax) of the request within one (1) working hour of notification to the ordering facility. Per Facility’s discretion the COR or designee shall also provide (via encrypted email and/or fax) notification if VA owned equipment is to be provided. The COR or designee shall also provide notification (via encrypted email and/or fax) to the Contractor of VA initiated discontinuation of service. The contractor shall provide the VA with a list of make, model and serial number(s) of all VA equipment picked-up from veterans upon discontinuation of service within 48 hours. The Contractor shall provide a toll free telephone number for the purpose of communicating with VA eligible beneficiaries (Veterans) and VA staff. In addition, the Contractor SHALL NOT place collect telephone calls to the VA or to any VA beneficiary, family member or caregiver.

7. Quality Control:

The Contractor shall develop a QC plan to ensure compliance with all applicable/current guidelines put forth by TJC standards and this PWS. The Contractor shall also develop and maintain an organization-wide planning structure and processes that focus on safety and quality to ensure services are performed in accordance with this PWS. The QC shall be submitted as part of the technical proposal. The QC plan shall address at a minimum:

a. Patient satisfaction data.

b. Initial Patient Set-Ups within 4 hours from notification if emergency, if routine within 6 hours.

c. Documentation of Patient Set-ups.

d. Emergency Services with 4 hours of notification.

e. Semi-annual TJC reports.

f. Incident reports within 24 hours.

g. Quarterly Customer satisfaction reports.

h. Semi-annual infection control reports.

i. Semi-annual performance improvement reports.

j. Preventative maintenance on equipment.

k. Preventative maintenance reports monthly.

l. 90-day reassessment of patient after initial set-up/equipment installation and submit reports.

m. Disaster Preparedness Plan.

n. Plan for prevention and control of infection

8. Patient Education Requirements:

The Contractor shall provide education or re-education to each Veteran and/or caregiver on all equipment which they are being used to include travel literature upon initial setup. This information is to be presented written and verbally on equipment, supplies, and services in the preference or learning style based on need. Education in demonstration and material covered shall be in written form to be left with the patient or care giver. The written material shall be in English as well as the foreign or preferred language of the patient; in the event the patient does not speak English. The Contractor provides information and instructions about infection control issues related to equipment and supplies it provides. The Contractor must evaluate the patient’s and/or caregiver’s understanding of the education and training it provided. Contractor provides education on how to communicate concerns about patient safety issues that occur before, during and after care is received. The Contractor, as directed by CO or COR shall implement any new or revised education material. The VA shall determine whether the Contractor shall use their forms or forms supplied by the VA for documentation of education services provided to Patients.

9. Patient Rights and Responsibilities:

The Contractor shall provide a copy of VA approved Patient Rights & Responsibilities and any applicable information concerning advance directives during initial setup to all patients.

10. Reports:

a. Incident: Reporting special incidents found or occurring during a home visit, to include finding patients in need of emergency medical assistance, safety hazards that do not fall into the category of presenting immediate life-threatening danger to the patient or Contractors staff, inability to contact a patient within a reasonable period of time, and any other incident meeting the Contractors written policy for incident reporting according to accreditation standards. Patients who are found to smoke, or acknowledge that that smoke, or a family member reports they smoke, at the time of initial set up, or at any subsequent home visit by the vendor’s employees, will be considered high risk patients and VA is to be notified within 24 hours of such information being identified. Notification will be sent via PKI encrypted email to facility COR.

b. Customer Satisfaction: In accordance with TJC standards the Contractor shall collect data on service satisfaction from contracted patients and their families from each facility on a quarterly basis. A copy of survey results shall be submitted to COR or designee in quarterly reports. 100% of patients will be offered the survey opportunity during the quarter with report reflecting number who participated.

c. Infection Control/Communicable Diseases: Quarterly Report shall include data related to the Contractor’s ongoing Infection Control Program.

d. Performance Improvement: The Contractor shall collect data on important processes and outcomes related to patient care and organizational functions on a semi-annual basis.

e. Emergency Patient Safety: The Contractor shall provide the following emergency patient safety reports, within five (5) business days of the action, throughout the contract period.

1) Sentinel Events: The Contractor is required to inform the COR or designated person within one (1) business day of a sentinel event (as defined by TJC) that occurs during the performance of this contract that involves VA beneficiaries.

2) Refusal of service: All beneficiaries have the right of refusal of service. In the event a beneficiary refuses service or orders the equipment to be removed from the home, the Contractor shall comply with the beneficiary’s wishes, however in addition to a written report; the Contractor shall report the specifics of the refusal to the COR or designee by telephone within one (1) hour (follow up via encrypted email and/or fax, within 24 hours). The Contractor shall obtain signed Against Medical Advice (AMA) form from veteran at time of service refusal and notify COR/designee within 24 hours.

3) Suspected incident: The Contractor shall report suspected incidents of abuse or neglect to the patient by family members or caregivers. Suspected incidents shall be reported immediately (within 24 hours during business hours) to the COR or designee, as well as to the adult protective agency. The Contractor shall follow all state and local laws in reporting suspected incidents of abuse or neglect.

f. Meetings:

1) The Contractor shall meet, or participate in a conference call, with each station COR on a monthly basis to discuss the progress of the service being provided to VA beneficiaries. Each station COR will discuss with the Contractor any issues and complaints from the Government, beneficiaries, or the Contractor. Any and all issues and complaints from the prior month will be addressed to ensure that all corrections have been made and a process is in place to help ensure corrections remain in effect. Each station COR will maintain a complaint log to ensure all issues and complaints are addressed.

2) The Contractor shall meet with or participate in a conference call with the Contracting Officer and each of the station CORs on a quarterly basis to discuss the progress of the contract and to address any issues or complaints from the government, beneficiaries or contractor. Any and all issues and complaints from the prior quarter will be addressed to ensure that all corrections have been made and a process is in place to help ensure corrections remain in effect. The COR will submit to the Contracting Officer each quarter a COR Quarterly Report that will address any issues or complaints.

11. Infection Control/Communicable Diseases Requirements:

a. Contractor shall have a QC plan for prevention and control of infection. The plan shall meet current TJC standards. Quarterly reports shall be provided to the COR within the first seven 7 calendar days of the first month beginning the new quarter.

b. Contractor shall provide a list of names to the COR or designee of all veteran patients exposed to communicable diseases by contracted staff during an identified incubation period. The type of exposure shall also be identified. This report will be provided to the COR within 24 hours of known exposure to the veteran patient.

c. The COR or designee shall consult with VA infection control staff regarding the need to contact exposed patients and/or complete any needed medical follow-up.

d. The Contractor shall report non-compliant reported or observed behavior with fire safety guidelines set forth in the patient education and re-assessment material and/or behaviors which pose a risk of self-harm or harm to others. Such behavior shall be reported to the COR or their designee during the home visit if the Contractor's staff determines the patient's non-compliant behavior, within the home environment, is not improving after education on the fire hazard of smoking when on oxygen treatment is provided. Noncompliant behavior and any follow-up actions (i.e. educations) shall be documented. Notification to the COR is required by the vendor within 24 hours of the incident.

12. Holidays:

The Contractor is required to perform services 365 (366 leap year) days a year, to include all holidays.

13. Place of Performance:

Services shall be performed in the Veteran's place of residence, VA Medical or VA authorized Facilities for patients being discharged who require oxygen for travel to their residence. An adequate supply of aluminum/composite compressed O2 tanks, with regulator, and E-tank stands shall be provided and stored at each participating VA listed in the Schedule, their respective community based outpatient clinics (CBOCs), as directed by the COR. Quantities, and sizes of tanks, shall vary from site to site and shall be agreed upon by the Contractor and facility COR. The reserve supply shall accommodate home oxygen patients who are either being discharged from the hospital or visiting (appointments, etc.) and require a supply of oxygen to reach their home. Adequate inventory levels shall be maintained by the Contractor, as determined by the facility COR. This reserve supply shall be provided at no additional cost to the Government. The area of service shall be all patients serviced by VISN 19, regardless of where patient resides. The equipment needs are subject to change as determined by the prescribing physician. Contractors shall have a facility or resources physically located in the geographic area in which they shall provide service. VA Health Care Systems and Medical Centers which are serviced by the VISN 19 include, but are not limited to the following (see Section D Attachments for detailed map of counties):

a. Eastern Colorado Health Care System

b. Grand Junction VA Medical Center

c. Cheyenne VA Medical Center

d. Salt Lake City Health Care System

e. Sheridan VA Medical Center

f. VA Montana Health Care System

g. Oklahoma City VA Health Care System

h. Eastern Oklahoma VA Health Care System

14. Special Qualifications:

a. Each branch office or distribution point shall meet or exceed all applicable TJC standards. Any and all documentation related to the patient record during the duration of this contract is the property of the VA and shall be turned over to the new Contractor as part of the Phase In/Phase Out upon the termination or non-renewal of this contract.

b. The Contractor shall have written policies and job descriptions that specify staff requirements to the specialized equipment, supplies and services it provides to patients such as; qualifications, experience, applicable certification, registration or license, training requirements and continuing education requirements. Contractor shall provide the CO/COR or designee with documented competency training to deliver prescribed supplies/cylinders/liquid oxygen (LOX) as required to each patient as needed.

c. The Contractor shall adhere to the provision of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI).

d. The Contractor shall internally maintain a patient account folder holding all documentation related to the supplies and services provided in compliance with the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA). All patient files are subject to review by designated VA officials and accreditation surveyors on behalf of the VA during accreditation surveys or consultation. At a minimum the patient folder shall adhere to current TJC standards for patient record keeping.

e. The Contractor shall provide upon request all Contractor personnel files; which shall comport to Federal & State laws/regulations which shall contain information relative to the contract requirements for each individual providing services is support of this contract. Information should include experience, training records, performance reports and any certifications/licenses. Contractor files for VA patient records will be maintained under double locks with keys (ie key locked file cabinet and key locked office door)

f. The Contractor shall provide CO/COR or their designee with a list of all employees currently competent to perform delivery/recovery and patient education services at the time the contract is awarded and through the life of the contract whenever there is a change to staffing. COR or their designee shall inspect employee files at the time of the inspection of Contractor premises and vehicles. Employee files shall be maintained at the local contract site.

g. The Contractor shall educate, evaluate and document employee education in strict accordance with current TJC accreditation standards.

h. Only employees that have been properly trained and who have demonstrated competency shall perform equipment deliveries, recoveries, and patient education on the equipment.

i. The contractor shall obtain PKI certification for all branch location managers to ensure secure communications.

15. Key Personnel:

The Contractor shall provide a listing of key personnel required to successfully implement this requirement within 30 days after award of contract to include all Certified Respiratory Therapists (CRT), Registered Respiratory Therapist (RRT), and/or Registered Nurse (RN). Key personnel are the members of the Contractor’s management team. In addition to having key personnel on the contract, the Contractor must also provide and maintain a comprehensive list of employees that are to be used in support of this contract action. Although these positions are not referenced as key personnel, they are integral in maintaining continuity of operations in support of this contract. The successful Offeror shall provide a quarterly listing of all personnel used in support of this contract. In the event a new contracted employee is brought on to support the contract, the Contractor shall notify the COR or designee immediately. * The Contractor shall be responsible for the correct title classification of workers and compliance with all applicable wage and hour laws, reference Department of Labor (DOL) wage rate information. (http://www.wdol.gov/sca.aspx).

16. Registration /Licensure/Accreditation requirements:

Contractor is responsible to comply with all applicable Federal & State laws/regulations in support of the contracted requirements.

a) Registration: National Provider Identification (NPI)

b) Distributor License:

1) Applicable State(s)

2) FDA permits and licenses as applicable

3) The Contractor's Respiratory Care Practitioner (RCP) shall be credentialed with the National Board for Respiratory Care (NBRC) and hold a current state license where the work shall be performed.

4) All personnel servicing Veterans shall maintain a current valid driver’s license.

c) TJC Accreditation (Primary Contractor).

d) Certified Respiratory Therapists (CRT), Registered Respiratory Therapist (RRT), or Registered Nurse (RN).

17. Service Transition (Phase In/Phase Out):

a. In the event award(s) are made to other than the incumbent Contractor, the new Contractor(s) shall arrange with the incumbent Contractor for exchange of equipment ensuring that there is no disruption of supplies/services to veteran beneficiaries. The Contractor recognizes that the services under this contract are vital to the Government and must be continued without interruption and that, upon contract expiration, a successor, either the Government or another contractor, may continue them. The Contractor agrees to furnish phase-in training; and exercise its best efforts and cooperation to effect an orderly and efficient transition to a successor. The Contractor shall, upon the Contracting Officer’s written notice, furnish phase-in, phase-out services for up to 90 days prior to this contract expiration and negotiate in good faith a plan with a successor to determine the nature and extent of phase-in, phase-out services required. The plan shall specify a training program and a date for transferring responsibilities for each division of work described in the plan, and shall be subject to the Contracting Officer’s approval. The Contractor shall provide sufficient experienced personnel during the phase-in, phase-out period to ensure that the services called for by this contract are maintained at the required level of proficiency. Successful Offeror shall provide a detailed contract change over plan that can be utilized upon contract award.

b. This transition period will be designated for the transfer of VA veteran beneficiaries from the incumbent to the successor Contractor. The change shall, at a minimum, include oxygen care and instructions, usage, set up, emergency service, etc. The transition shall be coordinated through the Contracting Officer, and facility COR. Any requirement for an RRT, CRT, or RN visit shall be coordinated between the Contractor and COR. The appropriate VA facility shall provide the successful Contractor(s) with an up to date prescription.

c. The Contractor shall provide the facility COR by 12:00 noon each Friday, during the transition period, a detailed listing of all VA beneficiaries contractor owned equipment who’s Oxygen Service has been changed over from the incumbent to the successor Contractor. The list shall include the exact date of the change for each beneficiary. Along with this list the successor Contractor shall also provide documentation showing that the incumbent Contractor has been notified to pick-up their equipment.

18. Physical Security:

The Contractor shall be responsible for safeguarding all Government equipment, personal patient information, information and property provided for Contractor use.

19. Government Furnished Property:

a. Equipment: The VA shall provide Government owned equipment to the Contractor. The Contractor shall be responsible to keep an adequate inventory of VA equipment in support of this contract and is responsible for all services associated with the support and delivery of equipment to the Veteran. The following equipment shall be issued or authorized by the VA in the performance of this contract, and shall be the property of the VA or be purchased directly from the Contractor:

1) Nebulizers (to include battery powered)

2) Cough Assist Devices

3) Percussive Vests

4) Airvo

5) (CPAP, non-sleep apnea related)

6) Bi-Level (Bi-PAP, non-sleep apnea related)

20. Contractor Furnished Items And Responsibilities:

The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract unless noted otherwise.. All electrically powered equipment used in performance of this contract shall be Underwriters Laboratories (UL) Approved Equipment and in compliance with regulatory standards. The Contractor shall be responsible for scheduling appointments with Patients to initiate set ups and deliveries. Deliveries shall not be left unattended at the patient's home; physical acceptance of deliveries must take place between the Contractor and either the patient or caregiver. If the patient fails to meet two (2) consecutive appointments, the Contractor shall notify (via encrypted email and/or fax) the COR/Representative within 24 hours of the second missed appointment. The COR shall notify (via encrypted email and/or fax) the Contractor of any changes. A valid attempt is calling the veteran or representative for setup/delivery and leaving a message if they do not answer. After three attempts, the Contractor is to notify/alert the COR via fax, encrypted email or Contractor tracking system. At that point, the government can opt to utilize a third party and bill the Contractor. If the Contractor has not documented valid attempts to contact the patient for set ups and or deliveries, the Government reserves the right to call in a third party and bill the Contractor. The Contractor shall not be paid for those services during the billing period if services are not rendered.

At the request of the VA, VA issued CPAP/Bi-Levels shall be set-up by an RRT, CRT, or RN. This service will be performed by the contractor within 72 business hours once the CPAP unit is received by the contractor or patient. Contractor shall call the patient and acknowledge the order and follow-up. Set-up shall include the pressure setting(s), instructions; mask fitting, bleed-in oxygen as prescribed, as well as safety and any other instructions necessary. All education shall be documented with a signature by the patient designated family member. All equipment and supplies other than any oxygen enrichment adapter and pressure (relief) valve necessary for bleed-in oxygen will be provided by the VA. Oxygen enrichment attachments shall be provided by the Contractor (as prescribed for bleed in oxygen).

At the time of setup of nocturnal oxygen for any patient using a pap device, contractor will provide and connect a home oxygen enrichment adapter and pressure valve if necessary per per manufactures guidelines for the use of PAP therapy with bleed-in oxygen. This service may also be requested by the VA for oxygen patients that are put on PAP therapy after the initial setup or for any other reason the VA deems appropriate. Visits that VA requests solely for this purpose will be paid for as a separate visit, however, if the contractor is already making a visit to the patient for another purpose, this service will be provided free of charge. Contractor Shall conduct education and properly document the visit of each CPAP/Bi level.

Contractor-Furnished Equipment: Contractor-furnished equipment shall be maintained per manufacture's specifications. Contractor-owned equipment shall be repaired or replaced at no cost to the Government.

The VA shall not pay for the Contractor's lost or damaged equipment provided under this contract unless circumstances as reviewed by the Contracting Officer are concluded to be the results of willful negligence on behalf of Patients or VA employees. The VA shall not be held liable for normal wear and tear of equipment. The VA shall not pay for rental on equipment used by an unauthorized individual during the performance of this contract or for equipment that is lost. Accordingly, this is considered to be the cost of doing business, and is the requirement of the Contractor to pay for this type of equipment. See Contract Disputes Act 41 USC 602 et al.

a) Materials: The Contractor shall provide the Operation and Service manual to the patient and/or caregiver upon delivering any equipment. The manual shall contain information on operation, maintenance, and troubleshooting for clinicians, users, caregivers and service technicians. Contractor shall provide to the Government, one (1) copy of the Operation and Service manual for each type of equipment with any proposals regarding this contract.

b) Supplies: The Contractor shall be staffed and have sufficient supplies to render satisfactory and courteous service at all times to the patient as listed below. The Contractor shall be responsible for the acts and omissions of their employees. In accordance with the order/consult received from the Government, the Contractor shall provide the patient with the following disposable supplies:

1) Oxygen cannula (including low flow and high flow cannulas, special order cannulas as requested by VA clinician and demand flow cannulas) colored extension tubing. The Contractor shall provide the patient or caregiver with enough supplies to change at a minimum of every two (2) weeks with a supply in reserve at all times until the Contractor’s next scheduled visit.

2) Various interfaces and connectors, swivel adapter, oxygen bleed in adapter, to enhance oxygen delivery, washers, wrenches, oxygen nipple adaptors (Christmas trees), provided as needed.

3) All masks types (when prescribed) for change every two (2) weeks with a 30 day supply in reserve at all times until the Contractor’s next scheduled visit.

4) 25-50 feet of oxygen connecting tubing shall be replaced on a 90 day supply with an equivalent section of tubing in reserve at all times until Contractor’s next scheduled visit.

5) Trachea collar or t-piece adapter and accessories (i.e. tubing, large volume nebulizer, drainage bag, oxygen bleed-in adapter when needed and any other supplies/equipment that is needed to carry out physician orders) allowing for change every three (3) days with a supply in reserve at all times until the Contractors next scheduled visit.

6) Humidifiers (both disposable and reusable) and water traps as ordered by a VA clinician. The number of humidifiers shall be sufficient to insure that they are not depleted between re-supply visits. The number of traps shall be based on the manufacturer’s recommended change rate.

7) Safety holder(s), storage rack(s), and/or an e-cylinder cart shall be provided for all veterans with a prescription for tanks (cylinders) and for use with the back-up system.

8) NO SMOKING OXYGEN IN USE SIGNAGE and one backup. Visible and legible from the street.

9) Valved Fireproof Cannula shall be provided to all oxygen users.

10) The Contractor shall install the Valved Fireproof Cannula devices during contract start-up and during any initial equipment set-ups.

11) The Contractor shall replace the Valved Fireproof Cannula devices annually with prescription renewal.

12) The VA reserves the right to replace disposable supplies issued from Contractor-owned inventory (including but not limited to masks, cannulas, tubing, filters, and nebulizer kits) for, Nebulizers, Suction Machines, Portable Oxygen Concentrator (POC) devices. These items shall be replaced on a one-for-one basis and shipped directly to the Contractor’s local facility. These supplies are separate and should not be confused with the disposable supplies which are included in the Contract Line Item Numbers (CLIN) and are inherent to the rental of the home oxygen systems.

13) Cough Assist Devices

14) Percussive Vests

15) Airvo high flow air generator device

16) SCOOP H2560/H1250 TRANSTRACH OR HOSE and all other necessary supplies

c) Equipment: The Contractor shall provide the following equipment to meet the requirements per the PWS. The following equipment is considered stationary and each unit shall have an attached sticker with a correct vendor name and emergency telephone number. The Contractor shall comply with all applicable Federal & State laws/regulations in support of the contracted requirements. The Contractor shall install and service all equipment and supplies ordered under this contract. All disposable supplies shall be new and unused. A label with the Contractor's name and emergency telephone number, where they can be reached 24 hours/day, shall be affixed to all equipment. Excess delivery: The Government shall not authorize payment on the delivery of excess supplies or equipment; excess deliveries are those provided without prior authorization by the COR.

1) Oxygen Concentrators: The oxygen concentrators shall be Underwriter Laboratory (UL) approved and shall at a minimum meet the following specifications:

a) Alarms for the following failures required: Power Failure, 02 Concentration, and Irregular Pressure and Loss of Flow.

b) The oxygen concentrator shall not perform below the manufacturer's specification, at minimum delivers 93±3% or higher concentration of oxygen at flow rates up to 10 liters per minute (LPM).

c) The oxygen concentrator shall contain an hour meter and oxygen concentration indicator (OCI).

d) Oxygen sensing devices.

e) The oxygen concentrator shall be grounded internally or plug into a three-prong wall outlet appropriate for the patient's home (outlet adaptors are not acceptable).

f) Be double insulated and have 3 prong plugs.

g) Be mounted on wheels for easy movement by patient/caregiver.

h) Shall meet Food and Drug Administration (FDA) Quality Systems Regulations (QSR) standards.

2) Types of Stationary Electrical Oxygen Concentrators:

a) Low-flow Concentrator ( ≤ 5 liter per minute (LPM)):

b) High-flow Concentrator (> 5 liter per minute (LPM)):

c) Low Decibel Concentrator – 40 decibels or less

3) Stationary Oxygen Cylinders: The Contractor shall furnish cylinders in accordance with the Interstate Commerce Commission Regulations. Contractor shall transport cylinders in accordance with the Code of Federal Regulations (CFR) Part 49, U.S. Department of Transportation.

a) Types of cylinders “G”, “H” and “M”.

b) Shall have a safety stand.

c) Regulator flow gauge.

d) Cylinder wrench and consumables.

e) Stationary gas oxygen systems used as backup may only be charged for when backing up VA owned equipment.

4) Liquid Oxygen Reservoir: Standard reservoir holds 110 pounds of liquid oxygen. The standard reservoir weighs 65 pounds full.

a) Reservoir shall have condensation collection tray.

b) Shall have quick release valve for easy refilling.

c) Flow meter range of 0 to 15 LPM.

d) Shall have electrical or mechanical content indicators.

e) Be mounted on wheels for easy movement by patient/caregiver.

5) Combined Stationary and Portable Units: Home Fill Stations: Concentrator base with compatibility for oxygen cylinder refill that allow a patient to fill their own high pressure cylinders from a concentrator. In addition to the requirements for a standard oxygen concentrator:

a) Oxygen Cylinder Refill Stations shall be a minimum of 5 LPM, fill capable of filling A, B, C and D size cylinders with capability for continuous or pulse dose.

b) Oxygen provided shall be United States Pharmacopoeia (U.S.P.) oxygen.

c) Have a minimum four (4) compatible Post Valve Cylinders with or without integrated conserver as required in (various sizes).

d) Gas cylinders have integral flow regulator.

e) Appropriate interlocking fill fitting for custom portable oxygen cylinders.

f) Indicator light when cylinder is full.

g) Audible alarm for compressor failure.

h) Carry bag (backpack, shoulder strap, waist pack) or wheeled cart for cylinders.

i) Oxygen provided shall be U.S.P. Oxygen.

6) Portable Oxygen Concentrator (POC): A concentrator that can be powered via AC or DC. It is similar to a stationary concentrator but is smaller and more mobile.

a) Must be Federal Aviation Administration Approved.

b) Shall be available for delivery within six (6) hours of a request. Also (two) 2 POCs shall be stored locally per location at all times.

c) Minimum continuous flow range of 0.5 LPM to 3 LPM.

d) Minimum pulse dose up to a setting of 6.

e) For travel, battery life must be at least 3 times the length of the Veteran’s flight time each way (if round trip).

f) Have continuous and pulse doses (40 ml or greater) flow option.

7) Portable Oxygen Systems:

a) Oxygen cylinders - The Contractor shall furnish aluminum cylinders 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.

b) Types of Cylinders “B”, “C”, “D”, and “E”.

c) Shall have a safety stand for storage, Safety stands are provided at no additional charge to the Government.

d) Carrying case, shoulder/waist bag, backpack or cart.

e) Regulator flow gauge.

f) Cylinder wrench and consumables.

g) The Contactor shall have available an unlimited supply of cylinders per month for issuance to patients, upon request, as directed by COR or designee and/or individual prescription.

8) Liquid portable systems: The Liquid oxygen system consists of large reservoir and portable unit that is filled from a Liquid Oxygen Reservoir.

a) Shall have carrying case (shoulder/waist bag, backpack or cart) or built in shoulder strap.

b) Easy to read contents gauge/scale.

c) Shall have flow setting of 1-6 for standard units or 1-15 high flow units.

d) Shall have quick release valve for easy refilling.

e) Shall have electrical or mechanical content indicators.

f) May have a built in Demand Valve Regulator (DVR).

9) Oxygen Regulators: Device which regulates gas flow and pressure from a portable oxygen system.

a) Continuous flow regulator - Flow 0-8 LPM or 0-15 LPM based on prescription.

b) Demand Valve Regulator (DVR): A device that limits the oxygen flow to inspiration only and thereby increases the duration of the oxygen supply. The Contractor shall only provide a demand valve regulator upon a special request by the VA. Gas DVR devices shall accommodate up to a setting of 6.

i. Pneumatic powered DVR: Pneumatic units shall appropriately meet the following specifications based on patient needs:

· Single or dual Lumen conserver

· Pulse dose from .25 to 6 or higher.

· Have easy to read content gauge.

· Conservation ratio of 3:1 or higher.

· Have continuous flow setting.

· Weigh less than 30 ounces.

· Notes: Conserving ratios are based on a breathe rate of 20 breaths per minute (BPM).

ii. Battery-Powered DVR: Battery units shall approximately meet the following specifications based on patient needs:

· Pulse dose from .5 to 6 or higher

· Have easy to read content gauge

· Conservation ratio of 3:1 or higher

· Bolus delivered per breath of at least 10cc per setting

· Have continuous flow setting

· Weigh less than 30 ounces

iii. Liquid System Conserving Device (DVR):

· Electronic DVR built into portable unit.

· Minimum flow setting 1 to 4 LPM on pulse (e.g. Helios)

· May also have continuous flow setting up to 6 LPM (e.g. Marathon, Spirit)

· Easy to read contents gauge/scale

· Carrying case, shoulder/waist bag or backpack

10) Ventilator: Used to provide ventilation or ventilation assistance in patients with impaired ventilator drive. The VA Clinical Staff shall decide which ventilator the patient shall be set-up with. Each unit shall have an attached sticker with an up to date vendor name and emergency telephone number. The type of ventilator used shall reflect the patient’s prescription.

a) The Contractor shall provide a back-up ventilator in the home for all patients being ventilated via invasive ventilation.

b) The Contractor shall have back-up ventilator available for exchange within one hour of notification of ventilator failure for all patients being ventilated via non-invasive ventilation.

c) Contractor shall provide a self-inflating resuscitation bag with mask to all patients using a ventilator.

d) All ventilator set ups/follow-ups/education shall be performed by a trained CRT/RRT/RN.

e) All new requests for ventilator set-ups shall be completed within 24 hours, unless otherwise indicated by the VA clinician.

f) The Contractor shall ensure a local CRT/RRT/RN is on-call and available to respond to a patient’s home within one hour of an emergency call.

g) The Contractor shall provide water chamber, large bore heated wire tubing, bacterial filters, sterile water and any other adapters, connectors or interface items necessary for a closed system based on the ventilator in use.

h) The Contractor shall provide the patient or caregiver with enough ventilator consumable supplies to change every seven (7) days with one complete set up in reserve.

i) Contractor shall provide a stand, carry case, and IV Pole for water bag.

j) All ventilator patients and equipment and prescription shall be assessed by CRT/RRT/RN monthly.

k) Ventilator specifications (limited specifications are listed as the VA clinical staff shall determine what unit is to be provided).

l) Units shall be capable of invasive or non-invasive therapy.

m) The Contractor shall provide a 50/60 Hz, 12 Volt DC batteries with up to 3 hours of operations for use in the event of power failure.

11) Cylinders: The Contractor shall furnish aluminum cylinders 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. Safety stands are provided at no additional charge to the Government.

12) Nebulizers: Small volume compressor used for delivery of aerosolized medication.

a) Nebulizer unit shall be provided by the VA to the Contractor or shipped directly to the patient.

b) The Contractor shall be responsible for same day delivery and instruction.

c) The Contractor shall provide one (1) disposable nebulizer kit per month with one (1) in reserve at all times.

13) Suction Machine: Negative pressure device used to assist with airway clearance.

a) Suction unit shall have battery backup.

b) The Contractor shall be responsible for same day delivery and instruction. Education shall be performed by a trained CRT/RRT/RN.

c) The Contractor shall provide the patient or caregiver with a 30 day supply and closed system suction catheter to be changed every 24 hours with one (1) in reserve at all times, 30 day supply.

d) Suction system shall include swivel adapter with Interface port, 7mm connection tubing and suction canister. The Contractor shall provide the patient or caregiver with enough supplies to change suction set up weekly.

e) The Contractor shall provide the patient or caregiver twelve (12) to fourteen (14) French suction catheters for daily used up to four (4) per day.

f) The Contractor shall provide the patient or caregiver with four (4) Yankauer tips per month with one (1) in reserve at all times.

g) The breakdown of the stations using suction machine are as follows:

Contractor Provide Line Item: Cheyenne Government Provided Line Item: Montana, Eastern Oklahoma, Sheridan Contractor and Government Provided Line Item: Grand Junction, Eastern Colorado, Oklahoma, Salt Lake City

14) Heat Moisture Exchange (HME): Used to enhance humidification of inhaled gases by conserving moisture from exhaled gases.

a) The Contractor shall provide the patient or caregiver with enough supplies to change the humidification and moisture exchange device every 24 hours or as needed with two (2) in reserves at all times.

b) The Contractor shall be responsible for setup and education on use of equipment for patient and caregiver. Education shall be performed by a trained CRT/RRT/RN.

15) Resuscitation Bag: If patient has a bypassed or artificial airway one (1) self-inflating resuscitation bag with mask and oxygen tubing shall be provided by the Contractor.

16) Large Volume Nebulizer: Used for aerosolized particle delivery

a) Contractor shall supply large volume compressor, large bore tubing, drainage bags, aerosol bottle with sterile water and patient interface.

b) The Contractor shall provide the patient or caregiver with enough supplies to change every three (3) days with one complete set up in reserve. Education shall be performed by a trained CRT/RRT/RN.

17) High Flow Humidification System: Used for high flow heated molecular humidification.

a) Contractor shall supply the high flow humidification delivery system, heated breathing tube, patient interface and humidification chamber.

b) The Contractor shall provide the patient or caregiver with enough supplies to change every seven (7) days with one (1) complete set up in reserve.

c) The Contractor shall be responsible for setup and education on use of equipment for patient and caregiver. Education shall be performed by a trained CRT/RRT/RN.

18) Cough Assist Device: Used to enhance airway clearance in patients with impaired cough reflex.

a) Equipment shall be provided by the Contractor.

b) Contractor shall supply patient interface, tubing and bacterial filter. The Contractor shall provide the patient or caregiver with enough supplies to change per manufacturer recommendations with one (1) complete set up in reserve.

c) The Contractor shall be responsible for setup and education on use of equipment for patient and caregiver. Education shall be performed by a trained CRT/RRT/RN.

d) The breakdown of the stations using cough assist device are as follows:

Contractor Provide Line Item: Cheyenne Government Provided Line Item: Montana, Eastern Oklahoma Contractor and Government Provided Line Item: Grand Junction, Eastern Colorado, Oklahoma, Salt Lake City

19) Percussive Vest: Used for mobilization of airway secretions.

a) The breakdown of the stations using cough assist device are as follows:

Contractor Provide Line Item: Cheyenne Government Provided Line Item: Eastern Oklahoma, Montana Contractor and Government Provided Line Item: Eastern Colorado, Oklahoma, Salt Lake City

b) Education may be provided Contractor. The Contractor shall be responsible for setup and education when requested by the VA clinician. Education shall be performed by a trained CRT/RRT/RN.

c) Equipment shall be provided by the Contractor

d) Specific size vest will be ordered by the facility (S,M,L,XL)

e) The Contractor shall provide the patient with enough supplies to change per manufacturer recommendations.

20) Air Compressor: A high volume air compressor capable of producing 15 liters of compressed air per minute, supplies shall include trach collar, "T" piece or mask and disposable or reusable type aerosol corrugated home 6 inch tubing, large volume nebulizer with adapter, reservoir for humidification. See prescription regarding if this equipment is either government or contractor furnished.

21) The Airvo: Equipment shall be provided by the Contractor or sent to the veteran directly from ordering facility. Contractor/VA will supply patient interface (optiflow NC, trach adapter, stepdown for a passy muir valve), heated tubing, water chamber. Contractor/VA shall provide the patient or caregiver with enough supplies to change per manufacturer recommendations with one (1) complete set up in reserve.

The Contractor shall be responsible for setup and education on use of equipment for patient and caregiver. Education shall be performed by a trained CRT/RRT/RN.

22) Bi-Level: Provides noninvasive ventilation for patients with respiratory insufficiency.

a. Equipment shall be provided by the Contractor.

b. The Contractor shall be responsible for setup and education on use of equipment for patient. Education shall be performed by a trained CRT/RRT/RN.

c. The breakdown of the stations using bi-pap for non-sleep apnea related issues is as follows: Government Provided Line Item: Montana

23) The Government may from time to time, not furnish some of the above equipment. Contractor shall submit a price for providing any item listed in the schedule regardless of the above list. Additional equipment or supplies may be added throughout the life of the contract.

21. Specific Tasks:

a. Oxygen therapy delivery system including but not limited to home oxygen and home respiratory equipment. Initial setup(s) for home oxygen at the patient’s residence shall be performed by a certified respiratory therapist (CRT), registered respiratory therapist (RRT) or a Registered Nurse (RN), which is licensed in accordance with the governing standards of the location where the services are to be provided.

b. Patient or caregiver education shall be performed on the proper utilization for all issued equipment to include the following:

1. An explanation of the plan for care, treatment and services.

2. Procedures to follow in an event of an emergency.

3. Basic health practices and safety.

4. Infection prevention and control.

5. Basic home safety.

6. Safe and effective use of medical equipment or supplies.

7. Potential hazards and safety considerations related to the equipment.

8. Storage, handling and access to medical gases.

9. Proper equipment usage.

10. Equipment maintenance, function and operation system.

11. Equipment power source: electric, battery, compressor air, oxygen, and UL approved.

12. Proper utilization of oxygen with the prescribed ventilator.

13. Troubleshooting the equipment and system alarms.

14. Equipment and equipment settings that have been prescribed.

15. Emergency Procedures and how to respond to:

i. Power failure

ii. Equipment failure

16. Infection control and patient supply storage:

i. Cleaning or replacement of the oxygen tubing, and humidifier.

ii. Cleaning or replacement of the resuscitation bag and supplies.

iii. Cleaning or replacement of all equipment and accessories.

17. Provide continuing education in use as needed or directed by a licensed and privileged Department of Veteran Affairs Physician.

18. All education material provided by the Contractor shall be…