PERFORMANCE WORK STATEMENT.docx

PERFORMANCE WORK STATEMENT

BIRMINGHAM VA MEDICAL CENTER HOME OXYGEN SERVICES

VISN 07-Station 521-BIRMINGHAM VETERANS AFFAIRS MEDICAL CENTER

1. SCOPE

This Performance Work Statement (PWS) defines the effort required for the setup, installation, and management of Home Oxygen and Ventilation, in accordance with Joint Commission (JC) standards for Homecare, to Veteran beneficiaries serviced by VISN 7-Staion 521-Birmingham Veterans Medical Center (BVAMC). This PWS includes the associated program management, human engineering, and logistic support planning requirements. The use of terms, “beneficiary”, “Veterans”, “Patients”, and “Patient” are used interchangeably and refer to the recipient of required supplies, equipment, and services required under the contract.

1.1 BACKGROUND

The acquisition of Home Oxygen is being initiated to provide Home Oxygen to Veteran beneficiaries serviced by VISN 7 BVAMC. VISN 7 BVAMC does not have the capacity to provide these supplies, so a contract has been sought for the provision of home oxygen and all associated products and services.

1.2 VETERANS SERVED

The Department of Veterans Affairs Medical Center (VAMC) in Birmingham, Alabama currently serves an estimated 850 oxygen-using patients. The volumes or amounts shown in the solicitation are estimates only and impose no obligation to the VA, either minimum or maximum.

1.3 LOCATIONS

The Contractor shall provide Home Oxygen within a defined area of responsibility/jurisdiction to the patients’ residence, or other location as indicated on the order for Home Oxygen. The area of responsibility/jurisdiction for each VA facility includes the counties identified (See below within this section for specific counties covered by the BVAMC) as applicable to the area of responsibility/jurisdiction.

(Birmingham VAMC Alabama catchment area by county) Counties: Autauga, Baldwin, Barbour, Bibb, Blount, Bullock, Butler, Calhoun, Chambers, Cherokee, Chilton, Choctaw, Clarke, Clay, Cleburne, Colbert, Coffee, Conecuh, Coosa, Covington, Crenshaw, Cullman, Dale, Dallas, DeKalb, Dothan, Elmore, Escambia, Etowah, Fayette, Franklin, Geneva, Greene, Hale, Henry, Houston, Lamar, Lee, Lowndes, Macon, Marengo, Marion, Mobile, Monroe, Montgomery, Perry, Pickens, Pike, Jackson, Jefferson, Lamar, Lauderdale, Lawrence, Lee, Limestone, Lowndes, Macon, Madison, Marengo, Marion, Marshall, Montgomery, Morgan, Perry, Pickens, Randolph, Russell, Shelby, St. Clair, Sumter, Talladega, Tallapoosa, Tuscaloosa, Walker, Washington, Wilcox, Winston.

Note: The catchment area is defined by the place of residence for the beneficiary/veteran/patient to whom the BVAMC provides services. Where these services fall outside the above counties, then the contractor is still obligated to coordinate these services to the beneficiary/veteran/patient.

VETERANS AFFAIRS MEDICAL CENTER (VAMC) LOCATED IN BIRMINGHAM, ALABAMA, AND ALL COMMUNITY-BASED OUTPATIENT CENTERS (CBOCS): Contractor shall provide delivery, setup, installation, and management of services/supplies ordered by Home Oxygen to any Patients that are treated at the Birmingham VA Medical Center and all Community-Based Outpatient Centers (CBOC’s) supported therein (Clinic of Jurisdiction/Primary Service Area COJ/PSA), regardless of their physical location. The listing of these counties does not exclude other counties. This includes Patients who reside near bordering states' catchment areas but prefer to be seen at the Birmingham VAMC. Portable cylinders, regulators, regulator keys, and 02 carriers shall be delivered to the BVAMC within one (1) business day of request to accommodate Home Oxygen beneficiaries who are visiting the VA or being discharged and require a tank of oxygen to go home. This shall be provided at no additional charge.

1.4 PORTABLE EQUIPMENT AT VA MEDICAL CENTERS

A stock of twelve (12) portable cylinders, regulators, regulator keys, nasal cannulas, fire safety valves (two (2) per tank), and 02 carriers shall be continuously maintained by the Contractor at the VA Medical Center located in Birmingham, Alabama. These cylinders shall be used only to accommodate Home Oxygen beneficiaries who are visiting the VA or being discharged and require a tank of oxygen to go home. This service shall be provided at no additional cost to the Government. VA shall furnish storage space and maintain all security for this equipment. The contractor shall be permitted access to the space and equipment when requested, by telephone, with 24 hours’ notice to the VA Medical Center’s Respiratory Therapy Department. The contractor shall maintain an updated inventory of all equipment on a quarterly basis.

NOTIFICATION AND DELIVERY

2 ORDERS

Per VHA Directive 1173.13(1) Home Oxygen Program. The prescribing provider is responsible for completing the annual prescription for home oxygen after the need is determined. Only credentialed staff are authorized via VA access controls to access and complete the prescriptions via the prosthetic consult module. The prosthetic consult is the order. Prosthetics and Sensory Aids Service (PSAS). The Contracting Officer Representative (COR) or VA designee shall provide the Contractor with the orders/prosthetic consult, via facsimile, secured email, and/or through a VA-approved portal in addition to phone contact to initiate individual patient service requirements. This shall include the patient’s oxygen prescription (notating any VA-provided equipment), oxygen prescription expiration date, equipment, supplies, and services to be provided including the date and place of delivery. The Contractor shall confirm receipt of the request within two (2) working hours of notification. The contractor shall confirm by facsimile, secure email, and/or documentation in the VA-approved portal to the VA designee/designated staff for all Home Oxygen initiations, plan of care changes, and discharges. The VA designee shall also provide notification of VA-initiated discontinuance of service via facsimile, email, and/or entry in VA approved portal. All changes to patient care shall be confirmed in one of the above mechanisms. The written documents shall include the authorizing official’s signature. The prescription is terminated the day the patient expires.

2.1 NOTIFICATION TO VA REGARDING STATUS OF DELIVERY OF HOME OXYGEN

SERVICES

a. The contractor shall notify the appropriate VA designee and/or COR monthly of the initial delivery of home oxygen equipment by sending copies of individual delivery tickets via encrypted email, secure portal or similar. The delivery ticket shall be signed and dated by the patient or their designated representative. This notification shall be made within two (2) working days. Also the notification shall be made when a patient requires changes in medical equipment or equipment switch-outs.

b. The Contractor shall notify the appropriate VA designee and/or COR by secure email or facsimile within one (1) working day if the expected delivery of medical equipment is not completed. This notification shall include the reason/explanation as to why the delivery was not able to be completed within the 24-hour timeframe; and a plan of action to resolve delivery failure.

c. The Contractor shall notify the appropriate VA designee and/or COR by secure email, facsimile, and/or documentation in VA approved portal within one (1) working day if the patient refuses delivery of medical equipment and/or signs the Contractor’s AMA (American Medical Association) form. A copy of the AMA form signed by the patient shall be included in this notification.

2.2 DELIVERY OF MEDICAL EQUIPMENT

a. The Contractor shall deliver and set up in the patient’s residence all equipment and supplies ordered. This contract is a full-service contract. Set-up shall include the establishment of operational parameters of equipment to VA prescription, ensuring purity of O2, Veteran training on system operations, review of safety checks, and discussion of home safety issues. Services are required to be provided 24 hours a day, seven (7) days a week, including holidays, including all emergency service calls. Contract prices are all-inclusive. The Contractor shall not be reimbursed for costs incurred more than the contract prices in the Schedule of Supplies/Services for services provided in accordance with the Schedule of Supplies/Services.

Patients shall be notified of expected delivery times by the Contractor. Veterans shall be provided with a four (4) hour delivery time window for an expected time of delivery.

b. Deliveries of medical equipment and supplies shall be made in full. If the contractor is unable to fulfill the full prescribed medical equipment and supplies list, they may choose partial delivery. The contractor shall notify the VA Designee and/or COR via secured email or facsimile or entry in VA approved portal within one (1) calendar day in the event of a partial delivery. In such cases where a partial delivery is made, the remainder of the delivery will be made within one (1) calendar day. Payment shall only be issued for full deliveries. The contractor shall maintain sufficient stock (or have it available) to ensure all deliveries can be made within the contractual timeframes. The cost for additional deliveries to complete the order shall be at no additional cost to VA.

c. The Contractor shall deliver portable oxygen equipment to previously established and new patients being discharged to their homes from non-VA Facilities and other facilities as requested by VA Staff per the needs of the Veteran. Equipment shall be delivered within four (4) hours of the request.

2.3 EXCESS DELIVERY

The Contractor shall not deliver supplies and/or equipment more than those prescribed, and the Contractor shall not be paid for any excess deliveries or equipment that is not prescribed.

2.4 NON-SCHEDULED DELIVERIES

The contractor shall provide non-scheduled deliveries in the event the patient requires “an additional” delivery to the routine delivery.

2.5 ORDERING

Per VHA Directive 1173.13(1) Home Oxygen Program. The prescribing provider is responsible for completing the annual prescription for home oxygen after the need is determined. Only credentialed staff are authorized via VA access controls to access and complete the prescriptions via the prosthetic consult module. The prosthetic consult is the order. Prosthetics and Sensory Aids Service (PSAS) and the Contracting Officer’s Representative (COR) or designee shall notify the Contractor via facsimile, email, or VA-approved portal in addition to a phone call to initiate individual patient service requirements. The consult includes the patient’s oxygen prescription, oxygen prescription expiration date, equipment, supplies, and services to be provided including the date and place of delivery. The Contractor shall confirm receipt within two (2) working hours of notification. The Contractor shall confirm by facsimile, secure email, and/or documentation in a VA-approved portal to COR or designee for Home Oxygen and Respiratory Service initiations, plan of care changes, and discharges.

3 SERVICE SPECIFICATIONS

3.1 PRESCRIPTION CHANGES: The Contractor shall not change and/or alter a patient’s oxygen prescription and/or equipment requirements without a new prescription from the patient’s VA physician.

3.2 HOME VISITS

a. The Contractor shall visit patients’ residences for regularly scheduled maintenance visits in performance of this contract by appointment only; between the hours of 7:00 a.m. and 7:00 p.m. Exceptions shall be made in the cases of emergencies.

b. The Contractor is responsible for scheduling the appointments at the patient’s home 24-48 hours prior to the appointment.

c. On each scheduled set-up/delivery the Contractor shall reassess the need to instruct the patient on the use and care of the equipment and supplies as necessary. The Contractor shall perform and document a home safety assessment that will include assessing for fall risk, evidence of smoking around oxygen equipment, working smoke detectors, and posted “No Smoking” signs in addition to all other Joint Commission (JC) requirements for home safety assessments.

d. Contractor shall re-instruct patient, family, and/or caregivers as necessary without formal order from the VA.

e. If patients refuse the home visit, every attempt will be made to see the oxygen patient at least once in a 90-day period. The refusal should be documented as why the patient refused. Contractor will work with the patient to accommodate the patients time and availability.

3.3 CDC COVID 19 PROCEDURES:

Contractor shall abide by all CDC guidelines regarding social distancing, cleaning of equipment and materials, and personal protection equipment. Updated guidelines can be found on the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/community/index.html.”

3.4 INITIAL SET-UPS

a. Initial set-ups are services provided to those patients who have not been provided a VA-authorized oxygen therapy delivery system to their place of residence on a previous occasion or have not used such a system continuously for the past 60 days. Once the initial set-up has been completed, the Contractor shall develop a regular delivery schedule for home oxygen and supplies to patients. All Initial 50 PSI setups shall include all disposables, large bore tubing, large volume nebulizers, drain bags, and masks.

b. Initial set-ups shall be performed 7 days a week and completed within eight (8) hours of request. Failure to deliver within the required time shall result in the VA obtaining oxygen from another source. Any costs in excess of contract pricing for services provided shall be billed to contractor or credited to the next invoice at the discretion of the ordering facility. The Contractor shall notify the appropriate VA designee and/or COR via secured email, facsimile, and/or documentation within one (1) calendar day if expected delivery is not completed. This notification shall include the reason why the delivery was unable to be completed.

c. Switch-outs are services provided to those patients who are presently using an oxygen delivery system or have used such a system continuously within the past 60 days. The Contractor shall provide equipment switch-outs by staff with documented competency training on the manufacturer’s recommended assembly, use, and maintenance of the equipment used under this contract.

d. Switch outs are to be completed within two (2) calendar days. Failure to complete the switch out within the required time shall result in the VA obtaining oxygen from another source. Any costs more than contract pricing for services provided shall be billed to the contractor or credited to the next invoice at the discretion of the ordering facility, COR, and/or designee.

e. Failure to perform the switch-outs as prescribed by VA prescription shall result in no cost to the government. Payment shall be made once switch-outs are completed as prescribed. Payments shall be assessed based on the provider’s established rate and pro-rated from the set-up date. Medical equipment switch-out requested to increase the patient’s quality of life or due to changes in the patient’s oxygen requirement shall be made at no additional charge to the government.

f. Set-up of Home Oxygen includes setting up and ensuring the appropriate oxygen system is operational, instruction and training of patient, and/or caregiver, and home environment safety check. Failure to deliver within the required time shall result in the VA obtaining oxygen from another source. Any costs more than contract pricing for services provided shall be billed to the contractor or credited to the next invoice at the discretion of the ordering facility, COR, and/or designee.

g. The Contractor is responsible for establishing appointments with patients when initiating set-ups, switch-outs, and deliveries within 24 hours of receipt of VA physician order, COR, or designee.

3.5 ASSESSMENT REQUIREMENTS

a. The Contractor shall perform an assessment of the patient’s home and environment in accordance with Joint Commission (JC) accreditation standards for Homecare and maintain documentation of assessments in the individual patient file or folder.

b. The Contractor shall notify the VA designee and/or COR during the 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, or in the case of an initial set-up, not placed in the home.

c. The Contractor shall notify the VA designee and/or COR by telephone or email within two (2) hours if any unsafe conditions are observed in the patient’s home that preclude the installation or continuance of oxygen service. Unsafe conditions shall include fire safety hazards, oxygen safety hazards, patient abuse by family or caregivers, or any instance that places the patient or Contractor’s staff in immediate danger. The Contractor shall provide written documentation of the safety hazard to the VA designee and/or COR within one (1) business day of the incident.

d. The Contractor shall check the adequacy of the electrical outlets in the patient’s home and while still in the patient’s residence, report any unsafe conditions to the VA designee and/or COR during the initial assessment. VA shall not be responsible or liable for any unsafe electrical conditions caused by the Contractor. Any alterations to the patient’s residence shall be the responsibility of the patient. If the ordered equipment cannot be safely installed, the VA designee and/or COR shall provide an alternative oxygen delivery system after the VA physician’s approval until a new prescription can be obtained. If no alternative is available, the prescribing VA physician shall be notified by the VA designee and/or COR.

3.5 PATIENT EDUCATION REQUIREMENTS

a. The Contractor shall provide initial education to each patient at the time of set-up. A Respiratory Therapist will follow-up within 7 days, after initial set-up, to confirm that the patient is properly educated in the operation and use of the equipment and to ensure that the prescribed therapy is being utilized and is adequate. A Respiratory Therapist will conduct Ventilator patient checks on a monthly basis and at the request of the COR or designee. A Respiratory Therapist will conduct one annual check per oxygen patient to reconfirm the prescribed therapy is being utilized and is adequate. The initial set up visit, stated above, will account for said annual check. This information shall be presented verbally, and in demonstration and the material covered shall be in written form to be left with the patient/caregiver. The written material shall be in English as well as the foreign language of the patient, should the patient not speak English. In the case of such an occurrence the Contractor is to advise the VA facility to facilitate adequate instructions. All patient education material must be presented in written form to the VA designee and/or COR for approval prior to distribution to patients. The Contractor shall implement any new or revised education material as directed by the VA designee and/or COR. The VA shall determine whether the Contractor shall use his/her forms or forms supplied by the VA for documentation of services provided to patients. Regardless of whether the VA provides a VA Patient Rights & Responsibilities document and/or forms to the Contractor, and/or the Contractor uses his/her VA Patient Rights & Responsibilities and/or forms, the Contractor is responsible for duplication of the documents/forms when copies are needed to give to patients.

b. Patients shall be provided a copy of VA Patient Rights & Responsibilities, and Advance Directives as appropriate. The Contractor shall document that the patient/caregiver has been instructed in accordance with JC Standards for Homecare.

3.6 DISCONTINUATION OF SERVICE

a. The Government shall notify the Contractor in the event of an order to discontinue oxygen service to any patient covered under this contract as soon as identified (but not earlier than two (2) weeks before expiration). Notification shall be by PKI encrypted email or telephone. At least two (2) weeks before the scheduled termination of the prescription the Contractor shall notify the COR or designee via telephone or PKI e-mail, if removal of home oxygen may be detrimental to the patient. Payment shall be pro-rated based upon the notification date of discontinuance of service. The Contractor shall notify the Government within the next business day of a patient's death, or upon finding a patient has moved out of the service area.

b. The Contractor shall remove equipment from the patient’s residence at the earliest possible time but no later than five (5) business days after notification unless approved by the COR or designee. The date and time of equipment pickup shall be coordinated with the patient and/or next of kin and/or significant other. The Contractor shall make every effort to meet the patient’s or patient’s families’ requests for pickup times. The Contractor shall honor the family’s requests to pick up equipment before or after funerals or family gatherings relative to patient funerals. The Contractor shall treat such requests with the utmost courtesy and give such requests the highest priority. In the event the patient refuses to release the equipment the Contractor shall immediately notify the COR or designee. Billing of services ends at the time of VA-issued notification when the patient deceases, or the prescribed duration of therapy to discontinue the order.

3.7 EMERGENCY SERVICES

a. The Contractor shall provide emergency services on a 24-hour basis, and the contractor shall provide services at the patient’s home no more than four (4) hours after receiving a call. If the Contractor is unable to respond to an emergency service call within four (4) hours, the Contractor shall be responsible for making arrangements with another supplier to provide oxygen, and the Contractor shall be responsible for any excess cost above the contract reimbursed price. A written explanation of why the Contractor was unable to respond to the emergency must be provided to the VA Designee and/or COR within one (1) business day. Time constraints in 3.6(a) do not apply to non-emergency requests.

b. An emergency exists if the VA Designee and/or COR informs the Contractor that he/she considers the situation an emergency, or if the patient states in a telephone call to the Contractor that an emergency exists regarding the function of the home oxygen equipment or use of the equipment. The Contractor shall provide written details of the patient emergency to the VA Designee and/or COR within one (1) business day of notification by the patient. This written report shall contain the time of initial call and time contractor arrived at the patient’s house with any other details requested by the VA COR and/or designee.

c. The Contractor shall maintain a telephone number for emergency purposes so that the VA and patients who have been authorized to receive home oxygen may contact the Contractor outside of normal business hours. The Contractor shall provide the telephone number to all patients and the VA COR and/or designee.

d. The Contractor shall notify the VA designee and/or COR immediately in the event of a disaster, natural or otherwise, that may affect the services covered under this contract.

e. The Contractor shall be prepared to provide services on an emergency basis. Contractor shall provide initial setups and emergency service seven (7) days a week, twenty-four (24) hours a day, this includes holidays. Patient discharges requiring initial setups after 7:00 pm shall be completed that same day.

3.8 SIGNAGE

The Contractor shall provide the patient signs for all entrances into the patient’s residence, stating “Warning Oxygen in Use, No Smoking” or other verbiage that No Smoking is allowed due to oxygen being present and document that the Patient/Caregiver is instructed in the safe use of oxygen and equipment per OSHA regulations. The Contractor shall attach patient education and expectations placards to all concentrators and liquid oxygen stationary systems.

3.9 TRAVELING PATIENTS

a. The Contractor shall be responsible for coordinating all home oxygen for patients who travel both within and outside their respective contracted area of responsibility/jurisdiction, unless otherwise indicated. The VA designee and/or COR shall be responsible for notifying the Contractor where/when the patient is traveling to and the mode of transportation. The Contractor is responsible for coordinating with the patient when travel has been completed.

b. Traveling patients shall be provided with a Federal Aviation Administration (FAA) approved portable concentrator for travel purposes at the request of the VA designee and/or COR. These units shall not be standard for long term use. The VA estimates 30% of patients will travel at some point within each year.

c. Invoices for travel patients within the Contractor’s area of responsibility/ jurisdiction shall be provided to the VA with the next monthly invoice. Should a patient travel outside the Contractor’s area of responsibility/ jurisdiction, a copy of the outside invoice from the area provider, in conjunction with the Contractor’s invoice for those services is required within seven (7) days of patient return from travel destination.

d. Patients traveling within the Contractor’s area of responsibility/jurisdiction shall be provided all home oxygen under the contract at the contract rate. Patients traveling within contracted areas of responsibility/jurisdiction covered under other VA contracts for home oxygen, but not within the Contractor’s area of responsibility/jurisdiction, shall be provided all required oxygen services at whatever contract rate that applies to the area the patient is traveling. The Contractor currently providing home oxygen shall work with the VA designee and/or COR, the Home Oxygen Coordinator, and the Prosthetic Representative to notify and arrange for home oxygen with the contractor whose area the patient is traveling.

e. For patients traveling outside the areas of responsibility/jurisdiction covered by other VA contracts for home oxygen, and/or temporarily relocating, the Contractor shall arrange for home oxygen from an area provider. The Contractor shall obtain pre-approval from the Contracting Officer or designee on pricing if it is above the contract price on the Contractor’s contract. If approved, the Contractor shall be reimbursed the contract rate plus the additional cost incurred for providing appropriate home oxygen.

f. Home oxygen for travel outside of the continental USA (“continental” is defined as lower 48 states), overseas travel, and cruises are the responsibility of the patient.

g. Patients not travelling but are permanently relocating outside of established contracted area of coverage will be provided up to 90 days of continuation of services.

EQUIPMENT SPECIFICATIONS AND ASSOCIATED REQUIREMENTS

4. EQUIPMENT MAINTENANCE

a. At least once every 90 days the Contractor shall visit the patient to reassess equipment compliance, educational needs, and to perform an environmental survey. A written report shall include at a minimum the following data:

1. Name and last four digits of social security number (SSN) of patient using the equipment.

2. Monitor compliance on prescription (Liters Per Minute (LPM), hours per day). Report will reflect hours of all equipment ordered.

3. Type of equipment, hours on concentrator (Serial numbers for the rented equipment shall be the Contractor’s responsibility and kept on file in the Contractor’s main office).

4. Inspection results of liter flow rate in monitoring patient compliance (as compared to prescription).

5. Inspection compliance of intake filters (exchange or clean by the patient); follow-up education and/or reinforcement of compliance documented.

6. Alarms on all equipment must be tested and documented that they are working. If any alarms fail to work or reported by the patient, documentation of what was done to address the issue must be provided to the COR.

7. Revised plan of service as needed.

8. A delivery report shall be developed by the Contractor, signed, and dated by the contract staff and the patient/caregiver and a copy shall be left with the patient. The reports shall be legible and attached to the invoice. All reports shall be submitted to the VA designee and/or COR in alphabetical order, with the monthly invoices by the 10th business day of the month following service. The report must include a patient list and associated scanned delivery/maintenance receipts with the patient’s signatures, patient-signed patient education notes, and clinical notes associated with the plan of care changes. The report shall be submitted by the Contractor in both hard copy and/or share point access provided by the contractor. Format to be approved by VA. Changes to the format shall not constitute a need for a contract modification.

4.1 NECESSARY EQUIPMENT AND SERVICES

a. In accordance with the prescription received from the VA facility, the Contractor shall provide the patient with the following items:

1. Humidifiers and water traps, when the liter flow is equal to or greater than four (4) liters per minute, or if prescribed. The number of humidifiers must be sufficient to ensure that they are not depleted between re-supply visits. The number of traps shall be based on the patient’s flow rate. Humidifiers and water traps are always changed every two weeks with a supply in reserve sufficient to last until the contractor’s next visit.

2. Six (6) disposable oxygen cannulas on hand for a change every two (2) weeks with a supply in reserve always until the Contractor’s next scheduled visit.

3. Six (6) disposable masks for a change/wash every two (2) weeks with a supply in reserve at all times (when masks are prescribed in lieu of nasal cannulas).

4. 25-50 feet of oxygen connecting tubing shall be replaced every 30 days with an equivalent section of tubing in reserve at all times (to be included in the initial setup) until the Contractor’s next scheduled visit.

5. Tracheotomy collar and accessories (e.g., tubing, and large volume nebulizer, drain bag) with a supply on hand allowing for change every three (3) days and a supply of five (5) each in reserve at all times until the Contractor’s next scheduled visit.

6. Safety holders shall be provided at no charge for all patients with a prescription for cylinders.

7. Two (2) oxygen safety valves per source, per patient IAW AL 18-01

a. Contractor shall schedule and perform home visit every 90 days for traditional concentrators and every 30 days traditional concentrators. Every home fill system to be educated and performed equipment inspection and maintenance in accordance with manufacturer’s recommendations.

b. Contractor shall maintain, deliver, and pick-up VA owned equipment

4.2 CONTRACTOR OWNED CONCENTRATORS

a. The Contractor shall furnish, install and service all oxygen equipment to dispense oxygen and supplies ordered under this contract. All equipment shall be the most current model and all supplies are to be new. 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.

b. The concentrators must meet the following standards and guidelines:

· The American Association for Respiratory Care for Respiratory Equipment Used in the Home. http://www.rcjournal.com/cpgs/pdf/08.07.1063.pdf

· Association for the Advancement of Medical Instrumentation (AAMI).

https://my.aami.org/aamiresources/previewfiles/HA6060101011_1508_preview.pdf

· Joint Commission (JC) Standard for Home Care.

http://www.jointcommission.org/accreditation/home_care.aspx

4.3 CYLINDERS

a. 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.

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

4.4 VENTILATORS

This is referring to ventilators that are being utilized “invasively” and not “non-invasively. Invasively means that patients are attached to the equipment via a tracheotomy. Non-invasively means that the patient is using a mask to the patient’s face.

a. Contractor shall track ventilators for preventive maintenance in accordance with the manufacture’s specifications.

b. If there are no manufacturer’s instructions then the VA designee and/or COR & Contractor shall determine the 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 it with another Contractor-owned ventilator.

d. The patient shall always have two (2) ventilators on hand. In cases of a multi-function ventilator being utilized, a standard ventilator, i.e., Trilogy, may be used as a secondary ventilator. The spare ventilator with accessories must always be present in the patient’s home. Those accessories would include, at minimum: ambulation bag (manual resuscitation bag); spare ventilator circuits; adaptors and supplies as needed; and a backup battery.

e. The Contractor shall always keep one (1) or more ventilators in stock for replacement purposes for each patient on a rental ventilator. All related supplies shall be provided by the Contractor.

f. Contractor shall provide the facility 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.

5. Patients may be on continuous or intermittent mechanical ventilation.

6. Contractor responsibility for ventilator usage is as follows:

7. Perform home visits (continuous patients shall be visited monthly and nocturnal/intermittent ventilation patients visited quarterly). This visit is to include a ventilator respiratory assessment by a Registered Respiratory Therapist.

8. Provide documentation of all home visits to the VA Home Oxygen Coordinator or designee within two (2) weeks of visit.

9. Provide thorough education to patient and caregiver in proper ventilator usage, ventilator function and operation including control knobs, power sources, adding oxygen, troubleshooting the ventilator and alarms, the remote alarm, checking tidal volume, ventilator tubing change, talking devices, cleaning of tubing and humidifier, back pressure with Jackson trach tube (if applicable), ventilate with AMBU bag, and supplies. When clinical respiratory services are provided to ventilator patients, education on trach changes, airway care and suctioning shall also be provided.

10. Provide continuing education in ventilator use as needed. All education provided by Contractor’s therapist shall be approved by the VA designee and/or COR upon consultation with Respiratory Care or the Home Oxygen Program Coordinator.

11. Contractor shall assess the home environment for safety and suitability for ventilator use.

12. Verify and document safe and proper use of the ventilator.

13. Contractor cannot adjust the ventilator prescription without an approved VA order. i.e., it cannot be adjusted at patient request.

g. Contractor Registered Respiratory Therapist Responsibilities/Competency shall include the following:

1. Home Ventilator Management and assessment.

2. Competency assessments 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

h. Competency assessment of the contractor’s Registered Respiratory Therapists shall remain the responsibility of the Contractor.

4.5 VENTILATOR EQUIPMENT AND SUPPLIES

Equipment, disposables, and trach care supplies shall be provided to patients receiving home ventilator service as described in Table 1 below. These items are to be provided to ventilator patients only.

Table1:

Ventilator Equipment and Supply Delivery Schedule

60 (monthly) 3ml Unit Dose Saline Bullets

60 (monthly) Trach Drain Sponges

60 (monthly) Basic Tracheostomy Care Kit

1 (monthly) Tracheostomy Tube

30 (monthly) Tracheostomy Disposable Inner Cannula

Options when medically necessary (Should notate on Rx VA-provided equip)

For all non-invasive ventilator patient, i.e. Trilogy or equivalent, the contractor shall provide a monthly compliance downloaded report from the device and send to the VA Chief of Respiratory Therapy.

4.6 CLOSED SUCTION CATHETERS

Contractor shall provide four (4) closed suction catheters to each ventilator patient each month. Patients shall have a replacement catheter each week. Catheters shall be replaced as needed during monthly visit by contractor RT. This item is to be provided to ventilator patients only.

4.7 INLINE HME

The Contractor shall provide an inline heated moisture exchanger (HME) to Veterans receiving invasive mechanical ventilation in order to provide optimal levels of heat and moisture to the patient’s airway. HME’s should not be used in conjunction with a heated humidifier and should mainly be used when the patient is traveling. This item is to be provided to Invasive ventilator patients only.

4.8 HEATED HUMIDIFIER

The Contractor shall provide a heated humidifier to Veterans receiving mechanical ventilation to provide optimal levels of heat and moisture to the patient’s airway. This item is to be provided to all ventilator patients.

4.9 AIR COMPRESSORS

a. Contractor shall provide and maintain 50-PSI compressors to run large volume nebulizers and other various respiratory needs. Setup shall include all disposables large bore tubing, large volume nebulizers, drain bags and masks.

b. All subsequent supplies and disposables for air compressors to include large bore tubing, large volume nebulizers and masks shall be provided by the Contractor and included in the monthly rental price of the unit.

c. Supplies and disposables shall be replaced according to infection control policy of the VAMC.

d. Contractor shall perform equipment maintenance check on 50 psi air compressors in accordance with manufacturer guidelines or every 90 days, whichever comes first, or as determined by COR and Contractor.

4.10 PORTABLE OXYGEN CONCENTRATORS

Portable oxygen concentrators shall include a suitable carrying device, such as a handcart or carrying pouch, to be determined by the size and weight of the portable oxygen concentrator along with the patient’s physical ability. Contractor shall provide portable concentrator to patient within 48 hours of request by VA medical staff. Contractor will submit PMI of each portable concentrator prescribed by the VA in accordance with manufacturers specifications. All supporting peripherals, maintenance, and/or repairs will be provided by the contracted vendor that supports the device.

a. Portable Oxygen Concentrator (Pulse Dose Only) weight </= 6 lbs.

1. Contractor shall provide FAA approved portable concentrators to beneficiaries. Portable concentrators shall be suitable for airline travel and extended and / or multi-destination land travel.

2. Provide 2 batteries, wall and car charger.

3. Deliver portable oxygen concentrator (POC) in accordance with prescription.

4. Should malfunctioning occur during beneficiaries’ travel, Contractor is responsible to make arrangements for replacement portable concentrator at beneficiaries’ place of travel.

b. Portable Oxygen Concentrator System (Continuous up to 2 (LPM) with pulse dose settings) weight </= 10 lbs.

1. Contractor shall provide FAA approved portable concentrators to beneficiaries. Portable concentrators shall be suitable for airline travel and extended and / or multi-destination land travel.

2. Must have pulse dose and continuous flow capabilities.

3. Provide 2 batteries, wall and car charger.

4. Deliver portable oxygen concentrator (POC) in accordance with prescription.

5. Should malfunctioning occur during beneficiaries’ travel, Contractor is responsible to make arrangements for replacement portable concentrator at beneficiaries’ place of travel.

c. Portable Oxygen Concentrator System (Continuous up to 3 (LPM) with Pulse dose settings) weight < or = 25 lbs.

1. Contractor shall provide FAA approved portable concentrators to beneficiaries. Portable concentrators shall be suitable for airline travel and extended and / or multi-destination land travel.

2. Must have pulse dose and continuous flow capabilities.

3. Provide 2 batteries, wall and car charger.

4. Deliver portable oxygen concentrator (POC) in accordance with prescription.

5. Should malfunctioning occur during beneficiaries’ travel, Contractor is responsible to make arrangements for replacement portable concentrator at beneficiaries’ place of travel.

4.11 OXYGEN SAFETY VALVES

a. The Contractor shall furnish bi-directional oxygen safety valves (fire safety valves) to each Veteran on home oxygen. These valves shall remain Contractor-owned and shall be replaced every year. Two (2) each bi-directional oxygen safety valves shall be issued for each Veteran, on stationary units and on all portable oxygen units/equipment, unless there is a documented clinical contraindication (i.e., patients using heated humidity, flow rates that exceed 25 liters per minute, patients with behavioral conditions that make use of oxygen safety valves impractical and/or patients using single lumen or dual lumen conservers.) If oxygen safety valves are not provided due to a clinical contraindication, this must be documented in the patient’s medical record.

1. One (1) bi-directional oxygen safety valve shall be placed between the nasal cannula and oxygen tubing (proximal to the patient)

2. The second bi-directional oxygen safety valve shall be placed between the oxygen source (at the flow meter) and oxygen tubing.

3. 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.

b. Oxygen safety valves act like a fuse to automatically isolate the oxygen supply in case of accidental fire, and potentially:

1. Provides an additional level of protection, buying the patient, caregivers, emergency personnel and others valuable time to evacuate.

2. Prevents the progression to upstream equipment oxygen concentrator, high pressure cylinder or liquid vessel.

3. Lessens the probability that the fire will spread further, minimizing the overall cost of restoration.

a. Veterans with heated humidity shall not be provided with a bi-directional oxygen safety valve, as this is a contraindication indicated by the manufacturer.

b. Veterans shall be instructed to clean exterior surfaces of the bi-directional oxygen safety valves every two (2) weeks with an alcohol or disinfectant wipe.

c. Bi-directional oxygen safety valves shall be provided during a regularly scheduled delivery or equipment maintenance visit. Special visits to deliver oxygen safety valves shall not be made. Broken and/or destroyed Bi-Directional valves, at the fault of the patient, will be replaced and charged to the Government.

d. If patient refuses a bi-directional oxygen safety valve, documentation of refusal, signed by the patient, must be provided to the VA.

e. If contractor is unable to contact patient, notification shall be made to the VA requesting updated contact information. If patient is still unable to be contacted, written documentation of three (3) attempts to contact patient shall be provided to the VA.

f. If the delivery of a bi-directional oxygen safety valve coincides with a patient’s extended winter vacation, notification of this shall be made to the VA in writing. Valves shall be delivered to patient during the first equipment delivery when the patient returns. Follow-up documentation shall be provided to the VA after the valves are delivered.

g. Valves to be used must meet or exceed the below device specifications:

(1) Likely upstream system pressure following activation of the valve; (2) Leak through the valve after activation, (3) Leak from the valve body after activation. Subject to correct installation as per instruction.

4.12 MALE-FEMALE OXYGEN SWIVEL CONNECTOR

a. The Contractor shall furnish a male-female oxygen swivel connector to each Veteran to be used in conjunction with the bi-directional oxygen safety valve, as requested by the Veteran or VA staff.

1. Oxygen swivel adapters shall not be routinely issued like oxygen tubing or filters, but only as requested by the Veteran or VA staff.

2. All requests for oxygen swivel connectors, made by either the Veteran or VA staff must be documented on the patient-signed equipment maintenance sheet or patient-signed delivery sheet.

3. Delivery of swivel connectors shall be completed during a regularly scheduled delivery and/or equipment maintenance appointment. Any deliveries made outside this defined time must have prior approval from the VA designee, and/or COR.

b. The swivel connector is designed to help prevent oxygen tubing from twisting, kinking, or becoming tangled.

c. Two (2) swivel connectors shall be issued for each Veteran who is receiving VA home oxygen and has an oxygen safety valve, as requested. These swivel connectors shall remain Contractor-owned and shall be replaced every - one (1) year and as needed with prior approval from the VA designee and/or COR.

d. Male-female oxygen swivel connectors must meet or exceed the following specifications:

4.13 HOME OXYGEN EQUIPMENT:

a. Installation - The installation of all machines and equipment by the Contractor shall be performed by a competent professional familiar with the nature of the equipment involved and fully qualified under the laws of the State in which the services are being rendered. Installation shall be consistent with local Fire and Safety Codes in the respective area of the State and shall conform to the most current National Fire Protection Association (NFPA) Life Safety Codes and NFPA Oxygen Cylinder Requirements.

The Contractor shall provide a safety/emergency checklist to be completed, then signed by the patient or his/her caregiver and retained in the beneficiary account folder.

b. Maintenance - The Contractor shall ensure that all equipment is inspected at the manufacturer’s recommended intervals. A Contractor’s staff member shall conduct a check of the concentrator using a certified oxygen analyzer that is calibrated according to the manufacturer’s standards. Equipment shall be maintained per the manufacturer’s specifications, and the maintenance shall be completed using the manufacturer’s checklist, which shall include compressor inlet pre-filter changes and compressor inlet bacteria filter changes according to the manufacturer's recommendations. The alarm battery shall be tested at each maintenance check, and changed as indicated, but not less than annually. The Contractor is responsible for tracking and documenting maintenance of equipment in accordance with manufacturer specifications and providing these records for review upon request. The contractor shall furnish parts and labor for routine maintenance at no additional cost to the VA. The Contractor shall have recall procedures for equipment and supplies.

4.14 EQUIPMENT SPECIFICATIONS FOR OXYGEN CONCENTRATORS

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

1. Electrically powered (115 volts).

2. There shall be a battery-operated audible alarm to indicate a power failure.

3. The oxygen concentrator shall not perform below the manufacturer’s specification.

4. Hour meter and OCI indicator.

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

b. All electrically powered equipment used in the performance of this contract shall be UL-approved and shall be the most recently developed in the field at the time of use.

c. Contractor-owned equipment shall be repaired or replaced at no additional cost to the Government when…